Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, Oxfordshire, UK
Nuffield Orthopaedic Centre, Oxford University Hospitals NHS Foundation Trust, Oxford, Oxfordshire, UK.
BMJ Open. 2021 Aug 27;11(8):e052598. doi: 10.1136/bmjopen-2021-052598.
To evaluate whether a home-based rehabilitation programme for people assessed as being at risk of a poor outcome after knee arthroplasty offers superior outcomes to traditional outpatient physiotherapy.
A prospective, single-blind, two-arm randomised controlled superiority trial.
14 National Health Service physiotherapy departments in the UK.
621 participants identified at high risk of a poor outcome after knee arthroplasty using a bespoke screening tool.
A multicomponent home-based rehabilitation programme delivered by rehabilitation assistants with supervision from qualified therapists versus usual care outpatient physiotherapy.
The primary outcome was the Late-Life Function and Disability Instrument (LLFDI) at 12 months. Secondary outcomes were the Oxford Knee Score (a disease-specific measure of function), Knee injury and Osteoarthritis Outcome Score Quality of Life subscale, Physical Activity Scale for the Elderly, 5 dimension, 5 level version of Euroqol (EQ-5D-5L) and physical function assessed using the Figure of 8 Walk test, 30 s Chair Stand Test and Single Leg Stance.
621 participants were randomised between March 2015 and January 2018. 309 were assigned to CORKA (Community Rehabilitation after Knee Arthroplasty) home-based rehabilitation, receiving a median five treatment sessions (IQR 4-7). 312 were assigned to usual care, receiving a median 4 sessions (IQR 2-6). The primary outcome, LLFDI function total score at 12 months, was collected for 279 participants (89%) in the home-based CORKA group and 287 participants (92%) in the usual care group. No clinically or statistically significant difference was found between the groups (intention-to-treat adjusted difference=0.49 points; 95% CI -0.89 to 1.88; p=0.48). There were no statistically significant differences between the groups on any of the patient-reported or physical secondary outcome measures at 6 or 12 months.There were 18 participants in the intervention group reporting a serious adverse event (5.8%), only one directly related to the intervention, all other adverse events recorded throughout the trial related to underlying chronic medical conditions.
The CORKA intervention was not superior to usual care. The trial detected no significant differences, clinical or statistical, between the two groups on either primary or secondary outcomes. CORKA offers an evaluation of an intervention utilising a different service delivery model for this patient group.
ISRCTN13517704.
评估膝关节置换术后预后不良风险较高的人群接受家庭康复方案与传统门诊物理治疗相比是否具有更好的效果。
前瞻性、单盲、双臂随机对照优效性试验。
英国 14 家国民保健署物理治疗部门。
使用特定筛查工具评估膝关节置换术后预后不良风险较高的 621 名参与者。
由康复助理提供的多组分家庭康复方案，由合格治疗师进行监督，与常规门诊物理治疗进行比较。
主要结局指标为 12 个月时的老年功能和残疾量表（LLFDI）。次要结局指标包括牛津膝关节评分（一种特定于疾病的功能测量）、膝关节损伤和骨关节炎结局评分生活质量量表、老年人体育活动量表、5 维 5 级欧洲生活质量量表（EQ-5D-5L）和使用 8 字形走测试、30 秒椅子站立测试和单腿站立测试评估的身体功能。
2015 年 3 月至 2018 年 1 月期间，621 名参与者被随机分配。309 名参与者被分配到 CORKA（膝关节置换术后社区康复）家庭康复组，接受中位数为 5 次治疗（IQR 4-7）。312 名参与者被分配到常规护理组，接受中位数为 4 次治疗（IQR 2-6）。主要结局指标，即 12 个月时的 LLFDI 功能总评分，在家庭 CORKA 组的 279 名参与者（89%）和常规护理组的 287 名参与者（92%）中进行了收集。两组之间未发现具有临床意义或统计学意义的差异（意向治疗调整差异=0.49 分；95%CI -0.89 至 1.88；p=0.48）。在 6 个月或 12 个月时的任何患者报告或身体次要结局测量指标上，两组之间均无统计学意义上的显著差异。干预组有 18 名参与者报告了 18 例严重不良事件（5.8%），仅 1 例与干预直接相关，整个试验期间记录的所有其他不良事件均与潜在的慢性医疗状况有关。
CORKA 干预措施并不优于常规护理。该试验在主要和次要结局上均未检测到两组之间具有临床意义或统计学意义的差异。CORKA 提供了对利用该患者群体不同服务提供模式的干预措施的评估。
ISRCTN85364124。
