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早期运动和定向运动(EMADE)在踝关节骨折固定后:一项实用随机对照试验。

Early Motion and Directed Exercise (EMADE) following ankle fracture fixation: a pragmatic randomized controlled trial.

机构信息

Academic Orthopaedics, Trauma and Sports Medicine, University of Nottingham, Nottingham, UK.

Trauma and Orthopaedic Department, Nottingham University Hospitals NHS Trust, Nottingham, UK.

出版信息

Bone Joint J. 2024 Sep 1;106-B(9):949-956. doi: 10.1302/0301-620X.106B9.BJJ-2023-1433.R1.

Abstract

AIMS

This study aimed to compare the outcomes of two different postoperative management approaches following surgical fixation of ankle fractures: traditional cast immobilization versus the Early Motion and Directed Exercise (EMADE) programme.

METHODS

A total of 157 patients aged 18 years or older who underwent successful open reduction and internal fixation (ORIF) of Weber B (AO44B) ankle fractures were recruited to this randomized controlled trial. At two weeks post-surgical fixation, participants were randomized to either light-weight cast-immobilization or the EMADE programme, consisting of progressive home exercises and weekly advice and education. Both groups were restricted to non-weightbearing until six weeks post-surgery. The primary outcome was assessed using the Olerud-Molander Ankle Score (OMAS) questionnaire at 12 weeks post-surgery, with secondary measures at two, six, 24, and 52 weeks. Exploratory cost-effectiveness analyses were also performed.

RESULTS

Overall, 130 participants returned their 12-week OMAS questionnaires. The mean OMAS was significantly higher in the EMADE group compared with the immobilized group (62.0 (SD 20.9) vs 48.8 (SD 22.5)), with a clinically meaningful mean difference of 13.2 (95% CI 5.66 to 20.73; p < 0.001). These differences were maintained at week 24, with convergence by week 52. No intervention-related adverse events, including instability, were reported.

CONCLUSION

The EMADE programme demonstrated an accelerated recovery compared to traditional six-week cast immobilization for those who have undergone ORIF surgery to stabilize Weber B (AO44B) ankle fractures. The study found the EMADE intervention to be safe.

摘要

目的

本研究旨在比较两种不同术后管理方法对踝关节骨折术后的疗效:传统石膏固定与早期运动和定向运动(EMADE)方案。

方法

本随机对照试验共纳入 157 名年龄在 18 岁及以上的接受切开复位内固定术(ORIF)治疗 Weber B(AO44B)型踝关节骨折的患者。在手术后两周,参与者被随机分为轻重量石膏固定组或 EMADE 组,包括渐进性家庭锻炼和每周的建议和教育。两组均在术后六周内限制非负重活动。主要结局指标采用 Olerud-Molander 踝关节评分(OMAS)问卷在术后 12 周进行评估,次要结局指标在术后 2、6、24 和 52 周进行评估。还进行了探索性成本效益分析。

结果

共有 130 名参与者返回了他们的 12 周 OMAS 问卷。与固定组相比,EMADE 组的 OMAS 评分明显更高(62.0(20.9)vs 48.8(22.5)),平均差异具有临床意义为 13.2(95%CI 5.66 至 20.73;p<0.001)。这些差异在第 24 周时保持不变,在第 52 周时趋于一致。没有报告与干预相关的不良事件,包括不稳定。

结论

与传统的六周石膏固定相比,EMADE 方案在接受切开复位内固定术治疗 Weber B(AO44B)型踝关节骨折的患者中表现出更快的恢复速度。研究发现 EMADE 干预是安全的。

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