Is postoperative non-weight-bearing necessary? INWN Study protocol for a pragmatic randomised multicentre trial of operatively treated ankle fracture

Abstract

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 weight-bearing limitation 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 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. 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 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 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 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 care condition. It is hoped that these results will contribute to the modern management of ankle fractures. Trial registration ISRCTN Registry ISRCTN76410775. Retrospectively registered on 30 June 2019.

The effect of early weight‐bearing and later weight‐bearing rehabilitation interventions on outcomes after ankle fracture surgery: A systematic review and meta‐analysis of randomised controlled trials

“…LWB, as the traditional post‐operative fracture rehabilitation program, has a high level of safety and is effective in avoiding the loss of reduction or fixation failure after surgery, thus reducing the risk of secondary surgery. In contrast, LWB may affect the recovery of patients' ankle function [ 14 , 15 ], and it may bring a heavier financial burden to patients, as LWB requires a longer rehabilitation time [ 16 , 17 , 18 ]. Therefore, researchers have recently begun to focus on the application of EWB in post‐operative ankle fracture rehabilitation programmes, considering that EWB can accelerate the speed of post‐operative ankle function recovery compared to LWB and enable patients to return to work/daily life earlier [ 6 , 10 ].…”

Correction to: Is postoperative non-weight-bearing necessary? INWN Study protocol for a pragmatic randomised multicentre trial of operatively treated ankle fracture

“…Following the publication of the original article [ 1 ], we were notified that in the Administrative Information table (Author details 5a), the numbering and the order of the institution was incorrect.…”