A multi-centre, parallel group, two arm, non-inferiority randomised controlled trial to compare clinical and cost-effectiveness of suture fixation versus tension band wiring for simple olecranon fracture fixation in adults. Simple Olecranon Fracture Fixation Trial (SOFFT) PROTOCOL

Aims: Olecranon fractures are usually caused by falling directly on to the olecranon or following a fall on to an outstretched arm. Displaced fractures of the olecranon with a stable ulnohumeral joint are commonly managed by open reduction and internal fixation. The current predominant method of management of simple displaced fractures with ulnohumeral stability (Mayo IIA) in the UK and internationally is a low-cost technique using tension band wiring. Suture or suture anchor techniques have been described with the aim of reducing the hardware related complications and re-operation. An all-suture technique has been developed to fix the fracture using strong synthetic sutures alone. The aim of this trial is to investigate the clinical and cost-effectiveness of tension suture repair versus traditional tension band wiring for the surgical fixation of Mayo Grade IIA fractures of the olecranon. Methods: SOFFT is a multi-centre, pragmatic, two-arm parallel-group, non-inferiority, randomised controlled trial. Participants will be assigned 1:1 to receive either tension suture fixation or tension band wiring. 280 adult participants will be recruited. The with the primary outcome being will be the Disabilities of the Arm Shoulder and Hand (DASH) score at 4-months post randomisation. Secondary outcome measures include DASH (at 12, 18, and 24 months), pain, Net Promotor Score (Patient Satisfaction), EuroQol 5 Dimensions (5L) Score (EQ5D-5L), radiological union, complications, elbow range of movement and re-operations related to the injury or to remove metalwork. An economic evaluation will assess the cost-effectiveness of treatments. Discussion: There is currently no high-quality evidence comparing the clinical and cost effectiveness of the tension suture repair to the traditional tension band wiring currently offered for the internal fixation of displaced fractures of the olecranon. The Simple Olecranon Fracture Fixation Trial (SOFFT) is a RCT with sufficient power and design rigour to provide this evidence for the subtype of Mayo Grade IIA fractures.