RecruitingNot Applicable

FRAME Study (Frailty-Related Ankle Fracture Management and Evaluation)

Canada172 participantsStarted 2022-04-21

Plain-language 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.

Who can participate

Age range40 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Short-Form 12 (SF-12).

Timeframe: 1 year post-surgery.

Trial details

NCT IDNCT05131321

SponsorLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-12

Contact for this trial

Emil Schemitsch, MD, FRCS(C)

519-663-3307 emil.schemitsch@lhsc.on.ca

View on ClinicalTrials.gov More Ankle Fractures trials