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

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.