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.
SOFFT is a multi-centre, non-inferiority RCT within UK Major Trauma Centres and Trauma Units, 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 280 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.
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.
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|National Institute for Health Research (NIHR)|
|Wrightington, Wigan & Leigh NHS Foundation Trust|
|End Date||April 2024|