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早期踝关节控制运动与非手术治疗急性跟腱断裂患者固定治疗的疗效比较:评估者盲法、随机对照试验。

Efficacy of early controlled motion of the ankle compared with immobilisation in non-operative treatment of patients with an acute Achilles tendon rupture: an assessor-blinded, randomised controlled trial.

机构信息

Department of Orthopeadic Surgery, Copenhagen University Hospital Hvidovre, Sports Orthopeadic Research Center - Copenhagen (SORC-C), Copenhagen, Denmark

Copenhagen University Hospital Hvidovre, Hvidovre, Denmark.

出版信息

Br J Sports Med. 2020 Jun;54(12):719-724. doi: 10.1136/bjsports-2019-100709. Epub 2019 Oct 9.

Abstract

BACKGROUND

Early controlled motion (ECM) of the ankle is widely used in the non-operative treatment of acute Achilles tendon rupture, although its safety and efficacy have not been investigated properly in a randomised set-up.

PURPOSE/AIM OF THE STUDY: To investigate if ECM of the ankle was superior to immobilisation in the treatment of acute Achilles tendon rupture.

MATERIALS AND METHODS

This was an assessor-blinded, randomised controlled trial with patients allocated in a 1:1 ratio to one of two parallel groups. Patients aged 18-70 years were eligible for inclusion. The ECM group performed movements of the ankle five times a day from week 3 to week 8 after rupture. The control group was immobilised for 8 weeks. The primary outcome was the Achilles tendon Total Rupture Score (ATRS) evaluated at 1-year postinjury. The secondary outcomes were heel-rise work test (HRW), Achilles tendon elongation and rate of rerupture. Analysis was conducted as intention-to-treat using inverse probability weighting.

FINDINGS/RESULTS: 189 patients were assessed for eligibility and 130 were included from February 2014 to December 2016. There were 64 patients in the ECM group and 58 in the immobilisation group. There were no statistically significant differences (p>0.3) between the ECM and the immobilisation groups at 1 year: mean (SD) ATRS was 74 (18) and 75 (18), respectively. HRW was 60% (21) and 60% (21) of the uninjured limb, and elongation was 18 mm (13) and 16 mm (11), respectively. Correspondingly, there were six and seven reruptures.

CONCLUSIONS

ECM revealed no benefit compared with immobilisation in any of the investigated outcomes.

TRIAL REGISTRATION NUMBER

NCT02015364.

摘要

背景

早期踝关节活动(ECM)被广泛应用于急性跟腱断裂的非手术治疗,但在随机分组研究中,其安全性和疗效尚未得到充分研究。

目的

研究 ECM 踝关节活动是否优于固定治疗急性跟腱断裂。

材料和方法

这是一项评估者设盲、随机对照试验,患者按 1:1 比例随机分配到两个平行组中的一组。18-70 岁的患者符合纳入标准。ECM 组在受伤后第 3 周到第 8 周,每天进行 5 次踝关节活动。对照组固定 8 周。主要结局为伤后 1 年时的跟腱总断裂评分(ATRS)。次要结局为跟腱提踵试验(HRW)、跟腱延长和再断裂率。采用逆概率加权进行意向治疗分析。

结果

189 名患者接受了评估,2014 年 2 月至 2016 年 12 月共纳入 130 名患者。ECM 组 64 例,固定组 58 例。1 年时,ECM 组和固定组之间无统计学差异(p>0.3):平均(SD)ATRS 分别为 74(18)和 75(18)。HRW 分别为未受伤侧的 60%(21)和 60%(21),伸长量分别为 18mm(13)和 16mm(11)。相应的,有 6 例和 7 例再断裂。

结论

与固定相比,ECM 在任何研究结果中均未显示出优势。

临床试验注册号

NCT02015364。

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