Trial Status: Open to Recruitment
Weight-bearing in Ankle Fractures
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. 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.
Aims and objectives
To determine whether functional outcomes at 4 months are not worse in people who are allowed to weight-bear at 2 weeks following surgery for an unstable ankle fracture compared to those waiting 6 weeks before weight-bearing.
1. To quantify and draw inferences on observed differences in ankle function between the trial treatment groups in the first 12 months post-surgery.
2. To quantify and draw inferences on observed differences in health-related quality of life between the trial and treatment groups in the first 12 months post-surgery.
3. To investigate the risk of adverse events between the trial treatment groups in the first 12 months post-surgery.
4. To investigate the resource use, costs and comparative cost effectiveness between the trial treatment groups in the first 12 months post-surgery.
5. Perform a process evaluation to understand the generalisability and acceptability of the trial.
Multi-centre, multi-surgeon, parallel, two arm, randomised non-inferiority trial.