FAME: The Fractured Ankle Management Evaluation Trial
Research type
Research Study
Full 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 Fractured Ankle Management Evaluation (FAME) Trial.
IRAS ID
266058
Contact name
Xavier Griffin
Contact email
Sponsor organisation
University of Oxford
Duration of Study in the UK
7 years, 4 months, 0 days
Research summary
Background: Ankle fracture is one of the most common UK musculoskeletal injuries. Routinely, unstable fractures are treated with surgery to maintain the joint alignment whilst the fracture heals. However, for patients who experience complications after surgery, their loss of ankle function and quality-of-life is considerable. An alternative, non-surgical treatment is to apply a close contact cast (CCC); a plaster cast carefully shaped to the patient’s ankle to correct and maintain alignment of the joint. The key benefit of CCC is a reduced risk of the complications of surgery. The main potential risk of CCC is a loss of joint alignment with a consequent reduction in ankle function. CCC is a current evidence-based treatment in the UK for patients over 60.
Aim: This study aims to determine whether ankle function four months after treatment in younger adult patients with unstable ankle fractures treated with CCC is not worse than those treated with surgery, which is the current standard-of-care.
Design: This is a pragmatic, multicentre, randomised non-inferiority clinical trial with an embedded pilot study and will also involve analysis of health economics. A surveillance study using routinely collected data will be performed annually to five years.
Methods
890 Adult patients aged up to 60 with unstable ankle fractures will be approached for recruitment prior to their treatment and randomised to receive surgery or CCC in hospitals around the UK. Data regarding ankle function, quality-of-life, complications and costs will be collected at eight weeks, four and twelve months and then annually for five years following treatment. The primary outcome measure is patient-reported ankle function at four months after randomisation.
Impact
The 12 months results will be presented and published internationally and will inform the NICE ‘non-complex fracture’ recommendations in 2024. Five year long-term outcomes will be reported in 2027.
REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
19/EM/0264
Date of REC Opinion
14 Aug 2019
REC opinion
Favourable Opinion