51. The FAME trial study protocol: In younger adults with unstable ankle fractures treated with close contact casting, is ankle function not worse than those treated with surgical intervention?
- Author
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Achten J, Marques EMR, Pinedo-Villanueva R, Whitehouse MR, Eardley WGP, Costa ML, Kearney RS, Keene DJ, and Griffin XL
- Abstract
Aims: Ankle fracture is one of the most common musculoskeletal injuries sustained in the UK. Many patients experience 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 while the fracture heals, and to reduce the risks of problems, such as stiffness. More severe injuries to the ankle 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 (Qol) 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 with the key benefit being a reduction in the frequency of common complications of surgery. The main potential risk of non-surgical treatment is a loss of alignment with a consequent reduction in ankle function. This study aims to determine whether ankle function, four months after treatment, in patients with unstable ankle fractures treated with close contact casting is not worse than in those treated with surgical intervention, which is the current standard of care., Methods: This trial is a pragmatic, multicentre, randomized non-inferiority clinical trial with an embedded pilot, and with 12 months clinical follow-up and parallel economic analysis. A surveillance study using routinely collected data will be performed annually to five years post-treatment. Adult patients, aged 60 years and younger, with unstable ankle fractures 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. Details of the surgical treatment, including how the operation is done, implant choice, and the recovery programme afterwards, will be at the discretion of the treating surgeon. The non-surgical treatment will be close-contact casting performed under anaesthetic, a technique which has gained in popularity since the publication of the Ankle Injury Management (AIM) trial. In all, 890 participants (445 per group) will be randomly allocated to surgical or non-surgical treatment. Data regarding ankle function, QoL, complications, and healthcare-related costs will be collected at eight weeks, four and 12 months, and then annually for five years following treatment. The primary outcome measure is patient-reported ankle function at four months from treatment., Anticipated Impact: The 12-month results will be presented and published internationally. This is anticipated to be the only pragmatic trial reporting outcomes comparing surgical with non-surgical treatment in unstable ankle fractures in younger adults (aged 60 years and younger), and, as such, will inform the National Institute for Health and Care Excellence (NICE) 'non-complex fracture' recommendations at their scheduled update in 2024. A report of long-term outcomes at five years will be produced by January 2027., Competing Interests: J. Achten, M. L. Costa, and R. Pinedo-Villanueva declare that the University of Oxford, UK, receives research grant funding from the National Institute for Health and Care Research (NIHR) and Wellcome for into musculoskeletal trauma, while S. Kearney being part funded via an NIHR grant. X. L. Griffin discloses being a lead applicant for eight trials, co-applicant for two trials; and being chair of Barts Bone and Joint Health Research Group, chair of the British Orthopaedic Trauma Society Research Committee, a British Orthopaedic Association (BOA) member, member of the BOA research committee, chair of the Research and Innovation Committee of NHS England Outcomes and Registries Programme, co-theme lead for Precision Musculoskeletal Care Theme of NIHR Barts Biomedical Research Centre, and being RCS England and British Orthopaedic Association surgical specialty lead (Orthopaedic Trauma) for research, all of which is unrelated to this article. D. J. Keene and M. R. Whitehouse disclose being co-applicant on the FAME trial, funded by NIHR Health Technology Assessment Programme (ref. NIHR127273), supported by the NIHR Biomedical Research Centre, Oxford, which is related to this work. In addition, D. J. Keene also reports being lead applicant on the AFTER trial, funded by the NIHR Research for Patient Benefit programme (ref. NIHR201950), and being a committee member for the Association of Trauma and Orthopedic Chartered Physiotherapists and the Fragility Fracture Network UK, both of which are unrelated. In addition, M. R Whitehouse reports grants or contracts from the NIHR for 18 trials and developments; royalties from Taylor & Francis; payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from Heraeus; being chair a number of trial steering committees or data monitoring committees for trials funded by NIHR; and having a leadership or fiduciary role for the British Hip Society; British Orthopaedic Association; and the Bone & Joint Journal editorial board, all of which is also unrelated. E. M. R. Marques declares grants or contracts from VS Arthritis and CeramTec, and support for attending meetings and/or travel from the NIHR as part of funding committee board for PGfAR programme, and as part of dissemination of research findings in conferences, all of which are also unrelated., (© 2024 Achten et al.)
- Published
- 2024
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