Suture fixation versus tension band wiring for simple olecranon fracture fixation: a multi-centre randomised controlled trial (Simple Olecranon Fracture Fixation Trial (SOFFT))

Background Currently, displaced fractures of the olecranon (bony point of the elbow) with a stable ulnohumeral joint are commonly managed by open reduction (open surgery to realign the fractured bone fragments) and internal fixation with tension band wiring. This is a low cost technique using two parallel Kirschner wires and a ‘figure of 8 loop’ wire. However, a common complication after fixation with tension band wiring is that the metalwork causes discomfort or even breaks through the skin. A second surgery, with the associated surgical risks and delayed recovery for patients and costs for the NHS, is frequently required. An alternative approach is to fix the fracture using strong synthetic sutures alone. This tension suture repair is considered less likely to require a second surgery to remove the fixation material, thereby reducing risk and inconvenience for the patient and saving the NHS money, without compromising the outcome. However, there is currently no high quality evidence from a randomised controlled trial (RCT) to determine whether the functional outcome of the tension suture repair is non-inferior to tension band wiring in restoring patient function and provides sufficient benefit to patients and the NHS in terms of reduced second surgeries Aims and objectives To undertake a multi-centre parallel group RCT to determine whether tension suture repair is not inferior to tension band wiring for surgical fixation of Mayo Grade IIA fractures of the olecranon in consenting patients over the age of 16 years. The primary outcome is the Disabilities of the Arm Shoulder and Hand (DASH) score at 4 months follow-up. The additional objectives are to undertake an analysis of the rate of re-operation and other secondary outcomes and a cost-effectiveness analysis of the two interventions from the NHS perspective. Methods The study will be a multi-centre, non-inferiority RCT within UK Major Trauma Centres and Trauma Units. There will be a 9-month internal pilot to assess assumptions about recruitment and fidelity of implementation of the tension suture technique. 280 patients will be recruited to provide 90% statistical power to establish non inferiority of suture fixation compared with tension band wiring technique using a non-inferiority margin of 10 points on the DASH (SD=23) and assuming 20% attrition at 4-months follow-up. Timelines for delivery The study will be 54 months duration. This will allow 6 months for study set up and approvals, 9-month internal pilot, a further 15 months for trial recruitment, 18 months of follow up and 6 months for statistical analysis and write up. Anticipated impact and dissemination Depending on the results of the trial, the study has the potential to change the type of surgical fixation used for simple olecranon fractures, allowing a more efficient use of NHS resources, or to prevent widespread adoption of a new fixation technique if it is not shown to have sufficient benefits for patients and use of NHS resources compared to the current method. Targets for dissemination will include to NICE, Clinical Commissioning Groups, the Department of Health and the Speciality Advisory Committees (SAC) for the curriculum for clinicians who will undertake treatment of olecranon fractures. The study protocol and results will be presented orally and published in high impact factor publications and a summary of the study will be made available in plain English for patient-focused outlets.