A Randomized, Controlled Trial of Total Knee Replacement.
BACKGROUND
More 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.


METHODS
In 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 from 0 (worst) to 100 (best).


RESULTS
A total of 95 patients completed the 12-month follow-up assessment. In the nonsurgical-treatment group, 13 patients (26%) underwent total knee replacement before the 12-month follow-up; in the total-knee-replacement group, 1 patient (2%) received only nonsurgical treatment. In the intention-to-treat analysis, the total-knee-replacement group had greater improvement in the KOOS4 score than did the nonsurgical-treatment group (32.5 vs. 16.0; adjusted mean difference, 15.8 [95% confidence interval, 10.0 to 21.5]). The total-knee-replacement group had a higher number of serious adverse events than did the nonsurgical-treatment group (24 vs. 6, P=0.005).


CONCLUSIONS
In patients with knee osteoarthritis who were eligible for unilateral total knee replacement, treatment with total knee replacement followed by nonsurgical treatment resulted in greater pain relief and functional improvement after 12 months than did nonsurgical treatment alone. However, total knee replacement was associated with a higher number of serious adverse events than was nonsurgical treatment, and most patients who were assigned to receive nonsurgical treatment alone did not undergo total knee replacement before the 12-month follow-up. (Funded by the Obel Family Foundation and others; MEDIC ClinicalTrials.gov number, NCT01410409.).
From the Research Unit for Musculoskeletal Function and Physiotherapy, Institute of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense (S.T.S., E.M.R.), Clinical Nursing Research Unit (S.T.S.) and Orthopedic Surgery Research Unit (S.T.S., M.B.L., O.S., S.R.), Aalborg University Hospital, and Center for Sensory-Motor Interaction, Department of Health Science and Technology, Faculty of Medicine (S.T.S., M.B.L., M.S.R., L.A.-N., O.S., S.R.), and Department of Clinical Medicine (M.B.L., O.S., S.R.), Aalborg University, Aalborg - all in Denmark.
Søren T
ST
Skou
Ewa M
EM
Roos
Mogens B
MB
Laursen
Michael S
MS
Rathleff
Lars
L
Arendt-Nielsen
Ole
O
Simonsen
Sten
S
Rasmussen
D000203:Activities of Daily Living; D000368:Aged; D000700:Analgesics / Q000627:therapeutic use; D019645:Arthroplasty, Replacement, Knee / Q000534:rehabilitation*; D003131:Combined Modality Therapy; D005081:Exercise Therapy; D005260:Female; D005500:Follow-Up Studies; D061826:Foot Orthoses; D006801:Humans; D057194:Intention to Treat Analysis; D008297:Male; D008875:Middle Aged; D020370:Osteoarthritis, Knee / Q000188:drug therapy / Q000601:surgery* / Q000628:therapy; D011183:Postoperative Complications; D011788:Quality of Life
D000700:Analgesics