Department of Orthopedics and Traumatology, Odense University Hospital, Sdr. Boulevard 29, 5000 Odense C, Odense, Denmark.
Department of Clinical Research, University of Southern Denmark, Odense, Denmark.
Trials. 2019 Jun 4;20(1):324. doi: 10.1186/s13063-019-3447-8.
There are no standardized therapy guidelines for rehabilitation of calcaneus fractures. While there is consensus on non or partial weight-bearing, the use of supporting devices such as specific foot ankle orthosis is still a matter of debate. Recently, a heel-unloading orthosis ("Settner shoe") was introduced for aftercare of these fractures, allowing walking by shifting the load to the middle-foot and forefoot. This orthosis enables early mobilization of patients suffering from either one-sided or two-sided fractures. The Settner shoe can be applied in non-operative therapy and after surgery. Specifically in calcaneus fractures, early regain of physical activity has been highlighted as one of the key factors for quality of life and the ability to return to work. Thus, we hypothesize that mobilization with the Settner shoe results in improved quality of life and greater physical activity within the first 3 months.
This is going to be analyzed by a randomized controlled study comparing treatment with and without this specific orthosis. The secondary outcome measure is the time point of return to work in patients aged between 18 and 60 years, with calcaneus fracture. Furthermore, the American Orthopaedic Foot and Ankle Society (AOFAS) ankle-hindfoot score, a 3-dimensional gait analysis, and the Euroqol-5 dimension-3 level (EQ-5D-3 L) questionnaire for quality of life are assessed.
This is the first trial applying a standardized rehabilitation protocol in patients with calcaneus fractures, aiming to improve the non-operative part of treatment by use of an orthosis.
ClinicalTrials.gov, NCT03572816 . Registered on 27 July 2018.
目前对于跟骨骨折的康复治疗并没有标准化的治疗指南。虽然对于非负重或部分负重已达成共识，但对于使用特定的足踝矫形器等支撑装置仍存在争议。最近，一种跟骨减压矫形器（“Settner 鞋”）被引入用于这些骨折的后续治疗，可以通过将负荷转移到中足和前足来实现行走。这种矫形器使单侧或双侧骨折的患者能够早期活动。Settner 鞋可用于非手术治疗和手术后。特别是在跟骨骨折中，早期恢复身体活动已被强调为提高生活质量和重返工作能力的关键因素之一。因此，我们假设使用 Settner 鞋进行活动可在最初 3 个月内提高生活质量并增加身体活动量。
这将通过一项随机对照研究进行分析，比较使用和不使用这种特殊矫形器的治疗效果。次要结局指标是年龄在 18 至 60 岁之间的跟骨骨折患者重返工作岗位的时间点。此外，还评估美国矫形足踝协会（AOFAS）踝关节后足评分、三维步态分析和生活质量的欧洲五维健康量表-3 级（EQ-5D-3L）问卷。
这是第一个在跟骨骨折患者中应用标准化康复方案的试验，旨在通过使用矫形器来改善非手术治疗部分。
ClinicalTrials.gov，NCT03572816。于 2018 年 7 月 27 日注册。
