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?
Chief investigator
Professor Xavier Griffin.
Sponsor
University of Oxford.
Funder
NIHR Health Technology Assessment Programme.
Local principal investigator
Simon Jameson.
Objective
To determine whether functional outcomes at four months are not worse in people with unstable ankle fractures treated with close contact casting than those treated with surgical intervention.
Design
Multi-centre, parallel, two arm, randomised non-inferiority clinical trial with parallel economic analysis.
Arm one
Close contact casting (non-surgical) (n = 445).
Arm two
Internal fixation (surgical) (n = 445).
Participants
Adult patients, aged 18 to 60 years inclusive with an unstable ankle fracture (n = 890).
Website
https://www.fame-study.digitrial.com/
ISCRTN registry
https://www.isrctn.com/ISRCTN67007305