Ankle Fracture FIXation surgery with or without Tourniquet (AFFIXT): protocol for a randomised controlled feasibility trial.

BACKGROUND: Ankle fracture fixation surgery may be performed with or without the use of a tourniquet. Surgeons who use a tourniquet report reduced intraoperative bleeding, which improves the visualisation of anatomical structures. This may facilitate more accurate fracture fixation and restoration of the anatomical configuration of the ankle joint, potentially leading to improved functional outcomes. An additional proposed benefit of tourniquet use is reduced operative time. In contrast, surgeons who choose not to use a tourniquet report concerns that it may exacerbate postoperative pain and increase the risk of venous thromboembolism, surgical site infection and other complications. However, existing clinical trials are limited by small sample sizes and high risk of bias, preventing the ability to draw robust conclusions. This study aimed to assess the feasibility of conducting a randomised controlled trial (RCT) to evaluate the potential benefits and risks of tourniquet use in ankle fracture fixation surgery.

METHODS: This study comprises a two-centre, participant-blinded and surgeon-blinded parallel-arm RCT and an integrated qualitative interview study. A computer-generated randomisation service will allocate up to 50 patients to undergo ankle fracture fixation surgery either with or without the use of a tourniquet. Participants will be followed up for 3 months postoperatively. Primary outcomes include recruitment and retention rates, data completeness, success of blinding and adherence to allocated intervention. Secondary outcomes include postoperative pain, quality of the surgical field, intraoperative blood loss, blood transfusions, procedure duration, skin assessment, awareness of tourniquet use, health-related quality of life (EuroQol-5D-5L), Olerud-Molander Ankle Score and intraoperative and postoperative complications. The integrated qualitative study will consist of semistructured interviews with up to 12 patients and 12 trauma and orthopaedic surgeons (~24 interviews). Interviews will explore perspectives on the feasibility trial, identify factors associated with unblinding and examine barriers and potential solutions to the design and delivery of a future definitive trial. Interviews will be analysed using inductive thematic analysis.

ETHICS AND DISSEMINATION: National Research Ethics Committee (East of England-Essex) approved this study on the 8 May 2025 (REC 25/EE/0051). The results will be disseminated via peer-reviewed publication.

TRIAL REGISTRATION NUMBER: ISRCTN91783787.