[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100449349":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":10,"centralContacts":36,"locations":47,"responsibleParty":65,"collaborators":10,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":69,"sex":75,"minAge":76,"maxAge":10,"enrollmentInfo":77,"targetDuration":10,"studyType":80,"phases":10,"briefSummary":81,"conditions":82,"keywords":85,"overallStatus":50,"whyStopped":10,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Part 1: Fusion Group",null,"Primary arthrodesis: Subjects allocated to the fusion group will have insertion of a retrograde locked calcaneal nail. Tibiotalar joint preparation, bone grafting, subtalar preparation, and fibulectomy will not be performed unless deemed necessary by the treating surgeon.",[13],"Procedure: Primary ankle arthrodesis (fusion)",{"label":15,"type":10,"description":16,"interventionNames":17},"Part 2: Fibula","Intramedullary Fibular Nailing: Participants allocated to the IMFN group will receive a locked fibular nail using a previously described technique.",[18],"Procedure: Intramedullary Fibular Nailing (IMFN)",{"label":20,"type":10,"description":21,"interventionNames":22},"Control Group: Internal Fixation","ORIF will be performed using modern techniques for timing and staging of fixation, soft tissue and fibula management, surgical approaches, reduction techniques, and plate choice.",[23],"Procedure: ORIF (open reduction and internal fixation)",[25,29,33],{"type":26,"name":27,"description":11,"armGroupLabels":28,"otherNames":10},"PROCEDURE","Primary ankle arthrodesis (fusion)",[9],{"type":26,"name":30,"description":31,"armGroupLabels":32,"otherNames":10},"ORIF (open reduction and internal fixation)","ORIF: ORIF will be performed using modern techniques for timing and staging of fixation, soft tissue and fibula management, surgical approaches, reduction techniques, and plate choice.",[20],{"type":26,"name":34,"description":16,"armGroupLabels":35,"otherNames":10},"Intramedullary Fibular Nailing (IMFN)",[15],[37,42],{"name":38,"role":39,"phone":40,"phoneExt":10,"email":41},"Emil Schemitsch, MD, FRCS(C)","CONTACT","519-663-3307","emil.schemitsch@lhsc.on.ca",{"name":43,"role":39,"phone":44,"phoneExt":45,"email":46},"Abdel Lawendy, MD, FRCS(C)","519-685-8500","58086","AbdelRahman.Lawendy@lhsc.on.ca",[48],{"facility":49,"status":50,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"London Health Sciences Centre","RECRUITING","London","Ontario","N6A5W9","Canada","CA",{"type":57,"coordinates":58},"Point",[59,60],-81.23304,42.98339,{"lat":60,"lon":59},[63],{"name":64,"role":39,"phone":10,"phoneExt":10,"email":10},"Lawson Health Research Institute",{"type":66,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100449349","frame-study-frailty-related-ankle-fracture-management-and-evaluation-100449349",false,"NCT05131321","FRAME Study (Frailty-Related Ankle Fracture Management and Evaluation)","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","FRAME","Patient Inclusion Criteria - Both Parts:\n\n(i) Age ≥ 60 years (ii) One or more of the following:\n\n* Severe soft tissue compromise\n* Significant co-morbidities (vascular disease + chronic trophic changes, diabetes + neuropathy, chronic renal failure, morbid obesity (BMI\\> 40))\n* Frailty as defined by a Dalhousie Clinical Frailty Scale score ≥4\n\nPart 1 Specific Inclusion Criteria:\n\n(i) Isolated fracture (within 4 weeks of injury): an AO\u002FOTA type 43C2 or C3 tibial pilon fracture or severe ankle fracture (fracture-dislocation, severe joint impaction, severe trimalleolar)\n\nPart 2 Specific Inclusion Criteria (i) Isolated fracture (within 4 weeks of injury): an AO\u002FOTA type 44B2, B3, C1 or C2 ankle fracture\n\nPatient Exclusion Criteria - Both Parts:\n\n(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","ALL","40 Years",{"count":78,"type":79},172,"ESTIMATED","OBSERVATIONAL","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\n\nThe 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.",[83,84],"Ankle Fractures","Pilon Fracture",[86,87,88,89,90,91,92,93],"Complex ankle fracture","Pilon fracture","Primary Ankle Arthrodesis","Fragility fracture","Elderly","Open reduction","Internal fixation","AO\u002FOTA type 44B2, B3, C1 or C2 ankle fracture","2026-01-26",{"date":96,"type":97},"2026-01-28","ACTUAL",{"date":99,"type":97},"2022-04-21",{"date":101,"type":79},"2028-12",{"name":5,"class":6},1]