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

Recruiting now

Conditions studied: Ankle Fractures, Pilon Fracture

In brief

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.

Key facts

Study ID
NCT05131321
Run by
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
People needed
172
Starts
2022-04-21
Expected to finish
2028-12-01
Last updated by the study team
2026-01-28

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

Where it is running

Full record on ClinicalTrials.gov

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