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.