Title: Suture fixation versus tension band wiring for simple olecranon fracture fixation: a multi-centre randomised controlled trial_x000D_ (Simple Olecranon Fracture Fixation Trial (SOFFT))
Funder: Department of Health and Social Care

Abstract: Fractures (break in the bone) of the olecranon (point of the elbow) are common and occur usually as a result of a fall on to the elbow. The risk of having this fracture increases as we get older. The bones typically move out of place due to the pull of the the large triceps muscle on the back of the upper arm. Provided a patient is well enough they usually have surgery to fix the fracture. How we keep the bone in the correct position is the subject of this study. The standard method is with metal wires, but these have to be removed in a second operation in 1/3 of cases because of prominence. An alternative method of fixation may reduce this re-operation rate which is better for the patient and has the potential to save the NHS money._x000D_ _x000D_ The surgery is usually done as a day case with the patient asleep. A cut is made on the back of the elbow and the bone is put back in to the correct position for the fracture to heal. The most widely used technique is to hold the bone with tension band wiring using metal wire bent around the bone and two smooth pins. This is usually effective in holding the position for the fracture to heal. However, the wires can cause pain when the patient leans on the elbow, because they lie just under the skin. Patients often ask the surgeon to remove the wires once the bone is fixed. Complications can happen such as incorrect wire placement, joint penetration, injury to nerves and blood vessels, elbow stiffness, wires can push out through the skin, wires can break or the bones move out of position. One in three patients will undergo a second operation with surgical risks and inconvenience to them and increased cost to the National Health Service._x000D_ _x000D_ Alternative methods of holding the bone have been used, with very strong material cord (tension suture fixation) to counter the muscle forces pulling the bone out of position. Small studies have shown that this technique can reliably hold the bones in a good position while they heal and that the patient does not experience any discomfort from prominence of the suture material. The need for further surgery was reduced in one small study from over one in three patients to less than one in twenty. This could save the NHS about 4 million pounds a year but a larger study is needed to confirm this finding. _x000D_ _x000D_ Funding is being sought to compare the tension suture method of fixing the fracture to tension band wiring in a larger group of patients in several hospitals. This is a randomised trial in which neither the clinician nor the consenting patient would choose which fixation method is used. We will assess how well patients are able to manage daily activities, pain, quality of life and whether they need a second operation. Patients would need to attend clinic at 4 months for an x-ray and questionnaire, and will receive questionaires at 12, 18 and 24 months by post or email. This will be followed by a telephone call if there is no response. All other care would be routine care that they could expect if they had not participated in the trial._x000D_ _x000D_ We have consulted with an existing patient group at a hospital who have contributed to the design and summary and agreed to provide advice during the trial if we are successful in securing funding. One member is a co-applicant on the bid. The protocol has been amended on their advice to include a standard information booklet for the patients recruited to the study to explain the likely recovery process and physiotherapy guideline.

Lay abstract: Background_x000D_ 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_x000D_ _x000D_ Aims and objectives _x000D_ 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._x000D_ _x000D_ Methods _x000D_ 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._x000D_ _x000D_ Timelines for delivery _x000D_ 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._x000D_ _x000D_ Anticipated impact and dissemination _x000D_ 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.

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