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

Recruitingn/aAges 40 Years - anyAllLondon Health Sciences Centre Research Institute …
NCT05131321 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Primary ankle arthrodesis (fusion)
  • ORIF (open reduction and internal fixation)
  • Intramedullary Fibular Nailing (IMFN)
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Where

1 site
London Health Sciences Centre
London, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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