| Popis: |
Background:Postoperative management regimes vary following open reduction and internal fixation (ORIF) of unstable ankle fractures. There is an evolving understanding that extended periods of immobilisation and limitation of weight-bearing may lead to poorer clinical outcomes. Traditional non-weight bearing cast immobilisation may prevent loss of fixation, and this practice continues in many centres. 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.Methods:A pragmatic randomised controlled multicentre trial, comparing IWB in a walking boot and ROM within 24 hours versus non-weight-bearing (NWB) and immobilisation in a cast for six weeks, following ORIF of all types of unstable adult ankle fractures (lateral malleolar, bimalleolar, trimalleolar with or without syndesmotic injury) is proposed. All patients presenting to three trauma units will be included. The exclusion criteria will be skeletal immaturity and tibial plafond fractures. The three institutional review boards have granted ethical approval. The primary outcome measure will be the functional Olerud-Molander Ankle Score (OMAS). Secondary outcomes included 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 trial will be reported in accordance with the CONSORT statement for reporting a pragmatic trial, and this protocol will follow the SPIRIT guidance.Discussion:Traditional management of operatively treated ankle fractures includes an extended period of non-weight bearing. There is emerging evidence that earlier weight-bearing may have equivocal outcomes and favourable patient satisfaction but with higher wound-related complications. These studies often preclude more complicated fracture patterns or patient-related factors. 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. This pragmatic randomised-controlled multicentre trial will investigate immediate weight-bearing following ORIF of all ankle fracture patterns in the usual condition of care. It is hoped that these results will contribute to the modern management of ankle fractures.Trial registration:The trial is retrospectively registered on the 30th of June 2019, ISRCTN - ISRCTN76410775.http://www.isrctn.com/ISRCTN76410775 |
