[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"periprosthetic-fracture-around-prosthetic-joint-implant-knee\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:periprosthetic-fracture-around-prosthetic-joint-implant-knee":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,48],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100501170","pdiffir-geriatric-periprosthetic-distal-femur-fixation-versus-replacement-100501170",false,"NCT05805774","pDIFFIR: Geriatric Periprosthetic DIstal Femur: FIxation Versus Replacement","pDIFFIR: Geriatric Periprosthetic DIstal Femur: FIxation Versus Replacement - A Randomized Controlled Trial of Acute Open Reduction Internal Fixation (ORIF) Versus Distal Femur Replacement (DFR)","pDIFFIR","Inclusion Criteria:\n\n* • 65 years and older\n\n  * Isolated periprosthetic fracture of the distal femur around a stable primary total knee arthroplasty (Lewis and Rorabeck Type 1-2)\n  * Fracture is acute (within 1 week from time of injury)\n  * Patient was ambulatory (with or without walking aids) in the community and at home prior to the injury\n  * Independent or moderately frail with score of 3 to 6 on the validated Clinical Frailty Scale\n  * Patient is able to read and understand the consent form document, or an interpreter is available to the patient at the time of consent and follow-up\n  * Patient or substitute decision maker is able to provide written informed consent to participate in the study\n\nExclusion Criteria:\n\n* • Active infection around the fracture (soft tissue or bone)\n\n  * Open fracture\n  * Bilateral femur fractures\n  * Major neuro-vascular injury requiring intervention, compartment syndrome and major neurologic injuries\n  * Pathological fracture excluding osteoporosis\n  * Ipsilateral total knee arthroplasty using revision components (varus\u002Fvalgus constraint, stemmed femoral components)\n  * Periprosthetic distal femur fracture around a loose or failing primary total knee arthroplasty (Lewis and Rorabeck Type III)\n  * Ipsilateral primary partial knee or patellofemoral arthroplasty\n  * Previous ORIF of the distal femur or proximal tibia or patella\n  * Current or previous extensor mechanism (patellar tendon, quadriceps tendon, or patella fracture) disruption or repair\n  * Poly-trauma status (Injury Severity Score\\>15) or any associated major injuries of the lower extremities that may hinder post-operative ambulation\n  * Medical contraindication to surgery","ALL","65 Years",{"count":20,"type":21},148,"ESTIMATED","INTERVENTIONAL",[24],"NA","Periprosthetic distal femur fractures are a significant source of morbidity and mortality for elderly patients. One treatment option involved a surgical fixation with plates or nails, screws and cables\u002Fwires along the side of your fractured bone. The second method consists in replacing your knee joint with an artificial knee prosthesis (artificial knee joint).\n\nThe primary objective is to determine if acute distal femur replacement improves knee pain and functional outcomes compared to surgical fixation. Secondary outcomes are mortality, reoperation, complications, post-operative pain and quality of life. A health economic analysis will be conducted to assess the cost-effectiveness of both treatments.\n\nA total of 148 patients (74\u002Fgroup) will be enrolled in the study.",[27,28,29],"Distal Femur Fracture","Periprosthetic Fracture Around Prosthetic Joint Implant Knee","Knee Fracture",[31,32,33,34],"Periprosthetic Distal Femur fracture","Knee replacement","Surgical fixation","Geriatric patients","RECRUITING","2025-12-10",{"date":38,"type":39},"2025-12-18","ACTUAL",{"date":41,"type":39},"2025-10-17",{"date":43,"type":21},"2032-12-10",{"name":45,"class":46},"Unity Health Toronto","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":22,"phases":59,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":4},"100556477","weight-bearing-ct-periprosthetic-distal-knee-fractures-100556477","NCT06525610","Weight-Bearing CT Periprosthetic Distal Knee Fractures","Assessment of Bone Displacement Under Loading Following Periprosthetic Fracture Repair With Weight-Bearing CT","Inclusion Criteria:\n\n* Recently underwent revision surgery for repair of a distal femur fracture surgery for total knee arthroplasty femoral component using a fracture fixation plate. Due to the study requiring the potential participant to be scanned \\\u003C1-week post-operation, the duration of \"recently\" will be defined as \\\u003C1 week post-operation.\n* Age 50-90 years\n* Body mass index up to 40kg\u002Fm2\n* Able to provide informed consent\n* Able and willing to do study assessments and follow instructions\n\nExclusion Criteria:\n\n* Prior revision surgery on the targeted knee\n* Does not understand English\n* Undergoing and\u002For have undergone revision surgery for any other indication\n* Received intramedullary nail or distal femur replacement\n* Cannot independently stand on one leg in the weight-bearing CT during the inducible displacement exam","50 Years","90 Years",{"count":58,"type":21},21,[24],"Total knee arthroplasty (TKA), a knee implant surgery, is a treatment for end-stage knee osteoarthritis. In some cases, patients suffer an associated periprosthetic fracture, a broken bone that occurs around the implant of a TKA, they may not receive excellent care due to a lack of a trustworthy assessments for fracture healing in the research world. The prevalence of TKA surgeries is increasing annually and is expected to increase further due to an ageing population and obesity issue. By extension to this primary surgery, more Canadians will require an invasive revision surgery that risks patient morbidity and mortality. Thus, it is important to set a standard for fracture stabilization and bone healing assessments to lessen revision burdens and improve patient outcomes. CT imaging is the main clinical tool to evaluate implant stabilization in TKA, which can effectively visualize areas of incomplete bone ingrowth, bone growing into the implant, that may be hidden from overlapping bone and muscle tissue on plain x-rays. The purpose of this prospective study is to examine the efficacy of weight-bearing CT as a diagnostic tool for 21 participants who experienced a distal femur periprosthetic fracture and have underwent revision surgery using a fracture fixation plate and screws, internal splints that hold the bone pieces together. Participants will be scanned under loaded (applying weight on limb) and unloaded conditions. Radiographic outcomes, x-ray imaging from the weight-bearing CT, will be evaluated, including any movement of the bone segments and how they would relate to participants' reports of pain.",[28],"NOT_YET_RECRUITING","2024-07-24",{"date":65,"type":39},"2024-07-29",{"date":67,"type":21},"2024-08",{"date":69,"type":21},"2025-08",{"name":71,"class":46},"London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's"]