The HUmeral SHaft fracture trial
Fractures of the humeral shaft represent 3-5% of all fractures. They occur in a bimodal distribution, typically affecting younger men and older women. The vast majority of humeral shaft fractures occur in patients over 50 years. 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 over 50 years old are:
- Functional bracing
- Surgical fixation using a humeral nail
A humeral shaft fracture is a break in the long bone of the upper arm. Although it also occurs in young men it most often affects people over 50, particularly women, as their bones are more fragile. 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.
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.
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.
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 50 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.
Those who receive surgery will undergo surgical nail fixation (where a long metal nail is inserted down the middle of the bone), 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.
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.
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.
To directly compare non-surgical (functional bracing) intervention with a surgical intervention (nail fixation) in the treatment of patients aged 50 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.
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.