Orthopedics

Dislocation of the knee is a severe injury that usually results from high-energy blunt trauma.¹ Recognition of knee dislocations has increased with expansion of the definition beyond radiographically confirmed loss of tibiofemoral articulation to include injury of multiple knee ligaments with multidirectional joint instability, or the rupture of the anterior and posterior cruciate ligaments (ACL, PCL) when no gross dislocation can be identified² (though knee dislocations without rupture of either ligament have been reported^3,4). Knee dislocations account for 0.02% to 0.2% of orthopedic injuries.⁵ These multiligamentous injuries are rare, but their clinical outcomes are often complicated by arthrofibrosis, pain, and instability, as surgeons contend with the competing interests of long-term joint stability and range of motion (ROM).^6-9

Whereas treatment standards for acute knee dislocations are becoming clearer, treatment of subacute and chronic tibiofemoral dislocations and subluxations is less defined.⁵ Success with articulated external fixation originally across the ankle and elbow inspired interest in its use for the knee.^10-12 Richter and Lobenhoffer¹³ and Simonian and colleagues¹⁴ were the first to report on the postoperative use of a hinged external fixation device to help maintain the reduction of chronic fixed posterior knee dislocations. The literature has even supported nonoperative reduction of small fixed anterior or posterior (sagittal) subluxations with knee bracing alone.^15,16 However, there are no reports on treatment of chronic tibial subluxation in the coronal plane.

We report a case of a hinged-knee external fixator (HEF) used alone to reduce a chronic medial tibia subluxation that presented after initial repair of a knee dislocation sustained in a motor vehicle accident. The patient provided written informed consent for print and electronic publication of this case report.

Case Report

A 51-year-old healthy woman who was traveling out of state sustained multiple orthopedic injuries in a motor vehicle accident. She had a pelvic fracture, a contralateral femoral shaft fracture, significant multiligamentous damage to the right knee, and a cavitary impaction fracture of the tibial eminence with resultant coronal tibial subluxation. Initial magnetic resonance imaging (MRI) showed the tibia injury likely was the result of varus translation, as the medial femoral condyle impacted the tibial spine, disrupting the ACL (Figures 1A, 1B).

The patient also had disruption of the posterolateral corner (PLC), including a lateral collateral ligament (LCL) fibular avulsion, an iliotibial band avulsion, and a popliteus myotendinous junction tear with an intact biceps femoris tendon. Three weeks after the accident and after the associated polytrauma injuries were stabilized, the patient underwent “en masse” repair of the PLC, at an outside institution, as described by Shelbourne and colleagues¹⁷ with tibial spine and ACL débridement.

On initial presentation to our clinic 5 weeks after injury, x-rays showed progressive medial subluxation of the tibia in relation to the femur with translation of about a third of the tibial width medially (Figures 2A, 2B).

The central tibial defect nearly apposed the medial femoral condyle, consistent with the initial impaction injury with translation in the coronal rather than anteroposterior plane. Additional MRI and computed tomography were performed to better define the bony and ligamentous anatomy (Figures 3A-3C).

They showed an intact en masse lateral repair, an intact superficial medial collateral ligament, a bucket-handle lateral meniscus tear, and absence of the ACL and tibial eminence.

Given the worsening tibial subluxation and resultant instability, the patient was taken to the operating room for examination under anesthesia, and planned closed reduction and spanning external fixation. Fluoroscopy of the lateral translation and external rotation of the tibia allowed us to reduce the joint, with the lateral tibial plateau and lateral femoral condyle relatively but not completely concentric. A rigid spanning multiplanar external fixator was then placed to maintain the knee joint in a more reduced position.

A week later, the patient was taken back to the operating room for arthroscopic evaluation of the knee joint. At the time of her index operation at the outside institution, she had undergone arthroscopic débridement of intra-articular loose bodies and lateral meniscus repair. Now it was found that the meniscus was not healed but had displaced. A bucket-handle lateral meniscus tear appeared to be blocking lateral translation of the tibia, thus impeding complete reduction.

Given the meniscus deformity that resulted from the chronicity of the injury and the resultant subluxation, a sub-total lateral meniscectomy was performed. As the patient was now noted to have an intact medial collateral ligament and an intact en masse lateral repair, we converted the spanning external fixator to a Compass Universal Hinge (Smith & Nephew) to maintain reduction without further ligamentous reconstruction (Figure 4).

As we were able to maintain reduction, we thought bone grafting for stability augmentation was not needed, despite the central tibial defect (analogous to an engaging Hill-Sachs defect in shoulder instability). The HEF allowed knee flexion while maintaining coronal alignment.

After HEF placement, the patient spent a short time recovering at an inpatient rehabilitation facility before starting aggressive twice-a-week outpatient physical therapy. Initially after HEF placement, she could not actively flex the knee to about 40° or fully extend it concentrically. Given these limitations and concern about interval development of arthrofibrosis, manipulation under anesthesia was performed, 3 weeks after surgery, and 90° of flexion was obtained.

When the HEF was removed, 6 weeks after placement, fluoroscopy and radiographs showed maintained tibiofemoral alignment (Figures 5A, 5B).

Six weeks after HEF removal, the patient was ambulating well with a cane, pain was minimal, and knee ROM was up to 110° of flexion. Tibiofemoral stability remained constant—no change in medial or lateral joint space opening. Full-extension radiographs showed medial translation of about 5 mm, which decreased to 1 mm on Rosenberg view. This represents marked improvement over the severe subluxation on initial presentation.

Follow-up over the next months revealed continued improvement in the right lower extremity strength, increased tolerance for physical activity, and stable right medial tibial translation.

A year after HEF removal, imaging showed adequate tibiofemoral alignment (Figures 6A-6C). There was mild to moderate joint space narrowing, lateral more than medial.

At 5-year follow-up, the patient was asymptomatic, had continued coronal and sagittal stability, and was tolerating regular aerobic exercise, including hiking, weight training, and cycling. Physical examination revealed grade 1B Lachman, grade 0 pivot shift, and grade 0 posterior drawer. There was 3 mm increased lateral compartment opening in full extension, which increased to about 6 mm at 30° with endpoint.

Radiographs (Figures 7A-7C) showed stable 2-mm coronal translation and asymptomatic though severe lateral compartment arthritis, likely secondary to the multiligament knee injury and the sub–total lateral meniscectomy performed on top of previous lateral compartment arthritis. Final International Knee Documentation Committee (IKDC) score was 78.2, final Tegner Lysholm Knee Score was 94 (“excellent”), Modified Cincinnati Rating System score was 80 (“excellent”), and Knee Injury and Osteoarthritis Outcome Score was 87.5.

 

Discussion

Although knee dislocations with multiligamentous involvement are rare, their outcomes can be poor. Fortunately, the principles of managing these complex injuries in the acute stage are becoming clearer. In a systematic review, Levy and colleagues¹⁸ found that operative treatment of a dislocated knee within 3 weeks after injury, compared with nonoperative or delayed treatment, resulted in improved functional outcomes. Ligament repair and reconstruction yielded similar outcomes, though repair of the posterolateral corner had a comparatively higher rate of failure. For associated lateral injuries, Shelbourne and colleagues¹⁷ advocated en masse repair in which the healing tissue complex is reattached to the tibia nonanatomically, without dissecting individual structures—a technique used in the original repair of our patient’s injuries.

Originally designed for other joints, hinged external fixators are now occasionally used for rehabilitation after traumatic knee injury. Stannard and colleagues⁹ recently confirmed the utility of the HEF as a supplement to ligament reconstruction for recovery from acute knee dislocation.⁹ Compared with postoperative use of a hinged-knee brace, HEF use resulted in fewer failed ligament reconstructions as well as equivalent joint ROM and Lysholm and IKDC scores at final follow-up. This clinical outcome is supported by results of kinematic studies of these hinged devices, which are capable of rigid fixation in all planes except sagittal and can reduce stress on intra-articular and periarticular ligaments when placed on the appropriate flexion-extension axis of the knee.^19,20Unfortunately, the situation is more complicated for subacute or chronic tibial subluxation than for acute subluxation. Maak and colleagues¹⁶ described 3 operative steps that are crucial in obtaining desired outcomes in this setting: complete release of scar tissue, re-creation of knee axis through ACL and PCL reconstruction, and postoperative application of a HEF or knee brace. These recommendations mimic the management course described by Richter and Lobenhoffer¹³ and Simonian and colleagues,¹⁴ who treated chronic fixed posterior tibial subluxations with arthrolysis, ligament reconstruction, and use of HEFs for 6 weeks, supporting postoperative rehabilitation. All cases maintained reduction at follow-up after fixator removal.

It is also possible for small fixed anterior or posterior tibial subluxations to be managed nonoperatively. Strobel and colleagues¹⁵ described a series of 109 patients with fixed posterior subluxations treated at night with posterior tibial support braces. Mean subluxation was reduced from 6.93 mm to 2.58 mm after an average treatment period of 180 days. Although 60% of all subluxations were completely reduced, reductions were significantly more successful for those displaced <10 mm.

Management of subacute or chronic fixed coronal tibial subluxations is yet to be described. In this article, we have reported on acceptable reduction of a subacute medial tibial subluxation with use of a HEF for 6 weeks after arthroscopic débridement of a deformed subacute bucket-handle lateral meniscus tear. Our case report is unique in that it describes use of a HEF alone for the reduction of a subacute tibial subluxation in any plane without the need for more extensive ligament reconstruction.

The injury here was primarily a lateral ligamentous injury. In the nonanatomical repair that was performed, the LCL and the iliotibial band were reattached to the proximal-lateral tibia. Had we started treating this injury from the time of the patient’s accident, then, depending on repair integrity, we might have considered acute augmentation of the anatomical repair of LCL with Larson-type reconstruction of the LCL and the popliteofibular ligament. Alternatively, acute reconstruction of the LCL and popliteus would be considered if the lateral structures were either irreparable or of very poor quality. In addition, had we initially seen the coronal instability/translation, we might have acutely considered either a staged procedure of a multiplanar external fixator or a HEF.

Given the narrowed lateral joint space, the débridement of the lateral meniscus, and the risk of developing posttraumatic arthritis, our patient will probably need total knee arthroplasty (TKA) at some point. We informed her that she had advanced lateral compartment joint space narrowing and arthritic progression and that she would eventually need TKA based on pain or dysfunction. We think the longevity of that TKA will be predictable and good, as she now had improved tibiofemoral alignment and stability of the collateral ligamentous structures. If she had been allowed to maintain the coronally subluxed position, it would have led to medial ligamentous attenuation and would have compromised the success and longevity of the TKA. In essence, a crucial part of the utility of the HEF was improved coronal tibiofemoral alignment and, therefore, decreased abnormal forces on both the repaired lateral ligaments and the native medial ligamentous structures. Although temporary external fixation issues related to infection risk and patient discomfort are recognized,^21-23 use of HEF alone can be part of the treatment considerations for fixed tibial subluxations in any plane when they present after treatment for multiligamentous injury.

Am J Orthop. 2016;45(7):E497-E502. Copyright Frontline Medical Communications Inc. 2016. All rights reserved.

Dislocation of the knee is a severe injury that usually results from high-energy blunt trauma.¹ Recognition of knee dislocations has increased with expansion of the definition beyond radiographically confirmed loss of tibiofemoral articulation to include injury of multiple knee ligaments with multidirectional joint instability, or the rupture of the anterior and posterior cruciate ligaments (ACL, PCL) when no gross dislocation can be identified² (though knee dislocations without rupture of either ligament have been reported^3,4). Knee dislocations account for 0.02% to 0.2% of orthopedic injuries.⁵ These multiligamentous injuries are rare, but their clinical outcomes are often complicated by arthrofibrosis, pain, and instability, as surgeons contend with the competing interests of long-term joint stability and range of motion (ROM).^6-9

Whereas treatment standards for acute knee dislocations are becoming clearer, treatment of subacute and chronic tibiofemoral dislocations and subluxations is less defined.⁵ Success with articulated external fixation originally across the ankle and elbow inspired interest in its use for the knee.^10-12 Richter and Lobenhoffer¹³ and Simonian and colleagues¹⁴ were the first to report on the postoperative use of a hinged external fixation device to help maintain the reduction of chronic fixed posterior knee dislocations. The literature has even supported nonoperative reduction of small fixed anterior or posterior (sagittal) subluxations with knee bracing alone.^15,16 However, there are no reports on treatment of chronic tibial subluxation in the coronal plane.

We report a case of a hinged-knee external fixator (HEF) used alone to reduce a chronic medial tibia subluxation that presented after initial repair of a knee dislocation sustained in a motor vehicle accident. The patient provided written informed consent for print and electronic publication of this case report.

Case Report

A 51-year-old healthy woman who was traveling out of state sustained multiple orthopedic injuries in a motor vehicle accident. She had a pelvic fracture, a contralateral femoral shaft fracture, significant multiligamentous damage to the right knee, and a cavitary impaction fracture of the tibial eminence with resultant coronal tibial subluxation. Initial magnetic resonance imaging (MRI) showed the tibia injury likely was the result of varus translation, as the medial femoral condyle impacted the tibial spine, disrupting the ACL (Figures 1A, 1B).

The patient also had disruption of the posterolateral corner (PLC), including a lateral collateral ligament (LCL) fibular avulsion, an iliotibial band avulsion, and a popliteus myotendinous junction tear with an intact biceps femoris tendon. Three weeks after the accident and after the associated polytrauma injuries were stabilized, the patient underwent “en masse” repair of the PLC, at an outside institution, as described by Shelbourne and colleagues¹⁷ with tibial spine and ACL débridement.

On initial presentation to our clinic 5 weeks after injury, x-rays showed progressive medial subluxation of the tibia in relation to the femur with translation of about a third of the tibial width medially (Figures 2A, 2B).

The central tibial defect nearly apposed the medial femoral condyle, consistent with the initial impaction injury with translation in the coronal rather than anteroposterior plane. Additional MRI and computed tomography were performed to better define the bony and ligamentous anatomy (Figures 3A-3C).

They showed an intact en masse lateral repair, an intact superficial medial collateral ligament, a bucket-handle lateral meniscus tear, and absence of the ACL and tibial eminence.

Given the worsening tibial subluxation and resultant instability, the patient was taken to the operating room for examination under anesthesia, and planned closed reduction and spanning external fixation. Fluoroscopy of the lateral translation and external rotation of the tibia allowed us to reduce the joint, with the lateral tibial plateau and lateral femoral condyle relatively but not completely concentric. A rigid spanning multiplanar external fixator was then placed to maintain the knee joint in a more reduced position.

A week later, the patient was taken back to the operating room for arthroscopic evaluation of the knee joint. At the time of her index operation at the outside institution, she had undergone arthroscopic débridement of intra-articular loose bodies and lateral meniscus repair. Now it was found that the meniscus was not healed but had displaced. A bucket-handle lateral meniscus tear appeared to be blocking lateral translation of the tibia, thus impeding complete reduction.

Given the meniscus deformity that resulted from the chronicity of the injury and the resultant subluxation, a sub-total lateral meniscectomy was performed. As the patient was now noted to have an intact medial collateral ligament and an intact en masse lateral repair, we converted the spanning external fixator to a Compass Universal Hinge (Smith & Nephew) to maintain reduction without further ligamentous reconstruction (Figure 4).

As we were able to maintain reduction, we thought bone grafting for stability augmentation was not needed, despite the central tibial defect (analogous to an engaging Hill-Sachs defect in shoulder instability). The HEF allowed knee flexion while maintaining coronal alignment.

After HEF placement, the patient spent a short time recovering at an inpatient rehabilitation facility before starting aggressive twice-a-week outpatient physical therapy. Initially after HEF placement, she could not actively flex the knee to about 40° or fully extend it concentrically. Given these limitations and concern about interval development of arthrofibrosis, manipulation under anesthesia was performed, 3 weeks after surgery, and 90° of flexion was obtained.

When the HEF was removed, 6 weeks after placement, fluoroscopy and radiographs showed maintained tibiofemoral alignment (Figures 5A, 5B).

Six weeks after HEF removal, the patient was ambulating well with a cane, pain was minimal, and knee ROM was up to 110° of flexion. Tibiofemoral stability remained constant—no change in medial or lateral joint space opening. Full-extension radiographs showed medial translation of about 5 mm, which decreased to 1 mm on Rosenberg view. This represents marked improvement over the severe subluxation on initial presentation.

Follow-up over the next months revealed continued improvement in the right lower extremity strength, increased tolerance for physical activity, and stable right medial tibial translation.

A year after HEF removal, imaging showed adequate tibiofemoral alignment (Figures 6A-6C). There was mild to moderate joint space narrowing, lateral more than medial.

At 5-year follow-up, the patient was asymptomatic, had continued coronal and sagittal stability, and was tolerating regular aerobic exercise, including hiking, weight training, and cycling. Physical examination revealed grade 1B Lachman, grade 0 pivot shift, and grade 0 posterior drawer. There was 3 mm increased lateral compartment opening in full extension, which increased to about 6 mm at 30° with endpoint.

Radiographs (Figures 7A-7C) showed stable 2-mm coronal translation and asymptomatic though severe lateral compartment arthritis, likely secondary to the multiligament knee injury and the sub–total lateral meniscectomy performed on top of previous lateral compartment arthritis. Final International Knee Documentation Committee (IKDC) score was 78.2, final Tegner Lysholm Knee Score was 94 (“excellent”), Modified Cincinnati Rating System score was 80 (“excellent”), and Knee Injury and Osteoarthritis Outcome Score was 87.5.

 

Discussion

Although knee dislocations with multiligamentous involvement are rare, their outcomes can be poor. Fortunately, the principles of managing these complex injuries in the acute stage are becoming clearer. In a systematic review, Levy and colleagues¹⁸ found that operative treatment of a dislocated knee within 3 weeks after injury, compared with nonoperative or delayed treatment, resulted in improved functional outcomes. Ligament repair and reconstruction yielded similar outcomes, though repair of the posterolateral corner had a comparatively higher rate of failure. For associated lateral injuries, Shelbourne and colleagues¹⁷ advocated en masse repair in which the healing tissue complex is reattached to the tibia nonanatomically, without dissecting individual structures—a technique used in the original repair of our patient’s injuries.

Originally designed for other joints, hinged external fixators are now occasionally used for rehabilitation after traumatic knee injury. Stannard and colleagues⁹ recently confirmed the utility of the HEF as a supplement to ligament reconstruction for recovery from acute knee dislocation.⁹ Compared with postoperative use of a hinged-knee brace, HEF use resulted in fewer failed ligament reconstructions as well as equivalent joint ROM and Lysholm and IKDC scores at final follow-up. This clinical outcome is supported by results of kinematic studies of these hinged devices, which are capable of rigid fixation in all planes except sagittal and can reduce stress on intra-articular and periarticular ligaments when placed on the appropriate flexion-extension axis of the knee.^19,20Unfortunately, the situation is more complicated for subacute or chronic tibial subluxation than for acute subluxation. Maak and colleagues¹⁶ described 3 operative steps that are crucial in obtaining desired outcomes in this setting: complete release of scar tissue, re-creation of knee axis through ACL and PCL reconstruction, and postoperative application of a HEF or knee brace. These recommendations mimic the management course described by Richter and Lobenhoffer¹³ and Simonian and colleagues,¹⁴ who treated chronic fixed posterior tibial subluxations with arthrolysis, ligament reconstruction, and use of HEFs for 6 weeks, supporting postoperative rehabilitation. All cases maintained reduction at follow-up after fixator removal.

It is also possible for small fixed anterior or posterior tibial subluxations to be managed nonoperatively. Strobel and colleagues¹⁵ described a series of 109 patients with fixed posterior subluxations treated at night with posterior tibial support braces. Mean subluxation was reduced from 6.93 mm to 2.58 mm after an average treatment period of 180 days. Although 60% of all subluxations were completely reduced, reductions were significantly more successful for those displaced <10 mm.

Management of subacute or chronic fixed coronal tibial subluxations is yet to be described. In this article, we have reported on acceptable reduction of a subacute medial tibial subluxation with use of a HEF for 6 weeks after arthroscopic débridement of a deformed subacute bucket-handle lateral meniscus tear. Our case report is unique in that it describes use of a HEF alone for the reduction of a subacute tibial subluxation in any plane without the need for more extensive ligament reconstruction.

The injury here was primarily a lateral ligamentous injury. In the nonanatomical repair that was performed, the LCL and the iliotibial band were reattached to the proximal-lateral tibia. Had we started treating this injury from the time of the patient’s accident, then, depending on repair integrity, we might have considered acute augmentation of the anatomical repair of LCL with Larson-type reconstruction of the LCL and the popliteofibular ligament. Alternatively, acute reconstruction of the LCL and popliteus would be considered if the lateral structures were either irreparable or of very poor quality. In addition, had we initially seen the coronal instability/translation, we might have acutely considered either a staged procedure of a multiplanar external fixator or a HEF.

Given the narrowed lateral joint space, the débridement of the lateral meniscus, and the risk of developing posttraumatic arthritis, our patient will probably need total knee arthroplasty (TKA) at some point. We informed her that she had advanced lateral compartment joint space narrowing and arthritic progression and that she would eventually need TKA based on pain or dysfunction. We think the longevity of that TKA will be predictable and good, as she now had improved tibiofemoral alignment and stability of the collateral ligamentous structures. If she had been allowed to maintain the coronally subluxed position, it would have led to medial ligamentous attenuation and would have compromised the success and longevity of the TKA. In essence, a crucial part of the utility of the HEF was improved coronal tibiofemoral alignment and, therefore, decreased abnormal forces on both the repaired lateral ligaments and the native medial ligamentous structures. Although temporary external fixation issues related to infection risk and patient discomfort are recognized,^21-23 use of HEF alone can be part of the treatment considerations for fixed tibial subluxations in any plane when they present after treatment for multiligamentous injury.

Am J Orthop. 2016;45(7):E497-E502. Copyright Frontline Medical Communications Inc. 2016. All rights reserved.

Dislocation of the knee is a severe injury that usually results from high-energy blunt trauma.¹ Recognition of knee dislocations has increased with expansion of the definition beyond radiographically confirmed loss of tibiofemoral articulation to include injury of multiple knee ligaments with multidirectional joint instability, or the rupture of the anterior and posterior cruciate ligaments (ACL, PCL) when no gross dislocation can be identified² (though knee dislocations without rupture of either ligament have been reported^3,4). Knee dislocations account for 0.02% to 0.2% of orthopedic injuries.⁵ These multiligamentous injuries are rare, but their clinical outcomes are often complicated by arthrofibrosis, pain, and instability, as surgeons contend with the competing interests of long-term joint stability and range of motion (ROM).^6-9

Whereas treatment standards for acute knee dislocations are becoming clearer, treatment of subacute and chronic tibiofemoral dislocations and subluxations is less defined.⁵ Success with articulated external fixation originally across the ankle and elbow inspired interest in its use for the knee.^10-12 Richter and Lobenhoffer¹³ and Simonian and colleagues¹⁴ were the first to report on the postoperative use of a hinged external fixation device to help maintain the reduction of chronic fixed posterior knee dislocations. The literature has even supported nonoperative reduction of small fixed anterior or posterior (sagittal) subluxations with knee bracing alone.^15,16 However, there are no reports on treatment of chronic tibial subluxation in the coronal plane.

We report a case of a hinged-knee external fixator (HEF) used alone to reduce a chronic medial tibia subluxation that presented after initial repair of a knee dislocation sustained in a motor vehicle accident. The patient provided written informed consent for print and electronic publication of this case report.

Case Report

A 51-year-old healthy woman who was traveling out of state sustained multiple orthopedic injuries in a motor vehicle accident. She had a pelvic fracture, a contralateral femoral shaft fracture, significant multiligamentous damage to the right knee, and a cavitary impaction fracture of the tibial eminence with resultant coronal tibial subluxation. Initial magnetic resonance imaging (MRI) showed the tibia injury likely was the result of varus translation, as the medial femoral condyle impacted the tibial spine, disrupting the ACL (Figures 1A, 1B).

The patient also had disruption of the posterolateral corner (PLC), including a lateral collateral ligament (LCL) fibular avulsion, an iliotibial band avulsion, and a popliteus myotendinous junction tear with an intact biceps femoris tendon. Three weeks after the accident and after the associated polytrauma injuries were stabilized, the patient underwent “en masse” repair of the PLC, at an outside institution, as described by Shelbourne and colleagues¹⁷ with tibial spine and ACL débridement.

On initial presentation to our clinic 5 weeks after injury, x-rays showed progressive medial subluxation of the tibia in relation to the femur with translation of about a third of the tibial width medially (Figures 2A, 2B).

The central tibial defect nearly apposed the medial femoral condyle, consistent with the initial impaction injury with translation in the coronal rather than anteroposterior plane. Additional MRI and computed tomography were performed to better define the bony and ligamentous anatomy (Figures 3A-3C).

They showed an intact en masse lateral repair, an intact superficial medial collateral ligament, a bucket-handle lateral meniscus tear, and absence of the ACL and tibial eminence.

Given the worsening tibial subluxation and resultant instability, the patient was taken to the operating room for examination under anesthesia, and planned closed reduction and spanning external fixation. Fluoroscopy of the lateral translation and external rotation of the tibia allowed us to reduce the joint, with the lateral tibial plateau and lateral femoral condyle relatively but not completely concentric. A rigid spanning multiplanar external fixator was then placed to maintain the knee joint in a more reduced position.

A week later, the patient was taken back to the operating room for arthroscopic evaluation of the knee joint. At the time of her index operation at the outside institution, she had undergone arthroscopic débridement of intra-articular loose bodies and lateral meniscus repair. Now it was found that the meniscus was not healed but had displaced. A bucket-handle lateral meniscus tear appeared to be blocking lateral translation of the tibia, thus impeding complete reduction.

Given the meniscus deformity that resulted from the chronicity of the injury and the resultant subluxation, a sub-total lateral meniscectomy was performed. As the patient was now noted to have an intact medial collateral ligament and an intact en masse lateral repair, we converted the spanning external fixator to a Compass Universal Hinge (Smith & Nephew) to maintain reduction without further ligamentous reconstruction (Figure 4).

As we were able to maintain reduction, we thought bone grafting for stability augmentation was not needed, despite the central tibial defect (analogous to an engaging Hill-Sachs defect in shoulder instability). The HEF allowed knee flexion while maintaining coronal alignment.

After HEF placement, the patient spent a short time recovering at an inpatient rehabilitation facility before starting aggressive twice-a-week outpatient physical therapy. Initially after HEF placement, she could not actively flex the knee to about 40° or fully extend it concentrically. Given these limitations and concern about interval development of arthrofibrosis, manipulation under anesthesia was performed, 3 weeks after surgery, and 90° of flexion was obtained.

When the HEF was removed, 6 weeks after placement, fluoroscopy and radiographs showed maintained tibiofemoral alignment (Figures 5A, 5B).

Six weeks after HEF removal, the patient was ambulating well with a cane, pain was minimal, and knee ROM was up to 110° of flexion. Tibiofemoral stability remained constant—no change in medial or lateral joint space opening. Full-extension radiographs showed medial translation of about 5 mm, which decreased to 1 mm on Rosenberg view. This represents marked improvement over the severe subluxation on initial presentation.

Follow-up over the next months revealed continued improvement in the right lower extremity strength, increased tolerance for physical activity, and stable right medial tibial translation.

A year after HEF removal, imaging showed adequate tibiofemoral alignment (Figures 6A-6C). There was mild to moderate joint space narrowing, lateral more than medial.

At 5-year follow-up, the patient was asymptomatic, had continued coronal and sagittal stability, and was tolerating regular aerobic exercise, including hiking, weight training, and cycling. Physical examination revealed grade 1B Lachman, grade 0 pivot shift, and grade 0 posterior drawer. There was 3 mm increased lateral compartment opening in full extension, which increased to about 6 mm at 30° with endpoint.

Radiographs (Figures 7A-7C) showed stable 2-mm coronal translation and asymptomatic though severe lateral compartment arthritis, likely secondary to the multiligament knee injury and the sub–total lateral meniscectomy performed on top of previous lateral compartment arthritis. Final International Knee Documentation Committee (IKDC) score was 78.2, final Tegner Lysholm Knee Score was 94 (“excellent”), Modified Cincinnati Rating System score was 80 (“excellent”), and Knee Injury and Osteoarthritis Outcome Score was 87.5.

 

Discussion

Although knee dislocations with multiligamentous involvement are rare, their outcomes can be poor. Fortunately, the principles of managing these complex injuries in the acute stage are becoming clearer. In a systematic review, Levy and colleagues¹⁸ found that operative treatment of a dislocated knee within 3 weeks after injury, compared with nonoperative or delayed treatment, resulted in improved functional outcomes. Ligament repair and reconstruction yielded similar outcomes, though repair of the posterolateral corner had a comparatively higher rate of failure. For associated lateral injuries, Shelbourne and colleagues¹⁷ advocated en masse repair in which the healing tissue complex is reattached to the tibia nonanatomically, without dissecting individual structures—a technique used in the original repair of our patient’s injuries.

Originally designed for other joints, hinged external fixators are now occasionally used for rehabilitation after traumatic knee injury. Stannard and colleagues⁹ recently confirmed the utility of the HEF as a supplement to ligament reconstruction for recovery from acute knee dislocation.⁹ Compared with postoperative use of a hinged-knee brace, HEF use resulted in fewer failed ligament reconstructions as well as equivalent joint ROM and Lysholm and IKDC scores at final follow-up. This clinical outcome is supported by results of kinematic studies of these hinged devices, which are capable of rigid fixation in all planes except sagittal and can reduce stress on intra-articular and periarticular ligaments when placed on the appropriate flexion-extension axis of the knee.^19,20Unfortunately, the situation is more complicated for subacute or chronic tibial subluxation than for acute subluxation. Maak and colleagues¹⁶ described 3 operative steps that are crucial in obtaining desired outcomes in this setting: complete release of scar tissue, re-creation of knee axis through ACL and PCL reconstruction, and postoperative application of a HEF or knee brace. These recommendations mimic the management course described by Richter and Lobenhoffer¹³ and Simonian and colleagues,¹⁴ who treated chronic fixed posterior tibial subluxations with arthrolysis, ligament reconstruction, and use of HEFs for 6 weeks, supporting postoperative rehabilitation. All cases maintained reduction at follow-up after fixator removal.

It is also possible for small fixed anterior or posterior tibial subluxations to be managed nonoperatively. Strobel and colleagues¹⁵ described a series of 109 patients with fixed posterior subluxations treated at night with posterior tibial support braces. Mean subluxation was reduced from 6.93 mm to 2.58 mm after an average treatment period of 180 days. Although 60% of all subluxations were completely reduced, reductions were significantly more successful for those displaced <10 mm.

Management of subacute or chronic fixed coronal tibial subluxations is yet to be described. In this article, we have reported on acceptable reduction of a subacute medial tibial subluxation with use of a HEF for 6 weeks after arthroscopic débridement of a deformed subacute bucket-handle lateral meniscus tear. Our case report is unique in that it describes use of a HEF alone for the reduction of a subacute tibial subluxation in any plane without the need for more extensive ligament reconstruction.

The injury here was primarily a lateral ligamentous injury. In the nonanatomical repair that was performed, the LCL and the iliotibial band were reattached to the proximal-lateral tibia. Had we started treating this injury from the time of the patient’s accident, then, depending on repair integrity, we might have considered acute augmentation of the anatomical repair of LCL with Larson-type reconstruction of the LCL and the popliteofibular ligament. Alternatively, acute reconstruction of the LCL and popliteus would be considered if the lateral structures were either irreparable or of very poor quality. In addition, had we initially seen the coronal instability/translation, we might have acutely considered either a staged procedure of a multiplanar external fixator or a HEF.

Given the narrowed lateral joint space, the débridement of the lateral meniscus, and the risk of developing posttraumatic arthritis, our patient will probably need total knee arthroplasty (TKA) at some point. We informed her that she had advanced lateral compartment joint space narrowing and arthritic progression and that she would eventually need TKA based on pain or dysfunction. We think the longevity of that TKA will be predictable and good, as she now had improved tibiofemoral alignment and stability of the collateral ligamentous structures. If she had been allowed to maintain the coronally subluxed position, it would have led to medial ligamentous attenuation and would have compromised the success and longevity of the TKA. In essence, a crucial part of the utility of the HEF was improved coronal tibiofemoral alignment and, therefore, decreased abnormal forces on both the repaired lateral ligaments and the native medial ligamentous structures. Although temporary external fixation issues related to infection risk and patient discomfort are recognized,^21-23 use of HEF alone can be part of the treatment considerations for fixed tibial subluxations in any plane when they present after treatment for multiligamentous injury.

Am J Orthop. 2016;45(7):E497-E502. Copyright Frontline Medical Communications Inc. 2016. All rights reserved.

The role of vitamin D in general health maintenance is a topic of increasing interest and importance in the medical community. Not only has vitamin D deficiency been linked to a myriad of nonorthopedic maladies, including cancer, diabetes, and cardiovascular disease, but it has demonstrated an adverse effect on musculoskeletal health.¹ Authors have found a correlation between vitamin D deficiency and muscle weakness, fragility fractures, and, most recently, fracture nonunion.¹ Despite the detrimental effects of vitamin D deficiency on musculoskeletal and general health, evidence exists that vitamin D deficiency is surprisingly prevalent.² This deficiency is known to be associated with increasing age, but recent studies have also found alarming rates of deficiency in younger populations.^3,4

Although there has been some discussion regarding optimal serum levels of 25-hydroxyvitamin D, most experts have defined vitamin D deficiency as a 25-hydroxyvitamin D level of 20 ng/mL or less and insufficiency as 21 to 32 ng/mL.⁵ Hollis and Wagner⁵ found increased serum parathyroid hormone and bone resorption and impaired dietary absorption of calcium when 25-hydroxyvitamin D levels were under 32 ng/mL. Given these data, a 25-hydroxyvitamin D level of 21 to 32 ng/mL (52-72 nmol/L) can be considered as indicating a relative insufficiency of vitamin D, and a level of 20 ng/mL or less can be considered as indicating vitamin D deficiency.

Vitamin D plays a vital role in bone metabolism and has been implicated in increased fracture risk and in fracture healing ability. Therefore, documenting the prevalence of vitamin D deficiency in patients with trauma is the first step in raising awareness among orthopedic traumatologists and further developing a screening-and-treatment strategy for vitamin D deficiency in these patients. Steele and colleagues⁶ retrospectively studied 44 patients with high- and low-energy fractures and found an almost 60% prevalence of vitamin D insufficiency. If vitamin D insufficiency is this prevalent, treatment protocols for patients with fractures may require modifications that include routine screening and treatment for low vitamin D levels.

After noting a regular occurrence of hypovitaminosis D in our patient population (independent of age, sex, or medical comorbidities), we conducted a study to determine the prevalence of vitamin D deficiency in a large orthopedic trauma population.

Patients and Methods

After obtaining Institutional Review Board approval for this study, we retrospectively reviewed the charts of all patients with a fracture treated by 1 of 4 orthopedic traumatologists within a 21-month period (January 1, 2009 to September 30, 2010). Acute fracture and recorded 25-hydroxyvitamin D level were the primary criteria for study inclusion. Given the concern about vitamin D deficiency, it became common protocol to check the serum 25-hydroxyvitamin D levels of patients with acute fractures during the review period. Exclusion criteria were age under 18 years and presence of vitamin D deficiency risk factors, including renal insufficiency (creatinine level, ≥2 mg/dL), malabsorption, gastrectomy, active liver disease, acute myocardial infarction, alcoholism, anorexia nervosa, and steroid dependency.

During the period studied, 1830 patients over age 18 years were treated by 4 fellowship-trained orthopedic traumatologists. Of these patients, 889 (487 female, 402 male) met the inclusion criteria. Mean age was 53.8 years. Demographic data (age, sex, race, independent living status, comorbid medical conditions, medications) were collected from the patients’ medical records. Clinical data collected were mechanism of injury, fracture location and type, injury date, surgery date and surgical procedure performed (when applicable), and serum 25-hydroxyvitamin D levels.

Statistical Methods

Descriptive statistics (mean, median, mode) were calculated. The χ² test was used when all cell frequencies were more than 5, and the Fisher exact probability test was used when any cell frequency was 5 or less. Prevalence of vitamin D deficiency and insufficiency was calculated in multiple patient populations. Patients were analyzed according to age and sex subgroups.

Definitions

Vitamin D deficiency was defined as a serum 25-hydroxyvitamin D level of 20 ng/mL or less and insufficiency as 21 to 32 ng/mL.² As the serum test was performed independent of the investigators and with use of standard medical laboratory protocols and techniques, there should be no bias in the results. We had intended to have all patients undergo serum testing during the review period because that was our usual protocol. However, test results were available for only 889 (49%) of the 1830 patients with orthopedic trauma during the review period. Although a false-positive is theoretically possible, this series of orthopedic trauma patients is the largest in the literature and therefore should be more accurate than the previously reported small series.

 

Results

There were no significant (P < .05) age or sex differences in prevalence of vitamin D deficiency or insufficiency in our patient population. Overall prevalence of deficiency/insufficiency was 77.39%, and prevalence of deficiency alone was 39.03% (Table 1).

Overall, patients in the 18- to 25-year age group had the lowest prevalence of deficiency (29.1%; P = .25) and insufficiency (54.7%; P = .08).

Patients in the 36- to 65-year age group had a higher prevalence of deficiency and insufficiency, but neither difference was statistically significant. Table 2 lists prevalence of deficiency and insufficiency by age group.

Women in the 18- to 25-year age group had a lower prevalence of deficiency (25%; P = .41) and insufficiency (41.7%; P = .16) than women in the other age groups (Table 3).

Men in the 18- to 25-year age group had a lower prevalence of insufficiency (59.7%; P = .24) than men in the other age groups (Table 4).

There were no other remarkable age or sex differences in prevalence of deficiency or insufficiency. There did not appear to be any seasonal effect based on injury date and serum 25-hydroxyvitamin D level.

Discussion

We conducted this study to determine the prevalence of vitamin D deficiency in a large population of patients with orthopedic trauma. Results showed that vitamin D deficiency and insufficiency were prevalent in this population, which to our knowledge is the largest studied for vitamin D deficiency. In a 6-month study of 44 fractures, Steele and colleagues⁶ found an overall 60% rate of deficiency/insufficiency. Although their investigation is important—it was the first of its kind to evaluate patients with various fracture types, including those with high-energy causes—its numbers were small, and the period evaluated (June 1, 2006 to February 1, 2007) was short (8 months). Use of that time frame may have led to an underestimate of the prevalence of vitamin D deficiency, as vitamin D levels are higher in late summer because of increased sun exposure. Our study of 889 patients over 21 months allowed for seasonal variability of vitamin D levels. We did not notice a specific difference in patients who were treated during winter vs summer. Furthermore, our 77% prevalence of vitamin D insufficiency and 39% prevalence of vitamin D deficiency indicate how widespread low vitamin D levels are in a large Midwestern orthopedic trauma population. In the Pacific Northwest, Bee and colleagues⁷ studied seasonal differences in patients with surgically treated fractures and found an average difference of 3 ng/mL between winter and summer serum levels. However, the real issue, which should not be overlooked, is that the average 25-hydroxyvitamin D level was under 30 ng/mL in both cohorts (26.4 ng/mL in winter vs 29.8 ng/mL in summer). The emphasis should be that both levels were insufficient and that seasonal variance does not really change prevalence.

With use of the current definitions, it has been estimated that 1 billion people worldwide have vitamin D deficiency or insufficiency, with the elderly and certain ethnic populations at higher risk.^8-10Vitamin D deficiency is a common diagnosis among elderly patients with hip fractures. According to various reports, 60% to 90% of patients treated for hip fractures are deficient or insufficient in vitamin D.^8,9Hypovitaminosis D has also been noted in medical inpatients with and without risks for this deficiency.² Surprisingly, low vitamin D levels are not isolated to the elderly. In Massachusetts, Gordon and colleagues¹¹ found a 52% prevalence of vitamin D deficiency in Hispanic and black adolescents. Nesby-O’Dell and colleagues¹⁰ found that 42% of 15- to 49-year-old black women in the United States had vitamin D deficiency at the end of winter. Bogunovic and colleagues¹² noted 5.5 times higher risk of low vitamin D levels in patients with darker skin tones. Although vitamin D deficiency has been linked to specific races, it frequently occurs in lower-risk populations as well. Sullivan and colleagues⁴ found a 48% prevalence of vitamin D deficiency in white preadolescent girls in Maine. Tangpricha and colleagues³ reported a 32% prevalence of vitamin D deficiency in otherwise fit healthcare providers sampled at a Boston hospital. Bogunovic and colleagues¹² also showed that patients between ages 18 years and 50 years, and men, were more likely to have low vitamin D levels.

Establishing the prevalence of hypovitaminosis D in orthopedic trauma patients is needed in order to raise awareness of the disease and modify screening and treatment protocols. Brinker and O’Connor¹³ found vitamin D deficiency in 68% of patients with fracture nonunions, which suggests that hypovitaminosis D may partly account for difficulty in achieving fracture union. Bogunovic and colleagues¹² found vitamin D insufficiency in 43% of 723 patients who underwent orthopedic surgery. Isolating the 121 patients on the trauma service revealed a 66% prevalence of low vitamin D levels. Our 77% prevalence of low vitamin D levels in 889 patients adds to the evidence that low levels are common in patients with orthopedic trauma. Understanding the importance of vitamin D deficiency can be significant in reducing the risk of complications, including delayed unions and nonunions, associated with treating orthopedic trauma cases.

Although our study indicates an alarming prevalence of insufficient vitamin D levels in our patient population, it does not provide a cause-and-effect link between low serum 25-hydroxyvitamin D levels and risk of fracture or nonunion. However, further investigations may yield clinically relevant data linking hypovitaminosis D with fracture risk. Although we did not include patients with nonunion in this study, new prospective investigations will address nonunions and subgroup analysis of race, fracture type, management type (surgical vs nonsurgical), injury date (to determine seasonal effect), and different treatment regimens.

The primary limitation of this study was its retrospective design. In addition, though we collected vitamin D data from 889 patients with acute fracture, our serum collection protocols were not standardized. Most patients who were admitted during initial orthopedic consultation in the emergency department had serum 25-hydroxyvitamin D levels drawn during their hospital stay, and patients initially treated in an ambulatory setting may not have had serum vitamin D levels drawn for up to 2 weeks after injury (the significance of this delay is unknown). Furthermore, the serum result rate for the overall orthopedic trauma population during the review period was only 49%, which could indicate selection bias. There are multiple explanations for the low rate. As with any new protocol or method, it takes time for the order to become standard practice; in the early stages, individuals can forget to ask for the test. In addition, during the review period, the serum test was also relatively new at our facility, and it was a “send-out” test, which could partly account for the lack of consistency. For example, some specimens were lost, and, in a number of other cases, excluded patients mistakenly had their 1,25-hydroxyvitamin D levels measured and were not comparable to included patients. Nevertheless, our sample of 889 patients with acute fractures remains the largest (by several hundred) reported in the literature.

From a practical standpoint, the present results were useful in updating our treatment protocols. Now we typically treat patients only prophylactically, with 50,000 units of vitamin D₂ for 8 weeks and daily vitamin D₃ and calcium until fracture healing. Patients are encouraged to continue daily vitamin D and calcium supplementation after fracture healing to maintain bone health. Compliance, however, remains a continued challenge and lack thereof can potentially explain the confusing effect of a supplementation protocol on the serum 25-hydroxyvitamin D level.¹⁴ The only patients who are not given prophylactic treatment are those who previously had been denied it (patients with chronic kidney disease or elevated blood calcium levels).

Vitamin D deficiency and insufficiency are prevalent in patients with orthopedic trauma. Studies are needed to further elucidate the relationship between low vitamin D levels and risk of complications. Retrospectively, without compliance monitoring, we have not seen a direct correlation with fracture complications.¹⁵ Our goal here was to increase orthopedic surgeons’ awareness of the problem and of the need to consider addressing low serum vitamin D levels. The treatment is low cost and low risk. The ultimate goal—if there is a prospective direct correlation between low serum vitamin D levels and complications—is to develop treatment strategies that can effectively lower the prevalence of low vitamin D levels.

Am J Orthop. 2016;45(7):E522-E526. Copyright Frontline Medical Communications Inc. 2016. All rights reserved.

The role of vitamin D in general health maintenance is a topic of increasing interest and importance in the medical community. Not only has vitamin D deficiency been linked to a myriad of nonorthopedic maladies, including cancer, diabetes, and cardiovascular disease, but it has demonstrated an adverse effect on musculoskeletal health.¹ Authors have found a correlation between vitamin D deficiency and muscle weakness, fragility fractures, and, most recently, fracture nonunion.¹ Despite the detrimental effects of vitamin D deficiency on musculoskeletal and general health, evidence exists that vitamin D deficiency is surprisingly prevalent.² This deficiency is known to be associated with increasing age, but recent studies have also found alarming rates of deficiency in younger populations.^3,4

Although there has been some discussion regarding optimal serum levels of 25-hydroxyvitamin D, most experts have defined vitamin D deficiency as a 25-hydroxyvitamin D level of 20 ng/mL or less and insufficiency as 21 to 32 ng/mL.⁵ Hollis and Wagner⁵ found increased serum parathyroid hormone and bone resorption and impaired dietary absorption of calcium when 25-hydroxyvitamin D levels were under 32 ng/mL. Given these data, a 25-hydroxyvitamin D level of 21 to 32 ng/mL (52-72 nmol/L) can be considered as indicating a relative insufficiency of vitamin D, and a level of 20 ng/mL or less can be considered as indicating vitamin D deficiency.

Vitamin D plays a vital role in bone metabolism and has been implicated in increased fracture risk and in fracture healing ability. Therefore, documenting the prevalence of vitamin D deficiency in patients with trauma is the first step in raising awareness among orthopedic traumatologists and further developing a screening-and-treatment strategy for vitamin D deficiency in these patients. Steele and colleagues⁶ retrospectively studied 44 patients with high- and low-energy fractures and found an almost 60% prevalence of vitamin D insufficiency. If vitamin D insufficiency is this prevalent, treatment protocols for patients with fractures may require modifications that include routine screening and treatment for low vitamin D levels.

After noting a regular occurrence of hypovitaminosis D in our patient population (independent of age, sex, or medical comorbidities), we conducted a study to determine the prevalence of vitamin D deficiency in a large orthopedic trauma population.

Patients and Methods

After obtaining Institutional Review Board approval for this study, we retrospectively reviewed the charts of all patients with a fracture treated by 1 of 4 orthopedic traumatologists within a 21-month period (January 1, 2009 to September 30, 2010). Acute fracture and recorded 25-hydroxyvitamin D level were the primary criteria for study inclusion. Given the concern about vitamin D deficiency, it became common protocol to check the serum 25-hydroxyvitamin D levels of patients with acute fractures during the review period. Exclusion criteria were age under 18 years and presence of vitamin D deficiency risk factors, including renal insufficiency (creatinine level, ≥2 mg/dL), malabsorption, gastrectomy, active liver disease, acute myocardial infarction, alcoholism, anorexia nervosa, and steroid dependency.

During the period studied, 1830 patients over age 18 years were treated by 4 fellowship-trained orthopedic traumatologists. Of these patients, 889 (487 female, 402 male) met the inclusion criteria. Mean age was 53.8 years. Demographic data (age, sex, race, independent living status, comorbid medical conditions, medications) were collected from the patients’ medical records. Clinical data collected were mechanism of injury, fracture location and type, injury date, surgery date and surgical procedure performed (when applicable), and serum 25-hydroxyvitamin D levels.

Statistical Methods

Descriptive statistics (mean, median, mode) were calculated. The χ² test was used when all cell frequencies were more than 5, and the Fisher exact probability test was used when any cell frequency was 5 or less. Prevalence of vitamin D deficiency and insufficiency was calculated in multiple patient populations. Patients were analyzed according to age and sex subgroups.

Definitions

Vitamin D deficiency was defined as a serum 25-hydroxyvitamin D level of 20 ng/mL or less and insufficiency as 21 to 32 ng/mL.² As the serum test was performed independent of the investigators and with use of standard medical laboratory protocols and techniques, there should be no bias in the results. We had intended to have all patients undergo serum testing during the review period because that was our usual protocol. However, test results were available for only 889 (49%) of the 1830 patients with orthopedic trauma during the review period. Although a false-positive is theoretically possible, this series of orthopedic trauma patients is the largest in the literature and therefore should be more accurate than the previously reported small series.

 

Results

There were no significant (P < .05) age or sex differences in prevalence of vitamin D deficiency or insufficiency in our patient population. Overall prevalence of deficiency/insufficiency was 77.39%, and prevalence of deficiency alone was 39.03% (Table 1).

Overall, patients in the 18- to 25-year age group had the lowest prevalence of deficiency (29.1%; P = .25) and insufficiency (54.7%; P = .08).

Patients in the 36- to 65-year age group had a higher prevalence of deficiency and insufficiency, but neither difference was statistically significant. Table 2 lists prevalence of deficiency and insufficiency by age group.

Women in the 18- to 25-year age group had a lower prevalence of deficiency (25%; P = .41) and insufficiency (41.7%; P = .16) than women in the other age groups (Table 3).

Men in the 18- to 25-year age group had a lower prevalence of insufficiency (59.7%; P = .24) than men in the other age groups (Table 4).

There were no other remarkable age or sex differences in prevalence of deficiency or insufficiency. There did not appear to be any seasonal effect based on injury date and serum 25-hydroxyvitamin D level.

Discussion

We conducted this study to determine the prevalence of vitamin D deficiency in a large population of patients with orthopedic trauma. Results showed that vitamin D deficiency and insufficiency were prevalent in this population, which to our knowledge is the largest studied for vitamin D deficiency. In a 6-month study of 44 fractures, Steele and colleagues⁶ found an overall 60% rate of deficiency/insufficiency. Although their investigation is important—it was the first of its kind to evaluate patients with various fracture types, including those with high-energy causes—its numbers were small, and the period evaluated (June 1, 2006 to February 1, 2007) was short (8 months). Use of that time frame may have led to an underestimate of the prevalence of vitamin D deficiency, as vitamin D levels are higher in late summer because of increased sun exposure. Our study of 889 patients over 21 months allowed for seasonal variability of vitamin D levels. We did not notice a specific difference in patients who were treated during winter vs summer. Furthermore, our 77% prevalence of vitamin D insufficiency and 39% prevalence of vitamin D deficiency indicate how widespread low vitamin D levels are in a large Midwestern orthopedic trauma population. In the Pacific Northwest, Bee and colleagues⁷ studied seasonal differences in patients with surgically treated fractures and found an average difference of 3 ng/mL between winter and summer serum levels. However, the real issue, which should not be overlooked, is that the average 25-hydroxyvitamin D level was under 30 ng/mL in both cohorts (26.4 ng/mL in winter vs 29.8 ng/mL in summer). The emphasis should be that both levels were insufficient and that seasonal variance does not really change prevalence.

With use of the current definitions, it has been estimated that 1 billion people worldwide have vitamin D deficiency or insufficiency, with the elderly and certain ethnic populations at higher risk.^8-10Vitamin D deficiency is a common diagnosis among elderly patients with hip fractures. According to various reports, 60% to 90% of patients treated for hip fractures are deficient or insufficient in vitamin D.^8,9Hypovitaminosis D has also been noted in medical inpatients with and without risks for this deficiency.² Surprisingly, low vitamin D levels are not isolated to the elderly. In Massachusetts, Gordon and colleagues¹¹ found a 52% prevalence of vitamin D deficiency in Hispanic and black adolescents. Nesby-O’Dell and colleagues¹⁰ found that 42% of 15- to 49-year-old black women in the United States had vitamin D deficiency at the end of winter. Bogunovic and colleagues¹² noted 5.5 times higher risk of low vitamin D levels in patients with darker skin tones. Although vitamin D deficiency has been linked to specific races, it frequently occurs in lower-risk populations as well. Sullivan and colleagues⁴ found a 48% prevalence of vitamin D deficiency in white preadolescent girls in Maine. Tangpricha and colleagues³ reported a 32% prevalence of vitamin D deficiency in otherwise fit healthcare providers sampled at a Boston hospital. Bogunovic and colleagues¹² also showed that patients between ages 18 years and 50 years, and men, were more likely to have low vitamin D levels.

Establishing the prevalence of hypovitaminosis D in orthopedic trauma patients is needed in order to raise awareness of the disease and modify screening and treatment protocols. Brinker and O’Connor¹³ found vitamin D deficiency in 68% of patients with fracture nonunions, which suggests that hypovitaminosis D may partly account for difficulty in achieving fracture union. Bogunovic and colleagues¹² found vitamin D insufficiency in 43% of 723 patients who underwent orthopedic surgery. Isolating the 121 patients on the trauma service revealed a 66% prevalence of low vitamin D levels. Our 77% prevalence of low vitamin D levels in 889 patients adds to the evidence that low levels are common in patients with orthopedic trauma. Understanding the importance of vitamin D deficiency can be significant in reducing the risk of complications, including delayed unions and nonunions, associated with treating orthopedic trauma cases.

Although our study indicates an alarming prevalence of insufficient vitamin D levels in our patient population, it does not provide a cause-and-effect link between low serum 25-hydroxyvitamin D levels and risk of fracture or nonunion. However, further investigations may yield clinically relevant data linking hypovitaminosis D with fracture risk. Although we did not include patients with nonunion in this study, new prospective investigations will address nonunions and subgroup analysis of race, fracture type, management type (surgical vs nonsurgical), injury date (to determine seasonal effect), and different treatment regimens.

The primary limitation of this study was its retrospective design. In addition, though we collected vitamin D data from 889 patients with acute fracture, our serum collection protocols were not standardized. Most patients who were admitted during initial orthopedic consultation in the emergency department had serum 25-hydroxyvitamin D levels drawn during their hospital stay, and patients initially treated in an ambulatory setting may not have had serum vitamin D levels drawn for up to 2 weeks after injury (the significance of this delay is unknown). Furthermore, the serum result rate for the overall orthopedic trauma population during the review period was only 49%, which could indicate selection bias. There are multiple explanations for the low rate. As with any new protocol or method, it takes time for the order to become standard practice; in the early stages, individuals can forget to ask for the test. In addition, during the review period, the serum test was also relatively new at our facility, and it was a “send-out” test, which could partly account for the lack of consistency. For example, some specimens were lost, and, in a number of other cases, excluded patients mistakenly had their 1,25-hydroxyvitamin D levels measured and were not comparable to included patients. Nevertheless, our sample of 889 patients with acute fractures remains the largest (by several hundred) reported in the literature.

From a practical standpoint, the present results were useful in updating our treatment protocols. Now we typically treat patients only prophylactically, with 50,000 units of vitamin D₂ for 8 weeks and daily vitamin D₃ and calcium until fracture healing. Patients are encouraged to continue daily vitamin D and calcium supplementation after fracture healing to maintain bone health. Compliance, however, remains a continued challenge and lack thereof can potentially explain the confusing effect of a supplementation protocol on the serum 25-hydroxyvitamin D level.¹⁴ The only patients who are not given prophylactic treatment are those who previously had been denied it (patients with chronic kidney disease or elevated blood calcium levels).

Vitamin D deficiency and insufficiency are prevalent in patients with orthopedic trauma. Studies are needed to further elucidate the relationship between low vitamin D levels and risk of complications. Retrospectively, without compliance monitoring, we have not seen a direct correlation with fracture complications.¹⁵ Our goal here was to increase orthopedic surgeons’ awareness of the problem and of the need to consider addressing low serum vitamin D levels. The treatment is low cost and low risk. The ultimate goal—if there is a prospective direct correlation between low serum vitamin D levels and complications—is to develop treatment strategies that can effectively lower the prevalence of low vitamin D levels.

Am J Orthop. 2016;45(7):E522-E526. Copyright Frontline Medical Communications Inc. 2016. All rights reserved.

The role of vitamin D in general health maintenance is a topic of increasing interest and importance in the medical community. Not only has vitamin D deficiency been linked to a myriad of nonorthopedic maladies, including cancer, diabetes, and cardiovascular disease, but it has demonstrated an adverse effect on musculoskeletal health.¹ Authors have found a correlation between vitamin D deficiency and muscle weakness, fragility fractures, and, most recently, fracture nonunion.¹ Despite the detrimental effects of vitamin D deficiency on musculoskeletal and general health, evidence exists that vitamin D deficiency is surprisingly prevalent.² This deficiency is known to be associated with increasing age, but recent studies have also found alarming rates of deficiency in younger populations.^3,4

Although there has been some discussion regarding optimal serum levels of 25-hydroxyvitamin D, most experts have defined vitamin D deficiency as a 25-hydroxyvitamin D level of 20 ng/mL or less and insufficiency as 21 to 32 ng/mL.⁵ Hollis and Wagner⁵ found increased serum parathyroid hormone and bone resorption and impaired dietary absorption of calcium when 25-hydroxyvitamin D levels were under 32 ng/mL. Given these data, a 25-hydroxyvitamin D level of 21 to 32 ng/mL (52-72 nmol/L) can be considered as indicating a relative insufficiency of vitamin D, and a level of 20 ng/mL or less can be considered as indicating vitamin D deficiency.

Vitamin D plays a vital role in bone metabolism and has been implicated in increased fracture risk and in fracture healing ability. Therefore, documenting the prevalence of vitamin D deficiency in patients with trauma is the first step in raising awareness among orthopedic traumatologists and further developing a screening-and-treatment strategy for vitamin D deficiency in these patients. Steele and colleagues⁶ retrospectively studied 44 patients with high- and low-energy fractures and found an almost 60% prevalence of vitamin D insufficiency. If vitamin D insufficiency is this prevalent, treatment protocols for patients with fractures may require modifications that include routine screening and treatment for low vitamin D levels.

After noting a regular occurrence of hypovitaminosis D in our patient population (independent of age, sex, or medical comorbidities), we conducted a study to determine the prevalence of vitamin D deficiency in a large orthopedic trauma population.

Patients and Methods

After obtaining Institutional Review Board approval for this study, we retrospectively reviewed the charts of all patients with a fracture treated by 1 of 4 orthopedic traumatologists within a 21-month period (January 1, 2009 to September 30, 2010). Acute fracture and recorded 25-hydroxyvitamin D level were the primary criteria for study inclusion. Given the concern about vitamin D deficiency, it became common protocol to check the serum 25-hydroxyvitamin D levels of patients with acute fractures during the review period. Exclusion criteria were age under 18 years and presence of vitamin D deficiency risk factors, including renal insufficiency (creatinine level, ≥2 mg/dL), malabsorption, gastrectomy, active liver disease, acute myocardial infarction, alcoholism, anorexia nervosa, and steroid dependency.

During the period studied, 1830 patients over age 18 years were treated by 4 fellowship-trained orthopedic traumatologists. Of these patients, 889 (487 female, 402 male) met the inclusion criteria. Mean age was 53.8 years. Demographic data (age, sex, race, independent living status, comorbid medical conditions, medications) were collected from the patients’ medical records. Clinical data collected were mechanism of injury, fracture location and type, injury date, surgery date and surgical procedure performed (when applicable), and serum 25-hydroxyvitamin D levels.

Statistical Methods

Descriptive statistics (mean, median, mode) were calculated. The χ² test was used when all cell frequencies were more than 5, and the Fisher exact probability test was used when any cell frequency was 5 or less. Prevalence of vitamin D deficiency and insufficiency was calculated in multiple patient populations. Patients were analyzed according to age and sex subgroups.

Definitions

Vitamin D deficiency was defined as a serum 25-hydroxyvitamin D level of 20 ng/mL or less and insufficiency as 21 to 32 ng/mL.² As the serum test was performed independent of the investigators and with use of standard medical laboratory protocols and techniques, there should be no bias in the results. We had intended to have all patients undergo serum testing during the review period because that was our usual protocol. However, test results were available for only 889 (49%) of the 1830 patients with orthopedic trauma during the review period. Although a false-positive is theoretically possible, this series of orthopedic trauma patients is the largest in the literature and therefore should be more accurate than the previously reported small series.

 

Results

There were no significant (P < .05) age or sex differences in prevalence of vitamin D deficiency or insufficiency in our patient population. Overall prevalence of deficiency/insufficiency was 77.39%, and prevalence of deficiency alone was 39.03% (Table 1).

Overall, patients in the 18- to 25-year age group had the lowest prevalence of deficiency (29.1%; P = .25) and insufficiency (54.7%; P = .08).

Patients in the 36- to 65-year age group had a higher prevalence of deficiency and insufficiency, but neither difference was statistically significant. Table 2 lists prevalence of deficiency and insufficiency by age group.

Women in the 18- to 25-year age group had a lower prevalence of deficiency (25%; P = .41) and insufficiency (41.7%; P = .16) than women in the other age groups (Table 3).

Men in the 18- to 25-year age group had a lower prevalence of insufficiency (59.7%; P = .24) than men in the other age groups (Table 4).

There were no other remarkable age or sex differences in prevalence of deficiency or insufficiency. There did not appear to be any seasonal effect based on injury date and serum 25-hydroxyvitamin D level.

Discussion

We conducted this study to determine the prevalence of vitamin D deficiency in a large population of patients with orthopedic trauma. Results showed that vitamin D deficiency and insufficiency were prevalent in this population, which to our knowledge is the largest studied for vitamin D deficiency. In a 6-month study of 44 fractures, Steele and colleagues⁶ found an overall 60% rate of deficiency/insufficiency. Although their investigation is important—it was the first of its kind to evaluate patients with various fracture types, including those with high-energy causes—its numbers were small, and the period evaluated (June 1, 2006 to February 1, 2007) was short (8 months). Use of that time frame may have led to an underestimate of the prevalence of vitamin D deficiency, as vitamin D levels are higher in late summer because of increased sun exposure. Our study of 889 patients over 21 months allowed for seasonal variability of vitamin D levels. We did not notice a specific difference in patients who were treated during winter vs summer. Furthermore, our 77% prevalence of vitamin D insufficiency and 39% prevalence of vitamin D deficiency indicate how widespread low vitamin D levels are in a large Midwestern orthopedic trauma population. In the Pacific Northwest, Bee and colleagues⁷ studied seasonal differences in patients with surgically treated fractures and found an average difference of 3 ng/mL between winter and summer serum levels. However, the real issue, which should not be overlooked, is that the average 25-hydroxyvitamin D level was under 30 ng/mL in both cohorts (26.4 ng/mL in winter vs 29.8 ng/mL in summer). The emphasis should be that both levels were insufficient and that seasonal variance does not really change prevalence.

With use of the current definitions, it has been estimated that 1 billion people worldwide have vitamin D deficiency or insufficiency, with the elderly and certain ethnic populations at higher risk.^8-10Vitamin D deficiency is a common diagnosis among elderly patients with hip fractures. According to various reports, 60% to 90% of patients treated for hip fractures are deficient or insufficient in vitamin D.^8,9Hypovitaminosis D has also been noted in medical inpatients with and without risks for this deficiency.² Surprisingly, low vitamin D levels are not isolated to the elderly. In Massachusetts, Gordon and colleagues¹¹ found a 52% prevalence of vitamin D deficiency in Hispanic and black adolescents. Nesby-O’Dell and colleagues¹⁰ found that 42% of 15- to 49-year-old black women in the United States had vitamin D deficiency at the end of winter. Bogunovic and colleagues¹² noted 5.5 times higher risk of low vitamin D levels in patients with darker skin tones. Although vitamin D deficiency has been linked to specific races, it frequently occurs in lower-risk populations as well. Sullivan and colleagues⁴ found a 48% prevalence of vitamin D deficiency in white preadolescent girls in Maine. Tangpricha and colleagues³ reported a 32% prevalence of vitamin D deficiency in otherwise fit healthcare providers sampled at a Boston hospital. Bogunovic and colleagues¹² also showed that patients between ages 18 years and 50 years, and men, were more likely to have low vitamin D levels.

Establishing the prevalence of hypovitaminosis D in orthopedic trauma patients is needed in order to raise awareness of the disease and modify screening and treatment protocols. Brinker and O’Connor¹³ found vitamin D deficiency in 68% of patients with fracture nonunions, which suggests that hypovitaminosis D may partly account for difficulty in achieving fracture union. Bogunovic and colleagues¹² found vitamin D insufficiency in 43% of 723 patients who underwent orthopedic surgery. Isolating the 121 patients on the trauma service revealed a 66% prevalence of low vitamin D levels. Our 77% prevalence of low vitamin D levels in 889 patients adds to the evidence that low levels are common in patients with orthopedic trauma. Understanding the importance of vitamin D deficiency can be significant in reducing the risk of complications, including delayed unions and nonunions, associated with treating orthopedic trauma cases.

Although our study indicates an alarming prevalence of insufficient vitamin D levels in our patient population, it does not provide a cause-and-effect link between low serum 25-hydroxyvitamin D levels and risk of fracture or nonunion. However, further investigations may yield clinically relevant data linking hypovitaminosis D with fracture risk. Although we did not include patients with nonunion in this study, new prospective investigations will address nonunions and subgroup analysis of race, fracture type, management type (surgical vs nonsurgical), injury date (to determine seasonal effect), and different treatment regimens.

The primary limitation of this study was its retrospective design. In addition, though we collected vitamin D data from 889 patients with acute fracture, our serum collection protocols were not standardized. Most patients who were admitted during initial orthopedic consultation in the emergency department had serum 25-hydroxyvitamin D levels drawn during their hospital stay, and patients initially treated in an ambulatory setting may not have had serum vitamin D levels drawn for up to 2 weeks after injury (the significance of this delay is unknown). Furthermore, the serum result rate for the overall orthopedic trauma population during the review period was only 49%, which could indicate selection bias. There are multiple explanations for the low rate. As with any new protocol or method, it takes time for the order to become standard practice; in the early stages, individuals can forget to ask for the test. In addition, during the review period, the serum test was also relatively new at our facility, and it was a “send-out” test, which could partly account for the lack of consistency. For example, some specimens were lost, and, in a number of other cases, excluded patients mistakenly had their 1,25-hydroxyvitamin D levels measured and were not comparable to included patients. Nevertheless, our sample of 889 patients with acute fractures remains the largest (by several hundred) reported in the literature.

From a practical standpoint, the present results were useful in updating our treatment protocols. Now we typically treat patients only prophylactically, with 50,000 units of vitamin D₂ for 8 weeks and daily vitamin D₃ and calcium until fracture healing. Patients are encouraged to continue daily vitamin D and calcium supplementation after fracture healing to maintain bone health. Compliance, however, remains a continued challenge and lack thereof can potentially explain the confusing effect of a supplementation protocol on the serum 25-hydroxyvitamin D level.¹⁴ The only patients who are not given prophylactic treatment are those who previously had been denied it (patients with chronic kidney disease or elevated blood calcium levels).

Vitamin D deficiency and insufficiency are prevalent in patients with orthopedic trauma. Studies are needed to further elucidate the relationship between low vitamin D levels and risk of complications. Retrospectively, without compliance monitoring, we have not seen a direct correlation with fracture complications.¹⁵ Our goal here was to increase orthopedic surgeons’ awareness of the problem and of the need to consider addressing low serum vitamin D levels. The treatment is low cost and low risk. The ultimate goal—if there is a prospective direct correlation between low serum vitamin D levels and complications—is to develop treatment strategies that can effectively lower the prevalence of low vitamin D levels.

Am J Orthop. 2016;45(7):E522-E526. Copyright Frontline Medical Communications Inc. 2016. All rights reserved.

Fat embolism syndrome (FES) occurs in long-bone fractures and classically presents with the triad of hypoxia, petechia, and altered mental status, or the criteria of Gurd and Wilson.¹ The Lindeque criteria (femur fracture, pH <7.3, increased work of breathing) are also used.^1,2 FES is a potentially fatal complication, with mortality rates ranging from 10% to 36%.^1,3 FES typically occurs within 24 to 72 hours after initial insult, with one study finding an average of 48.5 hours after injury and an incidence of 0.15% to 2.4%.⁴ The overall FES rate is <1% in retrospective reviews and 11% to 29% in prospective studies.⁵ FES may present without one or all of the Gurd and Wilson criteria,⁶ and cerebral fat embolism (CFE) can be even more difficult to diagnose. Patients with CFE typically present with a wide array of postoperative neurologic deficits, commonly in the 24- to 72-hour window in which FES typically occurs. Correct diagnosis and management of CFE require a high index of suspicion and knowledge of the diagnostic work-up. In the postoperative setting, it can be difficult to distinguish CFE-related neurologic deficits from the normal sequelae of anesthesia, pain medications, and other factors.

In this article, we report the case of a 42-year-old woman who developed CFE after reamed intramedullary nail fixation of femoral and tibial shaft fractures. The patient provided written informed consent for print and electronic publication of this case report.

Case Report

A 42-year-old woman with no past medical history was injured when a horse reared and fell on her. Initial emergent computed tomography (CT) was negative for intracranial hemorrhage, and injury radiographs were obtained (Figures 1A, 1B).

The next morning, the patient underwent reamed intramedullary nailing of femur and tibia (floating knee injury) through a transpatellar approach in a single operation. Oxygen saturation and vital signs were maintained at normal levels throughout the procedure, and there were no intraoperative complications. Postoperative radiographs were obtained (Figures 1C, 1D).

About 9 hours after surgery and 36 hours after injury, the patient was unresponsive. Vital signs, including oxygen saturation, were within normal limits, but she was unable to verbalize. Physical examination revealed symmetric facial musculature but also generalized weakness and diffuse hypertonicity and hyperreflexia. Initial laboratory results, including complete blood cell count, electrolyte panel, and troponin levels, were unremarkable. Naloxone was administered to rule out opioid overdose. An immediate code stroke and neurology consultation was requested. An emergent CT scan of the brain was negative; an urgent magnetic resonance imaging (MRI) scan showed multiple punctate T2/FLAIR (fluid attenuated inversion recovery) hyperintensities with restricted diffusion, predominantly in a parasagittal white matter distribution (Figure 2).

Findings were consistent with multifocal infarcts secondary to CFE. Hypercoagulability workup, CT with pulmonary embolism (PE) protocol, lumbar puncture, and electrocardiogram (EKG) with bubble study were all negative. There was no PE or patent foramen ovale (PFO). Levetiracetam was started as prophylaxis against seizure activity, and aspirin in the setting of embolic stroke.

The patient slowly and steadily improved. She was verbal by postoperative day 3 (POD-3), upper motor neuron signs resolved by POD-4, encephalopathy resolved by POD-7, and she was discharged to a rehabilitation center. Unresolved post-stroke symptoms included mild visual field deficits in the right eye (20/25 vision, central scotoma) and amnesia regarding the events immediately surrounding the surgery. There were no other neurologic or cognitive deficits. The patient was non-weight-bearing on the operative extremity and ambulating with assistance, and she started range-of-motion exercises. After 1 week, she was discharged home with crutches.

The patient followed up with neurology and ophthalmology for routine post-stroke care. At 2- and 6-month neurology follow-ups, she was still amnestic regarding her acute stroke event but did not exhibit any confusion, memory problems, speech deficits, facial droop, headaches, or weakness. According to neurology, the encephalopathy was completely resolved, and the patient was completely recovered from the event. Levetiracetam and aspirin were discontinued at 2 months. At the 2-month ophthalmology follow-up, the patient had 20/20 vision in both eyes and nearly complete resolution of the central scotoma. Ophthalmology confirmed symptom relief and recommended return to routine eye care and 1-year follow-up.

The patient began weight-bearing as tolerated on POD-14 and had no hardware or other complications. At 6-month orthopedics follow-up, range of motion of the affected knee was 0° to 120°, and rotation, length, and varus/valgus and anteroposterior knee laxity were all symmetric to the contralateral extremity. The patient walked with a cane for balance and had a mild limp. The affected thigh still had mild atrophy, but strength was 5/5 throughout. The patient denied pain or hardware sensitivity in the affected extremity and was very pleased with the result.

 

Discussion

Postoperative Acute Mental Status Change

There are many causes of postoperative mental status change after intramedullary nailing. Change may be cardiogenic, infectious, pharmacologic, or neurologic in origin. Age should be considered in the work-up of postoperative mental status change, as common complications differ between older and younger patients, with geriatric patients at particularly high risk for delirium.

In addition, past medical history is important in determining causes of mental status change, as many conditions (eg, cardiac disease, hypercoagulable state, dementia, polypharmacy) can cause or exacerbate these changes. A systematic approach is recommended for evaluating any patient with an acute mental status change (Figure 3).^1,5,7

Next to be evaluated are vital signs—particularly hypoxia, as isolated tachycardia may simply be a manifestation of pain. The cardiac system is then assessed with EKG and cardiac-specific laboratory tests, including a troponin level test if there is suspicion of myocardial infarction. PE and FES are complications with a higher prevalence in intramedullary nailing, and pulmonary involvement can be ruled out with the CT with PE protocol. Skin examination is important as well, as FES presents with petechial rash in 60% of patients⁸ (rash was absent in our patient’s case). Narcotic overdose is easily ruled out with administration of naloxone. Infection and sepsis can cause mental changes, though more commonly in the elderly and seldom so soon after surgery. Evaluation for infection and sepsis involves urinalysis and culturing of blood, urine, and other bodily fluids. If there is concern about surgical site infection, the postoperative dressing should be immediately removed and the wound examined. Last, neurologic and embolic phenomena can be initially investigated with CT to rule out hemorrhagic stroke. If CT of the brain is negative, MRI should be performed. MRI is the gold standard for diagnosing ischemic stroke and CFE caused by FES.⁹

Prevalence of Fat Embolism Syndrome

Development of intramedullary fat release in patients with long-bone injuries is common. A prospective study found circulating fat globules in 95% of 43 patients with femur fractures.¹⁰ In another study, transesophageal EKG showed cardiac embolism in 62% of patients who had undergone intramedullary nail fixation.¹¹ Despite this high rate, only 0.9% to 2.2% of patients developed symptomatic FES. Risk factors for FES include younger age, multiple fractures, closed fractures, and nonoperative or delayed management of long-bone fractures.² As already mentioned, average time to FES presentation after long-bone fracture is about 48 hours. One study found that FES typically occurs within 24 to 72 hours after initial insult (average, 48.5 hours) and that the incidence of FES is 0.15% in tibia fractures, 0.78% in femur fractures, and 2.4% in multiple long-bone fractures.⁴ The timeline is consistent with the present case—our patient developed symptoms about 36 hours after injury. In addition, other studies have found a higher mortality rate (5%-15%) for patients with bilateral femur fractures than for patients with only one fracture.^7,12,13 Patients with a floating knee injury (ipsilateral tibia and femur fractures) are at higher risk for FES and have higher overall morbidity and mortality rates in comparison with patients with an isolated femur or tibia fracture, though the increased risk has not been quantified.

Review of Case Literature: FES With CFE

Few cases of FES with symptomatic CFE in the setting of long-bone fracture or long-bone surgery have been reported in the literature. There is wide variation in the development of FES with respect to preoperative or postoperative status and mechanism of injury. Duran and colleagues¹⁴ described a 20-year-old man with ipsilateral tibia and femur fractures caused by gunshots. Twenty-four hours after presentation, he developed tonic-clonic seizures and the classic triad of rash, hypoxia, and altered mental status. MRI confirmed CFE secondary to FES. The patient was optimized neurologically before definitive fixation and was discharged with minimal neurologic deficits on POD-27. Chang and colleagues¹⁵ and Yeo and colleagues¹⁶ described CFE in patients who underwent bilateral total knee arthroplasty. Symptoms developed 9 hours and 2 days after surgery, respectively. Both patients had fat emboli in the lungs and brain, underwent intensive care treatment, and recovered from the initial insult. After discharge at 44 days and 2 weeks, respectively, they fully recovered.

Other patients with CFE have had less favorable outcomes. Chen and colleagues⁶ reported the case of a 31-year-old man who sustained closed femur and tibia fractures in an automobile collision and experienced an acute decline in neurologic status 1 hour after arrival in the emergency department. The patient was intubated, CFE was diagnosed on the basis of MRI findings, and the orthopedic injuries were treated with external fixation. After 2 weeks, the patient was discharged with persistent neurologic deficits and the need for long-term tube feeding. Walshe and colleagues¹⁷ reported the case of a 19-year-old woman who sustained multiple long-bone injuries and traumatic brain injury and showed fat emboli on MRI. The patient experienced brain herniation while in the intensive care unit and later was declared brain-dead. According to the literature, it is important to maintain high suspicion for FES and possible CFE in the setting of high-energy fracture but also to be aware that FES may develop even with nondisplaced fracture or with reaming of the intramedullary canal in elective total joint arthroplasty.¹⁸

 

Pathophysiology of Fat Embolism Syndrome

The pathophysiology of FES and specifically of CFE is not widely understood. Two main theories on the development of FES have been advanced.

The mechanical theory suggests that exposing intramedullary long-bone contents allows fat to mobilize into the bloodstream.¹⁹ This occurs in the setting of long-bone fracture and in canal preparation during joint replacement surgery. More fat extravasates into the venous system after femur fracture than after tibia fracture, which accounts for the higher risk for FES in femoral shaft fractures and the even higher risk in concomitant femur and tibia fractures.⁴ In addition to there being a risk of fat embolism from the fracture itself, placing the patient in traction or reaming the intramedullary canal may exacerbate this effect by increased extravasation of fat from the medullary canal. With extravasation of fatty bone marrow into the venous system, fat emboli are free to travel back to the lungs, where they can cause infarcts within the lung parenchyma.

In the mechanical theory, presence of PFO may allow fat globules to pass into the systemic circulation and cause end-organ emboli. In the event of cerebral emboli, neurologic symptoms may vary widely and may include diffuse encephalopathy and global deficits.²⁰ Dog studies have found a possible mechanism for CFE in the absence of PFO. One such study, which used femoral pressurization to replicate cemented femoral arthroplasty, found that many fat globules had traversed the lungs after release into bone marrow,²¹ supporting the theory that fat droplets can traverse the pulmonary system without sequestration in the lung parenchyma. Riding and colleagues²² reported finding pulmonary arteriovenous shunts, which are thought to allow CFE to occur in the absence of PFO. More studies are needed to determine the prevalence of shunts and their overall contribution to CFE development in patients with long-bone fracture.

The biochemical theory holds that bodily trauma induces the release of free fatty acids (FFAs) from the capillaries into the bloodstream.²³ This stress response is mediated by catecholamines, which activate the adenyl cyclase pathway, which activates lipase, which hydrolyzes stored triglycerides to FFAs and glycerol. The concentration of circulating FFA was increased in 9 of 10 patients in one study.²³ Increased FFAs in the bloodstream can accelerate local and end-organ clotting, leading to thrombocytopenia and endothelial injury. In addition, patients with hypercoagulable diseases are at higher risk for postoperative thromboembolism.²⁴ However, with a negative hypercoagulable work-up and with negative chest helical CT and EKG, which did not demonstrate PFO, the explanation for CFE in our patient may more likely reside with the arteriovenous shunt theory proposed by Riding and colleagues.²²

Diagnosis and Treatment

Proper care of orthopedic patients who potentially have FES/CFE involves prompt diagnosis, immediate symptomatic care, and early coordination with neurology and medical services to rule out other causes of symptoms. Obtaining advanced imaging to rule out other potential causes and to confirm the diagnosis is crucial. The patient in this case report did not exhibit any focal neurologic deficits, but emergent CT of the brain was indicated to rule out a hemorrhagic event. If a stroke secondary to FES is clinically suspected, MRI should be obtained as soon as possible. Multiple studies have found that the “starfield” pattern, which is best seen as multiple punctate hyperintensities on T2 imaging, is the typical radiographic manifestation of CFE.⁹ This applies to patients who are in the 24- to 72-hour window after long-bone fracture or fixation and who fit Gurd and Wilson¹ criteria or Lindeque^1,2criteria, or who exhibit a change in mental status but have a negative CT scan of the brain, as was the case with our patient. Once the diagnosis is made, treatment involves addressing the symptoms (Figure 4).

Hypoxia should be treated with supplementary oxygen; if acute respiratory distress syndrome develops, intubation and mechanical ventilation may be required. Patients with embolic phenomena causing CFE should receive aspirin for stroke prophylaxis and an antiepileptic for seizure prophylaxis. The best way to treat FES and CFE remains prevention with early operative fixation. If prevention fails, timely supportive care can help; a majority of patients who receive such care recover from neurologic and pulmonary sequelae (overall mortality rate, 10%).²⁵

Fat Embolism Syndrome in Reamed and Unreamed Nailing

Over the past several decades, the number of long bones fixed with intramedullary nails has increased significantly.²⁶ There is debate regarding whether use of reamed intramedullary nails increases the risk of fat emboli relative to use of unreamed nails, but multiple studies have found no significant difference.^26,27 Pulmonary shunting occurs in both reamed and unreamed nailing; neither technique has an advantage in terms of cardiopulmonary complications. In multiple studies, reamed nails have the advantage of improved healing rates.²⁷ A sheep study compared reamed and unreamed femoral nailing.²⁸ After nailing, sheep lungs were examined histologically for the presence of bone marrow fat embolism. The embolism rate was higher with unreamed nailing (10.25%) than with reamed nailing (6.66%). One large study of the adverse effects of reamed and unreamed nailing in 1226 patients with tibial shaft fracture found that those with open fractures had higher rates of a negative event (nonunion, infection, fasciotomy, hardware failure, need for dynamization) after reamed nailing.²⁹ Patients with closed fractures had fewer events after reamed nailing. The authors concluded there is a potential benefit in outcome with reamed intramedullary nailing in patients with closed tibial shaft fractures, but they did not comment on development of FES. In a study of the effect of subject position on intramedullary pressure and fat embolism release, dogs were positioned either supine or lateral for tibial and femoral reaming.³⁰ The authors measured various physiologic parameters, including cardiac output, pulmonary arterial wedge pressure, arterial and venous blood gas, and blood cell counts. There were no statistically significant differences in values between the 2 groups in any variable, indicating that position does not affect FES development in the orthopedic trauma setting.

 

Conclusion

FES and CFE are potential devastating sequelae of both long-bone fracture and long-bone instrumentation. It is important to recognize these entities in the acute setting and to consider them in the differential diagnosis of a trauma or postoperative patient who experiences sudden onset of altered mental status with or without dyspnea or a petechial rash. If CFE is suspected, early advanced imaging (including urgent MRI) should be obtained with rapid involvement of a multidisciplinary team that can optimize the chance for successful recovery of both neurologic and physical function. The best treatment, early prevention and diagnosis, maximizes care of symptoms. As is evidenced in this case report, rapid diagnosis and treatment often result in recovery from a majority of the symptoms of FES and CFE.

Am J Orthop. 2016;45(7):E515-E521. Copyright Frontline Medical Communications Inc. 2016. All rights reserved.

Fat embolism syndrome (FES) occurs in long-bone fractures and classically presents with the triad of hypoxia, petechia, and altered mental status, or the criteria of Gurd and Wilson.¹ The Lindeque criteria (femur fracture, pH <7.3, increased work of breathing) are also used.^1,2 FES is a potentially fatal complication, with mortality rates ranging from 10% to 36%.^1,3 FES typically occurs within 24 to 72 hours after initial insult, with one study finding an average of 48.5 hours after injury and an incidence of 0.15% to 2.4%.⁴ The overall FES rate is <1% in retrospective reviews and 11% to 29% in prospective studies.⁵ FES may present without one or all of the Gurd and Wilson criteria,⁶ and cerebral fat embolism (CFE) can be even more difficult to diagnose. Patients with CFE typically present with a wide array of postoperative neurologic deficits, commonly in the 24- to 72-hour window in which FES typically occurs. Correct diagnosis and management of CFE require a high index of suspicion and knowledge of the diagnostic work-up. In the postoperative setting, it can be difficult to distinguish CFE-related neurologic deficits from the normal sequelae of anesthesia, pain medications, and other factors.

In this article, we report the case of a 42-year-old woman who developed CFE after reamed intramedullary nail fixation of femoral and tibial shaft fractures. The patient provided written informed consent for print and electronic publication of this case report.

Case Report

A 42-year-old woman with no past medical history was injured when a horse reared and fell on her. Initial emergent computed tomography (CT) was negative for intracranial hemorrhage, and injury radiographs were obtained (Figures 1A, 1B).

The next morning, the patient underwent reamed intramedullary nailing of femur and tibia (floating knee injury) through a transpatellar approach in a single operation. Oxygen saturation and vital signs were maintained at normal levels throughout the procedure, and there were no intraoperative complications. Postoperative radiographs were obtained (Figures 1C, 1D).

About 9 hours after surgery and 36 hours after injury, the patient was unresponsive. Vital signs, including oxygen saturation, were within normal limits, but she was unable to verbalize. Physical examination revealed symmetric facial musculature but also generalized weakness and diffuse hypertonicity and hyperreflexia. Initial laboratory results, including complete blood cell count, electrolyte panel, and troponin levels, were unremarkable. Naloxone was administered to rule out opioid overdose. An immediate code stroke and neurology consultation was requested. An emergent CT scan of the brain was negative; an urgent magnetic resonance imaging (MRI) scan showed multiple punctate T2/FLAIR (fluid attenuated inversion recovery) hyperintensities with restricted diffusion, predominantly in a parasagittal white matter distribution (Figure 2).

Findings were consistent with multifocal infarcts secondary to CFE. Hypercoagulability workup, CT with pulmonary embolism (PE) protocol, lumbar puncture, and electrocardiogram (EKG) with bubble study were all negative. There was no PE or patent foramen ovale (PFO). Levetiracetam was started as prophylaxis against seizure activity, and aspirin in the setting of embolic stroke.

The patient slowly and steadily improved. She was verbal by postoperative day 3 (POD-3), upper motor neuron signs resolved by POD-4, encephalopathy resolved by POD-7, and she was discharged to a rehabilitation center. Unresolved post-stroke symptoms included mild visual field deficits in the right eye (20/25 vision, central scotoma) and amnesia regarding the events immediately surrounding the surgery. There were no other neurologic or cognitive deficits. The patient was non-weight-bearing on the operative extremity and ambulating with assistance, and she started range-of-motion exercises. After 1 week, she was discharged home with crutches.

The patient followed up with neurology and ophthalmology for routine post-stroke care. At 2- and 6-month neurology follow-ups, she was still amnestic regarding her acute stroke event but did not exhibit any confusion, memory problems, speech deficits, facial droop, headaches, or weakness. According to neurology, the encephalopathy was completely resolved, and the patient was completely recovered from the event. Levetiracetam and aspirin were discontinued at 2 months. At the 2-month ophthalmology follow-up, the patient had 20/20 vision in both eyes and nearly complete resolution of the central scotoma. Ophthalmology confirmed symptom relief and recommended return to routine eye care and 1-year follow-up.

The patient began weight-bearing as tolerated on POD-14 and had no hardware or other complications. At 6-month orthopedics follow-up, range of motion of the affected knee was 0° to 120°, and rotation, length, and varus/valgus and anteroposterior knee laxity were all symmetric to the contralateral extremity. The patient walked with a cane for balance and had a mild limp. The affected thigh still had mild atrophy, but strength was 5/5 throughout. The patient denied pain or hardware sensitivity in the affected extremity and was very pleased with the result.

 

Discussion

Postoperative Acute Mental Status Change

There are many causes of postoperative mental status change after intramedullary nailing. Change may be cardiogenic, infectious, pharmacologic, or neurologic in origin. Age should be considered in the work-up of postoperative mental status change, as common complications differ between older and younger patients, with geriatric patients at particularly high risk for delirium.

In addition, past medical history is important in determining causes of mental status change, as many conditions (eg, cardiac disease, hypercoagulable state, dementia, polypharmacy) can cause or exacerbate these changes. A systematic approach is recommended for evaluating any patient with an acute mental status change (Figure 3).^1,5,7

Next to be evaluated are vital signs—particularly hypoxia, as isolated tachycardia may simply be a manifestation of pain. The cardiac system is then assessed with EKG and cardiac-specific laboratory tests, including a troponin level test if there is suspicion of myocardial infarction. PE and FES are complications with a higher prevalence in intramedullary nailing, and pulmonary involvement can be ruled out with the CT with PE protocol. Skin examination is important as well, as FES presents with petechial rash in 60% of patients⁸ (rash was absent in our patient’s case). Narcotic overdose is easily ruled out with administration of naloxone. Infection and sepsis can cause mental changes, though more commonly in the elderly and seldom so soon after surgery. Evaluation for infection and sepsis involves urinalysis and culturing of blood, urine, and other bodily fluids. If there is concern about surgical site infection, the postoperative dressing should be immediately removed and the wound examined. Last, neurologic and embolic phenomena can be initially investigated with CT to rule out hemorrhagic stroke. If CT of the brain is negative, MRI should be performed. MRI is the gold standard for diagnosing ischemic stroke and CFE caused by FES.⁹

Prevalence of Fat Embolism Syndrome

Development of intramedullary fat release in patients with long-bone injuries is common. A prospective study found circulating fat globules in 95% of 43 patients with femur fractures.¹⁰ In another study, transesophageal EKG showed cardiac embolism in 62% of patients who had undergone intramedullary nail fixation.¹¹ Despite this high rate, only 0.9% to 2.2% of patients developed symptomatic FES. Risk factors for FES include younger age, multiple fractures, closed fractures, and nonoperative or delayed management of long-bone fractures.² As already mentioned, average time to FES presentation after long-bone fracture is about 48 hours. One study found that FES typically occurs within 24 to 72 hours after initial insult (average, 48.5 hours) and that the incidence of FES is 0.15% in tibia fractures, 0.78% in femur fractures, and 2.4% in multiple long-bone fractures.⁴ The timeline is consistent with the present case—our patient developed symptoms about 36 hours after injury. In addition, other studies have found a higher mortality rate (5%-15%) for patients with bilateral femur fractures than for patients with only one fracture.^7,12,13 Patients with a floating knee injury (ipsilateral tibia and femur fractures) are at higher risk for FES and have higher overall morbidity and mortality rates in comparison with patients with an isolated femur or tibia fracture, though the increased risk has not been quantified.

Review of Case Literature: FES With CFE

Few cases of FES with symptomatic CFE in the setting of long-bone fracture or long-bone surgery have been reported in the literature. There is wide variation in the development of FES with respect to preoperative or postoperative status and mechanism of injury. Duran and colleagues¹⁴ described a 20-year-old man with ipsilateral tibia and femur fractures caused by gunshots. Twenty-four hours after presentation, he developed tonic-clonic seizures and the classic triad of rash, hypoxia, and altered mental status. MRI confirmed CFE secondary to FES. The patient was optimized neurologically before definitive fixation and was discharged with minimal neurologic deficits on POD-27. Chang and colleagues¹⁵ and Yeo and colleagues¹⁶ described CFE in patients who underwent bilateral total knee arthroplasty. Symptoms developed 9 hours and 2 days after surgery, respectively. Both patients had fat emboli in the lungs and brain, underwent intensive care treatment, and recovered from the initial insult. After discharge at 44 days and 2 weeks, respectively, they fully recovered.

Other patients with CFE have had less favorable outcomes. Chen and colleagues⁶ reported the case of a 31-year-old man who sustained closed femur and tibia fractures in an automobile collision and experienced an acute decline in neurologic status 1 hour after arrival in the emergency department. The patient was intubated, CFE was diagnosed on the basis of MRI findings, and the orthopedic injuries were treated with external fixation. After 2 weeks, the patient was discharged with persistent neurologic deficits and the need for long-term tube feeding. Walshe and colleagues¹⁷ reported the case of a 19-year-old woman who sustained multiple long-bone injuries and traumatic brain injury and showed fat emboli on MRI. The patient experienced brain herniation while in the intensive care unit and later was declared brain-dead. According to the literature, it is important to maintain high suspicion for FES and possible CFE in the setting of high-energy fracture but also to be aware that FES may develop even with nondisplaced fracture or with reaming of the intramedullary canal in elective total joint arthroplasty.¹⁸

 

Pathophysiology of Fat Embolism Syndrome

The pathophysiology of FES and specifically of CFE is not widely understood. Two main theories on the development of FES have been advanced.

The mechanical theory suggests that exposing intramedullary long-bone contents allows fat to mobilize into the bloodstream.¹⁹ This occurs in the setting of long-bone fracture and in canal preparation during joint replacement surgery. More fat extravasates into the venous system after femur fracture than after tibia fracture, which accounts for the higher risk for FES in femoral shaft fractures and the even higher risk in concomitant femur and tibia fractures.⁴ In addition to there being a risk of fat embolism from the fracture itself, placing the patient in traction or reaming the intramedullary canal may exacerbate this effect by increased extravasation of fat from the medullary canal. With extravasation of fatty bone marrow into the venous system, fat emboli are free to travel back to the lungs, where they can cause infarcts within the lung parenchyma.

In the mechanical theory, presence of PFO may allow fat globules to pass into the systemic circulation and cause end-organ emboli. In the event of cerebral emboli, neurologic symptoms may vary widely and may include diffuse encephalopathy and global deficits.²⁰ Dog studies have found a possible mechanism for CFE in the absence of PFO. One such study, which used femoral pressurization to replicate cemented femoral arthroplasty, found that many fat globules had traversed the lungs after release into bone marrow,²¹ supporting the theory that fat droplets can traverse the pulmonary system without sequestration in the lung parenchyma. Riding and colleagues²² reported finding pulmonary arteriovenous shunts, which are thought to allow CFE to occur in the absence of PFO. More studies are needed to determine the prevalence of shunts and their overall contribution to CFE development in patients with long-bone fracture.

The biochemical theory holds that bodily trauma induces the release of free fatty acids (FFAs) from the capillaries into the bloodstream.²³ This stress response is mediated by catecholamines, which activate the adenyl cyclase pathway, which activates lipase, which hydrolyzes stored triglycerides to FFAs and glycerol. The concentration of circulating FFA was increased in 9 of 10 patients in one study.²³ Increased FFAs in the bloodstream can accelerate local and end-organ clotting, leading to thrombocytopenia and endothelial injury. In addition, patients with hypercoagulable diseases are at higher risk for postoperative thromboembolism.²⁴ However, with a negative hypercoagulable work-up and with negative chest helical CT and EKG, which did not demonstrate PFO, the explanation for CFE in our patient may more likely reside with the arteriovenous shunt theory proposed by Riding and colleagues.²²

Diagnosis and Treatment

Proper care of orthopedic patients who potentially have FES/CFE involves prompt diagnosis, immediate symptomatic care, and early coordination with neurology and medical services to rule out other causes of symptoms. Obtaining advanced imaging to rule out other potential causes and to confirm the diagnosis is crucial. The patient in this case report did not exhibit any focal neurologic deficits, but emergent CT of the brain was indicated to rule out a hemorrhagic event. If a stroke secondary to FES is clinically suspected, MRI should be obtained as soon as possible. Multiple studies have found that the “starfield” pattern, which is best seen as multiple punctate hyperintensities on T2 imaging, is the typical radiographic manifestation of CFE.⁹ This applies to patients who are in the 24- to 72-hour window after long-bone fracture or fixation and who fit Gurd and Wilson¹ criteria or Lindeque^1,2criteria, or who exhibit a change in mental status but have a negative CT scan of the brain, as was the case with our patient. Once the diagnosis is made, treatment involves addressing the symptoms (Figure 4).

Hypoxia should be treated with supplementary oxygen; if acute respiratory distress syndrome develops, intubation and mechanical ventilation may be required. Patients with embolic phenomena causing CFE should receive aspirin for stroke prophylaxis and an antiepileptic for seizure prophylaxis. The best way to treat FES and CFE remains prevention with early operative fixation. If prevention fails, timely supportive care can help; a majority of patients who receive such care recover from neurologic and pulmonary sequelae (overall mortality rate, 10%).²⁵

Fat Embolism Syndrome in Reamed and Unreamed Nailing

Over the past several decades, the number of long bones fixed with intramedullary nails has increased significantly.²⁶ There is debate regarding whether use of reamed intramedullary nails increases the risk of fat emboli relative to use of unreamed nails, but multiple studies have found no significant difference.^26,27 Pulmonary shunting occurs in both reamed and unreamed nailing; neither technique has an advantage in terms of cardiopulmonary complications. In multiple studies, reamed nails have the advantage of improved healing rates.²⁷ A sheep study compared reamed and unreamed femoral nailing.²⁸ After nailing, sheep lungs were examined histologically for the presence of bone marrow fat embolism. The embolism rate was higher with unreamed nailing (10.25%) than with reamed nailing (6.66%). One large study of the adverse effects of reamed and unreamed nailing in 1226 patients with tibial shaft fracture found that those with open fractures had higher rates of a negative event (nonunion, infection, fasciotomy, hardware failure, need for dynamization) after reamed nailing.²⁹ Patients with closed fractures had fewer events after reamed nailing. The authors concluded there is a potential benefit in outcome with reamed intramedullary nailing in patients with closed tibial shaft fractures, but they did not comment on development of FES. In a study of the effect of subject position on intramedullary pressure and fat embolism release, dogs were positioned either supine or lateral for tibial and femoral reaming.³⁰ The authors measured various physiologic parameters, including cardiac output, pulmonary arterial wedge pressure, arterial and venous blood gas, and blood cell counts. There were no statistically significant differences in values between the 2 groups in any variable, indicating that position does not affect FES development in the orthopedic trauma setting.

 

Conclusion

FES and CFE are potential devastating sequelae of both long-bone fracture and long-bone instrumentation. It is important to recognize these entities in the acute setting and to consider them in the differential diagnosis of a trauma or postoperative patient who experiences sudden onset of altered mental status with or without dyspnea or a petechial rash. If CFE is suspected, early advanced imaging (including urgent MRI) should be obtained with rapid involvement of a multidisciplinary team that can optimize the chance for successful recovery of both neurologic and physical function. The best treatment, early prevention and diagnosis, maximizes care of symptoms. As is evidenced in this case report, rapid diagnosis and treatment often result in recovery from a majority of the symptoms of FES and CFE.

Am J Orthop. 2016;45(7):E515-E521. Copyright Frontline Medical Communications Inc. 2016. All rights reserved.

Fat embolism syndrome (FES) occurs in long-bone fractures and classically presents with the triad of hypoxia, petechia, and altered mental status, or the criteria of Gurd and Wilson.¹ The Lindeque criteria (femur fracture, pH <7.3, increased work of breathing) are also used.^1,2 FES is a potentially fatal complication, with mortality rates ranging from 10% to 36%.^1,3 FES typically occurs within 24 to 72 hours after initial insult, with one study finding an average of 48.5 hours after injury and an incidence of 0.15% to 2.4%.⁴ The overall FES rate is <1% in retrospective reviews and 11% to 29% in prospective studies.⁵ FES may present without one or all of the Gurd and Wilson criteria,⁶ and cerebral fat embolism (CFE) can be even more difficult to diagnose. Patients with CFE typically present with a wide array of postoperative neurologic deficits, commonly in the 24- to 72-hour window in which FES typically occurs. Correct diagnosis and management of CFE require a high index of suspicion and knowledge of the diagnostic work-up. In the postoperative setting, it can be difficult to distinguish CFE-related neurologic deficits from the normal sequelae of anesthesia, pain medications, and other factors.

In this article, we report the case of a 42-year-old woman who developed CFE after reamed intramedullary nail fixation of femoral and tibial shaft fractures. The patient provided written informed consent for print and electronic publication of this case report.

Case Report

A 42-year-old woman with no past medical history was injured when a horse reared and fell on her. Initial emergent computed tomography (CT) was negative for intracranial hemorrhage, and injury radiographs were obtained (Figures 1A, 1B).

The next morning, the patient underwent reamed intramedullary nailing of femur and tibia (floating knee injury) through a transpatellar approach in a single operation. Oxygen saturation and vital signs were maintained at normal levels throughout the procedure, and there were no intraoperative complications. Postoperative radiographs were obtained (Figures 1C, 1D).

About 9 hours after surgery and 36 hours after injury, the patient was unresponsive. Vital signs, including oxygen saturation, were within normal limits, but she was unable to verbalize. Physical examination revealed symmetric facial musculature but also generalized weakness and diffuse hypertonicity and hyperreflexia. Initial laboratory results, including complete blood cell count, electrolyte panel, and troponin levels, were unremarkable. Naloxone was administered to rule out opioid overdose. An immediate code stroke and neurology consultation was requested. An emergent CT scan of the brain was negative; an urgent magnetic resonance imaging (MRI) scan showed multiple punctate T2/FLAIR (fluid attenuated inversion recovery) hyperintensities with restricted diffusion, predominantly in a parasagittal white matter distribution (Figure 2).

Findings were consistent with multifocal infarcts secondary to CFE. Hypercoagulability workup, CT with pulmonary embolism (PE) protocol, lumbar puncture, and electrocardiogram (EKG) with bubble study were all negative. There was no PE or patent foramen ovale (PFO). Levetiracetam was started as prophylaxis against seizure activity, and aspirin in the setting of embolic stroke.

The patient slowly and steadily improved. She was verbal by postoperative day 3 (POD-3), upper motor neuron signs resolved by POD-4, encephalopathy resolved by POD-7, and she was discharged to a rehabilitation center. Unresolved post-stroke symptoms included mild visual field deficits in the right eye (20/25 vision, central scotoma) and amnesia regarding the events immediately surrounding the surgery. There were no other neurologic or cognitive deficits. The patient was non-weight-bearing on the operative extremity and ambulating with assistance, and she started range-of-motion exercises. After 1 week, she was discharged home with crutches.

The patient followed up with neurology and ophthalmology for routine post-stroke care. At 2- and 6-month neurology follow-ups, she was still amnestic regarding her acute stroke event but did not exhibit any confusion, memory problems, speech deficits, facial droop, headaches, or weakness. According to neurology, the encephalopathy was completely resolved, and the patient was completely recovered from the event. Levetiracetam and aspirin were discontinued at 2 months. At the 2-month ophthalmology follow-up, the patient had 20/20 vision in both eyes and nearly complete resolution of the central scotoma. Ophthalmology confirmed symptom relief and recommended return to routine eye care and 1-year follow-up.

The patient began weight-bearing as tolerated on POD-14 and had no hardware or other complications. At 6-month orthopedics follow-up, range of motion of the affected knee was 0° to 120°, and rotation, length, and varus/valgus and anteroposterior knee laxity were all symmetric to the contralateral extremity. The patient walked with a cane for balance and had a mild limp. The affected thigh still had mild atrophy, but strength was 5/5 throughout. The patient denied pain or hardware sensitivity in the affected extremity and was very pleased with the result.

 

Discussion

Postoperative Acute Mental Status Change

There are many causes of postoperative mental status change after intramedullary nailing. Change may be cardiogenic, infectious, pharmacologic, or neurologic in origin. Age should be considered in the work-up of postoperative mental status change, as common complications differ between older and younger patients, with geriatric patients at particularly high risk for delirium.

In addition, past medical history is important in determining causes of mental status change, as many conditions (eg, cardiac disease, hypercoagulable state, dementia, polypharmacy) can cause or exacerbate these changes. A systematic approach is recommended for evaluating any patient with an acute mental status change (Figure 3).^1,5,7

Next to be evaluated are vital signs—particularly hypoxia, as isolated tachycardia may simply be a manifestation of pain. The cardiac system is then assessed with EKG and cardiac-specific laboratory tests, including a troponin level test if there is suspicion of myocardial infarction. PE and FES are complications with a higher prevalence in intramedullary nailing, and pulmonary involvement can be ruled out with the CT with PE protocol. Skin examination is important as well, as FES presents with petechial rash in 60% of patients⁸ (rash was absent in our patient’s case). Narcotic overdose is easily ruled out with administration of naloxone. Infection and sepsis can cause mental changes, though more commonly in the elderly and seldom so soon after surgery. Evaluation for infection and sepsis involves urinalysis and culturing of blood, urine, and other bodily fluids. If there is concern about surgical site infection, the postoperative dressing should be immediately removed and the wound examined. Last, neurologic and embolic phenomena can be initially investigated with CT to rule out hemorrhagic stroke. If CT of the brain is negative, MRI should be performed. MRI is the gold standard for diagnosing ischemic stroke and CFE caused by FES.⁹

Prevalence of Fat Embolism Syndrome

Development of intramedullary fat release in patients with long-bone injuries is common. A prospective study found circulating fat globules in 95% of 43 patients with femur fractures.¹⁰ In another study, transesophageal EKG showed cardiac embolism in 62% of patients who had undergone intramedullary nail fixation.¹¹ Despite this high rate, only 0.9% to 2.2% of patients developed symptomatic FES. Risk factors for FES include younger age, multiple fractures, closed fractures, and nonoperative or delayed management of long-bone fractures.² As already mentioned, average time to FES presentation after long-bone fracture is about 48 hours. One study found that FES typically occurs within 24 to 72 hours after initial insult (average, 48.5 hours) and that the incidence of FES is 0.15% in tibia fractures, 0.78% in femur fractures, and 2.4% in multiple long-bone fractures.⁴ The timeline is consistent with the present case—our patient developed symptoms about 36 hours after injury. In addition, other studies have found a higher mortality rate (5%-15%) for patients with bilateral femur fractures than for patients with only one fracture.^7,12,13 Patients with a floating knee injury (ipsilateral tibia and femur fractures) are at higher risk for FES and have higher overall morbidity and mortality rates in comparison with patients with an isolated femur or tibia fracture, though the increased risk has not been quantified.

Review of Case Literature: FES With CFE

Few cases of FES with symptomatic CFE in the setting of long-bone fracture or long-bone surgery have been reported in the literature. There is wide variation in the development of FES with respect to preoperative or postoperative status and mechanism of injury. Duran and colleagues¹⁴ described a 20-year-old man with ipsilateral tibia and femur fractures caused by gunshots. Twenty-four hours after presentation, he developed tonic-clonic seizures and the classic triad of rash, hypoxia, and altered mental status. MRI confirmed CFE secondary to FES. The patient was optimized neurologically before definitive fixation and was discharged with minimal neurologic deficits on POD-27. Chang and colleagues¹⁵ and Yeo and colleagues¹⁶ described CFE in patients who underwent bilateral total knee arthroplasty. Symptoms developed 9 hours and 2 days after surgery, respectively. Both patients had fat emboli in the lungs and brain, underwent intensive care treatment, and recovered from the initial insult. After discharge at 44 days and 2 weeks, respectively, they fully recovered.

Other patients with CFE have had less favorable outcomes. Chen and colleagues⁶ reported the case of a 31-year-old man who sustained closed femur and tibia fractures in an automobile collision and experienced an acute decline in neurologic status 1 hour after arrival in the emergency department. The patient was intubated, CFE was diagnosed on the basis of MRI findings, and the orthopedic injuries were treated with external fixation. After 2 weeks, the patient was discharged with persistent neurologic deficits and the need for long-term tube feeding. Walshe and colleagues¹⁷ reported the case of a 19-year-old woman who sustained multiple long-bone injuries and traumatic brain injury and showed fat emboli on MRI. The patient experienced brain herniation while in the intensive care unit and later was declared brain-dead. According to the literature, it is important to maintain high suspicion for FES and possible CFE in the setting of high-energy fracture but also to be aware that FES may develop even with nondisplaced fracture or with reaming of the intramedullary canal in elective total joint arthroplasty.¹⁸

 

Pathophysiology of Fat Embolism Syndrome

The pathophysiology of FES and specifically of CFE is not widely understood. Two main theories on the development of FES have been advanced.

The mechanical theory suggests that exposing intramedullary long-bone contents allows fat to mobilize into the bloodstream.¹⁹ This occurs in the setting of long-bone fracture and in canal preparation during joint replacement surgery. More fat extravasates into the venous system after femur fracture than after tibia fracture, which accounts for the higher risk for FES in femoral shaft fractures and the even higher risk in concomitant femur and tibia fractures.⁴ In addition to there being a risk of fat embolism from the fracture itself, placing the patient in traction or reaming the intramedullary canal may exacerbate this effect by increased extravasation of fat from the medullary canal. With extravasation of fatty bone marrow into the venous system, fat emboli are free to travel back to the lungs, where they can cause infarcts within the lung parenchyma.

In the mechanical theory, presence of PFO may allow fat globules to pass into the systemic circulation and cause end-organ emboli. In the event of cerebral emboli, neurologic symptoms may vary widely and may include diffuse encephalopathy and global deficits.²⁰ Dog studies have found a possible mechanism for CFE in the absence of PFO. One such study, which used femoral pressurization to replicate cemented femoral arthroplasty, found that many fat globules had traversed the lungs after release into bone marrow,²¹ supporting the theory that fat droplets can traverse the pulmonary system without sequestration in the lung parenchyma. Riding and colleagues²² reported finding pulmonary arteriovenous shunts, which are thought to allow CFE to occur in the absence of PFO. More studies are needed to determine the prevalence of shunts and their overall contribution to CFE development in patients with long-bone fracture.

The biochemical theory holds that bodily trauma induces the release of free fatty acids (FFAs) from the capillaries into the bloodstream.²³ This stress response is mediated by catecholamines, which activate the adenyl cyclase pathway, which activates lipase, which hydrolyzes stored triglycerides to FFAs and glycerol. The concentration of circulating FFA was increased in 9 of 10 patients in one study.²³ Increased FFAs in the bloodstream can accelerate local and end-organ clotting, leading to thrombocytopenia and endothelial injury. In addition, patients with hypercoagulable diseases are at higher risk for postoperative thromboembolism.²⁴ However, with a negative hypercoagulable work-up and with negative chest helical CT and EKG, which did not demonstrate PFO, the explanation for CFE in our patient may more likely reside with the arteriovenous shunt theory proposed by Riding and colleagues.²²

Diagnosis and Treatment

Proper care of orthopedic patients who potentially have FES/CFE involves prompt diagnosis, immediate symptomatic care, and early coordination with neurology and medical services to rule out other causes of symptoms. Obtaining advanced imaging to rule out other potential causes and to confirm the diagnosis is crucial. The patient in this case report did not exhibit any focal neurologic deficits, but emergent CT of the brain was indicated to rule out a hemorrhagic event. If a stroke secondary to FES is clinically suspected, MRI should be obtained as soon as possible. Multiple studies have found that the “starfield” pattern, which is best seen as multiple punctate hyperintensities on T2 imaging, is the typical radiographic manifestation of CFE.⁹ This applies to patients who are in the 24- to 72-hour window after long-bone fracture or fixation and who fit Gurd and Wilson¹ criteria or Lindeque^1,2criteria, or who exhibit a change in mental status but have a negative CT scan of the brain, as was the case with our patient. Once the diagnosis is made, treatment involves addressing the symptoms (Figure 4).

Hypoxia should be treated with supplementary oxygen; if acute respiratory distress syndrome develops, intubation and mechanical ventilation may be required. Patients with embolic phenomena causing CFE should receive aspirin for stroke prophylaxis and an antiepileptic for seizure prophylaxis. The best way to treat FES and CFE remains prevention with early operative fixation. If prevention fails, timely supportive care can help; a majority of patients who receive such care recover from neurologic and pulmonary sequelae (overall mortality rate, 10%).²⁵

Fat Embolism Syndrome in Reamed and Unreamed Nailing

Over the past several decades, the number of long bones fixed with intramedullary nails has increased significantly.²⁶ There is debate regarding whether use of reamed intramedullary nails increases the risk of fat emboli relative to use of unreamed nails, but multiple studies have found no significant difference.^26,27 Pulmonary shunting occurs in both reamed and unreamed nailing; neither technique has an advantage in terms of cardiopulmonary complications. In multiple studies, reamed nails have the advantage of improved healing rates.²⁷ A sheep study compared reamed and unreamed femoral nailing.²⁸ After nailing, sheep lungs were examined histologically for the presence of bone marrow fat embolism. The embolism rate was higher with unreamed nailing (10.25%) than with reamed nailing (6.66%). One large study of the adverse effects of reamed and unreamed nailing in 1226 patients with tibial shaft fracture found that those with open fractures had higher rates of a negative event (nonunion, infection, fasciotomy, hardware failure, need for dynamization) after reamed nailing.²⁹ Patients with closed fractures had fewer events after reamed nailing. The authors concluded there is a potential benefit in outcome with reamed intramedullary nailing in patients with closed tibial shaft fractures, but they did not comment on development of FES. In a study of the effect of subject position on intramedullary pressure and fat embolism release, dogs were positioned either supine or lateral for tibial and femoral reaming.³⁰ The authors measured various physiologic parameters, including cardiac output, pulmonary arterial wedge pressure, arterial and venous blood gas, and blood cell counts. There were no statistically significant differences in values between the 2 groups in any variable, indicating that position does not affect FES development in the orthopedic trauma setting.

 

Conclusion

FES and CFE are potential devastating sequelae of both long-bone fracture and long-bone instrumentation. It is important to recognize these entities in the acute setting and to consider them in the differential diagnosis of a trauma or postoperative patient who experiences sudden onset of altered mental status with or without dyspnea or a petechial rash. If CFE is suspected, early advanced imaging (including urgent MRI) should be obtained with rapid involvement of a multidisciplinary team that can optimize the chance for successful recovery of both neurologic and physical function. The best treatment, early prevention and diagnosis, maximizes care of symptoms. As is evidenced in this case report, rapid diagnosis and treatment often result in recovery from a majority of the symptoms of FES and CFE.

Am J Orthop. 2016;45(7):E515-E521. Copyright Frontline Medical Communications Inc. 2016. All rights reserved.

Bone grafting is the main method of treating nonunions.¹ The multiple bone graft options available include autogenous bone grafts, allogenic bone grafts, and synthetic bone graft substitutes.^2,3 Autogenous bone graft has long been considered the gold standard, as it reduces the risk of infection and eliminates the risk of immune rejection associated with allograft; in addition, autograft has the optimal combination of osteogenic, osteoinductive, and osteoconductive properties.^2,4,5 Iliac crest bone graft (ICBG), though the most commonly used autogenous bone graft source, has been associated with infection, hematoma, poor cosmetic outcomes, hernia, neurovascular insults, and chronic persistent pain.^6,7 Intramedullary bone graft harvest performed with the Reamer/Irrigator/Aspirator (RIA) system (DePuy Synthes) is a novel technique that allows for simultaneous débridement and collection of bone graft, protects against thermal necrosis and extravasation of marrow contents, and maintains biomechanical strength for weight-bearing.^3,4,8,9 Furthermore, RIA aspirate is a rich source of autologous bone graft and provides equal or superior amounts of graft in comparison with ICBG.^5-7,10-12

In some cases, RIA is associated with the complication of host bone fracture.^4,6,7,11,12 In addition, introducing the reamer may contribute to pain at its entry site and may require violation of local soft-tissue attachments at the hip or knees.^4,7,13 In this study, we assessed the possibility of using a new RIA technique to eliminate these adverse effects. We hypothesized that distal femoral nonunions could be successfully treated with the RIA passed retrograde through the nonunion site. This technique may obviate the need for a secondary surgical site (required in traditional intramedullary bone graft harvest), minimize the potential entry-site tissue (eg, hip abductor) damage encountered with the antegrade technique, and yield harvested bone graft in quantities similar to those obtained with the standard technique.

After obtaining Institutional Review Board approval for this study, we retrospectively reviewed the medical records of all patients with a distal femur nonunion treated with autogenous bone grafting between 2009 and 2013. Identified patients had undergone a novel intramedullary harvest technique that involved passing an RIA retrograde through the nonunion site. Data (patient demographics, volume of graft obtained, perioperative complications, postoperative clinical course) were extracted from the medical records. Before data collection, all patients provided written informed consent for print and electronic publication of their case reports.

Technique

The patient was laid supine on a radiolucent table, and the affected extremity was prepared and draped free. A standard lateral incision previously used for the index procedure was employed. After implant removal, a rongeur, curette, and/or high-speed burr was used to débride the distal femur nonunion of all fibrous tissue. After mobilization and preparation of the distal femoral nonunion, varus angulation was accentuated with delivery of the proximal and distal segments of the nonunion into the wound (Figure A).

A ball-tipped guide wire was subsequently passed through the nonunion site for intramedullary bone graft harvest. The standard RIA technique was then applied to obtain the bone graft (Figure B).

Six patients underwent 7 separate procedures for distal femoral nonunion. Of these patients, 5 underwent retrograde RIA through the nonunion site, as described above; the sixth underwent antegrade RIA in the traditional fashion and was therefore excluded. One of the 5 patients underwent another bone grafting procedure after the initial retrograde RIA treatment through the nonunion site. Several outcomes were measured: ability to obtain graft, volume of graft obtained, perioperative complications, and feasibility of the procedure.

Mean age of the 5 patients was 40.4 years (range, 22-66 years). Mean reamer size was 13.4 mm (mode, 14 mm), producing an average bone graft volume of 33 mL. There were no intraoperative or postoperative fractures. In 1 case, the reamer shaft broke during insertion and was retrieved with no retained hardware; passage was made with a new reamer shaft. No patient experienced additional pain or discomfort, as there was no separate entry site for the RIA.

Discussion

Bone grafting for nonunion is one of the most commonly performed procedures in orthopedic trauma surgery. Use of an intramedullary harvest system has become increasingly popular relative to alternative techniques. The RIA system is associated with less donor-site pain and provides relatively more bone graft volume in comparison with ICBG harvest.^6,7,10,13 Conversely, intramedullary bone graft harvest may be associated with higher risk of host bone fractures, occurring either during surgery (technical error being the cause) or afterward (a result of patient noncompliance or overaggressive reaming).^6,7,11,12 Multiple methods of reducing the risk of iatrogenic fracture caused by technical error of eccentric reaming have been described, including appropriate guide wire placement aided by frequent use of fluoroscopy in 2 planes.⁴ Despite these potential complications and improved donor-site pain complaints in comparison with ICBG harvest, traditional RIA harvest is still associated with pain at the entry site.^4,7,13

 

In this study, we introduced a novel RIA technique for distal femur nonunion. This technique reduces the complications and adverse effects associated with RIA. It removes the added pain and discomfort associated with a separate entry site. As the reamer is introduced into the medullary canal through the femoral nonunion site, and proximal harvest is limited to the subtrochanteric region, the technique also avoids the complications associated with eccentric reaming of the distal and proximal femur, which may contribute to secondary fracture.^6,7,11,12Although the proposed technique is practical, it may present some technical difficulties. First, failed fixation hardware must be removed, and by necessity some stripping of soft tissues is required. These actions are unavoidable, as hardware revision is inherent in the treatment of nonunion. During the procedure, the focus should be on minimizing the insult to bony healing. The nonunion also needs to be completely mobilized to allow adequate angulation, guide wire passage, and sequential reaming. The dual vascular insult of intramedullary reaming combined with the soft-tissue débridement and detachment required for hardware removal and mobilization can be concerning for devascularization of the fracture fragment. However, animal studies have suggested reaming does not affect metaphyseal blood flow; it affects only diaphyseal bone.^6,14 The metaphyseal/diaphyseal location of these distal femur nonunions is thought to provide at least partial sparing from the endosteal injury that the RIA may cause. Another difficulty is that the angle of passage of the wire requires a relatively steeper curve to be able to pass beyond the medial distal femoral wall and proceed more proximally. Strong manipulation of the segment is required, which in 1 case caused the reamer shaft to break. This complication had minimal sequelae; the shaft was easily retrieved by withdrawing the ball-tipped guide wire. In addition, strong manipulation of the segment can lead to asymmetric medial reaming or fracture—an outcome easily avoided with a small bend in the distal tip of the guide wire and frequent use of fluoroscopy. In all cases in this series, we achieved proximal passage of the wire and the reamer.

Most RIA bone graft is harvested by reaming the medullary canal at the midshaft of the femur. Passing from the distal femoral nonunion precludes obtaining only a small source of potential distal femoral bone graft, though this metaphyseal bone typically is not used for fear of eccentric reaming and secondary fracture.^6,7,11,12 The amount of bone graft obtained from selected patients who undergo retrograde RIA passage through the nonunion site should be similar to the amount obtained with the traditional antegrade method. Our newly proposed technique provided an average bone graft volume of 33 mL, which compares favorably with that reported in the literature for the traditional RIA technique.^{1,5,6,13,15,16}

Conclusion

In distal femoral cases, retrograde passage of the RIA through the nonunion site is technically feasible and has reproducible yields of intramedullary bone graft. Adequate mobilization of the nonunion is a prerequisite for reamer harvest. However, this technique obviates the need for an additional entry point. Furthermore, the technique may limit the perioperative fracture risk previously seen with eccentric reaming of the distal and proximal femur using traditional intramedullary harvest.

Am J Orthop. 2016;45(7):E493-E496. Copyright Frontline Medical Communications Inc. 2016. All rights reserved.

Bone grafting is the main method of treating nonunions.¹ The multiple bone graft options available include autogenous bone grafts, allogenic bone grafts, and synthetic bone graft substitutes.^2,3 Autogenous bone graft has long been considered the gold standard, as it reduces the risk of infection and eliminates the risk of immune rejection associated with allograft; in addition, autograft has the optimal combination of osteogenic, osteoinductive, and osteoconductive properties.^2,4,5 Iliac crest bone graft (ICBG), though the most commonly used autogenous bone graft source, has been associated with infection, hematoma, poor cosmetic outcomes, hernia, neurovascular insults, and chronic persistent pain.^6,7 Intramedullary bone graft harvest performed with the Reamer/Irrigator/Aspirator (RIA) system (DePuy Synthes) is a novel technique that allows for simultaneous débridement and collection of bone graft, protects against thermal necrosis and extravasation of marrow contents, and maintains biomechanical strength for weight-bearing.^3,4,8,9 Furthermore, RIA aspirate is a rich source of autologous bone graft and provides equal or superior amounts of graft in comparison with ICBG.^5-7,10-12

In some cases, RIA is associated with the complication of host bone fracture.^4,6,7,11,12 In addition, introducing the reamer may contribute to pain at its entry site and may require violation of local soft-tissue attachments at the hip or knees.^4,7,13 In this study, we assessed the possibility of using a new RIA technique to eliminate these adverse effects. We hypothesized that distal femoral nonunions could be successfully treated with the RIA passed retrograde through the nonunion site. This technique may obviate the need for a secondary surgical site (required in traditional intramedullary bone graft harvest), minimize the potential entry-site tissue (eg, hip abductor) damage encountered with the antegrade technique, and yield harvested bone graft in quantities similar to those obtained with the standard technique.

After obtaining Institutional Review Board approval for this study, we retrospectively reviewed the medical records of all patients with a distal femur nonunion treated with autogenous bone grafting between 2009 and 2013. Identified patients had undergone a novel intramedullary harvest technique that involved passing an RIA retrograde through the nonunion site. Data (patient demographics, volume of graft obtained, perioperative complications, postoperative clinical course) were extracted from the medical records. Before data collection, all patients provided written informed consent for print and electronic publication of their case reports.

Technique

The patient was laid supine on a radiolucent table, and the affected extremity was prepared and draped free. A standard lateral incision previously used for the index procedure was employed. After implant removal, a rongeur, curette, and/or high-speed burr was used to débride the distal femur nonunion of all fibrous tissue. After mobilization and preparation of the distal femoral nonunion, varus angulation was accentuated with delivery of the proximal and distal segments of the nonunion into the wound (Figure A).

A ball-tipped guide wire was subsequently passed through the nonunion site for intramedullary bone graft harvest. The standard RIA technique was then applied to obtain the bone graft (Figure B).

Six patients underwent 7 separate procedures for distal femoral nonunion. Of these patients, 5 underwent retrograde RIA through the nonunion site, as described above; the sixth underwent antegrade RIA in the traditional fashion and was therefore excluded. One of the 5 patients underwent another bone grafting procedure after the initial retrograde RIA treatment through the nonunion site. Several outcomes were measured: ability to obtain graft, volume of graft obtained, perioperative complications, and feasibility of the procedure.

Mean age of the 5 patients was 40.4 years (range, 22-66 years). Mean reamer size was 13.4 mm (mode, 14 mm), producing an average bone graft volume of 33 mL. There were no intraoperative or postoperative fractures. In 1 case, the reamer shaft broke during insertion and was retrieved with no retained hardware; passage was made with a new reamer shaft. No patient experienced additional pain or discomfort, as there was no separate entry site for the RIA.

Discussion

Bone grafting for nonunion is one of the most commonly performed procedures in orthopedic trauma surgery. Use of an intramedullary harvest system has become increasingly popular relative to alternative techniques. The RIA system is associated with less donor-site pain and provides relatively more bone graft volume in comparison with ICBG harvest.^6,7,10,13 Conversely, intramedullary bone graft harvest may be associated with higher risk of host bone fractures, occurring either during surgery (technical error being the cause) or afterward (a result of patient noncompliance or overaggressive reaming).^6,7,11,12 Multiple methods of reducing the risk of iatrogenic fracture caused by technical error of eccentric reaming have been described, including appropriate guide wire placement aided by frequent use of fluoroscopy in 2 planes.⁴ Despite these potential complications and improved donor-site pain complaints in comparison with ICBG harvest, traditional RIA harvest is still associated with pain at the entry site.^4,7,13

 

In this study, we introduced a novel RIA technique for distal femur nonunion. This technique reduces the complications and adverse effects associated with RIA. It removes the added pain and discomfort associated with a separate entry site. As the reamer is introduced into the medullary canal through the femoral nonunion site, and proximal harvest is limited to the subtrochanteric region, the technique also avoids the complications associated with eccentric reaming of the distal and proximal femur, which may contribute to secondary fracture.^6,7,11,12Although the proposed technique is practical, it may present some technical difficulties. First, failed fixation hardware must be removed, and by necessity some stripping of soft tissues is required. These actions are unavoidable, as hardware revision is inherent in the treatment of nonunion. During the procedure, the focus should be on minimizing the insult to bony healing. The nonunion also needs to be completely mobilized to allow adequate angulation, guide wire passage, and sequential reaming. The dual vascular insult of intramedullary reaming combined with the soft-tissue débridement and detachment required for hardware removal and mobilization can be concerning for devascularization of the fracture fragment. However, animal studies have suggested reaming does not affect metaphyseal blood flow; it affects only diaphyseal bone.^6,14 The metaphyseal/diaphyseal location of these distal femur nonunions is thought to provide at least partial sparing from the endosteal injury that the RIA may cause. Another difficulty is that the angle of passage of the wire requires a relatively steeper curve to be able to pass beyond the medial distal femoral wall and proceed more proximally. Strong manipulation of the segment is required, which in 1 case caused the reamer shaft to break. This complication had minimal sequelae; the shaft was easily retrieved by withdrawing the ball-tipped guide wire. In addition, strong manipulation of the segment can lead to asymmetric medial reaming or fracture—an outcome easily avoided with a small bend in the distal tip of the guide wire and frequent use of fluoroscopy. In all cases in this series, we achieved proximal passage of the wire and the reamer.

Most RIA bone graft is harvested by reaming the medullary canal at the midshaft of the femur. Passing from the distal femoral nonunion precludes obtaining only a small source of potential distal femoral bone graft, though this metaphyseal bone typically is not used for fear of eccentric reaming and secondary fracture.^6,7,11,12 The amount of bone graft obtained from selected patients who undergo retrograde RIA passage through the nonunion site should be similar to the amount obtained with the traditional antegrade method. Our newly proposed technique provided an average bone graft volume of 33 mL, which compares favorably with that reported in the literature for the traditional RIA technique.^{1,5,6,13,15,16}

Conclusion

In distal femoral cases, retrograde passage of the RIA through the nonunion site is technically feasible and has reproducible yields of intramedullary bone graft. Adequate mobilization of the nonunion is a prerequisite for reamer harvest. However, this technique obviates the need for an additional entry point. Furthermore, the technique may limit the perioperative fracture risk previously seen with eccentric reaming of the distal and proximal femur using traditional intramedullary harvest.

Am J Orthop. 2016;45(7):E493-E496. Copyright Frontline Medical Communications Inc. 2016. All rights reserved.

Bone grafting is the main method of treating nonunions.¹ The multiple bone graft options available include autogenous bone grafts, allogenic bone grafts, and synthetic bone graft substitutes.^2,3 Autogenous bone graft has long been considered the gold standard, as it reduces the risk of infection and eliminates the risk of immune rejection associated with allograft; in addition, autograft has the optimal combination of osteogenic, osteoinductive, and osteoconductive properties.^2,4,5 Iliac crest bone graft (ICBG), though the most commonly used autogenous bone graft source, has been associated with infection, hematoma, poor cosmetic outcomes, hernia, neurovascular insults, and chronic persistent pain.^6,7 Intramedullary bone graft harvest performed with the Reamer/Irrigator/Aspirator (RIA) system (DePuy Synthes) is a novel technique that allows for simultaneous débridement and collection of bone graft, protects against thermal necrosis and extravasation of marrow contents, and maintains biomechanical strength for weight-bearing.^3,4,8,9 Furthermore, RIA aspirate is a rich source of autologous bone graft and provides equal or superior amounts of graft in comparison with ICBG.^5-7,10-12

In some cases, RIA is associated with the complication of host bone fracture.^4,6,7,11,12 In addition, introducing the reamer may contribute to pain at its entry site and may require violation of local soft-tissue attachments at the hip or knees.^4,7,13 In this study, we assessed the possibility of using a new RIA technique to eliminate these adverse effects. We hypothesized that distal femoral nonunions could be successfully treated with the RIA passed retrograde through the nonunion site. This technique may obviate the need for a secondary surgical site (required in traditional intramedullary bone graft harvest), minimize the potential entry-site tissue (eg, hip abductor) damage encountered with the antegrade technique, and yield harvested bone graft in quantities similar to those obtained with the standard technique.

After obtaining Institutional Review Board approval for this study, we retrospectively reviewed the medical records of all patients with a distal femur nonunion treated with autogenous bone grafting between 2009 and 2013. Identified patients had undergone a novel intramedullary harvest technique that involved passing an RIA retrograde through the nonunion site. Data (patient demographics, volume of graft obtained, perioperative complications, postoperative clinical course) were extracted from the medical records. Before data collection, all patients provided written informed consent for print and electronic publication of their case reports.

Technique

The patient was laid supine on a radiolucent table, and the affected extremity was prepared and draped free. A standard lateral incision previously used for the index procedure was employed. After implant removal, a rongeur, curette, and/or high-speed burr was used to débride the distal femur nonunion of all fibrous tissue. After mobilization and preparation of the distal femoral nonunion, varus angulation was accentuated with delivery of the proximal and distal segments of the nonunion into the wound (Figure A).

A ball-tipped guide wire was subsequently passed through the nonunion site for intramedullary bone graft harvest. The standard RIA technique was then applied to obtain the bone graft (Figure B).

Six patients underwent 7 separate procedures for distal femoral nonunion. Of these patients, 5 underwent retrograde RIA through the nonunion site, as described above; the sixth underwent antegrade RIA in the traditional fashion and was therefore excluded. One of the 5 patients underwent another bone grafting procedure after the initial retrograde RIA treatment through the nonunion site. Several outcomes were measured: ability to obtain graft, volume of graft obtained, perioperative complications, and feasibility of the procedure.

Mean age of the 5 patients was 40.4 years (range, 22-66 years). Mean reamer size was 13.4 mm (mode, 14 mm), producing an average bone graft volume of 33 mL. There were no intraoperative or postoperative fractures. In 1 case, the reamer shaft broke during insertion and was retrieved with no retained hardware; passage was made with a new reamer shaft. No patient experienced additional pain or discomfort, as there was no separate entry site for the RIA.

Discussion

Bone grafting for nonunion is one of the most commonly performed procedures in orthopedic trauma surgery. Use of an intramedullary harvest system has become increasingly popular relative to alternative techniques. The RIA system is associated with less donor-site pain and provides relatively more bone graft volume in comparison with ICBG harvest.^6,7,10,13 Conversely, intramedullary bone graft harvest may be associated with higher risk of host bone fractures, occurring either during surgery (technical error being the cause) or afterward (a result of patient noncompliance or overaggressive reaming).^6,7,11,12 Multiple methods of reducing the risk of iatrogenic fracture caused by technical error of eccentric reaming have been described, including appropriate guide wire placement aided by frequent use of fluoroscopy in 2 planes.⁴ Despite these potential complications and improved donor-site pain complaints in comparison with ICBG harvest, traditional RIA harvest is still associated with pain at the entry site.^4,7,13

 

In this study, we introduced a novel RIA technique for distal femur nonunion. This technique reduces the complications and adverse effects associated with RIA. It removes the added pain and discomfort associated with a separate entry site. As the reamer is introduced into the medullary canal through the femoral nonunion site, and proximal harvest is limited to the subtrochanteric region, the technique also avoids the complications associated with eccentric reaming of the distal and proximal femur, which may contribute to secondary fracture.^6,7,11,12Although the proposed technique is practical, it may present some technical difficulties. First, failed fixation hardware must be removed, and by necessity some stripping of soft tissues is required. These actions are unavoidable, as hardware revision is inherent in the treatment of nonunion. During the procedure, the focus should be on minimizing the insult to bony healing. The nonunion also needs to be completely mobilized to allow adequate angulation, guide wire passage, and sequential reaming. The dual vascular insult of intramedullary reaming combined with the soft-tissue débridement and detachment required for hardware removal and mobilization can be concerning for devascularization of the fracture fragment. However, animal studies have suggested reaming does not affect metaphyseal blood flow; it affects only diaphyseal bone.^6,14 The metaphyseal/diaphyseal location of these distal femur nonunions is thought to provide at least partial sparing from the endosteal injury that the RIA may cause. Another difficulty is that the angle of passage of the wire requires a relatively steeper curve to be able to pass beyond the medial distal femoral wall and proceed more proximally. Strong manipulation of the segment is required, which in 1 case caused the reamer shaft to break. This complication had minimal sequelae; the shaft was easily retrieved by withdrawing the ball-tipped guide wire. In addition, strong manipulation of the segment can lead to asymmetric medial reaming or fracture—an outcome easily avoided with a small bend in the distal tip of the guide wire and frequent use of fluoroscopy. In all cases in this series, we achieved proximal passage of the wire and the reamer.

Most RIA bone graft is harvested by reaming the medullary canal at the midshaft of the femur. Passing from the distal femoral nonunion precludes obtaining only a small source of potential distal femoral bone graft, though this metaphyseal bone typically is not used for fear of eccentric reaming and secondary fracture.^6,7,11,12 The amount of bone graft obtained from selected patients who undergo retrograde RIA passage through the nonunion site should be similar to the amount obtained with the traditional antegrade method. Our newly proposed technique provided an average bone graft volume of 33 mL, which compares favorably with that reported in the literature for the traditional RIA technique.^{1,5,6,13,15,16}

Conclusion

In distal femoral cases, retrograde passage of the RIA through the nonunion site is technically feasible and has reproducible yields of intramedullary bone graft. Adequate mobilization of the nonunion is a prerequisite for reamer harvest. However, this technique obviates the need for an additional entry point. Furthermore, the technique may limit the perioperative fracture risk previously seen with eccentric reaming of the distal and proximal femur using traditional intramedullary harvest.

Am J Orthop. 2016;45(7):E493-E496. Copyright Frontline Medical Communications Inc. 2016. All rights reserved.

Septic arthritis is a common orthopedic emergency. The most common causative organism is Staphylococcus aureus. Mycotic infections, such as those involving Candida organisms, are much less common but just as debilitating. Delayed diagnosis of septic arthritis caused by Candida infection may result in increased morbidity, making treatment more challenging. Here we report a case of Candida albicans septic arthritis of the ankle and subtalar joint in a patient with diabetes mellitus (DM) and rheumatoid arthritis (RA). The patient provided written informed consent for print and electronic publication of this case report.

Case Report

A 52-year-old woman with type 2 DM (requiring subcutaneous insulin analogue therapy) and RA presented to a local emergency department with a 3-day history of right ankle pain after having the subtalar joint injected with steroid by a rheumatologist 4 weeks earlier. For about 2 weeks, there was purulent discharge from the peroneal sheath. The patient’s RA was being treated with prednisolone (maintenance therapy). Physical examination revealed low-grade pyrexia (37.8°C) and difficulty bearing full weight on the ankle. Clinically, the joint was not erythematous, but active and passive movements were painful. Blood tests revealed a C-reactive protein level of 98 mg/dL and a white blood cell (WBC) count of 11.3 × 10⁹/L. Erythrocyte sedimentation rate (ESR) was not checked. The ankle underwent magnetic resonance imaging (Figures A-D).

The subtalar joint was aspirated under ultrasound guidance, and specimens were sent for identification of organisms and sensitivities. More aspirate was obtained 1 week later. Both aspirates grew mycotic organisms.

Mycotic screening of the fluid was positive for C albicans. The patient was referred to the orthopedic team, which performed urgent arthroscopic surgical débridement, biopsy, and washout of the subtalar joint. After surgery, a 6-week course of antifungal therapy with anidulafungin was started, per specialist microbiology advice.

The septic ankle was successfully managed with arthroscopic surgical débridement followed by treatment with anidulafungin. The patient continued to make good progress and was weight-bearing when discharged home from the orthopedic unit.

Discussion

Worldwide, about 1 in 6 people has arthritis, which affects daily lifestyle and reduces quality of life. Degenerative, inflammatory, and septic arthritis each has its management challenges.¹

Septic arthritis is an acute infection of the joint, usually of bacterial etiology. It can present as a polyarticular arthropathy (~15% of cases),^2,3 but a monoarthropathy of the hip, knee, or ankle is more common.⁴The Kocher criteria are often applied to cases of suspected septic arthritis of joints, even though they were initially used to distinguish septic arthritis from transient synovitis in pediatric hip joints.⁵ Kocher and colleagues⁵ reported 4 key clinical criteria: inability to bear weight, WBC count over 12 × 10⁹/L, ESR over 40 mm/h, and temperature over 38.5°C. When all 4 criteria are met, the predictive value is 99.6%. These criteria are now widely applied to adult joints, and not only the hips.

In septic arthritis, the most common causative pathogen is S aureus.^3,6Streptococcus, Neisseria, and Pseudomonas also are common.⁷ Although much rarer, Candida variants and other mycotic pathogens have been implicated as well.⁸C albicans is a well-known fungus that colonizes mucosal surfaces. Research indicates increased oral C albicans colonization in rheumatoid patients.⁹ Although most Candida septic arthritis cases are caused by C albicans, there is no large body of data showing the true incidence of fungal pathogens in septic arthritis.

Our literature search yielded 2 case reports on Candida septic arthritis involving the ankle, but the causative organisms were Candida parapsilosis and Candida glabrata.^9,10 Cases of Candida septic arthritis involving the knee or shoulder have also been reported.^11-15 Case reports demonstrate that Candida fungal arthritis is extremely rare.⁹ Etiology reportedly includes direct intra-articular inoculation by surgery or secondary to hematogenous seeding, particularly in immunocompromised patients.¹⁰ Risk factors include immunosuppression and joint suppression. DM and RA are common comorbidities in patients with septic arthritis.^6,16 The pathophysiology of RA is inflammatory pannus formation of the periarticular surface with subsequent articular cartilage destruction and erosion, as well as progressive deformity and functional debilitation.¹Patients with DM are at increased risk for developing fungal and other infections. Factors increasing this risk include disruption of skin-barrier integrity; reduced peripheral oxygen and blood supply, which also disrupts antibiotic delivery; and hyperglycemia-induced reduction in antibody function and disruption of phagocytosis and chemotaxis.¹⁷Fungi are eukaryotic, and infections caused by these organisms are difficult to treat.¹⁸ As fungal infections are more prevalent among immunosuppressed patients, they often result in prolonged treatment without guarantee of eradication, as spores may persist subclinically.

Literature on C albicans septic arthritis is lacking in general but especially in rheumatoid patients. Delayed diagnosis and suboptimal treatment may result in fungal osteomyelitis. There is little evidence on treating this rare fungal complication, and outcomes historically have been poor.¹⁹In an animal model, Marijnissen and colleagues²⁰ found that C albicans infection can increase destruction in an arthritic joint by cytokine environment modification. The result was advanced destruction of the joint and debilitation. For disease management, the authors considered these essential: early diagnosis, prompt treatment, and, as indicated, surgical débridement.

Treatment of Candida septic arthritis largely involves use of antifungal medication, either with surgical débridement, as in our patient’s case, or without. Which antifungal medication to use should be based on sensitivities, identified from wound aspirate, and microbiology advice about treatment duration. The antibiotic should be a broad-spectrum antifungal cover, in keeping with local antibiotic prescribing guidelines, which can be refined once definitive organism culture and sensitivity results are known. However, early aggressive treatment is essential. Periprosthetic fungal infection is rarely resolved without implant removal.²¹

 

Conclusion

This case reflects the complexities of septic arthritis caused by atypical pathogens and highlights the need for clinical vigilance in the setting of comorbidities, such as DM and RA. Failure to consider the diagnosis early on might result in delayed and inadequate treatment, increased joint destruction, and, potentially, osteomyelitis with subsequent increased morbidity. Early diagnosis (based on joint aspirate findings), surgical débridement, and prolonged aggressive treatment with antifungal medication are the mainstays of treatment.

Am J Orthop. 2016;45(7):E478-E480. Copyright Frontline Medical Communications Inc. 2016. All rights reserved.

Septic arthritis is a common orthopedic emergency. The most common causative organism is Staphylococcus aureus. Mycotic infections, such as those involving Candida organisms, are much less common but just as debilitating. Delayed diagnosis of septic arthritis caused by Candida infection may result in increased morbidity, making treatment more challenging. Here we report a case of Candida albicans septic arthritis of the ankle and subtalar joint in a patient with diabetes mellitus (DM) and rheumatoid arthritis (RA). The patient provided written informed consent for print and electronic publication of this case report.

Case Report

A 52-year-old woman with type 2 DM (requiring subcutaneous insulin analogue therapy) and RA presented to a local emergency department with a 3-day history of right ankle pain after having the subtalar joint injected with steroid by a rheumatologist 4 weeks earlier. For about 2 weeks, there was purulent discharge from the peroneal sheath. The patient’s RA was being treated with prednisolone (maintenance therapy). Physical examination revealed low-grade pyrexia (37.8°C) and difficulty bearing full weight on the ankle. Clinically, the joint was not erythematous, but active and passive movements were painful. Blood tests revealed a C-reactive protein level of 98 mg/dL and a white blood cell (WBC) count of 11.3 × 10⁹/L. Erythrocyte sedimentation rate (ESR) was not checked. The ankle underwent magnetic resonance imaging (Figures A-D).

The subtalar joint was aspirated under ultrasound guidance, and specimens were sent for identification of organisms and sensitivities. More aspirate was obtained 1 week later. Both aspirates grew mycotic organisms.

Mycotic screening of the fluid was positive for C albicans. The patient was referred to the orthopedic team, which performed urgent arthroscopic surgical débridement, biopsy, and washout of the subtalar joint. After surgery, a 6-week course of antifungal therapy with anidulafungin was started, per specialist microbiology advice.

The septic ankle was successfully managed with arthroscopic surgical débridement followed by treatment with anidulafungin. The patient continued to make good progress and was weight-bearing when discharged home from the orthopedic unit.

Discussion

Worldwide, about 1 in 6 people has arthritis, which affects daily lifestyle and reduces quality of life. Degenerative, inflammatory, and septic arthritis each has its management challenges.¹

Septic arthritis is an acute infection of the joint, usually of bacterial etiology. It can present as a polyarticular arthropathy (~15% of cases),^2,3 but a monoarthropathy of the hip, knee, or ankle is more common.⁴The Kocher criteria are often applied to cases of suspected septic arthritis of joints, even though they were initially used to distinguish septic arthritis from transient synovitis in pediatric hip joints.⁵ Kocher and colleagues⁵ reported 4 key clinical criteria: inability to bear weight, WBC count over 12 × 10⁹/L, ESR over 40 mm/h, and temperature over 38.5°C. When all 4 criteria are met, the predictive value is 99.6%. These criteria are now widely applied to adult joints, and not only the hips.

In septic arthritis, the most common causative pathogen is S aureus.^3,6Streptococcus, Neisseria, and Pseudomonas also are common.⁷ Although much rarer, Candida variants and other mycotic pathogens have been implicated as well.⁸C albicans is a well-known fungus that colonizes mucosal surfaces. Research indicates increased oral C albicans colonization in rheumatoid patients.⁹ Although most Candida septic arthritis cases are caused by C albicans, there is no large body of data showing the true incidence of fungal pathogens in septic arthritis.

Our literature search yielded 2 case reports on Candida septic arthritis involving the ankle, but the causative organisms were Candida parapsilosis and Candida glabrata.^9,10 Cases of Candida septic arthritis involving the knee or shoulder have also been reported.^11-15 Case reports demonstrate that Candida fungal arthritis is extremely rare.⁹ Etiology reportedly includes direct intra-articular inoculation by surgery or secondary to hematogenous seeding, particularly in immunocompromised patients.¹⁰ Risk factors include immunosuppression and joint suppression. DM and RA are common comorbidities in patients with septic arthritis.^6,16 The pathophysiology of RA is inflammatory pannus formation of the periarticular surface with subsequent articular cartilage destruction and erosion, as well as progressive deformity and functional debilitation.¹Patients with DM are at increased risk for developing fungal and other infections. Factors increasing this risk include disruption of skin-barrier integrity; reduced peripheral oxygen and blood supply, which also disrupts antibiotic delivery; and hyperglycemia-induced reduction in antibody function and disruption of phagocytosis and chemotaxis.¹⁷Fungi are eukaryotic, and infections caused by these organisms are difficult to treat.¹⁸ As fungal infections are more prevalent among immunosuppressed patients, they often result in prolonged treatment without guarantee of eradication, as spores may persist subclinically.

Literature on C albicans septic arthritis is lacking in general but especially in rheumatoid patients. Delayed diagnosis and suboptimal treatment may result in fungal osteomyelitis. There is little evidence on treating this rare fungal complication, and outcomes historically have been poor.¹⁹In an animal model, Marijnissen and colleagues²⁰ found that C albicans infection can increase destruction in an arthritic joint by cytokine environment modification. The result was advanced destruction of the joint and debilitation. For disease management, the authors considered these essential: early diagnosis, prompt treatment, and, as indicated, surgical débridement.

Treatment of Candida septic arthritis largely involves use of antifungal medication, either with surgical débridement, as in our patient’s case, or without. Which antifungal medication to use should be based on sensitivities, identified from wound aspirate, and microbiology advice about treatment duration. The antibiotic should be a broad-spectrum antifungal cover, in keeping with local antibiotic prescribing guidelines, which can be refined once definitive organism culture and sensitivity results are known. However, early aggressive treatment is essential. Periprosthetic fungal infection is rarely resolved without implant removal.²¹

 

Conclusion

This case reflects the complexities of septic arthritis caused by atypical pathogens and highlights the need for clinical vigilance in the setting of comorbidities, such as DM and RA. Failure to consider the diagnosis early on might result in delayed and inadequate treatment, increased joint destruction, and, potentially, osteomyelitis with subsequent increased morbidity. Early diagnosis (based on joint aspirate findings), surgical débridement, and prolonged aggressive treatment with antifungal medication are the mainstays of treatment.

Am J Orthop. 2016;45(7):E478-E480. Copyright Frontline Medical Communications Inc. 2016. All rights reserved.

Septic arthritis is a common orthopedic emergency. The most common causative organism is Staphylococcus aureus. Mycotic infections, such as those involving Candida organisms, are much less common but just as debilitating. Delayed diagnosis of septic arthritis caused by Candida infection may result in increased morbidity, making treatment more challenging. Here we report a case of Candida albicans septic arthritis of the ankle and subtalar joint in a patient with diabetes mellitus (DM) and rheumatoid arthritis (RA). The patient provided written informed consent for print and electronic publication of this case report.

Case Report

A 52-year-old woman with type 2 DM (requiring subcutaneous insulin analogue therapy) and RA presented to a local emergency department with a 3-day history of right ankle pain after having the subtalar joint injected with steroid by a rheumatologist 4 weeks earlier. For about 2 weeks, there was purulent discharge from the peroneal sheath. The patient’s RA was being treated with prednisolone (maintenance therapy). Physical examination revealed low-grade pyrexia (37.8°C) and difficulty bearing full weight on the ankle. Clinically, the joint was not erythematous, but active and passive movements were painful. Blood tests revealed a C-reactive protein level of 98 mg/dL and a white blood cell (WBC) count of 11.3 × 10⁹/L. Erythrocyte sedimentation rate (ESR) was not checked. The ankle underwent magnetic resonance imaging (Figures A-D).

The subtalar joint was aspirated under ultrasound guidance, and specimens were sent for identification of organisms and sensitivities. More aspirate was obtained 1 week later. Both aspirates grew mycotic organisms.

Mycotic screening of the fluid was positive for C albicans. The patient was referred to the orthopedic team, which performed urgent arthroscopic surgical débridement, biopsy, and washout of the subtalar joint. After surgery, a 6-week course of antifungal therapy with anidulafungin was started, per specialist microbiology advice.

The septic ankle was successfully managed with arthroscopic surgical débridement followed by treatment with anidulafungin. The patient continued to make good progress and was weight-bearing when discharged home from the orthopedic unit.

Discussion

Worldwide, about 1 in 6 people has arthritis, which affects daily lifestyle and reduces quality of life. Degenerative, inflammatory, and septic arthritis each has its management challenges.¹

Septic arthritis is an acute infection of the joint, usually of bacterial etiology. It can present as a polyarticular arthropathy (~15% of cases),^2,3 but a monoarthropathy of the hip, knee, or ankle is more common.⁴The Kocher criteria are often applied to cases of suspected septic arthritis of joints, even though they were initially used to distinguish septic arthritis from transient synovitis in pediatric hip joints.⁵ Kocher and colleagues⁵ reported 4 key clinical criteria: inability to bear weight, WBC count over 12 × 10⁹/L, ESR over 40 mm/h, and temperature over 38.5°C. When all 4 criteria are met, the predictive value is 99.6%. These criteria are now widely applied to adult joints, and not only the hips.

In septic arthritis, the most common causative pathogen is S aureus.^3,6Streptococcus, Neisseria, and Pseudomonas also are common.⁷ Although much rarer, Candida variants and other mycotic pathogens have been implicated as well.⁸C albicans is a well-known fungus that colonizes mucosal surfaces. Research indicates increased oral C albicans colonization in rheumatoid patients.⁹ Although most Candida septic arthritis cases are caused by C albicans, there is no large body of data showing the true incidence of fungal pathogens in septic arthritis.

Our literature search yielded 2 case reports on Candida septic arthritis involving the ankle, but the causative organisms were Candida parapsilosis and Candida glabrata.^9,10 Cases of Candida septic arthritis involving the knee or shoulder have also been reported.^11-15 Case reports demonstrate that Candida fungal arthritis is extremely rare.⁹ Etiology reportedly includes direct intra-articular inoculation by surgery or secondary to hematogenous seeding, particularly in immunocompromised patients.¹⁰ Risk factors include immunosuppression and joint suppression. DM and RA are common comorbidities in patients with septic arthritis.^6,16 The pathophysiology of RA is inflammatory pannus formation of the periarticular surface with subsequent articular cartilage destruction and erosion, as well as progressive deformity and functional debilitation.¹Patients with DM are at increased risk for developing fungal and other infections. Factors increasing this risk include disruption of skin-barrier integrity; reduced peripheral oxygen and blood supply, which also disrupts antibiotic delivery; and hyperglycemia-induced reduction in antibody function and disruption of phagocytosis and chemotaxis.¹⁷Fungi are eukaryotic, and infections caused by these organisms are difficult to treat.¹⁸ As fungal infections are more prevalent among immunosuppressed patients, they often result in prolonged treatment without guarantee of eradication, as spores may persist subclinically.

Literature on C albicans septic arthritis is lacking in general but especially in rheumatoid patients. Delayed diagnosis and suboptimal treatment may result in fungal osteomyelitis. There is little evidence on treating this rare fungal complication, and outcomes historically have been poor.¹⁹In an animal model, Marijnissen and colleagues²⁰ found that C albicans infection can increase destruction in an arthritic joint by cytokine environment modification. The result was advanced destruction of the joint and debilitation. For disease management, the authors considered these essential: early diagnosis, prompt treatment, and, as indicated, surgical débridement.

Treatment of Candida septic arthritis largely involves use of antifungal medication, either with surgical débridement, as in our patient’s case, or without. Which antifungal medication to use should be based on sensitivities, identified from wound aspirate, and microbiology advice about treatment duration. The antibiotic should be a broad-spectrum antifungal cover, in keeping with local antibiotic prescribing guidelines, which can be refined once definitive organism culture and sensitivity results are known. However, early aggressive treatment is essential. Periprosthetic fungal infection is rarely resolved without implant removal.²¹

 

Conclusion

This case reflects the complexities of septic arthritis caused by atypical pathogens and highlights the need for clinical vigilance in the setting of comorbidities, such as DM and RA. Failure to consider the diagnosis early on might result in delayed and inadequate treatment, increased joint destruction, and, potentially, osteomyelitis with subsequent increased morbidity. Early diagnosis (based on joint aspirate findings), surgical débridement, and prolonged aggressive treatment with antifungal medication are the mainstays of treatment.

Am J Orthop. 2016;45(7):E478-E480. Copyright Frontline Medical Communications Inc. 2016. All rights reserved.

Over the past several decades, patient-reported outcomes (PROs) have become increasingly important in assessing the quality and effectiveness of medical and surgical care.^1,2 The benefit lies in the ability of PROs to characterize the impact of medical interventions on symptoms, function, and other outcomes from the patient’s perspective. Consequently, clinical practices can improve patients’ objective findings (from radiographic and clinical examinations) as well as their preferences in a social-psychological context.^2,3 As a patient’s satisfaction with a surgical intervention may not correlate with the surgeon’s objective assessment of outcome, PROs offer unique insight into the patient’s perceptions of well-being.⁴

Health-related quality-of-life assessments can be made with either general-health or disease-specific instruments. These instruments traditionally are administered with pen and paper—a data collection method with several limitations, chief being the need to manually transfer the data into an electronic medical record, a research database, or both. In addition, administering surveys on paper risks potential disqualification of partially or incorrectly completed surveys. With pen and paper, it is difficult to mandate that every question be answered accurately.

Currently, there is a potential role for electronic medical records and digital tablet devices in survey administration and data collection and storage. Theoretical advantages include direct input of survey data into databases (eliminating manual data entry and associated entry errors), improved accuracy and completion rates, and long-term storage not dependent on paper charts.⁵To our knowledge, there have been no prospective studies of different orthopedic outcomes collection methods. Some studies have evaluated use of touch-based tablets in data collection. Dy and colleagues⁶ considered administration of the DASH (Disabilities of the Arm, Shoulder, and Hand) survey on an iPad tablet (Apple Computers) and retrospectively compared the tablet and paper completion rates. The tablet group’s rate (98%) was significantly higher than the paper group’s rate (76%). Aktas and colleagues⁷ reported a high completion rate for a tablet survey of palliative care outcomes (they did not compare modalities). A handful of other studies have found higher intraclass correlation and validation for digital data collection than for paper collection.^7-14 The comparability of the data collected digitally vs on paper was the nidus for our decision to prospectively evaluate the ease and reliability of digital data collection.

We conducted a prospective, randomized study to compare the performance of tablet and paper versions of several general-health and musculoskeletal disease–specific questionnaires. We hypothesized the tablet and paper surveys would have similar completion rates and times.

Methods

This study was approved by our Institutional Review Board. Participants were recruited during their clinic visit to 3 subspecialty orthopedic services (upper extremity, spine, arthroplasty). The questionnaires included basic demographics questions and questions about tablet use (comfort level with computers, measured on a Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree), and ownership of a tablet or smartphone). Also included were European Quality of Life–5 Dimensions (EQ-5D, General Health), a disease questionnaire specific to 1 of the 3 subspecialty services, and a satisfaction survey. Patients were asked to complete the Oswestry Disability Index (ODI) for low-back pain, the Neck Disability Index (NDI) for neck pain, the Hip Disability and Osteoarthritis Outcomes Score (HOOS) for hip pain, the Knee Injury and Osteoarthritis Outcomes Score (KOOS) for knee pain, or the QuickDASH survey for upper extremity complaints (subspecialty-specific). After recruitment, a computer-generated randomization technique was used to randomly assign patients to either a paper or an electronic (iPad) data collection group.¹⁵ We included all surveys for which patients had sufficient completion time (no clinic staff interruptions) and excluded surveys marked incomplete (because of interruptions for clinic workflow efficiency). For direct input from tablets and for data storage, we used the Research Electronic Data Capture (REDCap) system hosted at our institution.¹⁶ Our staff registered patients as REDCap participants, assigned them to their disease-specific study arms, and gave them tablets to use to complete the surveys.

Patients who were randomly assigned to take the surveys on paper were given a packet that included the demographics survey, the EQ-5D, a disease-specific survey, and a satisfaction survey. Their responses were then manually entered by the investigators into the REDCap system.

Patients who were randomly assigned to take the surveys on tablets used the REDCap survey feature, which allowed them to directly input their responses into the database (Figure).

To allow them to skip a question (same as on paper), we did not activate the REDCap “require” feature. Had this feature been used, patients would have had to answer each question before being allowed to proceed to the next one. Similarly, patients could select multiple answers for a single question (as on paper). With these modifications, we attempted to replicate, as much as possible, the experience of taking a survey on paper.

Our primary outcome measure was survey completion rate. Secondary outcome measures were total time for completion, number of questions left unanswered on incomplete surveys, patient satisfaction with survey length (Likert scale, 1-5), ease of completion (Likert scale, 1-5), ability to comprehend questions (Likert scale, 1-5), and preference for the other survey modality (Appendix).

We used the findings of Dy and colleagues⁶ to identify the sample size needed for detecting a significant difference between the tablet and the paper group when using a 2-sided test with a power set to 80%. In their study, 24% of paper surveys and 2% of tablet surveys were unscorable,⁶ which we used as our predicted incompletion rate.

We used SPSS statistical software (IBM) to analyze our data, t test to compare continuous variables, χ² test to compare categorical variables, and linear regression to test the relationship between number of questions and completion rate. Statistical significance was set at P < .05.

 

Results

Of the 510 patients enrolled in the study, 483 completed the initial demographics questionnaire and were included in the analysis. Patients were excluded if they were unable to complete the initial demographics questionnaire because of clinic workflow (eg, immediate need to be seen by physician, need to transfer to radiology for imaging and not being able to revisit the survey). Mean age was 56 years (range, 14-93 years), and 51% of the respondents were female. Fifty percent owned tablets, 70% owned smartphones, and mean (SD) self-rating of computer skills was 3.13 (1.16) (Likert scale, 1-5). There were no significant demographic differences between the tablet and paper groups (Table 1).

The EQ-5D was completed by 477 patients (252 tablet, 225 paper). Regarding the disease-specific questionnaires, 212 patients (102 tablet, 110 paper) were administered the ODI, 65 (30 tablet, 35 paper) the NDI, 28 (14 tablet, 14 paper) the HOOS, 57 (24 tablet, 33 paper) the KOOS, and 101 (67 tablet, 34 paper) the QuickDASH.

For each disease-specific questionnaire, the instrument’s published instructions for calculating scores were followed; these scores were then compared in order to further characterize the groups. There were significant differences in scores on the EQ-5D descriptive questions, a pain visual analog scale (VAS), and the NDI. Mean EQ-5D score was 0.664 for the tablet group and 0.699 for the paper group (P = .041), mean pain VAS score was 62.5 for the tablet group and 71.6 for the paper group (P < .001), and mean NDI score was 42.8 for the tablet group and 32.4 for the paper group (P = .033).

The other scores were not significantly different between the 2 groups (Table 2).

The overall completion rate for all questionnaires was 84.4%. The KOOS completion rate was 83.3% for the tablet group and 54.5% for the paper group (P = .023). Although it was not statistically significant, there was a trend toward higher rates of completing all disease-specific questionnaires in the tablet group relative to the paper group.

Time for completion of PRO questionnaires did not differ between the groups (Table 3).

Satisfaction regarding the surveys and their modalities was similar between the groups.

However, the 41.4% of paper group patients who reported they would prefer to use a tablet to take the survey in the future was higher (P < .001) than the 19.7% of tablet group patients who reported they would prefer the paper survey (Table 4).

Discussion

Electronic data entry has many advantages over traditional paper-based data collection and can be used with PRO surveys to measure response to treatment. Our study evaluated whether completion rates differed between surveys administered on digital tablets and those administered on traditional paper forms in a clinic setting. We selected general-health and disease-specific instruments commonly used to collect PROs from orthopedic patients. Our primary outcome measure was survey completion rate. Secondary outcome measures were total time for completion, number of questions left unanswered on incomplete surveys, patient satisfaction, and survey preferences.

In this study, our tablet and paper groups had similar overall survey completion rates, which suggests digital tablet-based data collection is noninferior to traditional pen-and-paper data collection with respect to patient response rate in the clinical setting. It is worth emphasizing that the tablet surveys were made to resemble and function as much as possible like the paper surveys. For example, patients were allowed to select multiple answers as well as advance without answering a question. Paper surveys were mimicked so we could study inherent differences in patient responsiveness without adding digital features to prevent patients from selecting multiple answers or skipping questions. We postulate that adding these digital features could have introduced a significant difference in patient responsiveness.

Time for survey completion was not significantly different between the tablet and paper groups, demonstrating that data can be digitally collected and the aforementioned advantages realized without significant delay or clinic workflow disruption. In the future, patients may be able to complete their forms digitally, on their own devices, before arriving for their clinic visits—resulting in improved clinic workflow and data collection efficiency.

Scores computed for the health-related quality-of-life questionnaires were not significantly different between the tablet and paper groups, except for EQ-5D and NDI. Although statistically significant, the 0.035 difference between the groups’ EQ-5D scores (0.664, 0.699) is not clinically significant. (Pickard and colleagues¹⁷ established that 0.06 is the clinically significant difference between EQ-5D scores in the United States.) If there were any clinical difference in the present study, our paper group patients appeared to be in better health than our tablet group patients.

Patients’ motivation to complete surveys often plays a large role in meaningful rates of completion. On our subjective satisfaction survey, a larger percentage of patients reported they would prefer to use a tablet for future surveys (Table 4). This finding may be driven by the novelty or ease of using a popular device. Nevertheless, we think it is worthwhile to heed patient preferences, as they may point to more successful data collection and compliance.

Several other studies have compared electronic and paper data capture.^{6,7,9-14,18-22} Dy and colleagues⁶ reported on administering the DASH survey on an iPad tablet using REDCap in an outpatient setting. They found that the percentage of surveys that could be scored (<3 questions left unanswered) was significantly higher for their tablet group (98%) than their paper group (76%). The larger difference in survey completion rates in their study (vs ours) may be attributable to their use of DASH, which has more survey items (compared with QuickDASH, the instrument we used) and thus may be more sensitive to detecting differences, at the risk of increasing the burden on survey takers.²³ Aktas and colleagues⁷ conducted a similar but smaller study of completion rates, completion times, and overall practicality of using digital tablets to collect PROs in a palliative care clinic (they did not compare tablet and paper modalities). Marsh and colleagues,¹² who studied the agreement between data collected on electronic and paper versions of the WOMAC (Western Ontario and McMaster Universities) Osteoarthritis Index and the SF-12 (12-item Short Form Health Survey, Version 2) after total hip and total knee arthroplasty, found a high intraclass correlation coefficient between the 2 methods. Griffiths-Jones and colleagues¹¹ also found a high degree of agreement between patient data collected on digital and paper surveys. In a similar study, Fanning and McAuley¹⁰ compared digital tablet and paper survey administration in an older population and found a higher percentage of preference for tablets, with ease of use and anxiety during survey completion correlating with preference. These findings mirror ours, even with our inclusion of patients in a broader age range.

Strengths of our study included its overall cohort size and the variety of measurement instruments used. In addition, we measured time for survey completion to assess the practicality of tablet-based data collection and refrained from using digital features that could have artificially improved the completion rate for this survey modality.

Our study had a few limitations. First, we recruited unequal numbers of patients from the different subspecialties—a result of each subspecialty having a different number of attending physicians and a different patient volume. Given randomization and use of similar patients across the study arms, however, this likely did not present any significant bias. Second, each patient completed a tablet survey or a paper survey but not both, and therefore we could not compare a patient’s performance on the 2 modalities. However, the burden of completing the same survey more than once likely would have lowered our participation rate and introduced additional biases we wanted to avoid. Third, despite our attempt to mimic the look of a paper survey, the tablet’s user interface presented several potential difficulties. For example, its small text and small answer buttons may have been limiting for patients with poor vision. These design features emphasize the importance of having a user interface that can be adapted to the individual, regardless of handicap. Indeed, adaptability is a potential strength of digital interfaces. For adaptability, an interface designer can use large, scalable text and add audio prompts and other features.

Our findings can be useful in evaluating patient responsiveness to surveys administered on digital tablets in an outpatient clinic setting. In this prospective, randomized study, we found that, for survey completion, use of a tablet device did not require more time than use of a paper form. In addition, the administration modalities had similar completion and error rates for a variety of orthopedic outcomes surveys. We did not activate digital features that would have given unfair advantage to the digital data collection modality. We also found a strong preference for use of technology in PRO data collection, and this may help improve collection rates. Last, though optimizing the flow of patients in our clinic was not a strict research metric, we prioritized making sure patients were not spending any more time completing these surveys than in the past. Given the potential benefits of digital surveys—immediate and accurate transfer of collected data into multiple databases, including the patient’s electronic medical record—our experience supports continuing validation of these instruments for potential wider use.

Am J Orthop. 2016;45(7):E451-E457. Copyright Frontline Medical Communications Inc. 2016. All rights reserved.

Over the past several decades, patient-reported outcomes (PROs) have become increasingly important in assessing the quality and effectiveness of medical and surgical care.^1,2 The benefit lies in the ability of PROs to characterize the impact of medical interventions on symptoms, function, and other outcomes from the patient’s perspective. Consequently, clinical practices can improve patients’ objective findings (from radiographic and clinical examinations) as well as their preferences in a social-psychological context.^2,3 As a patient’s satisfaction with a surgical intervention may not correlate with the surgeon’s objective assessment of outcome, PROs offer unique insight into the patient’s perceptions of well-being.⁴

Health-related quality-of-life assessments can be made with either general-health or disease-specific instruments. These instruments traditionally are administered with pen and paper—a data collection method with several limitations, chief being the need to manually transfer the data into an electronic medical record, a research database, or both. In addition, administering surveys on paper risks potential disqualification of partially or incorrectly completed surveys. With pen and paper, it is difficult to mandate that every question be answered accurately.

Currently, there is a potential role for electronic medical records and digital tablet devices in survey administration and data collection and storage. Theoretical advantages include direct input of survey data into databases (eliminating manual data entry and associated entry errors), improved accuracy and completion rates, and long-term storage not dependent on paper charts.⁵To our knowledge, there have been no prospective studies of different orthopedic outcomes collection methods. Some studies have evaluated use of touch-based tablets in data collection. Dy and colleagues⁶ considered administration of the DASH (Disabilities of the Arm, Shoulder, and Hand) survey on an iPad tablet (Apple Computers) and retrospectively compared the tablet and paper completion rates. The tablet group’s rate (98%) was significantly higher than the paper group’s rate (76%). Aktas and colleagues⁷ reported a high completion rate for a tablet survey of palliative care outcomes (they did not compare modalities). A handful of other studies have found higher intraclass correlation and validation for digital data collection than for paper collection.^7-14 The comparability of the data collected digitally vs on paper was the nidus for our decision to prospectively evaluate the ease and reliability of digital data collection.

We conducted a prospective, randomized study to compare the performance of tablet and paper versions of several general-health and musculoskeletal disease–specific questionnaires. We hypothesized the tablet and paper surveys would have similar completion rates and times.

Methods

This study was approved by our Institutional Review Board. Participants were recruited during their clinic visit to 3 subspecialty orthopedic services (upper extremity, spine, arthroplasty). The questionnaires included basic demographics questions and questions about tablet use (comfort level with computers, measured on a Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree), and ownership of a tablet or smartphone). Also included were European Quality of Life–5 Dimensions (EQ-5D, General Health), a disease questionnaire specific to 1 of the 3 subspecialty services, and a satisfaction survey. Patients were asked to complete the Oswestry Disability Index (ODI) for low-back pain, the Neck Disability Index (NDI) for neck pain, the Hip Disability and Osteoarthritis Outcomes Score (HOOS) for hip pain, the Knee Injury and Osteoarthritis Outcomes Score (KOOS) for knee pain, or the QuickDASH survey for upper extremity complaints (subspecialty-specific). After recruitment, a computer-generated randomization technique was used to randomly assign patients to either a paper or an electronic (iPad) data collection group.¹⁵ We included all surveys for which patients had sufficient completion time (no clinic staff interruptions) and excluded surveys marked incomplete (because of interruptions for clinic workflow efficiency). For direct input from tablets and for data storage, we used the Research Electronic Data Capture (REDCap) system hosted at our institution.¹⁶ Our staff registered patients as REDCap participants, assigned them to their disease-specific study arms, and gave them tablets to use to complete the surveys.

Patients who were randomly assigned to take the surveys on paper were given a packet that included the demographics survey, the EQ-5D, a disease-specific survey, and a satisfaction survey. Their responses were then manually entered by the investigators into the REDCap system.

Patients who were randomly assigned to take the surveys on tablets used the REDCap survey feature, which allowed them to directly input their responses into the database (Figure).

To allow them to skip a question (same as on paper), we did not activate the REDCap “require” feature. Had this feature been used, patients would have had to answer each question before being allowed to proceed to the next one. Similarly, patients could select multiple answers for a single question (as on paper). With these modifications, we attempted to replicate, as much as possible, the experience of taking a survey on paper.

Our primary outcome measure was survey completion rate. Secondary outcome measures were total time for completion, number of questions left unanswered on incomplete surveys, patient satisfaction with survey length (Likert scale, 1-5), ease of completion (Likert scale, 1-5), ability to comprehend questions (Likert scale, 1-5), and preference for the other survey modality (Appendix).

We used the findings of Dy and colleagues⁶ to identify the sample size needed for detecting a significant difference between the tablet and the paper group when using a 2-sided test with a power set to 80%. In their study, 24% of paper surveys and 2% of tablet surveys were unscorable,⁶ which we used as our predicted incompletion rate.

We used SPSS statistical software (IBM) to analyze our data, t test to compare continuous variables, χ² test to compare categorical variables, and linear regression to test the relationship between number of questions and completion rate. Statistical significance was set at P < .05.

 

Results

Of the 510 patients enrolled in the study, 483 completed the initial demographics questionnaire and were included in the analysis. Patients were excluded if they were unable to complete the initial demographics questionnaire because of clinic workflow (eg, immediate need to be seen by physician, need to transfer to radiology for imaging and not being able to revisit the survey). Mean age was 56 years (range, 14-93 years), and 51% of the respondents were female. Fifty percent owned tablets, 70% owned smartphones, and mean (SD) self-rating of computer skills was 3.13 (1.16) (Likert scale, 1-5). There were no significant demographic differences between the tablet and paper groups (Table 1).

The EQ-5D was completed by 477 patients (252 tablet, 225 paper). Regarding the disease-specific questionnaires, 212 patients (102 tablet, 110 paper) were administered the ODI, 65 (30 tablet, 35 paper) the NDI, 28 (14 tablet, 14 paper) the HOOS, 57 (24 tablet, 33 paper) the KOOS, and 101 (67 tablet, 34 paper) the QuickDASH.

For each disease-specific questionnaire, the instrument’s published instructions for calculating scores were followed; these scores were then compared in order to further characterize the groups. There were significant differences in scores on the EQ-5D descriptive questions, a pain visual analog scale (VAS), and the NDI. Mean EQ-5D score was 0.664 for the tablet group and 0.699 for the paper group (P = .041), mean pain VAS score was 62.5 for the tablet group and 71.6 for the paper group (P < .001), and mean NDI score was 42.8 for the tablet group and 32.4 for the paper group (P = .033).

The other scores were not significantly different between the 2 groups (Table 2).

The overall completion rate for all questionnaires was 84.4%. The KOOS completion rate was 83.3% for the tablet group and 54.5% for the paper group (P = .023). Although it was not statistically significant, there was a trend toward higher rates of completing all disease-specific questionnaires in the tablet group relative to the paper group.

Time for completion of PRO questionnaires did not differ between the groups (Table 3).

Satisfaction regarding the surveys and their modalities was similar between the groups.

However, the 41.4% of paper group patients who reported they would prefer to use a tablet to take the survey in the future was higher (P < .001) than the 19.7% of tablet group patients who reported they would prefer the paper survey (Table 4).

Discussion

Electronic data entry has many advantages over traditional paper-based data collection and can be used with PRO surveys to measure response to treatment. Our study evaluated whether completion rates differed between surveys administered on digital tablets and those administered on traditional paper forms in a clinic setting. We selected general-health and disease-specific instruments commonly used to collect PROs from orthopedic patients. Our primary outcome measure was survey completion rate. Secondary outcome measures were total time for completion, number of questions left unanswered on incomplete surveys, patient satisfaction, and survey preferences.

In this study, our tablet and paper groups had similar overall survey completion rates, which suggests digital tablet-based data collection is noninferior to traditional pen-and-paper data collection with respect to patient response rate in the clinical setting. It is worth emphasizing that the tablet surveys were made to resemble and function as much as possible like the paper surveys. For example, patients were allowed to select multiple answers as well as advance without answering a question. Paper surveys were mimicked so we could study inherent differences in patient responsiveness without adding digital features to prevent patients from selecting multiple answers or skipping questions. We postulate that adding these digital features could have introduced a significant difference in patient responsiveness.

Time for survey completion was not significantly different between the tablet and paper groups, demonstrating that data can be digitally collected and the aforementioned advantages realized without significant delay or clinic workflow disruption. In the future, patients may be able to complete their forms digitally, on their own devices, before arriving for their clinic visits—resulting in improved clinic workflow and data collection efficiency.

Scores computed for the health-related quality-of-life questionnaires were not significantly different between the tablet and paper groups, except for EQ-5D and NDI. Although statistically significant, the 0.035 difference between the groups’ EQ-5D scores (0.664, 0.699) is not clinically significant. (Pickard and colleagues¹⁷ established that 0.06 is the clinically significant difference between EQ-5D scores in the United States.) If there were any clinical difference in the present study, our paper group patients appeared to be in better health than our tablet group patients.

Patients’ motivation to complete surveys often plays a large role in meaningful rates of completion. On our subjective satisfaction survey, a larger percentage of patients reported they would prefer to use a tablet for future surveys (Table 4). This finding may be driven by the novelty or ease of using a popular device. Nevertheless, we think it is worthwhile to heed patient preferences, as they may point to more successful data collection and compliance.

Several other studies have compared electronic and paper data capture.^{6,7,9-14,18-22} Dy and colleagues⁶ reported on administering the DASH survey on an iPad tablet using REDCap in an outpatient setting. They found that the percentage of surveys that could be scored (<3 questions left unanswered) was significantly higher for their tablet group (98%) than their paper group (76%). The larger difference in survey completion rates in their study (vs ours) may be attributable to their use of DASH, which has more survey items (compared with QuickDASH, the instrument we used) and thus may be more sensitive to detecting differences, at the risk of increasing the burden on survey takers.²³ Aktas and colleagues⁷ conducted a similar but smaller study of completion rates, completion times, and overall practicality of using digital tablets to collect PROs in a palliative care clinic (they did not compare tablet and paper modalities). Marsh and colleagues,¹² who studied the agreement between data collected on electronic and paper versions of the WOMAC (Western Ontario and McMaster Universities) Osteoarthritis Index and the SF-12 (12-item Short Form Health Survey, Version 2) after total hip and total knee arthroplasty, found a high intraclass correlation coefficient between the 2 methods. Griffiths-Jones and colleagues¹¹ also found a high degree of agreement between patient data collected on digital and paper surveys. In a similar study, Fanning and McAuley¹⁰ compared digital tablet and paper survey administration in an older population and found a higher percentage of preference for tablets, with ease of use and anxiety during survey completion correlating with preference. These findings mirror ours, even with our inclusion of patients in a broader age range.

Strengths of our study included its overall cohort size and the variety of measurement instruments used. In addition, we measured time for survey completion to assess the practicality of tablet-based data collection and refrained from using digital features that could have artificially improved the completion rate for this survey modality.

Our study had a few limitations. First, we recruited unequal numbers of patients from the different subspecialties—a result of each subspecialty having a different number of attending physicians and a different patient volume. Given randomization and use of similar patients across the study arms, however, this likely did not present any significant bias. Second, each patient completed a tablet survey or a paper survey but not both, and therefore we could not compare a patient’s performance on the 2 modalities. However, the burden of completing the same survey more than once likely would have lowered our participation rate and introduced additional biases we wanted to avoid. Third, despite our attempt to mimic the look of a paper survey, the tablet’s user interface presented several potential difficulties. For example, its small text and small answer buttons may have been limiting for patients with poor vision. These design features emphasize the importance of having a user interface that can be adapted to the individual, regardless of handicap. Indeed, adaptability is a potential strength of digital interfaces. For adaptability, an interface designer can use large, scalable text and add audio prompts and other features.

Our findings can be useful in evaluating patient responsiveness to surveys administered on digital tablets in an outpatient clinic setting. In this prospective, randomized study, we found that, for survey completion, use of a tablet device did not require more time than use of a paper form. In addition, the administration modalities had similar completion and error rates for a variety of orthopedic outcomes surveys. We did not activate digital features that would have given unfair advantage to the digital data collection modality. We also found a strong preference for use of technology in PRO data collection, and this may help improve collection rates. Last, though optimizing the flow of patients in our clinic was not a strict research metric, we prioritized making sure patients were not spending any more time completing these surveys than in the past. Given the potential benefits of digital surveys—immediate and accurate transfer of collected data into multiple databases, including the patient’s electronic medical record—our experience supports continuing validation of these instruments for potential wider use.

Am J Orthop. 2016;45(7):E451-E457. Copyright Frontline Medical Communications Inc. 2016. All rights reserved.

Over the past several decades, patient-reported outcomes (PROs) have become increasingly important in assessing the quality and effectiveness of medical and surgical care.^1,2 The benefit lies in the ability of PROs to characterize the impact of medical interventions on symptoms, function, and other outcomes from the patient’s perspective. Consequently, clinical practices can improve patients’ objective findings (from radiographic and clinical examinations) as well as their preferences in a social-psychological context.^2,3 As a patient’s satisfaction with a surgical intervention may not correlate with the surgeon’s objective assessment of outcome, PROs offer unique insight into the patient’s perceptions of well-being.⁴

Health-related quality-of-life assessments can be made with either general-health or disease-specific instruments. These instruments traditionally are administered with pen and paper—a data collection method with several limitations, chief being the need to manually transfer the data into an electronic medical record, a research database, or both. In addition, administering surveys on paper risks potential disqualification of partially or incorrectly completed surveys. With pen and paper, it is difficult to mandate that every question be answered accurately.

Currently, there is a potential role for electronic medical records and digital tablet devices in survey administration and data collection and storage. Theoretical advantages include direct input of survey data into databases (eliminating manual data entry and associated entry errors), improved accuracy and completion rates, and long-term storage not dependent on paper charts.⁵To our knowledge, there have been no prospective studies of different orthopedic outcomes collection methods. Some studies have evaluated use of touch-based tablets in data collection. Dy and colleagues⁶ considered administration of the DASH (Disabilities of the Arm, Shoulder, and Hand) survey on an iPad tablet (Apple Computers) and retrospectively compared the tablet and paper completion rates. The tablet group’s rate (98%) was significantly higher than the paper group’s rate (76%). Aktas and colleagues⁷ reported a high completion rate for a tablet survey of palliative care outcomes (they did not compare modalities). A handful of other studies have found higher intraclass correlation and validation for digital data collection than for paper collection.^7-14 The comparability of the data collected digitally vs on paper was the nidus for our decision to prospectively evaluate the ease and reliability of digital data collection.

We conducted a prospective, randomized study to compare the performance of tablet and paper versions of several general-health and musculoskeletal disease–specific questionnaires. We hypothesized the tablet and paper surveys would have similar completion rates and times.

Methods

This study was approved by our Institutional Review Board. Participants were recruited during their clinic visit to 3 subspecialty orthopedic services (upper extremity, spine, arthroplasty). The questionnaires included basic demographics questions and questions about tablet use (comfort level with computers, measured on a Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree), and ownership of a tablet or smartphone). Also included were European Quality of Life–5 Dimensions (EQ-5D, General Health), a disease questionnaire specific to 1 of the 3 subspecialty services, and a satisfaction survey. Patients were asked to complete the Oswestry Disability Index (ODI) for low-back pain, the Neck Disability Index (NDI) for neck pain, the Hip Disability and Osteoarthritis Outcomes Score (HOOS) for hip pain, the Knee Injury and Osteoarthritis Outcomes Score (KOOS) for knee pain, or the QuickDASH survey for upper extremity complaints (subspecialty-specific). After recruitment, a computer-generated randomization technique was used to randomly assign patients to either a paper or an electronic (iPad) data collection group.¹⁵ We included all surveys for which patients had sufficient completion time (no clinic staff interruptions) and excluded surveys marked incomplete (because of interruptions for clinic workflow efficiency). For direct input from tablets and for data storage, we used the Research Electronic Data Capture (REDCap) system hosted at our institution.¹⁶ Our staff registered patients as REDCap participants, assigned them to their disease-specific study arms, and gave them tablets to use to complete the surveys.

Patients who were randomly assigned to take the surveys on paper were given a packet that included the demographics survey, the EQ-5D, a disease-specific survey, and a satisfaction survey. Their responses were then manually entered by the investigators into the REDCap system.

Patients who were randomly assigned to take the surveys on tablets used the REDCap survey feature, which allowed them to directly input their responses into the database (Figure).

To allow them to skip a question (same as on paper), we did not activate the REDCap “require” feature. Had this feature been used, patients would have had to answer each question before being allowed to proceed to the next one. Similarly, patients could select multiple answers for a single question (as on paper). With these modifications, we attempted to replicate, as much as possible, the experience of taking a survey on paper.

Our primary outcome measure was survey completion rate. Secondary outcome measures were total time for completion, number of questions left unanswered on incomplete surveys, patient satisfaction with survey length (Likert scale, 1-5), ease of completion (Likert scale, 1-5), ability to comprehend questions (Likert scale, 1-5), and preference for the other survey modality (Appendix).

We used the findings of Dy and colleagues⁶ to identify the sample size needed for detecting a significant difference between the tablet and the paper group when using a 2-sided test with a power set to 80%. In their study, 24% of paper surveys and 2% of tablet surveys were unscorable,⁶ which we used as our predicted incompletion rate.

We used SPSS statistical software (IBM) to analyze our data, t test to compare continuous variables, χ² test to compare categorical variables, and linear regression to test the relationship between number of questions and completion rate. Statistical significance was set at P < .05.

 

Results

Of the 510 patients enrolled in the study, 483 completed the initial demographics questionnaire and were included in the analysis. Patients were excluded if they were unable to complete the initial demographics questionnaire because of clinic workflow (eg, immediate need to be seen by physician, need to transfer to radiology for imaging and not being able to revisit the survey). Mean age was 56 years (range, 14-93 years), and 51% of the respondents were female. Fifty percent owned tablets, 70% owned smartphones, and mean (SD) self-rating of computer skills was 3.13 (1.16) (Likert scale, 1-5). There were no significant demographic differences between the tablet and paper groups (Table 1).

The EQ-5D was completed by 477 patients (252 tablet, 225 paper). Regarding the disease-specific questionnaires, 212 patients (102 tablet, 110 paper) were administered the ODI, 65 (30 tablet, 35 paper) the NDI, 28 (14 tablet, 14 paper) the HOOS, 57 (24 tablet, 33 paper) the KOOS, and 101 (67 tablet, 34 paper) the QuickDASH.

For each disease-specific questionnaire, the instrument’s published instructions for calculating scores were followed; these scores were then compared in order to further characterize the groups. There were significant differences in scores on the EQ-5D descriptive questions, a pain visual analog scale (VAS), and the NDI. Mean EQ-5D score was 0.664 for the tablet group and 0.699 for the paper group (P = .041), mean pain VAS score was 62.5 for the tablet group and 71.6 for the paper group (P < .001), and mean NDI score was 42.8 for the tablet group and 32.4 for the paper group (P = .033).

The other scores were not significantly different between the 2 groups (Table 2).

The overall completion rate for all questionnaires was 84.4%. The KOOS completion rate was 83.3% for the tablet group and 54.5% for the paper group (P = .023). Although it was not statistically significant, there was a trend toward higher rates of completing all disease-specific questionnaires in the tablet group relative to the paper group.

Time for completion of PRO questionnaires did not differ between the groups (Table 3).

Satisfaction regarding the surveys and their modalities was similar between the groups.

However, the 41.4% of paper group patients who reported they would prefer to use a tablet to take the survey in the future was higher (P < .001) than the 19.7% of tablet group patients who reported they would prefer the paper survey (Table 4).

Discussion

Electronic data entry has many advantages over traditional paper-based data collection and can be used with PRO surveys to measure response to treatment. Our study evaluated whether completion rates differed between surveys administered on digital tablets and those administered on traditional paper forms in a clinic setting. We selected general-health and disease-specific instruments commonly used to collect PROs from orthopedic patients. Our primary outcome measure was survey completion rate. Secondary outcome measures were total time for completion, number of questions left unanswered on incomplete surveys, patient satisfaction, and survey preferences.

In this study, our tablet and paper groups had similar overall survey completion rates, which suggests digital tablet-based data collection is noninferior to traditional pen-and-paper data collection with respect to patient response rate in the clinical setting. It is worth emphasizing that the tablet surveys were made to resemble and function as much as possible like the paper surveys. For example, patients were allowed to select multiple answers as well as advance without answering a question. Paper surveys were mimicked so we could study inherent differences in patient responsiveness without adding digital features to prevent patients from selecting multiple answers or skipping questions. We postulate that adding these digital features could have introduced a significant difference in patient responsiveness.

Time for survey completion was not significantly different between the tablet and paper groups, demonstrating that data can be digitally collected and the aforementioned advantages realized without significant delay or clinic workflow disruption. In the future, patients may be able to complete their forms digitally, on their own devices, before arriving for their clinic visits—resulting in improved clinic workflow and data collection efficiency.

Scores computed for the health-related quality-of-life questionnaires were not significantly different between the tablet and paper groups, except for EQ-5D and NDI. Although statistically significant, the 0.035 difference between the groups’ EQ-5D scores (0.664, 0.699) is not clinically significant. (Pickard and colleagues¹⁷ established that 0.06 is the clinically significant difference between EQ-5D scores in the United States.) If there were any clinical difference in the present study, our paper group patients appeared to be in better health than our tablet group patients.

Patients’ motivation to complete surveys often plays a large role in meaningful rates of completion. On our subjective satisfaction survey, a larger percentage of patients reported they would prefer to use a tablet for future surveys (Table 4). This finding may be driven by the novelty or ease of using a popular device. Nevertheless, we think it is worthwhile to heed patient preferences, as they may point to more successful data collection and compliance.

Several other studies have compared electronic and paper data capture.^{6,7,9-14,18-22} Dy and colleagues⁶ reported on administering the DASH survey on an iPad tablet using REDCap in an outpatient setting. They found that the percentage of surveys that could be scored (<3 questions left unanswered) was significantly higher for their tablet group (98%) than their paper group (76%). The larger difference in survey completion rates in their study (vs ours) may be attributable to their use of DASH, which has more survey items (compared with QuickDASH, the instrument we used) and thus may be more sensitive to detecting differences, at the risk of increasing the burden on survey takers.²³ Aktas and colleagues⁷ conducted a similar but smaller study of completion rates, completion times, and overall practicality of using digital tablets to collect PROs in a palliative care clinic (they did not compare tablet and paper modalities). Marsh and colleagues,¹² who studied the agreement between data collected on electronic and paper versions of the WOMAC (Western Ontario and McMaster Universities) Osteoarthritis Index and the SF-12 (12-item Short Form Health Survey, Version 2) after total hip and total knee arthroplasty, found a high intraclass correlation coefficient between the 2 methods. Griffiths-Jones and colleagues¹¹ also found a high degree of agreement between patient data collected on digital and paper surveys. In a similar study, Fanning and McAuley¹⁰ compared digital tablet and paper survey administration in an older population and found a higher percentage of preference for tablets, with ease of use and anxiety during survey completion correlating with preference. These findings mirror ours, even with our inclusion of patients in a broader age range.

Strengths of our study included its overall cohort size and the variety of measurement instruments used. In addition, we measured time for survey completion to assess the practicality of tablet-based data collection and refrained from using digital features that could have artificially improved the completion rate for this survey modality.

Our study had a few limitations. First, we recruited unequal numbers of patients from the different subspecialties—a result of each subspecialty having a different number of attending physicians and a different patient volume. Given randomization and use of similar patients across the study arms, however, this likely did not present any significant bias. Second, each patient completed a tablet survey or a paper survey but not both, and therefore we could not compare a patient’s performance on the 2 modalities. However, the burden of completing the same survey more than once likely would have lowered our participation rate and introduced additional biases we wanted to avoid. Third, despite our attempt to mimic the look of a paper survey, the tablet’s user interface presented several potential difficulties. For example, its small text and small answer buttons may have been limiting for patients with poor vision. These design features emphasize the importance of having a user interface that can be adapted to the individual, regardless of handicap. Indeed, adaptability is a potential strength of digital interfaces. For adaptability, an interface designer can use large, scalable text and add audio prompts and other features.

Our findings can be useful in evaluating patient responsiveness to surveys administered on digital tablets in an outpatient clinic setting. In this prospective, randomized study, we found that, for survey completion, use of a tablet device did not require more time than use of a paper form. In addition, the administration modalities had similar completion and error rates for a variety of orthopedic outcomes surveys. We did not activate digital features that would have given unfair advantage to the digital data collection modality. We also found a strong preference for use of technology in PRO data collection, and this may help improve collection rates. Last, though optimizing the flow of patients in our clinic was not a strict research metric, we prioritized making sure patients were not spending any more time completing these surveys than in the past. Given the potential benefits of digital surveys—immediate and accurate transfer of collected data into multiple databases, including the patient’s electronic medical record—our experience supports continuing validation of these instruments for potential wider use.

Am J Orthop. 2016;45(7):E451-E457. Copyright Frontline Medical Communications Inc. 2016. All rights reserved.

Total knee arthroplasty (TKA) is an efficacious procedure for end-stage knee arthritis. Although TKA is cost-effective and has a high rate of success,^1-6 TKAs fail and may require revision surgery. Failure mechanisms include periprosthetic fracture, aseptic loosening, wear, osteolysis, instability, and infection.^7-9 In these cases, revision arthroplasty may be needed in order to restore function.

There has been a steady increase in the number of primary and revision TKAs performed in the United States.^8,10,11 Revision rates are 4% at 5 years after index TKA and 8.9% at 9 years.¹² However, surgical techniques and improved implants have led to improved outcomes after primary TKA, as evidenced by the reduction in revisions performed for polyethylene wear and osteolysis.¹³ Given the continuing need for revision TKAs (despite technical improvements¹³), evidence-based standard protocols that improve outcomes after revision TKA are necessary.

The Total Joint Replacement Perioperative Surgical Home (TJR-PSH) implemented and used by surgeons and anesthesiologists at our institution has shown that an evidence-based perioperative protocol can provide consistent and improved outcomes in primary TKA.^14-16

TJR-PSH is a clinical care pathway that defines and standardizes preoperative, intraoperative, postoperative, and postdischarge management for patients who undergo elective primary total knee and total hip arthroplasty.^14,15

The clinical pathway developed by the TJR-PSH team is briefly described in Appendixes A and B.

Garson and colleagues¹⁴ and Chaurasia and colleagues¹⁵ found that patients who underwent primary TKA in a TJA-PSH had a predicted short length of stay (LOS): <3 days. About half were discharged to a location other than home, and 1.1% were readmitted within the first 30 days after surgery. There were no major complications and no mortalities. Conversely, as shown in different nationwide database analysis,^17,18 mean LOS after primary unilateral TKA was 5.3 days, 8.2% of patients had procedure-related complications, 30-day readmission rate was 4.2%, and the in-hospital mortality rate was 0.3%. As with TJA-PSH, about half the patients were discharged to a place other than home.

We conducted a study to test the effect of the TJA-PSH clinical pathway on revision TKA patients. Early perioperative outcomes, such as LOS, readmission rate, and reoperation rate, are invaluable tools in measuring TKA outcomes and correlate with the dedicated orthopedic complication grading system proposed by the Knee Society.^14,15,17,19 We hypothesized that the TJR-PSH clinical pathway would close the perioperative morbidity gap between primary and revision TKAs and yield equivalent perioperative outcomes.

Materials and Methods

In this study, which received Institutional Review Board approval, we performed a prospective cross-sectional analysis comparing the perioperative outcomes of patients who underwent primary TKA with those of patients who underwent revision TKA. Medical records and our institution’s data registry were queried for LOS, discharge disposition, readmission rates, and reoperation rates.

The study included all primary and revision TKAs performed at our institution since the inception of TJA-PSH. Unicompartmental knee arthroplasties and exchanges of a single component (patella, tibia, or femur) were excluded. We identified a total of 285 consecutive primary or revision TKAs, all performed by a single surgeon. Three cases lacked complete data and were excluded, leaving 282 cases: 235 primary and 50 revision TKAs (no simultaneous bilateral TKAs). The demographic data we collected included age, sex, body mass index (BMI), American Society of Anesthesiologists (ASA) score, calculated Charlson Comorbidity Index (CCI), LOS, and discharge disposition.

The same established perioperative surgical home clinical pathway was used to care for all patients, whether they underwent primary or revision TKA. The primary outcomes studied were LOS, discharge disposition (subacute nursing facility or home), 30-day orthopedic readmission, and return to operating room. All reoperations on the same knee were analyzed.

Statistical Analysis

Primary and revision TKAs were compared on LOS (with an independent-sample t test) and discharge disposition, 30-day readmissions, and reoperations (χ² Fisher exact test). Multivariate regression analysis was performed with each primary outcome, using age, sex, BMI, ASA score, and CCI as covariates. Statistical significance was set at P ≤ .05. All analyses were performed with SPSS Version 16.0 (SPSS Inc.) and Microsoft Excel 2011 (Microsoft).

Results

Mean (SD) age was 66 (13.2) years for primary TKA patients and 62 (12.8) years for revision TKA patients. The cohort had more women (62.5%) than men (37.5%). There was no statistical difference in patient demographics with respect to age (P = .169) or BMI (P = .701) between the 2 groups. There was an even age distribution within each group and between the groups (Table).

There was no statistically significant difference in mean ASA score between the groups (P = .914).

 

There was no statistically significant difference in LOS between the groups. Mean (SD) LOS was 2.55 (1.25) days for primary TKA and 2.92 (1.24) days for revision TKA (P = .061; 95% confidence interval [CI], 0.017-0.749). Regression analysis showed a correlation between ASA score and LOS for primary TKAs but not revision TKAs. For every unit increase in ASA score, there was a 0.39-day increase in LOS for primary TKA (P = .46; 95% CI, 0.006-0.781). There was no correlation between ASA score and LOS for revision TKA when controlling for covariates (P = .124). Eighty (34%) of the 235 primary TKA patients and 21 (41%) of the 50 revision TKA patients were discharged to a subacute nursing facility; the difference was not significant (P = .123). No patient was discharged to an acute inpatient rehabilitation unit. In addition, there was no significant difference in 30-day readmission rates between primary and revision TKA (P = .081). One primary TKA patient (0.4%) and 2 revision TKA patients (4%) were readmitted within 30 days after surgery (P = .081). The primary TKA readmission was for severe spasticity and a history of cerebral palsy leading to a quadriceps avulsion fracture from the superior pole of the patella. One revision TKA readmission was for acute periprosthetic joint infection, and the other for periprosthetic fracture around a press-fit distal femoral replacement stem. There was no significant difference in number of 30-day reoperations between the groups (P = .993). None of the primary TKAs and 2 (4%) of the revision TKAs underwent reoperation. Of the revision TKA patients who returned to the operating room within 30 days after surgery, one was treated for an acute periprosthetic joint infection, the other for a femoral periprosthetic fracture.

Discussion

Advances in multidisciplinary co-management of TKA patients and their clinical effects are highlighted in the TJR-PSH.¹⁴ TJR-PSH allows the health team and the patient to prepare for surgery with an understanding of probable outcomes and to optimize the patient’s medical and educational standing to better meet expectations and increase satisfaction.

Previous studies have focused on the etiologies of revision TKA^7,8 and on understanding the factors that may predict increased risk for a poor outcome after primary TKA and indicate a possible need for revision.^8,12 The present study focused on practical clinical processes that could potentially constitute a standardized perioperative protocol for revision TKA. An organized TJR-PSH may allow the health team to educate patients that LOS, rehabilitation and acute recovery, risk of acute (30-day) complications, and risk of readmission and return to the operating room within the first 30 days after surgery are similar for revision and primary TKAs, as long as proper preoperative optimization and education occur within the TJR-PSH.

Studies have found correlations between revision TKA and significantly increased LOS and postoperative complications.^20,21 In contrast, we found no significant difference in LOS between our primary and revision TKA groups. LOS was 2.6 days for primary TKA and 2.9 days for revision TKA—a significant improvement in care and cost for revision TKA patients. That the reduced mean LOS for revision TKA is similar to the mean LOS for primary TKA also implies a reduction in the higher cost of care in revision TKA.²⁰ In addition to obtaining similar LOS for primary and revision TKA, TJR-PSH achieved an overall reduction in LOS.^17,22Our results also showed no difference in discharge disposition between primary and revision TKA in our protocol. Discharge disposition also did not correlate with age, sex, BMI, ASA score, or CCI. In TJR-PSH, discharge planning starts before admission and is patient-oriented for optimal recovery. About 66% of primary TKA patients and 58% of revision TKA patients in our cohort were discharged home—implying we are able to send a majority of our postoperative patients home after a shorter hospital stay, while obtaining the same good outcomes. Discharging fewer revision TKA patients to extended-care facilities also indicates a possible reduction in the cost of postoperative care, bringing it in line with the cost in primary TKA. Early individualized discharge planning in TJA-PSH accounts for the similar outcomes in primary and revision TKAs.

There was no significant difference in 30-day readmission rates between our primary and revision TKA patients. An important component of the TJR-PSH pathway is the individualized postdischarge recovery plan, which helps with optimal recovery and reduces readmission rates. Our cohort’s 30-day readmission rate was 0.4% for primary TKA and 4% for revision TKA (P = .081). Thirty-day readmission is a good indicator of postoperative complications and recovery from surgery. We have previously reported on primary TKA outcomes.^{14,15,,18,22,23} In a study using an NSQIP (National Surgical Quality Improvement Program) database, 11,814 primary TKAs had a 30-day readmission rate of 4.2%.¹⁸ In an outcomes study of 17,994 patients who underwent primary TKA in a single fiscal year, the 30-day readmission rate was 5.9%.⁹ In addition, in a single-institution cohort study of 1032 primary TKA patients, Schairer and colleagues²³ found a 30-day unplanned readmission rate of 3.4%. Compared with primary TKA, revision TKA traditionally has had a higher postoperative complication rate.^20,21 There is also concern that shorter hospital stays may indicate that significant complications of revision TKAs are being missed. In this study, however, we established that the equal outcomes obtained in the perioperative period carry over to the 30-day postoperative period in our revision TKA group. Good postoperative follow-up and planning are important factors in readmission reduction. Readmissions also have significant overall cost implications.²⁴There was no statistical difference in 30-day reoperation rates between our primary and revision TKA patients. The primary TKA patients had no 30-day reoperations. Previous studies have found reoperation rates ranging from 1.8% to 4.7%.^25,26 Revision TKA patients are up to 6 times more likely than primary TKA patients to require reoperation.²⁰ Our study found no significant difference in outcomes between primary and revision TKAs.

Comparison of the outcomes of primary TKA and revision TKA in TJR-PSH showed no difference in acute recovery from surgery. LOS and discharge disposition, 30-day readmission rate, and 30-day return to the operating room were the same for primary and revision TKAs. The morbidity gap between primary and revision TKA patients has been closed in our research cohort. This outcome is important, as indications for primary TKA continue to expand and more primary TKAs are performed in younger patients.^18,23 The implication is that, in the future, more knees will need to be revised as patients outlive their prostheses.

Our study had some limitations. First, it involved a small sample of patients, operated on by a single surgeon in a well-organized TJR-PSH at a large academic center. This population might not represent the US patient population, but that should not have adversely affected data analysis, because patients were compared with a similar population. Second, the data might be incomplete because some patients with complications might have sought care at other medical facilities, and we might not have been aware of these cases. Third, we focused on objective clinical outcomes in order to measure the success of TKAs. We did not include any subjective, patient-reported data, such as rehabilitation advances and functioning levels. Fourth, multiple parameters can be used to address complication outcomes, but we used LOS, discharge disposition, 30-day readmission rate, and 30-day reoperation rate because current payers and institutions often consider these variables when assessing quality of care. These parameters can be influenced by factors such as inpatient physical therapy goals, facility discharge practices, individual social support structure, and hospital pay-for-performance model. The implication is that different facilities have different outcomes in terms of LOS, discharge disposition, readmissions, and reoperations. However, we expect proportionate similarities in these parameters as patient perioperative outcomes become more complicated. Nevertheless, a multicenter study would be able to answer questions raised by this limitation. Fifth, our statistical analysis might have been affected by decreased power of some of the outcome variables.

TJR-PSH has succeeded in closing the perioperative morbidity and outcomes gap between primary and revision TKAs. Outcome parameters used to measure the success of TJR-PSH are standard measures of the immediate postoperative recovery and short-term outcomes of TKA patients. These measures are linked to complication rates and overall outcomes in many TKA studies.^14,15,17,19 Also important is that hospital costs can be drastically cut by reducing LOS, readmissions, and reoperations. Presence of any complication of primary or revision TKA raises the cost up to 34%. This increase can go as high as 64% in the 90 days after surgery.²⁷

 

Conclusion

The major challenge of the changing medical landscape is to integrate quality care and a continually improving healthcare system with the goal of cost-effective delivery of healthcare. Surgical care costs can be significantly increased by evitable hospital stays, complications that lead to readmissions, and unplanned returns to the operating room after index surgery. The new perioperative surgical home created for TJA has helped drastically reduce LOS, discharge disposition, 30-day readmission rate, and 30-day reoperation rate in revision TKA. This study demonstrates similar outcomes in our revision TKA patients relative to their primary TKA counterparts.

Am J Orthop. 2016;45(7):E458-E464. Copyright Frontline Medical Communications Inc. 2016. All rights reserved.

Total knee arthroplasty (TKA) is an efficacious procedure for end-stage knee arthritis. Although TKA is cost-effective and has a high rate of success,^1-6 TKAs fail and may require revision surgery. Failure mechanisms include periprosthetic fracture, aseptic loosening, wear, osteolysis, instability, and infection.^7-9 In these cases, revision arthroplasty may be needed in order to restore function.

There has been a steady increase in the number of primary and revision TKAs performed in the United States.^8,10,11 Revision rates are 4% at 5 years after index TKA and 8.9% at 9 years.¹² However, surgical techniques and improved implants have led to improved outcomes after primary TKA, as evidenced by the reduction in revisions performed for polyethylene wear and osteolysis.¹³ Given the continuing need for revision TKAs (despite technical improvements¹³), evidence-based standard protocols that improve outcomes after revision TKA are necessary.

The Total Joint Replacement Perioperative Surgical Home (TJR-PSH) implemented and used by surgeons and anesthesiologists at our institution has shown that an evidence-based perioperative protocol can provide consistent and improved outcomes in primary TKA.^14-16

TJR-PSH is a clinical care pathway that defines and standardizes preoperative, intraoperative, postoperative, and postdischarge management for patients who undergo elective primary total knee and total hip arthroplasty.^14,15

The clinical pathway developed by the TJR-PSH team is briefly described in Appendixes A and B.

Garson and colleagues¹⁴ and Chaurasia and colleagues¹⁵ found that patients who underwent primary TKA in a TJA-PSH had a predicted short length of stay (LOS): <3 days. About half were discharged to a location other than home, and 1.1% were readmitted within the first 30 days after surgery. There were no major complications and no mortalities. Conversely, as shown in different nationwide database analysis,^17,18 mean LOS after primary unilateral TKA was 5.3 days, 8.2% of patients had procedure-related complications, 30-day readmission rate was 4.2%, and the in-hospital mortality rate was 0.3%. As with TJA-PSH, about half the patients were discharged to a place other than home.

We conducted a study to test the effect of the TJA-PSH clinical pathway on revision TKA patients. Early perioperative outcomes, such as LOS, readmission rate, and reoperation rate, are invaluable tools in measuring TKA outcomes and correlate with the dedicated orthopedic complication grading system proposed by the Knee Society.^14,15,17,19 We hypothesized that the TJR-PSH clinical pathway would close the perioperative morbidity gap between primary and revision TKAs and yield equivalent perioperative outcomes.

Materials and Methods

In this study, which received Institutional Review Board approval, we performed a prospective cross-sectional analysis comparing the perioperative outcomes of patients who underwent primary TKA with those of patients who underwent revision TKA. Medical records and our institution’s data registry were queried for LOS, discharge disposition, readmission rates, and reoperation rates.

The study included all primary and revision TKAs performed at our institution since the inception of TJA-PSH. Unicompartmental knee arthroplasties and exchanges of a single component (patella, tibia, or femur) were excluded. We identified a total of 285 consecutive primary or revision TKAs, all performed by a single surgeon. Three cases lacked complete data and were excluded, leaving 282 cases: 235 primary and 50 revision TKAs (no simultaneous bilateral TKAs). The demographic data we collected included age, sex, body mass index (BMI), American Society of Anesthesiologists (ASA) score, calculated Charlson Comorbidity Index (CCI), LOS, and discharge disposition.

The same established perioperative surgical home clinical pathway was used to care for all patients, whether they underwent primary or revision TKA. The primary outcomes studied were LOS, discharge disposition (subacute nursing facility or home), 30-day orthopedic readmission, and return to operating room. All reoperations on the same knee were analyzed.

Statistical Analysis

Primary and revision TKAs were compared on LOS (with an independent-sample t test) and discharge disposition, 30-day readmissions, and reoperations (χ² Fisher exact test). Multivariate regression analysis was performed with each primary outcome, using age, sex, BMI, ASA score, and CCI as covariates. Statistical significance was set at P ≤ .05. All analyses were performed with SPSS Version 16.0 (SPSS Inc.) and Microsoft Excel 2011 (Microsoft).

Results

Mean (SD) age was 66 (13.2) years for primary TKA patients and 62 (12.8) years for revision TKA patients. The cohort had more women (62.5%) than men (37.5%). There was no statistical difference in patient demographics with respect to age (P = .169) or BMI (P = .701) between the 2 groups. There was an even age distribution within each group and between the groups (Table).

There was no statistically significant difference in mean ASA score between the groups (P = .914).

 

There was no statistically significant difference in LOS between the groups. Mean (SD) LOS was 2.55 (1.25) days for primary TKA and 2.92 (1.24) days for revision TKA (P = .061; 95% confidence interval [CI], 0.017-0.749). Regression analysis showed a correlation between ASA score and LOS for primary TKAs but not revision TKAs. For every unit increase in ASA score, there was a 0.39-day increase in LOS for primary TKA (P = .46; 95% CI, 0.006-0.781). There was no correlation between ASA score and LOS for revision TKA when controlling for covariates (P = .124). Eighty (34%) of the 235 primary TKA patients and 21 (41%) of the 50 revision TKA patients were discharged to a subacute nursing facility; the difference was not significant (P = .123). No patient was discharged to an acute inpatient rehabilitation unit. In addition, there was no significant difference in 30-day readmission rates between primary and revision TKA (P = .081). One primary TKA patient (0.4%) and 2 revision TKA patients (4%) were readmitted within 30 days after surgery (P = .081). The primary TKA readmission was for severe spasticity and a history of cerebral palsy leading to a quadriceps avulsion fracture from the superior pole of the patella. One revision TKA readmission was for acute periprosthetic joint infection, and the other for periprosthetic fracture around a press-fit distal femoral replacement stem. There was no significant difference in number of 30-day reoperations between the groups (P = .993). None of the primary TKAs and 2 (4%) of the revision TKAs underwent reoperation. Of the revision TKA patients who returned to the operating room within 30 days after surgery, one was treated for an acute periprosthetic joint infection, the other for a femoral periprosthetic fracture.

Discussion

Advances in multidisciplinary co-management of TKA patients and their clinical effects are highlighted in the TJR-PSH.¹⁴ TJR-PSH allows the health team and the patient to prepare for surgery with an understanding of probable outcomes and to optimize the patient’s medical and educational standing to better meet expectations and increase satisfaction.

Previous studies have focused on the etiologies of revision TKA^7,8 and on understanding the factors that may predict increased risk for a poor outcome after primary TKA and indicate a possible need for revision.^8,12 The present study focused on practical clinical processes that could potentially constitute a standardized perioperative protocol for revision TKA. An organized TJR-PSH may allow the health team to educate patients that LOS, rehabilitation and acute recovery, risk of acute (30-day) complications, and risk of readmission and return to the operating room within the first 30 days after surgery are similar for revision and primary TKAs, as long as proper preoperative optimization and education occur within the TJR-PSH.

Studies have found correlations between revision TKA and significantly increased LOS and postoperative complications.^20,21 In contrast, we found no significant difference in LOS between our primary and revision TKA groups. LOS was 2.6 days for primary TKA and 2.9 days for revision TKA—a significant improvement in care and cost for revision TKA patients. That the reduced mean LOS for revision TKA is similar to the mean LOS for primary TKA also implies a reduction in the higher cost of care in revision TKA.²⁰ In addition to obtaining similar LOS for primary and revision TKA, TJR-PSH achieved an overall reduction in LOS.^17,22Our results also showed no difference in discharge disposition between primary and revision TKA in our protocol. Discharge disposition also did not correlate with age, sex, BMI, ASA score, or CCI. In TJR-PSH, discharge planning starts before admission and is patient-oriented for optimal recovery. About 66% of primary TKA patients and 58% of revision TKA patients in our cohort were discharged home—implying we are able to send a majority of our postoperative patients home after a shorter hospital stay, while obtaining the same good outcomes. Discharging fewer revision TKA patients to extended-care facilities also indicates a possible reduction in the cost of postoperative care, bringing it in line with the cost in primary TKA. Early individualized discharge planning in TJA-PSH accounts for the similar outcomes in primary and revision TKAs.

There was no significant difference in 30-day readmission rates between our primary and revision TKA patients. An important component of the TJR-PSH pathway is the individualized postdischarge recovery plan, which helps with optimal recovery and reduces readmission rates. Our cohort’s 30-day readmission rate was 0.4% for primary TKA and 4% for revision TKA (P = .081). Thirty-day readmission is a good indicator of postoperative complications and recovery from surgery. We have previously reported on primary TKA outcomes.^{14,15,,18,22,23} In a study using an NSQIP (National Surgical Quality Improvement Program) database, 11,814 primary TKAs had a 30-day readmission rate of 4.2%.¹⁸ In an outcomes study of 17,994 patients who underwent primary TKA in a single fiscal year, the 30-day readmission rate was 5.9%.⁹ In addition, in a single-institution cohort study of 1032 primary TKA patients, Schairer and colleagues²³ found a 30-day unplanned readmission rate of 3.4%. Compared with primary TKA, revision TKA traditionally has had a higher postoperative complication rate.^20,21 There is also concern that shorter hospital stays may indicate that significant complications of revision TKAs are being missed. In this study, however, we established that the equal outcomes obtained in the perioperative period carry over to the 30-day postoperative period in our revision TKA group. Good postoperative follow-up and planning are important factors in readmission reduction. Readmissions also have significant overall cost implications.²⁴There was no statistical difference in 30-day reoperation rates between our primary and revision TKA patients. The primary TKA patients had no 30-day reoperations. Previous studies have found reoperation rates ranging from 1.8% to 4.7%.^25,26 Revision TKA patients are up to 6 times more likely than primary TKA patients to require reoperation.²⁰ Our study found no significant difference in outcomes between primary and revision TKAs.

Comparison of the outcomes of primary TKA and revision TKA in TJR-PSH showed no difference in acute recovery from surgery. LOS and discharge disposition, 30-day readmission rate, and 30-day return to the operating room were the same for primary and revision TKAs. The morbidity gap between primary and revision TKA patients has been closed in our research cohort. This outcome is important, as indications for primary TKA continue to expand and more primary TKAs are performed in younger patients.^18,23 The implication is that, in the future, more knees will need to be revised as patients outlive their prostheses.

Our study had some limitations. First, it involved a small sample of patients, operated on by a single surgeon in a well-organized TJR-PSH at a large academic center. This population might not represent the US patient population, but that should not have adversely affected data analysis, because patients were compared with a similar population. Second, the data might be incomplete because some patients with complications might have sought care at other medical facilities, and we might not have been aware of these cases. Third, we focused on objective clinical outcomes in order to measure the success of TKAs. We did not include any subjective, patient-reported data, such as rehabilitation advances and functioning levels. Fourth, multiple parameters can be used to address complication outcomes, but we used LOS, discharge disposition, 30-day readmission rate, and 30-day reoperation rate because current payers and institutions often consider these variables when assessing quality of care. These parameters can be influenced by factors such as inpatient physical therapy goals, facility discharge practices, individual social support structure, and hospital pay-for-performance model. The implication is that different facilities have different outcomes in terms of LOS, discharge disposition, readmissions, and reoperations. However, we expect proportionate similarities in these parameters as patient perioperative outcomes become more complicated. Nevertheless, a multicenter study would be able to answer questions raised by this limitation. Fifth, our statistical analysis might have been affected by decreased power of some of the outcome variables.

TJR-PSH has succeeded in closing the perioperative morbidity and outcomes gap between primary and revision TKAs. Outcome parameters used to measure the success of TJR-PSH are standard measures of the immediate postoperative recovery and short-term outcomes of TKA patients. These measures are linked to complication rates and overall outcomes in many TKA studies.^14,15,17,19 Also important is that hospital costs can be drastically cut by reducing LOS, readmissions, and reoperations. Presence of any complication of primary or revision TKA raises the cost up to 34%. This increase can go as high as 64% in the 90 days after surgery.²⁷

 

Conclusion

The major challenge of the changing medical landscape is to integrate quality care and a continually improving healthcare system with the goal of cost-effective delivery of healthcare. Surgical care costs can be significantly increased by evitable hospital stays, complications that lead to readmissions, and unplanned returns to the operating room after index surgery. The new perioperative surgical home created for TJA has helped drastically reduce LOS, discharge disposition, 30-day readmission rate, and 30-day reoperation rate in revision TKA. This study demonstrates similar outcomes in our revision TKA patients relative to their primary TKA counterparts.

Am J Orthop. 2016;45(7):E458-E464. Copyright Frontline Medical Communications Inc. 2016. All rights reserved.

Total knee arthroplasty (TKA) is an efficacious procedure for end-stage knee arthritis. Although TKA is cost-effective and has a high rate of success,^1-6 TKAs fail and may require revision surgery. Failure mechanisms include periprosthetic fracture, aseptic loosening, wear, osteolysis, instability, and infection.^7-9 In these cases, revision arthroplasty may be needed in order to restore function.

There has been a steady increase in the number of primary and revision TKAs performed in the United States.^8,10,11 Revision rates are 4% at 5 years after index TKA and 8.9% at 9 years.¹² However, surgical techniques and improved implants have led to improved outcomes after primary TKA, as evidenced by the reduction in revisions performed for polyethylene wear and osteolysis.¹³ Given the continuing need for revision TKAs (despite technical improvements¹³), evidence-based standard protocols that improve outcomes after revision TKA are necessary.

The Total Joint Replacement Perioperative Surgical Home (TJR-PSH) implemented and used by surgeons and anesthesiologists at our institution has shown that an evidence-based perioperative protocol can provide consistent and improved outcomes in primary TKA.^14-16

TJR-PSH is a clinical care pathway that defines and standardizes preoperative, intraoperative, postoperative, and postdischarge management for patients who undergo elective primary total knee and total hip arthroplasty.^14,15

The clinical pathway developed by the TJR-PSH team is briefly described in Appendixes A and B.

Garson and colleagues¹⁴ and Chaurasia and colleagues¹⁵ found that patients who underwent primary TKA in a TJA-PSH had a predicted short length of stay (LOS): <3 days. About half were discharged to a location other than home, and 1.1% were readmitted within the first 30 days after surgery. There were no major complications and no mortalities. Conversely, as shown in different nationwide database analysis,^17,18 mean LOS after primary unilateral TKA was 5.3 days, 8.2% of patients had procedure-related complications, 30-day readmission rate was 4.2%, and the in-hospital mortality rate was 0.3%. As with TJA-PSH, about half the patients were discharged to a place other than home.

We conducted a study to test the effect of the TJA-PSH clinical pathway on revision TKA patients. Early perioperative outcomes, such as LOS, readmission rate, and reoperation rate, are invaluable tools in measuring TKA outcomes and correlate with the dedicated orthopedic complication grading system proposed by the Knee Society.^14,15,17,19 We hypothesized that the TJR-PSH clinical pathway would close the perioperative morbidity gap between primary and revision TKAs and yield equivalent perioperative outcomes.

Materials and Methods

In this study, which received Institutional Review Board approval, we performed a prospective cross-sectional analysis comparing the perioperative outcomes of patients who underwent primary TKA with those of patients who underwent revision TKA. Medical records and our institution’s data registry were queried for LOS, discharge disposition, readmission rates, and reoperation rates.

The study included all primary and revision TKAs performed at our institution since the inception of TJA-PSH. Unicompartmental knee arthroplasties and exchanges of a single component (patella, tibia, or femur) were excluded. We identified a total of 285 consecutive primary or revision TKAs, all performed by a single surgeon. Three cases lacked complete data and were excluded, leaving 282 cases: 235 primary and 50 revision TKAs (no simultaneous bilateral TKAs). The demographic data we collected included age, sex, body mass index (BMI), American Society of Anesthesiologists (ASA) score, calculated Charlson Comorbidity Index (CCI), LOS, and discharge disposition.

The same established perioperative surgical home clinical pathway was used to care for all patients, whether they underwent primary or revision TKA. The primary outcomes studied were LOS, discharge disposition (subacute nursing facility or home), 30-day orthopedic readmission, and return to operating room. All reoperations on the same knee were analyzed.

Statistical Analysis

Primary and revision TKAs were compared on LOS (with an independent-sample t test) and discharge disposition, 30-day readmissions, and reoperations (χ² Fisher exact test). Multivariate regression analysis was performed with each primary outcome, using age, sex, BMI, ASA score, and CCI as covariates. Statistical significance was set at P ≤ .05. All analyses were performed with SPSS Version 16.0 (SPSS Inc.) and Microsoft Excel 2011 (Microsoft).

Results

Mean (SD) age was 66 (13.2) years for primary TKA patients and 62 (12.8) years for revision TKA patients. The cohort had more women (62.5%) than men (37.5%). There was no statistical difference in patient demographics with respect to age (P = .169) or BMI (P = .701) between the 2 groups. There was an even age distribution within each group and between the groups (Table).

There was no statistically significant difference in mean ASA score between the groups (P = .914).

 

There was no statistically significant difference in LOS between the groups. Mean (SD) LOS was 2.55 (1.25) days for primary TKA and 2.92 (1.24) days for revision TKA (P = .061; 95% confidence interval [CI], 0.017-0.749). Regression analysis showed a correlation between ASA score and LOS for primary TKAs but not revision TKAs. For every unit increase in ASA score, there was a 0.39-day increase in LOS for primary TKA (P = .46; 95% CI, 0.006-0.781). There was no correlation between ASA score and LOS for revision TKA when controlling for covariates (P = .124). Eighty (34%) of the 235 primary TKA patients and 21 (41%) of the 50 revision TKA patients were discharged to a subacute nursing facility; the difference was not significant (P = .123). No patient was discharged to an acute inpatient rehabilitation unit. In addition, there was no significant difference in 30-day readmission rates between primary and revision TKA (P = .081). One primary TKA patient (0.4%) and 2 revision TKA patients (4%) were readmitted within 30 days after surgery (P = .081). The primary TKA readmission was for severe spasticity and a history of cerebral palsy leading to a quadriceps avulsion fracture from the superior pole of the patella. One revision TKA readmission was for acute periprosthetic joint infection, and the other for periprosthetic fracture around a press-fit distal femoral replacement stem. There was no significant difference in number of 30-day reoperations between the groups (P = .993). None of the primary TKAs and 2 (4%) of the revision TKAs underwent reoperation. Of the revision TKA patients who returned to the operating room within 30 days after surgery, one was treated for an acute periprosthetic joint infection, the other for a femoral periprosthetic fracture.

Discussion

Advances in multidisciplinary co-management of TKA patients and their clinical effects are highlighted in the TJR-PSH.¹⁴ TJR-PSH allows the health team and the patient to prepare for surgery with an understanding of probable outcomes and to optimize the patient’s medical and educational standing to better meet expectations and increase satisfaction.

Previous studies have focused on the etiologies of revision TKA^7,8 and on understanding the factors that may predict increased risk for a poor outcome after primary TKA and indicate a possible need for revision.^8,12 The present study focused on practical clinical processes that could potentially constitute a standardized perioperative protocol for revision TKA. An organized TJR-PSH may allow the health team to educate patients that LOS, rehabilitation and acute recovery, risk of acute (30-day) complications, and risk of readmission and return to the operating room within the first 30 days after surgery are similar for revision and primary TKAs, as long as proper preoperative optimization and education occur within the TJR-PSH.

Studies have found correlations between revision TKA and significantly increased LOS and postoperative complications.^20,21 In contrast, we found no significant difference in LOS between our primary and revision TKA groups. LOS was 2.6 days for primary TKA and 2.9 days for revision TKA—a significant improvement in care and cost for revision TKA patients. That the reduced mean LOS for revision TKA is similar to the mean LOS for primary TKA also implies a reduction in the higher cost of care in revision TKA.²⁰ In addition to obtaining similar LOS for primary and revision TKA, TJR-PSH achieved an overall reduction in LOS.^17,22Our results also showed no difference in discharge disposition between primary and revision TKA in our protocol. Discharge disposition also did not correlate with age, sex, BMI, ASA score, or CCI. In TJR-PSH, discharge planning starts before admission and is patient-oriented for optimal recovery. About 66% of primary TKA patients and 58% of revision TKA patients in our cohort were discharged home—implying we are able to send a majority of our postoperative patients home after a shorter hospital stay, while obtaining the same good outcomes. Discharging fewer revision TKA patients to extended-care facilities also indicates a possible reduction in the cost of postoperative care, bringing it in line with the cost in primary TKA. Early individualized discharge planning in TJA-PSH accounts for the similar outcomes in primary and revision TKAs.

There was no significant difference in 30-day readmission rates between our primary and revision TKA patients. An important component of the TJR-PSH pathway is the individualized postdischarge recovery plan, which helps with optimal recovery and reduces readmission rates. Our cohort’s 30-day readmission rate was 0.4% for primary TKA and 4% for revision TKA (P = .081). Thirty-day readmission is a good indicator of postoperative complications and recovery from surgery. We have previously reported on primary TKA outcomes.^{14,15,,18,22,23} In a study using an NSQIP (National Surgical Quality Improvement Program) database, 11,814 primary TKAs had a 30-day readmission rate of 4.2%.¹⁸ In an outcomes study of 17,994 patients who underwent primary TKA in a single fiscal year, the 30-day readmission rate was 5.9%.⁹ In addition, in a single-institution cohort study of 1032 primary TKA patients, Schairer and colleagues²³ found a 30-day unplanned readmission rate of 3.4%. Compared with primary TKA, revision TKA traditionally has had a higher postoperative complication rate.^20,21 There is also concern that shorter hospital stays may indicate that significant complications of revision TKAs are being missed. In this study, however, we established that the equal outcomes obtained in the perioperative period carry over to the 30-day postoperative period in our revision TKA group. Good postoperative follow-up and planning are important factors in readmission reduction. Readmissions also have significant overall cost implications.²⁴There was no statistical difference in 30-day reoperation rates between our primary and revision TKA patients. The primary TKA patients had no 30-day reoperations. Previous studies have found reoperation rates ranging from 1.8% to 4.7%.^25,26 Revision TKA patients are up to 6 times more likely than primary TKA patients to require reoperation.²⁰ Our study found no significant difference in outcomes between primary and revision TKAs.

Comparison of the outcomes of primary TKA and revision TKA in TJR-PSH showed no difference in acute recovery from surgery. LOS and discharge disposition, 30-day readmission rate, and 30-day return to the operating room were the same for primary and revision TKAs. The morbidity gap between primary and revision TKA patients has been closed in our research cohort. This outcome is important, as indications for primary TKA continue to expand and more primary TKAs are performed in younger patients.^18,23 The implication is that, in the future, more knees will need to be revised as patients outlive their prostheses.

Our study had some limitations. First, it involved a small sample of patients, operated on by a single surgeon in a well-organized TJR-PSH at a large academic center. This population might not represent the US patient population, but that should not have adversely affected data analysis, because patients were compared with a similar population. Second, the data might be incomplete because some patients with complications might have sought care at other medical facilities, and we might not have been aware of these cases. Third, we focused on objective clinical outcomes in order to measure the success of TKAs. We did not include any subjective, patient-reported data, such as rehabilitation advances and functioning levels. Fourth, multiple parameters can be used to address complication outcomes, but we used LOS, discharge disposition, 30-day readmission rate, and 30-day reoperation rate because current payers and institutions often consider these variables when assessing quality of care. These parameters can be influenced by factors such as inpatient physical therapy goals, facility discharge practices, individual social support structure, and hospital pay-for-performance model. The implication is that different facilities have different outcomes in terms of LOS, discharge disposition, readmissions, and reoperations. However, we expect proportionate similarities in these parameters as patient perioperative outcomes become more complicated. Nevertheless, a multicenter study would be able to answer questions raised by this limitation. Fifth, our statistical analysis might have been affected by decreased power of some of the outcome variables.

TJR-PSH has succeeded in closing the perioperative morbidity and outcomes gap between primary and revision TKAs. Outcome parameters used to measure the success of TJR-PSH are standard measures of the immediate postoperative recovery and short-term outcomes of TKA patients. These measures are linked to complication rates and overall outcomes in many TKA studies.^14,15,17,19 Also important is that hospital costs can be drastically cut by reducing LOS, readmissions, and reoperations. Presence of any complication of primary or revision TKA raises the cost up to 34%. This increase can go as high as 64% in the 90 days after surgery.²⁷

 

Conclusion

The major challenge of the changing medical landscape is to integrate quality care and a continually improving healthcare system with the goal of cost-effective delivery of healthcare. Surgical care costs can be significantly increased by evitable hospital stays, complications that lead to readmissions, and unplanned returns to the operating room after index surgery. The new perioperative surgical home created for TJA has helped drastically reduce LOS, discharge disposition, 30-day readmission rate, and 30-day reoperation rate in revision TKA. This study demonstrates similar outcomes in our revision TKA patients relative to their primary TKA counterparts.

Am J Orthop. 2016;45(7):E458-E464. Copyright Frontline Medical Communications Inc. 2016. All rights reserved.

The incidence of midsubstance Achilles tendon ruptures is increasing in patients 30 years to 50 years of age, and more than 50% of these injuries occur during recreational basketball.^1,2 Achilles ruptures occur more in deconditioned individuals engaged in explosive push-off and jumping activities. Management of these injuries has been controversial over the past decade; there is no consensus on nonoperative treatment, surgical repair, or optimal repair technique.^1,3-7 According to American Academy of Orthopaedic Surgeons (AAOS) clinical practice guidelines, limited-incision approaches have fewer overall complications relative to traditional open repair.^3,4

Modern repair techniques, such as the Percutaneous Achilles Repair System (PARS; Arthrex), combine limited soft-tissue dissection with percutaneous suture insertion and knot tying.^1,8 This limited-incision technique, employed since 2010, uses a 2-cm transverse incision and nondisposable metal jig with divergent needle passes and locking suture fixation options to secure and fix both tendon ends with minimal dissection of skin, subcutaneous tissue, and paratenon. A review of 270 surgically treated Achilles tendon ruptures (101 PARS, 169 traditional open repair) found that, compared with the open repair group, the PARS group had significantly shorter operative times and more patients returning to baseline physical activities within 5 months after surgery.¹ Although the difference was not statistically significant, the overall postoperative complication rate was 5% for the PARS group and 11% for the open repair group. The PARS group had no cases of sural neuritis or deep infection requiring reoperation.

Although the PARS technique has had good outcomes with few complications, care must be taken during surgery to prevent sutures from pulling through the tendon near the rupture site, which can result from overtensioning and from suture knot irritation against superficial soft tissues. Given these potential issues, the PARS procedure was modified (Achilles Midsubstance SpeedBridge; Arthrex) to provide knotless restoration of musculotendinous length in a reliable, reproducible fashion and direct fixation of tendon to bone for early mobilization.⁹ This new procedure bypasses suture fixation in the compromised tendon ends adjacent to the rupture site, thereby reducing suture slippage and allowing for potential early range of motion and weight-bearing relative to previous techniques. Preliminary results from a cohort of 34 patients treated with this technique are promising: Average return to baseline activities was 18.2 weeks (range, 9-26 weeks), and there were no wound complications, nerve injuries, or reruptures.⁹Indications are overall health and an acute midsubstance Achilles rupture that presents within 3 weeks after injury (the time limit is used to ensure that both tendon ends can be mobilized and repaired to appropriate length). A relative contraindication is delayed presentation (≥4 weeks), which may require open reconstruction in combination with V-Y lengthening or other adjuvant procedures. Other relative contraindications are insertional rupture, Achilles tendinopathy, and a significant medical comorbidity that prohibits surgical intervention.

Surgical Technique

Operating Room Setup and Approach

The patient is positioned prone with chest rolls and kneepads and with arms at <90° of abduction (Figures 1A-1E).

A thigh tourniquet is placed on the operative extremity, and the feet are placed slightly hanging off the end of the bed with a small bump underneath to adjust the degree of ankle plantarflexion and Achilles tension during the case. It is important that the operative leg be in neutral rotation to allow for central positioning of the PARS jig. After sterile preparation and draping, the extremity is exsanguinated and the tourniquet inflated. The defect within the Achilles tendon is palpated and marked out, and a 2-cm transverse skin incision is made along the proximal aspect of the rupture site.

A “no-touch” technique is used without pickups, and soft tissues are carefully dissected with small scissors down to the paratenon. The sural nerve typically is not visible in the operative field, but, if it is, it can be dissected out and retracted out of the way. A transverse incision is made through the paratenon, and expression of rupture hematoma often follows. Paratenon preservation is key in minimizing disruption of the native vascular supply of the tendon and allowing for repair at the end of the case. A freer can be placed within the wound to confirm that the center of the rupture has been identified.

An Allis clamp is inserted into the wound, and the proximal tendon stump is secured and then pulled about 1 cm through the wound. A freer is circumferentially run along the sides of the proximal tendon to release any potential adhesions that may limit distal excursion.

PARS Jig Insertion and Suture Passing

The PARS jig is inserted into the wound with the inner prongs in the narrowest position possible. The curved jig is inserted proximally, and the center turn wheel is used to widen the inner prongs so they can slide along the sides of the tendon in the paratenon. Proper jig placement should be smooth and encounter little resistance. The proximal tendon is in a superficial location and can be palpated within the prongs of the jig to double-check that the tendon is centered within the jig. A frequent error is to insert the jig too deep, which subsequently causes needles and sutures to miss the tendon and pull through.

 

Keeping the jig centralized in neutral rotation minimizes improper suture passing and avoids iatrogenic injury to the medial and lateral neurovascular structures. During suture passing, all needles (1.6 mm) with nitinol loops are first used unloaded without suture. The first 2 needles are inserted into their respective, numbered holes, through the tendon, and then through the opposite side of the jig. Each needle is checked to make sure that it does not pass outside the jig. Having 2 needles within the jig and tendon at all times during suture passing helps stabilize the jig and avoids adjacent suture piercing with the subsequent needle.

A No. 2 FiberWire suture (Arthrex) is then passed through the first hole using the needle suture passer and made even in length on both sides. The specific colors of the suture are not important, but the order of the sutures placed is. An assistant can write down the colors and order of the sutures passed. Before the second suture is passed, the first needle is inserted back through the jig and tendon into the third hole. The third and fourth sutures (green-striped) differ from the other sutures in that one end has a loop and the other has a tail, and they are passed in an oblique, crossing pattern. These sutures later help create a locking suture on either side of the tendon.

After these sutures are passed, the final result should be 1 green-striped loop and 1 green-striped tail on either side of the tendon. The fifth suture is passed straight across the tendon in a trajectory similar to that of the first suture. In large laborers, obese patients, and elite athletes, 2 additional green-striped sutures can be passed through the optional sixth and seventh holes to create an additional locking suture.

PARS Jig Removal and Suture Management

After all sutures are passed, the turn wheel is used to narrow the inner prongs while gentle, controlled tension is applied to the jig to remove it from the wound (Figures 2A-2C).

All sutures from both sides of the tendon should emerge from the wound. Before the jig is completely pulled out, a hemostat is used through each loop of sutures to guide them out of the wound and reduce tangling. Both pairs of sutures are pulled distally to ensure adequate proximal fixation.

Pullout of any suture from the tendon indicates that the tendon was not centered in the jig or was not proximal enough along the tendon during suture passing. If a suture pulls out, it is removed, and the previous steps are repeated with close attention paid to tendon positioning within the jig. It is not advised to extend the incision longitudinally on either end of the transverse incision, as doing so can lead to potential wound-healing complications. After proximal fixation is achieved, all sutures on each side of the tendon are neatly spread apart in the following order from proximal to distal: first suture, second suture, looped green-striped (third) suture, tail green-striped (fourth) suture, fifth suture. The second suture on both sides is then looped around the 2 green-striped sutures and back proximally through the looped end of the green-striped suture.

The green-striped suture tail is pulled through the tendon to the opposite side to create a locking suture on both sides of the tendon. In the end, there are 2 nonlocking sutures and 1 locking suture on either side of the tendon. Each pair of sutures is pulled distally to confirm fixation and remove any initial suture creep from the system. A hemostat is placed on each group of 3 sutures to keep them out of the way during distal anchor preparation.

Distal Anchor Preparation and Banana SutureLasso Passing

Two longitudinal 5-mm incisions are made along the posterior aspect of the heel just distal to the area of maximal heel convexity. Incisions are spaced 1.5 cm apart along the sides of the Achilles tendon insertion. A 3.5-mm drill and a drill guide are used through each incision and placed flush against bone (Figures 3A-3E).

The drill is inserted into bone oriented slightly proximally and toward midline until it bottoms out against the guide. Each drill hole is then tapped to receive a 4.75-mm SwiveLock anchor (Arthrex).

A Banana SutureLasso (Arthrex) with inner nitinol wire is passed through the center of the distal Achilles tendon stump and out the proximal incision to retrieve one side of the proximal sutures. SutureLasso passage through tendon can be facilitated with tactile feedback. The surgeon’s nondominant thumb is placed directly against the distal tendon while the dominant hand grasps the SutureLasso with the thumb near the tip. As the SutureLasso is advanced proximally through the tendon, the surgeon can feel its tip meeting mild resistance. Confirm that the tip of the SutureLasso is in the center of the distal tendon by direct visual inspection through the wound.

The inner nitinol wire is advanced 2 cm to 3 cm out of the tip of the SutureLasso, and sutures are passed through the distal Achilles tendon. During suture passing, the nitinol wire is drawn back to the tip of the SutureLasso, and then the entire SutureLasso is removed from the distal incision. Trying to pass the sutures only through the inner nitinol wire can result in suture tangling and increased resistance. The process is then repeated for the sutures on the opposite side. Suture pairs are placed under maximal tension and cycled multiple times (5-10) to remove any residual proximal suture creep.¹⁰

 

Achilles Tensioning and Anchor Insertion

The ankle is plantar flexed to tension the Achilles tendon relative to the contralateral limb and is held in place by an assistant (Figures 4A-4E).

At the same time, the assistant holds tension on the opposite pair of sutures to ensure that Achilles length and tension do not change before initial anchor insertion. The rupture site can be palpated to confirm there is no residual gap or excessive overlap of the tendon ends. Sutures are passed through the eyelet of the SwiveLock anchor, and then the anchor is gently malleted into the calcaneal drill hole and hand-tightened until flush with bone. Often, squeaking can be heard as the anchor reaches its final depth in bone.

Position of the drill holes can be rechecked with a Kirschner wire before anchor insertion, as their relative position changes with ankle plantar flexion. It is not necessary to premeasure and adjust suture length at the tip of the anchor as in other blind tunnel anchor insertion techniques (eg, InternalBrace; Arthrex). Once the anchor tip is malleted into bone, the free suture ends are released to avoid overtensioning the tendon. Before the anchor insertion handle is completely removed, the tip of a mosquito clamp can be used to feel the bony surface and confirm the anchor is completely seated.

With the ankle still held in the appropriate amount of plantarflexion, the process is repeated and the other SwiveLock anchor inserted. Sutures are cut flush with the anchor, and the surgeon performs wound irrigation and layered closure, with absorbable suture, of the paratenon and subcutaneous tissues. After skin closure with nylon suture, resting ankle plantarflexion is assessed and the Thompson test performed. The patient is placed in a well-padded non-weight-bearing plantar flexion splint for incision and initial tendon healing during the first 2 weeks after surgery.

Discussion

A key aspect of recovery is the balance achieved between skin and tendon healing and early mobilization, as outcomes of surgical repair of Achilles ruptures are improved with early weight-bearing and functional rehabilitation.^11-13 Some surgeons recommend weight-bearing immediately after surgery, given the direct tendon-to-bone fixation achieved with repair.⁹ I prefer 2 weeks of non-weight-bearing, which allows the skin to heal adequately and the initial soft-tissue inflammation to subside. If the incision is healed at 2 weeks, sutures are removed, and the patient is transitioned to a tall, non-weight-bearing CAM (controlled ankle motion) boot, worn for 1 to 2 weeks with initiation of gentle ankle range-of-motion exercises. If there is any concern about wound healing, sutures are maintained for another 1 to 2 weeks.

Between 3 and 8 weeks after surgery, progressive weight-bearing is initiated with a peel-away heel lift (~2 cm thick total, 3 layers). Each lift layer is removed as pain allows, every 2 to 3 days. The goal is full weight-bearing with the foot flat 5 to 6 weeks after surgery. Physical therapy focusing on ankle motion and gentle Achilles stretching and strengthening is started 5 to 6 weeks after surgery, depending on progression and functional needs. Between 8 and 12 weeks after surgery, the patient is transitioned to normal shoe wear with increased activities. Running and jumping are allowed, as pain and swelling allow, starting at 12 weeks.

Although preliminary outcomes and experience with the Achilles Midsubstance SpeedBridge have been favorable, long-term clinical and functional studies are needed to determine the specific advantages and disadvantages of this new technique relative to other repairs. The main benefits observed thus far are reduced subjective knot tying and tensioning, decreased reliance on suture fixation in compromised tissue at the rupture site, reduced risk of FiberWire knot irritation of superficial soft tissues, lower risk of distal suture pullout, and earlier mobilization owing to bony fixation of the tendon. Potential complications include anchor-site heel pain caused by prominent anchors or by the bone edema that occurs when a patient increases physical activity by a significant amount at 12 weeks.⁹ Heel pain caused by bone edema resolves by 20 weeks without intervention.

Stress shielding of the distal Achilles tendon is a theoretical concern given the tendon–bone construct, but there have been no reports of tendon atrophy or repair failure caused by stress shielding. The original PARS technique was often used to create Achilles tension with the ankle maximally plantar flexed—the idea being that the tendon would gradually stretch over time.¹ Overtensioning the Achilles repair is a potential complication with the SpeedBridge, as the distal anchors provide a more rigid point of distal fixation. Surgeons can avoid this complication by cycling the sutures to remove any residual creep and then tensioning the Achilles according to the contralateral limb and/or palpating tendon opposition at the rupture site.

Overall, this new limited-incision knotless Achilles tendon repair technique allows for minimal soft-tissue dissection, restoration of Achilles musculotendinous length, and direct tendon-to-bone fixation. Early results are promising, but long-term clinical outcomes and comparative analysis are needed. In addition, many details of this technique must be clarified—including incidence of short- and long-term complications in larger cohorts, optimal suture material and configuration, and risks and benefits of immediate (<2 weeks) and delayed (2-4 weeks) weight-bearing.

Am J Orthop. 2016;45(7):E487-E492. Copyright Frontline Medical Communications Inc. 2016. All rights reserved.

The incidence of midsubstance Achilles tendon ruptures is increasing in patients 30 years to 50 years of age, and more than 50% of these injuries occur during recreational basketball.^1,2 Achilles ruptures occur more in deconditioned individuals engaged in explosive push-off and jumping activities. Management of these injuries has been controversial over the past decade; there is no consensus on nonoperative treatment, surgical repair, or optimal repair technique.^1,3-7 According to American Academy of Orthopaedic Surgeons (AAOS) clinical practice guidelines, limited-incision approaches have fewer overall complications relative to traditional open repair.^3,4

Modern repair techniques, such as the Percutaneous Achilles Repair System (PARS; Arthrex), combine limited soft-tissue dissection with percutaneous suture insertion and knot tying.^1,8 This limited-incision technique, employed since 2010, uses a 2-cm transverse incision and nondisposable metal jig with divergent needle passes and locking suture fixation options to secure and fix both tendon ends with minimal dissection of skin, subcutaneous tissue, and paratenon. A review of 270 surgically treated Achilles tendon ruptures (101 PARS, 169 traditional open repair) found that, compared with the open repair group, the PARS group had significantly shorter operative times and more patients returning to baseline physical activities within 5 months after surgery.¹ Although the difference was not statistically significant, the overall postoperative complication rate was 5% for the PARS group and 11% for the open repair group. The PARS group had no cases of sural neuritis or deep infection requiring reoperation.

Although the PARS technique has had good outcomes with few complications, care must be taken during surgery to prevent sutures from pulling through the tendon near the rupture site, which can result from overtensioning and from suture knot irritation against superficial soft tissues. Given these potential issues, the PARS procedure was modified (Achilles Midsubstance SpeedBridge; Arthrex) to provide knotless restoration of musculotendinous length in a reliable, reproducible fashion and direct fixation of tendon to bone for early mobilization.⁹ This new procedure bypasses suture fixation in the compromised tendon ends adjacent to the rupture site, thereby reducing suture slippage and allowing for potential early range of motion and weight-bearing relative to previous techniques. Preliminary results from a cohort of 34 patients treated with this technique are promising: Average return to baseline activities was 18.2 weeks (range, 9-26 weeks), and there were no wound complications, nerve injuries, or reruptures.⁹Indications are overall health and an acute midsubstance Achilles rupture that presents within 3 weeks after injury (the time limit is used to ensure that both tendon ends can be mobilized and repaired to appropriate length). A relative contraindication is delayed presentation (≥4 weeks), which may require open reconstruction in combination with V-Y lengthening or other adjuvant procedures. Other relative contraindications are insertional rupture, Achilles tendinopathy, and a significant medical comorbidity that prohibits surgical intervention.

Surgical Technique

Operating Room Setup and Approach

The patient is positioned prone with chest rolls and kneepads and with arms at <90° of abduction (Figures 1A-1E).

A thigh tourniquet is placed on the operative extremity, and the feet are placed slightly hanging off the end of the bed with a small bump underneath to adjust the degree of ankle plantarflexion and Achilles tension during the case. It is important that the operative leg be in neutral rotation to allow for central positioning of the PARS jig. After sterile preparation and draping, the extremity is exsanguinated and the tourniquet inflated. The defect within the Achilles tendon is palpated and marked out, and a 2-cm transverse skin incision is made along the proximal aspect of the rupture site.

A “no-touch” technique is used without pickups, and soft tissues are carefully dissected with small scissors down to the paratenon. The sural nerve typically is not visible in the operative field, but, if it is, it can be dissected out and retracted out of the way. A transverse incision is made through the paratenon, and expression of rupture hematoma often follows. Paratenon preservation is key in minimizing disruption of the native vascular supply of the tendon and allowing for repair at the end of the case. A freer can be placed within the wound to confirm that the center of the rupture has been identified.

An Allis clamp is inserted into the wound, and the proximal tendon stump is secured and then pulled about 1 cm through the wound. A freer is circumferentially run along the sides of the proximal tendon to release any potential adhesions that may limit distal excursion.

PARS Jig Insertion and Suture Passing

The PARS jig is inserted into the wound with the inner prongs in the narrowest position possible. The curved jig is inserted proximally, and the center turn wheel is used to widen the inner prongs so they can slide along the sides of the tendon in the paratenon. Proper jig placement should be smooth and encounter little resistance. The proximal tendon is in a superficial location and can be palpated within the prongs of the jig to double-check that the tendon is centered within the jig. A frequent error is to insert the jig too deep, which subsequently causes needles and sutures to miss the tendon and pull through.

 

Keeping the jig centralized in neutral rotation minimizes improper suture passing and avoids iatrogenic injury to the medial and lateral neurovascular structures. During suture passing, all needles (1.6 mm) with nitinol loops are first used unloaded without suture. The first 2 needles are inserted into their respective, numbered holes, through the tendon, and then through the opposite side of the jig. Each needle is checked to make sure that it does not pass outside the jig. Having 2 needles within the jig and tendon at all times during suture passing helps stabilize the jig and avoids adjacent suture piercing with the subsequent needle.

A No. 2 FiberWire suture (Arthrex) is then passed through the first hole using the needle suture passer and made even in length on both sides. The specific colors of the suture are not important, but the order of the sutures placed is. An assistant can write down the colors and order of the sutures passed. Before the second suture is passed, the first needle is inserted back through the jig and tendon into the third hole. The third and fourth sutures (green-striped) differ from the other sutures in that one end has a loop and the other has a tail, and they are passed in an oblique, crossing pattern. These sutures later help create a locking suture on either side of the tendon.

After these sutures are passed, the final result should be 1 green-striped loop and 1 green-striped tail on either side of the tendon. The fifth suture is passed straight across the tendon in a trajectory similar to that of the first suture. In large laborers, obese patients, and elite athletes, 2 additional green-striped sutures can be passed through the optional sixth and seventh holes to create an additional locking suture.

PARS Jig Removal and Suture Management

After all sutures are passed, the turn wheel is used to narrow the inner prongs while gentle, controlled tension is applied to the jig to remove it from the wound (Figures 2A-2C).

All sutures from both sides of the tendon should emerge from the wound. Before the jig is completely pulled out, a hemostat is used through each loop of sutures to guide them out of the wound and reduce tangling. Both pairs of sutures are pulled distally to ensure adequate proximal fixation.

Pullout of any suture from the tendon indicates that the tendon was not centered in the jig or was not proximal enough along the tendon during suture passing. If a suture pulls out, it is removed, and the previous steps are repeated with close attention paid to tendon positioning within the jig. It is not advised to extend the incision longitudinally on either end of the transverse incision, as doing so can lead to potential wound-healing complications. After proximal fixation is achieved, all sutures on each side of the tendon are neatly spread apart in the following order from proximal to distal: first suture, second suture, looped green-striped (third) suture, tail green-striped (fourth) suture, fifth suture. The second suture on both sides is then looped around the 2 green-striped sutures and back proximally through the looped end of the green-striped suture.

The green-striped suture tail is pulled through the tendon to the opposite side to create a locking suture on both sides of the tendon. In the end, there are 2 nonlocking sutures and 1 locking suture on either side of the tendon. Each pair of sutures is pulled distally to confirm fixation and remove any initial suture creep from the system. A hemostat is placed on each group of 3 sutures to keep them out of the way during distal anchor preparation.

Distal Anchor Preparation and Banana SutureLasso Passing

Two longitudinal 5-mm incisions are made along the posterior aspect of the heel just distal to the area of maximal heel convexity. Incisions are spaced 1.5 cm apart along the sides of the Achilles tendon insertion. A 3.5-mm drill and a drill guide are used through each incision and placed flush against bone (Figures 3A-3E).

The drill is inserted into bone oriented slightly proximally and toward midline until it bottoms out against the guide. Each drill hole is then tapped to receive a 4.75-mm SwiveLock anchor (Arthrex).

A Banana SutureLasso (Arthrex) with inner nitinol wire is passed through the center of the distal Achilles tendon stump and out the proximal incision to retrieve one side of the proximal sutures. SutureLasso passage through tendon can be facilitated with tactile feedback. The surgeon’s nondominant thumb is placed directly against the distal tendon while the dominant hand grasps the SutureLasso with the thumb near the tip. As the SutureLasso is advanced proximally through the tendon, the surgeon can feel its tip meeting mild resistance. Confirm that the tip of the SutureLasso is in the center of the distal tendon by direct visual inspection through the wound.

The inner nitinol wire is advanced 2 cm to 3 cm out of the tip of the SutureLasso, and sutures are passed through the distal Achilles tendon. During suture passing, the nitinol wire is drawn back to the tip of the SutureLasso, and then the entire SutureLasso is removed from the distal incision. Trying to pass the sutures only through the inner nitinol wire can result in suture tangling and increased resistance. The process is then repeated for the sutures on the opposite side. Suture pairs are placed under maximal tension and cycled multiple times (5-10) to remove any residual proximal suture creep.¹⁰

 

Achilles Tensioning and Anchor Insertion

The ankle is plantar flexed to tension the Achilles tendon relative to the contralateral limb and is held in place by an assistant (Figures 4A-4E).

At the same time, the assistant holds tension on the opposite pair of sutures to ensure that Achilles length and tension do not change before initial anchor insertion. The rupture site can be palpated to confirm there is no residual gap or excessive overlap of the tendon ends. Sutures are passed through the eyelet of the SwiveLock anchor, and then the anchor is gently malleted into the calcaneal drill hole and hand-tightened until flush with bone. Often, squeaking can be heard as the anchor reaches its final depth in bone.

Position of the drill holes can be rechecked with a Kirschner wire before anchor insertion, as their relative position changes with ankle plantar flexion. It is not necessary to premeasure and adjust suture length at the tip of the anchor as in other blind tunnel anchor insertion techniques (eg, InternalBrace; Arthrex). Once the anchor tip is malleted into bone, the free suture ends are released to avoid overtensioning the tendon. Before the anchor insertion handle is completely removed, the tip of a mosquito clamp can be used to feel the bony surface and confirm the anchor is completely seated.

With the ankle still held in the appropriate amount of plantarflexion, the process is repeated and the other SwiveLock anchor inserted. Sutures are cut flush with the anchor, and the surgeon performs wound irrigation and layered closure, with absorbable suture, of the paratenon and subcutaneous tissues. After skin closure with nylon suture, resting ankle plantarflexion is assessed and the Thompson test performed. The patient is placed in a well-padded non-weight-bearing plantar flexion splint for incision and initial tendon healing during the first 2 weeks after surgery.

Discussion

A key aspect of recovery is the balance achieved between skin and tendon healing and early mobilization, as outcomes of surgical repair of Achilles ruptures are improved with early weight-bearing and functional rehabilitation.^11-13 Some surgeons recommend weight-bearing immediately after surgery, given the direct tendon-to-bone fixation achieved with repair.⁹ I prefer 2 weeks of non-weight-bearing, which allows the skin to heal adequately and the initial soft-tissue inflammation to subside. If the incision is healed at 2 weeks, sutures are removed, and the patient is transitioned to a tall, non-weight-bearing CAM (controlled ankle motion) boot, worn for 1 to 2 weeks with initiation of gentle ankle range-of-motion exercises. If there is any concern about wound healing, sutures are maintained for another 1 to 2 weeks.

Between 3 and 8 weeks after surgery, progressive weight-bearing is initiated with a peel-away heel lift (~2 cm thick total, 3 layers). Each lift layer is removed as pain allows, every 2 to 3 days. The goal is full weight-bearing with the foot flat 5 to 6 weeks after surgery. Physical therapy focusing on ankle motion and gentle Achilles stretching and strengthening is started 5 to 6 weeks after surgery, depending on progression and functional needs. Between 8 and 12 weeks after surgery, the patient is transitioned to normal shoe wear with increased activities. Running and jumping are allowed, as pain and swelling allow, starting at 12 weeks.

Although preliminary outcomes and experience with the Achilles Midsubstance SpeedBridge have been favorable, long-term clinical and functional studies are needed to determine the specific advantages and disadvantages of this new technique relative to other repairs. The main benefits observed thus far are reduced subjective knot tying and tensioning, decreased reliance on suture fixation in compromised tissue at the rupture site, reduced risk of FiberWire knot irritation of superficial soft tissues, lower risk of distal suture pullout, and earlier mobilization owing to bony fixation of the tendon. Potential complications include anchor-site heel pain caused by prominent anchors or by the bone edema that occurs when a patient increases physical activity by a significant amount at 12 weeks.⁹ Heel pain caused by bone edema resolves by 20 weeks without intervention.

Stress shielding of the distal Achilles tendon is a theoretical concern given the tendon–bone construct, but there have been no reports of tendon atrophy or repair failure caused by stress shielding. The original PARS technique was often used to create Achilles tension with the ankle maximally plantar flexed—the idea being that the tendon would gradually stretch over time.¹ Overtensioning the Achilles repair is a potential complication with the SpeedBridge, as the distal anchors provide a more rigid point of distal fixation. Surgeons can avoid this complication by cycling the sutures to remove any residual creep and then tensioning the Achilles according to the contralateral limb and/or palpating tendon opposition at the rupture site.

Overall, this new limited-incision knotless Achilles tendon repair technique allows for minimal soft-tissue dissection, restoration of Achilles musculotendinous length, and direct tendon-to-bone fixation. Early results are promising, but long-term clinical outcomes and comparative analysis are needed. In addition, many details of this technique must be clarified—including incidence of short- and long-term complications in larger cohorts, optimal suture material and configuration, and risks and benefits of immediate (<2 weeks) and delayed (2-4 weeks) weight-bearing.

Am J Orthop. 2016;45(7):E487-E492. Copyright Frontline Medical Communications Inc. 2016. All rights reserved.

The incidence of midsubstance Achilles tendon ruptures is increasing in patients 30 years to 50 years of age, and more than 50% of these injuries occur during recreational basketball.^1,2 Achilles ruptures occur more in deconditioned individuals engaged in explosive push-off and jumping activities. Management of these injuries has been controversial over the past decade; there is no consensus on nonoperative treatment, surgical repair, or optimal repair technique.^1,3-7 According to American Academy of Orthopaedic Surgeons (AAOS) clinical practice guidelines, limited-incision approaches have fewer overall complications relative to traditional open repair.^3,4

Modern repair techniques, such as the Percutaneous Achilles Repair System (PARS; Arthrex), combine limited soft-tissue dissection with percutaneous suture insertion and knot tying.^1,8 This limited-incision technique, employed since 2010, uses a 2-cm transverse incision and nondisposable metal jig with divergent needle passes and locking suture fixation options to secure and fix both tendon ends with minimal dissection of skin, subcutaneous tissue, and paratenon. A review of 270 surgically treated Achilles tendon ruptures (101 PARS, 169 traditional open repair) found that, compared with the open repair group, the PARS group had significantly shorter operative times and more patients returning to baseline physical activities within 5 months after surgery.¹ Although the difference was not statistically significant, the overall postoperative complication rate was 5% for the PARS group and 11% for the open repair group. The PARS group had no cases of sural neuritis or deep infection requiring reoperation.

Although the PARS technique has had good outcomes with few complications, care must be taken during surgery to prevent sutures from pulling through the tendon near the rupture site, which can result from overtensioning and from suture knot irritation against superficial soft tissues. Given these potential issues, the PARS procedure was modified (Achilles Midsubstance SpeedBridge; Arthrex) to provide knotless restoration of musculotendinous length in a reliable, reproducible fashion and direct fixation of tendon to bone for early mobilization.⁹ This new procedure bypasses suture fixation in the compromised tendon ends adjacent to the rupture site, thereby reducing suture slippage and allowing for potential early range of motion and weight-bearing relative to previous techniques. Preliminary results from a cohort of 34 patients treated with this technique are promising: Average return to baseline activities was 18.2 weeks (range, 9-26 weeks), and there were no wound complications, nerve injuries, or reruptures.⁹Indications are overall health and an acute midsubstance Achilles rupture that presents within 3 weeks after injury (the time limit is used to ensure that both tendon ends can be mobilized and repaired to appropriate length). A relative contraindication is delayed presentation (≥4 weeks), which may require open reconstruction in combination with V-Y lengthening or other adjuvant procedures. Other relative contraindications are insertional rupture, Achilles tendinopathy, and a significant medical comorbidity that prohibits surgical intervention.

Surgical Technique

Operating Room Setup and Approach

The patient is positioned prone with chest rolls and kneepads and with arms at <90° of abduction (Figures 1A-1E).

A thigh tourniquet is placed on the operative extremity, and the feet are placed slightly hanging off the end of the bed with a small bump underneath to adjust the degree of ankle plantarflexion and Achilles tension during the case. It is important that the operative leg be in neutral rotation to allow for central positioning of the PARS jig. After sterile preparation and draping, the extremity is exsanguinated and the tourniquet inflated. The defect within the Achilles tendon is palpated and marked out, and a 2-cm transverse skin incision is made along the proximal aspect of the rupture site.

A “no-touch” technique is used without pickups, and soft tissues are carefully dissected with small scissors down to the paratenon. The sural nerve typically is not visible in the operative field, but, if it is, it can be dissected out and retracted out of the way. A transverse incision is made through the paratenon, and expression of rupture hematoma often follows. Paratenon preservation is key in minimizing disruption of the native vascular supply of the tendon and allowing for repair at the end of the case. A freer can be placed within the wound to confirm that the center of the rupture has been identified.

An Allis clamp is inserted into the wound, and the proximal tendon stump is secured and then pulled about 1 cm through the wound. A freer is circumferentially run along the sides of the proximal tendon to release any potential adhesions that may limit distal excursion.

PARS Jig Insertion and Suture Passing

The PARS jig is inserted into the wound with the inner prongs in the narrowest position possible. The curved jig is inserted proximally, and the center turn wheel is used to widen the inner prongs so they can slide along the sides of the tendon in the paratenon. Proper jig placement should be smooth and encounter little resistance. The proximal tendon is in a superficial location and can be palpated within the prongs of the jig to double-check that the tendon is centered within the jig. A frequent error is to insert the jig too deep, which subsequently causes needles and sutures to miss the tendon and pull through.

 

Keeping the jig centralized in neutral rotation minimizes improper suture passing and avoids iatrogenic injury to the medial and lateral neurovascular structures. During suture passing, all needles (1.6 mm) with nitinol loops are first used unloaded without suture. The first 2 needles are inserted into their respective, numbered holes, through the tendon, and then through the opposite side of the jig. Each needle is checked to make sure that it does not pass outside the jig. Having 2 needles within the jig and tendon at all times during suture passing helps stabilize the jig and avoids adjacent suture piercing with the subsequent needle.

A No. 2 FiberWire suture (Arthrex) is then passed through the first hole using the needle suture passer and made even in length on both sides. The specific colors of the suture are not important, but the order of the sutures placed is. An assistant can write down the colors and order of the sutures passed. Before the second suture is passed, the first needle is inserted back through the jig and tendon into the third hole. The third and fourth sutures (green-striped) differ from the other sutures in that one end has a loop and the other has a tail, and they are passed in an oblique, crossing pattern. These sutures later help create a locking suture on either side of the tendon.

After these sutures are passed, the final result should be 1 green-striped loop and 1 green-striped tail on either side of the tendon. The fifth suture is passed straight across the tendon in a trajectory similar to that of the first suture. In large laborers, obese patients, and elite athletes, 2 additional green-striped sutures can be passed through the optional sixth and seventh holes to create an additional locking suture.

PARS Jig Removal and Suture Management

After all sutures are passed, the turn wheel is used to narrow the inner prongs while gentle, controlled tension is applied to the jig to remove it from the wound (Figures 2A-2C).

All sutures from both sides of the tendon should emerge from the wound. Before the jig is completely pulled out, a hemostat is used through each loop of sutures to guide them out of the wound and reduce tangling. Both pairs of sutures are pulled distally to ensure adequate proximal fixation.

Pullout of any suture from the tendon indicates that the tendon was not centered in the jig or was not proximal enough along the tendon during suture passing. If a suture pulls out, it is removed, and the previous steps are repeated with close attention paid to tendon positioning within the jig. It is not advised to extend the incision longitudinally on either end of the transverse incision, as doing so can lead to potential wound-healing complications. After proximal fixation is achieved, all sutures on each side of the tendon are neatly spread apart in the following order from proximal to distal: first suture, second suture, looped green-striped (third) suture, tail green-striped (fourth) suture, fifth suture. The second suture on both sides is then looped around the 2 green-striped sutures and back proximally through the looped end of the green-striped suture.

The green-striped suture tail is pulled through the tendon to the opposite side to create a locking suture on both sides of the tendon. In the end, there are 2 nonlocking sutures and 1 locking suture on either side of the tendon. Each pair of sutures is pulled distally to confirm fixation and remove any initial suture creep from the system. A hemostat is placed on each group of 3 sutures to keep them out of the way during distal anchor preparation.

Distal Anchor Preparation and Banana SutureLasso Passing

Two longitudinal 5-mm incisions are made along the posterior aspect of the heel just distal to the area of maximal heel convexity. Incisions are spaced 1.5 cm apart along the sides of the Achilles tendon insertion. A 3.5-mm drill and a drill guide are used through each incision and placed flush against bone (Figures 3A-3E).

The drill is inserted into bone oriented slightly proximally and toward midline until it bottoms out against the guide. Each drill hole is then tapped to receive a 4.75-mm SwiveLock anchor (Arthrex).

A Banana SutureLasso (Arthrex) with inner nitinol wire is passed through the center of the distal Achilles tendon stump and out the proximal incision to retrieve one side of the proximal sutures. SutureLasso passage through tendon can be facilitated with tactile feedback. The surgeon’s nondominant thumb is placed directly against the distal tendon while the dominant hand grasps the SutureLasso with the thumb near the tip. As the SutureLasso is advanced proximally through the tendon, the surgeon can feel its tip meeting mild resistance. Confirm that the tip of the SutureLasso is in the center of the distal tendon by direct visual inspection through the wound.

The inner nitinol wire is advanced 2 cm to 3 cm out of the tip of the SutureLasso, and sutures are passed through the distal Achilles tendon. During suture passing, the nitinol wire is drawn back to the tip of the SutureLasso, and then the entire SutureLasso is removed from the distal incision. Trying to pass the sutures only through the inner nitinol wire can result in suture tangling and increased resistance. The process is then repeated for the sutures on the opposite side. Suture pairs are placed under maximal tension and cycled multiple times (5-10) to remove any residual proximal suture creep.¹⁰

 

Achilles Tensioning and Anchor Insertion

The ankle is plantar flexed to tension the Achilles tendon relative to the contralateral limb and is held in place by an assistant (Figures 4A-4E).

At the same time, the assistant holds tension on the opposite pair of sutures to ensure that Achilles length and tension do not change before initial anchor insertion. The rupture site can be palpated to confirm there is no residual gap or excessive overlap of the tendon ends. Sutures are passed through the eyelet of the SwiveLock anchor, and then the anchor is gently malleted into the calcaneal drill hole and hand-tightened until flush with bone. Often, squeaking can be heard as the anchor reaches its final depth in bone.

Position of the drill holes can be rechecked with a Kirschner wire before anchor insertion, as their relative position changes with ankle plantar flexion. It is not necessary to premeasure and adjust suture length at the tip of the anchor as in other blind tunnel anchor insertion techniques (eg, InternalBrace; Arthrex). Once the anchor tip is malleted into bone, the free suture ends are released to avoid overtensioning the tendon. Before the anchor insertion handle is completely removed, the tip of a mosquito clamp can be used to feel the bony surface and confirm the anchor is completely seated.

With the ankle still held in the appropriate amount of plantarflexion, the process is repeated and the other SwiveLock anchor inserted. Sutures are cut flush with the anchor, and the surgeon performs wound irrigation and layered closure, with absorbable suture, of the paratenon and subcutaneous tissues. After skin closure with nylon suture, resting ankle plantarflexion is assessed and the Thompson test performed. The patient is placed in a well-padded non-weight-bearing plantar flexion splint for incision and initial tendon healing during the first 2 weeks after surgery.

Discussion

A key aspect of recovery is the balance achieved between skin and tendon healing and early mobilization, as outcomes of surgical repair of Achilles ruptures are improved with early weight-bearing and functional rehabilitation.^11-13 Some surgeons recommend weight-bearing immediately after surgery, given the direct tendon-to-bone fixation achieved with repair.⁹ I prefer 2 weeks of non-weight-bearing, which allows the skin to heal adequately and the initial soft-tissue inflammation to subside. If the incision is healed at 2 weeks, sutures are removed, and the patient is transitioned to a tall, non-weight-bearing CAM (controlled ankle motion) boot, worn for 1 to 2 weeks with initiation of gentle ankle range-of-motion exercises. If there is any concern about wound healing, sutures are maintained for another 1 to 2 weeks.

Between 3 and 8 weeks after surgery, progressive weight-bearing is initiated with a peel-away heel lift (~2 cm thick total, 3 layers). Each lift layer is removed as pain allows, every 2 to 3 days. The goal is full weight-bearing with the foot flat 5 to 6 weeks after surgery. Physical therapy focusing on ankle motion and gentle Achilles stretching and strengthening is started 5 to 6 weeks after surgery, depending on progression and functional needs. Between 8 and 12 weeks after surgery, the patient is transitioned to normal shoe wear with increased activities. Running and jumping are allowed, as pain and swelling allow, starting at 12 weeks.

Although preliminary outcomes and experience with the Achilles Midsubstance SpeedBridge have been favorable, long-term clinical and functional studies are needed to determine the specific advantages and disadvantages of this new technique relative to other repairs. The main benefits observed thus far are reduced subjective knot tying and tensioning, decreased reliance on suture fixation in compromised tissue at the rupture site, reduced risk of FiberWire knot irritation of superficial soft tissues, lower risk of distal suture pullout, and earlier mobilization owing to bony fixation of the tendon. Potential complications include anchor-site heel pain caused by prominent anchors or by the bone edema that occurs when a patient increases physical activity by a significant amount at 12 weeks.⁹ Heel pain caused by bone edema resolves by 20 weeks without intervention.

Stress shielding of the distal Achilles tendon is a theoretical concern given the tendon–bone construct, but there have been no reports of tendon atrophy or repair failure caused by stress shielding. The original PARS technique was often used to create Achilles tension with the ankle maximally plantar flexed—the idea being that the tendon would gradually stretch over time.¹ Overtensioning the Achilles repair is a potential complication with the SpeedBridge, as the distal anchors provide a more rigid point of distal fixation. Surgeons can avoid this complication by cycling the sutures to remove any residual creep and then tensioning the Achilles according to the contralateral limb and/or palpating tendon opposition at the rupture site.

Overall, this new limited-incision knotless Achilles tendon repair technique allows for minimal soft-tissue dissection, restoration of Achilles musculotendinous length, and direct tendon-to-bone fixation. Early results are promising, but long-term clinical outcomes and comparative analysis are needed. In addition, many details of this technique must be clarified—including incidence of short- and long-term complications in larger cohorts, optimal suture material and configuration, and risks and benefits of immediate (<2 weeks) and delayed (2-4 weeks) weight-bearing.

Am J Orthop. 2016;45(7):E487-E492. Copyright Frontline Medical Communications Inc. 2016. All rights reserved.

Total hip arthroplasty (THA) and total knee arthroplasty (TKA) can be associated with significant blood loss that in some cases requires transfusion. The incidence of transfusion ranges from 16% to 37% in patients who undergo THA and from 11% to 21% in patients who undergo TKA.^1-3 Allogeneic blood transfusions have been associated with several risks (transfusion-related acute lung injury, hemolytic reactions, immunologic reactions, fluid overload, renal failure, infections), increased cost, and longer hospital length of stay (LOS).^4-7 With improved patient outcomes the ultimate goal, blood-conserving strategies designed to decrease blood loss and transfusions have been adopted as a standard in successful joint replacement programs.

Tranexamic acid (TXA), an antifibrinolytic agent, has become a major component of blood conservation management after THA and TKA. TXA stabilizes clots at the surgical site by inhibiting plasminogen activation and thereby blocking fibrinolysis.⁸ The literature supports intravenous (IV) TXA as effective in significantly reducing blood loss and transfusion rates in elective THA and TKA.^9,10 However, data on increased risk of thrombotic events with IV TXA in both THA and TKA are conflicting.^11,12 Topical TXA is thought to have an advantage over IV TXA in that it provides a higher concentration of drug at the surgical site and is associated with little systemic absorption.^2,13Recent prospective randomized studies have compared the efficacy and safety of IV and topical TXA in THA and TKA.^9,14 However, controversy remains because relatively few studies have compared these 2 routes of administration. In addition, healthcare–associated costs have come under increased scrutiny, and the cost of these treatments should be considered. More research is needed to determine which application is most efficacious and cost-conscious and poses the least risk to patients. Therefore, we conducted a study to compare the cost, efficacy, and safety of IV and topical TXA in primary THA and TKA.

Materials and Methods

Our Institutional Review Board approved this study. Patients who were age 18 years or older, underwent primary THA or TKA, and received IV or topical TXA between August 2013 and September 2014 were considered eligible for the study. For both groups, exclusion criteria were trauma service admission, TXA hypersensitivity, pregnancy, and concomitant use of IV and topical TXA.

We collected demographic data (age, sex, weight, height, body mass index), noted all transfusions of packed red blood cells, and recorded preoperative and postoperative hemoglobin (Hgb) levels and surgical drain outputs. We also recorded any complications that occurred within 90 days after surgery: deep vein thrombosis (DVT), pulmonary embolism (PE), cardiac events, cerebrovascular events, and wound drainage. Wound drainage was defined as readmission to hospital or return to operating room for wound drainage caused by infection or hematoma. Postoperative care (disposition, LOS, follow-up) was documented. Average cost of both IV and topical TXA administration was calculated using average wholesale price.

Use of IV TXA and use of topical TXA were compared in both THA and TKA. Patients in the IV TXA group received TXA in two 10-mg/kg doses with a maximum of 1 g per dose. The first IV dose was given before the incision, and the second was given 3 hours after the first. Patients in the topical TXA group underwent direct irrigation with 3 g of TXA in 100 mL of normal saline at the surgical site after closure of the deep fascia in THA and after closure of the knee arthrotomy in TKA. The drain remained occluded for 30 minutes after surgery. The wound was irrigated with topical TXA before wound closure in the THA group and before tourniquet release in the TKA group. TXA dosing was based on institutional formulary dosing restrictions and was consistent with best practices and current literature.^3,9,14,15Primary outcomes measured for each cohort and treatment arm were Hgb levels (difference between preoperative levels and lowest postoperative levels 24 hours after surgery), blood loss, transfusion rates, and cost. Secondary outcomes were LOS and complications that occurred within 90 days after surgery (DVT, PE, cardiac events, cerebrovascular events, wound drainage).

Calculated blood loss was determined with equations described by Konig and colleagues,³ Good and colleagues,¹⁶ and Nadler and colleagues.¹⁷ Total calculated blood loss was based on the difference in Hgb levels before surgery and the lowest Hgb levels 24 hours after surgery:

Blood loss (mL) = 100 mL/dL × Hgb_loss/Hgb_i

Hgb_loss = BV × (Hgb_i – Hgb_e) × 10 dL/L + Hgb_t

= 0.3669 × Height³ (m) + 0.03219 × Weight (kg) + 0.6041 (for men)

= 0.3561 × Height³ (m) + 0.03308 × Weight (kg) + 0.1833 (for women)

 

where Hgb_i is the Hgb concentration (g/dL) before surgery, Hgb_e is the lowest Hgb concentration (g/dL) 24 hours after surgery, Hgb_t is the total amount (g) of allogeneic Hgb transfused, and BV is the estimated total body blood volume (L).¹⁷ As Hgb concentrations after blood transfusions were compared in this study, the Hgb_t variable was removed from the equation. Based on Hgb decrease data in a study that compared IV and topical TXA in TKA,¹⁴ we determined that a sample size of least 140 patients (70 in each cohort) was needed in order to have 80% power to detect a difference in Hgb decrease of 0.36 g/dL in IV and topical TXA.

All data were reported with descriptive statistics. Frequencies and percentages were reported for categorical variables. Means and standard deviations were reported for continuous variables. The groups of continuous data were compared with unpaired Student t tests and 1-way analysis of variance. Comparisons among groups of categorical data were analyzed with Fisher exact tests. Statistical significance was set at P < .05.

Results

Data were collected on 291 patients (156 THA, 135 TKA). There was a significant (P = .044) sex difference in the THA group: more men in the topical TXA subgroup and more women in the IV TXA subgroup. Other patient demographics were similarly matched with respect to age, height, weight, and body mass index (Table 1).

The primary outcomes (differences in cost, Hgb decrease, estimated blood loss, calculated blood loss, and transfusions) are listed in Table 2.

In the THA group, mean (SD) Hgb change was significantly (P = .031) higher with IV TXA, 3.33 (1.02) g/dL, than with topical TXA, 2.89 (1.44) g/dL, and the cost of topical TXA ($2100) was significantly (P ≤ .0001) higher than the cost of IV TXA ($1161). There were no differences in calculated blood loss, estimated blood loss, or transfusion rates. In the TKA group, calculated blood loss was significantly (P = .019) higher with IV TXA (1084.2 mL) than with topical TXA (859.6 mL), mean (SD) Hgb change was significantly (P = .015) higher with IV TXA, 2.35 (0.99) g/dL, than with topical TXA, 1.93 (0.90) g/dL, and the cost of topical TXA ($2100) was significantly (P ≤ .0001) higher than the cost of IV TXA ($1271). There were no differences in estimated blood loss or transfusion rates.

The secondary outcomes (differences in complications and LOS) are listed in Table 3.

In the THA group, postoperative cardiac events occurred in 3 (6%) of the 48 patients in the topical TXA subgroup and in none of the patients in the IV TXA subgroup (P = .007). There were no differences in other complications (DVT, PE, cerebrovascular events, wound drainage) or LOS. In the TKA group, there were no differences in postoperative complications or LOS between the IV and topical TXA subgroups.

Discussion

TXA, an analog of the amino acid lysine, is an antifibrinolytic agent that has been used for many years to inhibit fibrin degradation.^3,18 TXA works by competitively inhibiting tissue plasminogen activation, which is elevated by the trauma of surgery, and blocking plasmin binding to fibrin.^3,19 The mechanism of action is not procoagulant, as TXA prevents fibrin breakdown and supports coagulation that is underway rather than increasing clot formation. These characteristics make the drug attractive for orthopedic joint surgery—TXA reduces postoperative blood loss in patients who need fibrinolysis suppressed in order to maintain homeostasis without increasing the risk of venous thromboembolism. IV TXA has been well studied, which supports its efficacy profile for reducing blood loss and transfusions; there are no reports of increased risk of thromboembolic events.^20-22 Despite these studies, the risk of adverse events is still a major concern, especially in patients with medical conditions that predispose them to venothrombotic events. Topical TXA has become a viable option, especially in high-risk patients, as studies have shown 70% lower systemic absorption relative to IV TXA plasma concentration.²³ Still, too few studies have compared the efficacy, safety, and cost of IV and topical TXA in both THA and TKA.

Topical TXA costs an average of $2100 per case, primarily because standard dosing is 3 g per case. Despite repeat dosing for IV TXA (first dose at incision, second dose 3 hours after first), IV TXA costs were much lower on average: $939 less for THA and $829 less for TKA. As numerous studies have outlined results similar to ours, cost-effectiveness should be considered in decisions about treatment options.

Patel and colleagues¹⁴ reported that the efficacy of topical TXA was similar to that of IV TXA and that there were no significant differences in Hgb decrease, wound drainage, or need for transfusions after TKA. Their report conflicts with our finding significant differences favoring topical TXA for Hgb change (P = .015) and reduced calculated blood loss (P = .019) in TKA. A potential reason for these differing results is that the topical TXA doses were different (2 g in the study by Patel and colleagues,¹⁴ 3 g in our study). Martin and colleagues²⁴ compared the effects of topical TXA and placebo and found a nonsignificant difference in reduced blood loss and postoperative transfusions when the drug was dosed at 2 g. Konig and colleagues³ found that topical TXA dosed at 3 g (vs placebo) could reduce blood loss and transfusions after THA and TKA. These studies support our 3-g dose protocol for topical TXA rather than the 2-g protocol used in the study by Patel and colleagues.¹⁴ Our results are congruent with those of Seo and colleagues,²⁵ who found topical TXA superior in decreasing blood loss in TKA. Furthermore, our study is unique in that it compared costs and found topical TXA to be more expensive by almost $1000 on average.

Wei and Wei⁹ concluded that IV TXA 3 g and topical TXA 3 g were equally effective in reducing total blood loss, change in hematocrit, and need for transfusion after THA. In contrast, we found a significant (P = .031) difference favoring topical TXA for Hgb change. The 2 studies differed in their dosing protocols: Wei and Wei⁹ infused a 3-g dose, whereas we gave a maximum of two 1-g IV doses. The higher IV dose used by Wei and Wei⁹ could explain why they found no difference between IV and topical TXA, whereas we did find a difference. Our study was unique in that it measured Hgb change, blood loss, and cost.

Our study included an in-depth analysis of blood loss: estimated blood loss, drain outputs, calculated blood loss, and Hgb change. The equation we used for calculated blood loss is well established and has been used in multiple studies.^3,16,17 To thoroughly assess the safety of TXA, we reviewed and documented complications that occurred within 90 days after surgery and that could be attributed to TXA. This study was adequately powered and exceeded the required sample size to detect a difference in one primary outcome measure, perioperative Hgb change, as calculated by the prestudy statistical power analysis.

Our study had several limitations. First, it was a retrospective chart review; documentation could have been incomplete or missing. Second, the study was not randomized and thus subject to drug selection bias. Third, patients were selected for topical TXA on the basis of perceived risk factors, such as prior or family history of DVT, PE, cardiac events, or cerebrovascular events. It was thought that, given the decrease in systemic absorption with topical TXA, these high-risk patients would be less likely to have a thromboembolic event. Their complex past medical histories may explain why the topical TXA group had more cardiac events. Furthermore, 1 orthopedic surgeon used topical TXA exclusively, and the other 3 used it selectively, according to risk factors. In addition, unlike TKA patients, not all THA patients received drains. This study was powered to measure a difference in perioperative Hgb change but may not have been powered to detect the statistically significant difference favoring topical TXA for calculated blood loss in TKA. In the THA group, a statistically significant difference was found for reduced Hgb decrease but not for estimated or calculated blood loss. This finding reinforces some of the disparities in measurements of the effects of blood conservation strategies. The study also lacked a placebo or control group. However, several other studies have found that both IV TXA and topical TXA are superior to placebo in decreasing blood loss, Hgb change, and transfusion requirements.^10,12,20,22 In addition, the effects of TXA are based on estimates of blood conservation and are not without their disparities.

 

Conclusion

The present study found that both IV TXA and topical TXA were effective in decreasing blood loss, Hgb levels, and need for transfusion after THA and TKA. Topical TXA appears to be more effective than IV TXA in preventing Hgb decrease during THA and TKA and calculated blood loss during TKA. This increased efficacy comes with a higher cost. Thromboembolic complications were similar between groups. More studies are needed to compare the efficacy and safety profiles of topical TXA against the routine standard of IV TXA, especially in patients with perceived contraindications to IV TXA.

Am J Orthop. 2016;45(7):E439-E443. Copyright Frontline Medical Communications Inc. 2016. All rights reserved.

Total hip arthroplasty (THA) and total knee arthroplasty (TKA) can be associated with significant blood loss that in some cases requires transfusion. The incidence of transfusion ranges from 16% to 37% in patients who undergo THA and from 11% to 21% in patients who undergo TKA.^1-3 Allogeneic blood transfusions have been associated with several risks (transfusion-related acute lung injury, hemolytic reactions, immunologic reactions, fluid overload, renal failure, infections), increased cost, and longer hospital length of stay (LOS).^4-7 With improved patient outcomes the ultimate goal, blood-conserving strategies designed to decrease blood loss and transfusions have been adopted as a standard in successful joint replacement programs.

Tranexamic acid (TXA), an antifibrinolytic agent, has become a major component of blood conservation management after THA and TKA. TXA stabilizes clots at the surgical site by inhibiting plasminogen activation and thereby blocking fibrinolysis.⁸ The literature supports intravenous (IV) TXA as effective in significantly reducing blood loss and transfusion rates in elective THA and TKA.^9,10 However, data on increased risk of thrombotic events with IV TXA in both THA and TKA are conflicting.^11,12 Topical TXA is thought to have an advantage over IV TXA in that it provides a higher concentration of drug at the surgical site and is associated with little systemic absorption.^2,13Recent prospective randomized studies have compared the efficacy and safety of IV and topical TXA in THA and TKA.^9,14 However, controversy remains because relatively few studies have compared these 2 routes of administration. In addition, healthcare–associated costs have come under increased scrutiny, and the cost of these treatments should be considered. More research is needed to determine which application is most efficacious and cost-conscious and poses the least risk to patients. Therefore, we conducted a study to compare the cost, efficacy, and safety of IV and topical TXA in primary THA and TKA.

Materials and Methods

Our Institutional Review Board approved this study. Patients who were age 18 years or older, underwent primary THA or TKA, and received IV or topical TXA between August 2013 and September 2014 were considered eligible for the study. For both groups, exclusion criteria were trauma service admission, TXA hypersensitivity, pregnancy, and concomitant use of IV and topical TXA.

We collected demographic data (age, sex, weight, height, body mass index), noted all transfusions of packed red blood cells, and recorded preoperative and postoperative hemoglobin (Hgb) levels and surgical drain outputs. We also recorded any complications that occurred within 90 days after surgery: deep vein thrombosis (DVT), pulmonary embolism (PE), cardiac events, cerebrovascular events, and wound drainage. Wound drainage was defined as readmission to hospital or return to operating room for wound drainage caused by infection or hematoma. Postoperative care (disposition, LOS, follow-up) was documented. Average cost of both IV and topical TXA administration was calculated using average wholesale price.

Use of IV TXA and use of topical TXA were compared in both THA and TKA. Patients in the IV TXA group received TXA in two 10-mg/kg doses with a maximum of 1 g per dose. The first IV dose was given before the incision, and the second was given 3 hours after the first. Patients in the topical TXA group underwent direct irrigation with 3 g of TXA in 100 mL of normal saline at the surgical site after closure of the deep fascia in THA and after closure of the knee arthrotomy in TKA. The drain remained occluded for 30 minutes after surgery. The wound was irrigated with topical TXA before wound closure in the THA group and before tourniquet release in the TKA group. TXA dosing was based on institutional formulary dosing restrictions and was consistent with best practices and current literature.^3,9,14,15Primary outcomes measured for each cohort and treatment arm were Hgb levels (difference between preoperative levels and lowest postoperative levels 24 hours after surgery), blood loss, transfusion rates, and cost. Secondary outcomes were LOS and complications that occurred within 90 days after surgery (DVT, PE, cardiac events, cerebrovascular events, wound drainage).

Calculated blood loss was determined with equations described by Konig and colleagues,³ Good and colleagues,¹⁶ and Nadler and colleagues.¹⁷ Total calculated blood loss was based on the difference in Hgb levels before surgery and the lowest Hgb levels 24 hours after surgery:

Blood loss (mL) = 100 mL/dL × Hgb_loss/Hgb_i

Hgb_loss = BV × (Hgb_i – Hgb_e) × 10 dL/L + Hgb_t

= 0.3669 × Height³ (m) + 0.03219 × Weight (kg) + 0.6041 (for men)

= 0.3561 × Height³ (m) + 0.03308 × Weight (kg) + 0.1833 (for women)

 

where Hgb_i is the Hgb concentration (g/dL) before surgery, Hgb_e is the lowest Hgb concentration (g/dL) 24 hours after surgery, Hgb_t is the total amount (g) of allogeneic Hgb transfused, and BV is the estimated total body blood volume (L).¹⁷ As Hgb concentrations after blood transfusions were compared in this study, the Hgb_t variable was removed from the equation. Based on Hgb decrease data in a study that compared IV and topical TXA in TKA,¹⁴ we determined that a sample size of least 140 patients (70 in each cohort) was needed in order to have 80% power to detect a difference in Hgb decrease of 0.36 g/dL in IV and topical TXA.

All data were reported with descriptive statistics. Frequencies and percentages were reported for categorical variables. Means and standard deviations were reported for continuous variables. The groups of continuous data were compared with unpaired Student t tests and 1-way analysis of variance. Comparisons among groups of categorical data were analyzed with Fisher exact tests. Statistical significance was set at P < .05.

Results

Data were collected on 291 patients (156 THA, 135 TKA). There was a significant (P = .044) sex difference in the THA group: more men in the topical TXA subgroup and more women in the IV TXA subgroup. Other patient demographics were similarly matched with respect to age, height, weight, and body mass index (Table 1).

The primary outcomes (differences in cost, Hgb decrease, estimated blood loss, calculated blood loss, and transfusions) are listed in Table 2.

In the THA group, mean (SD) Hgb change was significantly (P = .031) higher with IV TXA, 3.33 (1.02) g/dL, than with topical TXA, 2.89 (1.44) g/dL, and the cost of topical TXA ($2100) was significantly (P ≤ .0001) higher than the cost of IV TXA ($1161). There were no differences in calculated blood loss, estimated blood loss, or transfusion rates. In the TKA group, calculated blood loss was significantly (P = .019) higher with IV TXA (1084.2 mL) than with topical TXA (859.6 mL), mean (SD) Hgb change was significantly (P = .015) higher with IV TXA, 2.35 (0.99) g/dL, than with topical TXA, 1.93 (0.90) g/dL, and the cost of topical TXA ($2100) was significantly (P ≤ .0001) higher than the cost of IV TXA ($1271). There were no differences in estimated blood loss or transfusion rates.

The secondary outcomes (differences in complications and LOS) are listed in Table 3.

In the THA group, postoperative cardiac events occurred in 3 (6%) of the 48 patients in the topical TXA subgroup and in none of the patients in the IV TXA subgroup (P = .007). There were no differences in other complications (DVT, PE, cerebrovascular events, wound drainage) or LOS. In the TKA group, there were no differences in postoperative complications or LOS between the IV and topical TXA subgroups.

Discussion

TXA, an analog of the amino acid lysine, is an antifibrinolytic agent that has been used for many years to inhibit fibrin degradation.^3,18 TXA works by competitively inhibiting tissue plasminogen activation, which is elevated by the trauma of surgery, and blocking plasmin binding to fibrin.^3,19 The mechanism of action is not procoagulant, as TXA prevents fibrin breakdown and supports coagulation that is underway rather than increasing clot formation. These characteristics make the drug attractive for orthopedic joint surgery—TXA reduces postoperative blood loss in patients who need fibrinolysis suppressed in order to maintain homeostasis without increasing the risk of venous thromboembolism. IV TXA has been well studied, which supports its efficacy profile for reducing blood loss and transfusions; there are no reports of increased risk of thromboembolic events.^20-22 Despite these studies, the risk of adverse events is still a major concern, especially in patients with medical conditions that predispose them to venothrombotic events. Topical TXA has become a viable option, especially in high-risk patients, as studies have shown 70% lower systemic absorption relative to IV TXA plasma concentration.²³ Still, too few studies have compared the efficacy, safety, and cost of IV and topical TXA in both THA and TKA.

Topical TXA costs an average of $2100 per case, primarily because standard dosing is 3 g per case. Despite repeat dosing for IV TXA (first dose at incision, second dose 3 hours after first), IV TXA costs were much lower on average: $939 less for THA and $829 less for TKA. As numerous studies have outlined results similar to ours, cost-effectiveness should be considered in decisions about treatment options.

Patel and colleagues¹⁴ reported that the efficacy of topical TXA was similar to that of IV TXA and that there were no significant differences in Hgb decrease, wound drainage, or need for transfusions after TKA. Their report conflicts with our finding significant differences favoring topical TXA for Hgb change (P = .015) and reduced calculated blood loss (P = .019) in TKA. A potential reason for these differing results is that the topical TXA doses were different (2 g in the study by Patel and colleagues,¹⁴ 3 g in our study). Martin and colleagues²⁴ compared the effects of topical TXA and placebo and found a nonsignificant difference in reduced blood loss and postoperative transfusions when the drug was dosed at 2 g. Konig and colleagues³ found that topical TXA dosed at 3 g (vs placebo) could reduce blood loss and transfusions after THA and TKA. These studies support our 3-g dose protocol for topical TXA rather than the 2-g protocol used in the study by Patel and colleagues.¹⁴ Our results are congruent with those of Seo and colleagues,²⁵ who found topical TXA superior in decreasing blood loss in TKA. Furthermore, our study is unique in that it compared costs and found topical TXA to be more expensive by almost $1000 on average.

Wei and Wei⁹ concluded that IV TXA 3 g and topical TXA 3 g were equally effective in reducing total blood loss, change in hematocrit, and need for transfusion after THA. In contrast, we found a significant (P = .031) difference favoring topical TXA for Hgb change. The 2 studies differed in their dosing protocols: Wei and Wei⁹ infused a 3-g dose, whereas we gave a maximum of two 1-g IV doses. The higher IV dose used by Wei and Wei⁹ could explain why they found no difference between IV and topical TXA, whereas we did find a difference. Our study was unique in that it measured Hgb change, blood loss, and cost.

Our study included an in-depth analysis of blood loss: estimated blood loss, drain outputs, calculated blood loss, and Hgb change. The equation we used for calculated blood loss is well established and has been used in multiple studies.^3,16,17 To thoroughly assess the safety of TXA, we reviewed and documented complications that occurred within 90 days after surgery and that could be attributed to TXA. This study was adequately powered and exceeded the required sample size to detect a difference in one primary outcome measure, perioperative Hgb change, as calculated by the prestudy statistical power analysis.

Our study had several limitations. First, it was a retrospective chart review; documentation could have been incomplete or missing. Second, the study was not randomized and thus subject to drug selection bias. Third, patients were selected for topical TXA on the basis of perceived risk factors, such as prior or family history of DVT, PE, cardiac events, or cerebrovascular events. It was thought that, given the decrease in systemic absorption with topical TXA, these high-risk patients would be less likely to have a thromboembolic event. Their complex past medical histories may explain why the topical TXA group had more cardiac events. Furthermore, 1 orthopedic surgeon used topical TXA exclusively, and the other 3 used it selectively, according to risk factors. In addition, unlike TKA patients, not all THA patients received drains. This study was powered to measure a difference in perioperative Hgb change but may not have been powered to detect the statistically significant difference favoring topical TXA for calculated blood loss in TKA. In the THA group, a statistically significant difference was found for reduced Hgb decrease but not for estimated or calculated blood loss. This finding reinforces some of the disparities in measurements of the effects of blood conservation strategies. The study also lacked a placebo or control group. However, several other studies have found that both IV TXA and topical TXA are superior to placebo in decreasing blood loss, Hgb change, and transfusion requirements.^10,12,20,22 In addition, the effects of TXA are based on estimates of blood conservation and are not without their disparities.

 

Conclusion

The present study found that both IV TXA and topical TXA were effective in decreasing blood loss, Hgb levels, and need for transfusion after THA and TKA. Topical TXA appears to be more effective than IV TXA in preventing Hgb decrease during THA and TKA and calculated blood loss during TKA. This increased efficacy comes with a higher cost. Thromboembolic complications were similar between groups. More studies are needed to compare the efficacy and safety profiles of topical TXA against the routine standard of IV TXA, especially in patients with perceived contraindications to IV TXA.

Am J Orthop. 2016;45(7):E439-E443. Copyright Frontline Medical Communications Inc. 2016. All rights reserved.

Total hip arthroplasty (THA) and total knee arthroplasty (TKA) can be associated with significant blood loss that in some cases requires transfusion. The incidence of transfusion ranges from 16% to 37% in patients who undergo THA and from 11% to 21% in patients who undergo TKA.^1-3 Allogeneic blood transfusions have been associated with several risks (transfusion-related acute lung injury, hemolytic reactions, immunologic reactions, fluid overload, renal failure, infections), increased cost, and longer hospital length of stay (LOS).^4-7 With improved patient outcomes the ultimate goal, blood-conserving strategies designed to decrease blood loss and transfusions have been adopted as a standard in successful joint replacement programs.

Tranexamic acid (TXA), an antifibrinolytic agent, has become a major component of blood conservation management after THA and TKA. TXA stabilizes clots at the surgical site by inhibiting plasminogen activation and thereby blocking fibrinolysis.⁸ The literature supports intravenous (IV) TXA as effective in significantly reducing blood loss and transfusion rates in elective THA and TKA.^9,10 However, data on increased risk of thrombotic events with IV TXA in both THA and TKA are conflicting.^11,12 Topical TXA is thought to have an advantage over IV TXA in that it provides a higher concentration of drug at the surgical site and is associated with little systemic absorption.^2,13Recent prospective randomized studies have compared the efficacy and safety of IV and topical TXA in THA and TKA.^9,14 However, controversy remains because relatively few studies have compared these 2 routes of administration. In addition, healthcare–associated costs have come under increased scrutiny, and the cost of these treatments should be considered. More research is needed to determine which application is most efficacious and cost-conscious and poses the least risk to patients. Therefore, we conducted a study to compare the cost, efficacy, and safety of IV and topical TXA in primary THA and TKA.

Materials and Methods

Our Institutional Review Board approved this study. Patients who were age 18 years or older, underwent primary THA or TKA, and received IV or topical TXA between August 2013 and September 2014 were considered eligible for the study. For both groups, exclusion criteria were trauma service admission, TXA hypersensitivity, pregnancy, and concomitant use of IV and topical TXA.

We collected demographic data (age, sex, weight, height, body mass index), noted all transfusions of packed red blood cells, and recorded preoperative and postoperative hemoglobin (Hgb) levels and surgical drain outputs. We also recorded any complications that occurred within 90 days after surgery: deep vein thrombosis (DVT), pulmonary embolism (PE), cardiac events, cerebrovascular events, and wound drainage. Wound drainage was defined as readmission to hospital or return to operating room for wound drainage caused by infection or hematoma. Postoperative care (disposition, LOS, follow-up) was documented. Average cost of both IV and topical TXA administration was calculated using average wholesale price.

Use of IV TXA and use of topical TXA were compared in both THA and TKA. Patients in the IV TXA group received TXA in two 10-mg/kg doses with a maximum of 1 g per dose. The first IV dose was given before the incision, and the second was given 3 hours after the first. Patients in the topical TXA group underwent direct irrigation with 3 g of TXA in 100 mL of normal saline at the surgical site after closure of the deep fascia in THA and after closure of the knee arthrotomy in TKA. The drain remained occluded for 30 minutes after surgery. The wound was irrigated with topical TXA before wound closure in the THA group and before tourniquet release in the TKA group. TXA dosing was based on institutional formulary dosing restrictions and was consistent with best practices and current literature.^3,9,14,15Primary outcomes measured for each cohort and treatment arm were Hgb levels (difference between preoperative levels and lowest postoperative levels 24 hours after surgery), blood loss, transfusion rates, and cost. Secondary outcomes were LOS and complications that occurred within 90 days after surgery (DVT, PE, cardiac events, cerebrovascular events, wound drainage).

Calculated blood loss was determined with equations described by Konig and colleagues,³ Good and colleagues,¹⁶ and Nadler and colleagues.¹⁷ Total calculated blood loss was based on the difference in Hgb levels before surgery and the lowest Hgb levels 24 hours after surgery:

Blood loss (mL) = 100 mL/dL × Hgb_loss/Hgb_i

Hgb_loss = BV × (Hgb_i – Hgb_e) × 10 dL/L + Hgb_t

= 0.3669 × Height³ (m) + 0.03219 × Weight (kg) + 0.6041 (for men)

= 0.3561 × Height³ (m) + 0.03308 × Weight (kg) + 0.1833 (for women)

 

where Hgb_i is the Hgb concentration (g/dL) before surgery, Hgb_e is the lowest Hgb concentration (g/dL) 24 hours after surgery, Hgb_t is the total amount (g) of allogeneic Hgb transfused, and BV is the estimated total body blood volume (L).¹⁷ As Hgb concentrations after blood transfusions were compared in this study, the Hgb_t variable was removed from the equation. Based on Hgb decrease data in a study that compared IV and topical TXA in TKA,¹⁴ we determined that a sample size of least 140 patients (70 in each cohort) was needed in order to have 80% power to detect a difference in Hgb decrease of 0.36 g/dL in IV and topical TXA.

All data were reported with descriptive statistics. Frequencies and percentages were reported for categorical variables. Means and standard deviations were reported for continuous variables. The groups of continuous data were compared with unpaired Student t tests and 1-way analysis of variance. Comparisons among groups of categorical data were analyzed with Fisher exact tests. Statistical significance was set at P < .05.

Results

Data were collected on 291 patients (156 THA, 135 TKA). There was a significant (P = .044) sex difference in the THA group: more men in the topical TXA subgroup and more women in the IV TXA subgroup. Other patient demographics were similarly matched with respect to age, height, weight, and body mass index (Table 1).

The primary outcomes (differences in cost, Hgb decrease, estimated blood loss, calculated blood loss, and transfusions) are listed in Table 2.

In the THA group, mean (SD) Hgb change was significantly (P = .031) higher with IV TXA, 3.33 (1.02) g/dL, than with topical TXA, 2.89 (1.44) g/dL, and the cost of topical TXA ($2100) was significantly (P ≤ .0001) higher than the cost of IV TXA ($1161). There were no differences in calculated blood loss, estimated blood loss, or transfusion rates. In the TKA group, calculated blood loss was significantly (P = .019) higher with IV TXA (1084.2 mL) than with topical TXA (859.6 mL), mean (SD) Hgb change was significantly (P = .015) higher with IV TXA, 2.35 (0.99) g/dL, than with topical TXA, 1.93 (0.90) g/dL, and the cost of topical TXA ($2100) was significantly (P ≤ .0001) higher than the cost of IV TXA ($1271). There were no differences in estimated blood loss or transfusion rates.

The secondary outcomes (differences in complications and LOS) are listed in Table 3.

In the THA group, postoperative cardiac events occurred in 3 (6%) of the 48 patients in the topical TXA subgroup and in none of the patients in the IV TXA subgroup (P = .007). There were no differences in other complications (DVT, PE, cerebrovascular events, wound drainage) or LOS. In the TKA group, there were no differences in postoperative complications or LOS between the IV and topical TXA subgroups.

Discussion

TXA, an analog of the amino acid lysine, is an antifibrinolytic agent that has been used for many years to inhibit fibrin degradation.^3,18 TXA works by competitively inhibiting tissue plasminogen activation, which is elevated by the trauma of surgery, and blocking plasmin binding to fibrin.^3,19 The mechanism of action is not procoagulant, as TXA prevents fibrin breakdown and supports coagulation that is underway rather than increasing clot formation. These characteristics make the drug attractive for orthopedic joint surgery—TXA reduces postoperative blood loss in patients who need fibrinolysis suppressed in order to maintain homeostasis without increasing the risk of venous thromboembolism. IV TXA has been well studied, which supports its efficacy profile for reducing blood loss and transfusions; there are no reports of increased risk of thromboembolic events.^20-22 Despite these studies, the risk of adverse events is still a major concern, especially in patients with medical conditions that predispose them to venothrombotic events. Topical TXA has become a viable option, especially in high-risk patients, as studies have shown 70% lower systemic absorption relative to IV TXA plasma concentration.²³ Still, too few studies have compared the efficacy, safety, and cost of IV and topical TXA in both THA and TKA.

Topical TXA costs an average of $2100 per case, primarily because standard dosing is 3 g per case. Despite repeat dosing for IV TXA (first dose at incision, second dose 3 hours after first), IV TXA costs were much lower on average: $939 less for THA and $829 less for TKA. As numerous studies have outlined results similar to ours, cost-effectiveness should be considered in decisions about treatment options.

Patel and colleagues¹⁴ reported that the efficacy of topical TXA was similar to that of IV TXA and that there were no significant differences in Hgb decrease, wound drainage, or need for transfusions after TKA. Their report conflicts with our finding significant differences favoring topical TXA for Hgb change (P = .015) and reduced calculated blood loss (P = .019) in TKA. A potential reason for these differing results is that the topical TXA doses were different (2 g in the study by Patel and colleagues,¹⁴ 3 g in our study). Martin and colleagues²⁴ compared the effects of topical TXA and placebo and found a nonsignificant difference in reduced blood loss and postoperative transfusions when the drug was dosed at 2 g. Konig and colleagues³ found that topical TXA dosed at 3 g (vs placebo) could reduce blood loss and transfusions after THA and TKA. These studies support our 3-g dose protocol for topical TXA rather than the 2-g protocol used in the study by Patel and colleagues.¹⁴ Our results are congruent with those of Seo and colleagues,²⁵ who found topical TXA superior in decreasing blood loss in TKA. Furthermore, our study is unique in that it compared costs and found topical TXA to be more expensive by almost $1000 on average.

Wei and Wei⁹ concluded that IV TXA 3 g and topical TXA 3 g were equally effective in reducing total blood loss, change in hematocrit, and need for transfusion after THA. In contrast, we found a significant (P = .031) difference favoring topical TXA for Hgb change. The 2 studies differed in their dosing protocols: Wei and Wei⁹ infused a 3-g dose, whereas we gave a maximum of two 1-g IV doses. The higher IV dose used by Wei and Wei⁹ could explain why they found no difference between IV and topical TXA, whereas we did find a difference. Our study was unique in that it measured Hgb change, blood loss, and cost.

Our study included an in-depth analysis of blood loss: estimated blood loss, drain outputs, calculated blood loss, and Hgb change. The equation we used for calculated blood loss is well established and has been used in multiple studies.^3,16,17 To thoroughly assess the safety of TXA, we reviewed and documented complications that occurred within 90 days after surgery and that could be attributed to TXA. This study was adequately powered and exceeded the required sample size to detect a difference in one primary outcome measure, perioperative Hgb change, as calculated by the prestudy statistical power analysis.

Our study had several limitations. First, it was a retrospective chart review; documentation could have been incomplete or missing. Second, the study was not randomized and thus subject to drug selection bias. Third, patients were selected for topical TXA on the basis of perceived risk factors, such as prior or family history of DVT, PE, cardiac events, or cerebrovascular events. It was thought that, given the decrease in systemic absorption with topical TXA, these high-risk patients would be less likely to have a thromboembolic event. Their complex past medical histories may explain why the topical TXA group had more cardiac events. Furthermore, 1 orthopedic surgeon used topical TXA exclusively, and the other 3 used it selectively, according to risk factors. In addition, unlike TKA patients, not all THA patients received drains. This study was powered to measure a difference in perioperative Hgb change but may not have been powered to detect the statistically significant difference favoring topical TXA for calculated blood loss in TKA. In the THA group, a statistically significant difference was found for reduced Hgb decrease but not for estimated or calculated blood loss. This finding reinforces some of the disparities in measurements of the effects of blood conservation strategies. The study also lacked a placebo or control group. However, several other studies have found that both IV TXA and topical TXA are superior to placebo in decreasing blood loss, Hgb change, and transfusion requirements.^10,12,20,22 In addition, the effects of TXA are based on estimates of blood conservation and are not without their disparities.

 

Conclusion

The present study found that both IV TXA and topical TXA were effective in decreasing blood loss, Hgb levels, and need for transfusion after THA and TKA. Topical TXA appears to be more effective than IV TXA in preventing Hgb decrease during THA and TKA and calculated blood loss during TKA. This increased efficacy comes with a higher cost. Thromboembolic complications were similar between groups. More studies are needed to compare the efficacy and safety profiles of topical TXA against the routine standard of IV TXA, especially in patients with perceived contraindications to IV TXA.

Am J Orthop. 2016;45(7):E439-E443. Copyright Frontline Medical Communications Inc. 2016. All rights reserved.

Technique

The patient is positioned on a radiolucent table, and a mobile fluoroscopy unit is available. A tourniquet is applied to the upper thigh but typically is not inflated during the percutaneous hardware removal portion of the operation. It is crucial to have information on retained implants so the correct screwdrivers for screw removal can be selected. In addition, provisions for stripped screws should be made. In each of the 3 cases we managed, the Synthes Screw Removal Set was available. Presence of an implant system known to have problems with cold welding of screws (eg, Less Invasive Stabilization System; Synthes) may necessitate additional preparations, such as making conical extraction devices available.¹

After preoperative administration of antibiotics, the surgeon typically removes only those proximal tibia screws that are preventing insertion of the tibial base plate. Fluoroscopic guidance is used to locate these screws and then remove them with percutaneous stab incisions. (Retained plates are not removed.) The exact method of localizing and removing the screws percutaneously is crucial. A small stab incision is made in the dermal layer. The number of stab incisions to be made depends on the number of screws to be removed. One small incision is needed for each screw hole. Occasionally mobilizing the skin and redirecting the screwdriver in the deep tissues can allow 2 screws to be removed through a single skin wound. The screwdriver head can be inserted through the muscle and fascial layers without the need for deep dissection. The plate is then felt with the screwdriver and the screw head located. It is very important that the screw head be adequately engaged to prevent stripping. The surgeon should not rush this step. The C-arm can be helpful here. Fluoroscopy not only can guide the screwdriver to the screw hole but can confirm the screwdriver is at right angles to the plate, not oblique. Only when the surgeon is completely satisfied that the screw head is well engaged should the attempt to back out the screw be made. If the screw strips, the screwdriver can be removed, and an attempt can be made to insert a percutaneous stripped screw removal device.¹ If this fails, then the technique must be abandoned for a more traditional approach.

Plating complex tibial plateau fractures through a separate posteromedial approach is now popular.² The deep location and screw orientation of posteromedial hardware make percutaneous removal unfeasible. In these cases, a separate posteromedial incision may be needed—usually posterior enough so it minimally compromises the anterior soft tissues. The incision typically uses the old posteromedial surgical scar but may not need to be as large as the original approach, as only selected screws need be removed. The saphenous neurovascular bundle may still be at risk, depending on the location of these incisions. The plate is not removed.

After the necessary screws are removed, the tourniquet can be inflated, if desired. The total knee arthroplasty (TKA) then proceeds in usual fashion through a single incision and a medial parapatellar arthrotomy.

Results

Between January 2009 and February 2014, Dr. Georgiadis converted 3 cases of retained tibial hardware and severe knee arthrosis to a TKA in a single operation. These cases were reviewed after Institutional Review Board approval was obtained. One patient underwent a closing-wedge high tibial osteotomy 14 years earlier, and the other 2 sustained tibial plateau fractures. Clinical details of the 3 cases are presented in the Table.

The data were derived from a review of inpatient electronic healthcare records. We did not specifically record the time needed for percutaneous implant removal or TKA. Follow-up consisted of a retrospective chart review of wound status, range of motion, and radiographs; knee function scores were not obtained.

In 2 of the cases, anterolateral surgical scars were present. New, separate percutaneous stab incisions were used to remove screws, which meant less of the original skin incision could be used for the TKA (Figures 1A, 1B).

The medial parapatellar arthrotomy was then performed with less lateral dissection and no exposure of the anterolateral plate.

In the third case, involving multiple plates, a similar strategy was used, but an additional small posteromedial incision was required (Figures 2-5). The TKA then proceeded through a new midline incision. This case was performed for tibiofemoral arthrosis in the setting of an acute distal femur fracture, but this had no bearing on the technique.

After the proximal tibial screws were removed, the case proceeded in the usual manner, though a stripped screw required insertion of a conical extraction device for percutaneous removal.

Tibial base plates were inserted in the usual manner. Length and type of tibial stem were left to the discretion of the surgeon. There were no changes from the usual surgical technique. All patients went on to routine, uneventful wound healing. Follow-up ranged from 10 months to 59 months.

 

Discussion

If the decision is made to proceed with TKA after previous knee surgery, careful preoperative planning is needed.

The most common reasons for retained implants are previous proximal tibial osteotomy and previous fracture.

For young patients with knee arthrosis and angular deformity, it has been recommended that proximal tibial osteotomy be performed to delay the need for joint replacement.^3,4 Although a wide variety of osteotomy techniques is available, plates and screws are often used. With long-term follow-up, knee arthrosis can be expected to progress, and some of these cases will be converted to knee arthroplasty.^3,4Displaced tibial plateau fractures are intra-articular injuries. Treatment requires surgery.

Treatment principles include restoration of articular anatomy, mechanical alignment, early motion, and, usually, open reduction and internal fixation (ORIF) with plates and screws. In the past, complex bicondylar fractures were often treated with medial and lateral plating through a single anterior approach. The resulting high infection rate was attributable to the initial soft-tissue injury and the additional surgical stripping.^5-8 In the more fragment-specific approach that was subsequently developed, combined anterolateral and posteromedial plating decreased but did not eliminate the risk of infection.^9-11Posttraumatic arthrosis is not an uncommon radiographic finding after ORIF of tibial plateau fractures.^12,13 However, only a relatively small percentage of these patients go on to TKA.^14,15In the presence of previous incisions and retained hardware, TKA is expected to be more technically difficult. Satisfactory outcomes of tibial osteotomy have been reported,¹⁶ as have poorer outcomes.^17,18 In many cases, lateral staples and not plate–screw constructs had been retained. Rates of complications (wounds, infections) after conversion of tibial plateau fractures to TKAs were higher in numerous studies.^19-21

Blood work for inflammatory markers (erythrocyte sedimentation rate, C-reactive protein level) should be performed before surgery. In the event of an elevated laboratory value or clinical suspicion (joint effusion), the joint should be aspirated before any arthroplasty procedure.

Preoperative planning for hardware removal is essential.²² The correct screwdriver and a metal cutting burr (for stripped screws) should be available. These needs may be anticipated with certain types of locking plates.¹

In such situations, minimally invasive hardware removal may not be possible. Meticulous planning regarding type of prosthesis is needed as well. Revision implants with long tibial stems are often needed to bypass previous tibial hardware or stress risers. We did not encounter any soft-tissue or bony difficulties in implanting a tibial base plate with a retained lateral tibial fracture plate in this 3-case series.

Surgical incision planning is also crucial in preventing wound problems that can lead to deep prosthetic infection.^23,24 Blood supply to the skin of the anterior knee is primarily medially derived; incisions that are more medial put lateral skin flaps at risk.²⁵ Use of the most recently healed or previous lateral-based scars has been recommended. In cases of adherent skin or poor soft-tissue envelope, plastic surgery (eg, soft-tissue expansion, gastrocnemius muscle, fasciocutaneous flaps) may be necessary.^26-28Surgeons must decide to perform either a single operation or a multiple-stage operation. Naturally, most patients prefer a single procedure. All previous hardware can be removed, or only the hardware that is preventing insertion of the tibial base plate. Removing the least amount of hardware is advantageous in that surgical stripping and soft-tissue damage are reduced.

In this initial series, we successfully converted 3 tibial implants to TKAs (each as a single operation) by removing only screws in percutaneous or minimally invasive fashion—the prosthetic joint approach did not involve additional soft-tissue stripping. We did not specifically record the time needed for implant removal separately from the time needed for TKA. As the Table shows, this technique can lengthen surgery. Operative time and blood loss can be more variable because of numerous factors, including scar tissue and an altered surgical field from previous surgery, in addition to hardware removal difficulties. Therefore, surgeons should budget more operative time for these procedures. Although longer operations theoretically may increase infection rates, we think the risk is mitigated by the percutaneous aspects of the described technique.

We do not think that most orthopedic surgeons addressing retained plate–screw constructs consider minimally invasive screw removal and plate retention. To our knowledge, the literature includes only 1 case report of a similar technique.²⁹This technique has many potential drawbacks, the foremost being use of intraoperative fluoroscopy. For more complex fractures, fluoroscopy time can be significant if the surgeon is committed to a true percutaneous approach (Table). In addition, use of a mobile fluoroscopy unit adds personnel to the operating theater, which potentially increases the infection rate. There may be cases in which tibial hardware interferes with tibial cuts, necessitating plate removal, but we did not encounter this in our series. This technique is potentially time-consuming. Operating room time can be expected to increase relative to wide exposures that allow quick access to existing implants. For this reason, some surgeons may decide to forgo this technique. Most modern proximal tibial fracture plates are contoured to fit well over the bone. However, some may still be prominent, and surgeons may choose to perform an open approach to remove them. Last, the clinical impact of plates retained without screws in the proximal tibia is not known. Theoretically, they may still act as a nidus for occult infection, and may act as a stress riser for peri-implant fracture. Therefore, for each patient, the surgeon must decide if the extra surgical time, fluoroscopy exposure, and plate retention are worthwhile.

In this 3-case series, screws were removed percutaneously over the proximal tibia. There were no neurovascular injuries in these cases, though there is potential for nerve and artery injuries with percutaneous screw removal, as in the anterolateral area of the distal third of the tibia.^30,31 Thus, our technique may not be applicable in such cases. Most patients with plates and screws retained after proximal tibial surgery do not need to have the screws removed from the distal tibia. There also is the potential for saphenous nerve injury if a small medial or posteromedial incision is made. No such injury occurred in our small series.

Surgeons must consider many factors when deciding whether to proceed with TKA in the setting of existing tibial hardware. If staged reconstruction is not planned, consideration can be given to percutaneous screw removal without plate removal in an attempt to minimize further soft-tissue stripping. This has the theoretical advantage of decreasing wound complications. We have been pleased with our initial patient experience and continue to use this technique.

Am J Orthop. 2016;45(7):E481-E486. Copyright Frontline Medical Communications Inc. 2016. All rights reserved.

Technique

The patient is positioned on a radiolucent table, and a mobile fluoroscopy unit is available. A tourniquet is applied to the upper thigh but typically is not inflated during the percutaneous hardware removal portion of the operation. It is crucial to have information on retained implants so the correct screwdrivers for screw removal can be selected. In addition, provisions for stripped screws should be made. In each of the 3 cases we managed, the Synthes Screw Removal Set was available. Presence of an implant system known to have problems with cold welding of screws (eg, Less Invasive Stabilization System; Synthes) may necessitate additional preparations, such as making conical extraction devices available.¹

After preoperative administration of antibiotics, the surgeon typically removes only those proximal tibia screws that are preventing insertion of the tibial base plate. Fluoroscopic guidance is used to locate these screws and then remove them with percutaneous stab incisions. (Retained plates are not removed.) The exact method of localizing and removing the screws percutaneously is crucial. A small stab incision is made in the dermal layer. The number of stab incisions to be made depends on the number of screws to be removed. One small incision is needed for each screw hole. Occasionally mobilizing the skin and redirecting the screwdriver in the deep tissues can allow 2 screws to be removed through a single skin wound. The screwdriver head can be inserted through the muscle and fascial layers without the need for deep dissection. The plate is then felt with the screwdriver and the screw head located. It is very important that the screw head be adequately engaged to prevent stripping. The surgeon should not rush this step. The C-arm can be helpful here. Fluoroscopy not only can guide the screwdriver to the screw hole but can confirm the screwdriver is at right angles to the plate, not oblique. Only when the surgeon is completely satisfied that the screw head is well engaged should the attempt to back out the screw be made. If the screw strips, the screwdriver can be removed, and an attempt can be made to insert a percutaneous stripped screw removal device.¹ If this fails, then the technique must be abandoned for a more traditional approach.

Plating complex tibial plateau fractures through a separate posteromedial approach is now popular.² The deep location and screw orientation of posteromedial hardware make percutaneous removal unfeasible. In these cases, a separate posteromedial incision may be needed—usually posterior enough so it minimally compromises the anterior soft tissues. The incision typically uses the old posteromedial surgical scar but may not need to be as large as the original approach, as only selected screws need be removed. The saphenous neurovascular bundle may still be at risk, depending on the location of these incisions. The plate is not removed.

After the necessary screws are removed, the tourniquet can be inflated, if desired. The total knee arthroplasty (TKA) then proceeds in usual fashion through a single incision and a medial parapatellar arthrotomy.

Results

Between January 2009 and February 2014, Dr. Georgiadis converted 3 cases of retained tibial hardware and severe knee arthrosis to a TKA in a single operation. These cases were reviewed after Institutional Review Board approval was obtained. One patient underwent a closing-wedge high tibial osteotomy 14 years earlier, and the other 2 sustained tibial plateau fractures. Clinical details of the 3 cases are presented in the Table.

The data were derived from a review of inpatient electronic healthcare records. We did not specifically record the time needed for percutaneous implant removal or TKA. Follow-up consisted of a retrospective chart review of wound status, range of motion, and radiographs; knee function scores were not obtained.

In 2 of the cases, anterolateral surgical scars were present. New, separate percutaneous stab incisions were used to remove screws, which meant less of the original skin incision could be used for the TKA (Figures 1A, 1B).

The medial parapatellar arthrotomy was then performed with less lateral dissection and no exposure of the anterolateral plate.

In the third case, involving multiple plates, a similar strategy was used, but an additional small posteromedial incision was required (Figures 2-5). The TKA then proceeded through a new midline incision. This case was performed for tibiofemoral arthrosis in the setting of an acute distal femur fracture, but this had no bearing on the technique.

After the proximal tibial screws were removed, the case proceeded in the usual manner, though a stripped screw required insertion of a conical extraction device for percutaneous removal.

Tibial base plates were inserted in the usual manner. Length and type of tibial stem were left to the discretion of the surgeon. There were no changes from the usual surgical technique. All patients went on to routine, uneventful wound healing. Follow-up ranged from 10 months to 59 months.

 

Discussion

If the decision is made to proceed with TKA after previous knee surgery, careful preoperative planning is needed.

The most common reasons for retained implants are previous proximal tibial osteotomy and previous fracture.

For young patients with knee arthrosis and angular deformity, it has been recommended that proximal tibial osteotomy be performed to delay the need for joint replacement.^3,4 Although a wide variety of osteotomy techniques is available, plates and screws are often used. With long-term follow-up, knee arthrosis can be expected to progress, and some of these cases will be converted to knee arthroplasty.^3,4Displaced tibial plateau fractures are intra-articular injuries. Treatment requires surgery.

Treatment principles include restoration of articular anatomy, mechanical alignment, early motion, and, usually, open reduction and internal fixation (ORIF) with plates and screws. In the past, complex bicondylar fractures were often treated with medial and lateral plating through a single anterior approach. The resulting high infection rate was attributable to the initial soft-tissue injury and the additional surgical stripping.^5-8 In the more fragment-specific approach that was subsequently developed, combined anterolateral and posteromedial plating decreased but did not eliminate the risk of infection.^9-11Posttraumatic arthrosis is not an uncommon radiographic finding after ORIF of tibial plateau fractures.^12,13 However, only a relatively small percentage of these patients go on to TKA.^14,15In the presence of previous incisions and retained hardware, TKA is expected to be more technically difficult. Satisfactory outcomes of tibial osteotomy have been reported,¹⁶ as have poorer outcomes.^17,18 In many cases, lateral staples and not plate–screw constructs had been retained. Rates of complications (wounds, infections) after conversion of tibial plateau fractures to TKAs were higher in numerous studies.^19-21

Blood work for inflammatory markers (erythrocyte sedimentation rate, C-reactive protein level) should be performed before surgery. In the event of an elevated laboratory value or clinical suspicion (joint effusion), the joint should be aspirated before any arthroplasty procedure.

Preoperative planning for hardware removal is essential.²² The correct screwdriver and a metal cutting burr (for stripped screws) should be available. These needs may be anticipated with certain types of locking plates.¹

In such situations, minimally invasive hardware removal may not be possible. Meticulous planning regarding type of prosthesis is needed as well. Revision implants with long tibial stems are often needed to bypass previous tibial hardware or stress risers. We did not encounter any soft-tissue or bony difficulties in implanting a tibial base plate with a retained lateral tibial fracture plate in this 3-case series.

Surgical incision planning is also crucial in preventing wound problems that can lead to deep prosthetic infection.^23,24 Blood supply to the skin of the anterior knee is primarily medially derived; incisions that are more medial put lateral skin flaps at risk.²⁵ Use of the most recently healed or previous lateral-based scars has been recommended. In cases of adherent skin or poor soft-tissue envelope, plastic surgery (eg, soft-tissue expansion, gastrocnemius muscle, fasciocutaneous flaps) may be necessary.^26-28Surgeons must decide to perform either a single operation or a multiple-stage operation. Naturally, most patients prefer a single procedure. All previous hardware can be removed, or only the hardware that is preventing insertion of the tibial base plate. Removing the least amount of hardware is advantageous in that surgical stripping and soft-tissue damage are reduced.

In this initial series, we successfully converted 3 tibial implants to TKAs (each as a single operation) by removing only screws in percutaneous or minimally invasive fashion—the prosthetic joint approach did not involve additional soft-tissue stripping. We did not specifically record the time needed for implant removal separately from the time needed for TKA. As the Table shows, this technique can lengthen surgery. Operative time and blood loss can be more variable because of numerous factors, including scar tissue and an altered surgical field from previous surgery, in addition to hardware removal difficulties. Therefore, surgeons should budget more operative time for these procedures. Although longer operations theoretically may increase infection rates, we think the risk is mitigated by the percutaneous aspects of the described technique.

We do not think that most orthopedic surgeons addressing retained plate–screw constructs consider minimally invasive screw removal and plate retention. To our knowledge, the literature includes only 1 case report of a similar technique.²⁹This technique has many potential drawbacks, the foremost being use of intraoperative fluoroscopy. For more complex fractures, fluoroscopy time can be significant if the surgeon is committed to a true percutaneous approach (Table). In addition, use of a mobile fluoroscopy unit adds personnel to the operating theater, which potentially increases the infection rate. There may be cases in which tibial hardware interferes with tibial cuts, necessitating plate removal, but we did not encounter this in our series. This technique is potentially time-consuming. Operating room time can be expected to increase relative to wide exposures that allow quick access to existing implants. For this reason, some surgeons may decide to forgo this technique. Most modern proximal tibial fracture plates are contoured to fit well over the bone. However, some may still be prominent, and surgeons may choose to perform an open approach to remove them. Last, the clinical impact of plates retained without screws in the proximal tibia is not known. Theoretically, they may still act as a nidus for occult infection, and may act as a stress riser for peri-implant fracture. Therefore, for each patient, the surgeon must decide if the extra surgical time, fluoroscopy exposure, and plate retention are worthwhile.

In this 3-case series, screws were removed percutaneously over the proximal tibia. There were no neurovascular injuries in these cases, though there is potential for nerve and artery injuries with percutaneous screw removal, as in the anterolateral area of the distal third of the tibia.^30,31 Thus, our technique may not be applicable in such cases. Most patients with plates and screws retained after proximal tibial surgery do not need to have the screws removed from the distal tibia. There also is the potential for saphenous nerve injury if a small medial or posteromedial incision is made. No such injury occurred in our small series.

Surgeons must consider many factors when deciding whether to proceed with TKA in the setting of existing tibial hardware. If staged reconstruction is not planned, consideration can be given to percutaneous screw removal without plate removal in an attempt to minimize further soft-tissue stripping. This has the theoretical advantage of decreasing wound complications. We have been pleased with our initial patient experience and continue to use this technique.

Am J Orthop. 2016;45(7):E481-E486. Copyright Frontline Medical Communications Inc. 2016. All rights reserved.

Technique

The patient is positioned on a radiolucent table, and a mobile fluoroscopy unit is available. A tourniquet is applied to the upper thigh but typically is not inflated during the percutaneous hardware removal portion of the operation. It is crucial to have information on retained implants so the correct screwdrivers for screw removal can be selected. In addition, provisions for stripped screws should be made. In each of the 3 cases we managed, the Synthes Screw Removal Set was available. Presence of an implant system known to have problems with cold welding of screws (eg, Less Invasive Stabilization System; Synthes) may necessitate additional preparations, such as making conical extraction devices available.¹

After preoperative administration of antibiotics, the surgeon typically removes only those proximal tibia screws that are preventing insertion of the tibial base plate. Fluoroscopic guidance is used to locate these screws and then remove them with percutaneous stab incisions. (Retained plates are not removed.) The exact method of localizing and removing the screws percutaneously is crucial. A small stab incision is made in the dermal layer. The number of stab incisions to be made depends on the number of screws to be removed. One small incision is needed for each screw hole. Occasionally mobilizing the skin and redirecting the screwdriver in the deep tissues can allow 2 screws to be removed through a single skin wound. The screwdriver head can be inserted through the muscle and fascial layers without the need for deep dissection. The plate is then felt with the screwdriver and the screw head located. It is very important that the screw head be adequately engaged to prevent stripping. The surgeon should not rush this step. The C-arm can be helpful here. Fluoroscopy not only can guide the screwdriver to the screw hole but can confirm the screwdriver is at right angles to the plate, not oblique. Only when the surgeon is completely satisfied that the screw head is well engaged should the attempt to back out the screw be made. If the screw strips, the screwdriver can be removed, and an attempt can be made to insert a percutaneous stripped screw removal device.¹ If this fails, then the technique must be abandoned for a more traditional approach.

Plating complex tibial plateau fractures through a separate posteromedial approach is now popular.² The deep location and screw orientation of posteromedial hardware make percutaneous removal unfeasible. In these cases, a separate posteromedial incision may be needed—usually posterior enough so it minimally compromises the anterior soft tissues. The incision typically uses the old posteromedial surgical scar but may not need to be as large as the original approach, as only selected screws need be removed. The saphenous neurovascular bundle may still be at risk, depending on the location of these incisions. The plate is not removed.

After the necessary screws are removed, the tourniquet can be inflated, if desired. The total knee arthroplasty (TKA) then proceeds in usual fashion through a single incision and a medial parapatellar arthrotomy.

Results

Between January 2009 and February 2014, Dr. Georgiadis converted 3 cases of retained tibial hardware and severe knee arthrosis to a TKA in a single operation. These cases were reviewed after Institutional Review Board approval was obtained. One patient underwent a closing-wedge high tibial osteotomy 14 years earlier, and the other 2 sustained tibial plateau fractures. Clinical details of the 3 cases are presented in the Table.

The data were derived from a review of inpatient electronic healthcare records. We did not specifically record the time needed for percutaneous implant removal or TKA. Follow-up consisted of a retrospective chart review of wound status, range of motion, and radiographs; knee function scores were not obtained.

In 2 of the cases, anterolateral surgical scars were present. New, separate percutaneous stab incisions were used to remove screws, which meant less of the original skin incision could be used for the TKA (Figures 1A, 1B).

The medial parapatellar arthrotomy was then performed with less lateral dissection and no exposure of the anterolateral plate.

In the third case, involving multiple plates, a similar strategy was used, but an additional small posteromedial incision was required (Figures 2-5). The TKA then proceeded through a new midline incision. This case was performed for tibiofemoral arthrosis in the setting of an acute distal femur fracture, but this had no bearing on the technique.

After the proximal tibial screws were removed, the case proceeded in the usual manner, though a stripped screw required insertion of a conical extraction device for percutaneous removal.

Tibial base plates were inserted in the usual manner. Length and type of tibial stem were left to the discretion of the surgeon. There were no changes from the usual surgical technique. All patients went on to routine, uneventful wound healing. Follow-up ranged from 10 months to 59 months.

 

Discussion

If the decision is made to proceed with TKA after previous knee surgery, careful preoperative planning is needed.

The most common reasons for retained implants are previous proximal tibial osteotomy and previous fracture.

For young patients with knee arthrosis and angular deformity, it has been recommended that proximal tibial osteotomy be performed to delay the need for joint replacement.^3,4 Although a wide variety of osteotomy techniques is available, plates and screws are often used. With long-term follow-up, knee arthrosis can be expected to progress, and some of these cases will be converted to knee arthroplasty.^3,4Displaced tibial plateau fractures are intra-articular injuries. Treatment requires surgery.

Treatment principles include restoration of articular anatomy, mechanical alignment, early motion, and, usually, open reduction and internal fixation (ORIF) with plates and screws. In the past, complex bicondylar fractures were often treated with medial and lateral plating through a single anterior approach. The resulting high infection rate was attributable to the initial soft-tissue injury and the additional surgical stripping.^5-8 In the more fragment-specific approach that was subsequently developed, combined anterolateral and posteromedial plating decreased but did not eliminate the risk of infection.^9-11Posttraumatic arthrosis is not an uncommon radiographic finding after ORIF of tibial plateau fractures.^12,13 However, only a relatively small percentage of these patients go on to TKA.^14,15In the presence of previous incisions and retained hardware, TKA is expected to be more technically difficult. Satisfactory outcomes of tibial osteotomy have been reported,¹⁶ as have poorer outcomes.^17,18 In many cases, lateral staples and not plate–screw constructs had been retained. Rates of complications (wounds, infections) after conversion of tibial plateau fractures to TKAs were higher in numerous studies.^19-21

Blood work for inflammatory markers (erythrocyte sedimentation rate, C-reactive protein level) should be performed before surgery. In the event of an elevated laboratory value or clinical suspicion (joint effusion), the joint should be aspirated before any arthroplasty procedure.

Preoperative planning for hardware removal is essential.²² The correct screwdriver and a metal cutting burr (for stripped screws) should be available. These needs may be anticipated with certain types of locking plates.¹

In such situations, minimally invasive hardware removal may not be possible. Meticulous planning regarding type of prosthesis is needed as well. Revision implants with long tibial stems are often needed to bypass previous tibial hardware or stress risers. We did not encounter any soft-tissue or bony difficulties in implanting a tibial base plate with a retained lateral tibial fracture plate in this 3-case series.

Surgical incision planning is also crucial in preventing wound problems that can lead to deep prosthetic infection.^23,24 Blood supply to the skin of the anterior knee is primarily medially derived; incisions that are more medial put lateral skin flaps at risk.²⁵ Use of the most recently healed or previous lateral-based scars has been recommended. In cases of adherent skin or poor soft-tissue envelope, plastic surgery (eg, soft-tissue expansion, gastrocnemius muscle, fasciocutaneous flaps) may be necessary.^26-28Surgeons must decide to perform either a single operation or a multiple-stage operation. Naturally, most patients prefer a single procedure. All previous hardware can be removed, or only the hardware that is preventing insertion of the tibial base plate. Removing the least amount of hardware is advantageous in that surgical stripping and soft-tissue damage are reduced.

In this initial series, we successfully converted 3 tibial implants to TKAs (each as a single operation) by removing only screws in percutaneous or minimally invasive fashion—the prosthetic joint approach did not involve additional soft-tissue stripping. We did not specifically record the time needed for implant removal separately from the time needed for TKA. As the Table shows, this technique can lengthen surgery. Operative time and blood loss can be more variable because of numerous factors, including scar tissue and an altered surgical field from previous surgery, in addition to hardware removal difficulties. Therefore, surgeons should budget more operative time for these procedures. Although longer operations theoretically may increase infection rates, we think the risk is mitigated by the percutaneous aspects of the described technique.

We do not think that most orthopedic surgeons addressing retained plate–screw constructs consider minimally invasive screw removal and plate retention. To our knowledge, the literature includes only 1 case report of a similar technique.²⁹This technique has many potential drawbacks, the foremost being use of intraoperative fluoroscopy. For more complex fractures, fluoroscopy time can be significant if the surgeon is committed to a true percutaneous approach (Table). In addition, use of a mobile fluoroscopy unit adds personnel to the operating theater, which potentially increases the infection rate. There may be cases in which tibial hardware interferes with tibial cuts, necessitating plate removal, but we did not encounter this in our series. This technique is potentially time-consuming. Operating room time can be expected to increase relative to wide exposures that allow quick access to existing implants. For this reason, some surgeons may decide to forgo this technique. Most modern proximal tibial fracture plates are contoured to fit well over the bone. However, some may still be prominent, and surgeons may choose to perform an open approach to remove them. Last, the clinical impact of plates retained without screws in the proximal tibia is not known. Theoretically, they may still act as a nidus for occult infection, and may act as a stress riser for peri-implant fracture. Therefore, for each patient, the surgeon must decide if the extra surgical time, fluoroscopy exposure, and plate retention are worthwhile.

In this 3-case series, screws were removed percutaneously over the proximal tibia. There were no neurovascular injuries in these cases, though there is potential for nerve and artery injuries with percutaneous screw removal, as in the anterolateral area of the distal third of the tibia.^30,31 Thus, our technique may not be applicable in such cases. Most patients with plates and screws retained after proximal tibial surgery do not need to have the screws removed from the distal tibia. There also is the potential for saphenous nerve injury if a small medial or posteromedial incision is made. No such injury occurred in our small series.

Surgeons must consider many factors when deciding whether to proceed with TKA in the setting of existing tibial hardware. If staged reconstruction is not planned, consideration can be given to percutaneous screw removal without plate removal in an attempt to minimize further soft-tissue stripping. This has the theoretical advantage of decreasing wound complications. We have been pleased with our initial patient experience and continue to use this technique.

Am J Orthop. 2016;45(7):E481-E486. Copyright Frontline Medical Communications Inc. 2016. All rights reserved.