A prospective randomised controlled trial of operative versus non-operative management of fractures of the humeral diaphysis: the HUmeral Shaft Fracture FIXation (HU-FIX) Study protocol

BACKGROUND: Humeral shaft fractures constitute around 1% of adult fractures in the UK, with an annual incidence of approximately 13 per 100,000 population. Historically, these injuries have been primarily managed non-operatively, with operative fixation reserved for specific indications. Although some recent retrospective studies have suggested there are potential benefits of operative fixation over humeral bracing, there is a deficiency in level 1 evidence to support operative management as the primary treatment for humeral shaft fractures. METHODS/DESIGN: This single-centre prospective randomised controlled trial aims to recruit 70 adult patients with an isolated closed fracture of the humeral diaphysis into one of two treatment arms: operative (n = 35) or non-operative (n = 35). The operative arm will undergo open reduction and internal fixation (ORIF) of the fracture using a standard fixation technique (plate and screws). The non-operative arm will be fitted with a prefabricated humeral brace until fracture union. All patients will be followed up for 1 year post-intervention. The primary outcome measure will be the Disabilities of the Arm, Shoulder and Hand (DASH) score at 3 months post-intervention. Secondary outcome measures will include pain, treatment complications, return to work or sporting activities, shoulder and elbow range of motion, radiographic assessment, EuroQol (EQ-5D) Health Outcome score and 12-item Short Form (SF-12) Health Survey score. A health economic analysis will be performed to compare the cost implications of each treatment strategy. DISCUSSION: This randomised controlled trial will provide level 1 evidence comparing a standard ORIF technique against functional bracing for isolated closed humeral shaft fractures. The investigators hope that the study results will assist surgeons in their decision-making when managing patients with these injuries. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03689335. Registered on 28 September 2018 (retrospectively). ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s13063-019-3576-0) contains supplementary material, which is available to authorized users.