Award Title: In younger adults with unstable ankle fractures treated with close contact casting, is ankle function not worse than those treated with surgical intervention? The FAME Trial
Funder: Department of Health and Social Care

Abstract: Every day in the UK around 170 people break an ankle. They tell us that they 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 can have pain in their ankle as well as some functional limitations for as long as three years or even longer._x000D_
_x000D_
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._x000D_
_x000D_
A recent study looked at treatments for these complicated 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 was just as good as having surgery for treating this sort of ankle break in older people._x000D_
_x000D_
Now we want to know if this is the same for younger people._x000D_
_x000D_
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 would 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._x000D_
_x000D_
We will start with a pilot study at a smaller group of hospitals looking closely at the processes we are using. We do this to find out if we can find enough people who want to take part before we go ahead with the big study. It also allows us to make any changes to make the main study better before we get started. All the information from this pilot study will be included in the main study too._x000D_
_x000D_
We think we will 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 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. _x000D_
_x000D_
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 6 weeks, 4 months and 1 year after the injury, and the results from the two groups compared. A few questions will be asked each year for five years to find out about any longer term effects. _x000D_
_x000D_
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.

Lay Abstract: BACKGROUND_x000D_
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 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._x000D_
_x000D_
AIM_x000D_
This study aims to determine whether functional outcomes four months after treatment in patients with unstable ankle fractures treated with close contact casting are not worse than those treated with surgical intervention, which is the current standard-of-care._x000D_
_x000D_
DESIGN_x000D_
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._x000D_
_x000D_
METHODS_x000D_
All adult patients with unstable ankle fractures are potentially eligible to take part in this study. Eligible patients will be identified in daily trauma meetings and fracture clinics and approached for recruitment prior to their treatment. Treatments will be performed in trauma units across the UK by a wide range of surgeons to ensure generalisability. Surgical treatment, including position, implant choice and rehabilitation will be at the discretion of the treating surgeon. Non-surgical treatment will be close-contact casting, a technique which has gained in popularity since the publication of the AIM trial. Eight hundred and ninety participants (445 per group) will be randomly allocated to operative or non-operative treatment. The trial will employ 1:1 random allocation by a remote computer system, stratified by centre and by fracture severity. Data regarding ankle function, quality of life, complications and costs will be collected at six weeks, four and twelve months and then annually for five years following treatment. The primary outcome measure is ankle function measured using the Olerud and Molander ankle score at four months from treatment, with a parallel economic analysis._x000D_
_x000D_
TIMELINES FOR DELIVERY_x000D_
Funding commences in May 2019 and the trial is expected to take 46 months, with reporting soon afterwards. The five-year follow-up of long-term outcomes will run to month 92, and the report will be produced shortly after completion._x000D_
_x000D_
ANTICIPATED IMPACT AND DISSEMINATION_x000D_
The 12 months results will be presented and published internationally. Patient representatives will help disseminate the results through patient advocacy groups and beyond routine scientific media. This is anticipated to be the only pragmatic trial reporting outcomes after non-surgical treatment in unstable ankle fractures in younger adults and as such will inform the NICE ‘non-complex fracture’ recommendations at their scheduled update in 2024.

Research Activity Codes: 6.4 SURGERY
Health Categories: INJURIES AND ACCIDENTS