FRAME Study (Frailty-Related Ankle Fracture Management and Evaluation)
Recruiting
Observational Study
Ankle Fractures
Pilon Fracture
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Age
- 40 and older
- Sex
- Any
- Study type
- Observational
- Participants needed
- 172 (estimated)
- Sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Other
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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) wil…
Trial Locations
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Eligibility Criteria
Patient Inclusion Criteria - Both Parts:
(i) Age ≥ 60 years (ii) One or more of the following:
* 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 …
Contacts