Warwick Clinical Trials Unit, University of Warwick, Coventry, UK.
Warwick Medical School, University of Warwick, Coventry, UK.
Bone Joint J. 2023 Mar 15;105-B(4):382-388. doi: 10.1302/0301-620X.105B4.BJJ-2022-0602.R3.
The aim of this study was to compare the longer-term outcomes of operatively and nonoperatively managed patients treated with a removable brace (fixed-angle removable orthosis) or a plaster cast immobilization for an acute ankle fracture. This is a secondary analysis of a multicentre randomized controlled trial comparing adults with an acute ankle fracture, initially managed either by operative or nonoperative care. Patients were randomly allocated to receive either a cast immobilization or a fixed-angle removable orthosis (removable brace). Data were collected on baseline characteristics, ankle function, quality of life, and complications. The Olerud-Molander Ankle Score (OMAS) was the primary outcome which was used to measure the participant's ankle function. The primary endpoint was at 16 weeks, with longer-term follow-up at 24 weeks and two years. Overall, 436 patients (65%) completed the final two-year follow-up. The mean difference in OMAS at two years was -0.3 points favouring the plaster cast (95% confidence interval -3.9 to 3.4), indicating no statistically significant difference between the interventions. There was no evidence of differences in patient quality of life (measured using the EuroQol five-dimension five-level questionnaire) or Disability Rating Index. This study demonstrated that patients treated with a removable brace had similar outcomes to those treated with a plaster cast in the first two years after injury. A removable brace is an effective alternative to traditional immobilization in a plaster cast for patients with an ankle fracture.
本研究旨在比较手术和非手术治疗的急性踝关节骨折患者在可移动支具(固定角度可移动矫正器)或石膏固定方面的长期结果。这是一项多中心随机对照试验的二次分析,该试验比较了初始接受手术或非手术治疗的急性踝关节骨折的成年人。患者被随机分配接受石膏固定或固定角度可移动矫正器(可移动支具)治疗。收集基线特征、踝关节功能、生活质量和并发症的数据。Olerud-Molander 踝关节评分(OMAS)是主要结局,用于测量参与者的踝关节功能。主要终点为 16 周,24 周和两年的长期随访。总体而言,436 名患者(65%)完成了最终的两年随访。两年时 OMAS 的平均差异为 0.3 分,有利于石膏固定(95%置信区间-3.9 至 3.4),表明干预措施之间无统计学差异。患者生活质量(使用 EuroQol 五维五度问卷测量)或残疾评定指数无差异的证据。这项研究表明,在受伤后的头两年,使用可移动支具治疗的患者与使用石膏固定治疗的患者的结果相似。对于踝关节骨折患者,可移动支具是传统石膏固定的有效替代方法。