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全膝关节置换术后早期康复:一项多中心、非劣效性、随机临床试验,比较家庭运动方案与常规门诊治疗。

Early rehabilitation after total knee replacement surgery: a multicenter, noninferiority, randomized clinical trial comparing a home exercise program with usual outpatient care.

机构信息

University of Sydney, Lidcombe, New South Wales, Australia.

出版信息

Arthritis Care Res (Hoboken). 2015 Feb;67(2):196-202. doi: 10.1002/acr.22457.

Abstract

OBJECTIVE

To determine, at 6 weeks postsurgery, if a monitored home exercise program (HEP) is not inferior to usual care rehabilitation for patients undergoing primary unilateral total knee replacement (TKR) surgery for osteoarthritis.

METHODS

We conducted a multicenter, randomized clinical trial. Patients ages 45-75 years were allocated at the time of hospital discharge to usual care rehabilitation (n = 196) or the HEP (n = 194). Outcomes assessed 6 weeks after surgery included the Western Ontario and McMaster Universities Osteoarthritis Index pain and physical function subscales, knee range of motion, and the 50-foot walk time. The upper bound of the 95% confidence interval (95% CI) mean difference favoring usual care was used to determine noninferiority.

RESULTS

At 6 weeks after surgery there were no significant differences between usual care and HEP, respectively, for pain (7.4 and 7.2; 95% CI mean difference [MD] -0.7, 0.9), physical function (22.5 and 22.4; 95% CI MD -2.5, 2.6), knee flexion (96° and 97°; 95% CI MD -4°, 2°), knee extension (-7° and -6°; 95% CI MD -2°, 1°), or the 50-foot walk time (12.9 and 12.9 seconds; 95% CI MD -0.8, 0.7 seconds). At 6 weeks, 18 patients (9%) allocated to usual care and 11 (6%) to the HEP did not achieve 80° knee flexion. There was no difference between the treatment allocations in the number of hospital readmissions.

CONCLUSION

The HEP was not inferior to usual care as an early rehabilitation protocol after primary TKR.

摘要

目的

在术后 6 周时确定,对于接受单侧初次全膝关节置换术(TKR)治疗骨关节炎的患者,监测家庭运动方案(HEP)是否不比常规护理康复差。

方法

我们进行了一项多中心、随机临床试验。在出院时,将年龄在 45-75 岁之间的患者分配到常规护理康复组(n=196)或 HEP 组(n=194)。术后 6 周评估的结果包括西安大略和麦克马斯特大学骨关节炎指数疼痛和身体功能子量表、膝关节活动度和 50 英尺步行时间。使用常规护理的 95%置信区间(95%CI)上限均值差值来确定非劣效性。

结果

术后 6 周时,常规护理和 HEP 组之间在疼痛方面(7.4 和 7.2;95%CI 均值差值[MD] -0.7,0.9)、身体功能(22.5 和 22.4;95%CI MD -2.5,2.6)、膝关节屈曲(96°和 97°;95%CI MD -4°,2°)、膝关节伸展(-7°和-6°;95%CI MD -2°,1°)或 50 英尺步行时间(12.9 和 12.9 秒;95%CI MD -0.8,0.7 秒)方面均无显著差异。在 6 周时,18 名(9%)接受常规护理的患者和 11 名(6%)接受 HEP 的患者未达到 80°膝关节屈曲。两种治疗方案的住院再入院人数无差异。

结论

HEP 作为初次 TKR 后的早期康复方案并不逊于常规护理。

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