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Cohort Study Reveals Link Between Menopausal Symptoms and Bone Health

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Cohort Study Reveals Link Between Menopausal Symptoms and Bone Health

Women with moderate to severe vasomotor symptoms (VMS) have lower bone mineral density and increased hip fracture rates, according to a study published online ahead of print December 18, 2014, in Journal of Clinical Endocrinology & Metabolism.

“This is the first large cohort study to examine the relationship between menopausal symptoms and bone health in menopausal women,” said lead author, Carolyn J. Crandall, MD, MS, of the David Geffen School of Medicine at the University of California, Los Angeles.

Carolyn J. Crandall, MD, MS

Data were examined from 23,573 participants in the Women’s Health Initiative (WHI) Clinical Trial. The participants were women between the ages of 50 and 79. This study, which was conducted at 40 clinical centers across the country, tracked women’s annual visits for 8 years on average.

Participants were asked about their menopausal symptoms, including hot flashes and night sweats, during their initial visit. WHI participants were monitored for fractures during the follow-up period. Among the study participants, 4,867 had their bone mineral density measured as part of a sub-study.

The analysis found that women who reported having moderate to severe hot flashes when they entered the study were more likely to fracture a hip during the follow-up period than were women who showed no menopausal symptoms. In addition, after researchers adjusted for age, body mass index, and demographic factors, they found that women who had moderate to severe menopausal symptoms had lower bone mass density at the neck and spine during the follow-up period than women with no symptoms.

“Our findings suggest that women who exhibit moderate or severe menopausal symptoms are more likely to have issues with bone health than their peers,” said Dr. Crandall. “Improved understanding would help clinicians advise women on how to better prevent osteoporosis and other bone conditions. Women who have hot flashes and want to protect their bones may benefit from healthy lifestyle habits such as avoiding smoking and excessive alcohol consumption, exercising, and getting sufficient calcium and vitamin D,” said Dr. Crandall.

References

Suggested Reading
Crandall CJ, Aragaki A, Cauley JA, et al. Associations of menopausal vasomotor symptoms with fracture incidence. J Clin Endocrinol Metab. 2014 Dec 18 [Epub ahead of print].

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Women with moderate to severe vasomotor symptoms (VMS) have lower bone mineral density and increased hip fracture rates, according to a study published online ahead of print December 18, 2014, in Journal of Clinical Endocrinology & Metabolism.

“This is the first large cohort study to examine the relationship between menopausal symptoms and bone health in menopausal women,” said lead author, Carolyn J. Crandall, MD, MS, of the David Geffen School of Medicine at the University of California, Los Angeles.

Carolyn J. Crandall, MD, MS

Data were examined from 23,573 participants in the Women’s Health Initiative (WHI) Clinical Trial. The participants were women between the ages of 50 and 79. This study, which was conducted at 40 clinical centers across the country, tracked women’s annual visits for 8 years on average.

Participants were asked about their menopausal symptoms, including hot flashes and night sweats, during their initial visit. WHI participants were monitored for fractures during the follow-up period. Among the study participants, 4,867 had their bone mineral density measured as part of a sub-study.

The analysis found that women who reported having moderate to severe hot flashes when they entered the study were more likely to fracture a hip during the follow-up period than were women who showed no menopausal symptoms. In addition, after researchers adjusted for age, body mass index, and demographic factors, they found that women who had moderate to severe menopausal symptoms had lower bone mass density at the neck and spine during the follow-up period than women with no symptoms.

“Our findings suggest that women who exhibit moderate or severe menopausal symptoms are more likely to have issues with bone health than their peers,” said Dr. Crandall. “Improved understanding would help clinicians advise women on how to better prevent osteoporosis and other bone conditions. Women who have hot flashes and want to protect their bones may benefit from healthy lifestyle habits such as avoiding smoking and excessive alcohol consumption, exercising, and getting sufficient calcium and vitamin D,” said Dr. Crandall.

Women with moderate to severe vasomotor symptoms (VMS) have lower bone mineral density and increased hip fracture rates, according to a study published online ahead of print December 18, 2014, in Journal of Clinical Endocrinology & Metabolism.

“This is the first large cohort study to examine the relationship between menopausal symptoms and bone health in menopausal women,” said lead author, Carolyn J. Crandall, MD, MS, of the David Geffen School of Medicine at the University of California, Los Angeles.

Carolyn J. Crandall, MD, MS

Data were examined from 23,573 participants in the Women’s Health Initiative (WHI) Clinical Trial. The participants were women between the ages of 50 and 79. This study, which was conducted at 40 clinical centers across the country, tracked women’s annual visits for 8 years on average.

Participants were asked about their menopausal symptoms, including hot flashes and night sweats, during their initial visit. WHI participants were monitored for fractures during the follow-up period. Among the study participants, 4,867 had their bone mineral density measured as part of a sub-study.

The analysis found that women who reported having moderate to severe hot flashes when they entered the study were more likely to fracture a hip during the follow-up period than were women who showed no menopausal symptoms. In addition, after researchers adjusted for age, body mass index, and demographic factors, they found that women who had moderate to severe menopausal symptoms had lower bone mass density at the neck and spine during the follow-up period than women with no symptoms.

“Our findings suggest that women who exhibit moderate or severe menopausal symptoms are more likely to have issues with bone health than their peers,” said Dr. Crandall. “Improved understanding would help clinicians advise women on how to better prevent osteoporosis and other bone conditions. Women who have hot flashes and want to protect their bones may benefit from healthy lifestyle habits such as avoiding smoking and excessive alcohol consumption, exercising, and getting sufficient calcium and vitamin D,” said Dr. Crandall.

References

Suggested Reading
Crandall CJ, Aragaki A, Cauley JA, et al. Associations of menopausal vasomotor symptoms with fracture incidence. J Clin Endocrinol Metab. 2014 Dec 18 [Epub ahead of print].

References

Suggested Reading
Crandall CJ, Aragaki A, Cauley JA, et al. Associations of menopausal vasomotor symptoms with fracture incidence. J Clin Endocrinol Metab. 2014 Dec 18 [Epub ahead of print].

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Should Men Receiving Androgen Deprivation Therapy Also Receive Bone-Strengthening Drugs?

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Should Men Receiving Androgen Deprivation Therapy Also Receive Bone-Strengthening Drugs?

Although some guidelines recommend use of bisphosphonates for men on androgen deprivation therapy (ADT), a study published in the December 3, 2014, JAMA reports that prescriptions for these drugs remain low, even for those men at high risk of subsequent fractures.

“Although the optimal rate of bisphosphonate use in men on ADT is unknown, it is reasonable that most men with prior osteoporosis or fracture should be taking a bisphosphonate or other effective bone medication,” stated Husayn Gulamhusein, BHSc, of the University Health Network in Toronto, and his research colleagues.

Using administrative databases at the Institute for Clinical Evaluative Sciences and the Ontario Cancer Registry, Mr. Gulamhusein and his team examined rates of bisphosphonate prescriptions in men initiating ADT in Ontario between 1995 and 2012. The study group included men ages 66 or older who were starting ADT for prostate cancer, who had undergone surgical removal of one or both testicles, or who received at least 6 months of continuous medical ADT and survived at least one year after ADT initiation.

Bisphosphonate claims within 12 months of ADT initiation were captured through drug database claims. Bisphosphonate prescription was examined for three groups: all nonusers of bisphosphonates, those with prior osteoporosis, and those with prior fragility fracture.

A total of 35,487 men with prostate cancer who began ADT during the study period were identified. Bisphosphonate claims among all nonusers increased from 0.35 per 100 persons in 1995 to 1997 to 3.40 per 100 persons in 2010 to 2012. Rates remained low, even among those with prior osteoporosis or fragility fracture. Among all three groups, peak bisphosphonate claims occurred between 2007 to 2009, with a high of 11.89 per 100 persons in those with prior osteoporosis.

Mr. Gulamhusein and his research team speculate that the decrease in bisphosphonate prescriptions after 2009 may be partly due to recent negative media attention regarding the association of bisphosphonates with rare osteonecrosis of the jaw and atypical femoral fractures. “This is appropriate for groups at low risk for fractures, but the decrease in use for high-risk patients is troubling,” the study authors wrote.

References

Suggested Reading
Gulamhusein H, Yun L, Cheung AM, et al. Bisphosphonate prescriptions in men with androgen deprivation therapy use. JAMA. 2014;312(21):2285-2286.

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Although some guidelines recommend use of bisphosphonates for men on androgen deprivation therapy (ADT), a study published in the December 3, 2014, JAMA reports that prescriptions for these drugs remain low, even for those men at high risk of subsequent fractures.

“Although the optimal rate of bisphosphonate use in men on ADT is unknown, it is reasonable that most men with prior osteoporosis or fracture should be taking a bisphosphonate or other effective bone medication,” stated Husayn Gulamhusein, BHSc, of the University Health Network in Toronto, and his research colleagues.

Using administrative databases at the Institute for Clinical Evaluative Sciences and the Ontario Cancer Registry, Mr. Gulamhusein and his team examined rates of bisphosphonate prescriptions in men initiating ADT in Ontario between 1995 and 2012. The study group included men ages 66 or older who were starting ADT for prostate cancer, who had undergone surgical removal of one or both testicles, or who received at least 6 months of continuous medical ADT and survived at least one year after ADT initiation.

Bisphosphonate claims within 12 months of ADT initiation were captured through drug database claims. Bisphosphonate prescription was examined for three groups: all nonusers of bisphosphonates, those with prior osteoporosis, and those with prior fragility fracture.

A total of 35,487 men with prostate cancer who began ADT during the study period were identified. Bisphosphonate claims among all nonusers increased from 0.35 per 100 persons in 1995 to 1997 to 3.40 per 100 persons in 2010 to 2012. Rates remained low, even among those with prior osteoporosis or fragility fracture. Among all three groups, peak bisphosphonate claims occurred between 2007 to 2009, with a high of 11.89 per 100 persons in those with prior osteoporosis.

Mr. Gulamhusein and his research team speculate that the decrease in bisphosphonate prescriptions after 2009 may be partly due to recent negative media attention regarding the association of bisphosphonates with rare osteonecrosis of the jaw and atypical femoral fractures. “This is appropriate for groups at low risk for fractures, but the decrease in use for high-risk patients is troubling,” the study authors wrote.

Although some guidelines recommend use of bisphosphonates for men on androgen deprivation therapy (ADT), a study published in the December 3, 2014, JAMA reports that prescriptions for these drugs remain low, even for those men at high risk of subsequent fractures.

“Although the optimal rate of bisphosphonate use in men on ADT is unknown, it is reasonable that most men with prior osteoporosis or fracture should be taking a bisphosphonate or other effective bone medication,” stated Husayn Gulamhusein, BHSc, of the University Health Network in Toronto, and his research colleagues.

Using administrative databases at the Institute for Clinical Evaluative Sciences and the Ontario Cancer Registry, Mr. Gulamhusein and his team examined rates of bisphosphonate prescriptions in men initiating ADT in Ontario between 1995 and 2012. The study group included men ages 66 or older who were starting ADT for prostate cancer, who had undergone surgical removal of one or both testicles, or who received at least 6 months of continuous medical ADT and survived at least one year after ADT initiation.

Bisphosphonate claims within 12 months of ADT initiation were captured through drug database claims. Bisphosphonate prescription was examined for three groups: all nonusers of bisphosphonates, those with prior osteoporosis, and those with prior fragility fracture.

A total of 35,487 men with prostate cancer who began ADT during the study period were identified. Bisphosphonate claims among all nonusers increased from 0.35 per 100 persons in 1995 to 1997 to 3.40 per 100 persons in 2010 to 2012. Rates remained low, even among those with prior osteoporosis or fragility fracture. Among all three groups, peak bisphosphonate claims occurred between 2007 to 2009, with a high of 11.89 per 100 persons in those with prior osteoporosis.

Mr. Gulamhusein and his research team speculate that the decrease in bisphosphonate prescriptions after 2009 may be partly due to recent negative media attention regarding the association of bisphosphonates with rare osteonecrosis of the jaw and atypical femoral fractures. “This is appropriate for groups at low risk for fractures, but the decrease in use for high-risk patients is troubling,” the study authors wrote.

References

Suggested Reading
Gulamhusein H, Yun L, Cheung AM, et al. Bisphosphonate prescriptions in men with androgen deprivation therapy use. JAMA. 2014;312(21):2285-2286.

References

Suggested Reading
Gulamhusein H, Yun L, Cheung AM, et al. Bisphosphonate prescriptions in men with androgen deprivation therapy use. JAMA. 2014;312(21):2285-2286.

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Should Men Receiving Androgen Deprivation Therapy Also Receive Bone-Strengthening Drugs?
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Periprosthetic Supracondylar Femur Fracture Treated With Spanning External Fixation

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Periprosthetic Supracondylar Femur Fracture Treated With Spanning External Fixation

The incidence of periprosthetic supracondylar fractures of the femur after total knee arthroplasty (TKA) ranges from 0.6% to 2.5%.1 Treatment of periprosthetic fractures is often complicated by advanced patient age and osteoporosis, which frequently accompanies these fractures. Management of a periprosthetic fracture depends on the relation between the fracture site and the prosthesis, displacement of the prosthesis, integrity of the fixation of the prosthesis, extent of the bone loss caused by fracture comminution or preexisting osteolysis, general health of the patient, and surgeon expertise.2,3 The aim is to achieve fracture union around a stable, well-aligned arthroplasty with preserved or restored bone stock and therefore to return the patient to previous level of function. Although nonoperative treatments have been shown to be successful,4,5 in the great majority of cases surgical treatment is advised for these fractures.6-10 In cases in which bone stock is adequate for fixation rather than replacement of the distal femur, 2 modalities are commonly used: retrograde intramedullary nailing and locking plates. Each has its drawbacks and advantages.11,12

Although external fixation has been used in the treatment of distal femoral fractures,13 it is seldom considered in the treatment of periprosthetic fractures. Several authors have described cases that used external fixators, occasionally spanning the knee. The specific types of external fixators discussed in the literature have included ring fixators,14-17 hybrid fixators,18 and uniplanar nonspanning fixators14,19 (Table). Use of a simple anterior spanning external fixator in treating a periprosthetic femoral fracture has received little attention in the literature.

The patient provided written informed consent for print and electronic publication of this case report.

Case Report

A 54-year-old woman with previous total hip arthroplasty (THA) and ipsilateral TKA tripped on a carpet and sustained a comminuted fracture of the distal femur just above the TKA prosthesis (Figure 1). She was a Jehovah’s Witness and thus refused all blood products. She had an extensive history of osteoporosis, morbid obesity (5 feet tall, 250 pounds; body mass index, 49), diabetes, and rheumatoid arthritis. Evaluation by the internal medicine service revealed severe coronary artery disease on a stress thallium test and anemia with hematocrit of 24%. Given the patient’s medical comorbidities and religious status, and the location of the comminuted distal femur fracture, several treatment options were considered. First was nonoperative treatment with a cast or cast-brace (hinged cast). Because of her body habitus, however, we thought she would very likely experience skin complications, inadequate immobilization of the bone, and significant discomfort. Ultimately, use of a spanning external fixator was chosen as the safest course, given the significant medical risks accompanying a more extensive surgical reconstruction. With the spanning external fixator, the main risks were the inability to fully control fracture alignment and the potential introduction of infection into the functional THA. We thought that, by limiting the amount of time in the fixator and managing the pin site aggressively, we could minimize the risk for infection in this setting.

The procedure was performed with the patient under general anesthesia. During surgery, a lateral image of the femur was used to identify the distal end of the THA prosthesis. A level was marked 2 to 3 cm distal to the tip of this prosthesis, and another about 1 cm above the fracture (noted to be above the most proximal extent of the knee joint). These planned pin-entry sites were prepared from an anterior approach with incisions (using a No. 11 blade) of about 1 cm each. Blunt dissection was carried down to the femur. Each planned pin site was predrilled with a 3.5-mm drill; then, a 5-mm Shanz pin was placed. This process was repeated immediately distal to the tibial component and at the junction of the mid and distal thirds of the tibia (Figure 2). The preliminary external fixator frame was then applied. Once the reduction was satisfactory in the anteroposterior and lateral planes, the fixator clamps were tightened. A second row of bars was then incorporated.

Six weeks after surgery, radiographs showed early callus formation. Removing the external fixator and examining the knee under anesthesia confirmed there was no significant motion through the fracture site. A cast-brace (fiberglass thigh segment, fiberglass lower leg cast with hinged knee segment) was then applied. We remained concerned about skin complications but were encouraged by the early healing achieved with the fixator. The patient was started on a physical therapy program of gait training with a walker and toe-touch weight-bearing on the injured extremity. She also started a limited lower-extremity strengthening program. Three months after surgery, she was tolerating weight-bearing on the injured extremity with no pain. At 6 months, knee radiographs showed fracture consolidation with active range of motion of 10° to 120° and no pain (Figures 3A, 3B). Distal sensation, motor function, and vascular examination were normal. Two years after surgery, radiographs of the right knee showed minor malalignment in the coronal and sagittal planes (Figures 4A, 4B) and complete consolidation of the fracture.

 

 

Discussion

Periprosthetic fractures of the femur after TKA often occur in the setting of osteopenia, and some are associated with concurrent implant loosening. In most cases, these fractures require surgical stabilization. Nevertheless, the goals of treatment are to obtain and maintain anatomical alignment and stability to allow early range of motion. Nonoperative options include skeletal traction, cast, pins and plaster, and cast-brace.3-5,20 Operative options include intramedullary fixation,12,21 stabilization with various plates,21-23 revision knee arthroplasty, and arthrodesis.1 Treatment selection should be based on patient health, fracture displacement, comminution, osteopenia severity, and status of the prosthetic components.

The present case exemplifies some of the highest degrees of medical and surgical risk factors in people with a periprosthetic femoral fracture after TKA. Patients with rheumatoid arthritis, patients having corticosteroid treatment, patients of advanced age, and female patients are all at higher risk for supracondylar femoral fracture.9 Our patient had these risk factors on a background of anemia and extensive coronary artery disease. Given her past medical history and refusal of blood products out of religious belief, we thought she was too high risk for extensive surgical treatment for her fracture. In addition, she was not an ideal candidate for nonoperative treatment, as a periprosthetic fracture typically is treated with surgical revision or open reduction and internal fixation. Therefore, we selected an unconventional treatment modality, typically used as a temporizing measure in severe fractures around the knee—a spanning external fixator worn for 6 weeks and a cast-brace for an additional 6 weeks. This led to successful clinical and radiographic outcomes. We consider spanning external fixation a viable option for periprosthetic fractures after TKA in morbidly obese patients with relatively well-aligned fractures and extremely high risk for medical complications associated with traditional open surgery.

References

1.    Figgie MP, Goldberg VM, Figgie HE 3rd, Sobel M. The results of treatment of supracondylar fracture above total knee arthroplasty. J Arthroplasty. 1990;5(3):267-276.

2.    Su ET, Kubiak EN, Dewal H, Hiebert R, Di Cesare PE. A proposed classification of supracondylar femur fractures above total knee arthroplasties. J Arthroplasty. 2006;21(3):405-408.

3.    Kim KI, Egol KA, Hozack WJ, Parvizi J. Periprosthetic fractures after total knee arthroplasties. Clin Orthop. 2006;(446):167-175.

4.    Sochart DH, Hardinge K. Nonsurgical management of supracondylar fracture above total knee arthroplasty. Still the nineties option. J Arthroplasty. 1997;12(7):830-834.

5.    Delport PH, Van Audekercke R, Martens M, Mulier JC. Conservative treatment of ipsilateral supracondylar femoral fracture after total knee arthroplasty. J Trauma. 1984;24(9):846-849.

6.    Frigg R, Appenzeller A, Christensen R, Frenk A, Gilbert S, Schavan R. The development of the distal femur less invasive stabilization system (LISS). Injury. 2001;32(suppl 3):SC24-SC31.

7.    Goesling T, Frenk A, Appenzeller A, Garapati R, Marti A, Krettek C. LISS PLT: design, mechanical and biomechanical characteristics. Injury. 2003;34(suppl 1):A11-A15.

8.    Huang HT, Huang PJ, Su JY, Lin SY. Indirect reduction and bridge plating of supracondylar fractures of the femur. Injury. 2003;34(2):135-140.

9.    Dennis DA. Periprosthetic fractures following total knee arthroplasty. Instr Course Lect. 2001;50:379-389.

10.  Jamali AA, Lee MA, Donthineni R, Meehan JP. Minimally invasive management of a floating prosthesis injury with locking plates. J Arthroplasty. 2007;22(6):928-933.

11.  Bong MR, Egol KA, Koval KJ, et al. Comparison of the LISS and a retrograde-inserted supracondylar intramedullary nail for fixation of a periprosthetic distal femur fracture proximal to a total knee arthroplasty. J Arthroplasty. 2002;17(7):876-881.

12.  Firoozbakhsh K, Behzadi K, DeCoster TA, Moneim MS, Naraghi FF. Mechanics of retrograde nail versus plate fixation for supracondylar femur fractures. J Orthop Trauma. 1995;9(2):152-157.

13.  Arazi M, Memik R, Ogun TC, Yel M. Ilizarov external fixation for severely comminuted supracondylar and intercondylar fractures of the distal femur. J Bone Joint Surg Br. 2001;83(5):663-667.

14.  Pleva L, Sir M, Madeja R. Our experiences with the treatment of periprosthetic fractures of femur. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2004;148(1):75-79.

15.  Simon RG, Brinker MR. Use of Ilizarov external fixation for a periprosthetic supracondylar femur fracture. J Arthroplasty. 1999;14(1):118-121.

16.  Hurson C, Synnott K, McCormack D. Above-knee Ilizarov external fixation for early periprosthetic supracondylar femoral fracture—a case report. Knee. 2005;12(2):145-147.

17.  Beris AE, Lykissas MG, Sioros V, Mavrodontidis AN, Korompilias AV. Femoral periprosthetic fracture in osteoporotic bone after a total knee replacement: treatment with Ilizarov external fixation. J Arthroplasty. 2010;25(7):1168.e9-e12.

18.  Pafilas D, Kourtzis N. Hybrid external fixation as a new treatment method for periprosthetic femoral fracture. A case report. J Bone Joint Surg Am. 2006;88(1):188-192.

19.  Merkel KD, Johnson EW Jr. Supracondylar fracture of the femur after total knee arthroplasty. J Bone Joint Surg Am. 1986;68(1):29-43.

20.  Cordeiro EN, Costa RC, Carazzato JG, Silva Jdos S. Periprosthetic fractures in patients with total knee arthroplasties. Clin Orthop. 1990;(252):182-189.

21.  Riemer BL, Butterfield SL, Burke CJ 3rd, Mathews D. Immediate plate fixation of highly comminuted femoral diaphyseal fractures in blunt polytrauma patients. Orthopedics. 1992;15(8):907-916.

22.  Kregor PJ, Hughes JL, Cole PA. Fixation of distal femoral fractures above total knee arthroplasty utilizing the less invasive stabilization system (L.I.S.S.). Injury. 2001;32(suppl 3):SC64-SC75.

23.   Althausen PL, Lee MA, Finkemeier CG, Meehan JP, Rodrigo JJ. Operative stabilization of supracondylar femur fractures above total knee arthroplasty: a comparison of four treatment methods. J Arthroplasty. 2003;18(7):834-839.

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Motasem Refaat, MD, Sheldon Coleman, MD, John P. Meehan, MD, and Amir A. Jamali, MD

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The incidence of periprosthetic supracondylar fractures of the femur after total knee arthroplasty (TKA) ranges from 0.6% to 2.5%.1 Treatment of periprosthetic fractures is often complicated by advanced patient age and osteoporosis, which frequently accompanies these fractures. Management of a periprosthetic fracture depends on the relation between the fracture site and the prosthesis, displacement of the prosthesis, integrity of the fixation of the prosthesis, extent of the bone loss caused by fracture comminution or preexisting osteolysis, general health of the patient, and surgeon expertise.2,3 The aim is to achieve fracture union around a stable, well-aligned arthroplasty with preserved or restored bone stock and therefore to return the patient to previous level of function. Although nonoperative treatments have been shown to be successful,4,5 in the great majority of cases surgical treatment is advised for these fractures.6-10 In cases in which bone stock is adequate for fixation rather than replacement of the distal femur, 2 modalities are commonly used: retrograde intramedullary nailing and locking plates. Each has its drawbacks and advantages.11,12

Although external fixation has been used in the treatment of distal femoral fractures,13 it is seldom considered in the treatment of periprosthetic fractures. Several authors have described cases that used external fixators, occasionally spanning the knee. The specific types of external fixators discussed in the literature have included ring fixators,14-17 hybrid fixators,18 and uniplanar nonspanning fixators14,19 (Table). Use of a simple anterior spanning external fixator in treating a periprosthetic femoral fracture has received little attention in the literature.

The patient provided written informed consent for print and electronic publication of this case report.

Case Report

A 54-year-old woman with previous total hip arthroplasty (THA) and ipsilateral TKA tripped on a carpet and sustained a comminuted fracture of the distal femur just above the TKA prosthesis (Figure 1). She was a Jehovah’s Witness and thus refused all blood products. She had an extensive history of osteoporosis, morbid obesity (5 feet tall, 250 pounds; body mass index, 49), diabetes, and rheumatoid arthritis. Evaluation by the internal medicine service revealed severe coronary artery disease on a stress thallium test and anemia with hematocrit of 24%. Given the patient’s medical comorbidities and religious status, and the location of the comminuted distal femur fracture, several treatment options were considered. First was nonoperative treatment with a cast or cast-brace (hinged cast). Because of her body habitus, however, we thought she would very likely experience skin complications, inadequate immobilization of the bone, and significant discomfort. Ultimately, use of a spanning external fixator was chosen as the safest course, given the significant medical risks accompanying a more extensive surgical reconstruction. With the spanning external fixator, the main risks were the inability to fully control fracture alignment and the potential introduction of infection into the functional THA. We thought that, by limiting the amount of time in the fixator and managing the pin site aggressively, we could minimize the risk for infection in this setting.

The procedure was performed with the patient under general anesthesia. During surgery, a lateral image of the femur was used to identify the distal end of the THA prosthesis. A level was marked 2 to 3 cm distal to the tip of this prosthesis, and another about 1 cm above the fracture (noted to be above the most proximal extent of the knee joint). These planned pin-entry sites were prepared from an anterior approach with incisions (using a No. 11 blade) of about 1 cm each. Blunt dissection was carried down to the femur. Each planned pin site was predrilled with a 3.5-mm drill; then, a 5-mm Shanz pin was placed. This process was repeated immediately distal to the tibial component and at the junction of the mid and distal thirds of the tibia (Figure 2). The preliminary external fixator frame was then applied. Once the reduction was satisfactory in the anteroposterior and lateral planes, the fixator clamps were tightened. A second row of bars was then incorporated.

Six weeks after surgery, radiographs showed early callus formation. Removing the external fixator and examining the knee under anesthesia confirmed there was no significant motion through the fracture site. A cast-brace (fiberglass thigh segment, fiberglass lower leg cast with hinged knee segment) was then applied. We remained concerned about skin complications but were encouraged by the early healing achieved with the fixator. The patient was started on a physical therapy program of gait training with a walker and toe-touch weight-bearing on the injured extremity. She also started a limited lower-extremity strengthening program. Three months after surgery, she was tolerating weight-bearing on the injured extremity with no pain. At 6 months, knee radiographs showed fracture consolidation with active range of motion of 10° to 120° and no pain (Figures 3A, 3B). Distal sensation, motor function, and vascular examination were normal. Two years after surgery, radiographs of the right knee showed minor malalignment in the coronal and sagittal planes (Figures 4A, 4B) and complete consolidation of the fracture.

 

 

Discussion

Periprosthetic fractures of the femur after TKA often occur in the setting of osteopenia, and some are associated with concurrent implant loosening. In most cases, these fractures require surgical stabilization. Nevertheless, the goals of treatment are to obtain and maintain anatomical alignment and stability to allow early range of motion. Nonoperative options include skeletal traction, cast, pins and plaster, and cast-brace.3-5,20 Operative options include intramedullary fixation,12,21 stabilization with various plates,21-23 revision knee arthroplasty, and arthrodesis.1 Treatment selection should be based on patient health, fracture displacement, comminution, osteopenia severity, and status of the prosthetic components.

The present case exemplifies some of the highest degrees of medical and surgical risk factors in people with a periprosthetic femoral fracture after TKA. Patients with rheumatoid arthritis, patients having corticosteroid treatment, patients of advanced age, and female patients are all at higher risk for supracondylar femoral fracture.9 Our patient had these risk factors on a background of anemia and extensive coronary artery disease. Given her past medical history and refusal of blood products out of religious belief, we thought she was too high risk for extensive surgical treatment for her fracture. In addition, she was not an ideal candidate for nonoperative treatment, as a periprosthetic fracture typically is treated with surgical revision or open reduction and internal fixation. Therefore, we selected an unconventional treatment modality, typically used as a temporizing measure in severe fractures around the knee—a spanning external fixator worn for 6 weeks and a cast-brace for an additional 6 weeks. This led to successful clinical and radiographic outcomes. We consider spanning external fixation a viable option for periprosthetic fractures after TKA in morbidly obese patients with relatively well-aligned fractures and extremely high risk for medical complications associated with traditional open surgery.

The incidence of periprosthetic supracondylar fractures of the femur after total knee arthroplasty (TKA) ranges from 0.6% to 2.5%.1 Treatment of periprosthetic fractures is often complicated by advanced patient age and osteoporosis, which frequently accompanies these fractures. Management of a periprosthetic fracture depends on the relation between the fracture site and the prosthesis, displacement of the prosthesis, integrity of the fixation of the prosthesis, extent of the bone loss caused by fracture comminution or preexisting osteolysis, general health of the patient, and surgeon expertise.2,3 The aim is to achieve fracture union around a stable, well-aligned arthroplasty with preserved or restored bone stock and therefore to return the patient to previous level of function. Although nonoperative treatments have been shown to be successful,4,5 in the great majority of cases surgical treatment is advised for these fractures.6-10 In cases in which bone stock is adequate for fixation rather than replacement of the distal femur, 2 modalities are commonly used: retrograde intramedullary nailing and locking plates. Each has its drawbacks and advantages.11,12

Although external fixation has been used in the treatment of distal femoral fractures,13 it is seldom considered in the treatment of periprosthetic fractures. Several authors have described cases that used external fixators, occasionally spanning the knee. The specific types of external fixators discussed in the literature have included ring fixators,14-17 hybrid fixators,18 and uniplanar nonspanning fixators14,19 (Table). Use of a simple anterior spanning external fixator in treating a periprosthetic femoral fracture has received little attention in the literature.

The patient provided written informed consent for print and electronic publication of this case report.

Case Report

A 54-year-old woman with previous total hip arthroplasty (THA) and ipsilateral TKA tripped on a carpet and sustained a comminuted fracture of the distal femur just above the TKA prosthesis (Figure 1). She was a Jehovah’s Witness and thus refused all blood products. She had an extensive history of osteoporosis, morbid obesity (5 feet tall, 250 pounds; body mass index, 49), diabetes, and rheumatoid arthritis. Evaluation by the internal medicine service revealed severe coronary artery disease on a stress thallium test and anemia with hematocrit of 24%. Given the patient’s medical comorbidities and religious status, and the location of the comminuted distal femur fracture, several treatment options were considered. First was nonoperative treatment with a cast or cast-brace (hinged cast). Because of her body habitus, however, we thought she would very likely experience skin complications, inadequate immobilization of the bone, and significant discomfort. Ultimately, use of a spanning external fixator was chosen as the safest course, given the significant medical risks accompanying a more extensive surgical reconstruction. With the spanning external fixator, the main risks were the inability to fully control fracture alignment and the potential introduction of infection into the functional THA. We thought that, by limiting the amount of time in the fixator and managing the pin site aggressively, we could minimize the risk for infection in this setting.

The procedure was performed with the patient under general anesthesia. During surgery, a lateral image of the femur was used to identify the distal end of the THA prosthesis. A level was marked 2 to 3 cm distal to the tip of this prosthesis, and another about 1 cm above the fracture (noted to be above the most proximal extent of the knee joint). These planned pin-entry sites were prepared from an anterior approach with incisions (using a No. 11 blade) of about 1 cm each. Blunt dissection was carried down to the femur. Each planned pin site was predrilled with a 3.5-mm drill; then, a 5-mm Shanz pin was placed. This process was repeated immediately distal to the tibial component and at the junction of the mid and distal thirds of the tibia (Figure 2). The preliminary external fixator frame was then applied. Once the reduction was satisfactory in the anteroposterior and lateral planes, the fixator clamps were tightened. A second row of bars was then incorporated.

Six weeks after surgery, radiographs showed early callus formation. Removing the external fixator and examining the knee under anesthesia confirmed there was no significant motion through the fracture site. A cast-brace (fiberglass thigh segment, fiberglass lower leg cast with hinged knee segment) was then applied. We remained concerned about skin complications but were encouraged by the early healing achieved with the fixator. The patient was started on a physical therapy program of gait training with a walker and toe-touch weight-bearing on the injured extremity. She also started a limited lower-extremity strengthening program. Three months after surgery, she was tolerating weight-bearing on the injured extremity with no pain. At 6 months, knee radiographs showed fracture consolidation with active range of motion of 10° to 120° and no pain (Figures 3A, 3B). Distal sensation, motor function, and vascular examination were normal. Two years after surgery, radiographs of the right knee showed minor malalignment in the coronal and sagittal planes (Figures 4A, 4B) and complete consolidation of the fracture.

 

 

Discussion

Periprosthetic fractures of the femur after TKA often occur in the setting of osteopenia, and some are associated with concurrent implant loosening. In most cases, these fractures require surgical stabilization. Nevertheless, the goals of treatment are to obtain and maintain anatomical alignment and stability to allow early range of motion. Nonoperative options include skeletal traction, cast, pins and plaster, and cast-brace.3-5,20 Operative options include intramedullary fixation,12,21 stabilization with various plates,21-23 revision knee arthroplasty, and arthrodesis.1 Treatment selection should be based on patient health, fracture displacement, comminution, osteopenia severity, and status of the prosthetic components.

The present case exemplifies some of the highest degrees of medical and surgical risk factors in people with a periprosthetic femoral fracture after TKA. Patients with rheumatoid arthritis, patients having corticosteroid treatment, patients of advanced age, and female patients are all at higher risk for supracondylar femoral fracture.9 Our patient had these risk factors on a background of anemia and extensive coronary artery disease. Given her past medical history and refusal of blood products out of religious belief, we thought she was too high risk for extensive surgical treatment for her fracture. In addition, she was not an ideal candidate for nonoperative treatment, as a periprosthetic fracture typically is treated with surgical revision or open reduction and internal fixation. Therefore, we selected an unconventional treatment modality, typically used as a temporizing measure in severe fractures around the knee—a spanning external fixator worn for 6 weeks and a cast-brace for an additional 6 weeks. This led to successful clinical and radiographic outcomes. We consider spanning external fixation a viable option for periprosthetic fractures after TKA in morbidly obese patients with relatively well-aligned fractures and extremely high risk for medical complications associated with traditional open surgery.

References

1.    Figgie MP, Goldberg VM, Figgie HE 3rd, Sobel M. The results of treatment of supracondylar fracture above total knee arthroplasty. J Arthroplasty. 1990;5(3):267-276.

2.    Su ET, Kubiak EN, Dewal H, Hiebert R, Di Cesare PE. A proposed classification of supracondylar femur fractures above total knee arthroplasties. J Arthroplasty. 2006;21(3):405-408.

3.    Kim KI, Egol KA, Hozack WJ, Parvizi J. Periprosthetic fractures after total knee arthroplasties. Clin Orthop. 2006;(446):167-175.

4.    Sochart DH, Hardinge K. Nonsurgical management of supracondylar fracture above total knee arthroplasty. Still the nineties option. J Arthroplasty. 1997;12(7):830-834.

5.    Delport PH, Van Audekercke R, Martens M, Mulier JC. Conservative treatment of ipsilateral supracondylar femoral fracture after total knee arthroplasty. J Trauma. 1984;24(9):846-849.

6.    Frigg R, Appenzeller A, Christensen R, Frenk A, Gilbert S, Schavan R. The development of the distal femur less invasive stabilization system (LISS). Injury. 2001;32(suppl 3):SC24-SC31.

7.    Goesling T, Frenk A, Appenzeller A, Garapati R, Marti A, Krettek C. LISS PLT: design, mechanical and biomechanical characteristics. Injury. 2003;34(suppl 1):A11-A15.

8.    Huang HT, Huang PJ, Su JY, Lin SY. Indirect reduction and bridge plating of supracondylar fractures of the femur. Injury. 2003;34(2):135-140.

9.    Dennis DA. Periprosthetic fractures following total knee arthroplasty. Instr Course Lect. 2001;50:379-389.

10.  Jamali AA, Lee MA, Donthineni R, Meehan JP. Minimally invasive management of a floating prosthesis injury with locking plates. J Arthroplasty. 2007;22(6):928-933.

11.  Bong MR, Egol KA, Koval KJ, et al. Comparison of the LISS and a retrograde-inserted supracondylar intramedullary nail for fixation of a periprosthetic distal femur fracture proximal to a total knee arthroplasty. J Arthroplasty. 2002;17(7):876-881.

12.  Firoozbakhsh K, Behzadi K, DeCoster TA, Moneim MS, Naraghi FF. Mechanics of retrograde nail versus plate fixation for supracondylar femur fractures. J Orthop Trauma. 1995;9(2):152-157.

13.  Arazi M, Memik R, Ogun TC, Yel M. Ilizarov external fixation for severely comminuted supracondylar and intercondylar fractures of the distal femur. J Bone Joint Surg Br. 2001;83(5):663-667.

14.  Pleva L, Sir M, Madeja R. Our experiences with the treatment of periprosthetic fractures of femur. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2004;148(1):75-79.

15.  Simon RG, Brinker MR. Use of Ilizarov external fixation for a periprosthetic supracondylar femur fracture. J Arthroplasty. 1999;14(1):118-121.

16.  Hurson C, Synnott K, McCormack D. Above-knee Ilizarov external fixation for early periprosthetic supracondylar femoral fracture—a case report. Knee. 2005;12(2):145-147.

17.  Beris AE, Lykissas MG, Sioros V, Mavrodontidis AN, Korompilias AV. Femoral periprosthetic fracture in osteoporotic bone after a total knee replacement: treatment with Ilizarov external fixation. J Arthroplasty. 2010;25(7):1168.e9-e12.

18.  Pafilas D, Kourtzis N. Hybrid external fixation as a new treatment method for periprosthetic femoral fracture. A case report. J Bone Joint Surg Am. 2006;88(1):188-192.

19.  Merkel KD, Johnson EW Jr. Supracondylar fracture of the femur after total knee arthroplasty. J Bone Joint Surg Am. 1986;68(1):29-43.

20.  Cordeiro EN, Costa RC, Carazzato JG, Silva Jdos S. Periprosthetic fractures in patients with total knee arthroplasties. Clin Orthop. 1990;(252):182-189.

21.  Riemer BL, Butterfield SL, Burke CJ 3rd, Mathews D. Immediate plate fixation of highly comminuted femoral diaphyseal fractures in blunt polytrauma patients. Orthopedics. 1992;15(8):907-916.

22.  Kregor PJ, Hughes JL, Cole PA. Fixation of distal femoral fractures above total knee arthroplasty utilizing the less invasive stabilization system (L.I.S.S.). Injury. 2001;32(suppl 3):SC64-SC75.

23.   Althausen PL, Lee MA, Finkemeier CG, Meehan JP, Rodrigo JJ. Operative stabilization of supracondylar femur fractures above total knee arthroplasty: a comparison of four treatment methods. J Arthroplasty. 2003;18(7):834-839.

References

1.    Figgie MP, Goldberg VM, Figgie HE 3rd, Sobel M. The results of treatment of supracondylar fracture above total knee arthroplasty. J Arthroplasty. 1990;5(3):267-276.

2.    Su ET, Kubiak EN, Dewal H, Hiebert R, Di Cesare PE. A proposed classification of supracondylar femur fractures above total knee arthroplasties. J Arthroplasty. 2006;21(3):405-408.

3.    Kim KI, Egol KA, Hozack WJ, Parvizi J. Periprosthetic fractures after total knee arthroplasties. Clin Orthop. 2006;(446):167-175.

4.    Sochart DH, Hardinge K. Nonsurgical management of supracondylar fracture above total knee arthroplasty. Still the nineties option. J Arthroplasty. 1997;12(7):830-834.

5.    Delport PH, Van Audekercke R, Martens M, Mulier JC. Conservative treatment of ipsilateral supracondylar femoral fracture after total knee arthroplasty. J Trauma. 1984;24(9):846-849.

6.    Frigg R, Appenzeller A, Christensen R, Frenk A, Gilbert S, Schavan R. The development of the distal femur less invasive stabilization system (LISS). Injury. 2001;32(suppl 3):SC24-SC31.

7.    Goesling T, Frenk A, Appenzeller A, Garapati R, Marti A, Krettek C. LISS PLT: design, mechanical and biomechanical characteristics. Injury. 2003;34(suppl 1):A11-A15.

8.    Huang HT, Huang PJ, Su JY, Lin SY. Indirect reduction and bridge plating of supracondylar fractures of the femur. Injury. 2003;34(2):135-140.

9.    Dennis DA. Periprosthetic fractures following total knee arthroplasty. Instr Course Lect. 2001;50:379-389.

10.  Jamali AA, Lee MA, Donthineni R, Meehan JP. Minimally invasive management of a floating prosthesis injury with locking plates. J Arthroplasty. 2007;22(6):928-933.

11.  Bong MR, Egol KA, Koval KJ, et al. Comparison of the LISS and a retrograde-inserted supracondylar intramedullary nail for fixation of a periprosthetic distal femur fracture proximal to a total knee arthroplasty. J Arthroplasty. 2002;17(7):876-881.

12.  Firoozbakhsh K, Behzadi K, DeCoster TA, Moneim MS, Naraghi FF. Mechanics of retrograde nail versus plate fixation for supracondylar femur fractures. J Orthop Trauma. 1995;9(2):152-157.

13.  Arazi M, Memik R, Ogun TC, Yel M. Ilizarov external fixation for severely comminuted supracondylar and intercondylar fractures of the distal femur. J Bone Joint Surg Br. 2001;83(5):663-667.

14.  Pleva L, Sir M, Madeja R. Our experiences with the treatment of periprosthetic fractures of femur. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2004;148(1):75-79.

15.  Simon RG, Brinker MR. Use of Ilizarov external fixation for a periprosthetic supracondylar femur fracture. J Arthroplasty. 1999;14(1):118-121.

16.  Hurson C, Synnott K, McCormack D. Above-knee Ilizarov external fixation for early periprosthetic supracondylar femoral fracture—a case report. Knee. 2005;12(2):145-147.

17.  Beris AE, Lykissas MG, Sioros V, Mavrodontidis AN, Korompilias AV. Femoral periprosthetic fracture in osteoporotic bone after a total knee replacement: treatment with Ilizarov external fixation. J Arthroplasty. 2010;25(7):1168.e9-e12.

18.  Pafilas D, Kourtzis N. Hybrid external fixation as a new treatment method for periprosthetic femoral fracture. A case report. J Bone Joint Surg Am. 2006;88(1):188-192.

19.  Merkel KD, Johnson EW Jr. Supracondylar fracture of the femur after total knee arthroplasty. J Bone Joint Surg Am. 1986;68(1):29-43.

20.  Cordeiro EN, Costa RC, Carazzato JG, Silva Jdos S. Periprosthetic fractures in patients with total knee arthroplasties. Clin Orthop. 1990;(252):182-189.

21.  Riemer BL, Butterfield SL, Burke CJ 3rd, Mathews D. Immediate plate fixation of highly comminuted femoral diaphyseal fractures in blunt polytrauma patients. Orthopedics. 1992;15(8):907-916.

22.  Kregor PJ, Hughes JL, Cole PA. Fixation of distal femoral fractures above total knee arthroplasty utilizing the less invasive stabilization system (L.I.S.S.). Injury. 2001;32(suppl 3):SC64-SC75.

23.   Althausen PL, Lee MA, Finkemeier CG, Meehan JP, Rodrigo JJ. Operative stabilization of supracondylar femur fractures above total knee arthroplasty: a comparison of four treatment methods. J Arthroplasty. 2003;18(7):834-839.

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The American Journal of Orthopedics - 44(2)
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Periprosthetic Supracondylar Femur Fracture Treated With Spanning External Fixation
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american journal of orthopedics, AJO, case report and literature review, case report, femur fracture, femur, fracture, periprosthetic supraconylar, external fixation, fixation, fractures, total knee arthroplasty, TKA, knee, arthroplasty, obesity, overweight, weight, fracture union, total hip arthroplasty, hip, joint, joints, refaat, coleman, meehan, jamali
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Biomechanical Comparison of Hamstring Tendon Fixation Devices for Anterior Cruciate Ligament Reconstruction: Part 2. Four Tibial Devices

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Biomechanical Comparison of Hamstring Tendon Fixation Devices for Anterior Cruciate Ligament Reconstruction: Part 2. Four Tibial Devices

Of the procedures performed by surgeons specializing in sports medicine and by general orthopedists, anterior cruciate ligament (ACL) reconstruction remains one of the most common.1 Recent years have seen a trend toward replacing the “gold standard” of bone–patellar tendon–bone autograft with autograft or allograft hamstring tendon in ACL reconstruction.2 This shift is being made to try to avoid the donor-site morbidity of patellar tendon autografts and decrease the incidence of postoperative anterior knee pain. With increased use of hamstring grafts in ACL reconstruction, it is important to determine the strength of different methods of graft fixation.

Rigid fixation of hamstring grafts is recognized as a crucial factor in the long-term success of ACL reconstruction. Grafts must withstand early rehabilitation forces as high as 500 N.2 There is therefore much concern about the strength of tibial fixation, given the lower bone density of the tibial metaphysis versus the femoral metaphysis. In addition, stability is more a concern in the tibia, as the forces are directly in line with the tibial tunnel.3,4

The challenge has been to engineer devices that provide stable, rigid graft fixation that allows expeditious tendon-to-bone healing and increased construct stiffness. Many new fixation devices are being marketed. There is much interest in determining which devices have the most fixation strength,4-9 but so far several products have not been compared with one another.

We conducted a study to determine if tibial hamstring fixation devices used in ACL reconstruction differ in fixation strength. We hypothesized we would find no differences.

Materials and Methods

Forty porcine tibias were harvested after the animals had been euthanized for other studies at our institution. Our study was approved by the institutional animal care and use committee. Specimens were stored at –25°C and, on day of testing, thawed to room temperature. Gracilis and semitendinosus tendon grafts were donated by a tissue bank (LifeNet Health, Virginia Beach, Virginia). The grafts were stored at –25°C; on day of testing, tendons were thawed to room temperature.

We evaluated 4 different tibial fixation devices (Figure 1): Delta screw and Retroscrew (Arthrex, Naples, Florida), WasherLoc (Arthrotek, Warsaw, Indiana), and Intrafix (Depuy Mitek, Raynham, Massachusetts). For each device, 10 ACL fixation constructs were tested.

Quadrupled human semitendinosus–gracilis tendon grafts were fixed into the tibias using the 4 tibial fixation devices. All fixations were done according to manufacturer specifications. All interference screws were placed eccentrically. The testing apparatus and procedure are described in an article by Kousa and colleagues.6 The specimens were mounted on the mechanical testing apparatus by threaded bars and custom clamps to secure fixation (Figure 2). Constant tension was maintained on all 4 strands of the hamstring grafts to equalize the tendons. After the looped end of the hamstring graft was secured by clamps, 25 mm of graft was left between the clamp and the intra-articular tunnel.

In the cyclic loading test, the load was applied parallel to the long axis of the tibial tunnel. A 50-N preload was initially applied to each specimen for 10 seconds. Subsequently, 1500 loading cycles between 50 N and 200 N at a rate of 1 cycle per 120 seconds were performed. Standard force-displacement curves were then generated. Each tibial fixation device underwent 10 cyclic loading tests. Specimens surviving the cyclic loading then underwent a single-cycle load-to-failure (LTF) test in which the load was applied parallel to the long axis of the drill hole at a rate of 50 mm per minute.

Residual displacement, stiffness, and ultimate LTF data were recorded from the force-displacement curves. Residual displacement data were generated from the cyclic loading test; residual displacement was determined by subtracting preload displacement from displacement at 1, 10, 50, 100, 250, 500, 1000, and 1500 cycles. Stiffness data were generated from the single-cycle LTF test; stiffness was defined as the linear region slope of the force-displacement curve corresponding to the steepest straight-line tangent to the loading curve. Ultimate LTF (yield load) data were generated from the single-cycle LTF test; ultimate LTF was defined as the load at the point where the slope of the load displacement curve initially decreases.

Statistical analysis generated standard descriptive statistics: means, standard deviations, and proportions. One-way analysis of variance (ANOVA) was used to determine any statistically significant differences in stiffness, yield load, and residual displacement between the different fixation devices. Differences in force (load) between the single cycle and the cyclic loading test were determined by ANOVA. P < .05 was considered statistically significant for all tests.

Results

The modes of failure for the devices were similar. In all 10 tests, Intrafix was pulled through the tunnel with the hamstring allografts. WasherLoc failed in each test, with the tendons eventually being pulled through the washer and thus out through the tunnel. Delta screw and Retroscrew both failed with slippage of the fixation device and the tendons pulled out through the tunnel.

 

 

For the cyclic loading tests, 8 of the 10 Delta screws and only 2 of the 10 Retroscrews completed the 1500-cycle loading test before failure. The 2 Delta screws that did not complete the testing failed after about 500 cycles, and the 8 Retroscrews that did not complete the testing failed after about 250 cycles. All 10 WasherLoc and Intrafix devices completed the testing.

Residual displacement data were calculated from the cyclic loading tests (Table). Mean (SS) residual displacement was lowest for Intrafix at 2.9 (1.2) mm, followed by WasherLoc at 5.6 (2.2) mm and Delta at 6.4 (3.3) mm. Retroscrew at 25.5 (11.0) mm had the highest residual displacement, though only 2 completed the cyclic tests. Intrafix, WasherLoc, and Delta were not statistically different, but there was a statistical difference between Retroscrew and the other devices (P < .001).

Stiffness data were calculated from the LTF tests (Table). Mean (SD) stiffness was highest for Intrafix at 129 (32.7) N/mm, followed by WasherLoc at 97 (11.6) N/mm, Delta at 93 (9.5) N/mm, and Retroscrew at 80.2 (8.8) N/mm. Intrafix had statistically higher stiffness compared with WasherLoc (P < .05), Delta (P < .01), and Retroscrew (P < .05). There were no significant differences in stiffness among WasherLoc, Delta, and Retroscrew.

Mean (SD) ultimate LTF was highest for Intrafix at 656 (182.6) N, followed by WasherLoc at 630 (129.3) N, Delta at 430 (90.0) N, and Retroscrew at 285 (33.8) N (Table). There were significant differences between Intrafix and Delta (P < .05) and Retroscrew (P < .05). WasherLoc failed at a significantly higher load compared with Delta (P < .05) and Retroscrew (P < .05). There were no significant differences in mean LTF between Intrafix and WasherLoc.

Discussion

In this biomechanical comparison of 4 different tibial fixation devices, Intrafix had results superior to those of the other implants. Intrafix failed at higher LTF and lower residual displacement and had higher stiffness. WasherLoc performed well and had LTF similar to that of Intrafix. The interference screws performed poorly with respect to LTF, residual displacement, and stiffness, and a large proportion of them failed early into cyclic loading.

Intrafix is a central fixation device that uses a 4-quadrant sleeve and a screw to establish tensioning across all 4 hamstring graft strands. The theory is this configuration increases the contact area between graft and bone for proper integration of graft into bone. Intrafix has performed well in other biomechanical studies. Using a study design similar to ours, Kousa and colleagues7 found the performance of Intrafix to be superior to that of other devices, including interference screws and WasherLoc. Starch and colleagues10 reported that, compared with a standard interference screw, Intrafix required significantly higher load to cause a millimeter of graft laxity. They concluded that this demonstrates superior fixation strength and reduced laxity of the graft after cyclic loading. Coleridge and Amis4 found that, compared with WasherLoc and various interference screws, Intrafix had the lower residual displacement. However, they also found that, compared with Intrafix and interference screws, WasherLoc had the highest ultimate tensile strength. Their findings may be difficult to compare with ours, as they tested fixation of calf extensor tendons, and we tested human hamstring grafts.

An important concern in the present study was the poor performance of the interference screws. Other authors recently expressed concern with using interference screws in soft-tissue ACL grafts—based on biomechanical study results of increased slippage, bone tunnel widening, and less strength.11 Delta screws and Retroscrews have not been specifically evaluated, and their fixation strengths have not been directly compared with those of other devices. In the present study, Delta screws and Retroscrews consistently performed the poorest with respect to ultimate LTF, residual displacement, and stiffness. Twenty percent of the Delta screws and 80% of the Retroscrews did not complete 1500 cycles. The poor performance of the interference screws was echoed in studies by Magen and colleagues12 and Kousa and colleagues,7 in which the only complete failures were in the cyclic loading of the interference screws.

Three possible confounding factors may have affected the performance of the interference screws: bone density of porcine tibia, length of interference screw, and location of screw placement. In addition, in clinical practice these screws may be used with other modes of graft fixation. Combined fixation (interference screws, other devices) was not evaluated in this study.

Porcine models have been used in many biomechanical graft fixation studies.4,6,7,12,13 Some authors have found porcine tibia to be a poor substitute for human cadaver tibia because the volumetric density of porcine bone is higher than that of human bone.14,15 Other authors have demonstrated fairly similar bone density between human and porcine tibia.16 The concern is that interference screw fixation strength correlates with the density of the bone in which screws are fixed.17 Therefore, one limitation of our study is that we did not determine the bone density of the porcine tibias for comparison with that of young human tibias.

 

 

Another important variable that could have affected the performance of the interference screws is screw length. One study found no significant difference in screw strength between various lengths, and longer screws failed to protect against graft slippage.18 However, Selby and colleagues19 found that, compared with 28-mm screws, 35-mm bioabsorbable interference screws failed at higher LTF. This is in part why we selected 35-mm Delta screws for our study. Both 35-mm Delta screws and 20-mm Retroscrews performed poorly. However, we could not determine if the poorer performance of Retroscrews was related to their length.

We used an eccentric placement for our interference screws. Although some studies have suggested concentric placement might improve fixation strength by increasing bone–tendon contact,20 Simonian and colleagues21 found no difference in graft slippage or ultimate LTF between eccentrically and concentrically placed screws. Although they were not biomechanically tested in our study, a few grafts were fixed with concentrically placed screws, and these tendons appeared to be more clinically damaged than the eccentrically placed screws.

Combined tibial fixation techniques may be used in clinical practice, but we did not evaluate them in our study. Yoo and colleagues9 compared interference screw, interference screw plus cortical screw and spiked washer, and cortical screw and spiked washer alone. They found that stiffness nearly doubled, residual displacement was less, and ultimate LTF was significantly higher in the group with interference screw plus cortical screw and spiked washer. In a similar study, Walsh and colleagues13 demonstrated improved stiffness and LTF in cyclic testing with the combination of retrograde interference screw and suture button over interference screw alone. Further study may include direct comparisons of additional tibial fixation techniques using more than one device. Cost analysis of use of additional fixation devices would be beneficial as well.

Study results have clearly demonstrated that tibial fixation is the weak point in ACL reconstruction3,17 and that early aggressive rehabilitation can help restore range of motion, strength, and function.22,23 Implants that can withstand early loads during rehabilitation periods are therefore of utmost importance.

Conclusion

Intrafix demonstrated superior strength in the fixation of hamstring grafts in the tibia, followed closely by WasherLoc. When used as the sole tibial fixation device, interference screws had low LTF, decreased stiffness, and high residual displacement, which may have clinical implications for early rehabilitation after ACL reconstruction.

References

1.    Garrett WE Jr, Swiontkowski MF, Weinsten JN, et al. American Board of Orthopaedic Surgery Practice of the Orthopaedic Surgeon: part-II, certification examination case mix. J Bone Joint Surg Am. 2006;88(3):660-667.

2.    West RV, Harner CD. Graft selection in anterior cruciate ligament reconstruction. J Am Acad Orthop Surg. 2005;13(3):197-207.

3.    Brand J Jr, Weiler A, Caborn DN, Brown CH Jr, Johnson DL. Graft fixation in cruciate ligament reconstruction. Am J Sports Med. 2000;28(5):761-774.

4.    Coleridge SD, Amis AA. A comparison of five tibial-fixation systems in hamstring-graft anterior cruciate ligament reconstruction. Knee Surg Sports Traumatol Arthrosc. 2004;12(5):391-397.

5.    Fabbriciani C, Mulas PD, Ziranu F, Deriu L, Zarelli D, Milano G. Mechanical analysis of fixation methods for anterior cruciate ligament reconstruction with hamstring tendon graft. An experimental study in sheep knees. Knee. 2005;12(2):135-138.

6.    Kousa P, Järvinen TL, Vihavainen M, Kannus P, Järvinen M. The fixation strength of six hamstring tendon graft fixation devices in anterior cruciate ligament reconstruction. Part I: femoral site. Am J Sports Med. 2003;31(2):174-181.

7.    Kousa P, Järvinen TL, Vihavainen M, Kannus P, Järvinen M. The fixation strength of six hamstring tendon graft fixation devices in anterior cruciate ligament reconstruction. Part II: tibial site. Am J Sports Med. 2003;31(2):182-188.

8.    Weiler A, Hoffmann RF, Stähelin AC, Bail HJ, Siepe CJ, Südkamp NP. Hamstring tendon fixation using interference screws: a biomechanical study in calf tibial bone. Arthroscopy. 1998;14(1):29-37.

9.    Yoo JC, Ahn JH, Kim JH, et al. Biomechanical testing of hybrid hamstring graft tibial fixation in anterior cruciate ligament reconstruction. Knee. 2006;13(6):455-459.

10.  Starch DW, Alexander JW, Noble PC, Reddy S, Lintner DM. Multistranded hamstring tendon graft fixation with a central four-quadrant or a standard tibial interference screw for anterior cruciate ligament reconstruction. Am J Sports Med. 2003;31(3):338-344.

11.  Prodromos CC, Fu FH, Howell SM, Johnson DH, Lawhorn K. Controversies in soft-tissue anterior cruciate ligament reconstruction: grafts, bundles, tunnels, fixation, and harvest. J Am Acad Orthop Surg. 2008;16(7):376-384.

12.  Magen HE, Howell SM, Hull ML. Structural properties of six tibial fixation methods for anterior cruciate ligament soft tissue grafts. Am J Sports Med. 1999;27(1):35-43.

13.  Walsh MP, Wijdicks CA, Parker JB, Hapa O, LaPrade RF. A comparison between a retrograde interference screw, suture button, and combined fixation on the tibial side in an all-inside anterior cruciate ligament reconstruction: a biomechanical study in a porcine model. Am J Sports Med. 2009;37(1):160-167.

14.  Nurmi JT, Järvinen TL, Kannus P, Sievänen H, Toukosalo J, Järvinen M. Compaction versus extraction drilling for fixation of the hamstring tendon graft in anterior cruciate ligament reconstruction. Am J Sports Med. 2002;30(2):167-173.

15.  Nurmi JT, Sievänen H, Kannus P, Järvinen M, Järvinen TL. Porcine tibia is a poor substitute for human cadaver tibia for evaluating interference screw fixation. Am J Sports Med. 2004;32(3):765-771.

16.  Nagarkatti DG, McKeon BP, Donahue BS, Fulkerson JP. Mechanical evaluation of a soft tissue interference screw in free tendon anterior cruciate ligament graft fixation. Am J Sports Med. 2001;29(1):67-71.

17.  Brand JC Jr, Pienkowski D, Steenlage E, Hamilton D, Johnson DL, Caborn DN. Interference screw fixation strength of a quadrupled hamstring tendon graft is directly related to bone mineral density and insertion torque. Am J Sports Med. 2000;28(5):705-710.

18.  Stadelmaier DM, Lowe WR, Ilahi OA, Noble PC, Kohl HW 3rd. Cyclic pull-out strength of hamstring tendon graft fixation with soft tissue interference screws. Influence of screw length. Am J Sports Med. 1999;27(6):778-783.

19.  Selby JB, Johnson DL, Hester P, Caborn DN. Effect of screw length on bioabsorbable interference screw fixation in a tibial bone tunnel. Am J Sports Med. 2001;29(5):614-619.

20.  Shino K, Pflaster DS. Comparison of eccentric and concentric screw placement for hamstring graft fixation in the tibial tunnel. Knee Surg Sports Traumatol Arthrosc. 2000;8(2):73-75.

21.  Simonian PT, Sussmann PS, Baldini TH, Crockett HC, Wickiewicz TL. Interference screw position and hamstring graft location for anterior cruciate ligament reconstruction. Arthroscopy. 1998;14(5):459-464.

22.  Shelbourne KD, Nitz P. Accelerated rehabilitation after anterior cruciate ligament reconstruction. Am J Sports Med. 1990;18(3):292-299.

23.   Shelbourne KD, Wilckens JH. Current concepts in anterior cruciate ligament rehabilitation. Orthop Rev. 1990;19(11):957-964.

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Brian P. Scannell, MD, Bryan J. Loeffler, MD, Michael Hoenig, MD, Richard D. Peindl, PhD, Donald F. D’Alessandro, MD, Patrick M. Connor, MD, and James E. Fleischli, MD

Authors’ Disclosure Statement: All implants used in this study were donated by Biomet Sports Medicine (Arthrotek), Depuy Mitek, and Arthrex. Hamstring allografts were donated by LifeNet Health. Dr. D’Alessandro wishes to report that he is a paid consultant to Biomet Sports Medicine, and Dr. Connor wishes to report that he is a paid consultant to Biomet Sports Medicine and Zimmer. The other authors report no actual or potential conflict of interest in relation to this article.

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The American Journal of Orthopedics - 44(2)
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82-85
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american journal of orthopedics, AJO, original study, study, hamstring tendon fixation devices, hamstring, tendon, devices, anterior cruciate ligament, ACL, part 2, tibial devices, ACL reconstruction, tibial, tibias, fixation, scannell, loeffler, hoenig, peindl, d'alessandro, connor, fleischli
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Brian P. Scannell, MD, Bryan J. Loeffler, MD, Michael Hoenig, MD, Richard D. Peindl, PhD, Donald F. D’Alessandro, MD, Patrick M. Connor, MD, and James E. Fleischli, MD

Authors’ Disclosure Statement: All implants used in this study were donated by Biomet Sports Medicine (Arthrotek), Depuy Mitek, and Arthrex. Hamstring allografts were donated by LifeNet Health. Dr. D’Alessandro wishes to report that he is a paid consultant to Biomet Sports Medicine, and Dr. Connor wishes to report that he is a paid consultant to Biomet Sports Medicine and Zimmer. The other authors report no actual or potential conflict of interest in relation to this article.

Author and Disclosure Information

Brian P. Scannell, MD, Bryan J. Loeffler, MD, Michael Hoenig, MD, Richard D. Peindl, PhD, Donald F. D’Alessandro, MD, Patrick M. Connor, MD, and James E. Fleischli, MD

Authors’ Disclosure Statement: All implants used in this study were donated by Biomet Sports Medicine (Arthrotek), Depuy Mitek, and Arthrex. Hamstring allografts were donated by LifeNet Health. Dr. D’Alessandro wishes to report that he is a paid consultant to Biomet Sports Medicine, and Dr. Connor wishes to report that he is a paid consultant to Biomet Sports Medicine and Zimmer. The other authors report no actual or potential conflict of interest in relation to this article.

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Of the procedures performed by surgeons specializing in sports medicine and by general orthopedists, anterior cruciate ligament (ACL) reconstruction remains one of the most common.1 Recent years have seen a trend toward replacing the “gold standard” of bone–patellar tendon–bone autograft with autograft or allograft hamstring tendon in ACL reconstruction.2 This shift is being made to try to avoid the donor-site morbidity of patellar tendon autografts and decrease the incidence of postoperative anterior knee pain. With increased use of hamstring grafts in ACL reconstruction, it is important to determine the strength of different methods of graft fixation.

Rigid fixation of hamstring grafts is recognized as a crucial factor in the long-term success of ACL reconstruction. Grafts must withstand early rehabilitation forces as high as 500 N.2 There is therefore much concern about the strength of tibial fixation, given the lower bone density of the tibial metaphysis versus the femoral metaphysis. In addition, stability is more a concern in the tibia, as the forces are directly in line with the tibial tunnel.3,4

The challenge has been to engineer devices that provide stable, rigid graft fixation that allows expeditious tendon-to-bone healing and increased construct stiffness. Many new fixation devices are being marketed. There is much interest in determining which devices have the most fixation strength,4-9 but so far several products have not been compared with one another.

We conducted a study to determine if tibial hamstring fixation devices used in ACL reconstruction differ in fixation strength. We hypothesized we would find no differences.

Materials and Methods

Forty porcine tibias were harvested after the animals had been euthanized for other studies at our institution. Our study was approved by the institutional animal care and use committee. Specimens were stored at –25°C and, on day of testing, thawed to room temperature. Gracilis and semitendinosus tendon grafts were donated by a tissue bank (LifeNet Health, Virginia Beach, Virginia). The grafts were stored at –25°C; on day of testing, tendons were thawed to room temperature.

We evaluated 4 different tibial fixation devices (Figure 1): Delta screw and Retroscrew (Arthrex, Naples, Florida), WasherLoc (Arthrotek, Warsaw, Indiana), and Intrafix (Depuy Mitek, Raynham, Massachusetts). For each device, 10 ACL fixation constructs were tested.

Quadrupled human semitendinosus–gracilis tendon grafts were fixed into the tibias using the 4 tibial fixation devices. All fixations were done according to manufacturer specifications. All interference screws were placed eccentrically. The testing apparatus and procedure are described in an article by Kousa and colleagues.6 The specimens were mounted on the mechanical testing apparatus by threaded bars and custom clamps to secure fixation (Figure 2). Constant tension was maintained on all 4 strands of the hamstring grafts to equalize the tendons. After the looped end of the hamstring graft was secured by clamps, 25 mm of graft was left between the clamp and the intra-articular tunnel.

In the cyclic loading test, the load was applied parallel to the long axis of the tibial tunnel. A 50-N preload was initially applied to each specimen for 10 seconds. Subsequently, 1500 loading cycles between 50 N and 200 N at a rate of 1 cycle per 120 seconds were performed. Standard force-displacement curves were then generated. Each tibial fixation device underwent 10 cyclic loading tests. Specimens surviving the cyclic loading then underwent a single-cycle load-to-failure (LTF) test in which the load was applied parallel to the long axis of the drill hole at a rate of 50 mm per minute.

Residual displacement, stiffness, and ultimate LTF data were recorded from the force-displacement curves. Residual displacement data were generated from the cyclic loading test; residual displacement was determined by subtracting preload displacement from displacement at 1, 10, 50, 100, 250, 500, 1000, and 1500 cycles. Stiffness data were generated from the single-cycle LTF test; stiffness was defined as the linear region slope of the force-displacement curve corresponding to the steepest straight-line tangent to the loading curve. Ultimate LTF (yield load) data were generated from the single-cycle LTF test; ultimate LTF was defined as the load at the point where the slope of the load displacement curve initially decreases.

Statistical analysis generated standard descriptive statistics: means, standard deviations, and proportions. One-way analysis of variance (ANOVA) was used to determine any statistically significant differences in stiffness, yield load, and residual displacement between the different fixation devices. Differences in force (load) between the single cycle and the cyclic loading test were determined by ANOVA. P < .05 was considered statistically significant for all tests.

Results

The modes of failure for the devices were similar. In all 10 tests, Intrafix was pulled through the tunnel with the hamstring allografts. WasherLoc failed in each test, with the tendons eventually being pulled through the washer and thus out through the tunnel. Delta screw and Retroscrew both failed with slippage of the fixation device and the tendons pulled out through the tunnel.

 

 

For the cyclic loading tests, 8 of the 10 Delta screws and only 2 of the 10 Retroscrews completed the 1500-cycle loading test before failure. The 2 Delta screws that did not complete the testing failed after about 500 cycles, and the 8 Retroscrews that did not complete the testing failed after about 250 cycles. All 10 WasherLoc and Intrafix devices completed the testing.

Residual displacement data were calculated from the cyclic loading tests (Table). Mean (SS) residual displacement was lowest for Intrafix at 2.9 (1.2) mm, followed by WasherLoc at 5.6 (2.2) mm and Delta at 6.4 (3.3) mm. Retroscrew at 25.5 (11.0) mm had the highest residual displacement, though only 2 completed the cyclic tests. Intrafix, WasherLoc, and Delta were not statistically different, but there was a statistical difference between Retroscrew and the other devices (P < .001).

Stiffness data were calculated from the LTF tests (Table). Mean (SD) stiffness was highest for Intrafix at 129 (32.7) N/mm, followed by WasherLoc at 97 (11.6) N/mm, Delta at 93 (9.5) N/mm, and Retroscrew at 80.2 (8.8) N/mm. Intrafix had statistically higher stiffness compared with WasherLoc (P < .05), Delta (P < .01), and Retroscrew (P < .05). There were no significant differences in stiffness among WasherLoc, Delta, and Retroscrew.

Mean (SD) ultimate LTF was highest for Intrafix at 656 (182.6) N, followed by WasherLoc at 630 (129.3) N, Delta at 430 (90.0) N, and Retroscrew at 285 (33.8) N (Table). There were significant differences between Intrafix and Delta (P < .05) and Retroscrew (P < .05). WasherLoc failed at a significantly higher load compared with Delta (P < .05) and Retroscrew (P < .05). There were no significant differences in mean LTF between Intrafix and WasherLoc.

Discussion

In this biomechanical comparison of 4 different tibial fixation devices, Intrafix had results superior to those of the other implants. Intrafix failed at higher LTF and lower residual displacement and had higher stiffness. WasherLoc performed well and had LTF similar to that of Intrafix. The interference screws performed poorly with respect to LTF, residual displacement, and stiffness, and a large proportion of them failed early into cyclic loading.

Intrafix is a central fixation device that uses a 4-quadrant sleeve and a screw to establish tensioning across all 4 hamstring graft strands. The theory is this configuration increases the contact area between graft and bone for proper integration of graft into bone. Intrafix has performed well in other biomechanical studies. Using a study design similar to ours, Kousa and colleagues7 found the performance of Intrafix to be superior to that of other devices, including interference screws and WasherLoc. Starch and colleagues10 reported that, compared with a standard interference screw, Intrafix required significantly higher load to cause a millimeter of graft laxity. They concluded that this demonstrates superior fixation strength and reduced laxity of the graft after cyclic loading. Coleridge and Amis4 found that, compared with WasherLoc and various interference screws, Intrafix had the lower residual displacement. However, they also found that, compared with Intrafix and interference screws, WasherLoc had the highest ultimate tensile strength. Their findings may be difficult to compare with ours, as they tested fixation of calf extensor tendons, and we tested human hamstring grafts.

An important concern in the present study was the poor performance of the interference screws. Other authors recently expressed concern with using interference screws in soft-tissue ACL grafts—based on biomechanical study results of increased slippage, bone tunnel widening, and less strength.11 Delta screws and Retroscrews have not been specifically evaluated, and their fixation strengths have not been directly compared with those of other devices. In the present study, Delta screws and Retroscrews consistently performed the poorest with respect to ultimate LTF, residual displacement, and stiffness. Twenty percent of the Delta screws and 80% of the Retroscrews did not complete 1500 cycles. The poor performance of the interference screws was echoed in studies by Magen and colleagues12 and Kousa and colleagues,7 in which the only complete failures were in the cyclic loading of the interference screws.

Three possible confounding factors may have affected the performance of the interference screws: bone density of porcine tibia, length of interference screw, and location of screw placement. In addition, in clinical practice these screws may be used with other modes of graft fixation. Combined fixation (interference screws, other devices) was not evaluated in this study.

Porcine models have been used in many biomechanical graft fixation studies.4,6,7,12,13 Some authors have found porcine tibia to be a poor substitute for human cadaver tibia because the volumetric density of porcine bone is higher than that of human bone.14,15 Other authors have demonstrated fairly similar bone density between human and porcine tibia.16 The concern is that interference screw fixation strength correlates with the density of the bone in which screws are fixed.17 Therefore, one limitation of our study is that we did not determine the bone density of the porcine tibias for comparison with that of young human tibias.

 

 

Another important variable that could have affected the performance of the interference screws is screw length. One study found no significant difference in screw strength between various lengths, and longer screws failed to protect against graft slippage.18 However, Selby and colleagues19 found that, compared with 28-mm screws, 35-mm bioabsorbable interference screws failed at higher LTF. This is in part why we selected 35-mm Delta screws for our study. Both 35-mm Delta screws and 20-mm Retroscrews performed poorly. However, we could not determine if the poorer performance of Retroscrews was related to their length.

We used an eccentric placement for our interference screws. Although some studies have suggested concentric placement might improve fixation strength by increasing bone–tendon contact,20 Simonian and colleagues21 found no difference in graft slippage or ultimate LTF between eccentrically and concentrically placed screws. Although they were not biomechanically tested in our study, a few grafts were fixed with concentrically placed screws, and these tendons appeared to be more clinically damaged than the eccentrically placed screws.

Combined tibial fixation techniques may be used in clinical practice, but we did not evaluate them in our study. Yoo and colleagues9 compared interference screw, interference screw plus cortical screw and spiked washer, and cortical screw and spiked washer alone. They found that stiffness nearly doubled, residual displacement was less, and ultimate LTF was significantly higher in the group with interference screw plus cortical screw and spiked washer. In a similar study, Walsh and colleagues13 demonstrated improved stiffness and LTF in cyclic testing with the combination of retrograde interference screw and suture button over interference screw alone. Further study may include direct comparisons of additional tibial fixation techniques using more than one device. Cost analysis of use of additional fixation devices would be beneficial as well.

Study results have clearly demonstrated that tibial fixation is the weak point in ACL reconstruction3,17 and that early aggressive rehabilitation can help restore range of motion, strength, and function.22,23 Implants that can withstand early loads during rehabilitation periods are therefore of utmost importance.

Conclusion

Intrafix demonstrated superior strength in the fixation of hamstring grafts in the tibia, followed closely by WasherLoc. When used as the sole tibial fixation device, interference screws had low LTF, decreased stiffness, and high residual displacement, which may have clinical implications for early rehabilitation after ACL reconstruction.

Of the procedures performed by surgeons specializing in sports medicine and by general orthopedists, anterior cruciate ligament (ACL) reconstruction remains one of the most common.1 Recent years have seen a trend toward replacing the “gold standard” of bone–patellar tendon–bone autograft with autograft or allograft hamstring tendon in ACL reconstruction.2 This shift is being made to try to avoid the donor-site morbidity of patellar tendon autografts and decrease the incidence of postoperative anterior knee pain. With increased use of hamstring grafts in ACL reconstruction, it is important to determine the strength of different methods of graft fixation.

Rigid fixation of hamstring grafts is recognized as a crucial factor in the long-term success of ACL reconstruction. Grafts must withstand early rehabilitation forces as high as 500 N.2 There is therefore much concern about the strength of tibial fixation, given the lower bone density of the tibial metaphysis versus the femoral metaphysis. In addition, stability is more a concern in the tibia, as the forces are directly in line with the tibial tunnel.3,4

The challenge has been to engineer devices that provide stable, rigid graft fixation that allows expeditious tendon-to-bone healing and increased construct stiffness. Many new fixation devices are being marketed. There is much interest in determining which devices have the most fixation strength,4-9 but so far several products have not been compared with one another.

We conducted a study to determine if tibial hamstring fixation devices used in ACL reconstruction differ in fixation strength. We hypothesized we would find no differences.

Materials and Methods

Forty porcine tibias were harvested after the animals had been euthanized for other studies at our institution. Our study was approved by the institutional animal care and use committee. Specimens were stored at –25°C and, on day of testing, thawed to room temperature. Gracilis and semitendinosus tendon grafts were donated by a tissue bank (LifeNet Health, Virginia Beach, Virginia). The grafts were stored at –25°C; on day of testing, tendons were thawed to room temperature.

We evaluated 4 different tibial fixation devices (Figure 1): Delta screw and Retroscrew (Arthrex, Naples, Florida), WasherLoc (Arthrotek, Warsaw, Indiana), and Intrafix (Depuy Mitek, Raynham, Massachusetts). For each device, 10 ACL fixation constructs were tested.

Quadrupled human semitendinosus–gracilis tendon grafts were fixed into the tibias using the 4 tibial fixation devices. All fixations were done according to manufacturer specifications. All interference screws were placed eccentrically. The testing apparatus and procedure are described in an article by Kousa and colleagues.6 The specimens were mounted on the mechanical testing apparatus by threaded bars and custom clamps to secure fixation (Figure 2). Constant tension was maintained on all 4 strands of the hamstring grafts to equalize the tendons. After the looped end of the hamstring graft was secured by clamps, 25 mm of graft was left between the clamp and the intra-articular tunnel.

In the cyclic loading test, the load was applied parallel to the long axis of the tibial tunnel. A 50-N preload was initially applied to each specimen for 10 seconds. Subsequently, 1500 loading cycles between 50 N and 200 N at a rate of 1 cycle per 120 seconds were performed. Standard force-displacement curves were then generated. Each tibial fixation device underwent 10 cyclic loading tests. Specimens surviving the cyclic loading then underwent a single-cycle load-to-failure (LTF) test in which the load was applied parallel to the long axis of the drill hole at a rate of 50 mm per minute.

Residual displacement, stiffness, and ultimate LTF data were recorded from the force-displacement curves. Residual displacement data were generated from the cyclic loading test; residual displacement was determined by subtracting preload displacement from displacement at 1, 10, 50, 100, 250, 500, 1000, and 1500 cycles. Stiffness data were generated from the single-cycle LTF test; stiffness was defined as the linear region slope of the force-displacement curve corresponding to the steepest straight-line tangent to the loading curve. Ultimate LTF (yield load) data were generated from the single-cycle LTF test; ultimate LTF was defined as the load at the point where the slope of the load displacement curve initially decreases.

Statistical analysis generated standard descriptive statistics: means, standard deviations, and proportions. One-way analysis of variance (ANOVA) was used to determine any statistically significant differences in stiffness, yield load, and residual displacement between the different fixation devices. Differences in force (load) between the single cycle and the cyclic loading test were determined by ANOVA. P < .05 was considered statistically significant for all tests.

Results

The modes of failure for the devices were similar. In all 10 tests, Intrafix was pulled through the tunnel with the hamstring allografts. WasherLoc failed in each test, with the tendons eventually being pulled through the washer and thus out through the tunnel. Delta screw and Retroscrew both failed with slippage of the fixation device and the tendons pulled out through the tunnel.

 

 

For the cyclic loading tests, 8 of the 10 Delta screws and only 2 of the 10 Retroscrews completed the 1500-cycle loading test before failure. The 2 Delta screws that did not complete the testing failed after about 500 cycles, and the 8 Retroscrews that did not complete the testing failed after about 250 cycles. All 10 WasherLoc and Intrafix devices completed the testing.

Residual displacement data were calculated from the cyclic loading tests (Table). Mean (SS) residual displacement was lowest for Intrafix at 2.9 (1.2) mm, followed by WasherLoc at 5.6 (2.2) mm and Delta at 6.4 (3.3) mm. Retroscrew at 25.5 (11.0) mm had the highest residual displacement, though only 2 completed the cyclic tests. Intrafix, WasherLoc, and Delta were not statistically different, but there was a statistical difference between Retroscrew and the other devices (P < .001).

Stiffness data were calculated from the LTF tests (Table). Mean (SD) stiffness was highest for Intrafix at 129 (32.7) N/mm, followed by WasherLoc at 97 (11.6) N/mm, Delta at 93 (9.5) N/mm, and Retroscrew at 80.2 (8.8) N/mm. Intrafix had statistically higher stiffness compared with WasherLoc (P < .05), Delta (P < .01), and Retroscrew (P < .05). There were no significant differences in stiffness among WasherLoc, Delta, and Retroscrew.

Mean (SD) ultimate LTF was highest for Intrafix at 656 (182.6) N, followed by WasherLoc at 630 (129.3) N, Delta at 430 (90.0) N, and Retroscrew at 285 (33.8) N (Table). There were significant differences between Intrafix and Delta (P < .05) and Retroscrew (P < .05). WasherLoc failed at a significantly higher load compared with Delta (P < .05) and Retroscrew (P < .05). There were no significant differences in mean LTF between Intrafix and WasherLoc.

Discussion

In this biomechanical comparison of 4 different tibial fixation devices, Intrafix had results superior to those of the other implants. Intrafix failed at higher LTF and lower residual displacement and had higher stiffness. WasherLoc performed well and had LTF similar to that of Intrafix. The interference screws performed poorly with respect to LTF, residual displacement, and stiffness, and a large proportion of them failed early into cyclic loading.

Intrafix is a central fixation device that uses a 4-quadrant sleeve and a screw to establish tensioning across all 4 hamstring graft strands. The theory is this configuration increases the contact area between graft and bone for proper integration of graft into bone. Intrafix has performed well in other biomechanical studies. Using a study design similar to ours, Kousa and colleagues7 found the performance of Intrafix to be superior to that of other devices, including interference screws and WasherLoc. Starch and colleagues10 reported that, compared with a standard interference screw, Intrafix required significantly higher load to cause a millimeter of graft laxity. They concluded that this demonstrates superior fixation strength and reduced laxity of the graft after cyclic loading. Coleridge and Amis4 found that, compared with WasherLoc and various interference screws, Intrafix had the lower residual displacement. However, they also found that, compared with Intrafix and interference screws, WasherLoc had the highest ultimate tensile strength. Their findings may be difficult to compare with ours, as they tested fixation of calf extensor tendons, and we tested human hamstring grafts.

An important concern in the present study was the poor performance of the interference screws. Other authors recently expressed concern with using interference screws in soft-tissue ACL grafts—based on biomechanical study results of increased slippage, bone tunnel widening, and less strength.11 Delta screws and Retroscrews have not been specifically evaluated, and their fixation strengths have not been directly compared with those of other devices. In the present study, Delta screws and Retroscrews consistently performed the poorest with respect to ultimate LTF, residual displacement, and stiffness. Twenty percent of the Delta screws and 80% of the Retroscrews did not complete 1500 cycles. The poor performance of the interference screws was echoed in studies by Magen and colleagues12 and Kousa and colleagues,7 in which the only complete failures were in the cyclic loading of the interference screws.

Three possible confounding factors may have affected the performance of the interference screws: bone density of porcine tibia, length of interference screw, and location of screw placement. In addition, in clinical practice these screws may be used with other modes of graft fixation. Combined fixation (interference screws, other devices) was not evaluated in this study.

Porcine models have been used in many biomechanical graft fixation studies.4,6,7,12,13 Some authors have found porcine tibia to be a poor substitute for human cadaver tibia because the volumetric density of porcine bone is higher than that of human bone.14,15 Other authors have demonstrated fairly similar bone density between human and porcine tibia.16 The concern is that interference screw fixation strength correlates with the density of the bone in which screws are fixed.17 Therefore, one limitation of our study is that we did not determine the bone density of the porcine tibias for comparison with that of young human tibias.

 

 

Another important variable that could have affected the performance of the interference screws is screw length. One study found no significant difference in screw strength between various lengths, and longer screws failed to protect against graft slippage.18 However, Selby and colleagues19 found that, compared with 28-mm screws, 35-mm bioabsorbable interference screws failed at higher LTF. This is in part why we selected 35-mm Delta screws for our study. Both 35-mm Delta screws and 20-mm Retroscrews performed poorly. However, we could not determine if the poorer performance of Retroscrews was related to their length.

We used an eccentric placement for our interference screws. Although some studies have suggested concentric placement might improve fixation strength by increasing bone–tendon contact,20 Simonian and colleagues21 found no difference in graft slippage or ultimate LTF between eccentrically and concentrically placed screws. Although they were not biomechanically tested in our study, a few grafts were fixed with concentrically placed screws, and these tendons appeared to be more clinically damaged than the eccentrically placed screws.

Combined tibial fixation techniques may be used in clinical practice, but we did not evaluate them in our study. Yoo and colleagues9 compared interference screw, interference screw plus cortical screw and spiked washer, and cortical screw and spiked washer alone. They found that stiffness nearly doubled, residual displacement was less, and ultimate LTF was significantly higher in the group with interference screw plus cortical screw and spiked washer. In a similar study, Walsh and colleagues13 demonstrated improved stiffness and LTF in cyclic testing with the combination of retrograde interference screw and suture button over interference screw alone. Further study may include direct comparisons of additional tibial fixation techniques using more than one device. Cost analysis of use of additional fixation devices would be beneficial as well.

Study results have clearly demonstrated that tibial fixation is the weak point in ACL reconstruction3,17 and that early aggressive rehabilitation can help restore range of motion, strength, and function.22,23 Implants that can withstand early loads during rehabilitation periods are therefore of utmost importance.

Conclusion

Intrafix demonstrated superior strength in the fixation of hamstring grafts in the tibia, followed closely by WasherLoc. When used as the sole tibial fixation device, interference screws had low LTF, decreased stiffness, and high residual displacement, which may have clinical implications for early rehabilitation after ACL reconstruction.

References

1.    Garrett WE Jr, Swiontkowski MF, Weinsten JN, et al. American Board of Orthopaedic Surgery Practice of the Orthopaedic Surgeon: part-II, certification examination case mix. J Bone Joint Surg Am. 2006;88(3):660-667.

2.    West RV, Harner CD. Graft selection in anterior cruciate ligament reconstruction. J Am Acad Orthop Surg. 2005;13(3):197-207.

3.    Brand J Jr, Weiler A, Caborn DN, Brown CH Jr, Johnson DL. Graft fixation in cruciate ligament reconstruction. Am J Sports Med. 2000;28(5):761-774.

4.    Coleridge SD, Amis AA. A comparison of five tibial-fixation systems in hamstring-graft anterior cruciate ligament reconstruction. Knee Surg Sports Traumatol Arthrosc. 2004;12(5):391-397.

5.    Fabbriciani C, Mulas PD, Ziranu F, Deriu L, Zarelli D, Milano G. Mechanical analysis of fixation methods for anterior cruciate ligament reconstruction with hamstring tendon graft. An experimental study in sheep knees. Knee. 2005;12(2):135-138.

6.    Kousa P, Järvinen TL, Vihavainen M, Kannus P, Järvinen M. The fixation strength of six hamstring tendon graft fixation devices in anterior cruciate ligament reconstruction. Part I: femoral site. Am J Sports Med. 2003;31(2):174-181.

7.    Kousa P, Järvinen TL, Vihavainen M, Kannus P, Järvinen M. The fixation strength of six hamstring tendon graft fixation devices in anterior cruciate ligament reconstruction. Part II: tibial site. Am J Sports Med. 2003;31(2):182-188.

8.    Weiler A, Hoffmann RF, Stähelin AC, Bail HJ, Siepe CJ, Südkamp NP. Hamstring tendon fixation using interference screws: a biomechanical study in calf tibial bone. Arthroscopy. 1998;14(1):29-37.

9.    Yoo JC, Ahn JH, Kim JH, et al. Biomechanical testing of hybrid hamstring graft tibial fixation in anterior cruciate ligament reconstruction. Knee. 2006;13(6):455-459.

10.  Starch DW, Alexander JW, Noble PC, Reddy S, Lintner DM. Multistranded hamstring tendon graft fixation with a central four-quadrant or a standard tibial interference screw for anterior cruciate ligament reconstruction. Am J Sports Med. 2003;31(3):338-344.

11.  Prodromos CC, Fu FH, Howell SM, Johnson DH, Lawhorn K. Controversies in soft-tissue anterior cruciate ligament reconstruction: grafts, bundles, tunnels, fixation, and harvest. J Am Acad Orthop Surg. 2008;16(7):376-384.

12.  Magen HE, Howell SM, Hull ML. Structural properties of six tibial fixation methods for anterior cruciate ligament soft tissue grafts. Am J Sports Med. 1999;27(1):35-43.

13.  Walsh MP, Wijdicks CA, Parker JB, Hapa O, LaPrade RF. A comparison between a retrograde interference screw, suture button, and combined fixation on the tibial side in an all-inside anterior cruciate ligament reconstruction: a biomechanical study in a porcine model. Am J Sports Med. 2009;37(1):160-167.

14.  Nurmi JT, Järvinen TL, Kannus P, Sievänen H, Toukosalo J, Järvinen M. Compaction versus extraction drilling for fixation of the hamstring tendon graft in anterior cruciate ligament reconstruction. Am J Sports Med. 2002;30(2):167-173.

15.  Nurmi JT, Sievänen H, Kannus P, Järvinen M, Järvinen TL. Porcine tibia is a poor substitute for human cadaver tibia for evaluating interference screw fixation. Am J Sports Med. 2004;32(3):765-771.

16.  Nagarkatti DG, McKeon BP, Donahue BS, Fulkerson JP. Mechanical evaluation of a soft tissue interference screw in free tendon anterior cruciate ligament graft fixation. Am J Sports Med. 2001;29(1):67-71.

17.  Brand JC Jr, Pienkowski D, Steenlage E, Hamilton D, Johnson DL, Caborn DN. Interference screw fixation strength of a quadrupled hamstring tendon graft is directly related to bone mineral density and insertion torque. Am J Sports Med. 2000;28(5):705-710.

18.  Stadelmaier DM, Lowe WR, Ilahi OA, Noble PC, Kohl HW 3rd. Cyclic pull-out strength of hamstring tendon graft fixation with soft tissue interference screws. Influence of screw length. Am J Sports Med. 1999;27(6):778-783.

19.  Selby JB, Johnson DL, Hester P, Caborn DN. Effect of screw length on bioabsorbable interference screw fixation in a tibial bone tunnel. Am J Sports Med. 2001;29(5):614-619.

20.  Shino K, Pflaster DS. Comparison of eccentric and concentric screw placement for hamstring graft fixation in the tibial tunnel. Knee Surg Sports Traumatol Arthrosc. 2000;8(2):73-75.

21.  Simonian PT, Sussmann PS, Baldini TH, Crockett HC, Wickiewicz TL. Interference screw position and hamstring graft location for anterior cruciate ligament reconstruction. Arthroscopy. 1998;14(5):459-464.

22.  Shelbourne KD, Nitz P. Accelerated rehabilitation after anterior cruciate ligament reconstruction. Am J Sports Med. 1990;18(3):292-299.

23.   Shelbourne KD, Wilckens JH. Current concepts in anterior cruciate ligament rehabilitation. Orthop Rev. 1990;19(11):957-964.

References

1.    Garrett WE Jr, Swiontkowski MF, Weinsten JN, et al. American Board of Orthopaedic Surgery Practice of the Orthopaedic Surgeon: part-II, certification examination case mix. J Bone Joint Surg Am. 2006;88(3):660-667.

2.    West RV, Harner CD. Graft selection in anterior cruciate ligament reconstruction. J Am Acad Orthop Surg. 2005;13(3):197-207.

3.    Brand J Jr, Weiler A, Caborn DN, Brown CH Jr, Johnson DL. Graft fixation in cruciate ligament reconstruction. Am J Sports Med. 2000;28(5):761-774.

4.    Coleridge SD, Amis AA. A comparison of five tibial-fixation systems in hamstring-graft anterior cruciate ligament reconstruction. Knee Surg Sports Traumatol Arthrosc. 2004;12(5):391-397.

5.    Fabbriciani C, Mulas PD, Ziranu F, Deriu L, Zarelli D, Milano G. Mechanical analysis of fixation methods for anterior cruciate ligament reconstruction with hamstring tendon graft. An experimental study in sheep knees. Knee. 2005;12(2):135-138.

6.    Kousa P, Järvinen TL, Vihavainen M, Kannus P, Järvinen M. The fixation strength of six hamstring tendon graft fixation devices in anterior cruciate ligament reconstruction. Part I: femoral site. Am J Sports Med. 2003;31(2):174-181.

7.    Kousa P, Järvinen TL, Vihavainen M, Kannus P, Järvinen M. The fixation strength of six hamstring tendon graft fixation devices in anterior cruciate ligament reconstruction. Part II: tibial site. Am J Sports Med. 2003;31(2):182-188.

8.    Weiler A, Hoffmann RF, Stähelin AC, Bail HJ, Siepe CJ, Südkamp NP. Hamstring tendon fixation using interference screws: a biomechanical study in calf tibial bone. Arthroscopy. 1998;14(1):29-37.

9.    Yoo JC, Ahn JH, Kim JH, et al. Biomechanical testing of hybrid hamstring graft tibial fixation in anterior cruciate ligament reconstruction. Knee. 2006;13(6):455-459.

10.  Starch DW, Alexander JW, Noble PC, Reddy S, Lintner DM. Multistranded hamstring tendon graft fixation with a central four-quadrant or a standard tibial interference screw for anterior cruciate ligament reconstruction. Am J Sports Med. 2003;31(3):338-344.

11.  Prodromos CC, Fu FH, Howell SM, Johnson DH, Lawhorn K. Controversies in soft-tissue anterior cruciate ligament reconstruction: grafts, bundles, tunnels, fixation, and harvest. J Am Acad Orthop Surg. 2008;16(7):376-384.

12.  Magen HE, Howell SM, Hull ML. Structural properties of six tibial fixation methods for anterior cruciate ligament soft tissue grafts. Am J Sports Med. 1999;27(1):35-43.

13.  Walsh MP, Wijdicks CA, Parker JB, Hapa O, LaPrade RF. A comparison between a retrograde interference screw, suture button, and combined fixation on the tibial side in an all-inside anterior cruciate ligament reconstruction: a biomechanical study in a porcine model. Am J Sports Med. 2009;37(1):160-167.

14.  Nurmi JT, Järvinen TL, Kannus P, Sievänen H, Toukosalo J, Järvinen M. Compaction versus extraction drilling for fixation of the hamstring tendon graft in anterior cruciate ligament reconstruction. Am J Sports Med. 2002;30(2):167-173.

15.  Nurmi JT, Sievänen H, Kannus P, Järvinen M, Järvinen TL. Porcine tibia is a poor substitute for human cadaver tibia for evaluating interference screw fixation. Am J Sports Med. 2004;32(3):765-771.

16.  Nagarkatti DG, McKeon BP, Donahue BS, Fulkerson JP. Mechanical evaluation of a soft tissue interference screw in free tendon anterior cruciate ligament graft fixation. Am J Sports Med. 2001;29(1):67-71.

17.  Brand JC Jr, Pienkowski D, Steenlage E, Hamilton D, Johnson DL, Caborn DN. Interference screw fixation strength of a quadrupled hamstring tendon graft is directly related to bone mineral density and insertion torque. Am J Sports Med. 2000;28(5):705-710.

18.  Stadelmaier DM, Lowe WR, Ilahi OA, Noble PC, Kohl HW 3rd. Cyclic pull-out strength of hamstring tendon graft fixation with soft tissue interference screws. Influence of screw length. Am J Sports Med. 1999;27(6):778-783.

19.  Selby JB, Johnson DL, Hester P, Caborn DN. Effect of screw length on bioabsorbable interference screw fixation in a tibial bone tunnel. Am J Sports Med. 2001;29(5):614-619.

20.  Shino K, Pflaster DS. Comparison of eccentric and concentric screw placement for hamstring graft fixation in the tibial tunnel. Knee Surg Sports Traumatol Arthrosc. 2000;8(2):73-75.

21.  Simonian PT, Sussmann PS, Baldini TH, Crockett HC, Wickiewicz TL. Interference screw position and hamstring graft location for anterior cruciate ligament reconstruction. Arthroscopy. 1998;14(5):459-464.

22.  Shelbourne KD, Nitz P. Accelerated rehabilitation after anterior cruciate ligament reconstruction. Am J Sports Med. 1990;18(3):292-299.

23.   Shelbourne KD, Wilckens JH. Current concepts in anterior cruciate ligament rehabilitation. Orthop Rev. 1990;19(11):957-964.

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Biomechanical Comparison of Hamstring Tendon Fixation Devices for Anterior Cruciate Ligament Reconstruction: Part 2. Four Tibial Devices
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Prevention of Venous Thromboembolism After Total Joint Arthroplasty: Aspirin Is Enough for Most Patients

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Prevention of Venous Thromboembolism After Total Joint Arthroplasty: Aspirin Is Enough for Most Patients

The orthopedic community continues to be concerned about venous thromboembolism (VTE) after orthopedic procedures. There is currently no consensus on the optimal strategy for prevention of VTE after knee and hip arthroplasty. In North America, the American Association of Orthopaedic Surgeons (AAOS) and the American College of Chest Physicians (ACCP) have both been involved in putting forth guidelines that are intended to minimize this complication after orthopedic procedures.1-2

Both of these guidelines have evaluated the available literature, whenever present, to reach their recommendations. Although the AAOS guidelines do not mention aspirin specifically, they do endorse any form of anticoagulation as acceptable after total hip and knee arthroplasty. The ACCP, on the other hand, gives their highest endorsement (1B) to aspirin as an effective prophylactic agent for prevention of VTE after total joint arthroplasty (TJA).1 In the analysis, surgeon choice of VTE prophylaxis should be based on a balance between safety and efficacy of a particular anticoagulant, with risk stratification used to identify patients at standard risk (the vast majority) or high risk of VTE or bleeding.

Recent studies have helped to dispel the age-old misconception that aspirin is an effective modality for prevention of clots in the high-pressure (arterial) system but not in the low-pressure (venous) system. The ASPIRE study evaluated 822 patients and detected that the incidence of VTE was 4.8% in patients who received aspirin versus 6.5% in patients who did not receive aspirin.3 Although the difference in the incidence of VTE in the given sample size did not reach statistical significance, the difference did reach statistical significance when other major vascular issues were taken into account.3 Another study (WARFASA), evaluating 402 patients with prior VTE, detected 42% reduction in the incidence of recurrent VTE in patients that received aspirin, confirming the fact that aspirin does indeed act on the venous low-pressure system.4

The prevailing evidence over the last decade supports the notion that aspirin is an effective agent for prevention of VTE with a lower risk of imparting many of the harms that other aggressive anticoagulant agents are likely to cause, such as wound drainage, bleeding, increased incidence of readmission, reoperation, periprosthetic infection, and even mortality.5-7

With the increasing scrutiny and penalties imposed on surgeons and health care systems by the regulatory bodies in the United States for a variety of “quality metric” considerations related to readmission and reoperation, including VTE prevention and its complications, the notion of using anticoagulant agents that are not only effective but also less harmful is gaining momentum and greater endorsement. Visiting the US Food and Drug Administration website reveals that among all drugs in the medical community, aggressive anticoagulants are associated with the highest number of adverse effects, including mortality.8

The medical community also needs to recognize that there have been immense changes in the practice of orthopedics, particularly in the realm of knee and hip arthroplasty. The majority of patients undergoing TJA receive regional anesthesia, using expeditious surgical techniques, and are mobilized immediately in the postoperative period—all of these elements have contributed to a declining incidence of VTE after TJA. Furthermore, patients are often discharged from the hospital within a day or two, making compliance with outpatient anticoagulant therapy more of a challenge. Thus, the historical protocols related to TJA—when patients stayed in bed for days before beginning a delayed and limited physical therapy program and a lengthy hospital stay—are behind us. These major changes in surgical and anesthesia techniques as well as accelerated postoperative protocols highlight the fact that any literature from the far past needs to be examined with caution as it may not be applicable to modern-day surgical patients.

Moving forward, while we strongly endorse risk stratification for VTE prophylaxis, in our opinion aspirin will become the mainstay of prevention of VTE for the majority of patients after TJA. The challenge that lies ahead is to determine which patients are at increased risk of VTE and in need of more aggressive anticoagulants. There has been a recent development on this front that aims to provide some guidance for selection of high-risk patients.9 It appears that over 90% of patients undergoing TJA can safely receive aspirin as an anticoagulation prophylaxis, while a validated risk profile can be used to detect those at higher risk for VTE and in need of more aggressive agents.9

Thanks to the diligent work of the ACCP and AAOS workgroups and many other scholars in the field, the science of VTE prophylaxis after TJA has truly evolved. The adaptation of the recent ACCP guidelines by the Surgical Care Improvement Project (SCIP), which accepts aspirin as an effective anticoagulation modality, is yet another step in the direction of optimizing outcomes for our patients, by preventing the feared VTE while also limiting untoward bleeding complications that can occur with administration of aggressive anticoagulants.10

References

1.    Falck-Ytter Y, Francis CW, Johanson NA, et al; American College of Chest Physicians. Prevention of VTE in Orthopedic Surgery Patients: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012;141(2 Suppl):e278S-325S.

2.    Sharrock NE, Gonzalez Della Valle A, Go G, Lyman S, Salvati EA. Potent anticoagulants are associated with a higher all-cause mortality rate after hip and knee arthroplasty. Clin Orthop. 2008;466(3):714-721.

3.    Brighton TA, Eikelboom JW, Mann K, et al; ASPIRE Investigators. Low-dose aspirin for preventing recurrent venous thromboembolism. N Engl J Med. 2012;367(21):1979-1987.

4.    Becattini C, Agnelli G, Schenone A, et al; WARFASA Investigators. Aspirin for preventing the recurrence of venous thromboembolism. N Engl J Med. 2012;366(21):1959-1967.

5.    Parvizi J, Ghanem E, Joshi A, Sharkey PF, Hozack WJ, Rothman RH. Does “excessive” anticoagulation predispose to periprosthetic infection? J Arthroplasty. 2007;22(6 Suppl 2):24-28.

6.    Sachs RA, Smith JH, Kuney M, Paxton L. Does anticoagulation do more harm than good? A comparison of patients treated without prophylaxis and patients treated with low-dose warfarin after total knee arthroplasty. J Arthroplasty. 2003;18(4):389-395.

7.    Lotke PA, Lonner JH. The benefit of aspirin chemoprophylaxis for thromboembolism after total knee arthroplasty. Clin Orthop. 2006;452:175-180.

8.    Medical Product Safety Information. US Food and Drug Administration website. http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm. Updated December 11, 2014. Accessed December 29, 2014.

9.    Parvizi J, Huang R, Raphael IJ, Arnold WV, Rothman RH. Symptomatic pulmonary embolus after joint arthroplasty: stratification of risk factors. Clin Orthop. 2014;472(3):903-912.

10.    Mont MA, Hozack WJ, Callaghan JJ, Krebs V, Parvizi J, Mason JB. Venous thromboemboli following total joint arthroplasty: SCIP measures move us closer to an agreement. J Arthroplasty. 2014;29(4):651-652.

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David Dalury, MD, Jess Lonner, MD, and Javad Parvizi, MD, FRCS

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The orthopedic community continues to be concerned about venous thromboembolism (VTE) after orthopedic procedures. There is currently no consensus on the optimal strategy for prevention of VTE after knee and hip arthroplasty. In North America, the American Association of Orthopaedic Surgeons (AAOS) and the American College of Chest Physicians (ACCP) have both been involved in putting forth guidelines that are intended to minimize this complication after orthopedic procedures.1-2

Both of these guidelines have evaluated the available literature, whenever present, to reach their recommendations. Although the AAOS guidelines do not mention aspirin specifically, they do endorse any form of anticoagulation as acceptable after total hip and knee arthroplasty. The ACCP, on the other hand, gives their highest endorsement (1B) to aspirin as an effective prophylactic agent for prevention of VTE after total joint arthroplasty (TJA).1 In the analysis, surgeon choice of VTE prophylaxis should be based on a balance between safety and efficacy of a particular anticoagulant, with risk stratification used to identify patients at standard risk (the vast majority) or high risk of VTE or bleeding.

Recent studies have helped to dispel the age-old misconception that aspirin is an effective modality for prevention of clots in the high-pressure (arterial) system but not in the low-pressure (venous) system. The ASPIRE study evaluated 822 patients and detected that the incidence of VTE was 4.8% in patients who received aspirin versus 6.5% in patients who did not receive aspirin.3 Although the difference in the incidence of VTE in the given sample size did not reach statistical significance, the difference did reach statistical significance when other major vascular issues were taken into account.3 Another study (WARFASA), evaluating 402 patients with prior VTE, detected 42% reduction in the incidence of recurrent VTE in patients that received aspirin, confirming the fact that aspirin does indeed act on the venous low-pressure system.4

The prevailing evidence over the last decade supports the notion that aspirin is an effective agent for prevention of VTE with a lower risk of imparting many of the harms that other aggressive anticoagulant agents are likely to cause, such as wound drainage, bleeding, increased incidence of readmission, reoperation, periprosthetic infection, and even mortality.5-7

With the increasing scrutiny and penalties imposed on surgeons and health care systems by the regulatory bodies in the United States for a variety of “quality metric” considerations related to readmission and reoperation, including VTE prevention and its complications, the notion of using anticoagulant agents that are not only effective but also less harmful is gaining momentum and greater endorsement. Visiting the US Food and Drug Administration website reveals that among all drugs in the medical community, aggressive anticoagulants are associated with the highest number of adverse effects, including mortality.8

The medical community also needs to recognize that there have been immense changes in the practice of orthopedics, particularly in the realm of knee and hip arthroplasty. The majority of patients undergoing TJA receive regional anesthesia, using expeditious surgical techniques, and are mobilized immediately in the postoperative period—all of these elements have contributed to a declining incidence of VTE after TJA. Furthermore, patients are often discharged from the hospital within a day or two, making compliance with outpatient anticoagulant therapy more of a challenge. Thus, the historical protocols related to TJA—when patients stayed in bed for days before beginning a delayed and limited physical therapy program and a lengthy hospital stay—are behind us. These major changes in surgical and anesthesia techniques as well as accelerated postoperative protocols highlight the fact that any literature from the far past needs to be examined with caution as it may not be applicable to modern-day surgical patients.

Moving forward, while we strongly endorse risk stratification for VTE prophylaxis, in our opinion aspirin will become the mainstay of prevention of VTE for the majority of patients after TJA. The challenge that lies ahead is to determine which patients are at increased risk of VTE and in need of more aggressive anticoagulants. There has been a recent development on this front that aims to provide some guidance for selection of high-risk patients.9 It appears that over 90% of patients undergoing TJA can safely receive aspirin as an anticoagulation prophylaxis, while a validated risk profile can be used to detect those at higher risk for VTE and in need of more aggressive agents.9

Thanks to the diligent work of the ACCP and AAOS workgroups and many other scholars in the field, the science of VTE prophylaxis after TJA has truly evolved. The adaptation of the recent ACCP guidelines by the Surgical Care Improvement Project (SCIP), which accepts aspirin as an effective anticoagulation modality, is yet another step in the direction of optimizing outcomes for our patients, by preventing the feared VTE while also limiting untoward bleeding complications that can occur with administration of aggressive anticoagulants.10

The orthopedic community continues to be concerned about venous thromboembolism (VTE) after orthopedic procedures. There is currently no consensus on the optimal strategy for prevention of VTE after knee and hip arthroplasty. In North America, the American Association of Orthopaedic Surgeons (AAOS) and the American College of Chest Physicians (ACCP) have both been involved in putting forth guidelines that are intended to minimize this complication after orthopedic procedures.1-2

Both of these guidelines have evaluated the available literature, whenever present, to reach their recommendations. Although the AAOS guidelines do not mention aspirin specifically, they do endorse any form of anticoagulation as acceptable after total hip and knee arthroplasty. The ACCP, on the other hand, gives their highest endorsement (1B) to aspirin as an effective prophylactic agent for prevention of VTE after total joint arthroplasty (TJA).1 In the analysis, surgeon choice of VTE prophylaxis should be based on a balance between safety and efficacy of a particular anticoagulant, with risk stratification used to identify patients at standard risk (the vast majority) or high risk of VTE or bleeding.

Recent studies have helped to dispel the age-old misconception that aspirin is an effective modality for prevention of clots in the high-pressure (arterial) system but not in the low-pressure (venous) system. The ASPIRE study evaluated 822 patients and detected that the incidence of VTE was 4.8% in patients who received aspirin versus 6.5% in patients who did not receive aspirin.3 Although the difference in the incidence of VTE in the given sample size did not reach statistical significance, the difference did reach statistical significance when other major vascular issues were taken into account.3 Another study (WARFASA), evaluating 402 patients with prior VTE, detected 42% reduction in the incidence of recurrent VTE in patients that received aspirin, confirming the fact that aspirin does indeed act on the venous low-pressure system.4

The prevailing evidence over the last decade supports the notion that aspirin is an effective agent for prevention of VTE with a lower risk of imparting many of the harms that other aggressive anticoagulant agents are likely to cause, such as wound drainage, bleeding, increased incidence of readmission, reoperation, periprosthetic infection, and even mortality.5-7

With the increasing scrutiny and penalties imposed on surgeons and health care systems by the regulatory bodies in the United States for a variety of “quality metric” considerations related to readmission and reoperation, including VTE prevention and its complications, the notion of using anticoagulant agents that are not only effective but also less harmful is gaining momentum and greater endorsement. Visiting the US Food and Drug Administration website reveals that among all drugs in the medical community, aggressive anticoagulants are associated with the highest number of adverse effects, including mortality.8

The medical community also needs to recognize that there have been immense changes in the practice of orthopedics, particularly in the realm of knee and hip arthroplasty. The majority of patients undergoing TJA receive regional anesthesia, using expeditious surgical techniques, and are mobilized immediately in the postoperative period—all of these elements have contributed to a declining incidence of VTE after TJA. Furthermore, patients are often discharged from the hospital within a day or two, making compliance with outpatient anticoagulant therapy more of a challenge. Thus, the historical protocols related to TJA—when patients stayed in bed for days before beginning a delayed and limited physical therapy program and a lengthy hospital stay—are behind us. These major changes in surgical and anesthesia techniques as well as accelerated postoperative protocols highlight the fact that any literature from the far past needs to be examined with caution as it may not be applicable to modern-day surgical patients.

Moving forward, while we strongly endorse risk stratification for VTE prophylaxis, in our opinion aspirin will become the mainstay of prevention of VTE for the majority of patients after TJA. The challenge that lies ahead is to determine which patients are at increased risk of VTE and in need of more aggressive anticoagulants. There has been a recent development on this front that aims to provide some guidance for selection of high-risk patients.9 It appears that over 90% of patients undergoing TJA can safely receive aspirin as an anticoagulation prophylaxis, while a validated risk profile can be used to detect those at higher risk for VTE and in need of more aggressive agents.9

Thanks to the diligent work of the ACCP and AAOS workgroups and many other scholars in the field, the science of VTE prophylaxis after TJA has truly evolved. The adaptation of the recent ACCP guidelines by the Surgical Care Improvement Project (SCIP), which accepts aspirin as an effective anticoagulation modality, is yet another step in the direction of optimizing outcomes for our patients, by preventing the feared VTE while also limiting untoward bleeding complications that can occur with administration of aggressive anticoagulants.10

References

1.    Falck-Ytter Y, Francis CW, Johanson NA, et al; American College of Chest Physicians. Prevention of VTE in Orthopedic Surgery Patients: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012;141(2 Suppl):e278S-325S.

2.    Sharrock NE, Gonzalez Della Valle A, Go G, Lyman S, Salvati EA. Potent anticoagulants are associated with a higher all-cause mortality rate after hip and knee arthroplasty. Clin Orthop. 2008;466(3):714-721.

3.    Brighton TA, Eikelboom JW, Mann K, et al; ASPIRE Investigators. Low-dose aspirin for preventing recurrent venous thromboembolism. N Engl J Med. 2012;367(21):1979-1987.

4.    Becattini C, Agnelli G, Schenone A, et al; WARFASA Investigators. Aspirin for preventing the recurrence of venous thromboembolism. N Engl J Med. 2012;366(21):1959-1967.

5.    Parvizi J, Ghanem E, Joshi A, Sharkey PF, Hozack WJ, Rothman RH. Does “excessive” anticoagulation predispose to periprosthetic infection? J Arthroplasty. 2007;22(6 Suppl 2):24-28.

6.    Sachs RA, Smith JH, Kuney M, Paxton L. Does anticoagulation do more harm than good? A comparison of patients treated without prophylaxis and patients treated with low-dose warfarin after total knee arthroplasty. J Arthroplasty. 2003;18(4):389-395.

7.    Lotke PA, Lonner JH. The benefit of aspirin chemoprophylaxis for thromboembolism after total knee arthroplasty. Clin Orthop. 2006;452:175-180.

8.    Medical Product Safety Information. US Food and Drug Administration website. http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm. Updated December 11, 2014. Accessed December 29, 2014.

9.    Parvizi J, Huang R, Raphael IJ, Arnold WV, Rothman RH. Symptomatic pulmonary embolus after joint arthroplasty: stratification of risk factors. Clin Orthop. 2014;472(3):903-912.

10.    Mont MA, Hozack WJ, Callaghan JJ, Krebs V, Parvizi J, Mason JB. Venous thromboemboli following total joint arthroplasty: SCIP measures move us closer to an agreement. J Arthroplasty. 2014;29(4):651-652.

References

1.    Falck-Ytter Y, Francis CW, Johanson NA, et al; American College of Chest Physicians. Prevention of VTE in Orthopedic Surgery Patients: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012;141(2 Suppl):e278S-325S.

2.    Sharrock NE, Gonzalez Della Valle A, Go G, Lyman S, Salvati EA. Potent anticoagulants are associated with a higher all-cause mortality rate after hip and knee arthroplasty. Clin Orthop. 2008;466(3):714-721.

3.    Brighton TA, Eikelboom JW, Mann K, et al; ASPIRE Investigators. Low-dose aspirin for preventing recurrent venous thromboembolism. N Engl J Med. 2012;367(21):1979-1987.

4.    Becattini C, Agnelli G, Schenone A, et al; WARFASA Investigators. Aspirin for preventing the recurrence of venous thromboembolism. N Engl J Med. 2012;366(21):1959-1967.

5.    Parvizi J, Ghanem E, Joshi A, Sharkey PF, Hozack WJ, Rothman RH. Does “excessive” anticoagulation predispose to periprosthetic infection? J Arthroplasty. 2007;22(6 Suppl 2):24-28.

6.    Sachs RA, Smith JH, Kuney M, Paxton L. Does anticoagulation do more harm than good? A comparison of patients treated without prophylaxis and patients treated with low-dose warfarin after total knee arthroplasty. J Arthroplasty. 2003;18(4):389-395.

7.    Lotke PA, Lonner JH. The benefit of aspirin chemoprophylaxis for thromboembolism after total knee arthroplasty. Clin Orthop. 2006;452:175-180.

8.    Medical Product Safety Information. US Food and Drug Administration website. http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm. Updated December 11, 2014. Accessed December 29, 2014.

9.    Parvizi J, Huang R, Raphael IJ, Arnold WV, Rothman RH. Symptomatic pulmonary embolus after joint arthroplasty: stratification of risk factors. Clin Orthop. 2014;472(3):903-912.

10.    Mont MA, Hozack WJ, Callaghan JJ, Krebs V, Parvizi J, Mason JB. Venous thromboemboli following total joint arthroplasty: SCIP measures move us closer to an agreement. J Arthroplasty. 2014;29(4):651-652.

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Prevention of Venous Thromboembolism After Total Joint Arthroplasty: Aspirin Is Enough for Most Patients
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american journal of orthopedics, AJO, editorial, guest editorial, total joint arthroplasty, TJA, venous thromboembolism, aspirin, prevention, medicine, VTE, arthroplasty, knee, hip, knee arthroplasty, hip arthroplasty, joint, anticoagulants, dalury, lonner, parvizi
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Treatment of Proximal Humerus Fractures: Comparison of Shoulder and Trauma Surgeons

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Treatment of Proximal Humerus Fractures: Comparison of Shoulder and Trauma Surgeons

Proximal humerus fractures (PHFs), AO/OTA (Ar­ beitsgemeinschaft für Osteosynthesefragen/Orthopaedic Trauma Association) type 11,1 are common, representing 4% to 5% of all fractures in adults.2 However, there is no consensus as to optimal management of these injuries, with some reports supporting and others rejecting the various fixation methods,3 and there are no evidence-based practice guidelines informing treatment decisions.4 Not surprisingly, orthopedic surgeons do not agree on ideal treatment for PHFs5,6 and differ by region in their rates of surgical management.2 In addition, analyses of national databases have found variation in choice of surgical treatment for PHFs between surgeons and between hospitals of different patient volumes.4 Few studies have assessed surgeon agreement on treatment decisions. Findings from these limited investigations indicate there is little agreement on treatment choices, but training may have some impact.5-7 In 3 studies,5-7 shoulder and trauma fellowship–trained surgeons differed in their management of PHFs both in terms of rates of operative treatment5,7 and specific operative management choices.5,6 No study has assessed surgeon agreement on radiographic outcomes.

We conducted a study to compare expert shoulder and trauma surgeons’ treatment decision-making and agreement on final radiographic outcomes of surgically treated PHFs. We hypothesized there would be poor agreement on treatment decisions and better agreement on radiographic outcomes, with a difference between shoulder and trauma fellowship–trained surgeons.

Materials and Methods

After receiving institutional review board approval for this study, we collected data on 100 consecutive PHFs (AO/OTA type 111) surgically treated at 2 affiliated level I trauma centers between January 2004 and July 2008. None of the cases in the series was managed by any of the surgeons participating in this study.

We created a PowerPoint (Microsoft, Redmond, Washington) survey that included radiographs (preoperative, immediate postoperative, final postoperative) and, if available, a computed tomography image. This survey was sent to 4 orthopedic surgeons: Drs. Gardner, Gerber, Lorich, and Walch. Two of these authors are fellowship-trained in shoulder surgery, the other 2 in orthopedic traumatology with specialization in treating PHFs. All are internationally renowned in PHF management. Using the survey images and a 4-point Likert scale ranging from disagree strongly to agree strongly, the examiners rated their agreement with treatment decisions (arthroplasty vs fixation). They also rated (very poor to very good) immediate postoperative reduction or arthroplasty placement, immediate postoperative fixation methods for fractures treated with open reduction and internal fixation (ORIF), and final radiographic outcomes.

Interobserver agreement was calculated using the intraclass correlation coefficient (ICC),8,9 with scores of <0.2 (poor), 0.21 to 0.4 (fair), 0.41 to 0.6 (moderate), 0.61 to 0.8 (good), and >0.8 (excellent) used to indicate agreement among observers. ICC scores were determined by treating the 4 examiners as independent entities. Subgroup analyses were also performed to determine ICC scores comparing the 2 shoulder surgeons, comparing the 2 trauma surgeons, and comparing the shoulder surgeons and trauma surgeons as 2 separate groups. ICC scores were used instead of κ coefficients to assess agreement because ICC scores treat ratings as continuous variables, allow for comparison of 2 or more raters, and allow for assessment of correlation among raters, whereas κ coefficients treat data as categorical variables and assume the ratings have no natural ordering. ICC scores were generated by SAS 9.1.3 software (SAS Institute, Cary, North Carolina).

Results

The 4 surgeons’ overall ICC scores for agreement with the rating of immediate reduction or arthroplasty placement and the rating of final radiographic outcome indicated moderate levels of agreement (Table 1). Regarding treatment decision-making and ratings of fixation, the surgeons demonstrated poor and fair levels of agreement, respectively.

The ICC scores comparing the shoulder and trauma surgeons revealed similar levels of agreement (Table 2): moderate levels of agreement for ratings of both immediate postoperative reduction or arthroplasty placement and final radiographic outcomes, but poor and fair levels of agreement regarding treatment decision-making and the rating of immediate postoperative fixation methods for fractures treated with ORIF, respectively.

Subgroup analysis revealed that the 2 shoulder surgeons had poor and fair levels of agreement for treatment decisions and rating of immediate postoperative fixation, respectively, though they moderately agreed on rating of immediate postoperative reduction or arthroplasty placement and rating of final radiographic outcome (Table 3). When the 2 trauma surgeons were compared with each other, ICC scores revealed higher levels of agreement overall (Table 4). In other words, the 2 trauma surgeons agreed with each other more than the 2 shoulder surgeons agreed with each other.

Discussion

This study had 3 major findings: (1) Surgeons do not agree on treatment decisions, including fixation methods, regarding PHFs; (2) regardless of their opinions on ideal treatment, they moderately agree on reductions and final radiographic outcomes; (3) expert trauma surgeons may agree more on treatment decisions than expert shoulder surgeons do. In other words, surgeons do not agree on the best treatment, but they radiographically recognize when a procedure has been performed technically well or poorly. These results support our hypothesis and the limited current literature.

 

 

An analysis of Medicare databases showed marked regional variation in rates of operative treatment of PHFs.2 Similarly, a Nationwide Inpatient Sample analysis revealed nationwide variation in operative management of PHFs.4 Both findings are consistent with our results of poor agreement about treatment decisions and ratings of postoperative fixation of PHFs. In 2010, Petit and colleagues6 reported that surgeons do not agree on PHF management. In 2011, Foroohar and colleagues10 similarly reported low interobserver agreement for treatment recommendations made by 4 upper extremity orthopedic specialists, 4 general orthopedic surgeons, 4 senior residents, and 4 junior residents, for a series of 16 PHFs—also consistent with our findings.

The lack of agreement about PHF treatment may reflect a difference in training, particularly in light of the recent expansion of shoulder and elbow fellowships.2 Three separate studies performed at 2 affiliated level I trauma centers demonstrated significant differences in treatment decision-making between shoulder and trauma fellowship–trained surgeons.5-7 Our results are consistent with the hypothesis that training affects treatment decision-making, as we found poor agreement between shoulder and trauma fellowship–trained surgeons regarding treatment decision for PHFs. Subanalyses revealed that expert trauma surgeons agreed with each other on treatment decisions more than expert shoulder surgeons agreed with each other, further suggesting that training may affect how surgeons manage PHFs. Differences in fellowship training even within the same specialty may account for the observed lesser levels of agreement between the shoulder surgeons, even among experts in the field.

The evidence for optimal treatment historically has been poor,4,6 with few high-quality prospective, randomized controlled studies on the topic up until the past few years. The most recent Cochrane Review on optimal PHF treatment concluded that there is insufficient evidence to make an evidence-based recommendation and that the long-term benefit of surgery is unclear.11 However, at least 5 controlled trials on the topic have been published within the past 5 years.12-16 The evidence is striking and generally supports nonoperative treatment for most PHFs, including some displaced fractures—contrary to general orthopedic practice in many parts of the United States,2 which hitherto had been based mainly on individual surgeon experience and the limited literature. Without strong evidence to support one treatment option over another, surgeons are left with no objective, scientific way of coming to agreement.

Related to the poor status quo of evidence for PHF treatments is new technology (eg, locking plates, reverse total shoulder arthroplasty) that has expanded surgical indications.2,17 Although such developments have the potential to improve surgical treatments, they may also exacerbate the disagreement between surgeons regarding optimal operative treatment of PHFs. This potential consequence of new technology may be reflected in our finding of disagreement among surgeons on immediate postoperative fixation methods. Precisely because they are new, such technological innovations have limited evidence supporting their use. This leaves surgeons with little to nothing to inform their decisions to use these devices, other than familiarity with and impressions of the new technology.

Our study had several limitations. First is the small sample size, of surgeons who are leaders in the field. Our sample therefore may not be generalizable to the general population of shoulder and trauma surgeons. Second, we did not calculate intraobserver variability. Third, inherent to studies of interobserver agreement is the uncertainty of their clinical relevance. In the clinical setting, a surgeon has much more information at hand (eg, patient history, physical examination findings, colleague consultations), thus raising the possibility of underestimations of interobserver agreements.18 Fourth, our comparison of surgeons’ ratings of outcomes was purely radiographic, which may or may not represent or be indicative of clinical outcomes (eg, pain relief, function, range of motion, patient satisfaction). The conclusions we may draw are accordingly limited, as we did not directly evaluate clinical outcome parameters.

Our study had several strengths as well. First, to our knowledge this is the first study to assess interobserver variability in surgeons’ ratings of radiographic outcomes. Its findings may provide further insight into the reasons for poor agreement among orthopedic surgeons on both classification and treatment of PHFs. Second, our surveying of internationally renowned expert surgeons from 4 different institutions may have helped reduce single-institution bias, and it presents the highest level of expertise in the treatment of PHFs.

Although the surgeons in our study moderately agreed on final radiographic outcomes of PHFs, such levels of agreement may still be clinically unacceptable.19 The overall disagreement on treatment decisions highlights the need for better evidence for optimal treatment of PHFs in order to improve consensus, particularly with anticipated increases in age and comorbidities in the population in coming years.4 Subgroup analysis suggested trauma fellowships may contribute to better treatment agreement, though this idea requires further study, perhaps by surveying shoulder and trauma fellowship directors and their curricula for variability in teaching treatment decision-making. The surgeons in our study agreed more on what they consider acceptable final radiographic outcomes, which is encouraging. However, treatment consensus is the primary goal. The recent publication of prospective, randomized studies is helping with this issue, but more studies are needed. It is encouraging that several are planned or under way.20-22

 

 

Conclusion

The surgeons surveyed in this study did not agree on ideal treatment for PHFs but moderately agreed on quality of radiographic outcomes. These differences may reflect a difference in training. We conducted this study to compare experienced shoulder and trauma fellowship–trained surgeons’ treatment decision-making and ratings of radiographic outcomes of PHFs when presented with the same group of patients managed at 2 level I trauma centers. We hypothesized there would be little agreement on treatment decisions, better agreement on final radiographic outcome, and a difference between decision-making and ratings of radiographic outcomes between expert shoulder and trauma surgeons. Our results showed that surgeons do not agree on the best treatment for PHFs but radiographically recognize when an operative treatment has been performed well or poorly. Regarding treatment decisions, our results also showed that expert trauma surgeons may agree more with each other than shoulder surgeons agree with each other. These results support our hypothesis and the limited current literature. The overall disagreement among the surgeons in our study and an aging population that grows sicker each year highlight the need for better evidence for the optimal treatment of PHFs in order to improve consensus.

References

1.    Marsh JL, Slongo TF, Agel J, et al. Fracture and dislocation classification compendium – 2007: Orthopaedic Trauma Association classification, database and outcomes committee. J Orthop Trauma. 2007;21(10 suppl):S1-S133.

2.    Bell JE, Leung BC, Spratt KF, et al. Trends and variation in incidence, surgical treatment, and repeat surgery of proximal humeral fractures in the elderly. J Bone Joint Surg Am. 2011;93(2):121-131.

3.    McLaurin TM. Proximal humerus fractures in the elderly are we operating on too many? Bull Hosp Jt Dis. 2004;62(1-2):24-32.

4.    Jain NB, Kuye I, Higgins LD, Warner JJP. Surgeon volume is associated with cost and variation in surgical treatment of proximal humeral fractures. Clin Orthop. 2012;471(2):655-664.

5.    Boykin RE, Jawa A, O’Brien T, Higgins LD, Warner JJP. Variability in operative management of proximal humerus fractures. Shoulder Elbow. 2011;3(4):197-201.

6.    Petit CJ, Millett PJ, Endres NK, Diller D, Harris MB, Warner JJP. Management of proximal humeral fractures: surgeons don’t agree. J Shoulder Elbow Surg. 2010;19(3):446-451.

7.    Okike K, Lee OC, Makanji H, Harris MB, Vrahas MS. Factors associated with the decision for operative versus non-operative treatment of displaced proximal humerus fractures in the elderly. Injury. 2013;44(4):448-455.

8.    Kodali P, Jones MH, Polster J, Miniaci A, Fening SD. Accuracy of measurement of Hill-Sachs lesions with computed tomography. J Shoulder Elbow Surg. 2011;20(8):1328-1334.

9.    Shrout PE, Fleiss JL. Intraclass correlations: uses in assessing rater reliability. Psychol Bull. 1979;86(2):420-428.

10.  Foroohar A, Tosti R, Richmond JM, Gaughan JP, Ilyas AM. Classification and treatment of proximal humerus fractures: inter-observer reliability and agreement across imaging modalities and experience. J Orthop Surg Res. 2011;6:38.

11.  Handoll HH, Ollivere BJ. Interventions for treating proximal humeral fractures in adults. Cochrane Database Syst Rev. 2010;(12):CD000434.

12.  Boons HW, Goosen JH, van Grinsven S, van Susante JL, van Loon CJ. Hemiarthroplasty for humeral four-part fractures for patients 65 years and older: a randomized controlled trial. Clin Orthop. 2012;470(12):3483-3491.

13.  Fjalestad T, Hole MØ, Hovden IAH, Blücher J, Strømsøe K. Surgical treatment with an angular stable plate for complex displaced proximal humeral fractures in elderly patients: a randomized controlled trial. J Orthop Trauma. 2012;26(2):98-106.

14.    Fjalestad T, Hole MØ, Jørgensen JJ, Strømsøe K, Kristiansen IS. Health and cost consequences of surgical versus conservative treatment for a comminuted proximal humeral fracture in elderly patients. Injury. 2010;41(6):599-605.

15.  Olerud P, Ahrengart L, Ponzer S, Saving J, Tidermark J. Internal fixation versus nonoperative treatment of displaced 3-part proximal humeral fractures in elderly patients: a randomized controlled trial. J Shoulder Elbow Surg. 2011;20(5):747-755.

16.  Olerud P, Ahrengart L, Ponzer S, Saving J, Tidermark J. Hemiarthroplasty versus nonoperative treatment of displaced 4-part proximal humeral fractures in elderly patients: a randomized controlled trial. J Shoulder Elbow Surg. 2011;20(7):1025-1033.

17.  Agudelo J, Schürmann M, Stahel P, et al. Analysis of efficacy and failure in proximal humerus fractures treated with locking plates. J Orthop Trauma. 2007;21(10):676-681.

18.  Brorson S, Hróbjartsson A. Training improves agreement among doctors using the Neer system for proximal humeral fractures in a systematic review. J Clin Epidemiol. 2008;61(1):7-16.

19.  Brorson S, Olsen BS, Frich LH, et al. Surgeons agree more on treatment recommendations than on classification of proximal humeral fractures. BMC Musculoskelet Disord. 2012;13:114.

20.  Handoll H, Brealey S, Rangan A, et al. Protocol for the ProFHER (PROximal Fracture of the Humerus: Evaluation by Randomisation) trial: a pragmatic multi-centre randomised controlled trial of surgical versus non-surgical treatment for proximal fracture of the humerus in adults. BMC Musculoskelet Disord. 2009;10:140.

21.  Den Hartog D, Van Lieshout EMM, Tuinebreijer WE, et al. Primary hemiarthroplasty versus conservative treatment for comminuted fractures of the proximal humerus in the elderly (ProCon): a multicenter randomized controlled trial. BMC Musculoskelet Disord. 2010;11:97.

22.   Verbeek PA, van den Akker-Scheek I, Wendt KW, Diercks RL. Hemiarthroplasty versus angle-stable locking compression plate osteosynthesis in the treatment of three- and four-part fractures of the proximal humerus in the elderly: design of a randomized controlled trial. BMC Musculoskelet Disord. 2012;13:16.

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Andrew Jawa, MD, Paul H. Yi, MD, Robert E. Boykin, MD, Michael J. Gardner, MD, Christian Gerber, MD, Dean G. Lorich, MD, Gilles Walch, MD, and Jon J. P. Warner, MD

Authors’ Disclosure Statement: The authors report no actual or potential conflict of interest in relation to this article.

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The American Journal of Orthopedics - 44(2)
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77-81
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american journal of orthopedics, AJO, original study, study, shoulder and elbow, humerus, humerus fractures, fracture, arthroplasty, proximal humerus fractures, PHF, trauma, shoulder, surgeons, treatment, imaging, jawa, yi, boykin, gardner, gerber, lorich, walch, warner
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Andrew Jawa, MD, Paul H. Yi, MD, Robert E. Boykin, MD, Michael J. Gardner, MD, Christian Gerber, MD, Dean G. Lorich, MD, Gilles Walch, MD, and Jon J. P. Warner, MD

Authors’ Disclosure Statement: The authors report no actual or potential conflict of interest in relation to this article.

Author and Disclosure Information

Andrew Jawa, MD, Paul H. Yi, MD, Robert E. Boykin, MD, Michael J. Gardner, MD, Christian Gerber, MD, Dean G. Lorich, MD, Gilles Walch, MD, and Jon J. P. Warner, MD

Authors’ Disclosure Statement: The authors report no actual or potential conflict of interest in relation to this article.

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Proximal humerus fractures (PHFs), AO/OTA (Ar­ beitsgemeinschaft für Osteosynthesefragen/Orthopaedic Trauma Association) type 11,1 are common, representing 4% to 5% of all fractures in adults.2 However, there is no consensus as to optimal management of these injuries, with some reports supporting and others rejecting the various fixation methods,3 and there are no evidence-based practice guidelines informing treatment decisions.4 Not surprisingly, orthopedic surgeons do not agree on ideal treatment for PHFs5,6 and differ by region in their rates of surgical management.2 In addition, analyses of national databases have found variation in choice of surgical treatment for PHFs between surgeons and between hospitals of different patient volumes.4 Few studies have assessed surgeon agreement on treatment decisions. Findings from these limited investigations indicate there is little agreement on treatment choices, but training may have some impact.5-7 In 3 studies,5-7 shoulder and trauma fellowship–trained surgeons differed in their management of PHFs both in terms of rates of operative treatment5,7 and specific operative management choices.5,6 No study has assessed surgeon agreement on radiographic outcomes.

We conducted a study to compare expert shoulder and trauma surgeons’ treatment decision-making and agreement on final radiographic outcomes of surgically treated PHFs. We hypothesized there would be poor agreement on treatment decisions and better agreement on radiographic outcomes, with a difference between shoulder and trauma fellowship–trained surgeons.

Materials and Methods

After receiving institutional review board approval for this study, we collected data on 100 consecutive PHFs (AO/OTA type 111) surgically treated at 2 affiliated level I trauma centers between January 2004 and July 2008. None of the cases in the series was managed by any of the surgeons participating in this study.

We created a PowerPoint (Microsoft, Redmond, Washington) survey that included radiographs (preoperative, immediate postoperative, final postoperative) and, if available, a computed tomography image. This survey was sent to 4 orthopedic surgeons: Drs. Gardner, Gerber, Lorich, and Walch. Two of these authors are fellowship-trained in shoulder surgery, the other 2 in orthopedic traumatology with specialization in treating PHFs. All are internationally renowned in PHF management. Using the survey images and a 4-point Likert scale ranging from disagree strongly to agree strongly, the examiners rated their agreement with treatment decisions (arthroplasty vs fixation). They also rated (very poor to very good) immediate postoperative reduction or arthroplasty placement, immediate postoperative fixation methods for fractures treated with open reduction and internal fixation (ORIF), and final radiographic outcomes.

Interobserver agreement was calculated using the intraclass correlation coefficient (ICC),8,9 with scores of <0.2 (poor), 0.21 to 0.4 (fair), 0.41 to 0.6 (moderate), 0.61 to 0.8 (good), and >0.8 (excellent) used to indicate agreement among observers. ICC scores were determined by treating the 4 examiners as independent entities. Subgroup analyses were also performed to determine ICC scores comparing the 2 shoulder surgeons, comparing the 2 trauma surgeons, and comparing the shoulder surgeons and trauma surgeons as 2 separate groups. ICC scores were used instead of κ coefficients to assess agreement because ICC scores treat ratings as continuous variables, allow for comparison of 2 or more raters, and allow for assessment of correlation among raters, whereas κ coefficients treat data as categorical variables and assume the ratings have no natural ordering. ICC scores were generated by SAS 9.1.3 software (SAS Institute, Cary, North Carolina).

Results

The 4 surgeons’ overall ICC scores for agreement with the rating of immediate reduction or arthroplasty placement and the rating of final radiographic outcome indicated moderate levels of agreement (Table 1). Regarding treatment decision-making and ratings of fixation, the surgeons demonstrated poor and fair levels of agreement, respectively.

The ICC scores comparing the shoulder and trauma surgeons revealed similar levels of agreement (Table 2): moderate levels of agreement for ratings of both immediate postoperative reduction or arthroplasty placement and final radiographic outcomes, but poor and fair levels of agreement regarding treatment decision-making and the rating of immediate postoperative fixation methods for fractures treated with ORIF, respectively.

Subgroup analysis revealed that the 2 shoulder surgeons had poor and fair levels of agreement for treatment decisions and rating of immediate postoperative fixation, respectively, though they moderately agreed on rating of immediate postoperative reduction or arthroplasty placement and rating of final radiographic outcome (Table 3). When the 2 trauma surgeons were compared with each other, ICC scores revealed higher levels of agreement overall (Table 4). In other words, the 2 trauma surgeons agreed with each other more than the 2 shoulder surgeons agreed with each other.

Discussion

This study had 3 major findings: (1) Surgeons do not agree on treatment decisions, including fixation methods, regarding PHFs; (2) regardless of their opinions on ideal treatment, they moderately agree on reductions and final radiographic outcomes; (3) expert trauma surgeons may agree more on treatment decisions than expert shoulder surgeons do. In other words, surgeons do not agree on the best treatment, but they radiographically recognize when a procedure has been performed technically well or poorly. These results support our hypothesis and the limited current literature.

 

 

An analysis of Medicare databases showed marked regional variation in rates of operative treatment of PHFs.2 Similarly, a Nationwide Inpatient Sample analysis revealed nationwide variation in operative management of PHFs.4 Both findings are consistent with our results of poor agreement about treatment decisions and ratings of postoperative fixation of PHFs. In 2010, Petit and colleagues6 reported that surgeons do not agree on PHF management. In 2011, Foroohar and colleagues10 similarly reported low interobserver agreement for treatment recommendations made by 4 upper extremity orthopedic specialists, 4 general orthopedic surgeons, 4 senior residents, and 4 junior residents, for a series of 16 PHFs—also consistent with our findings.

The lack of agreement about PHF treatment may reflect a difference in training, particularly in light of the recent expansion of shoulder and elbow fellowships.2 Three separate studies performed at 2 affiliated level I trauma centers demonstrated significant differences in treatment decision-making between shoulder and trauma fellowship–trained surgeons.5-7 Our results are consistent with the hypothesis that training affects treatment decision-making, as we found poor agreement between shoulder and trauma fellowship–trained surgeons regarding treatment decision for PHFs. Subanalyses revealed that expert trauma surgeons agreed with each other on treatment decisions more than expert shoulder surgeons agreed with each other, further suggesting that training may affect how surgeons manage PHFs. Differences in fellowship training even within the same specialty may account for the observed lesser levels of agreement between the shoulder surgeons, even among experts in the field.

The evidence for optimal treatment historically has been poor,4,6 with few high-quality prospective, randomized controlled studies on the topic up until the past few years. The most recent Cochrane Review on optimal PHF treatment concluded that there is insufficient evidence to make an evidence-based recommendation and that the long-term benefit of surgery is unclear.11 However, at least 5 controlled trials on the topic have been published within the past 5 years.12-16 The evidence is striking and generally supports nonoperative treatment for most PHFs, including some displaced fractures—contrary to general orthopedic practice in many parts of the United States,2 which hitherto had been based mainly on individual surgeon experience and the limited literature. Without strong evidence to support one treatment option over another, surgeons are left with no objective, scientific way of coming to agreement.

Related to the poor status quo of evidence for PHF treatments is new technology (eg, locking plates, reverse total shoulder arthroplasty) that has expanded surgical indications.2,17 Although such developments have the potential to improve surgical treatments, they may also exacerbate the disagreement between surgeons regarding optimal operative treatment of PHFs. This potential consequence of new technology may be reflected in our finding of disagreement among surgeons on immediate postoperative fixation methods. Precisely because they are new, such technological innovations have limited evidence supporting their use. This leaves surgeons with little to nothing to inform their decisions to use these devices, other than familiarity with and impressions of the new technology.

Our study had several limitations. First is the small sample size, of surgeons who are leaders in the field. Our sample therefore may not be generalizable to the general population of shoulder and trauma surgeons. Second, we did not calculate intraobserver variability. Third, inherent to studies of interobserver agreement is the uncertainty of their clinical relevance. In the clinical setting, a surgeon has much more information at hand (eg, patient history, physical examination findings, colleague consultations), thus raising the possibility of underestimations of interobserver agreements.18 Fourth, our comparison of surgeons’ ratings of outcomes was purely radiographic, which may or may not represent or be indicative of clinical outcomes (eg, pain relief, function, range of motion, patient satisfaction). The conclusions we may draw are accordingly limited, as we did not directly evaluate clinical outcome parameters.

Our study had several strengths as well. First, to our knowledge this is the first study to assess interobserver variability in surgeons’ ratings of radiographic outcomes. Its findings may provide further insight into the reasons for poor agreement among orthopedic surgeons on both classification and treatment of PHFs. Second, our surveying of internationally renowned expert surgeons from 4 different institutions may have helped reduce single-institution bias, and it presents the highest level of expertise in the treatment of PHFs.

Although the surgeons in our study moderately agreed on final radiographic outcomes of PHFs, such levels of agreement may still be clinically unacceptable.19 The overall disagreement on treatment decisions highlights the need for better evidence for optimal treatment of PHFs in order to improve consensus, particularly with anticipated increases in age and comorbidities in the population in coming years.4 Subgroup analysis suggested trauma fellowships may contribute to better treatment agreement, though this idea requires further study, perhaps by surveying shoulder and trauma fellowship directors and their curricula for variability in teaching treatment decision-making. The surgeons in our study agreed more on what they consider acceptable final radiographic outcomes, which is encouraging. However, treatment consensus is the primary goal. The recent publication of prospective, randomized studies is helping with this issue, but more studies are needed. It is encouraging that several are planned or under way.20-22

 

 

Conclusion

The surgeons surveyed in this study did not agree on ideal treatment for PHFs but moderately agreed on quality of radiographic outcomes. These differences may reflect a difference in training. We conducted this study to compare experienced shoulder and trauma fellowship–trained surgeons’ treatment decision-making and ratings of radiographic outcomes of PHFs when presented with the same group of patients managed at 2 level I trauma centers. We hypothesized there would be little agreement on treatment decisions, better agreement on final radiographic outcome, and a difference between decision-making and ratings of radiographic outcomes between expert shoulder and trauma surgeons. Our results showed that surgeons do not agree on the best treatment for PHFs but radiographically recognize when an operative treatment has been performed well or poorly. Regarding treatment decisions, our results also showed that expert trauma surgeons may agree more with each other than shoulder surgeons agree with each other. These results support our hypothesis and the limited current literature. The overall disagreement among the surgeons in our study and an aging population that grows sicker each year highlight the need for better evidence for the optimal treatment of PHFs in order to improve consensus.

Proximal humerus fractures (PHFs), AO/OTA (Ar­ beitsgemeinschaft für Osteosynthesefragen/Orthopaedic Trauma Association) type 11,1 are common, representing 4% to 5% of all fractures in adults.2 However, there is no consensus as to optimal management of these injuries, with some reports supporting and others rejecting the various fixation methods,3 and there are no evidence-based practice guidelines informing treatment decisions.4 Not surprisingly, orthopedic surgeons do not agree on ideal treatment for PHFs5,6 and differ by region in their rates of surgical management.2 In addition, analyses of national databases have found variation in choice of surgical treatment for PHFs between surgeons and between hospitals of different patient volumes.4 Few studies have assessed surgeon agreement on treatment decisions. Findings from these limited investigations indicate there is little agreement on treatment choices, but training may have some impact.5-7 In 3 studies,5-7 shoulder and trauma fellowship–trained surgeons differed in their management of PHFs both in terms of rates of operative treatment5,7 and specific operative management choices.5,6 No study has assessed surgeon agreement on radiographic outcomes.

We conducted a study to compare expert shoulder and trauma surgeons’ treatment decision-making and agreement on final radiographic outcomes of surgically treated PHFs. We hypothesized there would be poor agreement on treatment decisions and better agreement on radiographic outcomes, with a difference between shoulder and trauma fellowship–trained surgeons.

Materials and Methods

After receiving institutional review board approval for this study, we collected data on 100 consecutive PHFs (AO/OTA type 111) surgically treated at 2 affiliated level I trauma centers between January 2004 and July 2008. None of the cases in the series was managed by any of the surgeons participating in this study.

We created a PowerPoint (Microsoft, Redmond, Washington) survey that included radiographs (preoperative, immediate postoperative, final postoperative) and, if available, a computed tomography image. This survey was sent to 4 orthopedic surgeons: Drs. Gardner, Gerber, Lorich, and Walch. Two of these authors are fellowship-trained in shoulder surgery, the other 2 in orthopedic traumatology with specialization in treating PHFs. All are internationally renowned in PHF management. Using the survey images and a 4-point Likert scale ranging from disagree strongly to agree strongly, the examiners rated their agreement with treatment decisions (arthroplasty vs fixation). They also rated (very poor to very good) immediate postoperative reduction or arthroplasty placement, immediate postoperative fixation methods for fractures treated with open reduction and internal fixation (ORIF), and final radiographic outcomes.

Interobserver agreement was calculated using the intraclass correlation coefficient (ICC),8,9 with scores of <0.2 (poor), 0.21 to 0.4 (fair), 0.41 to 0.6 (moderate), 0.61 to 0.8 (good), and >0.8 (excellent) used to indicate agreement among observers. ICC scores were determined by treating the 4 examiners as independent entities. Subgroup analyses were also performed to determine ICC scores comparing the 2 shoulder surgeons, comparing the 2 trauma surgeons, and comparing the shoulder surgeons and trauma surgeons as 2 separate groups. ICC scores were used instead of κ coefficients to assess agreement because ICC scores treat ratings as continuous variables, allow for comparison of 2 or more raters, and allow for assessment of correlation among raters, whereas κ coefficients treat data as categorical variables and assume the ratings have no natural ordering. ICC scores were generated by SAS 9.1.3 software (SAS Institute, Cary, North Carolina).

Results

The 4 surgeons’ overall ICC scores for agreement with the rating of immediate reduction or arthroplasty placement and the rating of final radiographic outcome indicated moderate levels of agreement (Table 1). Regarding treatment decision-making and ratings of fixation, the surgeons demonstrated poor and fair levels of agreement, respectively.

The ICC scores comparing the shoulder and trauma surgeons revealed similar levels of agreement (Table 2): moderate levels of agreement for ratings of both immediate postoperative reduction or arthroplasty placement and final radiographic outcomes, but poor and fair levels of agreement regarding treatment decision-making and the rating of immediate postoperative fixation methods for fractures treated with ORIF, respectively.

Subgroup analysis revealed that the 2 shoulder surgeons had poor and fair levels of agreement for treatment decisions and rating of immediate postoperative fixation, respectively, though they moderately agreed on rating of immediate postoperative reduction or arthroplasty placement and rating of final radiographic outcome (Table 3). When the 2 trauma surgeons were compared with each other, ICC scores revealed higher levels of agreement overall (Table 4). In other words, the 2 trauma surgeons agreed with each other more than the 2 shoulder surgeons agreed with each other.

Discussion

This study had 3 major findings: (1) Surgeons do not agree on treatment decisions, including fixation methods, regarding PHFs; (2) regardless of their opinions on ideal treatment, they moderately agree on reductions and final radiographic outcomes; (3) expert trauma surgeons may agree more on treatment decisions than expert shoulder surgeons do. In other words, surgeons do not agree on the best treatment, but they radiographically recognize when a procedure has been performed technically well or poorly. These results support our hypothesis and the limited current literature.

 

 

An analysis of Medicare databases showed marked regional variation in rates of operative treatment of PHFs.2 Similarly, a Nationwide Inpatient Sample analysis revealed nationwide variation in operative management of PHFs.4 Both findings are consistent with our results of poor agreement about treatment decisions and ratings of postoperative fixation of PHFs. In 2010, Petit and colleagues6 reported that surgeons do not agree on PHF management. In 2011, Foroohar and colleagues10 similarly reported low interobserver agreement for treatment recommendations made by 4 upper extremity orthopedic specialists, 4 general orthopedic surgeons, 4 senior residents, and 4 junior residents, for a series of 16 PHFs—also consistent with our findings.

The lack of agreement about PHF treatment may reflect a difference in training, particularly in light of the recent expansion of shoulder and elbow fellowships.2 Three separate studies performed at 2 affiliated level I trauma centers demonstrated significant differences in treatment decision-making between shoulder and trauma fellowship–trained surgeons.5-7 Our results are consistent with the hypothesis that training affects treatment decision-making, as we found poor agreement between shoulder and trauma fellowship–trained surgeons regarding treatment decision for PHFs. Subanalyses revealed that expert trauma surgeons agreed with each other on treatment decisions more than expert shoulder surgeons agreed with each other, further suggesting that training may affect how surgeons manage PHFs. Differences in fellowship training even within the same specialty may account for the observed lesser levels of agreement between the shoulder surgeons, even among experts in the field.

The evidence for optimal treatment historically has been poor,4,6 with few high-quality prospective, randomized controlled studies on the topic up until the past few years. The most recent Cochrane Review on optimal PHF treatment concluded that there is insufficient evidence to make an evidence-based recommendation and that the long-term benefit of surgery is unclear.11 However, at least 5 controlled trials on the topic have been published within the past 5 years.12-16 The evidence is striking and generally supports nonoperative treatment for most PHFs, including some displaced fractures—contrary to general orthopedic practice in many parts of the United States,2 which hitherto had been based mainly on individual surgeon experience and the limited literature. Without strong evidence to support one treatment option over another, surgeons are left with no objective, scientific way of coming to agreement.

Related to the poor status quo of evidence for PHF treatments is new technology (eg, locking plates, reverse total shoulder arthroplasty) that has expanded surgical indications.2,17 Although such developments have the potential to improve surgical treatments, they may also exacerbate the disagreement between surgeons regarding optimal operative treatment of PHFs. This potential consequence of new technology may be reflected in our finding of disagreement among surgeons on immediate postoperative fixation methods. Precisely because they are new, such technological innovations have limited evidence supporting their use. This leaves surgeons with little to nothing to inform their decisions to use these devices, other than familiarity with and impressions of the new technology.

Our study had several limitations. First is the small sample size, of surgeons who are leaders in the field. Our sample therefore may not be generalizable to the general population of shoulder and trauma surgeons. Second, we did not calculate intraobserver variability. Third, inherent to studies of interobserver agreement is the uncertainty of their clinical relevance. In the clinical setting, a surgeon has much more information at hand (eg, patient history, physical examination findings, colleague consultations), thus raising the possibility of underestimations of interobserver agreements.18 Fourth, our comparison of surgeons’ ratings of outcomes was purely radiographic, which may or may not represent or be indicative of clinical outcomes (eg, pain relief, function, range of motion, patient satisfaction). The conclusions we may draw are accordingly limited, as we did not directly evaluate clinical outcome parameters.

Our study had several strengths as well. First, to our knowledge this is the first study to assess interobserver variability in surgeons’ ratings of radiographic outcomes. Its findings may provide further insight into the reasons for poor agreement among orthopedic surgeons on both classification and treatment of PHFs. Second, our surveying of internationally renowned expert surgeons from 4 different institutions may have helped reduce single-institution bias, and it presents the highest level of expertise in the treatment of PHFs.

Although the surgeons in our study moderately agreed on final radiographic outcomes of PHFs, such levels of agreement may still be clinically unacceptable.19 The overall disagreement on treatment decisions highlights the need for better evidence for optimal treatment of PHFs in order to improve consensus, particularly with anticipated increases in age and comorbidities in the population in coming years.4 Subgroup analysis suggested trauma fellowships may contribute to better treatment agreement, though this idea requires further study, perhaps by surveying shoulder and trauma fellowship directors and their curricula for variability in teaching treatment decision-making. The surgeons in our study agreed more on what they consider acceptable final radiographic outcomes, which is encouraging. However, treatment consensus is the primary goal. The recent publication of prospective, randomized studies is helping with this issue, but more studies are needed. It is encouraging that several are planned or under way.20-22

 

 

Conclusion

The surgeons surveyed in this study did not agree on ideal treatment for PHFs but moderately agreed on quality of radiographic outcomes. These differences may reflect a difference in training. We conducted this study to compare experienced shoulder and trauma fellowship–trained surgeons’ treatment decision-making and ratings of radiographic outcomes of PHFs when presented with the same group of patients managed at 2 level I trauma centers. We hypothesized there would be little agreement on treatment decisions, better agreement on final radiographic outcome, and a difference between decision-making and ratings of radiographic outcomes between expert shoulder and trauma surgeons. Our results showed that surgeons do not agree on the best treatment for PHFs but radiographically recognize when an operative treatment has been performed well or poorly. Regarding treatment decisions, our results also showed that expert trauma surgeons may agree more with each other than shoulder surgeons agree with each other. These results support our hypothesis and the limited current literature. The overall disagreement among the surgeons in our study and an aging population that grows sicker each year highlight the need for better evidence for the optimal treatment of PHFs in order to improve consensus.

References

1.    Marsh JL, Slongo TF, Agel J, et al. Fracture and dislocation classification compendium – 2007: Orthopaedic Trauma Association classification, database and outcomes committee. J Orthop Trauma. 2007;21(10 suppl):S1-S133.

2.    Bell JE, Leung BC, Spratt KF, et al. Trends and variation in incidence, surgical treatment, and repeat surgery of proximal humeral fractures in the elderly. J Bone Joint Surg Am. 2011;93(2):121-131.

3.    McLaurin TM. Proximal humerus fractures in the elderly are we operating on too many? Bull Hosp Jt Dis. 2004;62(1-2):24-32.

4.    Jain NB, Kuye I, Higgins LD, Warner JJP. Surgeon volume is associated with cost and variation in surgical treatment of proximal humeral fractures. Clin Orthop. 2012;471(2):655-664.

5.    Boykin RE, Jawa A, O’Brien T, Higgins LD, Warner JJP. Variability in operative management of proximal humerus fractures. Shoulder Elbow. 2011;3(4):197-201.

6.    Petit CJ, Millett PJ, Endres NK, Diller D, Harris MB, Warner JJP. Management of proximal humeral fractures: surgeons don’t agree. J Shoulder Elbow Surg. 2010;19(3):446-451.

7.    Okike K, Lee OC, Makanji H, Harris MB, Vrahas MS. Factors associated with the decision for operative versus non-operative treatment of displaced proximal humerus fractures in the elderly. Injury. 2013;44(4):448-455.

8.    Kodali P, Jones MH, Polster J, Miniaci A, Fening SD. Accuracy of measurement of Hill-Sachs lesions with computed tomography. J Shoulder Elbow Surg. 2011;20(8):1328-1334.

9.    Shrout PE, Fleiss JL. Intraclass correlations: uses in assessing rater reliability. Psychol Bull. 1979;86(2):420-428.

10.  Foroohar A, Tosti R, Richmond JM, Gaughan JP, Ilyas AM. Classification and treatment of proximal humerus fractures: inter-observer reliability and agreement across imaging modalities and experience. J Orthop Surg Res. 2011;6:38.

11.  Handoll HH, Ollivere BJ. Interventions for treating proximal humeral fractures in adults. Cochrane Database Syst Rev. 2010;(12):CD000434.

12.  Boons HW, Goosen JH, van Grinsven S, van Susante JL, van Loon CJ. Hemiarthroplasty for humeral four-part fractures for patients 65 years and older: a randomized controlled trial. Clin Orthop. 2012;470(12):3483-3491.

13.  Fjalestad T, Hole MØ, Hovden IAH, Blücher J, Strømsøe K. Surgical treatment with an angular stable plate for complex displaced proximal humeral fractures in elderly patients: a randomized controlled trial. J Orthop Trauma. 2012;26(2):98-106.

14.    Fjalestad T, Hole MØ, Jørgensen JJ, Strømsøe K, Kristiansen IS. Health and cost consequences of surgical versus conservative treatment for a comminuted proximal humeral fracture in elderly patients. Injury. 2010;41(6):599-605.

15.  Olerud P, Ahrengart L, Ponzer S, Saving J, Tidermark J. Internal fixation versus nonoperative treatment of displaced 3-part proximal humeral fractures in elderly patients: a randomized controlled trial. J Shoulder Elbow Surg. 2011;20(5):747-755.

16.  Olerud P, Ahrengart L, Ponzer S, Saving J, Tidermark J. Hemiarthroplasty versus nonoperative treatment of displaced 4-part proximal humeral fractures in elderly patients: a randomized controlled trial. J Shoulder Elbow Surg. 2011;20(7):1025-1033.

17.  Agudelo J, Schürmann M, Stahel P, et al. Analysis of efficacy and failure in proximal humerus fractures treated with locking plates. J Orthop Trauma. 2007;21(10):676-681.

18.  Brorson S, Hróbjartsson A. Training improves agreement among doctors using the Neer system for proximal humeral fractures in a systematic review. J Clin Epidemiol. 2008;61(1):7-16.

19.  Brorson S, Olsen BS, Frich LH, et al. Surgeons agree more on treatment recommendations than on classification of proximal humeral fractures. BMC Musculoskelet Disord. 2012;13:114.

20.  Handoll H, Brealey S, Rangan A, et al. Protocol for the ProFHER (PROximal Fracture of the Humerus: Evaluation by Randomisation) trial: a pragmatic multi-centre randomised controlled trial of surgical versus non-surgical treatment for proximal fracture of the humerus in adults. BMC Musculoskelet Disord. 2009;10:140.

21.  Den Hartog D, Van Lieshout EMM, Tuinebreijer WE, et al. Primary hemiarthroplasty versus conservative treatment for comminuted fractures of the proximal humerus in the elderly (ProCon): a multicenter randomized controlled trial. BMC Musculoskelet Disord. 2010;11:97.

22.   Verbeek PA, van den Akker-Scheek I, Wendt KW, Diercks RL. Hemiarthroplasty versus angle-stable locking compression plate osteosynthesis in the treatment of three- and four-part fractures of the proximal humerus in the elderly: design of a randomized controlled trial. BMC Musculoskelet Disord. 2012;13:16.

References

1.    Marsh JL, Slongo TF, Agel J, et al. Fracture and dislocation classification compendium – 2007: Orthopaedic Trauma Association classification, database and outcomes committee. J Orthop Trauma. 2007;21(10 suppl):S1-S133.

2.    Bell JE, Leung BC, Spratt KF, et al. Trends and variation in incidence, surgical treatment, and repeat surgery of proximal humeral fractures in the elderly. J Bone Joint Surg Am. 2011;93(2):121-131.

3.    McLaurin TM. Proximal humerus fractures in the elderly are we operating on too many? Bull Hosp Jt Dis. 2004;62(1-2):24-32.

4.    Jain NB, Kuye I, Higgins LD, Warner JJP. Surgeon volume is associated with cost and variation in surgical treatment of proximal humeral fractures. Clin Orthop. 2012;471(2):655-664.

5.    Boykin RE, Jawa A, O’Brien T, Higgins LD, Warner JJP. Variability in operative management of proximal humerus fractures. Shoulder Elbow. 2011;3(4):197-201.

6.    Petit CJ, Millett PJ, Endres NK, Diller D, Harris MB, Warner JJP. Management of proximal humeral fractures: surgeons don’t agree. J Shoulder Elbow Surg. 2010;19(3):446-451.

7.    Okike K, Lee OC, Makanji H, Harris MB, Vrahas MS. Factors associated with the decision for operative versus non-operative treatment of displaced proximal humerus fractures in the elderly. Injury. 2013;44(4):448-455.

8.    Kodali P, Jones MH, Polster J, Miniaci A, Fening SD. Accuracy of measurement of Hill-Sachs lesions with computed tomography. J Shoulder Elbow Surg. 2011;20(8):1328-1334.

9.    Shrout PE, Fleiss JL. Intraclass correlations: uses in assessing rater reliability. Psychol Bull. 1979;86(2):420-428.

10.  Foroohar A, Tosti R, Richmond JM, Gaughan JP, Ilyas AM. Classification and treatment of proximal humerus fractures: inter-observer reliability and agreement across imaging modalities and experience. J Orthop Surg Res. 2011;6:38.

11.  Handoll HH, Ollivere BJ. Interventions for treating proximal humeral fractures in adults. Cochrane Database Syst Rev. 2010;(12):CD000434.

12.  Boons HW, Goosen JH, van Grinsven S, van Susante JL, van Loon CJ. Hemiarthroplasty for humeral four-part fractures for patients 65 years and older: a randomized controlled trial. Clin Orthop. 2012;470(12):3483-3491.

13.  Fjalestad T, Hole MØ, Hovden IAH, Blücher J, Strømsøe K. Surgical treatment with an angular stable plate for complex displaced proximal humeral fractures in elderly patients: a randomized controlled trial. J Orthop Trauma. 2012;26(2):98-106.

14.    Fjalestad T, Hole MØ, Jørgensen JJ, Strømsøe K, Kristiansen IS. Health and cost consequences of surgical versus conservative treatment for a comminuted proximal humeral fracture in elderly patients. Injury. 2010;41(6):599-605.

15.  Olerud P, Ahrengart L, Ponzer S, Saving J, Tidermark J. Internal fixation versus nonoperative treatment of displaced 3-part proximal humeral fractures in elderly patients: a randomized controlled trial. J Shoulder Elbow Surg. 2011;20(5):747-755.

16.  Olerud P, Ahrengart L, Ponzer S, Saving J, Tidermark J. Hemiarthroplasty versus nonoperative treatment of displaced 4-part proximal humeral fractures in elderly patients: a randomized controlled trial. J Shoulder Elbow Surg. 2011;20(7):1025-1033.

17.  Agudelo J, Schürmann M, Stahel P, et al. Analysis of efficacy and failure in proximal humerus fractures treated with locking plates. J Orthop Trauma. 2007;21(10):676-681.

18.  Brorson S, Hróbjartsson A. Training improves agreement among doctors using the Neer system for proximal humeral fractures in a systematic review. J Clin Epidemiol. 2008;61(1):7-16.

19.  Brorson S, Olsen BS, Frich LH, et al. Surgeons agree more on treatment recommendations than on classification of proximal humeral fractures. BMC Musculoskelet Disord. 2012;13:114.

20.  Handoll H, Brealey S, Rangan A, et al. Protocol for the ProFHER (PROximal Fracture of the Humerus: Evaluation by Randomisation) trial: a pragmatic multi-centre randomised controlled trial of surgical versus non-surgical treatment for proximal fracture of the humerus in adults. BMC Musculoskelet Disord. 2009;10:140.

21.  Den Hartog D, Van Lieshout EMM, Tuinebreijer WE, et al. Primary hemiarthroplasty versus conservative treatment for comminuted fractures of the proximal humerus in the elderly (ProCon): a multicenter randomized controlled trial. BMC Musculoskelet Disord. 2010;11:97.

22.   Verbeek PA, van den Akker-Scheek I, Wendt KW, Diercks RL. Hemiarthroplasty versus angle-stable locking compression plate osteosynthesis in the treatment of three- and four-part fractures of the proximal humerus in the elderly: design of a randomized controlled trial. BMC Musculoskelet Disord. 2012;13:16.

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The American Journal of Orthopedics - 44(2)
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Treatment of Proximal Humerus Fractures: Comparison of Shoulder and Trauma Surgeons
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Treatment of Proximal Humerus Fractures: Comparison of Shoulder and Trauma Surgeons
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american journal of orthopedics, AJO, original study, study, shoulder and elbow, humerus, humerus fractures, fracture, arthroplasty, proximal humerus fractures, PHF, trauma, shoulder, surgeons, treatment, imaging, jawa, yi, boykin, gardner, gerber, lorich, walch, warner
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american journal of orthopedics, AJO, original study, study, shoulder and elbow, humerus, humerus fractures, fracture, arthroplasty, proximal humerus fractures, PHF, trauma, shoulder, surgeons, treatment, imaging, jawa, yi, boykin, gardner, gerber, lorich, walch, warner
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Sports Activity After Reverse Total Shoulder Arthroplasty With Minimum 2-Year Follow-Up

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Sports Activity After Reverse Total Shoulder Arthroplasty With Minimum 2-Year Follow-Up

The treatment of patients with severe shoulder pain and disability combined with a nonfunctional rotator cuff was a clinical challenge until the development of the reverse total shoulder arthroplasty (RTSA).1-3 Massive rotator cuff tears can leave patients with a pseudoparalytic upper extremity and may result in advanced arthritis of the joint because of altered mechanical and nutritional factors.4 In this setting, simply replacing the arthritic joint with standard total shoulder arthroplasty (TSA) is not recommended because it does not address the functional deficits, and it has poor long-term outcomes.3,5 RTSA works by changing the center of rotation of the shoulder joint so that the deltoid muscle can be used to elevate the arm.6,7 The 4 rotator cuff muscles are not required for forward elevation or stability of this constrained implant.6,8

Current indications for RTSA are cuff tear arthropathy, complex proximal humerus fractures, and revision from hemiarthroplasty or TSA with rotator cuff dysfunction. Patients with advanced cuff tear arthropathy have minimal forward elevation and pseudoparalysis. Previous studies have shown mean preoperative forward flexion of 55º and mean ASES (American Shoulder and Elbow Surgeons) Standardized Shoulder Assessment Form score of 34.3.9 Thus, minimal overhead activity is possible without RTSA. Advances in the RTSA technique have led to promising results (excellent functional improvement), but there is limited information regarding the activity levels patients can achieve after surgery.7,9-11

We conducted a study of the types of sporting activities in which patients with RTSA could participate. We hypothesized that, relative to historic controls, patients with RTSA could return to low-intensity sporting activities with improvement in motion and ASES scores.

Materials and Methods

After this study received institutional review board approval, patients who had undergone RTSA at our institution between January 1, 2004 and December 31, 2010 were identified by the billing codes used for the procedure. Each patient who had RTSA performed during the study period was included in the study. Charts were then reviewed to extract demographic data, preoperative diagnosis, surgery date, operative side, dominant side, type of implant used, operative complications, and subsequent revisions. A questionnaire (Appendix) was designed and used to assess activity, functional status, pain, and satisfaction levels after RTSA. Patients had to be willing and able to complete this questionnaire in order to be included in the study.

The questionnaire included demographic questions; a list of 42 activities patients could choose from to describe their current activity level, activities they were able to perform before the surgery, and activities they wish they could perform; a list of reasons for any limitations; and questions about overall pain, strength, and satisfaction with the procedure. In addition, there was an open-ended question for activities that may not have been listed. The questionnaire also included a validated method for assessing shoulder range of motion (ROM) at home, where patients rated their overhead motion according to standardized physical landmarks, including the level of the shoulder, chin, eyebrows, top of head, and above head.12-14 Also provided was the ASES Standardized Shoulder Assessment Form, which features a 100-point visual analog scale for pain plus functional ability questions, with higher scores indicating less pain and better function.15,16 The minimal clinical significance in the ASES score is 6.4 points.17,18 Scores were recorded and analyzed. Student t test was used to calculate statistical differences between patients who had primary RTSA performed and patients who underwent revision RTSA.

Study personnel contacted patients by telephone and direct mailing. Patients who could not be reached initially were called at least 4 more times: twice during the weekday, once during the evening, and once on the weekend. Patients who could not be contacted by telephone were then cross-referenced with the Social Security database to see if any were deceased. Response data were tabulated, and patients were stratified into high-, moderate-, and low-intensity activity.

One of the 3 senior authors (Dr. Ahmad, Dr. Bigliani, Dr. Levine) performed the 95 RTSAs: 84 Zimmer (Warsaw, Indiana), 7 DePuy (Warsaw, Indiana), 4 Tornier (Minneapolis, Minnesota). The DePuy and Tornier implants were used when a 30-mm glenoid peg was required (before Zimmer offered this length in its system). The procedure was done with a deltopectoral approach with 20° of retroversion. In revision cases, the same approach was used, the hardware or implants were removed, and the position of the humeral component was determined based on the pectoralis major insertion and the deltoid tension. In 80% of cases, the subscapularis was not repaired; in the other 20%, it was. Whether it was repaired depended on tendon viability and surgeon preference, as subscapularis repair status has been shown not to affect functional outcome.19-21 No combined latissimus transfers were performed. Patients wore a sling the first 4 weeks after surgery (only wrist and elbow motion allowed) and then advanced to active shoulder ROM. Eight weeks after surgery, they began gentle shoulder strengthening.

 

 

Results

One hundred nine consecutive patients underwent RTSA at a single institution. Fifteen patients subsequently died, 14 could not be contacted, and 2 declined, leaving 78 patients available for clinical follow-up. Mean follow-up was 4.8 years (range 2-9 years). Mean (SD) age at surgery was 75.3 (7.5) years. Seventy-five percent of the patients were women. Sixty-one percent underwent surgery for cuff tear arthropathy, 31% for revision of previous arthroplasty or internal fixation, 7% for complex fractures, and 1% for tumor. Of the 24 revisions, 15 were for failed hemiarthroplasty, 3 were for failed TSA with rotator cuff dysfunction, 4 were for fracture with failed internal fixation, and 2 were for failed RTSA referred from other institutions. The dominant shoulder was involved 62% of the time. Preoperative active forward shoulder elevation was less than 90° in all patients. There were 10 complications: 2 dislocations that were closed-reduced and remained stable, 1 dislocation that required revision of the liner, 1 aseptic loosening in a patient who has declined revision, 2 dissociated glenosphere baseplates, 2 deep infections that required 2-stage exchanges, 1 deep infection that required a 2-stage exchange that was then complicated by dissociation of the glenosphere baseplate requiring revision, and 1 superficial infection that resolved with oral antibiotics.

After surgery, mean active forward elevation was 140°, mean active external rotation was 48°, and mean active internal rotation was to S1. Mean (SD) postoperative ASES score was 77.5 (23.4). Satisfaction level was high (mean, 8.3/10), and mean pain levels were low: 2.3 out of 10 on the visual analog scale and 44.0 (SD, 11.7) on the ASES pain component. Strength was rated a mean of good. Table 1 lists the clinical data for the primary and revision surgery patients.

Eighteen patients (23.1%) returned to 24 different high-intensity activities, such as hunting, golf, and skiing; 38 patients (48.7%) returned to moderate-intensity activities, such as swimming, bowling, and raking leaves; and 22 patients (28.2%) returned to low-intensity activities, such as riding a stationary bike, playing a musical instrument, and walking (Table 2). Four patients played golf before and after RTSA, but neither of the 2 patients who played tennis before RTSA were able to do so after. Patients reported they engaged in their favorite leisure activity a mean of 4.8 times per week and a mean of 1.5 hours each time.

A medical problem was cited by 58% of patients as the reason for limited activity. These patients reported physical decline resulting from cardiac disease, diabetes, asthma/chronic obstructive pulmonary disease, or arthritis in other joints. Reasons for activity limitation are listed in Table 3. Post-RTSA activities that patients could not do for any reason are listed in Table 4. Activity limitations that patients attributed to the RTSA are listed in Table 5.

The majority of patients (57.7%) reported no change, from before RTSA to after RTSA, in being unable to do certain desired activities (eg, softball, target shooting, horseback riding, running, traveling). Sixteen patients (20.8%) reported being unable to return to an activity (eg, tennis, swimming, baseball, kayaking) they had been able to do before surgery. Most (69%) of those patients reported being unable to return to a moderate- or high-intensity activity after RTSA, but 81.8% were able to return to different moderate- or high-intensity activities.

Revision patients, who reported lower overhead activity levels, constituted 73% of the patients who felt their shoulder mechanically limited their activity, despite the fact that revisions constituted only 25% of the cases overall. Mean active ROM was statistically lower for revision patients than for primary patients (P < .05). Mean ASES score was statistically lower for the revision group (P < .001) and represented a clinically significant difference. Mean pain level was low (3.3) and satisfaction still generally high (7.4), but pain, satisfaction, and strength were about 1 point worse on average in the revision group than in the primary group.

Discussion

In the United States and other countries, RTSA implant survivorship is good.9,22 In this article, we have reported on post-RTSA activity levels, on the significant impact of comorbidities on this group, and on the negative effect of revisions on postoperative activity. Patients in this population reported that concomitant medical problems were the most important factor limiting their post-RTSA activity levels. Understanding and interpreting quality-of-life or functional scores in this elderly group must take into account the impact of comorbidities.23

Patients should have realistic postoperative expectations.24 In this study, some patients engaged in high-intensity overhead activities, such as golf, chopping wood, and shooting. However, the most difficulty was encountered trying to return to activities (eg, tennis, kayaking, archery, combing hair) that required external rotation in abduction.

 

 

Patients who had a previous implant (eg, hemiarthroplasty, TSA, failed internal fixation) revised to RTSA had lower activity levels and were 9 times more likely than primary patients to report having a mechanical shoulder limitation affecting their activity. Revision patients also had worse forward elevation, external rotation, pain, and satisfaction.

This study is limited in that it is retrospective. Subsequent prospective studies focused on younger patients who undergo primary RTSA may be useful if indications expand. In addition, subscapularis status and especially infraspinatus status may affect activity levels and could be analyzed in a study. Another limitation is that we did not specifically record detailed preoperative data, though all patients were known to have preoperative forward elevation of less than 90°.

In general, the primary measure of success for RTSA has been pain relief. Some studies have also reported on strength and ROM.2,20,25,26 A recent study using similar methodology demonstrated comparable ROM and low pain after RTSA, though revisions were not included in that study.26 In contrast to the present study, no patient in that study was able to play tennis or golf, but the reasons for the limited activity were not explored. In both studies, post-RTSA sports were generally of lower intensity than those played by patients after anatomical TSA.27

Overall, the majority of patients were very satisfied with their low pain level after RTSA. In addition, many patients not limited by other medical conditions were able to return to their pre-RTSA moderate-intensity recreational activities.

References

1.    Baulot E, Chabernaud D, Grammont PM. Results of Grammont’s inverted prosthesis in omarthritis associated with major cuff destruction. Apropos of 16 cases [in French]. Acta Orthop Belg. 1995;61(suppl 1):112-119.

2.    Sirveaux F, Favard L, Oudet D, Huquet D, Walch G, Molé D. Grammont inverted total shoulder arthroplasty in the treatment of glenohumeral osteoarthritis with massive rupture of the cuff. Results of a multicentre study of 80 shoulders. J Bone Joint Surg Br. 2004;86(3):388-395.

3.    Franklin JL, Barrett WP, Jackins SE, Matsen FA 3rd. Glenoid loosening in total shoulder arthroplasty. Association with rotator cuff deficiency. J Arthroplasty. 1988;3(1):39-46.

4.    Neer CS 2nd, Craig EV, Fukuda H. Cuff-tear arthropathy. J Bone Joint Surg Am. 1983;65(9):1232-1244.

5.    Edwards TB, Boulahia A, Kempf JF, Boileau P, Nemoz C, Walch G. The influence of rotator cuff disease on the results of shoulder arthroplasty for primary osteoarthritis: results of a multicenter study. J Bone Joint Surg Am. 2002;84(12):2240-2248.

6.    Boileau P, Watkinson DJ, Hatzidakis AM, Balg F. Grammont reverse prosthesis: design, rationale, and biomechanics. J Shoulder Elbow Surg. 2005;14(1 suppl S):147S-161S.

7.    Nam D, Kepler CK, Neviaser AS, et al. Reverse total shoulder arthroplasty: current concepts, results, and component wear analysis. J Bone Joint Surg Am. 2010;92(suppl 2):23-35.

8.    Ackland DC, Roshan-Zamir S, Richardson M, Pandy MG. Moment arms of the shoulder musculature after reverse total shoulder arthroplasty. J Bone Joint Surg Am. 2010;92(5):1221-1230.

9.    Frankle M, Siegal S, Pupello D, Saleem A, Mighell M, Vasey M. The reverse shoulder prosthesis for glenohumeral arthritis associated with severe rotator cuff deficiency. A minimum two-year follow-up study of sixty patients. J Bone Joint Surg Am. 2005;87(8):1697-1705.

10.  Cazeneuve JF, Cristofari DJ. Long term functional outcome following reverse shoulder arthroplasty in the elderly. Orthop Traumatol Surg Res. 2011;97(6):583-589.

11.  Gerber C, Pennington, SD, Nyffeler RW. Reverse total shoulder arthroplasty. J Am Acad Orthop Surg. 2009;17(5):284-295.

12.  Brophy RH, Beauvais RL, Jones EC, Cordasco FA, Marx RG. Measurement of shoulder activity level. Clin Orthop. 2005;(439):101-108.

13.  Smith AM, Barnes SA, Sperling JW, Farrell CM, Cummings JD, Cofield RH. Patient and physician-assessed shoulder function after arthroplasty. J Bone Joint Surg Am. 2006;88(3):508-513.

14.  Zarkadas PC, Throckmorton TQ, Dahm DL, Sperling J, Schleck CD, Cofield R. Patient reported activities after shoulder replacement: total and hemiarthroplasty. J Shoulder Elbow Surg. 2011;20(2):273-280.

15.  Kocher, MS, Horan MP, Briggs KK, Richardson TR, O’Holleran J, Hawkins RJ. Reliability, validity, and responsiveness of the American Shoulder and Elbow Surgeons subjective shoulder scale in patients with shoulder instability, rotator cuff disease, and glenohumeral arthritis. J Bone Joint Surg Am. 2005;87(9):2006-2011.

16.  Richards RR, An KN, Bigliani LU, et al. A standardized method for the assessment of shoulder function. J Shoulder Elbow Surg. 1994;3(6):347-352.

17.  Michener LA, McClure PW, Sennett BJ. American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form, patient self-report section: reliability, validity, and responsiveness. J Shoulder Elbow Surg. 2002;11(6):587-594.

18.  Hunsaker FG, Cioffi DA, Amadio PC, Wright JG, Caughlin B. The American Academy of Orthopaedic Surgeons outcomes instruments: normative values from the general population. J Bone Joint Surg Am. 2002;84(2):208-215.

19.  Molé D, Favard L. Excentered scapulohumeral osteoarthritis [in French]. Rev Chir Orthop Reparatrice Appar Mot. 2007;93(6 suppl):37-94.

20.  Clark JC, Ritchie J, Song FS, et al. Complication rates, dislocation, pain, and postoperative range of motion after reverse shoulder arthroplasty in patients with and without repair of the subscapularis. J Shoulder Elbow Surg. 2012;21(1):36-41.

21.  Boulahia A, Edwards TB, Walch G, Baratta RV. Early results of a reverse design prosthesis in the treatment of arthritis of the shoulder in elderly patients with a large rotator cuff tear. Orthopedics. 2002;25(2):129-133.

22.  Guery J, Favard L, Sirveaux F, Oudet D, Mole D, Walch G. Reverse total shoulder arthroplasty. Survivorship analysis of eighty replacements followed for five to ten years. J Bone Joint Surg Am. 2006;88(8):1742-1747.

23.  Antuña SA, Sperling JW, Sánchez-Sotelo J, Cofield RH. Shoulder arthroplasty for proximal humeral nonunions. J Shoulder Elbow Surg. 2002;11(2):114-121.

24.  Cheung E, Willis M, Walker M, Clark R, Frankle MA. Complications in reverse total shoulder arthroplasty. J Am Acad Orthop Surg. 2011;19(7):439-449.

25.  Nolan BM, Ankerson E, Wiater JM. Reverse total shoulder arthroplasty improves function in cuff tear arthropathy. Clin Orthop. 2011;469(9):2476-2482.

26.  Lawrence TM, Ahmadi S, Sanchez-Sotelo J, Sperling JW, Cofield RH. Patient reported activities after reverse shoulder arthroplasty: part II. J Shoulder Elbow Surg. 2012;21(11):1464-1469.

27.   Schumann K, Flury MP, Schwyzer HK, Simmen BR, Drerup S, Goldhahn J. Sports activity after anatomical total shoulder arthroplasty. Am J Sports Med. 2010;38(10):2097-2105.

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Author and Disclosure Information

Leslie A. Fink Barnes, MD, W. Jeffrey Grantham, MD, Molly C. Meadows, MD, Louis U. Bigliani, MD, William N. Levine, MD, and Christopher S. Ahmad, MD

Authors’ Disclosure Statement: Dr. Bigliani wishes to report that he receives intellectual property royalties from Zimmer, and Dr. Levine wishes to report that he is an unpaid consultant to Zimmer. The other authors report no actual or potential conflict of interest in relation to this article.

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The American Journal of Orthopedics - 44(2)
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68-72
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american journal of orthopedics, AJO, original study, sports, sports activity, athletes, athletic, sports medicine, reverse total shoulder arthroplasty, RTSA, total shoulder arthroplasty, TSA, shoulder, arthroplasty, surgery, arm, rotator cuff, fink barnes, grantham, meadows, bigliani, levine, ahmad
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Leslie A. Fink Barnes, MD, W. Jeffrey Grantham, MD, Molly C. Meadows, MD, Louis U. Bigliani, MD, William N. Levine, MD, and Christopher S. Ahmad, MD

Authors’ Disclosure Statement: Dr. Bigliani wishes to report that he receives intellectual property royalties from Zimmer, and Dr. Levine wishes to report that he is an unpaid consultant to Zimmer. The other authors report no actual or potential conflict of interest in relation to this article.

Author and Disclosure Information

Leslie A. Fink Barnes, MD, W. Jeffrey Grantham, MD, Molly C. Meadows, MD, Louis U. Bigliani, MD, William N. Levine, MD, and Christopher S. Ahmad, MD

Authors’ Disclosure Statement: Dr. Bigliani wishes to report that he receives intellectual property royalties from Zimmer, and Dr. Levine wishes to report that he is an unpaid consultant to Zimmer. The other authors report no actual or potential conflict of interest in relation to this article.

Article PDF
Article PDF

The treatment of patients with severe shoulder pain and disability combined with a nonfunctional rotator cuff was a clinical challenge until the development of the reverse total shoulder arthroplasty (RTSA).1-3 Massive rotator cuff tears can leave patients with a pseudoparalytic upper extremity and may result in advanced arthritis of the joint because of altered mechanical and nutritional factors.4 In this setting, simply replacing the arthritic joint with standard total shoulder arthroplasty (TSA) is not recommended because it does not address the functional deficits, and it has poor long-term outcomes.3,5 RTSA works by changing the center of rotation of the shoulder joint so that the deltoid muscle can be used to elevate the arm.6,7 The 4 rotator cuff muscles are not required for forward elevation or stability of this constrained implant.6,8

Current indications for RTSA are cuff tear arthropathy, complex proximal humerus fractures, and revision from hemiarthroplasty or TSA with rotator cuff dysfunction. Patients with advanced cuff tear arthropathy have minimal forward elevation and pseudoparalysis. Previous studies have shown mean preoperative forward flexion of 55º and mean ASES (American Shoulder and Elbow Surgeons) Standardized Shoulder Assessment Form score of 34.3.9 Thus, minimal overhead activity is possible without RTSA. Advances in the RTSA technique have led to promising results (excellent functional improvement), but there is limited information regarding the activity levels patients can achieve after surgery.7,9-11

We conducted a study of the types of sporting activities in which patients with RTSA could participate. We hypothesized that, relative to historic controls, patients with RTSA could return to low-intensity sporting activities with improvement in motion and ASES scores.

Materials and Methods

After this study received institutional review board approval, patients who had undergone RTSA at our institution between January 1, 2004 and December 31, 2010 were identified by the billing codes used for the procedure. Each patient who had RTSA performed during the study period was included in the study. Charts were then reviewed to extract demographic data, preoperative diagnosis, surgery date, operative side, dominant side, type of implant used, operative complications, and subsequent revisions. A questionnaire (Appendix) was designed and used to assess activity, functional status, pain, and satisfaction levels after RTSA. Patients had to be willing and able to complete this questionnaire in order to be included in the study.

The questionnaire included demographic questions; a list of 42 activities patients could choose from to describe their current activity level, activities they were able to perform before the surgery, and activities they wish they could perform; a list of reasons for any limitations; and questions about overall pain, strength, and satisfaction with the procedure. In addition, there was an open-ended question for activities that may not have been listed. The questionnaire also included a validated method for assessing shoulder range of motion (ROM) at home, where patients rated their overhead motion according to standardized physical landmarks, including the level of the shoulder, chin, eyebrows, top of head, and above head.12-14 Also provided was the ASES Standardized Shoulder Assessment Form, which features a 100-point visual analog scale for pain plus functional ability questions, with higher scores indicating less pain and better function.15,16 The minimal clinical significance in the ASES score is 6.4 points.17,18 Scores were recorded and analyzed. Student t test was used to calculate statistical differences between patients who had primary RTSA performed and patients who underwent revision RTSA.

Study personnel contacted patients by telephone and direct mailing. Patients who could not be reached initially were called at least 4 more times: twice during the weekday, once during the evening, and once on the weekend. Patients who could not be contacted by telephone were then cross-referenced with the Social Security database to see if any were deceased. Response data were tabulated, and patients were stratified into high-, moderate-, and low-intensity activity.

One of the 3 senior authors (Dr. Ahmad, Dr. Bigliani, Dr. Levine) performed the 95 RTSAs: 84 Zimmer (Warsaw, Indiana), 7 DePuy (Warsaw, Indiana), 4 Tornier (Minneapolis, Minnesota). The DePuy and Tornier implants were used when a 30-mm glenoid peg was required (before Zimmer offered this length in its system). The procedure was done with a deltopectoral approach with 20° of retroversion. In revision cases, the same approach was used, the hardware or implants were removed, and the position of the humeral component was determined based on the pectoralis major insertion and the deltoid tension. In 80% of cases, the subscapularis was not repaired; in the other 20%, it was. Whether it was repaired depended on tendon viability and surgeon preference, as subscapularis repair status has been shown not to affect functional outcome.19-21 No combined latissimus transfers were performed. Patients wore a sling the first 4 weeks after surgery (only wrist and elbow motion allowed) and then advanced to active shoulder ROM. Eight weeks after surgery, they began gentle shoulder strengthening.

 

 

Results

One hundred nine consecutive patients underwent RTSA at a single institution. Fifteen patients subsequently died, 14 could not be contacted, and 2 declined, leaving 78 patients available for clinical follow-up. Mean follow-up was 4.8 years (range 2-9 years). Mean (SD) age at surgery was 75.3 (7.5) years. Seventy-five percent of the patients were women. Sixty-one percent underwent surgery for cuff tear arthropathy, 31% for revision of previous arthroplasty or internal fixation, 7% for complex fractures, and 1% for tumor. Of the 24 revisions, 15 were for failed hemiarthroplasty, 3 were for failed TSA with rotator cuff dysfunction, 4 were for fracture with failed internal fixation, and 2 were for failed RTSA referred from other institutions. The dominant shoulder was involved 62% of the time. Preoperative active forward shoulder elevation was less than 90° in all patients. There were 10 complications: 2 dislocations that were closed-reduced and remained stable, 1 dislocation that required revision of the liner, 1 aseptic loosening in a patient who has declined revision, 2 dissociated glenosphere baseplates, 2 deep infections that required 2-stage exchanges, 1 deep infection that required a 2-stage exchange that was then complicated by dissociation of the glenosphere baseplate requiring revision, and 1 superficial infection that resolved with oral antibiotics.

After surgery, mean active forward elevation was 140°, mean active external rotation was 48°, and mean active internal rotation was to S1. Mean (SD) postoperative ASES score was 77.5 (23.4). Satisfaction level was high (mean, 8.3/10), and mean pain levels were low: 2.3 out of 10 on the visual analog scale and 44.0 (SD, 11.7) on the ASES pain component. Strength was rated a mean of good. Table 1 lists the clinical data for the primary and revision surgery patients.

Eighteen patients (23.1%) returned to 24 different high-intensity activities, such as hunting, golf, and skiing; 38 patients (48.7%) returned to moderate-intensity activities, such as swimming, bowling, and raking leaves; and 22 patients (28.2%) returned to low-intensity activities, such as riding a stationary bike, playing a musical instrument, and walking (Table 2). Four patients played golf before and after RTSA, but neither of the 2 patients who played tennis before RTSA were able to do so after. Patients reported they engaged in their favorite leisure activity a mean of 4.8 times per week and a mean of 1.5 hours each time.

A medical problem was cited by 58% of patients as the reason for limited activity. These patients reported physical decline resulting from cardiac disease, diabetes, asthma/chronic obstructive pulmonary disease, or arthritis in other joints. Reasons for activity limitation are listed in Table 3. Post-RTSA activities that patients could not do for any reason are listed in Table 4. Activity limitations that patients attributed to the RTSA are listed in Table 5.

The majority of patients (57.7%) reported no change, from before RTSA to after RTSA, in being unable to do certain desired activities (eg, softball, target shooting, horseback riding, running, traveling). Sixteen patients (20.8%) reported being unable to return to an activity (eg, tennis, swimming, baseball, kayaking) they had been able to do before surgery. Most (69%) of those patients reported being unable to return to a moderate- or high-intensity activity after RTSA, but 81.8% were able to return to different moderate- or high-intensity activities.

Revision patients, who reported lower overhead activity levels, constituted 73% of the patients who felt their shoulder mechanically limited their activity, despite the fact that revisions constituted only 25% of the cases overall. Mean active ROM was statistically lower for revision patients than for primary patients (P < .05). Mean ASES score was statistically lower for the revision group (P < .001) and represented a clinically significant difference. Mean pain level was low (3.3) and satisfaction still generally high (7.4), but pain, satisfaction, and strength were about 1 point worse on average in the revision group than in the primary group.

Discussion

In the United States and other countries, RTSA implant survivorship is good.9,22 In this article, we have reported on post-RTSA activity levels, on the significant impact of comorbidities on this group, and on the negative effect of revisions on postoperative activity. Patients in this population reported that concomitant medical problems were the most important factor limiting their post-RTSA activity levels. Understanding and interpreting quality-of-life or functional scores in this elderly group must take into account the impact of comorbidities.23

Patients should have realistic postoperative expectations.24 In this study, some patients engaged in high-intensity overhead activities, such as golf, chopping wood, and shooting. However, the most difficulty was encountered trying to return to activities (eg, tennis, kayaking, archery, combing hair) that required external rotation in abduction.

 

 

Patients who had a previous implant (eg, hemiarthroplasty, TSA, failed internal fixation) revised to RTSA had lower activity levels and were 9 times more likely than primary patients to report having a mechanical shoulder limitation affecting their activity. Revision patients also had worse forward elevation, external rotation, pain, and satisfaction.

This study is limited in that it is retrospective. Subsequent prospective studies focused on younger patients who undergo primary RTSA may be useful if indications expand. In addition, subscapularis status and especially infraspinatus status may affect activity levels and could be analyzed in a study. Another limitation is that we did not specifically record detailed preoperative data, though all patients were known to have preoperative forward elevation of less than 90°.

In general, the primary measure of success for RTSA has been pain relief. Some studies have also reported on strength and ROM.2,20,25,26 A recent study using similar methodology demonstrated comparable ROM and low pain after RTSA, though revisions were not included in that study.26 In contrast to the present study, no patient in that study was able to play tennis or golf, but the reasons for the limited activity were not explored. In both studies, post-RTSA sports were generally of lower intensity than those played by patients after anatomical TSA.27

Overall, the majority of patients were very satisfied with their low pain level after RTSA. In addition, many patients not limited by other medical conditions were able to return to their pre-RTSA moderate-intensity recreational activities.

The treatment of patients with severe shoulder pain and disability combined with a nonfunctional rotator cuff was a clinical challenge until the development of the reverse total shoulder arthroplasty (RTSA).1-3 Massive rotator cuff tears can leave patients with a pseudoparalytic upper extremity and may result in advanced arthritis of the joint because of altered mechanical and nutritional factors.4 In this setting, simply replacing the arthritic joint with standard total shoulder arthroplasty (TSA) is not recommended because it does not address the functional deficits, and it has poor long-term outcomes.3,5 RTSA works by changing the center of rotation of the shoulder joint so that the deltoid muscle can be used to elevate the arm.6,7 The 4 rotator cuff muscles are not required for forward elevation or stability of this constrained implant.6,8

Current indications for RTSA are cuff tear arthropathy, complex proximal humerus fractures, and revision from hemiarthroplasty or TSA with rotator cuff dysfunction. Patients with advanced cuff tear arthropathy have minimal forward elevation and pseudoparalysis. Previous studies have shown mean preoperative forward flexion of 55º and mean ASES (American Shoulder and Elbow Surgeons) Standardized Shoulder Assessment Form score of 34.3.9 Thus, minimal overhead activity is possible without RTSA. Advances in the RTSA technique have led to promising results (excellent functional improvement), but there is limited information regarding the activity levels patients can achieve after surgery.7,9-11

We conducted a study of the types of sporting activities in which patients with RTSA could participate. We hypothesized that, relative to historic controls, patients with RTSA could return to low-intensity sporting activities with improvement in motion and ASES scores.

Materials and Methods

After this study received institutional review board approval, patients who had undergone RTSA at our institution between January 1, 2004 and December 31, 2010 were identified by the billing codes used for the procedure. Each patient who had RTSA performed during the study period was included in the study. Charts were then reviewed to extract demographic data, preoperative diagnosis, surgery date, operative side, dominant side, type of implant used, operative complications, and subsequent revisions. A questionnaire (Appendix) was designed and used to assess activity, functional status, pain, and satisfaction levels after RTSA. Patients had to be willing and able to complete this questionnaire in order to be included in the study.

The questionnaire included demographic questions; a list of 42 activities patients could choose from to describe their current activity level, activities they were able to perform before the surgery, and activities they wish they could perform; a list of reasons for any limitations; and questions about overall pain, strength, and satisfaction with the procedure. In addition, there was an open-ended question for activities that may not have been listed. The questionnaire also included a validated method for assessing shoulder range of motion (ROM) at home, where patients rated their overhead motion according to standardized physical landmarks, including the level of the shoulder, chin, eyebrows, top of head, and above head.12-14 Also provided was the ASES Standardized Shoulder Assessment Form, which features a 100-point visual analog scale for pain plus functional ability questions, with higher scores indicating less pain and better function.15,16 The minimal clinical significance in the ASES score is 6.4 points.17,18 Scores were recorded and analyzed. Student t test was used to calculate statistical differences between patients who had primary RTSA performed and patients who underwent revision RTSA.

Study personnel contacted patients by telephone and direct mailing. Patients who could not be reached initially were called at least 4 more times: twice during the weekday, once during the evening, and once on the weekend. Patients who could not be contacted by telephone were then cross-referenced with the Social Security database to see if any were deceased. Response data were tabulated, and patients were stratified into high-, moderate-, and low-intensity activity.

One of the 3 senior authors (Dr. Ahmad, Dr. Bigliani, Dr. Levine) performed the 95 RTSAs: 84 Zimmer (Warsaw, Indiana), 7 DePuy (Warsaw, Indiana), 4 Tornier (Minneapolis, Minnesota). The DePuy and Tornier implants were used when a 30-mm glenoid peg was required (before Zimmer offered this length in its system). The procedure was done with a deltopectoral approach with 20° of retroversion. In revision cases, the same approach was used, the hardware or implants were removed, and the position of the humeral component was determined based on the pectoralis major insertion and the deltoid tension. In 80% of cases, the subscapularis was not repaired; in the other 20%, it was. Whether it was repaired depended on tendon viability and surgeon preference, as subscapularis repair status has been shown not to affect functional outcome.19-21 No combined latissimus transfers were performed. Patients wore a sling the first 4 weeks after surgery (only wrist and elbow motion allowed) and then advanced to active shoulder ROM. Eight weeks after surgery, they began gentle shoulder strengthening.

 

 

Results

One hundred nine consecutive patients underwent RTSA at a single institution. Fifteen patients subsequently died, 14 could not be contacted, and 2 declined, leaving 78 patients available for clinical follow-up. Mean follow-up was 4.8 years (range 2-9 years). Mean (SD) age at surgery was 75.3 (7.5) years. Seventy-five percent of the patients were women. Sixty-one percent underwent surgery for cuff tear arthropathy, 31% for revision of previous arthroplasty or internal fixation, 7% for complex fractures, and 1% for tumor. Of the 24 revisions, 15 were for failed hemiarthroplasty, 3 were for failed TSA with rotator cuff dysfunction, 4 were for fracture with failed internal fixation, and 2 were for failed RTSA referred from other institutions. The dominant shoulder was involved 62% of the time. Preoperative active forward shoulder elevation was less than 90° in all patients. There were 10 complications: 2 dislocations that were closed-reduced and remained stable, 1 dislocation that required revision of the liner, 1 aseptic loosening in a patient who has declined revision, 2 dissociated glenosphere baseplates, 2 deep infections that required 2-stage exchanges, 1 deep infection that required a 2-stage exchange that was then complicated by dissociation of the glenosphere baseplate requiring revision, and 1 superficial infection that resolved with oral antibiotics.

After surgery, mean active forward elevation was 140°, mean active external rotation was 48°, and mean active internal rotation was to S1. Mean (SD) postoperative ASES score was 77.5 (23.4). Satisfaction level was high (mean, 8.3/10), and mean pain levels were low: 2.3 out of 10 on the visual analog scale and 44.0 (SD, 11.7) on the ASES pain component. Strength was rated a mean of good. Table 1 lists the clinical data for the primary and revision surgery patients.

Eighteen patients (23.1%) returned to 24 different high-intensity activities, such as hunting, golf, and skiing; 38 patients (48.7%) returned to moderate-intensity activities, such as swimming, bowling, and raking leaves; and 22 patients (28.2%) returned to low-intensity activities, such as riding a stationary bike, playing a musical instrument, and walking (Table 2). Four patients played golf before and after RTSA, but neither of the 2 patients who played tennis before RTSA were able to do so after. Patients reported they engaged in their favorite leisure activity a mean of 4.8 times per week and a mean of 1.5 hours each time.

A medical problem was cited by 58% of patients as the reason for limited activity. These patients reported physical decline resulting from cardiac disease, diabetes, asthma/chronic obstructive pulmonary disease, or arthritis in other joints. Reasons for activity limitation are listed in Table 3. Post-RTSA activities that patients could not do for any reason are listed in Table 4. Activity limitations that patients attributed to the RTSA are listed in Table 5.

The majority of patients (57.7%) reported no change, from before RTSA to after RTSA, in being unable to do certain desired activities (eg, softball, target shooting, horseback riding, running, traveling). Sixteen patients (20.8%) reported being unable to return to an activity (eg, tennis, swimming, baseball, kayaking) they had been able to do before surgery. Most (69%) of those patients reported being unable to return to a moderate- or high-intensity activity after RTSA, but 81.8% were able to return to different moderate- or high-intensity activities.

Revision patients, who reported lower overhead activity levels, constituted 73% of the patients who felt their shoulder mechanically limited their activity, despite the fact that revisions constituted only 25% of the cases overall. Mean active ROM was statistically lower for revision patients than for primary patients (P < .05). Mean ASES score was statistically lower for the revision group (P < .001) and represented a clinically significant difference. Mean pain level was low (3.3) and satisfaction still generally high (7.4), but pain, satisfaction, and strength were about 1 point worse on average in the revision group than in the primary group.

Discussion

In the United States and other countries, RTSA implant survivorship is good.9,22 In this article, we have reported on post-RTSA activity levels, on the significant impact of comorbidities on this group, and on the negative effect of revisions on postoperative activity. Patients in this population reported that concomitant medical problems were the most important factor limiting their post-RTSA activity levels. Understanding and interpreting quality-of-life or functional scores in this elderly group must take into account the impact of comorbidities.23

Patients should have realistic postoperative expectations.24 In this study, some patients engaged in high-intensity overhead activities, such as golf, chopping wood, and shooting. However, the most difficulty was encountered trying to return to activities (eg, tennis, kayaking, archery, combing hair) that required external rotation in abduction.

 

 

Patients who had a previous implant (eg, hemiarthroplasty, TSA, failed internal fixation) revised to RTSA had lower activity levels and were 9 times more likely than primary patients to report having a mechanical shoulder limitation affecting their activity. Revision patients also had worse forward elevation, external rotation, pain, and satisfaction.

This study is limited in that it is retrospective. Subsequent prospective studies focused on younger patients who undergo primary RTSA may be useful if indications expand. In addition, subscapularis status and especially infraspinatus status may affect activity levels and could be analyzed in a study. Another limitation is that we did not specifically record detailed preoperative data, though all patients were known to have preoperative forward elevation of less than 90°.

In general, the primary measure of success for RTSA has been pain relief. Some studies have also reported on strength and ROM.2,20,25,26 A recent study using similar methodology demonstrated comparable ROM and low pain after RTSA, though revisions were not included in that study.26 In contrast to the present study, no patient in that study was able to play tennis or golf, but the reasons for the limited activity were not explored. In both studies, post-RTSA sports were generally of lower intensity than those played by patients after anatomical TSA.27

Overall, the majority of patients were very satisfied with their low pain level after RTSA. In addition, many patients not limited by other medical conditions were able to return to their pre-RTSA moderate-intensity recreational activities.

References

1.    Baulot E, Chabernaud D, Grammont PM. Results of Grammont’s inverted prosthesis in omarthritis associated with major cuff destruction. Apropos of 16 cases [in French]. Acta Orthop Belg. 1995;61(suppl 1):112-119.

2.    Sirveaux F, Favard L, Oudet D, Huquet D, Walch G, Molé D. Grammont inverted total shoulder arthroplasty in the treatment of glenohumeral osteoarthritis with massive rupture of the cuff. Results of a multicentre study of 80 shoulders. J Bone Joint Surg Br. 2004;86(3):388-395.

3.    Franklin JL, Barrett WP, Jackins SE, Matsen FA 3rd. Glenoid loosening in total shoulder arthroplasty. Association with rotator cuff deficiency. J Arthroplasty. 1988;3(1):39-46.

4.    Neer CS 2nd, Craig EV, Fukuda H. Cuff-tear arthropathy. J Bone Joint Surg Am. 1983;65(9):1232-1244.

5.    Edwards TB, Boulahia A, Kempf JF, Boileau P, Nemoz C, Walch G. The influence of rotator cuff disease on the results of shoulder arthroplasty for primary osteoarthritis: results of a multicenter study. J Bone Joint Surg Am. 2002;84(12):2240-2248.

6.    Boileau P, Watkinson DJ, Hatzidakis AM, Balg F. Grammont reverse prosthesis: design, rationale, and biomechanics. J Shoulder Elbow Surg. 2005;14(1 suppl S):147S-161S.

7.    Nam D, Kepler CK, Neviaser AS, et al. Reverse total shoulder arthroplasty: current concepts, results, and component wear analysis. J Bone Joint Surg Am. 2010;92(suppl 2):23-35.

8.    Ackland DC, Roshan-Zamir S, Richardson M, Pandy MG. Moment arms of the shoulder musculature after reverse total shoulder arthroplasty. J Bone Joint Surg Am. 2010;92(5):1221-1230.

9.    Frankle M, Siegal S, Pupello D, Saleem A, Mighell M, Vasey M. The reverse shoulder prosthesis for glenohumeral arthritis associated with severe rotator cuff deficiency. A minimum two-year follow-up study of sixty patients. J Bone Joint Surg Am. 2005;87(8):1697-1705.

10.  Cazeneuve JF, Cristofari DJ. Long term functional outcome following reverse shoulder arthroplasty in the elderly. Orthop Traumatol Surg Res. 2011;97(6):583-589.

11.  Gerber C, Pennington, SD, Nyffeler RW. Reverse total shoulder arthroplasty. J Am Acad Orthop Surg. 2009;17(5):284-295.

12.  Brophy RH, Beauvais RL, Jones EC, Cordasco FA, Marx RG. Measurement of shoulder activity level. Clin Orthop. 2005;(439):101-108.

13.  Smith AM, Barnes SA, Sperling JW, Farrell CM, Cummings JD, Cofield RH. Patient and physician-assessed shoulder function after arthroplasty. J Bone Joint Surg Am. 2006;88(3):508-513.

14.  Zarkadas PC, Throckmorton TQ, Dahm DL, Sperling J, Schleck CD, Cofield R. Patient reported activities after shoulder replacement: total and hemiarthroplasty. J Shoulder Elbow Surg. 2011;20(2):273-280.

15.  Kocher, MS, Horan MP, Briggs KK, Richardson TR, O’Holleran J, Hawkins RJ. Reliability, validity, and responsiveness of the American Shoulder and Elbow Surgeons subjective shoulder scale in patients with shoulder instability, rotator cuff disease, and glenohumeral arthritis. J Bone Joint Surg Am. 2005;87(9):2006-2011.

16.  Richards RR, An KN, Bigliani LU, et al. A standardized method for the assessment of shoulder function. J Shoulder Elbow Surg. 1994;3(6):347-352.

17.  Michener LA, McClure PW, Sennett BJ. American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form, patient self-report section: reliability, validity, and responsiveness. J Shoulder Elbow Surg. 2002;11(6):587-594.

18.  Hunsaker FG, Cioffi DA, Amadio PC, Wright JG, Caughlin B. The American Academy of Orthopaedic Surgeons outcomes instruments: normative values from the general population. J Bone Joint Surg Am. 2002;84(2):208-215.

19.  Molé D, Favard L. Excentered scapulohumeral osteoarthritis [in French]. Rev Chir Orthop Reparatrice Appar Mot. 2007;93(6 suppl):37-94.

20.  Clark JC, Ritchie J, Song FS, et al. Complication rates, dislocation, pain, and postoperative range of motion after reverse shoulder arthroplasty in patients with and without repair of the subscapularis. J Shoulder Elbow Surg. 2012;21(1):36-41.

21.  Boulahia A, Edwards TB, Walch G, Baratta RV. Early results of a reverse design prosthesis in the treatment of arthritis of the shoulder in elderly patients with a large rotator cuff tear. Orthopedics. 2002;25(2):129-133.

22.  Guery J, Favard L, Sirveaux F, Oudet D, Mole D, Walch G. Reverse total shoulder arthroplasty. Survivorship analysis of eighty replacements followed for five to ten years. J Bone Joint Surg Am. 2006;88(8):1742-1747.

23.  Antuña SA, Sperling JW, Sánchez-Sotelo J, Cofield RH. Shoulder arthroplasty for proximal humeral nonunions. J Shoulder Elbow Surg. 2002;11(2):114-121.

24.  Cheung E, Willis M, Walker M, Clark R, Frankle MA. Complications in reverse total shoulder arthroplasty. J Am Acad Orthop Surg. 2011;19(7):439-449.

25.  Nolan BM, Ankerson E, Wiater JM. Reverse total shoulder arthroplasty improves function in cuff tear arthropathy. Clin Orthop. 2011;469(9):2476-2482.

26.  Lawrence TM, Ahmadi S, Sanchez-Sotelo J, Sperling JW, Cofield RH. Patient reported activities after reverse shoulder arthroplasty: part II. J Shoulder Elbow Surg. 2012;21(11):1464-1469.

27.   Schumann K, Flury MP, Schwyzer HK, Simmen BR, Drerup S, Goldhahn J. Sports activity after anatomical total shoulder arthroplasty. Am J Sports Med. 2010;38(10):2097-2105.

References

1.    Baulot E, Chabernaud D, Grammont PM. Results of Grammont’s inverted prosthesis in omarthritis associated with major cuff destruction. Apropos of 16 cases [in French]. Acta Orthop Belg. 1995;61(suppl 1):112-119.

2.    Sirveaux F, Favard L, Oudet D, Huquet D, Walch G, Molé D. Grammont inverted total shoulder arthroplasty in the treatment of glenohumeral osteoarthritis with massive rupture of the cuff. Results of a multicentre study of 80 shoulders. J Bone Joint Surg Br. 2004;86(3):388-395.

3.    Franklin JL, Barrett WP, Jackins SE, Matsen FA 3rd. Glenoid loosening in total shoulder arthroplasty. Association with rotator cuff deficiency. J Arthroplasty. 1988;3(1):39-46.

4.    Neer CS 2nd, Craig EV, Fukuda H. Cuff-tear arthropathy. J Bone Joint Surg Am. 1983;65(9):1232-1244.

5.    Edwards TB, Boulahia A, Kempf JF, Boileau P, Nemoz C, Walch G. The influence of rotator cuff disease on the results of shoulder arthroplasty for primary osteoarthritis: results of a multicenter study. J Bone Joint Surg Am. 2002;84(12):2240-2248.

6.    Boileau P, Watkinson DJ, Hatzidakis AM, Balg F. Grammont reverse prosthesis: design, rationale, and biomechanics. J Shoulder Elbow Surg. 2005;14(1 suppl S):147S-161S.

7.    Nam D, Kepler CK, Neviaser AS, et al. Reverse total shoulder arthroplasty: current concepts, results, and component wear analysis. J Bone Joint Surg Am. 2010;92(suppl 2):23-35.

8.    Ackland DC, Roshan-Zamir S, Richardson M, Pandy MG. Moment arms of the shoulder musculature after reverse total shoulder arthroplasty. J Bone Joint Surg Am. 2010;92(5):1221-1230.

9.    Frankle M, Siegal S, Pupello D, Saleem A, Mighell M, Vasey M. The reverse shoulder prosthesis for glenohumeral arthritis associated with severe rotator cuff deficiency. A minimum two-year follow-up study of sixty patients. J Bone Joint Surg Am. 2005;87(8):1697-1705.

10.  Cazeneuve JF, Cristofari DJ. Long term functional outcome following reverse shoulder arthroplasty in the elderly. Orthop Traumatol Surg Res. 2011;97(6):583-589.

11.  Gerber C, Pennington, SD, Nyffeler RW. Reverse total shoulder arthroplasty. J Am Acad Orthop Surg. 2009;17(5):284-295.

12.  Brophy RH, Beauvais RL, Jones EC, Cordasco FA, Marx RG. Measurement of shoulder activity level. Clin Orthop. 2005;(439):101-108.

13.  Smith AM, Barnes SA, Sperling JW, Farrell CM, Cummings JD, Cofield RH. Patient and physician-assessed shoulder function after arthroplasty. J Bone Joint Surg Am. 2006;88(3):508-513.

14.  Zarkadas PC, Throckmorton TQ, Dahm DL, Sperling J, Schleck CD, Cofield R. Patient reported activities after shoulder replacement: total and hemiarthroplasty. J Shoulder Elbow Surg. 2011;20(2):273-280.

15.  Kocher, MS, Horan MP, Briggs KK, Richardson TR, O’Holleran J, Hawkins RJ. Reliability, validity, and responsiveness of the American Shoulder and Elbow Surgeons subjective shoulder scale in patients with shoulder instability, rotator cuff disease, and glenohumeral arthritis. J Bone Joint Surg Am. 2005;87(9):2006-2011.

16.  Richards RR, An KN, Bigliani LU, et al. A standardized method for the assessment of shoulder function. J Shoulder Elbow Surg. 1994;3(6):347-352.

17.  Michener LA, McClure PW, Sennett BJ. American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form, patient self-report section: reliability, validity, and responsiveness. J Shoulder Elbow Surg. 2002;11(6):587-594.

18.  Hunsaker FG, Cioffi DA, Amadio PC, Wright JG, Caughlin B. The American Academy of Orthopaedic Surgeons outcomes instruments: normative values from the general population. J Bone Joint Surg Am. 2002;84(2):208-215.

19.  Molé D, Favard L. Excentered scapulohumeral osteoarthritis [in French]. Rev Chir Orthop Reparatrice Appar Mot. 2007;93(6 suppl):37-94.

20.  Clark JC, Ritchie J, Song FS, et al. Complication rates, dislocation, pain, and postoperative range of motion after reverse shoulder arthroplasty in patients with and without repair of the subscapularis. J Shoulder Elbow Surg. 2012;21(1):36-41.

21.  Boulahia A, Edwards TB, Walch G, Baratta RV. Early results of a reverse design prosthesis in the treatment of arthritis of the shoulder in elderly patients with a large rotator cuff tear. Orthopedics. 2002;25(2):129-133.

22.  Guery J, Favard L, Sirveaux F, Oudet D, Mole D, Walch G. Reverse total shoulder arthroplasty. Survivorship analysis of eighty replacements followed for five to ten years. J Bone Joint Surg Am. 2006;88(8):1742-1747.

23.  Antuña SA, Sperling JW, Sánchez-Sotelo J, Cofield RH. Shoulder arthroplasty for proximal humeral nonunions. J Shoulder Elbow Surg. 2002;11(2):114-121.

24.  Cheung E, Willis M, Walker M, Clark R, Frankle MA. Complications in reverse total shoulder arthroplasty. J Am Acad Orthop Surg. 2011;19(7):439-449.

25.  Nolan BM, Ankerson E, Wiater JM. Reverse total shoulder arthroplasty improves function in cuff tear arthropathy. Clin Orthop. 2011;469(9):2476-2482.

26.  Lawrence TM, Ahmadi S, Sanchez-Sotelo J, Sperling JW, Cofield RH. Patient reported activities after reverse shoulder arthroplasty: part II. J Shoulder Elbow Surg. 2012;21(11):1464-1469.

27.   Schumann K, Flury MP, Schwyzer HK, Simmen BR, Drerup S, Goldhahn J. Sports activity after anatomical total shoulder arthroplasty. Am J Sports Med. 2010;38(10):2097-2105.

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The Epidemic of Tommy John Surgery: The Role of the Orthopedic Surgeon

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The Epidemic of Tommy John Surgery: The Role of the Orthopedic Surgeon

Ulnar collateral ligament (UCL) reconstruction, commonly referred to as Tommy John surgery, is a well-described surgical treatment for elite athletes with a symptomatic, deficient UCL.1, 2 The procedure was first performed by the late Dr. Frank Jobe in 1974, described in 1986, and has undergone several modifications over the past 30 years.3 Different graft choices, tunnel positions, graft configurations, and tunnel fixation methods are just some of the alterations that have been made to the original Jobe technique.4-6 With time, the index procedure has become more refined, with predictable outcomes in Major League Baseball (MLB) pitchers as well as other elite overhead throwing athletes.2,7,8 However, though this surgery was originally described for elite athletes suffering from UCL deficiency, recent times have seen an increase of over 50% in the number of UCL reconstructions performed on high school–aged and younger athletes.9 Furthermore, in 2000, a total of 13 MLB pitchers underwent UCL reconstruction, while in 2012 this number increased nearly threefold to 32.2 This paradigm shift of performing UCL reconstructions more frequently and on younger athletes raises a very important question: what is the role of the orthopedic surgeon in this epidemic?

UCL reconstruction has become a reliable procedure for MLB pitchers and other overhead throwing athletes.7,10,11 Recent studies have reported that MLB pitchers who undergo UCL reconstruction return to pitch in the MLB 83% of the time, whereas only 3% fail to return to pitch in either MLB or the minor league.2 Furthermore, pitchers who undergo UCL reconstruction perform similarly after surgery as prior to their UCL reconstruction, with fewer innings pitched after surgery, but, more importantly, a lower earned run average (ERA) and walks plus hits per inning pitched (WHIP) after surgery. These last 2 statistics, known as sabermetrics, evaluate the pitcher’s effectiveness; the fact that these are improved after surgery is reassuring for pitchers who undergo this procedure. However, it must be recognized that these pitchers pitched fewer innings after surgery.

There has been a sharp increase in the number of MLB pitchers who have undergone UCL reconstruction in recent years, especially the past 3 seasons, in which over 60 pitchers have had Tommy John surgery.2 This increase, however, is not confined to MLB pitchers. High school–aged pitchers have also been part of this drastic rise in the number of UCL reconstructions performed throughout the country. Dr. James Andrews and colleagues noted a 50% increase from 1988-1994 to 1995-2003 in the proportion of high school–aged pitchers who underwent UCL reconstruction (while the absolute number increased from 7 to 77 in high school–aged players compared with 85 to 609 in adult athletes).9 Given the increase in MLB pitchers over the past few years, it is likely this number has also increased among adolescent pitchers.

This data again raises the question: what is the role of the orthopedic surgeon in this epidemic? There are many plausible responses, but in my opinion, there is one answer that surpasses the others. As a trained professional, surgeons are tasked with the responsibility of looking out for the best interest of their patients, even when this conflicts with the patient’s, or the patient’s parent’s or coach’s desires. This includes injury prevention, such as instituting pitch counts and developing products that allow coaches to determine when a pitcher may be at risk for injury from fatigue, as well as injury treatment.12 It is difficult for a patient to understand the gravity of surgery and the rehabilitation process, specifically a procedure as involved as UCL reconstruction, and especially if the patient is an adolescent who has their outlook clouded by the fact that they believe they will be the next MLB star pitcher. The reality is that the National Collegiate Athletic Association (NCAA)13 has released data that has demonstrated that only 6.8% of high school baseball players will play baseball in college. Furthermore, only 9.4% of college baseball players will reach the professional level. That equates to 0.5%, or 1 in 200 high school players who will eventually play professional baseball.13 However, the reverse of this is also true, that out of every 200 players, 1 will make it to the major leagues, and that 1 player could be the patient in question. Hence, the purpose of this data is to show parents and athletes that, while they do have a chance of playing professional, and certainly collegiate, baseball, that percentage must be weighed against the risks of surgery.

MLB pitchers who have an endless supply of rehabilitation facilities, trainers, etc, do not return to pitching competitively and consistently in the majors for more than 15 months after UCL reconstruction.2 The time commitment and rehabilitation required for these patients is staggering.14,15 Furthermore, parents of these children who are consenting for them also have a difficult time comprehending the workload they are signing their child up for. Some parents believe this surgery will help their child throw faster, longer, and more accurately—beliefs that numerous studies have shown to be flat-out inaccurate. In fact, pitchers tend to lose a slight amount of velocity and accuracy after UCL reconstruction.11,16 Ahmad and colleagues17 administered a questionnaire to 189 players, 15 coaches, and 31 parents about the indications, risks, benefits, etc, regarding UCL reconstruction to determine the public’s perception regarding this surgery. The results demonstrated that the public, including coaches, have a significantly skewed perception of exactly how serious this surgery is. The study showed that 28% of players and 20% of coaches believed the pitcher’s performance would be improved after surgery, and, more strikingly, 26% of collegiate athletes, 30% percent of coaches, 37% of parents, and 51% of high school athletes believed UCL reconstruction should be performed as a prophylactic procedure to enhance performance in an uninjured athlete.17

 

 

Henceforth, it becomes the surgeon’s responsibility to ensure that both the patient and the parents understand what the surgery and rehabilitation process entails, to keep the expectations of the patient and his or her family realistic, and to counsel these patients on alternative options with lower risks. As Ahmad and colleagues17 demonstrated, this is not an easy task given the public’s preconceived notions. Many patients, especially patients of the younger generation, seem to be willing to jump to surgery as the first option for treatment without having truly tried any nonoperative measures, because they believe surgery to be a quick, easy, and definitive answer. This is not always the case, and a trial of nonoperative treatment, including rest, ice, physical therapy, and possibly platelet-rich plasma (PRP), should be instituted for high school–aged players who present with UCL insufficiency prior to discussing surgery.18,19

Medial UCL reconstruction is a successful procedure for elite MLB athletes. However, UCL reconstruction is becoming a victim of its own success as younger and younger athletes who will likely never play at the major league level are undergoing this procedure at an alarming rate. This is an epidemic which must be addressed by surgeons, coaches, and parents alike to curb the beliefs that UCL reconstruction will make high school–aged pitchers more successful. This procedure should not be performed prophylactically on an athlete of any age, especially those in high school. Further studies on the effectiveness of both nonoperative rest and rehabilitation and of PRP on partial-thickness UCL tears are warranted. New technology in the form of a compression sleeve with imbedded sensors to track the biomechanics of a pitcher’s elbow has been released and will hopefully provide information to coaches about when pitchers’ elbows begin to fatigue based on several biomechanical parameters.12 The future of UCL reconstruction is still fluid, and with proper prevention strategies, nonoperative treatment, indications, and preoperative discussions, the Tommy John epidemic can be cured. ◾

References

1.    Conway JE, Jobe FW, Glousman RE, Pink M. Medial instability of the elbow in throwing athletes. Treatment by repair or reconstruction of the ulnar collateral ligament. J Bone Joint Surg Am. 1992;74(1):67-83.

2.    Erickson BJ, Gupta AK, Harris JD, et al. Rate of return to pitching and performance after Tommy John surgery in Major League Baseball pitchers. Am J Sports Med. 2014;42(3):536-543.

3.    Jobe FW, Stark H, Lombardo SJ. Reconstruction of the ulnar collateral ligament in athletes. J Bone Joint Surg Am. 1986;68(8):1158-1163.

4.    Jackson TJ, Adamson GJ, Peterson A, Patton J, McGarry MH, Lee TQ. Ulnar collateral ligament reconstruction using bisuspensory fixation: a biomechanical comparison with the docking technique. Am J Sports Med. 2013;41(5):1158-1164.

5.    Dines JS, ElAttrache NS, Conway JE, Smith W, Ahmad CS. Clinical outcomes of the DANE TJ technique to treat ulnar collateral ligament insufficiency of the elbow. Am J Sports Med. 2007;35(12):2039-2044.

6.    Andrews JR, Jost PW, Cain EL. The ulnar collateral ligament procedure revisited: the procedure we use. Sports Health. 2012;4(5):438-441.

7.    Dines JS, Jones KJ, Kahlenberg C, Rosenbaum A, Osbahr DC, Altchek DW. Elbow ulnar collateral ligament reconstruction in javelin throwers at a minimum 2-year follow-up. Am J Sports Med. 2012;40(1):148-151.

8.    Gibson BW, Webner D, Huffman GR, Sennett BJ. Ulnar collateral ligament reconstruction in major league baseball pitchers. Am J Sports Med. 2007;35(4):575-581.

9.    Petty DH, Andrews JR, Fleisig GS, Cain EL. Ulnar collateral ligament reconstruction in high school baseball players: clinical results and injury risk factors. Am J Sports Med. 2004;32(5):1158-1164.

10.  Osbahr DC, Cain EL Jr, Raines BT, Fortenbaugh D, Dugas JR, Andrews JR. Long-term outcomes after ulnar collateral ligament reconstruction in competitive baseball players: minimum 10-year follow-up. Am J Sports Med. 2014;42(6):1333-1342.

11.  Jiang JJ, Leland JM. Analysis of pitching velocity in major league baseball players before and after ulnar collateral ligament reconstruction. Am J Sports Med. 2014;42(4):880-885.

12.    Carroll W. The sleeve that could save baseball: exclusive look at new MLB technology. Bleacher Report. http://bleacherreport.com/articles/2097866-the-sleeve-that-could-save-baseball-exclusive-look-at-new-mlb-technology?utm_campaign=tsipad&utm_medium=referral&utm_source=teamstream. Published July 2, 2014. Accessed November 12, 2014.

13.    National Collegiate Athletic Association. Estimated probability of competing in athletics beyond the high school interscholastic level. https://www.ncaa.org/sites/default/files/Probability-of-going-pro-methodology_Update2013.pdf. Updated September 24, 2013. Accessed November 12, 2014.

14.  Wilk KE, Macrina LC, Cain EL, Dugas JR, Andrews JR. Rehabilitation of the overhead athlete’s elbow. Sports Health. 2012;4(5):404-414.

15.  Wilk KE, Reinold MM, Andrews JR. Rehabilitation of the thrower’s elbow. Tech Hand Up Extrem Surg. 2003;7(4):197-216.

16.  Makhni EC, Lee RW, Morrow ZS, Gualtieri AP, Gorroochurn P, Ahmad CS. Performance, return to competition, and reinjury after Tommy John surgery in Major League Baseball pitchers: a review of 147 cases. Am J Sports Med. 2014;42(6):1323-1332.

17.  Ahmad CS, Grantham WJ, Greiwe RM. Public perceptions of Tommy John surgery. Phys Sportsmed. 2012;40(2):64-72.

18.  Rettig AC, Sherrill C, Snead DS, Mendler JC, Mieling P. Nonoperative treatment of ulnar collateral ligament injuries in throwing athletes. Am J Sports Med. 2001;29(1):15-17.

19.   Podesta L, Crow SA, Volkmer D, Bert T, Yocum LA. Treatment of partial ulnar collateral ligament tears in the elbow with platelet-rich plasma. Am J Sports Med. 2013;41(7):1689-1694.

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Ulnar collateral ligament (UCL) reconstruction, commonly referred to as Tommy John surgery, is a well-described surgical treatment for elite athletes with a symptomatic, deficient UCL.1, 2 The procedure was first performed by the late Dr. Frank Jobe in 1974, described in 1986, and has undergone several modifications over the past 30 years.3 Different graft choices, tunnel positions, graft configurations, and tunnel fixation methods are just some of the alterations that have been made to the original Jobe technique.4-6 With time, the index procedure has become more refined, with predictable outcomes in Major League Baseball (MLB) pitchers as well as other elite overhead throwing athletes.2,7,8 However, though this surgery was originally described for elite athletes suffering from UCL deficiency, recent times have seen an increase of over 50% in the number of UCL reconstructions performed on high school–aged and younger athletes.9 Furthermore, in 2000, a total of 13 MLB pitchers underwent UCL reconstruction, while in 2012 this number increased nearly threefold to 32.2 This paradigm shift of performing UCL reconstructions more frequently and on younger athletes raises a very important question: what is the role of the orthopedic surgeon in this epidemic?

UCL reconstruction has become a reliable procedure for MLB pitchers and other overhead throwing athletes.7,10,11 Recent studies have reported that MLB pitchers who undergo UCL reconstruction return to pitch in the MLB 83% of the time, whereas only 3% fail to return to pitch in either MLB or the minor league.2 Furthermore, pitchers who undergo UCL reconstruction perform similarly after surgery as prior to their UCL reconstruction, with fewer innings pitched after surgery, but, more importantly, a lower earned run average (ERA) and walks plus hits per inning pitched (WHIP) after surgery. These last 2 statistics, known as sabermetrics, evaluate the pitcher’s effectiveness; the fact that these are improved after surgery is reassuring for pitchers who undergo this procedure. However, it must be recognized that these pitchers pitched fewer innings after surgery.

There has been a sharp increase in the number of MLB pitchers who have undergone UCL reconstruction in recent years, especially the past 3 seasons, in which over 60 pitchers have had Tommy John surgery.2 This increase, however, is not confined to MLB pitchers. High school–aged pitchers have also been part of this drastic rise in the number of UCL reconstructions performed throughout the country. Dr. James Andrews and colleagues noted a 50% increase from 1988-1994 to 1995-2003 in the proportion of high school–aged pitchers who underwent UCL reconstruction (while the absolute number increased from 7 to 77 in high school–aged players compared with 85 to 609 in adult athletes).9 Given the increase in MLB pitchers over the past few years, it is likely this number has also increased among adolescent pitchers.

This data again raises the question: what is the role of the orthopedic surgeon in this epidemic? There are many plausible responses, but in my opinion, there is one answer that surpasses the others. As a trained professional, surgeons are tasked with the responsibility of looking out for the best interest of their patients, even when this conflicts with the patient’s, or the patient’s parent’s or coach’s desires. This includes injury prevention, such as instituting pitch counts and developing products that allow coaches to determine when a pitcher may be at risk for injury from fatigue, as well as injury treatment.12 It is difficult for a patient to understand the gravity of surgery and the rehabilitation process, specifically a procedure as involved as UCL reconstruction, and especially if the patient is an adolescent who has their outlook clouded by the fact that they believe they will be the next MLB star pitcher. The reality is that the National Collegiate Athletic Association (NCAA)13 has released data that has demonstrated that only 6.8% of high school baseball players will play baseball in college. Furthermore, only 9.4% of college baseball players will reach the professional level. That equates to 0.5%, or 1 in 200 high school players who will eventually play professional baseball.13 However, the reverse of this is also true, that out of every 200 players, 1 will make it to the major leagues, and that 1 player could be the patient in question. Hence, the purpose of this data is to show parents and athletes that, while they do have a chance of playing professional, and certainly collegiate, baseball, that percentage must be weighed against the risks of surgery.

MLB pitchers who have an endless supply of rehabilitation facilities, trainers, etc, do not return to pitching competitively and consistently in the majors for more than 15 months after UCL reconstruction.2 The time commitment and rehabilitation required for these patients is staggering.14,15 Furthermore, parents of these children who are consenting for them also have a difficult time comprehending the workload they are signing their child up for. Some parents believe this surgery will help their child throw faster, longer, and more accurately—beliefs that numerous studies have shown to be flat-out inaccurate. In fact, pitchers tend to lose a slight amount of velocity and accuracy after UCL reconstruction.11,16 Ahmad and colleagues17 administered a questionnaire to 189 players, 15 coaches, and 31 parents about the indications, risks, benefits, etc, regarding UCL reconstruction to determine the public’s perception regarding this surgery. The results demonstrated that the public, including coaches, have a significantly skewed perception of exactly how serious this surgery is. The study showed that 28% of players and 20% of coaches believed the pitcher’s performance would be improved after surgery, and, more strikingly, 26% of collegiate athletes, 30% percent of coaches, 37% of parents, and 51% of high school athletes believed UCL reconstruction should be performed as a prophylactic procedure to enhance performance in an uninjured athlete.17

 

 

Henceforth, it becomes the surgeon’s responsibility to ensure that both the patient and the parents understand what the surgery and rehabilitation process entails, to keep the expectations of the patient and his or her family realistic, and to counsel these patients on alternative options with lower risks. As Ahmad and colleagues17 demonstrated, this is not an easy task given the public’s preconceived notions. Many patients, especially patients of the younger generation, seem to be willing to jump to surgery as the first option for treatment without having truly tried any nonoperative measures, because they believe surgery to be a quick, easy, and definitive answer. This is not always the case, and a trial of nonoperative treatment, including rest, ice, physical therapy, and possibly platelet-rich plasma (PRP), should be instituted for high school–aged players who present with UCL insufficiency prior to discussing surgery.18,19

Medial UCL reconstruction is a successful procedure for elite MLB athletes. However, UCL reconstruction is becoming a victim of its own success as younger and younger athletes who will likely never play at the major league level are undergoing this procedure at an alarming rate. This is an epidemic which must be addressed by surgeons, coaches, and parents alike to curb the beliefs that UCL reconstruction will make high school–aged pitchers more successful. This procedure should not be performed prophylactically on an athlete of any age, especially those in high school. Further studies on the effectiveness of both nonoperative rest and rehabilitation and of PRP on partial-thickness UCL tears are warranted. New technology in the form of a compression sleeve with imbedded sensors to track the biomechanics of a pitcher’s elbow has been released and will hopefully provide information to coaches about when pitchers’ elbows begin to fatigue based on several biomechanical parameters.12 The future of UCL reconstruction is still fluid, and with proper prevention strategies, nonoperative treatment, indications, and preoperative discussions, the Tommy John epidemic can be cured. ◾

Ulnar collateral ligament (UCL) reconstruction, commonly referred to as Tommy John surgery, is a well-described surgical treatment for elite athletes with a symptomatic, deficient UCL.1, 2 The procedure was first performed by the late Dr. Frank Jobe in 1974, described in 1986, and has undergone several modifications over the past 30 years.3 Different graft choices, tunnel positions, graft configurations, and tunnel fixation methods are just some of the alterations that have been made to the original Jobe technique.4-6 With time, the index procedure has become more refined, with predictable outcomes in Major League Baseball (MLB) pitchers as well as other elite overhead throwing athletes.2,7,8 However, though this surgery was originally described for elite athletes suffering from UCL deficiency, recent times have seen an increase of over 50% in the number of UCL reconstructions performed on high school–aged and younger athletes.9 Furthermore, in 2000, a total of 13 MLB pitchers underwent UCL reconstruction, while in 2012 this number increased nearly threefold to 32.2 This paradigm shift of performing UCL reconstructions more frequently and on younger athletes raises a very important question: what is the role of the orthopedic surgeon in this epidemic?

UCL reconstruction has become a reliable procedure for MLB pitchers and other overhead throwing athletes.7,10,11 Recent studies have reported that MLB pitchers who undergo UCL reconstruction return to pitch in the MLB 83% of the time, whereas only 3% fail to return to pitch in either MLB or the minor league.2 Furthermore, pitchers who undergo UCL reconstruction perform similarly after surgery as prior to their UCL reconstruction, with fewer innings pitched after surgery, but, more importantly, a lower earned run average (ERA) and walks plus hits per inning pitched (WHIP) after surgery. These last 2 statistics, known as sabermetrics, evaluate the pitcher’s effectiveness; the fact that these are improved after surgery is reassuring for pitchers who undergo this procedure. However, it must be recognized that these pitchers pitched fewer innings after surgery.

There has been a sharp increase in the number of MLB pitchers who have undergone UCL reconstruction in recent years, especially the past 3 seasons, in which over 60 pitchers have had Tommy John surgery.2 This increase, however, is not confined to MLB pitchers. High school–aged pitchers have also been part of this drastic rise in the number of UCL reconstructions performed throughout the country. Dr. James Andrews and colleagues noted a 50% increase from 1988-1994 to 1995-2003 in the proportion of high school–aged pitchers who underwent UCL reconstruction (while the absolute number increased from 7 to 77 in high school–aged players compared with 85 to 609 in adult athletes).9 Given the increase in MLB pitchers over the past few years, it is likely this number has also increased among adolescent pitchers.

This data again raises the question: what is the role of the orthopedic surgeon in this epidemic? There are many plausible responses, but in my opinion, there is one answer that surpasses the others. As a trained professional, surgeons are tasked with the responsibility of looking out for the best interest of their patients, even when this conflicts with the patient’s, or the patient’s parent’s or coach’s desires. This includes injury prevention, such as instituting pitch counts and developing products that allow coaches to determine when a pitcher may be at risk for injury from fatigue, as well as injury treatment.12 It is difficult for a patient to understand the gravity of surgery and the rehabilitation process, specifically a procedure as involved as UCL reconstruction, and especially if the patient is an adolescent who has their outlook clouded by the fact that they believe they will be the next MLB star pitcher. The reality is that the National Collegiate Athletic Association (NCAA)13 has released data that has demonstrated that only 6.8% of high school baseball players will play baseball in college. Furthermore, only 9.4% of college baseball players will reach the professional level. That equates to 0.5%, or 1 in 200 high school players who will eventually play professional baseball.13 However, the reverse of this is also true, that out of every 200 players, 1 will make it to the major leagues, and that 1 player could be the patient in question. Hence, the purpose of this data is to show parents and athletes that, while they do have a chance of playing professional, and certainly collegiate, baseball, that percentage must be weighed against the risks of surgery.

MLB pitchers who have an endless supply of rehabilitation facilities, trainers, etc, do not return to pitching competitively and consistently in the majors for more than 15 months after UCL reconstruction.2 The time commitment and rehabilitation required for these patients is staggering.14,15 Furthermore, parents of these children who are consenting for them also have a difficult time comprehending the workload they are signing their child up for. Some parents believe this surgery will help their child throw faster, longer, and more accurately—beliefs that numerous studies have shown to be flat-out inaccurate. In fact, pitchers tend to lose a slight amount of velocity and accuracy after UCL reconstruction.11,16 Ahmad and colleagues17 administered a questionnaire to 189 players, 15 coaches, and 31 parents about the indications, risks, benefits, etc, regarding UCL reconstruction to determine the public’s perception regarding this surgery. The results demonstrated that the public, including coaches, have a significantly skewed perception of exactly how serious this surgery is. The study showed that 28% of players and 20% of coaches believed the pitcher’s performance would be improved after surgery, and, more strikingly, 26% of collegiate athletes, 30% percent of coaches, 37% of parents, and 51% of high school athletes believed UCL reconstruction should be performed as a prophylactic procedure to enhance performance in an uninjured athlete.17

 

 

Henceforth, it becomes the surgeon’s responsibility to ensure that both the patient and the parents understand what the surgery and rehabilitation process entails, to keep the expectations of the patient and his or her family realistic, and to counsel these patients on alternative options with lower risks. As Ahmad and colleagues17 demonstrated, this is not an easy task given the public’s preconceived notions. Many patients, especially patients of the younger generation, seem to be willing to jump to surgery as the first option for treatment without having truly tried any nonoperative measures, because they believe surgery to be a quick, easy, and definitive answer. This is not always the case, and a trial of nonoperative treatment, including rest, ice, physical therapy, and possibly platelet-rich plasma (PRP), should be instituted for high school–aged players who present with UCL insufficiency prior to discussing surgery.18,19

Medial UCL reconstruction is a successful procedure for elite MLB athletes. However, UCL reconstruction is becoming a victim of its own success as younger and younger athletes who will likely never play at the major league level are undergoing this procedure at an alarming rate. This is an epidemic which must be addressed by surgeons, coaches, and parents alike to curb the beliefs that UCL reconstruction will make high school–aged pitchers more successful. This procedure should not be performed prophylactically on an athlete of any age, especially those in high school. Further studies on the effectiveness of both nonoperative rest and rehabilitation and of PRP on partial-thickness UCL tears are warranted. New technology in the form of a compression sleeve with imbedded sensors to track the biomechanics of a pitcher’s elbow has been released and will hopefully provide information to coaches about when pitchers’ elbows begin to fatigue based on several biomechanical parameters.12 The future of UCL reconstruction is still fluid, and with proper prevention strategies, nonoperative treatment, indications, and preoperative discussions, the Tommy John epidemic can be cured. ◾

References

1.    Conway JE, Jobe FW, Glousman RE, Pink M. Medial instability of the elbow in throwing athletes. Treatment by repair or reconstruction of the ulnar collateral ligament. J Bone Joint Surg Am. 1992;74(1):67-83.

2.    Erickson BJ, Gupta AK, Harris JD, et al. Rate of return to pitching and performance after Tommy John surgery in Major League Baseball pitchers. Am J Sports Med. 2014;42(3):536-543.

3.    Jobe FW, Stark H, Lombardo SJ. Reconstruction of the ulnar collateral ligament in athletes. J Bone Joint Surg Am. 1986;68(8):1158-1163.

4.    Jackson TJ, Adamson GJ, Peterson A, Patton J, McGarry MH, Lee TQ. Ulnar collateral ligament reconstruction using bisuspensory fixation: a biomechanical comparison with the docking technique. Am J Sports Med. 2013;41(5):1158-1164.

5.    Dines JS, ElAttrache NS, Conway JE, Smith W, Ahmad CS. Clinical outcomes of the DANE TJ technique to treat ulnar collateral ligament insufficiency of the elbow. Am J Sports Med. 2007;35(12):2039-2044.

6.    Andrews JR, Jost PW, Cain EL. The ulnar collateral ligament procedure revisited: the procedure we use. Sports Health. 2012;4(5):438-441.

7.    Dines JS, Jones KJ, Kahlenberg C, Rosenbaum A, Osbahr DC, Altchek DW. Elbow ulnar collateral ligament reconstruction in javelin throwers at a minimum 2-year follow-up. Am J Sports Med. 2012;40(1):148-151.

8.    Gibson BW, Webner D, Huffman GR, Sennett BJ. Ulnar collateral ligament reconstruction in major league baseball pitchers. Am J Sports Med. 2007;35(4):575-581.

9.    Petty DH, Andrews JR, Fleisig GS, Cain EL. Ulnar collateral ligament reconstruction in high school baseball players: clinical results and injury risk factors. Am J Sports Med. 2004;32(5):1158-1164.

10.  Osbahr DC, Cain EL Jr, Raines BT, Fortenbaugh D, Dugas JR, Andrews JR. Long-term outcomes after ulnar collateral ligament reconstruction in competitive baseball players: minimum 10-year follow-up. Am J Sports Med. 2014;42(6):1333-1342.

11.  Jiang JJ, Leland JM. Analysis of pitching velocity in major league baseball players before and after ulnar collateral ligament reconstruction. Am J Sports Med. 2014;42(4):880-885.

12.    Carroll W. The sleeve that could save baseball: exclusive look at new MLB technology. Bleacher Report. http://bleacherreport.com/articles/2097866-the-sleeve-that-could-save-baseball-exclusive-look-at-new-mlb-technology?utm_campaign=tsipad&utm_medium=referral&utm_source=teamstream. Published July 2, 2014. Accessed November 12, 2014.

13.    National Collegiate Athletic Association. Estimated probability of competing in athletics beyond the high school interscholastic level. https://www.ncaa.org/sites/default/files/Probability-of-going-pro-methodology_Update2013.pdf. Updated September 24, 2013. Accessed November 12, 2014.

14.  Wilk KE, Macrina LC, Cain EL, Dugas JR, Andrews JR. Rehabilitation of the overhead athlete’s elbow. Sports Health. 2012;4(5):404-414.

15.  Wilk KE, Reinold MM, Andrews JR. Rehabilitation of the thrower’s elbow. Tech Hand Up Extrem Surg. 2003;7(4):197-216.

16.  Makhni EC, Lee RW, Morrow ZS, Gualtieri AP, Gorroochurn P, Ahmad CS. Performance, return to competition, and reinjury after Tommy John surgery in Major League Baseball pitchers: a review of 147 cases. Am J Sports Med. 2014;42(6):1323-1332.

17.  Ahmad CS, Grantham WJ, Greiwe RM. Public perceptions of Tommy John surgery. Phys Sportsmed. 2012;40(2):64-72.

18.  Rettig AC, Sherrill C, Snead DS, Mendler JC, Mieling P. Nonoperative treatment of ulnar collateral ligament injuries in throwing athletes. Am J Sports Med. 2001;29(1):15-17.

19.   Podesta L, Crow SA, Volkmer D, Bert T, Yocum LA. Treatment of partial ulnar collateral ligament tears in the elbow with platelet-rich plasma. Am J Sports Med. 2013;41(7):1689-1694.

References

1.    Conway JE, Jobe FW, Glousman RE, Pink M. Medial instability of the elbow in throwing athletes. Treatment by repair or reconstruction of the ulnar collateral ligament. J Bone Joint Surg Am. 1992;74(1):67-83.

2.    Erickson BJ, Gupta AK, Harris JD, et al. Rate of return to pitching and performance after Tommy John surgery in Major League Baseball pitchers. Am J Sports Med. 2014;42(3):536-543.

3.    Jobe FW, Stark H, Lombardo SJ. Reconstruction of the ulnar collateral ligament in athletes. J Bone Joint Surg Am. 1986;68(8):1158-1163.

4.    Jackson TJ, Adamson GJ, Peterson A, Patton J, McGarry MH, Lee TQ. Ulnar collateral ligament reconstruction using bisuspensory fixation: a biomechanical comparison with the docking technique. Am J Sports Med. 2013;41(5):1158-1164.

5.    Dines JS, ElAttrache NS, Conway JE, Smith W, Ahmad CS. Clinical outcomes of the DANE TJ technique to treat ulnar collateral ligament insufficiency of the elbow. Am J Sports Med. 2007;35(12):2039-2044.

6.    Andrews JR, Jost PW, Cain EL. The ulnar collateral ligament procedure revisited: the procedure we use. Sports Health. 2012;4(5):438-441.

7.    Dines JS, Jones KJ, Kahlenberg C, Rosenbaum A, Osbahr DC, Altchek DW. Elbow ulnar collateral ligament reconstruction in javelin throwers at a minimum 2-year follow-up. Am J Sports Med. 2012;40(1):148-151.

8.    Gibson BW, Webner D, Huffman GR, Sennett BJ. Ulnar collateral ligament reconstruction in major league baseball pitchers. Am J Sports Med. 2007;35(4):575-581.

9.    Petty DH, Andrews JR, Fleisig GS, Cain EL. Ulnar collateral ligament reconstruction in high school baseball players: clinical results and injury risk factors. Am J Sports Med. 2004;32(5):1158-1164.

10.  Osbahr DC, Cain EL Jr, Raines BT, Fortenbaugh D, Dugas JR, Andrews JR. Long-term outcomes after ulnar collateral ligament reconstruction in competitive baseball players: minimum 10-year follow-up. Am J Sports Med. 2014;42(6):1333-1342.

11.  Jiang JJ, Leland JM. Analysis of pitching velocity in major league baseball players before and after ulnar collateral ligament reconstruction. Am J Sports Med. 2014;42(4):880-885.

12.    Carroll W. The sleeve that could save baseball: exclusive look at new MLB technology. Bleacher Report. http://bleacherreport.com/articles/2097866-the-sleeve-that-could-save-baseball-exclusive-look-at-new-mlb-technology?utm_campaign=tsipad&utm_medium=referral&utm_source=teamstream. Published July 2, 2014. Accessed November 12, 2014.

13.    National Collegiate Athletic Association. Estimated probability of competing in athletics beyond the high school interscholastic level. https://www.ncaa.org/sites/default/files/Probability-of-going-pro-methodology_Update2013.pdf. Updated September 24, 2013. Accessed November 12, 2014.

14.  Wilk KE, Macrina LC, Cain EL, Dugas JR, Andrews JR. Rehabilitation of the overhead athlete’s elbow. Sports Health. 2012;4(5):404-414.

15.  Wilk KE, Reinold MM, Andrews JR. Rehabilitation of the thrower’s elbow. Tech Hand Up Extrem Surg. 2003;7(4):197-216.

16.  Makhni EC, Lee RW, Morrow ZS, Gualtieri AP, Gorroochurn P, Ahmad CS. Performance, return to competition, and reinjury after Tommy John surgery in Major League Baseball pitchers: a review of 147 cases. Am J Sports Med. 2014;42(6):1323-1332.

17.  Ahmad CS, Grantham WJ, Greiwe RM. Public perceptions of Tommy John surgery. Phys Sportsmed. 2012;40(2):64-72.

18.  Rettig AC, Sherrill C, Snead DS, Mendler JC, Mieling P. Nonoperative treatment of ulnar collateral ligament injuries in throwing athletes. Am J Sports Med. 2001;29(1):15-17.

19.   Podesta L, Crow SA, Volkmer D, Bert T, Yocum LA. Treatment of partial ulnar collateral ligament tears in the elbow with platelet-rich plasma. Am J Sports Med. 2013;41(7):1689-1694.

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Evaluation of Wound Healing After Direct Anterior Total Hip Arthroplasty With Use of a Novel Retraction Device

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Evaluation of Wound Healing After Direct Anterior Total Hip Arthroplasty With Use of a Novel Retraction Device

It is thought that, by placing more emphasis on soft-tissue preservation, minimally invasive surgery total hip arthroplasty (MIS-THA) results in less soft-tissue trauma, less blood loss, and earlier recovery.1-3 Despite these improvements over standard methods, there is a concern that the vigorous retraction needed for proper visualization through smaller incisions could injure soft tissues.4-7 Single-incision direct anterior THA (DA-THA) has gained in popularity because of the true intermuscular/internervous plane through which the procedure can be performed with relatively minimal muscle dissection using MIS techniques.8,9 This approach may offer quicker recovery and superior stability in comparison with nonintermuscular methods, which unavoidably cause more muscle damage.10-12

Although the evidence of these early gains is encouraging, several studies have found high complication rates with DA-THA.8,13-17 Noted disadvantages include a steep learning curve, lateral femoral cutaneous neurapraxia, need for a specialized table, and higher fracture and wound complication rates. Not surprisingly, with increased surgeon experience, the complication rate decreased substantially.14,15 However, wound-related complications remained steady, with 2 recent large studies reporting rates of 4.6% and 2.1%.14,15 The thin anterior skin, high tensional forces along the groin crease and perpendicular to the typical DA incision, and less resilient soft-tissue envelope are postulated reasons for wound-related issues, which are likely magnified in patients who are more obese.15,16

A novel device designed to lessen tissue damage is the ring retractor (Figure 1). Used initially in general surgery and obstetrics, it consists of 2 semirigid polymer rings connected by a flexible cylindrical polymer membrane.18-20 The lower ring is tucked and anchored underneath the wound edge, and then the upper ring is rolled down and cinched onto the skin. The resultant tension on the polymer sleeve—imparted by the rigidity of the ring—provides strong, evenly distributed wound-edge retraction. It also provides a physical barrier between the wound edge and the rest of the operative field. Proponents of the ring retractor claim increased wound-edge moisture, less bruising, and reduced local trauma compared with standard metal retractors alone.

Wound-edge retractor forces are doubled during MIS-THA compared with conventional THA.14-20 This may explain reports of worse scar cosmesis with MIS-THA. Given the theoretical benefits of minimized wound-edge trauma, the ring retractor may improve scar appearance compared with standard retraction alone. Any clinically relevant effect on cosmesis should be readily apparent to justify use of the retractor in this regard. Although some surgeons routinely use the device for primary THA, it has not been the subject of any recent orthopedic studies.

In the present study, we prospectively investigated wound cosmesis with and without use of the ring retractor in patients undergoing DA-THA.

Materials and Methods

This prospective, single-center, randomized study was reviewed and approved by the institutional review board at our facility. Consent was obtained from all participating patients.

We evaluated 50 surgical incisions in 48 patients. Eligible participants were over age 18 years and undergoing primary DA-THA. Exclusion criteria included previous surgery on the affected hip, a pathological hip condition requiring an extensile exposure, systemic inflammatory illness, chronic corticosteroid use, and dermatologic abnormality of the incisional area. One patient was having simultaneous bilateral THAs, and another was having staged bilateral THAs. Each hip in these patients was given its own case number and treated separately. Of the 49 patients who met all the inclusion criteria, only 1 decided not to participate (Figure 2).

Stratified randomization with permuted block size (sex, body mass index [BMI]) was used to assign patients in a 1:1 ratio to either the treatment group or the control group. In the treatment group, the Protractor Incision Protector and Retractor (Gyrus ACMI, Southborough, Massachusetts) was used with standard metal retractors. In the control group, only standard metal retractors were used. Patients were blinded to their group assignments, and surgeons were informed about each assignment only after the initial incision was made.

Clinical research investigators were blinded to the groups’ prospectively collected data. Collection time points were preoperative clinical visit, day of surgery through discharge, and 2-, 6-, and 12-week postoperative follow-ups. Day-of-surgery data included estimated intraoperative blood loss, operative side, operative time, intraoperative complications, and American Society of Anesthesiologists (ASA) physical status classification. Total length of stay, pain scores (range, 0-10), estimated drain output, and blood-transfusion data were also recorded. To evaluate whether the device had any effect on short-term functional outcome, we collected Harris Hip Scores (HHS) and Short Form–12 (SF-12, Version 2) scores at the preoperative and 6-week postoperative visits. We also documented any wound-healing-related issues or complications that occurred up until the final visit.

 

 

To account for any effect of nutrition status on wound healing, we obtained pre-albumin and albumin levels and absolute lymphocyte counts from the preoperative electronic records. We used an albumin level under 3.5 g/dL and an absolute lymphocyte count under 1500/µL for our analysis, as these cutoffs have been associated with wound complications after primary THA.21 There is no similarly established threshold for pre-albumin level, so we used values under 20 mg/L based on comparable literature.22,23

At each postoperative visit, standardized high-resolution images were obtained. At the 12-week visit, patients completed 2 Likert scales regarding their overall opinion of their scars and how their scars compared with their expectations. They also ranked 5 separate THA-related outcomes in order of importance (Appendix).

Photographs were evaluated by 2 blinded plastic surgeons (Dr. Friedman and Dr. Jack) using 2 grading systems—the Stony Brook Scar Evaluation Scale (SBSES)24 (Table 1) and a modified Manchester Scar Scale (MSS)25 (Table 2). We used these systems because they were photograph-based, psychometrically studied, and specifically designed to assess surgical incision healing with established validity and reliability.24-27 A particular advantage, strictly related to cosmetic outcome, is their validity in scoring scars from high-definition photographs in a different place or time. The SBSES, an ordinal wound evaluation scale that measures short-term cosmetic outcomes, consists of 6 items, each receiving 1 or 0 point, yielding a total score between 0 (worst) and 5 (best). The modified MSS includes a visual analog scale (VAS), which has a vertical hash marked on a 10-cm line and is scored between 0 (excellent) and 10 (poor) to 1 decimal point.26,28 This value is added to grades on color, surface appearance, contour, and distortion, resulting in a score between 4 (best) and 24 (worst). The primary outcome measures were Likert-scale responses obtained at final visit and SBSES/MSS scores for each visit; 12-week scores were the primary end point.

Operative Procedure

Experienced fellowship-trained orthopedic surgeons performed all procedures. A modified Hueter approach was used for exposure.9 Mean incision length was about 12 cm. For the treatment group, the ring retractor was inserted at the level of the tensor fascia, with the inferior ring resting between the fascia and the subcutaneous layer and the superior ring cinched over the skin (Figure 3). The device is made in 4 different sizes for incisions from 2.5 to 17 cm; our study population required only 1 size. Otherwise, the surgical protocol was based on that described by Matta and colleagues.8 Wound closure (over a drain) was performed according to a standardized protocol—running No. 1 Vicryl suture for the superficial tensor fascia, interrupted 2-0 Vicryl for the deep dermal layer, and subcutaneous 4-0 Monocryl for the skin followed by application of Dermabond (Ethicon, Somerville, New Jersey) and Tegaderm +Pad (3M, St. Paul, Minnesota) for outer dressing, which was replaced on postoperative day 2 and removed at the 2-week visit.

Statistical Methods

An a priori sample-size calculation was performed. Power performed in a base of a prior study that evaluated anterolateral and posterolateral THA scars using a VAS, a component of the MSS, suggested a sample size of 16 per group to detect the minimal clinically important difference of 1.5 cm: SD (σ) = 1.5 cm, α = 0.05, β = 0.20.29,30 In addition, a general estimate for detecting a 1-unit change on an ordinal scale (σ = 1.0, α = 0.05, β = 0.20) resulted in the same number. We conservatively decided to enroll 25 patients per arm in case of larger true variance.

The Wilcoxon rank sum test was used for comparisons of continuous data between groups. Differences between means were analyzed with 2-sided t tests. Categorical data were compared with the Pearson χ2 test or the Fisher exact test, as indicated. Ordinal ranking scores were compared with the Mantel-Haenszel test. Multivariate logistic regression was applied to identify the significant independent predictors of better scar grades for each surgeon by considering candidate variables with Ps < .20 in the univariate analysis.

Results

We found no differences in demographic or perioperative characteristics between treatment and control groups (Tables 3, 4). The groups showed similar mean improvements in their respective 6-week HHS (38.7 and 36.4 points; P = .65), SF-12 physical component summary scores (11.8 and 14.5 points; P = .37), and SF-12 mental component summary scores (5.1 and 3.7; P = .70).

Patient questionnaire outcomes are listed in Table 5. For the control group, 25/25 image sets were obtained at the 2-week visit, 25/25 at the 6-week visit, and 24/25 at the 12-week visit. For the treatment group, there were 23/25, 24/25, and 23/25 images sets, respectively.

 

 

When surgeon scoring was analyzed separately, SBSES and MSS scores were similar between treatment and control groups, with 1 exception: 2-week MSS scores were better for the treatment group according to surgeon A (P = .026). When grades were averaged, SBSES scores were again similar at all time points (Figure 4A); MSS scores were better for the treatment group at 2 weeks (P = .036) and equivalent at all other time points (Figure 4B). For the SBSES, Spearman correlation coefficient ρ with 95% confidence interval (CI) was 0.37
(95% CI, 0.08-0.66) at 2 weeks, 0.48 (95% CI, 0.20-0.76) at 6 weeks, and 0.62 (95% CI, 0.33-0.91) at 12 weeks. Following the same pattern for the MSS, ρ was 0.20 (95% CI, –0.09 to 0.49), 0.51 (95% CI, 0.23-0.79), and 0.32 (95% CI, 0.03-0.61).

Independent multivariate analysis revealed that age over 65 years was a significant predictor of worse scores. On SBSES, the odds ratio (OR) was 1.15 (95% CI, 1.07-1.24) for surgeon A and 1.11 (95% CI, 1.05-1.18) for surgeon B. On MSS, the OR was 0.89 (95% CI, 0.84-0.94) for surgeon A and 0.95 (95% CI, 0.91-0.99) for surgeon B. The likelihood of having worse SBSES scores according to surgeon A was 4.72 times higher if the pre-albumin level was under 20 mg/L (95% CI, 1.15-19.36). Albumin level under 3.5 g/dL and absolute lymphocyte count under 1500 cells/µL were not found to be independent predictors of poorer scores.

Patients’ overall opinion (P = .63) and assessment of their scars relative to expectations (P = .25) on the Likert scales were not different between groups. More scars exceeded patients’ expectations and had more excellent ratings in the control group. The 2 groups were similar with regard to relative importance of various patient-related outcomes. Factors most important to overall outcome were relief of hip pain, followed by implant longevity and length of recovery. Least important were incision-related variables.

There were only 3 minor noninfectious wound complications (6%), 2 in the treatment group and 1 in the control group. In the treatment group, a 67-year-old man with diabetes (ASA class III; BMI, 32.1 kg/m2; received transfusion) had 2 small areas (<5 mm) of superficial ulceration at 6-week follow-up—one at the proximal aspect of the incision and the other near the midpoint along the flexion crease. Both lesions resolved by 12-week follow-up. Also in the treatment group, a 77-year-old woman (ASA class II; BMI, 24.9 kg/m2; received transfusion) at 6 weeks had a spitting suture, which was removed in clinic without further issue. In the control group, a 55-year-old woman (ASA class II; BMI, 27.4 kg/m2) had a suture reaction near the proximal aspect of her incision 3 weeks after surgery. This reaction, which presented as a mild, localized erythema without pain, tenderness, or drainage, resolved by 6-week follow-up. None of these wound complications required intervention beyond observation.

Discussion

This study was designed to provide a bipartisan measure of wound-healing cosmesis after DA-THA. Scar evaluation by blinded plastic surgeons served as a standardized, clinical assessment, whereas the patient questionnaire offered a more subjective appraisal. The modified MMS25 and the SBSES24 are the only 2 wound-grading systems designed and validated for photographic assessment of postsurgical scars. Most scar evaluation schemes pertain to burn or traumatic scars.26,27,31 As a result, many earlier studies intending to compare incisional scars used poorly suited evaluation systems.

The current literature includes reports on 3 studies with scoring-based scar assessment in THA; all used grading systems designed for either burns or traumatic wounds, but 2 also used a VAS.32-34 VASs have been validated for measuring wound cosmesis but are entirely subjective and without structure and provide no feedback as to why a scar was rated good or bad.24 Mow and colleagues32 prospectively compared scars after standard posterior or MIS approaches and found no differences according to a scoring system intended for burn scars. In our study population, we found no group differences in patients’ cosmesis of their scars.

Although scars can take a year or longer to fully mature, researchers from the University of Michigan discovered that scar appearance at 1 year correlates highly with cosmesis 12 weeks after closure, though poorly with cosmesis 10 days after closure.35 Therefore, any observed differences in scar cosmesis between groups at 12-week follow-up would likely persist, whereas differences at 2-week follow-up would have little bearing on ultimate appearance. For this reason, our primary outcome measure was healing process and cosmesis at 12 weeks. High wound complication rates have been reported for MIS-DA-THA.8,14-16 Jewett and Collis15 noted a 4.6% wound complication rate (3% noninfectious ulcerative dehiscence, 1.6% superficial infection), which is comparable to the 6% rate found in this study. However, there likely is some variability across studies in what constitutes a wound complication or superficial infection. Of our 3 wound complications—stitch reaction, spitting suture, small noninfectious ulceration—only the ulceration was of a severity similar to that reported by Jewett and Collis.15 Matta and colleagues8 reported only 3 wound complications (in 494 patients), all severe enough to require operative intervention. One explanation for this low complication rate is use of a ring retractor, as it is routinely depicted in their technique paper. However, no specific reference is made to gauge how often the device was used.

 

 

Rates of superficial infection after DA-THA range from 0.6% to 1.6% in 3 large observational studies (combined deep infection rate, 0.43%).8,14,15 In 2 of these studies, all patients with superficial infection underwent formal débridement, though none developed deep infection. A prospective randomized study of 221 patients who underwent colorectal surgery—where perioperative infectious morbidity ranges from 25% to 50%—found that ring retractor use significantly reduced superficial wound infection rates (8.1% vs 0%). A significant reduction in wound infection was shown in a similarly designed study involving 48 patients who had open appendectomy (14.6% vs 1.6%). The device had no effect on deep infection in either general surgery study. The wound infection rates reported in these general surgery studies are markedly higher than those in our study population. As a result, the effect of the ring retractor on wound infection in DA-THA may be less. Regardless of the effect on deep infection, fewer superficial infections, which often require operative intervention, would be of considerable benefit.

Below-threshold albumin level and absolute lymphocyte count have been associated with wound-healing complications after hip replacement.21 In the present study, pre-albumin level under 20 mg/L was the only nutritional marker predictive of poor wound appearance, but this finding was seen only in SBSES scores from surgeon A. Subgroup analysis did not reveal any relationship between wound appearance and any of the recorded demographic or perioperative variables, but for a small predictive influence with age over 65 years.

This study had some limitations. Our findings cannot be generalized to all patients who undergo THA, as only DA incisions were studied. Results also may not be generalizable to non-fellowship-trained orthopedists. In addition, selection bias likely resulted from including patients already selected for the DA approach. Using digital images for evaluation (vs real-life evaluation) may have affected reliability as well. Last, by not incorporating texture, we omitted a potentially informative feature from scoring.

It is paramount that surgeons undergo diligent training before undertaking this approach for minimizing unwanted results; furthermore, higher early complication rates level off with increased surgeon experience.14,36,37 We recommend meticulous soft-tissue handling, cautious retraction, and careful patient selection (relative contraindication for patients with an abdominal pannus overlying the incision) as primary measures for minimizing incisional trauma and potential wound-healing complications.38 Preservation of the tensor fascia is also crucial,39 as it is the only closable layer separating deep and superficial compartments. Without good closure of the tensor fascia, there is no containment or tamponade of deep bleeding, which can facilitate hematoma formation.

In the population studied, we found no significant long-term differences in cosmetic appearance (based on clinician or patient evaluation) between wounds managed with and without the ring retractor. Our data do not support routine use of the ring retractor, during DA-THA, for improved wound cosmesis. Whether the device has any significant role in reducing the number of wound complications in THA is yet to be determined. Last, the ring retractor may have a role in other areas of orthopedic surgery, such as hip fractures in the elderly or orthopedic oncology. In situations like these, where adequate nutrition and immunocompetency may be lacking, the added protection provided by the device may translate into a more notable benefit than in elective THA.

References

1.    Laffosse JM, Chiron P, Tricoire JL, Giordano G, Molinier F, Puget J. Prospective and comparative study of minimally invasive posterior approach versus standard posterior approach in total hip replacement [in French]. Rev Chir Orthop Reparatrice Appar Mot. 2007;93(3):228-237.

2.    Smith TO, Blake V, Hing CB. Minimally invasive versus conventional exposure for total hip arthroplasty: a systematic review and meta-analysis of clinical and radiological outcomes. Int Orthop. 2011;35(2):173-184.

3.    Wright JM, Crockett HC, Delgado S, Lyman S, Madsen M, Sculco TP. Mini-incision for total hip arthroplasty: a prospective, controlled investigation with 5-year follow-up evaluation. J Arthroplasty. 2004;19(5):538-545.

4.    Mardones R, Pagnano MW, Nemanich JP, Trousdale RT. The Frank Stinchfield Award: muscle damage after total hip arthroplasty done with the two-incision and mini-posterior techniques. Clin Orthop. 2005;(441):63-67.

5.    Müller M, Tohtz S, Dewey M, Springer I, Perka C. Age-related appearance of muscle trauma in primary total hip arthroplasty and the benefit of a minimally invasive approach for patients older than 70 years. Int Orthop. 2011;35(2):165-171.

6.    Noble PC, Johnston JD, Alexander JA, et al. Making minimally invasive THR safe: conclusions from biomechanical simulation and analysis. Int Orthop. 2007;31(suppl 1):S25-S28.

7.    Bremer AK, Kalberer F, Pfirrmann CW, Dora C. Soft-tissue changes in hip abductor muscles and tendons after total hip replacement: comparison between the direct anterior and the transgluteal approaches. J Bone Joint Surg Br. 2011;93(7):886-889.

8.    Matta JM, Shahrdar C, Ferguson T. Single-incision anterior approach for total hip arthroplasty on an orthopaedic table. Clin Orthop. 2005;(441):115-124.

9.    Rachbauer F, Kain MSH, Leunig M. The history of the anterior approach to the hip. Orthop Clin North Am. 2009;40(3):311-320.

10.  Bergin PF, Doppelt JD, Kephart CJ, et al. Comparison of minimally invasive direct anterior versus posterior total hip arthroplasty based on inflammation and muscle damage markers. J Bone Joint Surg Am. 2011;93(15):1392-1398.

11.  Mayr E, Nogler M, Benedetti MG, et al. A prospective randomized assessment of earlier functional recovery in THA patients treated by minimally invasive direct anterior approach: a gait analysis study. Clin Biomech. 2009;24(10):812-818.

12.  Meneghini RM, Pagnano MW, Trousdale RT, Hozack WJ. Muscle damage during MIS total hip arthroplasty: Smith-Petersen versus posterior approach. Clin Orthop. 2006;(453):293-298.

13.  Sculco TP. Anterior approach in THA improves outcomes: opposes. Orthopedics. 2011;34(9):e459-e461.

14.  Bhandari M, Matta JM, Dodgin D, et al; Anterior Total Hip Arthroplasty Collaborative Investigators. Outcomes following the single-incision anterior approach to total hip arthroplasty: a multicenter observational study. Orthop Clin North Am. 2009;40(3):329-342.

15.  Jewett BA, Collis DK. High complication rate with anterior total hip arthroplasties on a fracture table. Clin Orthop. 2011;469(2):503-507.

16.  Barton C, Kim PR. Complications of the direct anterior approach for total hip arthroplasty. Orthop Clin North Am. 2009;40(3):371-375.

17.  Bender B, Nogler M, Hozack WJ. Direct anterior approach for total hip arthroplasty. Orthop Clin North Am. 2009;40(3):321-328.

18.  Pelosi MA 2nd, Pelosi MA 3rd. Self-retaining abdominal retractor for minilaparotomy. Obstet Gynecol. 2000;96(5, pt 1):775-778.

19.  Lee P, Waxman K, Taylor B, Yim S. Use of wound-protection system and postoperative wound-infection rates in open appendectomy: a randomized prospective trial. Arch Surg. 2009;144(9):872-875.

20.  Horiuchi T, Tanishima H, Tamagawa K, et al. Randomized, controlled investigation of the anti-infective properties of the Alexis retractor/protector of incision sites. J Trauma. 2007;62(1):212-215.

21.  Greene KA, Wilde AH, Stulberg BN. Preoperative nutritional status of total joint patients. Relationship to postoperative wound complications. J Arthroplasty. 1991;6(4):321-325.

22.  Alijanipour P, Heller S, Parvizi J. Prevention of periprosthetic joint infection: what are the effective strategies? J Knee Surg. 2014;27(4):251-258.

23.  Suarez JC, Slotkin EM, Alvarez AM, Szubski CR, Barsoum WK, Patel PD. Prospective, randomized trial to evaluate efficacy of a thrombin-based hemostaticagent in total knee arthroplasty. J Arthroplasty. 2014;29(10):1950-1955.

24.  Singer AJ, Arora B, Dagum A, Valentine S, Hollander JE. Development and validation of a novel scar evaluation scale. Plast Reconstr Surg. 2007;120(7):1892-1897.

25.  Beausang E, Floyd H, Dunn KW, Orton CI, Ferguson MW. A new quantitative scale for clinical scar assessment. Plast Reconstr Surg. 1998;102(6):1954-1961.

26.  Durani P, McGrouther DA, Ferguson MW. Current scales for assessing human scarring: a review. J Plast Reconstr Aesthet Surg. 2009;62(6):713-720.

27.  Fearmonti R, Bond J, Erdmann D, Levinson H. A review of scar scales and scar measuring devices. Eplasty. 2010;10:e43.

28.  Duncan JA, Bond JS, Mason T, et al. Visual analogue scale scoring and ranking: a suitable and sensitive method for assessing scar quality? Plast Reconstr Surg. 2006;118(4):909-918.

29.  Quinn JV, Wells GA. An assessment of clinical wound evaluation scales. Acad Emerg Med. 1998;5(6):583-586.

30.  Livesey C, Wylde V, Descamps S, et al. Skin closure after total hip replacement: a randomised controlled trial of skin adhesive versus surgical staples. J Bone Joint Surg Br. 2009;91(6):725-729.

31.  Atiyeh BS. Nonsurgical management of hypertrophic scars: evidence-based therapies, standard practices, and emerging methods. Aesthetic Plast Surg. 2007;31(5):468-492.

32.  Mow CS, Woolson ST, Ngarmukos SG, Park EH, Lorenz HP. Comparison of scars from total hip replacements done with a standard or a mini-incision. Clin Orthop. 2005;(441):80-85.

33.  Khan RJ, Fick D, Yao F, et al. A comparison of three methods of wound closure following arthroplasty: a prospective, randomised, controlled trial. J Bone Joint Surg Br. 2006;88(2):238-242.

34.  Goldstein WM, Ali R, Branson JJ, Berland KA. Comparison of patient satisfaction with incision cosmesis after standard and minimally invasive total hip arthroplasty. Orthopedics. 2008;31(4):368.

35.  Quinn J, Wells G, Sutcliffe T, et al. Tissue adhesive versus suture wound repair at 1 year: randomized clinical trial correlating early, 3-month, and 1-year cosmetic outcome. Ann Emerg Med. 1998;32(6):645-649.

36.    Alberti LR, Petroianu A, Zac RI, Andrade JC Jr. The effect of surgical procedures on serum albumin concentration. Chirurgia (Bucur). 2008;103(1):39-43.

37.  Berend KR, Lombardi AV Jr, Seng BE, Adams JB. Enhanced early outcomes with the anterior supine intermuscular approach in primary total hip arthroplasty. J Bone Joint Surg Am. 2009;91(suppl 6):107-120.

38.  Mutnal A, Patel P, Cardona L, Suarez J. Periprosthetic Propionibacterium granulosum joint infection after direct anterior total hip arthroplasty: a case report. JBJS Case Connector. 2011;1(2):e10.

39.   Alvarez AM, Suarez JC, Patel P, Benton EG. Fluoroscopic imaging of acetabular cup position during THA through a direct anterior approach. Orthopedics. 2013;36(10):776-777. Erratum in: Orthopedics. 2014;37(1):16.

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Andres M. Alvarez-Pinzon, MD, MSc, Amar Mutnal, MD, Juan C. Suarez, MD, Megan Jack, MD, David Friedman, MD, Wael K. Barsoum, MD, and Preetesh D. Patel, MD

Authors’ Disclosure Statement: Dr. Barsoum wishes to report that he has stock options in OtisMed Corporation, Custom Orthopaedic Solutions, and iVHR; is a paid consultant to Stryker Orthopaedics; and a paid board member at KEF Healthcare. The other authors report no actual or potential conflict of interest in relation to this article.

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The American Journal of Orthopedics - 44(1)
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american journal of orthopedics, AJO, original study, study, online exclusive, wound, healing, total hip arthroplasty, THA, direct anterior, DA-THA, device, retractor, soft-tissue, surgery, trauma, alvarez-pinzon, mutnal, suarez, jack, friedman, barsoum, patel
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Andres M. Alvarez-Pinzon, MD, MSc, Amar Mutnal, MD, Juan C. Suarez, MD, Megan Jack, MD, David Friedman, MD, Wael K. Barsoum, MD, and Preetesh D. Patel, MD

Authors’ Disclosure Statement: Dr. Barsoum wishes to report that he has stock options in OtisMed Corporation, Custom Orthopaedic Solutions, and iVHR; is a paid consultant to Stryker Orthopaedics; and a paid board member at KEF Healthcare. The other authors report no actual or potential conflict of interest in relation to this article.

Author and Disclosure Information

Andres M. Alvarez-Pinzon, MD, MSc, Amar Mutnal, MD, Juan C. Suarez, MD, Megan Jack, MD, David Friedman, MD, Wael K. Barsoum, MD, and Preetesh D. Patel, MD

Authors’ Disclosure Statement: Dr. Barsoum wishes to report that he has stock options in OtisMed Corporation, Custom Orthopaedic Solutions, and iVHR; is a paid consultant to Stryker Orthopaedics; and a paid board member at KEF Healthcare. The other authors report no actual or potential conflict of interest in relation to this article.

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It is thought that, by placing more emphasis on soft-tissue preservation, minimally invasive surgery total hip arthroplasty (MIS-THA) results in less soft-tissue trauma, less blood loss, and earlier recovery.1-3 Despite these improvements over standard methods, there is a concern that the vigorous retraction needed for proper visualization through smaller incisions could injure soft tissues.4-7 Single-incision direct anterior THA (DA-THA) has gained in popularity because of the true intermuscular/internervous plane through which the procedure can be performed with relatively minimal muscle dissection using MIS techniques.8,9 This approach may offer quicker recovery and superior stability in comparison with nonintermuscular methods, which unavoidably cause more muscle damage.10-12

Although the evidence of these early gains is encouraging, several studies have found high complication rates with DA-THA.8,13-17 Noted disadvantages include a steep learning curve, lateral femoral cutaneous neurapraxia, need for a specialized table, and higher fracture and wound complication rates. Not surprisingly, with increased surgeon experience, the complication rate decreased substantially.14,15 However, wound-related complications remained steady, with 2 recent large studies reporting rates of 4.6% and 2.1%.14,15 The thin anterior skin, high tensional forces along the groin crease and perpendicular to the typical DA incision, and less resilient soft-tissue envelope are postulated reasons for wound-related issues, which are likely magnified in patients who are more obese.15,16

A novel device designed to lessen tissue damage is the ring retractor (Figure 1). Used initially in general surgery and obstetrics, it consists of 2 semirigid polymer rings connected by a flexible cylindrical polymer membrane.18-20 The lower ring is tucked and anchored underneath the wound edge, and then the upper ring is rolled down and cinched onto the skin. The resultant tension on the polymer sleeve—imparted by the rigidity of the ring—provides strong, evenly distributed wound-edge retraction. It also provides a physical barrier between the wound edge and the rest of the operative field. Proponents of the ring retractor claim increased wound-edge moisture, less bruising, and reduced local trauma compared with standard metal retractors alone.

Wound-edge retractor forces are doubled during MIS-THA compared with conventional THA.14-20 This may explain reports of worse scar cosmesis with MIS-THA. Given the theoretical benefits of minimized wound-edge trauma, the ring retractor may improve scar appearance compared with standard retraction alone. Any clinically relevant effect on cosmesis should be readily apparent to justify use of the retractor in this regard. Although some surgeons routinely use the device for primary THA, it has not been the subject of any recent orthopedic studies.

In the present study, we prospectively investigated wound cosmesis with and without use of the ring retractor in patients undergoing DA-THA.

Materials and Methods

This prospective, single-center, randomized study was reviewed and approved by the institutional review board at our facility. Consent was obtained from all participating patients.

We evaluated 50 surgical incisions in 48 patients. Eligible participants were over age 18 years and undergoing primary DA-THA. Exclusion criteria included previous surgery on the affected hip, a pathological hip condition requiring an extensile exposure, systemic inflammatory illness, chronic corticosteroid use, and dermatologic abnormality of the incisional area. One patient was having simultaneous bilateral THAs, and another was having staged bilateral THAs. Each hip in these patients was given its own case number and treated separately. Of the 49 patients who met all the inclusion criteria, only 1 decided not to participate (Figure 2).

Stratified randomization with permuted block size (sex, body mass index [BMI]) was used to assign patients in a 1:1 ratio to either the treatment group or the control group. In the treatment group, the Protractor Incision Protector and Retractor (Gyrus ACMI, Southborough, Massachusetts) was used with standard metal retractors. In the control group, only standard metal retractors were used. Patients were blinded to their group assignments, and surgeons were informed about each assignment only after the initial incision was made.

Clinical research investigators were blinded to the groups’ prospectively collected data. Collection time points were preoperative clinical visit, day of surgery through discharge, and 2-, 6-, and 12-week postoperative follow-ups. Day-of-surgery data included estimated intraoperative blood loss, operative side, operative time, intraoperative complications, and American Society of Anesthesiologists (ASA) physical status classification. Total length of stay, pain scores (range, 0-10), estimated drain output, and blood-transfusion data were also recorded. To evaluate whether the device had any effect on short-term functional outcome, we collected Harris Hip Scores (HHS) and Short Form–12 (SF-12, Version 2) scores at the preoperative and 6-week postoperative visits. We also documented any wound-healing-related issues or complications that occurred up until the final visit.

 

 

To account for any effect of nutrition status on wound healing, we obtained pre-albumin and albumin levels and absolute lymphocyte counts from the preoperative electronic records. We used an albumin level under 3.5 g/dL and an absolute lymphocyte count under 1500/µL for our analysis, as these cutoffs have been associated with wound complications after primary THA.21 There is no similarly established threshold for pre-albumin level, so we used values under 20 mg/L based on comparable literature.22,23

At each postoperative visit, standardized high-resolution images were obtained. At the 12-week visit, patients completed 2 Likert scales regarding their overall opinion of their scars and how their scars compared with their expectations. They also ranked 5 separate THA-related outcomes in order of importance (Appendix).

Photographs were evaluated by 2 blinded plastic surgeons (Dr. Friedman and Dr. Jack) using 2 grading systems—the Stony Brook Scar Evaluation Scale (SBSES)24 (Table 1) and a modified Manchester Scar Scale (MSS)25 (Table 2). We used these systems because they were photograph-based, psychometrically studied, and specifically designed to assess surgical incision healing with established validity and reliability.24-27 A particular advantage, strictly related to cosmetic outcome, is their validity in scoring scars from high-definition photographs in a different place or time. The SBSES, an ordinal wound evaluation scale that measures short-term cosmetic outcomes, consists of 6 items, each receiving 1 or 0 point, yielding a total score between 0 (worst) and 5 (best). The modified MSS includes a visual analog scale (VAS), which has a vertical hash marked on a 10-cm line and is scored between 0 (excellent) and 10 (poor) to 1 decimal point.26,28 This value is added to grades on color, surface appearance, contour, and distortion, resulting in a score between 4 (best) and 24 (worst). The primary outcome measures were Likert-scale responses obtained at final visit and SBSES/MSS scores for each visit; 12-week scores were the primary end point.

Operative Procedure

Experienced fellowship-trained orthopedic surgeons performed all procedures. A modified Hueter approach was used for exposure.9 Mean incision length was about 12 cm. For the treatment group, the ring retractor was inserted at the level of the tensor fascia, with the inferior ring resting between the fascia and the subcutaneous layer and the superior ring cinched over the skin (Figure 3). The device is made in 4 different sizes for incisions from 2.5 to 17 cm; our study population required only 1 size. Otherwise, the surgical protocol was based on that described by Matta and colleagues.8 Wound closure (over a drain) was performed according to a standardized protocol—running No. 1 Vicryl suture for the superficial tensor fascia, interrupted 2-0 Vicryl for the deep dermal layer, and subcutaneous 4-0 Monocryl for the skin followed by application of Dermabond (Ethicon, Somerville, New Jersey) and Tegaderm +Pad (3M, St. Paul, Minnesota) for outer dressing, which was replaced on postoperative day 2 and removed at the 2-week visit.

Statistical Methods

An a priori sample-size calculation was performed. Power performed in a base of a prior study that evaluated anterolateral and posterolateral THA scars using a VAS, a component of the MSS, suggested a sample size of 16 per group to detect the minimal clinically important difference of 1.5 cm: SD (σ) = 1.5 cm, α = 0.05, β = 0.20.29,30 In addition, a general estimate for detecting a 1-unit change on an ordinal scale (σ = 1.0, α = 0.05, β = 0.20) resulted in the same number. We conservatively decided to enroll 25 patients per arm in case of larger true variance.

The Wilcoxon rank sum test was used for comparisons of continuous data between groups. Differences between means were analyzed with 2-sided t tests. Categorical data were compared with the Pearson χ2 test or the Fisher exact test, as indicated. Ordinal ranking scores were compared with the Mantel-Haenszel test. Multivariate logistic regression was applied to identify the significant independent predictors of better scar grades for each surgeon by considering candidate variables with Ps < .20 in the univariate analysis.

Results

We found no differences in demographic or perioperative characteristics between treatment and control groups (Tables 3, 4). The groups showed similar mean improvements in their respective 6-week HHS (38.7 and 36.4 points; P = .65), SF-12 physical component summary scores (11.8 and 14.5 points; P = .37), and SF-12 mental component summary scores (5.1 and 3.7; P = .70).

Patient questionnaire outcomes are listed in Table 5. For the control group, 25/25 image sets were obtained at the 2-week visit, 25/25 at the 6-week visit, and 24/25 at the 12-week visit. For the treatment group, there were 23/25, 24/25, and 23/25 images sets, respectively.

 

 

When surgeon scoring was analyzed separately, SBSES and MSS scores were similar between treatment and control groups, with 1 exception: 2-week MSS scores were better for the treatment group according to surgeon A (P = .026). When grades were averaged, SBSES scores were again similar at all time points (Figure 4A); MSS scores were better for the treatment group at 2 weeks (P = .036) and equivalent at all other time points (Figure 4B). For the SBSES, Spearman correlation coefficient ρ with 95% confidence interval (CI) was 0.37
(95% CI, 0.08-0.66) at 2 weeks, 0.48 (95% CI, 0.20-0.76) at 6 weeks, and 0.62 (95% CI, 0.33-0.91) at 12 weeks. Following the same pattern for the MSS, ρ was 0.20 (95% CI, –0.09 to 0.49), 0.51 (95% CI, 0.23-0.79), and 0.32 (95% CI, 0.03-0.61).

Independent multivariate analysis revealed that age over 65 years was a significant predictor of worse scores. On SBSES, the odds ratio (OR) was 1.15 (95% CI, 1.07-1.24) for surgeon A and 1.11 (95% CI, 1.05-1.18) for surgeon B. On MSS, the OR was 0.89 (95% CI, 0.84-0.94) for surgeon A and 0.95 (95% CI, 0.91-0.99) for surgeon B. The likelihood of having worse SBSES scores according to surgeon A was 4.72 times higher if the pre-albumin level was under 20 mg/L (95% CI, 1.15-19.36). Albumin level under 3.5 g/dL and absolute lymphocyte count under 1500 cells/µL were not found to be independent predictors of poorer scores.

Patients’ overall opinion (P = .63) and assessment of their scars relative to expectations (P = .25) on the Likert scales were not different between groups. More scars exceeded patients’ expectations and had more excellent ratings in the control group. The 2 groups were similar with regard to relative importance of various patient-related outcomes. Factors most important to overall outcome were relief of hip pain, followed by implant longevity and length of recovery. Least important were incision-related variables.

There were only 3 minor noninfectious wound complications (6%), 2 in the treatment group and 1 in the control group. In the treatment group, a 67-year-old man with diabetes (ASA class III; BMI, 32.1 kg/m2; received transfusion) had 2 small areas (<5 mm) of superficial ulceration at 6-week follow-up—one at the proximal aspect of the incision and the other near the midpoint along the flexion crease. Both lesions resolved by 12-week follow-up. Also in the treatment group, a 77-year-old woman (ASA class II; BMI, 24.9 kg/m2; received transfusion) at 6 weeks had a spitting suture, which was removed in clinic without further issue. In the control group, a 55-year-old woman (ASA class II; BMI, 27.4 kg/m2) had a suture reaction near the proximal aspect of her incision 3 weeks after surgery. This reaction, which presented as a mild, localized erythema without pain, tenderness, or drainage, resolved by 6-week follow-up. None of these wound complications required intervention beyond observation.

Discussion

This study was designed to provide a bipartisan measure of wound-healing cosmesis after DA-THA. Scar evaluation by blinded plastic surgeons served as a standardized, clinical assessment, whereas the patient questionnaire offered a more subjective appraisal. The modified MMS25 and the SBSES24 are the only 2 wound-grading systems designed and validated for photographic assessment of postsurgical scars. Most scar evaluation schemes pertain to burn or traumatic scars.26,27,31 As a result, many earlier studies intending to compare incisional scars used poorly suited evaluation systems.

The current literature includes reports on 3 studies with scoring-based scar assessment in THA; all used grading systems designed for either burns or traumatic wounds, but 2 also used a VAS.32-34 VASs have been validated for measuring wound cosmesis but are entirely subjective and without structure and provide no feedback as to why a scar was rated good or bad.24 Mow and colleagues32 prospectively compared scars after standard posterior or MIS approaches and found no differences according to a scoring system intended for burn scars. In our study population, we found no group differences in patients’ cosmesis of their scars.

Although scars can take a year or longer to fully mature, researchers from the University of Michigan discovered that scar appearance at 1 year correlates highly with cosmesis 12 weeks after closure, though poorly with cosmesis 10 days after closure.35 Therefore, any observed differences in scar cosmesis between groups at 12-week follow-up would likely persist, whereas differences at 2-week follow-up would have little bearing on ultimate appearance. For this reason, our primary outcome measure was healing process and cosmesis at 12 weeks. High wound complication rates have been reported for MIS-DA-THA.8,14-16 Jewett and Collis15 noted a 4.6% wound complication rate (3% noninfectious ulcerative dehiscence, 1.6% superficial infection), which is comparable to the 6% rate found in this study. However, there likely is some variability across studies in what constitutes a wound complication or superficial infection. Of our 3 wound complications—stitch reaction, spitting suture, small noninfectious ulceration—only the ulceration was of a severity similar to that reported by Jewett and Collis.15 Matta and colleagues8 reported only 3 wound complications (in 494 patients), all severe enough to require operative intervention. One explanation for this low complication rate is use of a ring retractor, as it is routinely depicted in their technique paper. However, no specific reference is made to gauge how often the device was used.

 

 

Rates of superficial infection after DA-THA range from 0.6% to 1.6% in 3 large observational studies (combined deep infection rate, 0.43%).8,14,15 In 2 of these studies, all patients with superficial infection underwent formal débridement, though none developed deep infection. A prospective randomized study of 221 patients who underwent colorectal surgery—where perioperative infectious morbidity ranges from 25% to 50%—found that ring retractor use significantly reduced superficial wound infection rates (8.1% vs 0%). A significant reduction in wound infection was shown in a similarly designed study involving 48 patients who had open appendectomy (14.6% vs 1.6%). The device had no effect on deep infection in either general surgery study. The wound infection rates reported in these general surgery studies are markedly higher than those in our study population. As a result, the effect of the ring retractor on wound infection in DA-THA may be less. Regardless of the effect on deep infection, fewer superficial infections, which often require operative intervention, would be of considerable benefit.

Below-threshold albumin level and absolute lymphocyte count have been associated with wound-healing complications after hip replacement.21 In the present study, pre-albumin level under 20 mg/L was the only nutritional marker predictive of poor wound appearance, but this finding was seen only in SBSES scores from surgeon A. Subgroup analysis did not reveal any relationship between wound appearance and any of the recorded demographic or perioperative variables, but for a small predictive influence with age over 65 years.

This study had some limitations. Our findings cannot be generalized to all patients who undergo THA, as only DA incisions were studied. Results also may not be generalizable to non-fellowship-trained orthopedists. In addition, selection bias likely resulted from including patients already selected for the DA approach. Using digital images for evaluation (vs real-life evaluation) may have affected reliability as well. Last, by not incorporating texture, we omitted a potentially informative feature from scoring.

It is paramount that surgeons undergo diligent training before undertaking this approach for minimizing unwanted results; furthermore, higher early complication rates level off with increased surgeon experience.14,36,37 We recommend meticulous soft-tissue handling, cautious retraction, and careful patient selection (relative contraindication for patients with an abdominal pannus overlying the incision) as primary measures for minimizing incisional trauma and potential wound-healing complications.38 Preservation of the tensor fascia is also crucial,39 as it is the only closable layer separating deep and superficial compartments. Without good closure of the tensor fascia, there is no containment or tamponade of deep bleeding, which can facilitate hematoma formation.

In the population studied, we found no significant long-term differences in cosmetic appearance (based on clinician or patient evaluation) between wounds managed with and without the ring retractor. Our data do not support routine use of the ring retractor, during DA-THA, for improved wound cosmesis. Whether the device has any significant role in reducing the number of wound complications in THA is yet to be determined. Last, the ring retractor may have a role in other areas of orthopedic surgery, such as hip fractures in the elderly or orthopedic oncology. In situations like these, where adequate nutrition and immunocompetency may be lacking, the added protection provided by the device may translate into a more notable benefit than in elective THA.

It is thought that, by placing more emphasis on soft-tissue preservation, minimally invasive surgery total hip arthroplasty (MIS-THA) results in less soft-tissue trauma, less blood loss, and earlier recovery.1-3 Despite these improvements over standard methods, there is a concern that the vigorous retraction needed for proper visualization through smaller incisions could injure soft tissues.4-7 Single-incision direct anterior THA (DA-THA) has gained in popularity because of the true intermuscular/internervous plane through which the procedure can be performed with relatively minimal muscle dissection using MIS techniques.8,9 This approach may offer quicker recovery and superior stability in comparison with nonintermuscular methods, which unavoidably cause more muscle damage.10-12

Although the evidence of these early gains is encouraging, several studies have found high complication rates with DA-THA.8,13-17 Noted disadvantages include a steep learning curve, lateral femoral cutaneous neurapraxia, need for a specialized table, and higher fracture and wound complication rates. Not surprisingly, with increased surgeon experience, the complication rate decreased substantially.14,15 However, wound-related complications remained steady, with 2 recent large studies reporting rates of 4.6% and 2.1%.14,15 The thin anterior skin, high tensional forces along the groin crease and perpendicular to the typical DA incision, and less resilient soft-tissue envelope are postulated reasons for wound-related issues, which are likely magnified in patients who are more obese.15,16

A novel device designed to lessen tissue damage is the ring retractor (Figure 1). Used initially in general surgery and obstetrics, it consists of 2 semirigid polymer rings connected by a flexible cylindrical polymer membrane.18-20 The lower ring is tucked and anchored underneath the wound edge, and then the upper ring is rolled down and cinched onto the skin. The resultant tension on the polymer sleeve—imparted by the rigidity of the ring—provides strong, evenly distributed wound-edge retraction. It also provides a physical barrier between the wound edge and the rest of the operative field. Proponents of the ring retractor claim increased wound-edge moisture, less bruising, and reduced local trauma compared with standard metal retractors alone.

Wound-edge retractor forces are doubled during MIS-THA compared with conventional THA.14-20 This may explain reports of worse scar cosmesis with MIS-THA. Given the theoretical benefits of minimized wound-edge trauma, the ring retractor may improve scar appearance compared with standard retraction alone. Any clinically relevant effect on cosmesis should be readily apparent to justify use of the retractor in this regard. Although some surgeons routinely use the device for primary THA, it has not been the subject of any recent orthopedic studies.

In the present study, we prospectively investigated wound cosmesis with and without use of the ring retractor in patients undergoing DA-THA.

Materials and Methods

This prospective, single-center, randomized study was reviewed and approved by the institutional review board at our facility. Consent was obtained from all participating patients.

We evaluated 50 surgical incisions in 48 patients. Eligible participants were over age 18 years and undergoing primary DA-THA. Exclusion criteria included previous surgery on the affected hip, a pathological hip condition requiring an extensile exposure, systemic inflammatory illness, chronic corticosteroid use, and dermatologic abnormality of the incisional area. One patient was having simultaneous bilateral THAs, and another was having staged bilateral THAs. Each hip in these patients was given its own case number and treated separately. Of the 49 patients who met all the inclusion criteria, only 1 decided not to participate (Figure 2).

Stratified randomization with permuted block size (sex, body mass index [BMI]) was used to assign patients in a 1:1 ratio to either the treatment group or the control group. In the treatment group, the Protractor Incision Protector and Retractor (Gyrus ACMI, Southborough, Massachusetts) was used with standard metal retractors. In the control group, only standard metal retractors were used. Patients were blinded to their group assignments, and surgeons were informed about each assignment only after the initial incision was made.

Clinical research investigators were blinded to the groups’ prospectively collected data. Collection time points were preoperative clinical visit, day of surgery through discharge, and 2-, 6-, and 12-week postoperative follow-ups. Day-of-surgery data included estimated intraoperative blood loss, operative side, operative time, intraoperative complications, and American Society of Anesthesiologists (ASA) physical status classification. Total length of stay, pain scores (range, 0-10), estimated drain output, and blood-transfusion data were also recorded. To evaluate whether the device had any effect on short-term functional outcome, we collected Harris Hip Scores (HHS) and Short Form–12 (SF-12, Version 2) scores at the preoperative and 6-week postoperative visits. We also documented any wound-healing-related issues or complications that occurred up until the final visit.

 

 

To account for any effect of nutrition status on wound healing, we obtained pre-albumin and albumin levels and absolute lymphocyte counts from the preoperative electronic records. We used an albumin level under 3.5 g/dL and an absolute lymphocyte count under 1500/µL for our analysis, as these cutoffs have been associated with wound complications after primary THA.21 There is no similarly established threshold for pre-albumin level, so we used values under 20 mg/L based on comparable literature.22,23

At each postoperative visit, standardized high-resolution images were obtained. At the 12-week visit, patients completed 2 Likert scales regarding their overall opinion of their scars and how their scars compared with their expectations. They also ranked 5 separate THA-related outcomes in order of importance (Appendix).

Photographs were evaluated by 2 blinded plastic surgeons (Dr. Friedman and Dr. Jack) using 2 grading systems—the Stony Brook Scar Evaluation Scale (SBSES)24 (Table 1) and a modified Manchester Scar Scale (MSS)25 (Table 2). We used these systems because they were photograph-based, psychometrically studied, and specifically designed to assess surgical incision healing with established validity and reliability.24-27 A particular advantage, strictly related to cosmetic outcome, is their validity in scoring scars from high-definition photographs in a different place or time. The SBSES, an ordinal wound evaluation scale that measures short-term cosmetic outcomes, consists of 6 items, each receiving 1 or 0 point, yielding a total score between 0 (worst) and 5 (best). The modified MSS includes a visual analog scale (VAS), which has a vertical hash marked on a 10-cm line and is scored between 0 (excellent) and 10 (poor) to 1 decimal point.26,28 This value is added to grades on color, surface appearance, contour, and distortion, resulting in a score between 4 (best) and 24 (worst). The primary outcome measures were Likert-scale responses obtained at final visit and SBSES/MSS scores for each visit; 12-week scores were the primary end point.

Operative Procedure

Experienced fellowship-trained orthopedic surgeons performed all procedures. A modified Hueter approach was used for exposure.9 Mean incision length was about 12 cm. For the treatment group, the ring retractor was inserted at the level of the tensor fascia, with the inferior ring resting between the fascia and the subcutaneous layer and the superior ring cinched over the skin (Figure 3). The device is made in 4 different sizes for incisions from 2.5 to 17 cm; our study population required only 1 size. Otherwise, the surgical protocol was based on that described by Matta and colleagues.8 Wound closure (over a drain) was performed according to a standardized protocol—running No. 1 Vicryl suture for the superficial tensor fascia, interrupted 2-0 Vicryl for the deep dermal layer, and subcutaneous 4-0 Monocryl for the skin followed by application of Dermabond (Ethicon, Somerville, New Jersey) and Tegaderm +Pad (3M, St. Paul, Minnesota) for outer dressing, which was replaced on postoperative day 2 and removed at the 2-week visit.

Statistical Methods

An a priori sample-size calculation was performed. Power performed in a base of a prior study that evaluated anterolateral and posterolateral THA scars using a VAS, a component of the MSS, suggested a sample size of 16 per group to detect the minimal clinically important difference of 1.5 cm: SD (σ) = 1.5 cm, α = 0.05, β = 0.20.29,30 In addition, a general estimate for detecting a 1-unit change on an ordinal scale (σ = 1.0, α = 0.05, β = 0.20) resulted in the same number. We conservatively decided to enroll 25 patients per arm in case of larger true variance.

The Wilcoxon rank sum test was used for comparisons of continuous data between groups. Differences between means were analyzed with 2-sided t tests. Categorical data were compared with the Pearson χ2 test or the Fisher exact test, as indicated. Ordinal ranking scores were compared with the Mantel-Haenszel test. Multivariate logistic regression was applied to identify the significant independent predictors of better scar grades for each surgeon by considering candidate variables with Ps < .20 in the univariate analysis.

Results

We found no differences in demographic or perioperative characteristics between treatment and control groups (Tables 3, 4). The groups showed similar mean improvements in their respective 6-week HHS (38.7 and 36.4 points; P = .65), SF-12 physical component summary scores (11.8 and 14.5 points; P = .37), and SF-12 mental component summary scores (5.1 and 3.7; P = .70).

Patient questionnaire outcomes are listed in Table 5. For the control group, 25/25 image sets were obtained at the 2-week visit, 25/25 at the 6-week visit, and 24/25 at the 12-week visit. For the treatment group, there were 23/25, 24/25, and 23/25 images sets, respectively.

 

 

When surgeon scoring was analyzed separately, SBSES and MSS scores were similar between treatment and control groups, with 1 exception: 2-week MSS scores were better for the treatment group according to surgeon A (P = .026). When grades were averaged, SBSES scores were again similar at all time points (Figure 4A); MSS scores were better for the treatment group at 2 weeks (P = .036) and equivalent at all other time points (Figure 4B). For the SBSES, Spearman correlation coefficient ρ with 95% confidence interval (CI) was 0.37
(95% CI, 0.08-0.66) at 2 weeks, 0.48 (95% CI, 0.20-0.76) at 6 weeks, and 0.62 (95% CI, 0.33-0.91) at 12 weeks. Following the same pattern for the MSS, ρ was 0.20 (95% CI, –0.09 to 0.49), 0.51 (95% CI, 0.23-0.79), and 0.32 (95% CI, 0.03-0.61).

Independent multivariate analysis revealed that age over 65 years was a significant predictor of worse scores. On SBSES, the odds ratio (OR) was 1.15 (95% CI, 1.07-1.24) for surgeon A and 1.11 (95% CI, 1.05-1.18) for surgeon B. On MSS, the OR was 0.89 (95% CI, 0.84-0.94) for surgeon A and 0.95 (95% CI, 0.91-0.99) for surgeon B. The likelihood of having worse SBSES scores according to surgeon A was 4.72 times higher if the pre-albumin level was under 20 mg/L (95% CI, 1.15-19.36). Albumin level under 3.5 g/dL and absolute lymphocyte count under 1500 cells/µL were not found to be independent predictors of poorer scores.

Patients’ overall opinion (P = .63) and assessment of their scars relative to expectations (P = .25) on the Likert scales were not different between groups. More scars exceeded patients’ expectations and had more excellent ratings in the control group. The 2 groups were similar with regard to relative importance of various patient-related outcomes. Factors most important to overall outcome were relief of hip pain, followed by implant longevity and length of recovery. Least important were incision-related variables.

There were only 3 minor noninfectious wound complications (6%), 2 in the treatment group and 1 in the control group. In the treatment group, a 67-year-old man with diabetes (ASA class III; BMI, 32.1 kg/m2; received transfusion) had 2 small areas (<5 mm) of superficial ulceration at 6-week follow-up—one at the proximal aspect of the incision and the other near the midpoint along the flexion crease. Both lesions resolved by 12-week follow-up. Also in the treatment group, a 77-year-old woman (ASA class II; BMI, 24.9 kg/m2; received transfusion) at 6 weeks had a spitting suture, which was removed in clinic without further issue. In the control group, a 55-year-old woman (ASA class II; BMI, 27.4 kg/m2) had a suture reaction near the proximal aspect of her incision 3 weeks after surgery. This reaction, which presented as a mild, localized erythema without pain, tenderness, or drainage, resolved by 6-week follow-up. None of these wound complications required intervention beyond observation.

Discussion

This study was designed to provide a bipartisan measure of wound-healing cosmesis after DA-THA. Scar evaluation by blinded plastic surgeons served as a standardized, clinical assessment, whereas the patient questionnaire offered a more subjective appraisal. The modified MMS25 and the SBSES24 are the only 2 wound-grading systems designed and validated for photographic assessment of postsurgical scars. Most scar evaluation schemes pertain to burn or traumatic scars.26,27,31 As a result, many earlier studies intending to compare incisional scars used poorly suited evaluation systems.

The current literature includes reports on 3 studies with scoring-based scar assessment in THA; all used grading systems designed for either burns or traumatic wounds, but 2 also used a VAS.32-34 VASs have been validated for measuring wound cosmesis but are entirely subjective and without structure and provide no feedback as to why a scar was rated good or bad.24 Mow and colleagues32 prospectively compared scars after standard posterior or MIS approaches and found no differences according to a scoring system intended for burn scars. In our study population, we found no group differences in patients’ cosmesis of their scars.

Although scars can take a year or longer to fully mature, researchers from the University of Michigan discovered that scar appearance at 1 year correlates highly with cosmesis 12 weeks after closure, though poorly with cosmesis 10 days after closure.35 Therefore, any observed differences in scar cosmesis between groups at 12-week follow-up would likely persist, whereas differences at 2-week follow-up would have little bearing on ultimate appearance. For this reason, our primary outcome measure was healing process and cosmesis at 12 weeks. High wound complication rates have been reported for MIS-DA-THA.8,14-16 Jewett and Collis15 noted a 4.6% wound complication rate (3% noninfectious ulcerative dehiscence, 1.6% superficial infection), which is comparable to the 6% rate found in this study. However, there likely is some variability across studies in what constitutes a wound complication or superficial infection. Of our 3 wound complications—stitch reaction, spitting suture, small noninfectious ulceration—only the ulceration was of a severity similar to that reported by Jewett and Collis.15 Matta and colleagues8 reported only 3 wound complications (in 494 patients), all severe enough to require operative intervention. One explanation for this low complication rate is use of a ring retractor, as it is routinely depicted in their technique paper. However, no specific reference is made to gauge how often the device was used.

 

 

Rates of superficial infection after DA-THA range from 0.6% to 1.6% in 3 large observational studies (combined deep infection rate, 0.43%).8,14,15 In 2 of these studies, all patients with superficial infection underwent formal débridement, though none developed deep infection. A prospective randomized study of 221 patients who underwent colorectal surgery—where perioperative infectious morbidity ranges from 25% to 50%—found that ring retractor use significantly reduced superficial wound infection rates (8.1% vs 0%). A significant reduction in wound infection was shown in a similarly designed study involving 48 patients who had open appendectomy (14.6% vs 1.6%). The device had no effect on deep infection in either general surgery study. The wound infection rates reported in these general surgery studies are markedly higher than those in our study population. As a result, the effect of the ring retractor on wound infection in DA-THA may be less. Regardless of the effect on deep infection, fewer superficial infections, which often require operative intervention, would be of considerable benefit.

Below-threshold albumin level and absolute lymphocyte count have been associated with wound-healing complications after hip replacement.21 In the present study, pre-albumin level under 20 mg/L was the only nutritional marker predictive of poor wound appearance, but this finding was seen only in SBSES scores from surgeon A. Subgroup analysis did not reveal any relationship between wound appearance and any of the recorded demographic or perioperative variables, but for a small predictive influence with age over 65 years.

This study had some limitations. Our findings cannot be generalized to all patients who undergo THA, as only DA incisions were studied. Results also may not be generalizable to non-fellowship-trained orthopedists. In addition, selection bias likely resulted from including patients already selected for the DA approach. Using digital images for evaluation (vs real-life evaluation) may have affected reliability as well. Last, by not incorporating texture, we omitted a potentially informative feature from scoring.

It is paramount that surgeons undergo diligent training before undertaking this approach for minimizing unwanted results; furthermore, higher early complication rates level off with increased surgeon experience.14,36,37 We recommend meticulous soft-tissue handling, cautious retraction, and careful patient selection (relative contraindication for patients with an abdominal pannus overlying the incision) as primary measures for minimizing incisional trauma and potential wound-healing complications.38 Preservation of the tensor fascia is also crucial,39 as it is the only closable layer separating deep and superficial compartments. Without good closure of the tensor fascia, there is no containment or tamponade of deep bleeding, which can facilitate hematoma formation.

In the population studied, we found no significant long-term differences in cosmetic appearance (based on clinician or patient evaluation) between wounds managed with and without the ring retractor. Our data do not support routine use of the ring retractor, during DA-THA, for improved wound cosmesis. Whether the device has any significant role in reducing the number of wound complications in THA is yet to be determined. Last, the ring retractor may have a role in other areas of orthopedic surgery, such as hip fractures in the elderly or orthopedic oncology. In situations like these, where adequate nutrition and immunocompetency may be lacking, the added protection provided by the device may translate into a more notable benefit than in elective THA.

References

1.    Laffosse JM, Chiron P, Tricoire JL, Giordano G, Molinier F, Puget J. Prospective and comparative study of minimally invasive posterior approach versus standard posterior approach in total hip replacement [in French]. Rev Chir Orthop Reparatrice Appar Mot. 2007;93(3):228-237.

2.    Smith TO, Blake V, Hing CB. Minimally invasive versus conventional exposure for total hip arthroplasty: a systematic review and meta-analysis of clinical and radiological outcomes. Int Orthop. 2011;35(2):173-184.

3.    Wright JM, Crockett HC, Delgado S, Lyman S, Madsen M, Sculco TP. Mini-incision for total hip arthroplasty: a prospective, controlled investigation with 5-year follow-up evaluation. J Arthroplasty. 2004;19(5):538-545.

4.    Mardones R, Pagnano MW, Nemanich JP, Trousdale RT. The Frank Stinchfield Award: muscle damage after total hip arthroplasty done with the two-incision and mini-posterior techniques. Clin Orthop. 2005;(441):63-67.

5.    Müller M, Tohtz S, Dewey M, Springer I, Perka C. Age-related appearance of muscle trauma in primary total hip arthroplasty and the benefit of a minimally invasive approach for patients older than 70 years. Int Orthop. 2011;35(2):165-171.

6.    Noble PC, Johnston JD, Alexander JA, et al. Making minimally invasive THR safe: conclusions from biomechanical simulation and analysis. Int Orthop. 2007;31(suppl 1):S25-S28.

7.    Bremer AK, Kalberer F, Pfirrmann CW, Dora C. Soft-tissue changes in hip abductor muscles and tendons after total hip replacement: comparison between the direct anterior and the transgluteal approaches. J Bone Joint Surg Br. 2011;93(7):886-889.

8.    Matta JM, Shahrdar C, Ferguson T. Single-incision anterior approach for total hip arthroplasty on an orthopaedic table. Clin Orthop. 2005;(441):115-124.

9.    Rachbauer F, Kain MSH, Leunig M. The history of the anterior approach to the hip. Orthop Clin North Am. 2009;40(3):311-320.

10.  Bergin PF, Doppelt JD, Kephart CJ, et al. Comparison of minimally invasive direct anterior versus posterior total hip arthroplasty based on inflammation and muscle damage markers. J Bone Joint Surg Am. 2011;93(15):1392-1398.

11.  Mayr E, Nogler M, Benedetti MG, et al. A prospective randomized assessment of earlier functional recovery in THA patients treated by minimally invasive direct anterior approach: a gait analysis study. Clin Biomech. 2009;24(10):812-818.

12.  Meneghini RM, Pagnano MW, Trousdale RT, Hozack WJ. Muscle damage during MIS total hip arthroplasty: Smith-Petersen versus posterior approach. Clin Orthop. 2006;(453):293-298.

13.  Sculco TP. Anterior approach in THA improves outcomes: opposes. Orthopedics. 2011;34(9):e459-e461.

14.  Bhandari M, Matta JM, Dodgin D, et al; Anterior Total Hip Arthroplasty Collaborative Investigators. Outcomes following the single-incision anterior approach to total hip arthroplasty: a multicenter observational study. Orthop Clin North Am. 2009;40(3):329-342.

15.  Jewett BA, Collis DK. High complication rate with anterior total hip arthroplasties on a fracture table. Clin Orthop. 2011;469(2):503-507.

16.  Barton C, Kim PR. Complications of the direct anterior approach for total hip arthroplasty. Orthop Clin North Am. 2009;40(3):371-375.

17.  Bender B, Nogler M, Hozack WJ. Direct anterior approach for total hip arthroplasty. Orthop Clin North Am. 2009;40(3):321-328.

18.  Pelosi MA 2nd, Pelosi MA 3rd. Self-retaining abdominal retractor for minilaparotomy. Obstet Gynecol. 2000;96(5, pt 1):775-778.

19.  Lee P, Waxman K, Taylor B, Yim S. Use of wound-protection system and postoperative wound-infection rates in open appendectomy: a randomized prospective trial. Arch Surg. 2009;144(9):872-875.

20.  Horiuchi T, Tanishima H, Tamagawa K, et al. Randomized, controlled investigation of the anti-infective properties of the Alexis retractor/protector of incision sites. J Trauma. 2007;62(1):212-215.

21.  Greene KA, Wilde AH, Stulberg BN. Preoperative nutritional status of total joint patients. Relationship to postoperative wound complications. J Arthroplasty. 1991;6(4):321-325.

22.  Alijanipour P, Heller S, Parvizi J. Prevention of periprosthetic joint infection: what are the effective strategies? J Knee Surg. 2014;27(4):251-258.

23.  Suarez JC, Slotkin EM, Alvarez AM, Szubski CR, Barsoum WK, Patel PD. Prospective, randomized trial to evaluate efficacy of a thrombin-based hemostaticagent in total knee arthroplasty. J Arthroplasty. 2014;29(10):1950-1955.

24.  Singer AJ, Arora B, Dagum A, Valentine S, Hollander JE. Development and validation of a novel scar evaluation scale. Plast Reconstr Surg. 2007;120(7):1892-1897.

25.  Beausang E, Floyd H, Dunn KW, Orton CI, Ferguson MW. A new quantitative scale for clinical scar assessment. Plast Reconstr Surg. 1998;102(6):1954-1961.

26.  Durani P, McGrouther DA, Ferguson MW. Current scales for assessing human scarring: a review. J Plast Reconstr Aesthet Surg. 2009;62(6):713-720.

27.  Fearmonti R, Bond J, Erdmann D, Levinson H. A review of scar scales and scar measuring devices. Eplasty. 2010;10:e43.

28.  Duncan JA, Bond JS, Mason T, et al. Visual analogue scale scoring and ranking: a suitable and sensitive method for assessing scar quality? Plast Reconstr Surg. 2006;118(4):909-918.

29.  Quinn JV, Wells GA. An assessment of clinical wound evaluation scales. Acad Emerg Med. 1998;5(6):583-586.

30.  Livesey C, Wylde V, Descamps S, et al. Skin closure after total hip replacement: a randomised controlled trial of skin adhesive versus surgical staples. J Bone Joint Surg Br. 2009;91(6):725-729.

31.  Atiyeh BS. Nonsurgical management of hypertrophic scars: evidence-based therapies, standard practices, and emerging methods. Aesthetic Plast Surg. 2007;31(5):468-492.

32.  Mow CS, Woolson ST, Ngarmukos SG, Park EH, Lorenz HP. Comparison of scars from total hip replacements done with a standard or a mini-incision. Clin Orthop. 2005;(441):80-85.

33.  Khan RJ, Fick D, Yao F, et al. A comparison of three methods of wound closure following arthroplasty: a prospective, randomised, controlled trial. J Bone Joint Surg Br. 2006;88(2):238-242.

34.  Goldstein WM, Ali R, Branson JJ, Berland KA. Comparison of patient satisfaction with incision cosmesis after standard and minimally invasive total hip arthroplasty. Orthopedics. 2008;31(4):368.

35.  Quinn J, Wells G, Sutcliffe T, et al. Tissue adhesive versus suture wound repair at 1 year: randomized clinical trial correlating early, 3-month, and 1-year cosmetic outcome. Ann Emerg Med. 1998;32(6):645-649.

36.    Alberti LR, Petroianu A, Zac RI, Andrade JC Jr. The effect of surgical procedures on serum albumin concentration. Chirurgia (Bucur). 2008;103(1):39-43.

37.  Berend KR, Lombardi AV Jr, Seng BE, Adams JB. Enhanced early outcomes with the anterior supine intermuscular approach in primary total hip arthroplasty. J Bone Joint Surg Am. 2009;91(suppl 6):107-120.

38.  Mutnal A, Patel P, Cardona L, Suarez J. Periprosthetic Propionibacterium granulosum joint infection after direct anterior total hip arthroplasty: a case report. JBJS Case Connector. 2011;1(2):e10.

39.   Alvarez AM, Suarez JC, Patel P, Benton EG. Fluoroscopic imaging of acetabular cup position during THA through a direct anterior approach. Orthopedics. 2013;36(10):776-777. Erratum in: Orthopedics. 2014;37(1):16.

References

1.    Laffosse JM, Chiron P, Tricoire JL, Giordano G, Molinier F, Puget J. Prospective and comparative study of minimally invasive posterior approach versus standard posterior approach in total hip replacement [in French]. Rev Chir Orthop Reparatrice Appar Mot. 2007;93(3):228-237.

2.    Smith TO, Blake V, Hing CB. Minimally invasive versus conventional exposure for total hip arthroplasty: a systematic review and meta-analysis of clinical and radiological outcomes. Int Orthop. 2011;35(2):173-184.

3.    Wright JM, Crockett HC, Delgado S, Lyman S, Madsen M, Sculco TP. Mini-incision for total hip arthroplasty: a prospective, controlled investigation with 5-year follow-up evaluation. J Arthroplasty. 2004;19(5):538-545.

4.    Mardones R, Pagnano MW, Nemanich JP, Trousdale RT. The Frank Stinchfield Award: muscle damage after total hip arthroplasty done with the two-incision and mini-posterior techniques. Clin Orthop. 2005;(441):63-67.

5.    Müller M, Tohtz S, Dewey M, Springer I, Perka C. Age-related appearance of muscle trauma in primary total hip arthroplasty and the benefit of a minimally invasive approach for patients older than 70 years. Int Orthop. 2011;35(2):165-171.

6.    Noble PC, Johnston JD, Alexander JA, et al. Making minimally invasive THR safe: conclusions from biomechanical simulation and analysis. Int Orthop. 2007;31(suppl 1):S25-S28.

7.    Bremer AK, Kalberer F, Pfirrmann CW, Dora C. Soft-tissue changes in hip abductor muscles and tendons after total hip replacement: comparison between the direct anterior and the transgluteal approaches. J Bone Joint Surg Br. 2011;93(7):886-889.

8.    Matta JM, Shahrdar C, Ferguson T. Single-incision anterior approach for total hip arthroplasty on an orthopaedic table. Clin Orthop. 2005;(441):115-124.

9.    Rachbauer F, Kain MSH, Leunig M. The history of the anterior approach to the hip. Orthop Clin North Am. 2009;40(3):311-320.

10.  Bergin PF, Doppelt JD, Kephart CJ, et al. Comparison of minimally invasive direct anterior versus posterior total hip arthroplasty based on inflammation and muscle damage markers. J Bone Joint Surg Am. 2011;93(15):1392-1398.

11.  Mayr E, Nogler M, Benedetti MG, et al. A prospective randomized assessment of earlier functional recovery in THA patients treated by minimally invasive direct anterior approach: a gait analysis study. Clin Biomech. 2009;24(10):812-818.

12.  Meneghini RM, Pagnano MW, Trousdale RT, Hozack WJ. Muscle damage during MIS total hip arthroplasty: Smith-Petersen versus posterior approach. Clin Orthop. 2006;(453):293-298.

13.  Sculco TP. Anterior approach in THA improves outcomes: opposes. Orthopedics. 2011;34(9):e459-e461.

14.  Bhandari M, Matta JM, Dodgin D, et al; Anterior Total Hip Arthroplasty Collaborative Investigators. Outcomes following the single-incision anterior approach to total hip arthroplasty: a multicenter observational study. Orthop Clin North Am. 2009;40(3):329-342.

15.  Jewett BA, Collis DK. High complication rate with anterior total hip arthroplasties on a fracture table. Clin Orthop. 2011;469(2):503-507.

16.  Barton C, Kim PR. Complications of the direct anterior approach for total hip arthroplasty. Orthop Clin North Am. 2009;40(3):371-375.

17.  Bender B, Nogler M, Hozack WJ. Direct anterior approach for total hip arthroplasty. Orthop Clin North Am. 2009;40(3):321-328.

18.  Pelosi MA 2nd, Pelosi MA 3rd. Self-retaining abdominal retractor for minilaparotomy. Obstet Gynecol. 2000;96(5, pt 1):775-778.

19.  Lee P, Waxman K, Taylor B, Yim S. Use of wound-protection system and postoperative wound-infection rates in open appendectomy: a randomized prospective trial. Arch Surg. 2009;144(9):872-875.

20.  Horiuchi T, Tanishima H, Tamagawa K, et al. Randomized, controlled investigation of the anti-infective properties of the Alexis retractor/protector of incision sites. J Trauma. 2007;62(1):212-215.

21.  Greene KA, Wilde AH, Stulberg BN. Preoperative nutritional status of total joint patients. Relationship to postoperative wound complications. J Arthroplasty. 1991;6(4):321-325.

22.  Alijanipour P, Heller S, Parvizi J. Prevention of periprosthetic joint infection: what are the effective strategies? J Knee Surg. 2014;27(4):251-258.

23.  Suarez JC, Slotkin EM, Alvarez AM, Szubski CR, Barsoum WK, Patel PD. Prospective, randomized trial to evaluate efficacy of a thrombin-based hemostaticagent in total knee arthroplasty. J Arthroplasty. 2014;29(10):1950-1955.

24.  Singer AJ, Arora B, Dagum A, Valentine S, Hollander JE. Development and validation of a novel scar evaluation scale. Plast Reconstr Surg. 2007;120(7):1892-1897.

25.  Beausang E, Floyd H, Dunn KW, Orton CI, Ferguson MW. A new quantitative scale for clinical scar assessment. Plast Reconstr Surg. 1998;102(6):1954-1961.

26.  Durani P, McGrouther DA, Ferguson MW. Current scales for assessing human scarring: a review. J Plast Reconstr Aesthet Surg. 2009;62(6):713-720.

27.  Fearmonti R, Bond J, Erdmann D, Levinson H. A review of scar scales and scar measuring devices. Eplasty. 2010;10:e43.

28.  Duncan JA, Bond JS, Mason T, et al. Visual analogue scale scoring and ranking: a suitable and sensitive method for assessing scar quality? Plast Reconstr Surg. 2006;118(4):909-918.

29.  Quinn JV, Wells GA. An assessment of clinical wound evaluation scales. Acad Emerg Med. 1998;5(6):583-586.

30.  Livesey C, Wylde V, Descamps S, et al. Skin closure after total hip replacement: a randomised controlled trial of skin adhesive versus surgical staples. J Bone Joint Surg Br. 2009;91(6):725-729.

31.  Atiyeh BS. Nonsurgical management of hypertrophic scars: evidence-based therapies, standard practices, and emerging methods. Aesthetic Plast Surg. 2007;31(5):468-492.

32.  Mow CS, Woolson ST, Ngarmukos SG, Park EH, Lorenz HP. Comparison of scars from total hip replacements done with a standard or a mini-incision. Clin Orthop. 2005;(441):80-85.

33.  Khan RJ, Fick D, Yao F, et al. A comparison of three methods of wound closure following arthroplasty: a prospective, randomised, controlled trial. J Bone Joint Surg Br. 2006;88(2):238-242.

34.  Goldstein WM, Ali R, Branson JJ, Berland KA. Comparison of patient satisfaction with incision cosmesis after standard and minimally invasive total hip arthroplasty. Orthopedics. 2008;31(4):368.

35.  Quinn J, Wells G, Sutcliffe T, et al. Tissue adhesive versus suture wound repair at 1 year: randomized clinical trial correlating early, 3-month, and 1-year cosmetic outcome. Ann Emerg Med. 1998;32(6):645-649.

36.    Alberti LR, Petroianu A, Zac RI, Andrade JC Jr. The effect of surgical procedures on serum albumin concentration. Chirurgia (Bucur). 2008;103(1):39-43.

37.  Berend KR, Lombardi AV Jr, Seng BE, Adams JB. Enhanced early outcomes with the anterior supine intermuscular approach in primary total hip arthroplasty. J Bone Joint Surg Am. 2009;91(suppl 6):107-120.

38.  Mutnal A, Patel P, Cardona L, Suarez J. Periprosthetic Propionibacterium granulosum joint infection after direct anterior total hip arthroplasty: a case report. JBJS Case Connector. 2011;1(2):e10.

39.   Alvarez AM, Suarez JC, Patel P, Benton EG. Fluoroscopic imaging of acetabular cup position during THA through a direct anterior approach. Orthopedics. 2013;36(10):776-777. Erratum in: Orthopedics. 2014;37(1):16.

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Arm Pain in Young Baseball Players Is Common, Yet Preventable

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Arm Pain in Young Baseball Players Is Common, Yet Preventable

A majority of healthy, youth baseball players report some baseline arm pain and fatigue, and many players suffer adverse psychosocial effects from this pain, according to a study published online ahead of print November 3 in the American Journal of Sports Medicine.

“Both nationally and internationally, we’re witnessing a troubling increase of elbow and shoulder injuries in young baseball players,” said study leader Christopher S. Ahmad, MD, Chief of Sports Medicine and Professor of Orthopedic Surgery at New York-Presbyterian/Columbia and head team physician for the New York Yankees.

Christopher S. Ahmad, MD

Dr. Ahmad and his research colleagues designed a questionnaire to learn more about the frequency, severity, and psychosocial effects of arm pain among active adolescent baseball payers. The questionnaire was completed by 203 players from New York and New Jersey, who were between the ages of 8 and 18. All of the surveys were completed without input from parents or coaches.

Among the survey’s findings was that 74% of players reported having arm pain while throwing. Just 26% said they “never” had arm pain while throwing.

The study also found that:

• 54% reported that arm pain limited the number of innings they could play.

• 75% reported that arm pain limited how hard they could throw.

• 80% reported having arm pain the day after throwing.

• 82% reported arm fatigue during a game or practice.

Pitchers, compared with infielders and outfielders, were especially likely to have played with pain. One-quarter of pitchers reported that they “often” or “always” had pain the day after throwing. “These pitchers likely represent one of the higher-risk groups for incurring a future overuse injury and thus warrant particularly high monitoring,” said Dr. Ahmad.

Almost half (47%) of players reported that they had been encouraged to continue playing in a practice or game even though they were having pain. One in eight players ages 17 to 18 reported that they “always” felt encouraged to continue playing despite having arm pain. A majority of players reported that arm pain caused them to experience less enjoyment while playing and that it was responsible for holding them back from being a better player.

“It’s alarming that so many young baseball players are encouraged to play with pain,” said Dr. Ahmad. “Years ago, prior to concussion protocols, we observed something similar in football, where players who suffered a concussion were routinely sent back into the game after ‘recovering’ for a few minutes. The initial concussion lowered the threshold for another concussion, and the repeated concussions put the player at risk for permanent damage. I think we’re seeing a similar problem in baseball, where playing with arm pain is setting the stage for more serious injury.”

Dr. Ahmad suspects that this phenomenon has contributed to the recent rise in “Tommy John” surgeries among college and professional baseball players. According to Dr. Ahmad, current precautions and guidelines are inadequate for preventing injury. “It’s not enough to set pitch counts based on a player’s age,” he said. “While some 14 year olds are already quite mature, in terms of their skeletal structure, others haven’t even started their growth spurt yet. We need to come up with more individualized throwing programs and better ways to detect which players are at risk for injury.”

Dr. Ahmad is currently investigating the use of ultrasound for correlating arm pain with tissue damage.

References

Suggested Reading
Makhni EC, Morrow ZS, Luchetti TJ, et al. Arm pain in youth baseball players: a survey of healthy players. Am J Sports Med. 2014 Nov 3. pii: 0363546514555506. [Epub ahead of print]

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A majority of healthy, youth baseball players report some baseline arm pain and fatigue, and many players suffer adverse psychosocial effects from this pain, according to a study published online ahead of print November 3 in the American Journal of Sports Medicine.

“Both nationally and internationally, we’re witnessing a troubling increase of elbow and shoulder injuries in young baseball players,” said study leader Christopher S. Ahmad, MD, Chief of Sports Medicine and Professor of Orthopedic Surgery at New York-Presbyterian/Columbia and head team physician for the New York Yankees.

Christopher S. Ahmad, MD

Dr. Ahmad and his research colleagues designed a questionnaire to learn more about the frequency, severity, and psychosocial effects of arm pain among active adolescent baseball payers. The questionnaire was completed by 203 players from New York and New Jersey, who were between the ages of 8 and 18. All of the surveys were completed without input from parents or coaches.

Among the survey’s findings was that 74% of players reported having arm pain while throwing. Just 26% said they “never” had arm pain while throwing.

The study also found that:

• 54% reported that arm pain limited the number of innings they could play.

• 75% reported that arm pain limited how hard they could throw.

• 80% reported having arm pain the day after throwing.

• 82% reported arm fatigue during a game or practice.

Pitchers, compared with infielders and outfielders, were especially likely to have played with pain. One-quarter of pitchers reported that they “often” or “always” had pain the day after throwing. “These pitchers likely represent one of the higher-risk groups for incurring a future overuse injury and thus warrant particularly high monitoring,” said Dr. Ahmad.

Almost half (47%) of players reported that they had been encouraged to continue playing in a practice or game even though they were having pain. One in eight players ages 17 to 18 reported that they “always” felt encouraged to continue playing despite having arm pain. A majority of players reported that arm pain caused them to experience less enjoyment while playing and that it was responsible for holding them back from being a better player.

“It’s alarming that so many young baseball players are encouraged to play with pain,” said Dr. Ahmad. “Years ago, prior to concussion protocols, we observed something similar in football, where players who suffered a concussion were routinely sent back into the game after ‘recovering’ for a few minutes. The initial concussion lowered the threshold for another concussion, and the repeated concussions put the player at risk for permanent damage. I think we’re seeing a similar problem in baseball, where playing with arm pain is setting the stage for more serious injury.”

Dr. Ahmad suspects that this phenomenon has contributed to the recent rise in “Tommy John” surgeries among college and professional baseball players. According to Dr. Ahmad, current precautions and guidelines are inadequate for preventing injury. “It’s not enough to set pitch counts based on a player’s age,” he said. “While some 14 year olds are already quite mature, in terms of their skeletal structure, others haven’t even started their growth spurt yet. We need to come up with more individualized throwing programs and better ways to detect which players are at risk for injury.”

Dr. Ahmad is currently investigating the use of ultrasound for correlating arm pain with tissue damage.

A majority of healthy, youth baseball players report some baseline arm pain and fatigue, and many players suffer adverse psychosocial effects from this pain, according to a study published online ahead of print November 3 in the American Journal of Sports Medicine.

“Both nationally and internationally, we’re witnessing a troubling increase of elbow and shoulder injuries in young baseball players,” said study leader Christopher S. Ahmad, MD, Chief of Sports Medicine and Professor of Orthopedic Surgery at New York-Presbyterian/Columbia and head team physician for the New York Yankees.

Christopher S. Ahmad, MD

Dr. Ahmad and his research colleagues designed a questionnaire to learn more about the frequency, severity, and psychosocial effects of arm pain among active adolescent baseball payers. The questionnaire was completed by 203 players from New York and New Jersey, who were between the ages of 8 and 18. All of the surveys were completed without input from parents or coaches.

Among the survey’s findings was that 74% of players reported having arm pain while throwing. Just 26% said they “never” had arm pain while throwing.

The study also found that:

• 54% reported that arm pain limited the number of innings they could play.

• 75% reported that arm pain limited how hard they could throw.

• 80% reported having arm pain the day after throwing.

• 82% reported arm fatigue during a game or practice.

Pitchers, compared with infielders and outfielders, were especially likely to have played with pain. One-quarter of pitchers reported that they “often” or “always” had pain the day after throwing. “These pitchers likely represent one of the higher-risk groups for incurring a future overuse injury and thus warrant particularly high monitoring,” said Dr. Ahmad.

Almost half (47%) of players reported that they had been encouraged to continue playing in a practice or game even though they were having pain. One in eight players ages 17 to 18 reported that they “always” felt encouraged to continue playing despite having arm pain. A majority of players reported that arm pain caused them to experience less enjoyment while playing and that it was responsible for holding them back from being a better player.

“It’s alarming that so many young baseball players are encouraged to play with pain,” said Dr. Ahmad. “Years ago, prior to concussion protocols, we observed something similar in football, where players who suffered a concussion were routinely sent back into the game after ‘recovering’ for a few minutes. The initial concussion lowered the threshold for another concussion, and the repeated concussions put the player at risk for permanent damage. I think we’re seeing a similar problem in baseball, where playing with arm pain is setting the stage for more serious injury.”

Dr. Ahmad suspects that this phenomenon has contributed to the recent rise in “Tommy John” surgeries among college and professional baseball players. According to Dr. Ahmad, current precautions and guidelines are inadequate for preventing injury. “It’s not enough to set pitch counts based on a player’s age,” he said. “While some 14 year olds are already quite mature, in terms of their skeletal structure, others haven’t even started their growth spurt yet. We need to come up with more individualized throwing programs and better ways to detect which players are at risk for injury.”

Dr. Ahmad is currently investigating the use of ultrasound for correlating arm pain with tissue damage.

References

Suggested Reading
Makhni EC, Morrow ZS, Luchetti TJ, et al. Arm pain in youth baseball players: a survey of healthy players. Am J Sports Med. 2014 Nov 3. pii: 0363546514555506. [Epub ahead of print]

References

Suggested Reading
Makhni EC, Morrow ZS, Luchetti TJ, et al. Arm pain in youth baseball players: a survey of healthy players. Am J Sports Med. 2014 Nov 3. pii: 0363546514555506. [Epub ahead of print]

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Arm Pain in Young Baseball Players Is Common, Yet Preventable
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Arm Pain in Young Baseball Players Is Common, Yet Preventable
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