![]() The following are the exclusion criteria: ![]() Syndesmosis injuries that have been surgically fixed with either screw or tightropeĬlosed fractures and grade I or grade II open fractures The inclusion criteria include all skeletally mature (closed distal tibial physis), acute ankle fractures treated with anatomical reduction and stable internal fixation, including AO/OTA 44A1.3 to 44A3.3, 44B and 44C. Name and contact information for the trial sponsor Inclusion criteria Department of Trauma and Orthopaedic Surgery, Cork University Hospital, Cork, T12 DFK4, Ireland. Department of Orthopaedic Surgery, University College Cork, Cork, T12 YN60, IrelandĤ. Department of Surgery, Royal College of Surgeons in Ireland, Dublin, D02 YN77, Ireland.ģ. Department of Trauma and Orthopaedic Surgery, University Hospital Waterford, Waterford, X91 ER8E, IrelandĢ. Ramy Khojaly 1,2,3, Ruairi Mac Niocaill 1, Muhammad Shahab 1, Matthew Nagle 4, Colm Taylor 4, Fiachra E. ‘retrospectively registered’ ISRCTN - ISRCTN76410775 Is Postoperative Non-Weight-bearing Necessary? (INWN), study protocol for a pragmatic randomised multicentre trial of operatively treated ankle fracture. Retrospectively registered on 30 June 2019. It is hoped that these results will contribute to the modern management of ankle fractures. This pragmatic randomised-controlled multicentre trial will investigate immediate weight-bearing following ORIF of all ankle fracture patterns in the usual care condition. 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. These studies often preclude more complicated fracture patterns or patient-related factors. ![]() There is emerging evidence that earlier weight-bearing may have equivocal outcomes and favourable patient satisfaction but higher wound-related complications. Traditional management of operatively treated ankle fractures includes an extended period of non-weight-bearing. The trial will be reported in accordance with the CONSORT statement for reporting a pragmatic trial, and this protocol will follow the SPIRIT guidance. 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 primary outcome measure will be the functional Olerud-Molander Ankle Score (OMAS). The three institutional review boards have granted ethical approval. ![]() The exclusion criteria will be skeletal immaturity and tibial plafond fractures. All patients presenting to three trauma units will be included. MethodsĪ 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. 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. ![]() Traditional non-weight-bearing cast immobilisation may prevent loss of fixation, and this practice continues in many centres. There is an evolving understanding that extended periods of immobilisation and weight-bearing limitation may lead to poorer clinical outcomes. Postoperative management regimes vary following open reduction and internal fixation (ORIF) of unstable ankle fractures. ![]()
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