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2018 年约翰·N·英萨尔奖:全膝关节置换术后,未经监督的家庭锻炼在恢复膝关节屈曲方面并不逊于门诊物理治疗:一项随机试验。

2018 John N. Insall Award: Recovery of Knee Flexion With Unsupervised Home Exercise Is Not Inferior to Outpatient Physical Therapy After TKA: A Randomized Trial.

机构信息

The Rothman Institute at Thomas Jefferson University, Philadelphia, PA, USA.

出版信息

Clin Orthop Relat Res. 2019 Jan;477(1):60-69. doi: 10.1097/CORR.0000000000000561.

Abstract

BACKGROUND

Concerns about the cost and convenience of postsurgical physical therapy (PT) have sparked interest in unsupervised, home-based rehabilitation. However, the effectiveness of unsupervised home exercise after primary TKA has not been previously evaluated.

QUESTIONS/PURPOSES: (1) Can unsupervised home exercise after surgery provide noninferior recovery of passive knee flexion compared with formal outpatient PT? (2) Does a web-based platform for home-based exercise provide an advantage compared with a printed PT manual?

METHODS

We conducted a randomized, noninferiority trial involving 290 patients (20% of the 1464 eligible patients who could be contacted) who underwent primary TKA from March 2016 to April 2018. We included patients > 18 years old who were undergoing primary, unilateral TKA and provided written consent. We excluded patients with preoperative knee flexion < 90°, patients considering surgical intervention in a hip or the contralateral knee, patients discharged to an extended care facility, and revision or conversion TKA. We randomized patients to one of three groups: outpatient PT, unsupervised home exercise using a web-based platform (web PT), or unsupervised home exercise using a printed paper manual (paper PT). We also implemented a "delayed recovery intervention" within the home exercise program, in which patients were obliged to begin outpatient PT if knee flexion was < 70° at 2 weeks or < 90° at 4 weeks. The primary outcome was change in knee flexion from preoperative baseline after 4 to 6 weeks and 6 months. Secondary outcomes included Knee Injury and Osteoarthritis Outcome Score (KOOS), time back to activities of daily living, and time off narcotics. All analyses were intention to treat, and the noninferiority margin was 5% with maximum flexion as the outcome of interest for this parameter.

RESULTS

Adjusted differences in change in passive flexion for web PT +3° (95% confidence interval [CI], -1.2° to 6.4°) and paper PT +5° (95% CI, 0.99°-8.6°) were not inferior to outpatient PT based on a predefined 5° margin. Change in knee flexion from baseline was 0° for outpatient PT, -2° for web PT, and -1° for paper PT after 4 to 6 weeks and 8°, 8°, and 12° for the three groups, respectively, after 6 months. Additionally, there was no difference in the change in KOOS from baseline at 4 to 6 weeks or 6 months postoperatively as well as time back to work, driving, and walking without an assistive device.

CONCLUSIONS

Unsupervised home exercise is an effective rehabilitation strategy after primary TKA and was noninferior to formal outpatient PT in selected patients. It is worthwhile to reconsider the current practice of automatically designating patients for outpatient PT after primary TKA, because appropriately selected patients with adequate clinical support can achieve similar results at home.

LEVEL OF EVIDENCE

Level I, therapeutic study.

摘要

背景

对术后物理治疗(PT)的成本和便利性的担忧引发了人们对非监督、家庭为基础的康复的兴趣。然而,初次全膝关节置换术后非监督家庭锻炼的效果尚未得到评估。

问题/目的:(1)手术后的非监督家庭锻炼是否能与正规门诊 PT 一样,提供非劣效的被动膝关节弯曲恢复?(2)基于网络的家庭锻炼平台与纸质 PT 手册相比是否具有优势?

方法

我们进行了一项随机、非劣效性试验,涉及 290 名患者(可联系的 1464 名合格患者中的 20%),他们于 2016 年 3 月至 2018 年 4 月接受了初次 TKA。我们纳入了年龄大于 18 岁、接受初次单侧 TKA 并签署书面同意书的患者。我们排除了术前膝关节弯曲<90°、考虑髋关节或对侧膝关节手术干预、出院至延长护理机构以及翻修或转换 TKA 的患者。我们将患者随机分为三组:门诊 PT、基于网络的平台的非监督家庭锻炼(网络 PT)或基于纸质手册的非监督家庭锻炼(纸质 PT)。我们还在家庭锻炼计划中实施了“延迟康复干预”,如果患者在 2 周时膝关节弯曲<70°或 4 周时膝关节弯曲<90°,则必须开始门诊 PT。主要结局是术后 4 至 6 周和 6 个月时膝关节弯曲的变化。次要结局包括膝关节损伤和骨关节炎评分(KOOS)、恢复日常生活活动的时间和停用麻醉药物的时间。所有分析均为意向治疗,非劣效性边界为 5%,以最大弯曲度为该参数的感兴趣结果。

结果

基于预先设定的 5°边界,网络 PT 的被动弯曲变化差值为+3°(95%置信区间[CI],-1.2°至 6.4°)和纸质 PT 的+5°(95%CI,0.99°-8.6°)在调整后与门诊 PT 无差异。术后 4 至 6 周和 6 个月时,门诊 PT、网络 PT 和纸质 PT 的膝关节弯曲从基线的变化分别为 0°、-2°和-1°,6 个月时分别为 8°、8°和 12°。此外,术后 4 至 6 周和 6 个月时 KOOS 从基线的变化以及恢复工作、驾驶和无辅助设备行走的时间也没有差异。

结论

初次全膝关节置换术后的非监督家庭锻炼是一种有效的康复策略,在选择的患者中与正规门诊 PT 非劣效。有必要重新考虑初次全膝关节置换术后自动为患者指定门诊 PT 的当前做法,因为选择适当的、有充分临床支持的患者可以在家中取得类似的效果。

证据水平

Ⅰ级,治疗性研究。

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