HUSH - The Humeral Shaft Fracture Trial
Research type
Research Study
Full title
The HUmeral SHaft fracture trial: A multi-centre prospective randomised superiority trial of surgical versus non-surgical interventions for humeral shaft fractures in patients aged 18 years or older
IRAS ID
277059
Contact name
Steve Gwilym
Contact email
Sponsor organisation
University of Oxford / Clinical Trials an Research Governance
ISRCTN Number
ISRCTN17108318
Duration of Study in the UK
3 years, 10 months, 1 days
Research summary
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.
Currently, the most common treatment for these fractures is non-operative. Approximately 70% of cases are treated 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 is 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.
There appears to be a worldwide trend towards treating these fractures with surgery (rather than a cast and a 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.
Our aim is to directly compare these two methods of treating fractures of the humeral shaft. We want to find out whether arm function and quality of life in patient 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 improved results and acceptable costs.
The technique of surgery used for those patients allocated to the surgery group will be chosen by the surgeon. Surgery will typically be followed by two weeks in a sling. Patients treated non-surgically will have a cast applied in the Emergency Department which they will use 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.
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 the costs involved in both treatments.REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
20/EE/0127
Date of REC Opinion
2 Jun 2020
REC opinion
Further Information Favourable Opinion