FRAME Study (Frailty-Related Ankle Fracture Management and Evaluation)

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40+
SponsorLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

About this trial

This will be a multi-centre randomized controlled trial, with London Health Sciences Centre (LHSC) as the lead site. Elderly patients with complex ankle fractures who meet the inclusion criteria and provide consent will be randomized (through a web-based randomization system) to one of the two treatment arms. One group (Group A) will receive primary ankle fusion, and the second group (Group B) will receive primary ankle open reduction and internal fixation (ORIF). Patient important outcomes will be compared at one year post injury

The Investigators have amended the study to include a second part for patients with less complicated but still unstable ankle fractures. In this part, patients will be randomly assigned to receive either a procedure called ORIF or another one called retrograde intramedullary fibular nailing.

Eligibility criteria

Qualifiers

Severe soft tissue compromise

Significant co-morbidities (vascular disease + chronic trophic changes, diabetes + neuropathy, chronic renal failure, morbid obesity (BMI> 40))

Frailty as defined by a Dalhousie Clinical Frailty Scale score ≥4

Disqualifiers

None

Trial design

Treatments tested in this trial

  • Primary ankle arthrodesis (fusion)
  • ORIF (open reduction and internal fixation)
  • Intramedullary Fibular Nailing (IMFN)

Treatment groups

172 Participants
are divided into 3 treatment groups