Title: WAX: Weight-bearing in ankle fractures. A randomised clinical trial of weight-bearing following operatively treated ankle fracture.
Funder: Department of Health and Social Care

Abstract: A randomised clinical trial of weight-bearing following operatively treated ankle fracture. Background There are around 200 ankle fractures each day in the UK. Many of these injuries require surgery to restore the natural alignment of the ankle joint by open reduction and internal fixation. Following surgery, patients are often told to avoid walking on their affected leg for six weeks (delayed weight-bearing). There is little evidence to support this routine practice. There is a need to determine if early weight-bearing (within 3 weeks) produces similar clinical outcomes to delayed weight-bearing. The National Institute for Health and Care Excellence (NICE) and the James Lind Alliance Priority Setting Partnerships have identified this question as one of their top priorities for research in trauma. Aims and Objectives This study aims to determine whether functional outcomes after early weight-bearing in patients with operatively treated unstable ankle fractures are not worse than adopting a delayed weight-bearing regime which is usual care. Design This trial is a pragmatic, multicentre, randomised non-inferiority clinical trial with parallel economic analysis with follow-up extending to 12 months. Methods All adult patients with operatively treated ankle fracture are potentially eligible to take part in this study. Surgery will be performed in trauma units across the UK using the preferred technique of the treating surgeon and patients will remain non-weight-bearing for the first 2 weeks postoperatively. Patients will be then be approached for recruitment at their 2-week postoperative clinic visit. 436 patients will be randomly allocated to an instruction to avoid putting any weight on their affected leg (restricted weight-bearing) or to walk on their affected leg as much as they feel comfortable (unrestricted weight-bearing) for the next four weeks. The trial will employ 1:1 random allocation by a remote computer system, stratified by centre and by age. Data regarding ankle function, quality of life, complications and costs will be collected at six weeks and four and twelve months following surgery. The primary outcome measure is ankle function measured using the Olerud and Molander ankle score (OMAS) at 4 months from surgery, with a parallel economic analysis. Timelines for delivery The trial is set to commence in Sep 2019 and report in Aug 2022. Anticipated Impact and Dissemination The results will be presented and published internationally. This is anticipated to be the only trial reporting on weight-bearing in operatively treated ankle fractures in the next 5 years and so will inform NICE recommendations at their scheduled update. Our patient and public involvement representatives will help distribute the results through patient advocacy groups and beyond routine scientific media.

Lay abstract: There are around 200 ankle fractures each day in the UK. Many of these injuries heal with support in a plaster cast or splint, but some require surgery to restore the natural alignment of the bones and fix them in place with screws and plates. This promotes good ankle function once the fracture has healed. Following surgery for an ankle fracture, patients are commonly told not to walk on the affected leg for six weeks in order to allow the bones to heal. Whilst restricting the weight put through the affected leg might reduce the chance of surgical complications, including infection, breakage of the plates and screws and loss of alignment requiring revision surgery, it has been associated with problems such as blood clots, muscle weakness, stiffness and poorer recovery. It is unclear that the traditional six weeks period of limited walking is of any benefit. A recent national review found that surgeons gave patients very varied instructions following ankle fracture surgery, indicating that overall, UK surgeons have differing opinions about best treatment. There has been little high-quality research in this area. The National Institute for Health and Care Excellence (NICE) and the James Lind Alliance Priority Setting Partnerships have identified this question as one of their top priorities for research in trauma. This study aims to find out whether patients who have had surgery for an ankle fracture should walk on their operated leg following surgery or wait 6 weeks before bearing weight on that side. This study will include patients undergoing surgery for an ankle fracture. All patients will be treated non-weight-bearing until their two-week postoperative follow-up visit. They will then be instructed to either begin weight-bearing on the affected leg, or remain non-weight bearing. The decision with regards the group they will enter will be made by chance using a computer program so that neither patients nor surgeons can influence the choice. All other care will be as per usual treatment. Participants will report how well their ankle is working and their quality of life using questionnaires at different intervals over the first year following surgery. Differences in healthcare costs will also be compared. Patients and members of the public have led in designing the trial, deciding on outcome measures and considering other factors such as out-of-pocket expenses. Their continued involvement in the day-to-day management of the study will ensure the information given to participants is accurate and understandable and that results reflect patient priorities. The published results will inform NICE recommendations and will influence clinical practice. Patients and members of the public will help design a publicity strategy so that the results of the study are distributed outside of the routine scientific literature.

Research activity codes: 6.4 SURGERY
Health categories: INJURIES AND ACCIDENTS