Condition: Ankle Fracture · Rehabilitation · Recovery · Sponsor: Odense University Hospital
Ankle fractures are common, debilitating and usually treated with immobilisation using a foot-ankle brace (walker). Emerging evidence suggests that a less restrictive brace may reduce recovery time without increasing the risk of complications, and patients tend to prefer ankle stirrups. However, evidence supporting their non-inferiority remains limited and inconclusive. Thus, the aim is assess if an ankle stirrup is non-inferior to a standard walker in reducing pain and function measured by the Manchester-Oxford Foot Questionnaire (MOXFQ) three months after ankle fracture. The hypothesis is that ankel stirrups align better with patients preferenes for less immobilising braces and offer sufficient stability while the fracture heals. Secondarily it may lead to faster recovery of function, return to work and reduced cost. The sample size of a maximum of 1400 patients allow us to assess non-inferiority in age and sex specific subgroups and treatment (surgical or non-sugical). Non-inferiority will be assessed in a pragmatic, multicenter, randomised controlled trial involving Scandinavian orthopedic departments.
This description comes directly from the study's public registry record.
Jonas A Ipsen, phd · +4523925264 · Jonas.Ammundsen.Ipsen@rsyd.dk
Bjarke Viberg, Phd · bjarke.viberg@rsyd.dk
Always discuss trial participation with your own doctor first.
| Orthopedic Department, Hospital of Southern Jutland | Aabenraa, Denmark | Not Yet Recruiting |
| Orthopedic Department, Aalborg Universitets Hospital | Aalborg, Denmark | Not Yet Recruiting |
| Orthopedic Department, Aarhus University Hospital | Aarhus, Denmark | Recruiting |
| Orthopedic Department, Bispebjerg Hospital | Copenhagen, Denmark | Not Yet Recruiting |
| Orthopedic Department, Hospital of South West Jutland | Esbjerg, Denmark | Not Yet Recruiting |
| Orthopedic Department, Herlev Hospital | Herlev, Denmark | Not Yet Recruiting |
| Orthopedic Department, North Zealand Hospital | Hillerød, Denmark | Not Yet Recruiting |
| Orthopedic Department, Hvidovre Hospital | Hvidovre, Denmark | Not Yet Recruiting |
| Orthopedic Department, Hospital Lillebaelt - Kolding | Kolding, Denmark | Recruiting |
| Orthopedic Department, Zealand University Hospital - Køge | Køge, Denmark | Recruiting |
| Orthopedic Department, Odense University Hospital | Odense, Denmark | Recruiting |
| Orthopedic Department, Randers Hospital | Randers, Denmark | Not Yet Recruiting |
+ 4 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT07163091