Trial Status - In Set-Up
FAME was awarded in response to the NIHR HTA Commissioned Call ref: 18/15 Non-surgical vs surgical management of unstable ankle fractures
The Fractured Ankle Management Evaluation
Every day in the UK around 170 people break an ankle. They often have pain and physical limitations for several weeks, or sometimes months, after the injury. It can also mean that they have to take a long time off work. We know some people have pain in their ankle as well as some functional limitations for as long as three years or even longer.
In most hospitals, simple ankle breaks are treated with a plaster cast or a walking boot. If the break is more complicated with the broken bones out of place, or if they wouldn’t stay in line when walking in a boot or plaster, an operation is performed to fix the bones in place with screws and a plate.
Ankle fracture is one of the most common musculoskeletal injuries sustained in the UK. Many of these patients experience ongoing pain and physical impairment with the consequences of the fracture and its management lasting for several months or even years. The broad aim of ankle fracture treatment is to maintain the alignment of the joint whilst the fracture heals. More severe injuries to the ankle, those which require realignment or are expected to be unstable, are routinely treated surgically. However, even with advances in surgery, there remains a risk of complications; for patients experiencing these the associated loss of function and quality-of-life is considerable. Non-surgical treatment is an alternative to surgery and involves applying a cast carefully shaped to the patient’s ankle, called a close contact cast, to correct and maintain alignment of the joint; the key benefit being a reduction in the frequency of common complications of surgery. The potential risk of non-surgical treatment is a loss of that alignment with a consequent reduction in ankle function.
A recent study looked at treatments for these more complex breaks in people over 60 years old. It compared the results of the standard treatment, involving an operation, with using a closely moulded plaster cast, avoiding the operation. By the end of the study there was no real difference in the ankle function and quality-of-life experienced by the two groups. This suggests that using the special plaster cast was just as good as having surgery for treating this sort of ankle break in older people.
Now we want to know if this is the same for younger people.
This trial is a pragmatic, multicentre, randomised non-inferiority clinical trial and embedded pilot; with twelve months clinical follow-up and parallel economic analysis. A surveillance study using routinely collected data will be performed at five years.
Involving patients at 25-30 hospitals across the UK we want to see how using the special plaster cast instead of the operation affects the outcome of an ankle break in people aged 18-60. We will only include people who would normally have had an operation to treat the ankle break. We want to look at functional outcomes - how well people are and what they can do after a certain recovery time. We will also work out the costs of the different treatments - to the NHS, to the individual, and to wider social care services.
We will start with a pilot study at a smaller group of hospitals. We do this to find out if we can find enough people who want to take part before we go ahead with the larger study. It also allows us to make any changes to make the main study better before we get started. All the information gained from this pilot study will be included in the main study too.
We think we need 890 people to take part to compare the two treatments properly. If people agree to take part, they will be put into one of the two comparison groups by a computer program to make sure that the groups are similar and the comparison is fair. After the operation or the plaster cast treatment, all the patients in the study will have the usual additional treatment and follow-up that is currently standard practice at the hospitals.
The researchers will ask patients about their health and abilities and return to work and usual activities, as well as any complications and specific costs. The answers will be collected at the outset, and at 8 weeks, 4 months and 1 year after the injury, and the results from the two groups will be compared.
A few questions will be asked each year for four more years to find out about any longer term effects.
This project was developed by a team of patient representatives, clinical experts in orthopaedics, study management specialists, experienced statisticians and health economists. The Oxford Clinical Trials Research Unit, based within the University, will assure the quality of the study. Monitoring committees of patient representatives and independent experts will oversee the progress and conduct of the study.