[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100500125":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":26,"centralContacts":37,"locations":47,"responsibleParty":62,"collaborators":26,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":26,"eligibilityCriteria":70,"healthyVolunteers":66,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":26,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":26,"overallStatus":50,"whyStopped":26,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"University of Florida","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Open reduction and internal fixation (ORIF) of distal femur fracture","ACTIVE_COMPARATOR","Su Type 2 or 3 periprosthetic distal femur fractures about a total knee after undergoing ORIF for a minimum of 2 years",[13,14],"Other: Timed Up and Go Test on subjects with ORIF of distal femur fractures","Other: Koos Jr assesment on subjects with ORIF of distal femur fractures",{"label":16,"type":10,"description":17,"interventionNames":18},"Distal femur replacement total knee arthroplasty (DFR) of distal femur fracture","Su Type 2 or 3 periprosthetic distal femur fractures about a total knee after undergoing DFR for a minimum of 2 years",[19,20],"Other: Timed Up and Go Test on subjects with DFR of distal femur fracture","Other: Koos Jr assesment on subjects with DFR of distal femur fracture",[22,27,31,34],{"type":6,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"Timed Up and Go Test on subjects with ORIF of distal femur fractures","Subjects will perform the Timed Up and Go Test This test is used to assess mobility. Subjects are asked to wear regular footwear and can use their walking device as needed. Subjects begin by sitting in a standard armchair. Next participants are instructed to walk 10 feet to a designated line at a normal pace. Once they reach the line they are to turn and walk back to the chair and sit down. The test starts on the study staff go signal and ends once the subject is fully seated in the chair. Test will be performed at 6 weeks, 3 months, 6 months, 12 months and 24 months post surgical treatment.",[9],null,{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Koos Jr assesment on subjects with ORIF of distal femur fractures","Subjects will complete the KOOS Jr assessment. The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a self-reported outcome measure assessing the patient's opinion about the health, symptoms, and functionality of their knee. It is a 42-item questionnaire, including 5 subscales: symptoms, pain, ADLs, sports\u002Frecreation, and quality of life. The maximum score a patient can achieve is 100, indicating no knee problems. The minimum score is zero, indicating severe knee problems.",[9],{"type":6,"name":32,"description":24,"armGroupLabels":33,"otherNames":26},"Timed Up and Go Test on subjects with DFR of distal femur fracture",[16],{"type":6,"name":35,"description":29,"armGroupLabels":36,"otherNames":26},"Koos Jr assesment on subjects with DFR of distal femur fracture",[16],[38,43],{"name":39,"role":40,"phone":41,"phoneExt":26,"email":42},"Matthew Patrick, MD","CONTACT","352-273-7188","patrimr@ortho.ufl.edu",{"name":44,"role":40,"phone":45,"phoneExt":26,"email":46},"Dykes Viginia, DAT","352-273-7343","jacksve@ortho.ufl.edu",[48],{"facility":49,"status":50,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":26},"UF & Shands Orthopaedics and Sports Medicine Institute","RECRUITING","Gainesville","Florida","32607","United States","US",{"type":57,"coordinates":58},"Point",[59,60],-82.32483,29.65163,{"lat":60,"lon":59},{"type":63,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100500125","distal-femur-fx-orifopen-reduction-and-internal-fixation-vs-dfr-distal-femur-replacement-total-knee-arthroplasty-100500125",false,"NCT05792189","Distal Femur Fx: ORIF(Open Reduction and Internal Fixation) vs DFR (Distal Femur Replacement Total Knee Arthroplasty)","Evaluation of the Management of Periprosthetic Distal Femur Fractures and Native Knee Distal Femur Fractures, Comparing Open Reduction Internal Fixation With Distal Femur Replacement, a Prospective Cohort Study","Inclusion Criteria:\n\n* English speaking patients\n* 55 years or older with Su Type II or Su Type III periprosthetic femur fractures or OTA\u002FOA 33C or 338\u002F3 native knee distal femur fracturing requiring surgical intervention and are medically fit to undergo surgical intervention\n\nExclusion Criteria:\n\n* Patients with an active total knee prosthetic infection\n* Patients unable to undergo surgical intervention\n* Patient with an open fracture\n* Non-English-speaking patients\n* Oncologic\u002Fpathologic fracture\n* Poly-trauma patient (or other associated major orthopaedic injuries)","ALL","55 Years","100 Years",{"count":75,"type":76},100,"ESTIMATED","INTERVENTIONAL",[79],"NA","Supracondylar femur periprosthetic fractures about a total knee arthroplasty (TKA) are a catastrophic and challenging complication of TKA and unfortunately are increasing in incidence. Fixation of these fractures can be challenging due to altered anatomy for the TKA and the presence of the metallic femoral component and have a relatively high complication rate. As a result, some surgeons elect to treat these fractures with a distal femur replacement total knee arthroplasty (DFR). The purpose of this study is to prospectively evaluate periprosthetic femur fractures treated with ORIF or DFR and compare various outcomes measures (Get up and go times, KOOS Jr score)",[82],"Distal Femur Fracture","2025-07-29",{"date":85,"type":86},"2025-07-31","ACTUAL",{"date":88,"type":86},"2023-04-12",{"date":90,"type":76},"2029-04-01",{"name":5,"class":6},1]