Department of Trauma Surgery, Maastricht University Medical Center+, P. Debyelaan 25, Maastricht, 6229 HX, The Netherlands.
Department of Trauma Surgery, Radboud University Medical Center, Geert Grooteplein Zuid 10, Nijmegen, 6525 GA, The Netherlands.
Trials. 2024 Nov 18;25(1):778. doi: 10.1186/s13063-024-08617-5.
Following successful treatment, displaced intra-articular calcaneal fractures (DIACFs) necessitate an extensive rehabilitation regimen, significantly influencing functional and socio-economic outcomes. Apart from surgical intervention, the implementation of a comprehensive rehabilitation protocol is crucial to optimize foot stability and functional recovery. The objective of this study is to ascertain the optimal rehabilitation protocol for patients with surgically treated DIACFs, either permissive weight bearing (PWB) or Restricted Weight Bearing, focusing on functional outcomes, health-related quality of life (HRQoL), radiographic parameters, cost-effectiveness, and incidence of complications.
Study design: A prospective multicenter randomized controlled trial.
Presence of surgically (extended lateral, sinus tarsi, or percutaneous approach) treated unilateral DIACFs (Sanders type II to IV), aged 18-67 years (labor force). Patients must be able to understand and follow weight bearing instructions. N = 115 patients with DIACFs will be included.
Patients with DIACFs will be randomly allocated to one of the rehabilitation protocols, either PWB or RWB.
Functional outcome, measured with the American Orthopaedic Foot & Ankle Society Score (AOFAS)).
Functional outcome (Maryland Foot Score, MFS), HRQoL (EuroQol-5D, EQ-5D), differences in radiographic parameters, cost-effectiveness, and complications. Nature and extent of burden: The PWB protocol is aimed to be non-inferior to the RWB protocol. Previous analysis of this protocol in other lower extremity fractures has shown a safe complication rate. Follow-up is standardized according to current trauma guidelines, namely at time points 2, 6, 12 weeks, and 6 months. The radiation exposure for both groups will differ from standard care (one extra CT scan of the foot will be made). Therefore, the burden for participants is considered minimal, with no significant health risks.
This study will be the first study to define an optimal rehabilitation regime for surgically treated patients with DIACFs. The limitations of this study include the absence of patient blinding, as this is impossible in rehabilitation. Additionally, the primary outcome measure (AOFAS) has limited validity for DIACFs. However, it is the most commonly used questionnaire in the literature on DIACFs. There is an apparent need since current literature is lacking on this specific topic.
ClinicalTrials.gov NCT05721378, accepted on February 7, 2023.
经成功治疗后，移位的关节内跟骨骨折（DIACF）需要广泛的康复方案，这对功能和社会经济结果有重大影响。除了手术干预外，实施全面的康复方案对于优化足部稳定性和功能恢复至关重要。本研究的目的是确定手术治疗的 DIACF 患者（允许负重或限制负重）的最佳康复方案，重点关注功能结果、健康相关生活质量（HRQoL）、影像学参数、成本效益和并发症发生率。
研究设计：前瞻性多中心随机对照试验。
单侧 DIACF（Sanders Ⅱ至Ⅳ型）接受手术治疗（外侧扩展、跗骨窦或经皮入路），年龄 18-67 岁（劳动力）。患者必须能够理解和遵循负重指导。共纳入 115 例 DIACF 患者。
DIACF 患者将随机分配至允许负重或限制负重康复方案之一。
功能结果，采用美国矫形足踝协会评分（AOFAS）测量。
功能结果（Maryland 足部评分，MFS）、HRQoL（EuroQol-5D，EQ-5D）、影像学参数差异、成本效益和并发症。性质和负担程度：允许负重方案旨在不劣于限制负重方案。该方案在其他下肢骨折中的先前分析显示出安全的并发症发生率。随访根据当前创伤指南标准化，即在 2、6、12 周和 6 个月时进行。两组的辐射暴露将不同于标准护理（将额外进行一次足部 CT 扫描）。因此，参与者的负担被认为最小，没有重大健康风险。
这将是第一项确定手术治疗 DIACF 患者最佳康复方案的研究。本研究的局限性包括康复中无法对患者进行盲法，因为这是不可能的。此外，主要结局测量（AOFAS）对 DIACF 的有效性有限。然而，它是 DIACF 文献中最常用的问卷。由于目前关于这个特定主题的文献缺乏，因此存在明显的需求。
ClinicalTrials.gov NCT05721378，于 2023 年 2 月 7 日接受。
