[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100368394":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":40,"locations":47,"responsibleParty":64,"collaborators":66,"id":111,"slug":26,"hasResults":112,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":116,"eligibilityCriteria":117,"healthyVolunteers":112,"sex":118,"minAge":119,"maxAge":26,"enrollmentInfo":120,"targetDuration":26,"studyType":123,"phases":124,"briefSummary":126,"conditions":127,"keywords":129,"overallStatus":49,"whyStopped":26,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":140},{"fullName":5,"class":6},"Unity Health Toronto","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Distal femoral replacement (DFR)","EXPERIMENTAL","Distal femoral replacement will be performed by excising the distal portion of the femur (up to two thirds) and replacing with a prosthesis incorporating a hinged total knee replacement.\n\nSurgical approach and implant selection will be at the discretion of the treating surgeon and within the standard of care. Surgeons performing this procedure will be qualified by training and experience in arthroplasty.",[13],"Procedure: Distal femoral replacement",{"label":15,"type":16,"description":17,"interventionNames":18},"Surgical Fixation (ORIF)","ACTIVE_COMPARATOR","Surgical fixation of the distal femoral fracture will be performed with the goals of obtaining and maintaining anatomic reduction and stable fixation of the distal portion of the femur. Surgical approach and implant selection for the surgical fixation (ORIF) will be at the discretion of the treating surgeon and within the standard of care. Surgeons performing this procedure will be qualified by training and experience in trauma of the knee.",[19],"Procedure: Surgical Fixation (ORIF)",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Distal femoral replacement","The distal portion of the femur (up to two thirds) is excised and replaced by a endoprosthesis incorporating a hinged total knee replacement.",[9],null,{"type":22,"name":15,"description":28,"armGroupLabels":29,"otherNames":30},"A trained orthopaedic surgeon uses open or minimally invasive reduction techniques and achieves stable fixation with internal fixation devices (plates\u002Fscrews or intramedullary nail) to restore structural integrity and alignment of the distal femur",[15],[31],"open reduction and internal fixation",[33,37],{"name":34,"affiliation":35,"role":36},"Amir Khoshbin, MD","St Michael's Hospital - Unity Health Toronto","PRINCIPAL_INVESTIGATOR",{"name":38,"affiliation":39,"role":36},"Jesse Wolfstadt, MD","Mount Sinai Hospital, University of Toronto",[41],{"name":42,"role":43,"phone":44,"phoneExt":45,"email":46},"Cassandra Tardif-Theriault, BKin","CONTACT","+1416-864-6060","77117","cassandra.tardif-theriault@unityhealth.to",[48],{"facility":35,"status":49,"city":50,"state":51,"zip":26,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"RECRUITING","Toronto","Ontario","Canada","CA",{"type":55,"coordinates":56},"Point",[57,58],-79.39864,43.70643,{"lat":58,"lon":57},[61,63],{"name":42,"role":43,"phone":62,"phoneExt":45,"email":46},"416-864-6060",{"name":34,"role":36,"phone":26,"phoneExt":26,"email":26},{"type":65,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[67,69,71,73,75,77,79,81,84,86,88,90,92,94,96,98,100,103,105,107,109],{"name":68,"class":6},"Mount Sinai Hospital, Canada",{"name":70,"class":6},"NYU Langone Health",{"name":72,"class":6},"Brigham and Women's Hospital",{"name":74,"class":6},"Queen Elizabeth II Health Sciences Centre",{"name":76,"class":6},"Hamilton Health Sciences Corporation",{"name":78,"class":6},"Yale New Haven Health System Center for Healthcare Solutions",{"name":80,"class":6},"Oregon Health and Science University",{"name":82,"class":83},"OrthoCincy Orthopaedics & Sports Medicine","UNKNOWN",{"name":85,"class":6},"University of California",{"name":87,"class":6},"Hospital for Special Surgery, New York",{"name":89,"class":6},"Stanford University",{"name":91,"class":6},"Cedars-Sinai Medical Center",{"name":93,"class":6},"Thunder Bay Regional Health Sciences Centre",{"name":95,"class":6},"University of California, San Francisco",{"name":97,"class":6},"University of Arkansas",{"name":99,"class":6},"University of Calgary",{"name":101,"class":102},"Ascension Health","INDUSTRY",{"name":104,"class":6},"University of Otago",{"name":106,"class":83},"Gold Coast University Hospital, Australia",{"name":108,"class":6},"Humber River Hospital",{"name":110,"class":6},"Ottawa Hospital Research Institute","100368394",false,"NCT04076735","DIFFIR - Geriatric Distal Femur Fixation Versus Replacement","DIFFIR: Geriatric Distal Femur Fixation Versus Replacement - A Randomized Controlled Trial of Acute Open Reduction Internal Fixation (ORIF) Versus Distal Femoral Replacement (DFR)","DIFFIR","Inclusion Criteria:\n\n* Male and female patients\n* 65 years and older\n* Isolated fracture of the distal femur (Classification 33)\n* Fracture is amendable to both treatments\n* Fracture is acute (within 2 weeks from time of injury)\n* Patient was ambulatory (with or without walking aids) prior to the injury\n* Independent or moderately frail with score of 3 to 6 on the Clinical Frailty Scale\n* Patient is able to read and understand English, French, or Spanish\n* Patient or substitute decision maker is able to provide written informed consent to participate in the study\n\nExclusion Criteria:\n\n* Active or previous infection around the fracture (soft tissue or bone)\n* Open fracture\n* Bilateral femur fractures\n* Major vascular injuries requiring intervention, compartment syndrome and major neurologic injuries\n* Pathological fracture excluding osteoporosis\n* Previous surgical fixation or total knee replacement of the distal femur or proximal tibia\n* Previous surgical fixation or hemi\u002Ftotal replacement of the hip\n* Current or previous extensor mechanism (patellar tendon, quadriceps tendon, or patella fracture) disruption or repair\n* Polytrauma (Injury Severity Score \\> 15) or any associated major injuries of the lower extremities\n* Previous medical diagnosis of dementia\n* Medical or surgical contra-indication to surgery","ALL","65 Years",{"count":121,"type":122},140,"ESTIMATED","INTERVENTIONAL",[125],"NA","The current standard of care for most intra-articular distal femur fractures (above the knee joint) in geriatric patients is a surgical fixation using plates and screws to hold the fracture pieces in the correct position, until the fracture as healed.\n\nHowever, surgical fixation of these complex fractures in geriatric patients, is associated with significant complications, such as non-union (when the broken bone does not heal properly), infection and the need for revision surgery. Additionally, surgical fixation requires prolonged immobilization of of the affected limb (typically around 6-12 weeks post-operatively), which can lead to disability and other complications. Geriatric patients, especially those frail and with cognition impairment, are unable to adhere to the immobilization restrictions, which leads to an increased risk of fixation failure (broken bone does not heal).\n\nAnother treatment option for those patients is an acute distal femoral replacement (artificial knee), where damaged parts of the knee joint are replaced with artificial prosthesis. This procedure allows patients to walk immediately after the surgery and faster return to previous level of function, therefore avoiding the complications for immobilization.\n\nThere is a lack of guideline and evidence to suggest which surgical technique is best to provide superior function outcomes, lower complications and reduced costs. The proposed study seeks to answer this question by performing a large clinical trial comparing knee replacement versus surgical fixation in geriatric patients with distal femur fracture.",[128],"Distal Femur Fracture",[130],"Distal Femur Fracture; Geriatric fracture","2026-04-29",{"date":133,"type":134},"2026-05-06","ACTUAL",{"date":136,"type":134},"2021-10-01",{"date":138,"type":122},"2028-12-31",{"name":5,"class":6},1]