Mark-Christensen T, Thorborg K, Kallemose T, Bandholm T
Department of Rehabilitation, Centre of Health, Regional Municipality of Bornholm, Rønne, Bornholm, Denmark.
Department of Clinical Research, Copenhagen University Hospital - Amager and Hvidovre, Copenhagen, Denmark.
Osteoarthr Cartil Open. 2024 Oct 16;6(4):100530. doi: 10.1016/j.ocarto.2024.100530. eCollection 2024 Dec.
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?
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.
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.
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.
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.
NCT03750448 (November 23, 2018), URL: https://clinicaltrials.gov/ct2/show/NCT03750448.
比较有效性试验并未显示全髋关节置换术（THA）和全膝关节置换术（TKA）后一种物理康复方式优于另一种。因此，我们提出一个基本的有效性问题：物理康复是否比不进行物理康复“效果更好”？
比较6周物理康复计划（居家远程康复或居家康复）与THA和TKA后不进行物理康复的效果。
三臂、随机、对照、优效性试验，结局评估采用盲法。在达到目标样本量168例患者之前，对377例患者（210例THA/167例TKA）进行了资格筛查。在基线、干预结束时（6周）以及术后3个月和12个月评估结局指标。主要结局是髋关节残疾和骨关节炎结局评分（HOOS）/膝关节损伤和骨关节炎结局评分（KOOS）-子量表：日常生活功能。次要结局包括：HOOS/KOOS-子量表：疼痛、症状和生活质量、患者总体评估、镇痛药、助行器、30秒坐立试验、4×10米快步行走试验、运动依从性和满意度。
将物理康复（居家远程康复和居家康复）与不进行物理康复进行比较，主要结局的组间平均差异在6周时为3.3（95%CI：-1.9至8.6；p=0.10）分，在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。
在自我报告的功能或任何次要结局方面，THA或TKA后物理康复并不优于不进行物理康复的对照组。
NCT03750448（2018年11月23日），网址：https://clinicaltrials.gov/ct2/show/NCT03750448 。
