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

BACKGROUND 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. AIM 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. DESIGN 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. METHODS 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. TIMELINES FOR DELIVERY 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. ANTICIPATED IMPACT AND DISSEMINATION 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.