Every year, around 334 adults with a broken upper arm bone will be randomly assigned to either a fabric brace or surgery to see which treatment works better. This matters because fractures of the humeral shaft—the long bone between shoulder and elbow—account for 3–5% of all fractures, yet doctors have little solid evidence to guide whether to immobilise the arm in a functional brace or operate to fix the bone with plates or rods. The wrong choice can mean prolonged pain, poor arm function, or unnecessary surgery. If the trial shows one treatment is clearly superior, it will change clinical practice across the UK’s emergency departments and fracture clinics. Patients could recover faster with less pain and better arm use, while the NHS could save money by avoiding costly operations that offer no advantage. The results will be published in major medical journals and presented at orthopaedic conferences, directly influencing treatment guidelines for a common injury that currently lacks a clear best option.
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RESEARCH QUESTION Evaluation of the clinical and cost-effectiveness of functional bracing, compared to surgical fixation for the treatment of humeral shaft fractures in adult patients. BACKGROUND Fractures of the humeral shaft represent 3-5% of all fractures. They occur in a bimodal distribution, typically affecting younger men and older women. There is currently little evidence to support clinicians in their management choices when treating these fractures. Two of the most common treatments when treating humeral shaft fractures in patients are; (i) functional bracing and (ii) surgical fixation. OBJECTIVES To directly compare non-surgical (functional bracing) intervention with a surgical intervention in the treatment of patients aged 18 years or older with a fracture of the humerus. We will focus on the treatments’ effectiveness in reducing pain, improving the functionality of the arm and improvements in the patients’ quality of life. In addition, we will also make a comparison of cost effectiveness. DESIGN This is a two-phased, multi-centre, prospective, randomised superiority trial. Phase 1 (internal pilot) will confirm the expected rate of recruitment in a large-scale multi-centre randomised controlled trial. Phase 2 (main trial) will be the proposed randomised controlled trial in a minimum of 24 UK centres. SETTING Emergency departments (EDs) and fracture clinics within the UK PARTICIPANTS Adults patient aged 18 years and older with a fracture of the humeral shaft (diaphysis). SAMPLE SIZE At 90% power and 5% (2-sided) significance, the proposed sample size needed is 266 (133 per treatment arm) participants providing data at 12 months in order to detect a standardised effect size of 0.4. Allowing for 20% loss to follow-up yields an overall target of 334 (167 per arm). These calculations are based on the primary outcome of DASH at 12 months. ANALYSIS The DASH at 12 months is the primary outcome in this study and will be compared between treatment groups as the dependent variable in a mixed-effects linear regression model for the primary analysis with adjustments for stratification factors (recruitment centre and age), other important prognostic factors (for example BMI, smoking-status and diabetic-status, concomitant injuries which affect limb function) and baseline (preinjury) DASH score. In addition to DASH we will collect other clinical PROMS data (PROMIS upper limb and PROMIS pain interference) to further explore clinical effectiveness. EQ-5D-5L and data on complications, serious adverse effects and service use will be used to support a cost effectiveness evaluation. ANTICIPATED IMPACT AND DISSEMINATION On completion of the study, the findings of the HTA report will be presented at national and international meetings of organisations such as the British Orthopaedic Association Annual Congress, British Elbow and Shoulder Surgery Society (BESS) and the European Federation of National Associations of Orthopaedics and Traumatology (EFFORT). The final study report will be published in a peer reviewed, high impact, general medical or orthopaedic journal; such as Lancet, the British Medical Journal or similar. A summary of the study report, written in lay language will be produced and made available to participants and members of our Patient Advisory Group.
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