Clinical benefit of physical rehabilitation after total hip and knee arthroplasty: A pragmatic, randomized, controlled trial (The DRAW1 trial)

全髋关节和全膝关节置换术后物理康复的临床益处:一项实用性随机对照试验(DRAW1试验)

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Abstract

IMPORTANCE: Comparative effectiveness trials have not shown superiority of one type of physical rehabilitation over another following total hip (THA) and knee (TKA) arthroplasty. We therefore ask the fundamental effectiveness question: Does physical rehabilitation "work" better than no physical rehabilitation? OBJECTIVE: To compare the effectiveness of a 6-week program of physical rehabilitation (home-based telerehabilitation, or home-based rehabilitation) to no physical rehabilitation following THA and TKA. DESIGN: 3-arm,randomized, controlled, superiority trial with blinded outcome assessments. 377 patients (210 THA/167 TKA) were screened for eligibility before the targeted sample size of 168 patients was reached. Outcome measures were assessed at baseline, at the end of intervention (6 weeks), and 3 and 12 months postoperatively. The primary outcome was the Hip disability and Osteoarthritis Outcome Score (HOOS)/Knee injury and Osteoarthritis Outcome Score (KOOS)-subscale: function in daily living. Secondary outcomes included: HOOS/KOOS-subscales: pain, symptoms, and quality of life, patient global assessment, analgesics, walking aids, 30-s chair stand test, 4 ​× ​10 ​m fast-paced walk test, exercise adherence, and satisfaction. RESULTS: Comparing physical rehabilitation (home-based telerehabilitation, and home-based rehabilitation) to no physical rehabilitation, the mean group-differences for the primary outcome were 3.3 (95%CI: -1.9 to 8.6; p ​= ​0.10) points at 6 weeks, and 1.9 (95%CI: -3.7 to 7.6; p ​= ​0.25) and 2.6 (95%CI: -4.4 to 9.6; p ​= ​0.23) points at the 3- and 12-months follow-ups, respectively. CONCLUSION: Physical rehabilitation was not superior to the no physical rehabilitation comparator following THA or TKA in terms of self-reported function or any of the secondary outcomes. TRIAL REGISTRATION: NCT03750448 (November 23, 2018), URL: https://clinicaltrials.gov/ct2/show/NCT03750448.

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