WAX
Research type
Research Study
Full title
Weight Bearing in Ankle Fractures. A randomised clinical trial of weight-bearing following operatively treated ankle fracture.
IRAS ID
265559
Contact name
Xavier Griffin
Contact email
Sponsor organisation
University of Oxford/ Clinical Trials and Research Governance
Duration of Study in the UK
2 years, 9 months, 30 days
Research summary
Research Summary
A randomised clinical trial of weight-bearing following surgery for an ankle fracture.
There are around 170 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.
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 but it is unclear if that is of any benefit. A recent national review found that surgeons gave patients very varied instructions following ankle fracture surgery
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 2 weeks after surgery or wait 6 weeks before bearing weight on that side.
This study will include participants undergoing surgery for an ankle fracture. All participants will be treated as 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 for a further four weeks. The decision with regards the group they will enter, will be made by chance using a computer program which will randomise so that neither participants 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.
Summary of Results
Background Around 180 people break their ankle every day in the UK. About 40% need surgery to fix their bones in the right place with plates and screws. After surgery, patients are usually told not to walk on the affected leg for six weeks to allow the bones to heal. We know patients can find limiting their walking distressing. If it is safe to do so, patients would likely prefer to start walking sooner after their surgery if it does not affect their recovery.
Aim of study
The Weight-bearing in Ankle Fractures (WAX) study aimed to determine whether patients would be safe and recover similarly if they start walking sooner after surgery.What happened in the study?
Patients that had surgery for an ankle fracture were asked to take part in the study and either started walking on their injured leg 2 weeks after their surgery, or waited till 6 weeks after their surgery (which is currently the most common treatment). The choice was made using a process called randomisation which means the comparison between treatments is fair. Over the following 12 months, patients were asked how their ankle was working and how well they were able to live a normal life. They were also asked about visits to hospital or their GP and any costs they incurred as part of their recovery. The information from all the patients was combined to find out if there was a difference between the those patients who started walking after 2 weeks with those who waited until 6 weeks.What did the study find?
The results showed that starting walking 2 weeks after surgery was a safe option and produced an equally good recovery compared to waiting 6 weeks, which was also cheaper for patients and the NHS.How are patients and the public involved?
Patients and the public said that this research question was important to them. They also helped to decide which parts of recovery we should focus on. Two patient representatives also hosted discussion groups with injured participants to find out their experiences of recovery.REC name
South Central - Oxford A Research Ethics Committee
REC reference
19/SC/0566
Date of REC Opinion
22 Nov 2019
REC opinion
Favourable Opinion