Mason Blare, Jafarian Tangrood Zohreh, Sharr Jonathan, Powell Andrew
Division of Orthopaedic Surgery, Christchurch Hospital, Christchurch, New Zealand.
Department of Orthopedic Surgery and Musculoskeletal Research, University of Otago, Christchurch, New Zealand.
Contemp Clin Trials Commun. 2024 May 16;39:101304. doi: 10.1016/j.conctc.2024.101304. eCollection 2024 Jun.
Uncertainty regarding the timing of weight bearing following ankle open reduction internal fixation (ORIF) in patients with different ankle fracture patterns remains. Traditional rehabilitation methods, including six weeks of non-weight bearing (NWB), is still a common approach in many hospitals, while some previous evidence has shown immediate weight bearing (IWB) to be beneficial.
32 adult participants with unimalleolar, bimalleolar or trimalleolar ankle fractures and stable fixation following ankle ORIF will be randomly allocated to either Immediate Weight Bearing (IWB) or Delayed Weight Bearing (DWB) groups. Stability of fixation is a subjective assessment made by the operating surgeon at the completion of fixation and is independent of fracture pattern. Participants in the IWB group will be allowed to weight bear as tolerated within 24 h, while participants in the DWB group will remain non-weight bearing for six weeks. Participants' data including Olerud and Molander Ankle Score, Self-Reported Foot and Ankle Score, SF-36 health survey, time to return to work will be collected. X-rays will be assessed by orthopaedic team members for fixation-related complications including reduction loss, malreduction/malunion, implant failure and non-union. Participants data will be collected at six weeks, three and six-months post-surgery. We will determine the feasibility of a full RCT through assessing the recruitment rate, adherence rate, and drop-out rate.
Not applicable.This pilot RCT will endeavour to optimise standard rehabilitation protocols post ankle ORIF.
不同踝关节骨折类型患者在踝关节切开复位内固定(ORIF)术后负重时机仍存在不确定性。传统康复方法,包括六周不负重(NWB),在许多医院仍是常用方法,而此前一些证据表明即刻负重(IWB)有益。
32例单踝、双踝或三踝踝关节骨折且踝关节ORIF术后固定稳定的成年参与者将被随机分配至即刻负重(IWB)组或延迟负重(DWB)组。固定稳定性由手术医生在固定完成时进行主观评估,且与骨折类型无关。IWB组参与者将在24小时内根据耐受情况进行负重,而DWB组参与者将六周内持续不负重。将收集参与者的数据,包括奥勒鲁德和莫兰德踝关节评分、自我报告的足踝评分、SF-36健康调查、重返工作时间。骨科团队成员将对X线片进行评估,以确定与固定相关的并发症,包括复位丢失、复位不良/畸形愈合、植入物失败和骨不连。参与者的数据将在术后六周、三个月和六个月收集。我们将通过评估招募率、依从率和退出率来确定全面随机对照试验的可行性。
不适用。这项试点随机对照试验将努力优化踝关节ORIF术后的标准康复方案。