[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"distal-femur-fracture\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:distal-femur-fracture":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,43,68,96,118,141],{"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":28,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100368394","diffir---geriatric-distal-femur-fixation-versus-replacement-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":20,"type":21},140,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27],"Distal Femur Fracture",[29],"Distal Femur Fracture; Geriatric fracture","RECRUITING","2026-04-29",{"date":33,"type":34},"2026-05-06","ACTUAL",{"date":36,"type":34},"2021-10-01",{"date":38,"type":21},"2028-12-31",{"name":40,"class":41},"Unity Health Toronto","OTHER",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":17,"minAge":50,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":54,"conditions":55,"keywords":56,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":42},"100614482","carbo-fix-lateral-plate-devices-and-standard-plate-nail-constructs-in-distal-femur-fractures-100614482","NCT07280169","Carbo-fix Lateral Plate Devices and Standard Plate-Nail Constructs in Distal Femur Fractures","Identifying Non-Union Rates Using Carbo-fix Lateral Plate Devices and Standard Plate-Nail Construct in Distal Femur Fractures","Inclusion Criteria:\n\n* Adult patients, 18 years or older, with a distal femur fracture requiring surgery\n* Adult patients able to understand and sign the consent and answer PROs\n\nExclusion Criteria:\n\n* Age under 18 years\n* Currently pregnant or breastfeeding (patient will simply be asked pregnancy status)\n* Unable to give consent\n* Prisoner\n* Mentally disabled","18 Years",{"count":52,"type":21},100,[24],"The purpose of this randomized clinical trial is to decrease non-union rates in distal femur fracture fixation. Carbo-fix lateral femur plate and standard intramedullary nail-plate constructs have been shown to have lower non-union rates. With decreased non-union rates, re-operation rates will decrease, leading to improved patient outcomes and clinical care. This study will randomize patients to one of the two groups. Then investigators will be collecting data on the standard plate and nail combination and compare outcomes with the Carbofix plate to see differences in union rates. All procedures are currently standard of care and no procedures are research only.",[27],[27,57,58],"Carbofix","Plate-Nail Construct","2026-02-12",{"date":61,"type":34},"2026-02-17",{"date":63,"type":34},"2026-01-29",{"date":65,"type":21},"2029-12-01",{"name":67,"class":41},"University of Missouri-Columbia",{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":76,"targetDuration":4,"studyType":22,"phases":78,"briefSummary":79,"conditions":80,"keywords":83,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":42},"100501170","pdiffir-geriatric-periprosthetic-distal-femur-fixation-versus-replacement-100501170","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",{"count":77,"type":21},148,[24],"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.",[27,81,82],"Periprosthetic Fracture Around Prosthetic Joint Implant Knee","Knee Fracture",[84,85,86,87],"Periprosthetic Distal Femur fracture","Knee replacement","Surgical fixation","Geriatric patients","2025-12-10",{"date":90,"type":34},"2025-12-18",{"date":92,"type":34},"2025-10-17",{"date":94,"type":21},"2032-12-10",{"name":40,"class":41},{"id":97,"slug":98,"hasResults":11,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":4,"eligibilityCriteria":102,"healthyVolunteers":11,"sex":17,"minAge":103,"maxAge":104,"enrollmentInfo":105,"targetDuration":4,"studyType":22,"phases":106,"briefSummary":107,"conditions":108,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":42},"100500125","distal-femur-fx-orifopen-reduction-and-internal-fixation-vs-dfr-distal-femur-replacement-total-knee-arthroplasty-100500125","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)","55 Years","100 Years",{"count":52,"type":21},[24],"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)",[27],"2025-07-29",{"date":111,"type":34},"2025-07-31",{"date":113,"type":34},"2023-04-12",{"date":115,"type":21},"2029-04-01",{"name":117,"class":41},"University of Florida",{"id":119,"slug":120,"hasResults":11,"nctId":121,"briefTitle":122,"officialTitle":123,"acronym":4,"eligibilityCriteria":124,"healthyVolunteers":125,"sex":17,"minAge":50,"maxAge":4,"enrollmentInfo":126,"targetDuration":4,"studyType":22,"phases":128,"briefSummary":129,"conditions":130,"keywords":4,"overallStatus":131,"whyStopped":4,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":4},"100578095","early-weight-bearing-in-distal-femur-fractures-100578095","NCT06806839","Early Weight Bearing in Distal Femur Fractures","Early Weight Bearing in Distal Femoral Fractures, Dual Plating Versus Single Lateral Plating: a Randomized Controlled Study","Inclusion Criteria:\n\n* Skeletally mature patients.\n* Distal femur fracture type A2, A3, C1, C2 by X-ray (Arbeitsgemeinschaft für Osteosynthesefragen classification).\n* Injury Severity Score below 15.\n* Controlled comorbidities.\n* Fresh fractures: within 3 weeks of trauma.\n\nExclusion Criteria:\n\n* Distal femur fractures type A1, B, C3 and A2 if there is a medial wedge.\n* Open fracture grade 3 Gustilo Anderson Classification.",true,{"count":127,"type":21},34,[24],"Assessment of the effect of double plating and single lateral plating on early weight bearing as a primary outcome and improving union and decreasing complications as secondary outcomes.",[27],"NOT_YET_RECRUITING","2025-01-28",{"date":134,"type":34},"2025-02-04",{"date":136,"type":21},"2025-02-01",{"date":138,"type":21},"2027-03-01",{"name":140,"class":41},"Assiut University",{"id":142,"slug":143,"hasResults":11,"nctId":144,"briefTitle":145,"officialTitle":146,"acronym":4,"eligibilityCriteria":147,"healthyVolunteers":11,"sex":17,"minAge":50,"maxAge":4,"enrollmentInfo":148,"targetDuration":4,"studyType":22,"phases":150,"briefSummary":151,"conditions":152,"keywords":174,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":177,"lastUpdatePostDateStruct":178,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":184,"locationsCount":42},"100522111","opioid-free-pain-treatment-in-trauma-patients-100522111","NCT06078371","Opioid-Free Pain Treatment in Trauma Patients","Peri-operative Opioid-free Analgesic Protocol for Orthopedic Trauma Patients","Inclusion Criteria:\n\n* Patient is over the age of 18 years old\n* Underwent surgical treatment for the injuries of interest (stated elsewhere) by an Orthopedic Traumatology Attending Physician at the University of Kansas Hospital\n\nExclusion Criteria:\n\n* Patients that are unable to provide informed consent due to sustaining a head injury or incoherence from narcotics given to them post-injury\n* Chronic opioid use\n* Under the age of 18 years old\n* Undergoing revision surgery\n* Did not undergo surgical fixation\n* Pregnant\u002Fnursing women\n* Vulnerable populations as defined by the University of Kansas Medical Center IRB\n* Did not experience one of the following fractures listed in D.1. above.\n* Patients with CKD and\u002For cirrhosis will be excluded from the opioid-free pain block (block 2) and will only qualify for the standard of care opioid group (Block 1)",{"count":149,"type":21},250,[24],"Analgesic drug study that will compare pain outcomes of opioid analgesia and opioid-free analgesia in post-operative orthopedic patients.",[153,154,155,27,156,157,158,159,160,161,162,163,164,165,166,167,168,169,170,171,172,173],"Femoral Neck Fractures","Intertrochanteric Fractures","Femoral Shaft Fracture","Patella Fracture","Tibial Shaft Fracture with or Without Associated Fibula Fracture","Ankle Fracture (bimalleolar Equivalent, Bimalleolar, or Trimalleolar)","Tibial Pilon Fracture","Talar Head, Neck, Body, or Process Fractures","Calcaneus Fractures","Lisfranc Injuries","Isolated or Multiple Metatarsal Fractures","Phalanx Fractures of the Foot, Single or Multiple","Clavicle Fractures","Proximal Humerus Fractures","Humeral Shaft Fractures","Distal Humerus Fractures (intra or Extra-articular)","Olecranon Fractures","Radial Head or Neck Fractures","Elbow Fractures Involving a Combination of Fractures of the Radius and Uln","Forearm Fractures (both Bone Forearm Fractures, Isolated Ulnar Shaft, Isolated Radial Shaft)","Distal Radius Fractures",[175,176],"Surgical Intervention","Trauma","2024-10-22",{"date":179,"type":34},"2024-10-26",{"date":181,"type":34},"2023-11-01",{"date":183,"type":21},"2026-10",{"name":185,"class":41},"University of Kansas Medical Center"]