全髋关节和膝关节置换术后物理康复的临床益处：实用随机对照试验（DRAW1 试验）

Osteoarthritis and cartilage open Pub Date : 2024-10-16 DOI:10.1016/j.ocarto.2024.100530

T. Mark-Christensen , K. Thorborg , T. Kallemose , T. Bandholm

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引用次数: 0

摘要

重要性比较有效性试验并未显示全髋关节 (THA) 和膝关节 (TKA) 关节置换术后某种物理康复治疗优于另一种物理康复治疗。因此，我们提出了一个基本的有效性问题：目的比较全髋关节置换术（THA）和全膝关节置换术（TKA）后为期 6 周的物理康复计划（基于家庭的远程康复或基于家庭的康复）与无物理康复的效果。在达到168名患者的目标样本量之前，共筛选出377名患者（210名THA/167名TKA）符合条件。结果评估在基线、干预结束时（6 周）、术后 3 个月和 12 个月进行。主要结果是髋关节残疾和骨关节炎结果评分（HOOS）/膝关节损伤和骨关节炎结果评分（KOOS）子量表：日常生活功能。次要结果包括HOOS/KOOS-分量表：疼痛、症状和生活质量、患者总体评估、镇痛剂、助行器、30 秒椅子站立测试、4 × 10 米快步行走测试、运动依从性和满意度。结果物理康复（家庭远程康复和家庭康复）与无物理康复相比，主要结果的平均组间差异为 3.3（95%CI：-1.9 至 8.6；P = 0.10）分，3个月和12个月随访时分别为1.9（95%CI：-3.7至7.6；p = 0.25）分和2.6（95%CI：-4.4至9.6；p = 0.23）分。结论在THA或TKA术后，物理康复在自我报告的功能或任何次要结局方面均不优于无物理康复比较者。试验注册NCT03750448（2018年11月23日），网址：https://clinicaltrials.gov/ct2/show/NCT03750448。

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

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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来源期刊

Osteoarthritis and cartilage open Orthopedics, Sports Medicine and Rehabilitation

CiteScore

3.30

自引率

0.00%

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