Comparing immediate and delayed weight bearing in patients with ankle open reduction internal fixation–A protocol for feasibility randomised controlled trial

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL Contemporary Clinical Trials Communications Pub Date : 2024-05-16 DOI:10.1016/j.conctc.2024.101304
Blare Mason , Zohreh Jafarian Tangrood , Jonathan Sharr , Andrew Powell
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Abstract

Introduction

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.

Method

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.

Results

Not applicable.

This pilot RCT will endeavour to optimise standard rehabilitation protocols post ankle ORIF.

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比较踝关节开放复位内固定术患者立即和延迟负重--可行性随机对照试验方案
引言 对于不同踝关节骨折类型的患者,踝关节开放复位内固定术(ORIF)后的负重时机仍不确定。传统的康复方法,包括六周不负重(NWB),仍然是许多医院的常用方法,而之前的一些证据显示立即负重(IWB)是有益的。方法32名患有单极、双极或三极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到立即负重(IWB)组或延迟负重(DWB)组。固定的稳定性由手术医生在固定完成后进行主观评估,与骨折形态无关。IWB 组的参与者将在 24 小时内根据耐受情况负重,而 DWB 组的参与者将在六周内不负重。将收集参与者的数据,包括 Olerud 和 Molander 踝关节评分、足踝自述评分、SF-36 健康调查、重返工作岗位时间等。骨科团队成员将对 X 光片进行评估,以确定是否存在与固定相关的并发症,包括缩径损失、缩径不良/骨不连、植入失败和骨不连。参与者的数据将在术后六周、三个月和六个月时收集。我们将通过评估招募率、坚持率和退出率来确定全面 RCT 的可行性。结果不适用。这项试验性 RCT 将致力于优化踝关节 ORIF 术后的标准康复方案。
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来源期刊
Contemporary Clinical Trials Communications
Contemporary Clinical Trials Communications Pharmacology, Toxicology and Pharmaceutics-Pharmacology
CiteScore
2.70
自引率
6.70%
发文量
146
审稿时长
20 weeks
期刊介绍: Contemporary Clinical Trials Communications is an international peer reviewed open access journal that publishes articles pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from a wide range of disciplines including medicine, life science, pharmaceutical science, biostatistics, epidemiology, computer science, management science, behavioral science, and bioethics. Contemporary Clinical Trials Communications is unique in that it is outside the confines of disease specifications, and it strives to increase the transparency of medical research and reduce publication bias by publishing scientifically valid original research findings irrespective of their perceived importance, significance or impact. Both randomized and non-randomized trials are within the scope of the Journal. Some common topics include trial design rationale and methods, operational methodologies and challenges, and positive and negative trial results. In addition to original research, the Journal also welcomes other types of communications including, but are not limited to, methodology reviews, perspectives and discussions. Through timely dissemination of advances in clinical trials, the goal of Contemporary Clinical Trials Communications is to serve as a platform to enhance the communication and collaboration within the global clinical trials community that ultimately advances this field of research for the benefit of patients.
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