Braeside Hospital, HammondCare, Australia2South West Sydney Clinical School, University of New South Wales, Liverpool Hospital, Liverpool NSW 2170, Australia.
South West Sydney Clinical School, University of New South Wales, Liverpool Hospital, Liverpool NSW 2170, Australia3South West Sydney Local Health District, Liverpool 2170, NSW, Australia4Whitlam Orthopaedic Research Centre, Australia5Ingham Institute of Applied Medical Research, Liverpool 2170, NSW, Australia.
JAMA. 2017 Mar 14;317(10):1037-1046. doi: 10.1001/jama.2017.1224.
Formal rehabilitation programs, including inpatient programs, are often assumed to optimize recovery among patients after undergoing total knee arthroplasty. However, these programs have not been compared with any outpatient or home-based programs.
To determine whether 10 days of inpatient rehabilitation followed by a monitored home-based program after total knee arthroplasty provided greater improvements than a monitored home-based program alone in mobility, function, and quality of life.
DESIGN, SETTING, AND PARTICIPANTS: In this 2-group, parallel, randomized clinical trial, including a nonrandomized observational group, conducted at 2 public, high-volume arthroplasty hospitals in Sydney, Australia (July 2012-December 2015), 940 patients with osteoarthritis undergoing primary total knee arthroplasty were screened for eligibility. Of the 525 eligible patients consecutively invited to participate, 165 were randomized either to receive inpatient hospital rehabilitation and home-based rehabilitation or to receive home-based rehabilitation alone, and 87 patients enrolled in the observation group.
Eighty-one patients were randomized to receive 10 days of hospital inpatient rehabilitation followed by an 8-week clinician-monitored home-based program, 84 were randomized to receive the home-based program alone, and 87 agreed to be in the observational group, which included only the home-based program.
Mobility at 26 weeks after surgery, measured with the 6-minute walk test. Secondary outcomes included the Oxford Knee Score, which ranges from 0 (worst) to 48 (best) and has a minimal clinically important difference of 5 points; and EuroQol Group 5-Dimension Self-Report Questionnaire (EQ-5D) visual analog scale, which ranges from 0 (worst) to 100 (best), and has a minimal clinically important difference of 23 points.
Among the 165 randomized participants, 68% were women, and the cohort had a mean age, 66.9 years (SD, 8.4 years). There was no significant difference in the 6-minute walk test between the inpatient rehabilitation and either of the 2 home program groups (mean difference, -1.01; 95% CI, -25.56 to 23.55), nor in patient-reported pain and function (knee score mean difference, 2.06; 95% CI, -0.59 to 4.71), or quality of life (EQ-5D visual analog scale mean difference, 1.41; 95% CI, -6.42 to 3.60). The number of postdischarge complications for the inpatient group was 12 vs 9 among the home group, and there were no adverse events reported that were a result of trial participation.
Among adults undergoing uncomplicated total knee arthroplasty, the use of inpatient rehabilitation compared with a monitored home-based program did not improve mobility at 26 weeks after surgery. These findings do not support inpatient rehabilitation for this group of patients.
clinicaltrials.gov Identifier: NCT01583153.
人们通常认为,包括住院康复在内的正式康复方案可以优化全膝关节置换术后患者的康复。然而,这些方案尚未与任何门诊或家庭为基础的方案进行比较。
确定在全膝关节置换术后接受 10 天住院康复治疗,然后进行监测的家庭为基础的康复方案是否比单独进行监测的家庭为基础的康复方案更能改善患者的活动能力、功能和生活质量。
设计、地点和参与者:这是一项 2 组平行随机临床试验,包括一个非随机观察性研究组,在澳大利亚悉尼的 2 家公立、大容量关节置换医院进行(2012 年 7 月至 2015 年 12 月),共筛选了 940 例患有骨关节炎的患者,以确定其是否适合进行全膝关节置换术。在连续邀请参加的 525 名合格患者中,165 名被随机分为接受住院医院康复治疗和家庭康复治疗或仅接受家庭康复治疗,87 名患者参加了观察组。
81 名患者被随机分配接受 10 天的住院康复治疗,然后进行 8 周的临床医生监测家庭康复治疗,84 名患者被随机分配接受家庭康复治疗,87 名患者同意参加观察组,观察组仅包括家庭康复治疗。
术后 26 周的行走能力,采用 6 分钟步行测试进行测量。次要结局包括牛津膝关节评分(范围为 0(最差)至 48(最佳),有 5 分的最小临床重要差异);以及欧洲五维健康量表自我报告问卷(EQ-5D)视觉模拟量表(范围为 0(最差)至 100(最佳),有 23 分的最小临床重要差异)。
在 165 名随机参与者中,68%为女性,队列的平均年龄为 66.9 岁(标准差,8.4 岁)。在 6 分钟步行测试中,住院康复组与任何一个家庭康复组之间没有显著差异(平均差异,-1.01;95%置信区间,-25.56 至 23.55),也没有患者报告的疼痛和功能(膝关节评分平均差异,2.06;95%置信区间,-0.59 至 4.71)或生活质量(EQ-5D 视觉模拟量表平均差异,1.41;95%置信区间,-6.42 至 3.60)。与家庭组相比,住院组出院后并发症的数量为 12 例,而家庭组为 9 例,且没有因试验参与而报告任何不良事件。
在接受非复杂性全膝关节置换术的成年人中,与监测家庭为基础的方案相比,使用住院康复方案并未改善术后 26 周的活动能力。这些发现不支持为这组患者提供住院康复。
clinicaltrials.gov 标识符:NCT01583153。