Comparing two surgical methods for treating ankle fractures in elderly patients
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
This study is testing which surgical method works better for treating ankle fractures in frail elderly patients: a fusion surgery or a method that uses plates and screws.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 172 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's Academic / other |
| Locations | 1 site (London, Ontario) |
| Trial ID | NCT05131321 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness of primary ankle fusion versus open reduction and internal fixation (ORIF) for treating unstable ankle fractures in frail elderly patients. The study will involve randomizing participants to receive one of the two surgical interventions and will assess patient outcomes one year after the injury. Additionally, a second part of the trial will evaluate retrograde intramedullary fibular nailing against ORIF for less complicated unstable fractures. The goal is to determine which method provides better functional outcomes and lower complication rates in this vulnerable population.
Who should consider this trial
Good fit: Ideal candidates for this study are elderly individuals aged 60 and above with unstable ankle fractures and significant co-morbidities.
Not a fit: Patients with vascular injuries, pathologic fractures, or those unable to provide informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical options and outcomes for elderly patients with complex ankle fractures.
How similar studies have performed: While there is emerging evidence supporting primary ankle fusion, high-level studies comparing these surgical methods specifically in frail elderly patients are limited, making this approach relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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 a Dalhousie Clinical Frailty Scale score ≥4 Part 1 Specific Inclusion Criteria: (i) Isolated fracture (within 4 weeks of injury): an AO/OTA type 43C2 or C3 tibial pilon fracture or severe ankle fracture (fracture-dislocation, severe joint impaction, severe trimalleolar) Part 2 Specific Inclusion Criteria (i) Isolated fracture (within 4 weeks of injury): an AO/OTA type 44B2, B3, C1 or C2 ankle fracture Patient Exclusion Criteria - Both Parts: (i) Presence of vascular injury or pathologic fracture; (ii) Previous tibia pilon fracture or retained hardware in affected limb; (iii) Refusal to participate; (iv) Inability to obtain informed consent due to language barrier
Where this trial is running
London, Ontario
- London Health Sciences Centre — London, Ontario, Canada (Recruiting)
Study contacts
- Study coordinator: Emil Schemitsch, MD, FRCS(C)
- Email: emil.schemitsch@lhsc.on.ca
- Phone: 519-663-3307
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.