{"type":"trials","record":{"id":35047,"source_id":"clinicaltrials-gov","external_id":"NCT05131321","title":"FRAME Study (Frailty-Related Ankle Fracture Management and Evaluation)","brief_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.","overall_status":"Recruiting","phases":[],"study_type":"OBSERVATIONAL","sponsor":"London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's","enrollment":172,"countries":["Canada"],"start_date":"2022-04-21","completion_date":"2028-12-01","last_update_date":"2026-01-28","source_url":"https://clinicaltrials.gov/study/NCT05131321","editorial_summary":"A registered study indexed because it matched monitored longevity research terms. Registry status: Recruiting. Registration does not establish safety or effectiveness.","first_seen_at":"2026-09-25T01:20:20.087268+00:00","last_seen_at":"2026-09-25T06:10:07.378+00:00","metadata":{"sex":"ALL","acronym":"FRAME","age_range":"40 Years","comparator":null,"organization":"London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's","interventions":["Primary ankle arthrodesis (fusion)","ORIF (open reduction and internal fixation)","Intramedullary Fibular Nailing (IMFN)"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Short-Form 12 (SF-12). — 1 year post-surgery.","Numeric Pain Rating Scale — 1 year post-surgery","Function IndeX (FIX-IT) — 1 year post-surgery","Euro-Qol-5 Dimension (EQ5D) — 1 year post-surgery","PROMIS-Physical Function Short Form (PROMIS-PF), version 10a — 1 year post-surgery","Olerud Molander Ankle Score (OMAS) — 1 year post-surgery","Extended Timed-up and Go (TUG) Test — 1 year post-surgery","Rate of complications — 1 year post-surgery","Foot and Ankle Ability Measure (FAAM) — [Time Frame: 1 year post-surgery]"],"design_description":null,"source_has_results":false},"controlled_terms":["Ankle Fractures","Pilon Fracture","Primary ankle arthrodesis (fusion)","ORIF (open reduction and internal fixation)","Intramedullary Fibular Nailing (IMFN)"],"relevance_confidence":80,"source_quality_score":100,"freshness_score":85,"publication_state":"published","match_explanation":"Title contains controlled term: frailty.","quality_checked_at":"2026-09-25T06:10:20.034853+00:00","duplicate_cluster_key":"id:nct05131321","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2022-04-21 to 2028-12-01","comparator":null,"confidence":"structured-source","population":"ALL · 40 Years","provenance":{"duration":"start_date and completion_date","comparator":"registry arm fields","population":"registry eligibility fields","intervention":"registry intervention fields","participants":"enrollment","study_design":"study_type and registry design fields","evidence_stage":"phases","reported_outcome":"not available","outcomes_measured":"registry outcome-measure fields"},"generated_at":"2026-09-25T06:10:07.467Z","intervention":["Primary ankle arthrodesis (fusion)","ORIF (open reduction and internal fixation)","Intramedullary Fibular Nailing (IMFN)"],"participants":172,"study_design":"OBSERVATIONAL","subject_scope":"Human clinical study registration","evidence_stage":"Phase not reported","safety_context":"Eligibility, adverse-event details, and clinical decisions must be checked in the official registry and with qualified clinicians.","source_support":"Structured registry protocol metadata; no finding-level conclusion is generated.","main_limitation":"This is a study registration. No reusable structured result is available here, so it cannot show whether the intervention worked or was safe.","reported_outcome":null,"outcomes_measured":["Short-Form 12 (SF-12). — 1 year post-surgery.","Numeric Pain Rating Scale — 1 year post-surgery","Function IndeX (FIX-IT) — 1 year post-surgery","Euro-Qol-5 Dimension (EQ5D) — 1 year post-surgery","PROMIS-Physical Function Short Form (PROMIS-PF), version 10a — 1 year post-surgery","Olerud Molander Ankle Score (OMAS) — 1 year post-surgery","Extended Timed-up and Go (TUG) Test — 1 year post-surgery","Rate of complications — 1 year post-surgery","Foot and Ankle Ability Measure (FAAM) — [Time Frame: 1 year post-surgery]"],"regulatory_context":"Trial registration is not regulatory approval and does not establish that an intervention is available."},"clinical_trial_topics":[{"topic_slug":"frailty","is_published":true,"match_reasons":["Title contains controlled term: frailty.","Title supplies longevity context: frailty, frail.","Study type is explicitly identified as OBSERVATIONAL."],"matched_fields":["title","title context","study type"],"relevance_score":80,"intelligence_topics":{"name":"Frailty","slug":"frailty"}}],"content_sources":{"name":"ClinicalTrials.gov","homepage_url":"https://clinicaltrials.gov/"}},"canonical_url":"https://www.immortal.life/trials/35047","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}