Randomized Controlled Trial

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  • a Randomized Controlled Trial of total knee replacement
    The New England Journal of Medicine, 2015
    Co-Authors: Søren Thorgaard Skou, Mogens Berg Laursen, Ole Simonsen, Lars Arendtnielsen, Michael Skovdal Rathleff, Ewa M Roos, Sten Rasmussen
    Abstract:

    BackgroundMore than 670,000 total knee replacements are performed annually in the United States; however, high-quality evidence to support the effectiveness of the procedure, as compared with nonsurgical interventions, is lacking. MethodsIn this Randomized, Controlled Trial, we enrolled 100 patients with moderate-to-severe knee osteoarthritis who were eligible for unilateral total knee replacement. Patients were randomly assigned to undergo total knee replacement followed by 12 weeks of nonsurgical treatment (total-knee-replacement group) or to receive only the 12 weeks of nonsurgical treatment (nonsurgical-treatment group), which was delivered by physiotherapists and dietitians and consisted of exercise, education, dietary advice, use of insoles, and pain medication. The primary outcome was the change from baseline to 12 months in the mean score on four Knee Injury and Osteoarthritis Outcome Score subscales, covering pain, symptoms, activities of daily living, and quality of life (KOOS4); scores range fr...

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