Department of Trauma and Orthopaedic Surgery, University Hospital Waterford, Waterford, X91 ER8E, Ireland.
Department of Surgery, Royal College of Surgeons in Ireland, Dublin, D02 YN77, Ireland.
Trials. 2021 May 27;22(1):369. doi: 10.1186/s13063-021-05319-0.
Postoperative management regimes vary following open reduction and internal fixation (ORIF) of unstable ankle fractures. There is an evolving understanding that extended periods of immobilisation and weight-bearing limitation may lead to poorer clinical outcomes. Traditional non-weight-bearing cast immobilisation may prevent loss of fixation, and this practice continues in many centres. The purpose of this trial is to investigate the safety and efficacy of immediate weight-bearing (IWB) and range of motion (ROM) exercise regimes following ORIF of unstable ankle fractures with a particular focus on functional outcomes and complication rates.
A pragmatic randomised controlled multicentre trial, comparing IWB in a walking boot and ROM within 24 h versus non-weight-bearing (NWB) and immobilisation in a cast for 6 weeks, following ORIF of all types of unstable adult ankle fractures (lateral malleolar, bimalleolar, trimalleolar with or without syndesmotic injury) is proposed. All patients presenting to three trauma units will be included. The exclusion criteria will be skeletal immaturity and tibial plafond fractures. The three institutional review boards have granted ethical approval. The primary outcome measure will be the functional Olerud-Molander Ankle Score (OMAS). Secondary outcomes include wound infection (deep and superficial), displacement of osteosynthesis, the full arc of ankle motion (plantar flexion and dorsal flection), RAND-36 Item Short Form Survey (SF-36) scoring, time to return to work and postoperative hospital length of stay. The trial will be reported in accordance with the CONSORT statement for reporting a pragmatic trial, and this protocol will follow the SPIRIT guidance.
Traditional management of operatively treated ankle fractures includes an extended period of non-weight-bearing. There is emerging evidence that earlier weight-bearing may have equivocal outcomes and favourable patient satisfaction but higher wound-related complications. These studies often preclude more complicated fracture patterns or patient-related factors. To our knowledge, immediate weight-bearing (IWB) following ORIF of all types of unstable ankle fractures has not been investigated in a controlled prospective manner in recent decades. This pragmatic randomised-controlled multicentre trial will investigate immediate weight-bearing following ORIF of all ankle fracture patterns in the usual care condition. It is hoped that these results will contribute to the modern management of ankle fractures.
ISRCTN Registry ISRCTN76410775 . Retrospectively registered on 30 June 2019.
切开复位内固定术（ORIF）治疗不稳定踝关节骨折后的术后管理方案各不相同。人们逐渐认识到，长时间的固定和限制负重可能会导致较差的临床结果。传统的非负重石膏固定可能会防止固定丢失，许多中心仍在继续采用这种方法。本试验的目的是研究不稳定踝关节骨折 ORIF 后即刻负重（IWB）和活动范围（ROM）运动方案的安全性和有效性，特别关注功能结果和并发症发生率。
拟进行一项实用随机对照多中心试验，比较 ORIF 治疗所有类型成人不稳定踝关节骨折（外踝、双踝、三踝骨折伴或不伴下胫腓联合损伤）后，采用步行靴即刻负重（IWB）和 24 小时内 ROM 与非负重（NWB）和 6 周内石膏固定的安全性和疗效，所有患者均来自三个创伤单位。排除标准为骨骼未成熟和胫骨平台骨折。三个机构审查委员会已批准伦理批准。主要结局指标为功能 Olerud-Molander 踝关节评分（OMAS）。次要结局指标包括伤口感染（深部和浅部）、内固定移位、踝关节全活动范围（跖屈和背屈）、RAND-36 项简明健康调查问卷（SF-36）评分、重返工作时间和术后住院时间。该试验将按照实用临床试验报告的 CONSORT 声明进行报告，并遵循 SPIRIT 指南。
传统的手术治疗踝关节骨折的方法包括长时间的非负重。越来越多的证据表明，早期负重可能具有不确定的结果和有利的患者满意度，但伤口相关并发症较高。这些研究通常排除了更复杂的骨折模式或患者相关因素。据我们所知，近几十年来，在常规护理条件下，尚未以对照前瞻性方式研究过所有类型不稳定踝关节骨折 ORIF 后的即刻负重（IWB）。这项实用随机对照多中心试验将研究所有踝关节骨折类型 ORIF 后的即刻负重，希望这些结果能为踝关节骨折的现代治疗提供依据。
ISRCTN 注册处 ISRCTN76410775。于 2019 年 6 月 30 日回顾性注册。
