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Total knee replacement was superior to nonsurgical treatment in relieving pain, restoring function, and improving quality of life for patients with moderate to severe knee osteoarthritis, according to a report published online Oct. 22 in the New England Journal of Medicine.
Even though the number of total knee replacements performed each year is large and steadily increasing – with more than 670,000 done in 2012 in the United States alone – no high-quality randomized, controlled trials have ever compared the effectiveness of the procedure against nonsurgical treatment, said Søren T. Skou, Ph.D., of the Research Unit for Musculoskeletal Function and Physiotherapy, Institute of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, and his associates.
Dr. Skou and his colleagues remedied that situation by randomly assigning 100 adults (mean age, 66 years) who were eligible for unilateral total knee replacement to either undergo the procedure and then receive a comprehensive nonsurgical intervention (50 patients) or receive the comprehensive nonsurgical intervention alone (50 patients) at two specialized university clinics in Denmark. The 12-week nonsurgical intervention comprised a twice-weekly group exercise program to restore neutral, functional realignment of the legs; two 1-hour education sessions regarding osteoarthritis characteristics, treatments, and self-help strategies; a dietary (weight-loss) program; provision of individually fitted insoles with medial arch support and a lateral wedge if patients had knee-lateral-to-foot positioning; and as-needed pain medication for pain – acetaminophen and ibuprofen – and pantoprazole, a proton-pump inhibitor.
The primary outcome measure in the trial was the between-group difference at 1 year in improvement on four subscales of the Knee Injury and Osteoarthritis Outcome Scores (KOOS) for pain, symptoms, activities of daily living, and quality of life. The surgical group showed a significantly greater improvement (32.5 out of a possible 100 points) than the nonsurgical group (16.0 points) in this outcome. The surgical group also showed significantly greater improvements in all five individual subscales and in a timed chair-rising test, a timed 20-meter walk test, and on a quality-of-life index, the investigators said (N Engl J Med. 2015 373;17:1597-606).
However, it is important to note that patients who had only the nonsurgical intervention showed clinically relevant improvements, and only 26% of them chose to have the surgery after the conclusion of the study. As expected, the surgical group had more serious adverse events than did the nonsurgical group (24 vs. 6), including three cases of deep venous thrombosis and three cases of knee stiffness requiring brisement forcé while the patient was anesthetized, Dr. Skou and his associates said.
This study was supported by the Obel Family Foundation, the Danish Rheumatism Association, the Health Science Foundation of the North Denmark Region, Foot Science International, Spar Nord Foundation, the Bevica Foundation, the Association of Danish Physiotherapists Research Fund, the Medical Specialist Heinrich Kopp’s Grant, and the Danish Medical Association Research Fund. Dr. Skou and his associates reported having no relevant financial disclosures.
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Dr. Jeffrey N. Katz |
This study provides the first rigorously controlled data to inform discussions about whether patients should undergo total knee replacement or opt for comprehensive nonsurgical treatment. Surgery proved markedly superior in this trial, with 85% of surgical patients reporting a clinically important improvement in pain and function at 1 year, compared with 68% of nonsurgical patients.
But surgery was associated with several severe adverse events, including deep venous thrombosis, deep wound infection, supracondylar fracture, and stiffness requiring treatment under general anesthesia. Each patient must weigh these considerations; each physician should present the relevant data to their patients and then listen carefully to their preferences.
Dr. Jeffrey N. Katz is in the departments of medicine and orthopedic surgery at Brigham and Women’s Hospital and Harvard University, Boston. He reported having no relevant financial disclosures. Dr. Katz made these remarks in an editorial accompanying Dr. Skou’s report (N Engl J Med. 2015 373;17:1668-9).
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Dr. Jeffrey N. Katz |
This study provides the first rigorously controlled data to inform discussions about whether patients should undergo total knee replacement or opt for comprehensive nonsurgical treatment. Surgery proved markedly superior in this trial, with 85% of surgical patients reporting a clinically important improvement in pain and function at 1 year, compared with 68% of nonsurgical patients.
But surgery was associated with several severe adverse events, including deep venous thrombosis, deep wound infection, supracondylar fracture, and stiffness requiring treatment under general anesthesia. Each patient must weigh these considerations; each physician should present the relevant data to their patients and then listen carefully to their preferences.
Dr. Jeffrey N. Katz is in the departments of medicine and orthopedic surgery at Brigham and Women’s Hospital and Harvard University, Boston. He reported having no relevant financial disclosures. Dr. Katz made these remarks in an editorial accompanying Dr. Skou’s report (N Engl J Med. 2015 373;17:1668-9).
|
Dr. Jeffrey N. Katz |
This study provides the first rigorously controlled data to inform discussions about whether patients should undergo total knee replacement or opt for comprehensive nonsurgical treatment. Surgery proved markedly superior in this trial, with 85% of surgical patients reporting a clinically important improvement in pain and function at 1 year, compared with 68% of nonsurgical patients.
But surgery was associated with several severe adverse events, including deep venous thrombosis, deep wound infection, supracondylar fracture, and stiffness requiring treatment under general anesthesia. Each patient must weigh these considerations; each physician should present the relevant data to their patients and then listen carefully to their preferences.
Dr. Jeffrey N. Katz is in the departments of medicine and orthopedic surgery at Brigham and Women’s Hospital and Harvard University, Boston. He reported having no relevant financial disclosures. Dr. Katz made these remarks in an editorial accompanying Dr. Skou’s report (N Engl J Med. 2015 373;17:1668-9).
Total knee replacement was superior to nonsurgical treatment in relieving pain, restoring function, and improving quality of life for patients with moderate to severe knee osteoarthritis, according to a report published online Oct. 22 in the New England Journal of Medicine.
Even though the number of total knee replacements performed each year is large and steadily increasing – with more than 670,000 done in 2012 in the United States alone – no high-quality randomized, controlled trials have ever compared the effectiveness of the procedure against nonsurgical treatment, said Søren T. Skou, Ph.D., of the Research Unit for Musculoskeletal Function and Physiotherapy, Institute of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, and his associates.
Dr. Skou and his colleagues remedied that situation by randomly assigning 100 adults (mean age, 66 years) who were eligible for unilateral total knee replacement to either undergo the procedure and then receive a comprehensive nonsurgical intervention (50 patients) or receive the comprehensive nonsurgical intervention alone (50 patients) at two specialized university clinics in Denmark. The 12-week nonsurgical intervention comprised a twice-weekly group exercise program to restore neutral, functional realignment of the legs; two 1-hour education sessions regarding osteoarthritis characteristics, treatments, and self-help strategies; a dietary (weight-loss) program; provision of individually fitted insoles with medial arch support and a lateral wedge if patients had knee-lateral-to-foot positioning; and as-needed pain medication for pain – acetaminophen and ibuprofen – and pantoprazole, a proton-pump inhibitor.
The primary outcome measure in the trial was the between-group difference at 1 year in improvement on four subscales of the Knee Injury and Osteoarthritis Outcome Scores (KOOS) for pain, symptoms, activities of daily living, and quality of life. The surgical group showed a significantly greater improvement (32.5 out of a possible 100 points) than the nonsurgical group (16.0 points) in this outcome. The surgical group also showed significantly greater improvements in all five individual subscales and in a timed chair-rising test, a timed 20-meter walk test, and on a quality-of-life index, the investigators said (N Engl J Med. 2015 373;17:1597-606).
However, it is important to note that patients who had only the nonsurgical intervention showed clinically relevant improvements, and only 26% of them chose to have the surgery after the conclusion of the study. As expected, the surgical group had more serious adverse events than did the nonsurgical group (24 vs. 6), including three cases of deep venous thrombosis and three cases of knee stiffness requiring brisement forcé while the patient was anesthetized, Dr. Skou and his associates said.
This study was supported by the Obel Family Foundation, the Danish Rheumatism Association, the Health Science Foundation of the North Denmark Region, Foot Science International, Spar Nord Foundation, the Bevica Foundation, the Association of Danish Physiotherapists Research Fund, the Medical Specialist Heinrich Kopp’s Grant, and the Danish Medical Association Research Fund. Dr. Skou and his associates reported having no relevant financial disclosures.
Total knee replacement was superior to nonsurgical treatment in relieving pain, restoring function, and improving quality of life for patients with moderate to severe knee osteoarthritis, according to a report published online Oct. 22 in the New England Journal of Medicine.
Even though the number of total knee replacements performed each year is large and steadily increasing – with more than 670,000 done in 2012 in the United States alone – no high-quality randomized, controlled trials have ever compared the effectiveness of the procedure against nonsurgical treatment, said Søren T. Skou, Ph.D., of the Research Unit for Musculoskeletal Function and Physiotherapy, Institute of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, and his associates.
Dr. Skou and his colleagues remedied that situation by randomly assigning 100 adults (mean age, 66 years) who were eligible for unilateral total knee replacement to either undergo the procedure and then receive a comprehensive nonsurgical intervention (50 patients) or receive the comprehensive nonsurgical intervention alone (50 patients) at two specialized university clinics in Denmark. The 12-week nonsurgical intervention comprised a twice-weekly group exercise program to restore neutral, functional realignment of the legs; two 1-hour education sessions regarding osteoarthritis characteristics, treatments, and self-help strategies; a dietary (weight-loss) program; provision of individually fitted insoles with medial arch support and a lateral wedge if patients had knee-lateral-to-foot positioning; and as-needed pain medication for pain – acetaminophen and ibuprofen – and pantoprazole, a proton-pump inhibitor.
The primary outcome measure in the trial was the between-group difference at 1 year in improvement on four subscales of the Knee Injury and Osteoarthritis Outcome Scores (KOOS) for pain, symptoms, activities of daily living, and quality of life. The surgical group showed a significantly greater improvement (32.5 out of a possible 100 points) than the nonsurgical group (16.0 points) in this outcome. The surgical group also showed significantly greater improvements in all five individual subscales and in a timed chair-rising test, a timed 20-meter walk test, and on a quality-of-life index, the investigators said (N Engl J Med. 2015 373;17:1597-606).
However, it is important to note that patients who had only the nonsurgical intervention showed clinically relevant improvements, and only 26% of them chose to have the surgery after the conclusion of the study. As expected, the surgical group had more serious adverse events than did the nonsurgical group (24 vs. 6), including three cases of deep venous thrombosis and three cases of knee stiffness requiring brisement forcé while the patient was anesthetized, Dr. Skou and his associates said.
This study was supported by the Obel Family Foundation, the Danish Rheumatism Association, the Health Science Foundation of the North Denmark Region, Foot Science International, Spar Nord Foundation, the Bevica Foundation, the Association of Danish Physiotherapists Research Fund, the Medical Specialist Heinrich Kopp’s Grant, and the Danish Medical Association Research Fund. Dr. Skou and his associates reported having no relevant financial disclosures.
FROM THE NEW ENGLAND JOURNAL OF MEDICINE
Key clinical point: Total knee replacement is superior to nonsurgical treatment in decreasing pain and improving function and quality of life.
Major finding: The surgical group showed a significantly greater improvement 1 year from baseline (32.5 out of a possible 100 points) than did the nonsurgical group (16.0 points) in mean Knee Injury and Osteoarthritis Outcome Scores (KOOS) for pain, symptoms, activities of daily living, and quality of life.
Data source: A randomized, controlled trial comparing 1-year outcomes after total knee replacement (50 patients) vs. nonsurgical treatment (50 patients) for osteoarthritis.
Disclosures: This study was supported by the Obel Family Foundation, the Danish Rheumatism Association, the Health Science Foundation of the North Denmark Region, Foot Science International, Spar Nord Foundation, the Bevica Foundation, the Association of Danish Physiotherapists Research Fund, the Medical Specialist Heinrich Kopp’s Grant, and the Danish Medical Association Research Fund. Dr. Skou and his associates reported having no relevant financial disclosures.
