Actively Recruiting
FRAME Study (Frailty-Related Ankle Fracture Management and Evaluation)
Led by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Updated on 2026-01-28
172
Participants Needed
1
Research Sites
345 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
FRAME Study (Frailty-Related Ankle Fracture Management and Evaluation)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 60 years or older
- Severe soft tissue compromise or significant co-morbidities such as vascular disease with chronic trophic changes, diabetes with neuropathy, chronic renal failure, or morbid obesity (BMI > 40)
- Frailty defined by a Dalhousie Clinical Frailty Scale score of 4 or more
- For Part 1: Isolated fracture within 4 weeks of injury, AO/OTA type 43C2 or C3 tibial pilon fracture or severe ankle fracture (fracture dislocation, severe joint impaction, severe trimalleolar)
- For Part 2: Isolated fracture within 4 weeks of injury, AO/OTA type 44B2, B3, C1 or C2 ankle fracture
You will not qualify if you...
- Presence of vascular injury or pathologic fracture
- Previous tibia pilon fracture or retained hardware in the affected limb
- Refusal to participate in the study
- Inability to provide informed consent due to language barrier
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
London Health Sciences Centre
London, Ontario, Canada, N6A5W9
Actively Recruiting
Research Team
E
Emil Schemitsch, MD, FRCS(C)
CONTACT
A
Abdel Lawendy, MD, FRCS(C)
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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