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

William M Oliver, Thomas H Carter, Catriona Graham, Timothy O White, Nicholas D Clement, Andrew D Duckworth, Samuel G Molyneux, William M Oliver, Thomas H Carter, Catriona Graham, Timothy O White, Nicholas D Clement, Andrew D Duckworth, Samuel G Molyneux

Abstract

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).

Keywords: Bracing; Diaphysis; Fixation; Fracture; Humeral; Humerus; Non-operative; Operative; Patient outcome; Randomised controlled trial; Shaft; Trauma.

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
CONSORT flow diagram (with PRO extension) for the HU-FIX study. HU-FIX Humeral Shaft Fracture Fixation
Fig. 2
Fig. 2
Arbeitsgemeinschaft für Osteosynthesefragen definition of humeral shaft (diaphyseal segment, 12-), with Müller boxes delineating the proximal (11-) and distal (13-) segments
Fig. 3
Fig. 3
SPIRIT figure for the HU-FIX study. DASH Disabilities of the Arm, Shoulder and Hand, EQ-5D EuroQol Health Outcome, ROM range of movement, SF-12 12-item Short Form Health Survey, VAS visual analogue scale

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