Gregersen Martin G, Justad-Berg Ragnhild T, Gill Nicolaj E Q, Saatvedt Ola, Aas Lars K, Molund Marius
Department of Physical Medicine and Rehabilitation, Østfold Hospital Trust, Grålum, Norway.
Institute of Health and Society, Faculty of Medicine, University of Oslo, Oslo, Norway.
Bone Jt Open. 2023 Sep 19;4(9):713-719. doi: 10.1302/2633-1462.49.BJO-2023-0012.R1.
Treatment of Weber B ankle fractures that are stable on weightbearing radiographs but unstable on concomitant stress tests (classified SER4a) is controversial. Recent studies indicate that these fractures should be treated nonoperatively, but no studies have compared alternative nonoperative options. This study aims to evaluate patient-reported outcomes and the safety of fracture treatment using functional orthosis versus cast immobilization.
A total of 110 patients with Weber B/SER4a ankle fractures will be randomized (1:1 ratio) to receive six weeks of functional orthosis treatment or cast immobilization with a two-year follow-up. The primary outcome is patient-reported ankle function and symptoms measured by the Manchester-Oxford Foot and Ankle Questionnaire (MOxFQ); secondary outcomes include Olerud-Molander Ankle Score, radiological evaluation of ankle congruence in weightbearing and gravity stress tests, and rates of treatment-related adverse events. The Regional Committee for Medical and Health Research (approval number 277693) has granted ethical approval, and the study is funded by South-Eastern Norway Regional Health Authority (grant number 2023014).
Randomized controlled trials are needed to evaluate alternative nonoperative treatment options for Weber B/SER4a ankle fractures, as current clinical guidelines are based on biomechanical reasoning. The findings will be shared through publication in peer-reviewed journals and presentations at conferences.
对于Weber B型踝关节骨折,负重X线片显示稳定但伴随应力试验不稳定(分类为SER4a)的情况,其治疗存在争议。近期研究表明这些骨折应采取非手术治疗,但尚无研究比较不同的非手术治疗方案。本研究旨在评估使用功能性矫形器与石膏固定治疗骨折时患者报告的预后情况及治疗安全性。
总共110例Weber B/SER4a型踝关节骨折患者将按1:1比例随机分组,接受为期六周的功能性矫形器治疗或石膏固定,并进行两年的随访。主要结局指标是通过曼彻斯特 - 牛津足踝问卷(MOxFQ)测量的患者报告的踝关节功能和症状;次要结局指标包括奥勒鲁德 - 莫兰德踝关节评分、负重和重力应力试验中踝关节一致性的影像学评估以及治疗相关不良事件的发生率。医学与健康研究区域委员会(批准号277693)已给予伦理批准,本研究由挪威东南部地区卫生局资助(资助号2023014)。
由于当前临床指南基于生物力学推理,因此需要进行随机对照试验来评估Weber B/SER4a型踝关节骨折的替代非手术治疗方案。研究结果将通过在同行评审期刊上发表以及在会议上进行报告来分享。