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
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.
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