What this means
Researchers plan to randomly assign older patients to one of two surgeries for complex ankle fractures. This trial is still recruiting, so no results are available yet.
Plain-English summary written by an AI model from the registry listing.
- Status
- Recruiting
- Who can join
- Ages 40 and over
- Where
- 1 site
The science
- Registered title
- FRAME Study (Frailty-Related Ankle Fracture Management and Evaluation)
- Trial ID
- NCT05131321 ↗
- Phase
- Not applicable
- Study type
- observational
- Conditions
- Ankle Fractures, Pilon Fracture
- What is tested
- Primary ankle arthrodesis (fusion), ORIF (open reduction and internal fixation), Intramedullary Fibular Nailing (IMFN)
- Sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Ages
- 40 Years to no maximum
- Dates
- First posted Nov 23, 2021 · updated Jan 28, 2026
Registry summary
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.
Sites (1)
- London Health Sciences Centre, London, Ontario, Canada