Title: The HUmeral SHaft fracture trial (HUSH)
Funder: Department of Health and Social Care

Abstract: A humeral shaft fracture is a break in the long bone of the upper arm. It occurs mainly in two groups of individuals; young men and older women, as their bones are more fragile._x000D_ Currently, the most common treatment (approximately 70%) for these fractures is non-operative -using a cast for two weeks and then a brace until the bone begins to heal properly - although there is large variation in treatments between and in hospitals. The risk of complications is low and the cost also relatively low at £1,100. The disadvantages are that the patient is immobilised for a prolonged period and the cumbersome cast can lead to significant pain and discomfort in some patients. There is also a 20% chance that the break will not heal. This then requires surgery and involves additional costs of approximately £15,500._x000D_ There appears to be a worldwide trend towards treating these fractures with surgery (rather than a cast and brace), however there is no high quality evidence that this is indeed a better option. Various reviews of the current evidence have recognised the need for further trials. Surgery is the more expensive route, and has a higher risk of complication e.g. infection and nerve damage. However there is a better chance of the bone healing successfully and the patient is likely to recover more quickly allowing them to regain their independence sooner._x000D_ Our aim is to directly compare these two methods. We want to find out whether arm function and quality of life in patients with this fracture is better with the more conservative cast and brace treatment or with surgery. We also need to compare the cost effectiveness of both approaches. We want to produce sound evidence to establish if the drawbacks of surgery are balanced by the improved results and acceptable costs, compared with the non-surgical treatment._x000D_ The best way to determine this is by randomised trial, with patients allocated randomly to one or other treatment by a secure computer program. All patients over 18 who present at a trial hospital with this fracture, are eligible to be included in the trial. Once the trial has been explained, the patient has the choice whether to consent to being involved or not. Both treatments are widely used within the NHS and clinical teams will be familiar with both techniques._x000D_ The technique of surgery used for those patients allocated to the surgery group will be chosen by the surgeon and will be followed by two weeks in a sling. Patients treated non-surgically will have a splint applied in the Emergency Department which they wear for two weeks. They will then change to a brace which is usually worn for a further 8 – 10 weeks. Both groups will be given a structured rehabilitation programme._x000D_ The trial will last for 12 months. Patients will be followed up at 6 months and 12 months after their injury. They will be asked about their quality of life, daily activities, pain, physiotherapy treatment, and any complications. We will also look at resources and services they have used to determine costs involved._x000D_ _x000D_ The chief investigator and members of the research team have been heavily involved in research which identifies what these patients (and their carers) say is important to them. The patient representative will be part of the trial management team and will also be involved in communicating the final results of the trial to all groups involved in caring for these patients, as well as the patients themselves.

Lay abstract: RESEARCH QUESTION_x000D_ Evaluation of the clinical and cost-effectiveness of functional bracing, compared to surgical fixation for the treatment of humeral shaft fractures in adult patients._x000D_ _x000D_ BACKGROUND_x000D_ 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. _x000D_ OBJECTIVES_x000D_ 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._x000D_ DESIGN_x000D_ 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._x000D_ SETTING_x000D_ Emergency departments (EDs) and fracture clinics within the UK_x000D_ PARTICIPANTS_x000D_ Adults patient aged 18 years and older with a fracture of the humeral shaft (diaphysis)._x000D_ SAMPLE SIZE_x000D_ 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. _x000D_ ANALYSIS_x000D_ 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. _x000D_ ANTICIPATED IMPACT AND DISSEMINATION_x000D_ 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.

Research activity codes: 6.4 SURGERY
Health categories: INJURIES AND ACCIDENTS