Ankle Fracture Fixation with or without Tourniquet (AFFixT)
Research type
Research Study
Full title
Tourniquet use in ankle fracture fixation surgery: a feasibility randomised controlled trial
IRAS ID
331292
Contact name
Julie Bruce
Contact email
Sponsor organisation
University of Warwick
Duration of Study in the UK
0 years, 10 months, 1 days
Research summary
Ankle fracture fixation surgery is common. Some surgeons perform this operation with the use of a tourniquet. This is a cuff device placed around the patient’s thigh during surgery. Benefits of tourniquet use may include less bleeding, better visibility, and shorter procedure time. However, tourniquets may cause pain and increase the risks of complications e.g. infection. A definitive randomised controlled trial (RCT) is needed to compare outcomes on this topic and address clinical uncertainties. In preparation, a two-centre feasibility RCT and qualitative interviews will be carried out to improve the quality of the future trial and determine key study parameters. These include recruitment rate, reasons for non-participation, equipoise, effectiveness and views on blinding processes, protocol non-adherence, data incompleteness, and required sample size.
This study aims to determine whether a full RCT evaluating outcomes of ankle fracture fixation surgery performed with or without tourniquet is feasible.
The feasibility RCT will include patients aged ≥18 years undergoing ankle fracture fixation surgery. Recruitment sites are University Hospital Coventry and Royal London Hospital. 50 patients are planned to be recruited over three months and followed up for three months. Consented patients will be randomised 1:1 to the intervention (tourniquet to be used) or control (tourniquet not used). Feasibility outcomes under investigation include recruitment rates, retention rates, data completeness, and intervention adherence. Clinical outcomes under investigation include pain, surgical visibility, length of procedure blood loss, blood transfusion, knowledge of tourniquet use (blinding), skin assessment, ankle function, health-related quality of life, and post- and intra-operative complications.
Qualitative interviews will be conducted with up to 24 participants (patients and surgeons) to explore their experiences in the feasibility RCT, assess blinding effects and effectiveness, and identify improvements to enhance recruitment and retention in the full RCT. Thematic analysis using an inductive approach will be used to analyse these interviews.
REC name
East of England - Essex Research Ethics Committee
REC reference
25/EE/0051
Date of REC Opinion
9 May 2025
REC opinion
Further Information Favourable Opinion