FRAME Study (Frailty-Related Ankle Fracture Management and Evaluation) (NCT05131321)
FRAME Study (Frailty-Related Ankle Fracture Management and Evaluation): Retrograde Nailing Versus Open Reduction and Internal Fixation for Unstable Fractures Around the Ankle in the Frail Elderly - A Two-Part Prospective, Randomized, Multi-Center Clinical Trial
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: London Health Sciences Centre — London, Ontario
Age range: 40 Years
🧪 Interventions in This Study
- Primary ankle arthrodesis (fusion) (PROCEDURE)
- ORIF (open reduction and internal fixation) (PROCEDURE)
- Intramedullary Fibular Nailing (IMFN) (PROCEDURE)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- London Health Sciences Centre — London, Ontario
📞 Contact the Study Coordinator
Phone: (519) 663-3307
Email: emil.schemitsch@lhsc.on.ca
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Ankle Fractures
- Local Multimodal Injection Versus Regional Anesthesia in Controlling Pain for Treating Rotational Ankle Fractures — Salt Lake City, Utah
- Biodegradable Magnesium Screws for Unstable Ankle Fracture Surgery — Boston, Massachusetts
- Neuromuscular Electrical Stimulation in Foot and Ankle Surgery — New York, New York
- Simplified Post Op Rehabilitation for Ankle and Pilon Fractures — Charlottesville, Virginia
- Efficacy and Clinical Feasibility of the Ankle Muscle Power (AMP) Program for Return to Duty After an Ankle Fracture — Lexington, Kentucky
- Randomized Controlled Trial for Ankle Fracture Pain Control — Burlington, Massachusetts
Explore by condition: All Ankle Fractures clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.