Title: Ankle Fracture Fixation: a randomised controlled trial of tourniquet usage and postoperative management
Funder: Department of Health (England)

Abstract: Background Ankle fractures are rising among young active people and the elderly and are often treated operatively. Tourniquets are routinely used during surgery to create a bloodless field in which to operate. However, evidence suggests that use of a tourniquet is associated with higher rates of complications including infections and deep vein thrombosis leading to longer stays in hospital. Following surgery it is also unclear whether patients should receive the standard practice of immobilisation in a cast for 6 weeks since some evidence suggests that early mobilisation without a cast together with early weightbearing may facilitate recovery. Further research is needed to address the uncertainty of these two widely-used practices for treating ankle fractures. Aims The study aims to assess the benefits to patients and potential cost savings to the NHS of a) using a tourniquet versus not using a tourniquet during surgery to repair closed ankle fractures and b) early postoperative weight-bearing while in a plaster cast versus early postoperative weight-bearing and mobilisation without a cast. The primary outcome measure for use of a tourniquet will be length of stay in hospital. Operative time, rates of infection, deep vein thrombosis and range of movement will also be measured. Patients' functional scores at 3 months will be the primary outcome to assess postoperative management. The cost-benefits for the NHS and from a societal perspective (e.g. time off work, and personal costs to patients) will be assessed up to 6 months follow-up. Plan of Investigation A two-stage randomised controlled trial will be implemented at two acute hospital NHS Trusts to recruit at least 208 patients. Participants requiring surgery for closed ankle fractures will be randomised to one of two groups (tourniquet or no tourniquet). The same patients will be randomised postoperatively to cast/ no cast. The study is powered to detect a difference in mean length of stay of 2 days following surgery and a 10-point difference on a functional status scale. The EQ5D will be used to measure health status and utility. The procedures will be evaluated for their costs and benefits to patients over a 6-month period. Key costs will be time in theatre, length of stay, casting, readmissions, outpatient visits, physiotherapy, time off work and personal costs to participants. Potential Impact The current practice of using a tourniquet during ankle surgery may make the procedure quicker and easier to perform but these advantages are less likely to benefit patients or the NHS if the use of a tourniquet leads to a slower recovery, higher rates of infection, re-surgery and other complications. The conventional postoperative use of a cast may protect the fracture but it may also lead to a slower return of function by limiting the amount of early mobilisation compared to postoperative care not involving early removal of the cast. The proposed trial will provide much needed evidence to guide current practice, and if necessary, to change practice for the benefit of patients and the NHS.


Research activity codes: 6.4 SURGERY
Health categories: INJURIES AND ACCIDENTS