Comparing immediate and delayed weight bearing in patients with ankle open reduction internal fixation–A protocol for feasibility randomised controlled trial
Blare Mason , Zohreh Jafarian Tangrood , Jonathan Sharr , Andrew Powell
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引用次数: 0
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.
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.