不稳定踝关节骨折切开复位内固定术后早期负重与活动范围对比非负重与固定：一项随机对照试验

Early Weightbearing and Range of Motion Versus Non-Weightbearing and Immobilization After Open Reduction and Internal Fixation of Unstable Ankle Fractures: A Randomized Controlled Trial.

作者信息

Dehghan Niloofar, McKee Michael D, Jenkinson Richard J, Schemitsch Emil H, Stas Venessa, Nauth Aaron, Hall Jeremy A, Stephen David J, Kreder Hans J

机构信息

*Department of Orthopaedics, Li Ka Shing Institute, St. Michael's Hospital and the University of Toronto, Toronto, Canada; †Division of Orthopaedics, Department of Surgery, St. Michael's Hospital and the University of Toronto, Toronto, Canada; ‡Division of Orthopaedics, Department of Surgery, Sunnybrook Health Science Centre and the University of Toronto, Toronto, Canada; §Department of Surgery, Western University, London, Canada; ‖Department of Surgery, St. Vincent Medical Center, Portland, OR; ¶Division of Orthopaedics, Department of Surgery, Sunnybrook Health Science Centre and the University of Toronto, Toronto, Canada; and **Division of Orthopaedics, Department of Surgery, Sunnybrook Health Science Centre and the University of Toronto, Toronto, Canada.

出版信息

J Orthop Trauma. 2016 Jul;30(7):345-52. doi: 10.1097/BOT.0000000000000572.

DOI:10.1097/BOT.0000000000000572

PMID:27045369

Abstract

OBJECTIVES

The aim of this study was to compare early weightbearing and range of motion (ROM) to nonweightbearing and immobilization in a cast after surgical fixation of unstable ankle fractures.

DESIGN

Multicentre randomized controlled trial.

SETTING

Two-level one trauma centers.

PATIENTS

One hundred ten patients who underwent open reduction and internal fixation of an unstable ankle fracture were recruited and randomized.

INTERVENTION

One of 2 rehabilitation protocols: (1) Early weightbearing (weightbearing and ROM at 2 weeks, Early WB) or (2) Late weightbearing (nonweightbearing and cast immobilization for 6 weeks, Late WB).

MAIN OUTCOME MEASUREMENTS

The primary outcome measure was time to return to work (RTW). Secondary outcome measures included: ankle ROM, SF-36 heath outcome scores, Olerud/Molander ankle function score, and rates of complications.

RESULTS

There was no difference in RTW. At 6 weeks postoperatively, patients in the Early WB group had significantly improved ankle ROM (41 vs. 29, P < 0.0001); Olerud/Molander ankle function scores (45 vs. 32, P = 0.0007), and SF-36 scores on both the physical (51 vs. 42, P = 0.008) and mental (66 vs. 54, P = 0.0008) components. There were no differences with regard to wound complications or infections and no cases of fixation failure or loss of reduction. Patients in the Late WB group had higher rates of planned/performed hardware removal due to plate irritation (19% vs. 2%, P = 0.005).

CONCLUSIONS

Given the convenience for the patient, early improved functional outcome, and the lack of an increased complication rate, we recommend early postoperative weightbearing and ROM in patients with surgically treated ankle fractures.

LEVEL OF EVIDENCE

Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

摘要

目的

本研究旨在比较不稳定踝关节骨折手术固定后早期负重及活动范围（ROM）与非负重及石膏固定的效果。

设计

多中心随机对照试验。

地点

两级创伤中心。

患者

招募并随机分配110例接受不稳定踝关节骨折切开复位内固定术的患者。

干预措施

两种康复方案之一：（1）早期负重（2周时开始负重及活动范围训练，早期负重组）或（2）晚期负重（非负重及石膏固定6周，晚期负重组）。

主要观察指标

主要观察指标为重返工作岗位的时间（RTW）。次要观察指标包括：踝关节活动范围、SF-36健康结局评分、奥勒鲁德/莫兰德踝关节功能评分及并发症发生率。

结果

两组重返工作岗位的时间无差异。术后6周，早期负重组患者的踝关节活动范围显著改善（41°对29°，P<0.0001）；奥勒鲁德/莫兰德踝关节功能评分（45分对32分，P = 0.0007），以及SF-36身体（51分对42分，P = 0.008）和精神（66分对54分，P = 0.0008）成分评分。伤口并发症或感染方面无差异，也没有固定失败或复位丢失的病例。晚期负重组患者因钢板刺激导致计划/进行内固定取出的发生率更高（19%对2%，P = 0.005）。