[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"femoral-fracture\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:femoral-fracture":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,48,76,100,123,142,168,191,216],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"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},"100636737","magnesium-titanium-hybrid-intramedullary-nail-system-for-long-bone-fractures-100636737",false,"NCT07569575","Magnesium-Titanium Hybrid Intramedullary Nail System For Long Bone Fractures","A Prospective, Multicenter, Randomized, Controlled, Non-inferiority Clinical Trial to Evaluate the Safety and Effectiveness of the Magnesium-titanium Hybrid Intramedullary Nail System in Treating Long Bone Fractures of the Extremities","Inclusion Criteria:\n\n1. Aged ≥ 18 years and ≤ 80 years (inclusive), with skeletal maturity, regardless of gender;\n2. Diagnosed with long bone fractures of the extremities (including femur, tibia, humerus) requiring surgical fixation with intramedullary nail;\n3. Good treatment compliance, willing and able to complete follow-up and observation as required;\n4. Voluntarily participate in this trial and sign the written informed consent form.\n\nExclusion Criteria:\n\n1. Pregnant or lactating women, or individuals with family planning during the study period;\n2. Pathological fractures (e.g., bone tumor, bone metastasis, osteomalacia), or patients with too narrow or occluded medullary cavity;\n3. Patients complicated with osteomyelitis, osteofascial compartment syndrome, systemic infection or local infection at the surgical site;\n4. Patients with severe bone defects requiring artificial bone or autologous bone grafting;\n5. Patients with severe soft tissue or vascular injury, or previous surgical treatment at the fracture site, where intramedullary nailing may not provide stable fixation;\n6. Patients without sufficient soft tissue coverage at the proposed surgical site;\n7. Patients diagnosed with severe osteoporosis by the investigator based on medical history and X-ray films of the fracture site;\n8. Patients requiring simultaneous use of both intramedullary nail and screw-plate system at the planned surgical site;\n9. Patients with hypermagnesemia (serum magnesium \\> 1.25 mmol\u002FL (3.0 mg\u002FdL));\n10. Patients with uncontrolled diabetes mellitus (glycated hemoglobin HbA1c ≥ 8.0%);\n11. Patients with severe cardiovascular, hepatic, renal, pulmonary, hematological diseases or metabolic disorders who cannot tolerate surgery;\n12. Patients with previous or concurrent malignant tumors (excluding those cured and disease-free survival for more than 5 years, such as basal cell carcinoma of the skin, cervical carcinoma in situ, and papillary thyroid carcinoma);\n13. Patients who have received radiotherapy, chemotherapy, growth factors, immunosuppressants, systemic corticosteroids, long-term (continuous use for more than 3 months) sedative-hypnotics, non-steroidal anti-inflammatory drugs, or bisphosphonates within 6 months prior to screening;\n14. Patients with constitutions allergic to the implanted materials or known allergies;\n15. Patients who have participated or are participating in any drug clinical trials within 3 months, or other medical device clinical trials within 30 days;\n16. Other conditions where the investigator determines the patient is unsuitable for inclusion (e.g., metabolic bone disease, poliomyelitis sequelae, etc.).","ALL","18 Years","80 Years",{"count":20,"type":21},160,"ESTIMATED","INTERVENTIONAL",[24],"NA","This is a prospective, multicenter, randomized, controlled, non-inferiority clinical trial designed to evaluate the safety and effectiveness of the magnesium-titanium hybrid intramedullary nail system compared with the marketed metal locked intramedullary nail in the treatment of long bone fractures of the extremities.",[27,28,29],"Tibial Fracture","Femoral Fracture","Humeral Fracture",[31,32,33,34],"Magnesium-Titanium Hybrid Intramedullary Nail","Long Bone Fractures of the Extremities","Intramedullary Nailing","Biodegradable Magnesium Implant","NOT_YET_RECRUITING","2026-04-29",{"date":38,"type":39},"2026-05-06","ACTUAL",{"date":41,"type":21},"2026-05-01",{"date":43,"type":21},"2027-12-31",{"name":45,"class":46},"HuaMg Perfection Med Tech (Suzhou) Co., Ltd.","INDUSTRY",5,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":55,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":75},"100519985","phase-2-essential-amino-acid-supplementation-for-femoral-fragility-fractures-100519985","NCT06050668","Essential Amino Acid Supplementation for Femoral Fragility Fractures","MEND Repair & Recover Clinical Trial","Inclusion Criteria:\n\n* Hospital inpatient\n* Age ≥ 65 years old on admission\n* Low-energy mechanism of injury\n* Diagnosis of femur fracture (OTA 31, 32, or 33 fracture)\n* Indicated for surgical fixation\n* Able to provide informed consent\n\nExclusion Criteria:\n\n* Part of a vulnerable population (ex: Incarcerated, Non-English speaking)\n* Cognitive impairment (MMSE score ≤ 17)\n* Electrical medical implant (ex: Pacemaker\u002FDefibrillator, Left Ventricular Assist Device, Cochlear implant, Insulin pump, Pain medication pumps, Spinal cord stimulator)\n* Non-ambulatory prior to injury\n* Inability to consume an oral diet or allergy to supplement ingredients (ex: milk allergy)\n* Concern for inability to complete follow-up\n* Hemi or total arthroplasty (joint replacement)\n* Patients with a historical diagnosis of chronic kidney disease (CKD)","65 Years",{"count":57,"type":21},60,[59],"PHASE2","This trial will evaluate the impact of 4 weeks of postoperative essential amino acid (EAA)-based supplementation on muscle morphology after femoral fragility fracture. This trial will assess the ability of EAA-based to increase skeletal muscle metabolic activity, reduce inflammation, and induce muscle fiber hypertrophy, as well as preserve skeletal muscle mass and physical performance up to 6 months after injury. Participants will be randomized in a 1:1 ratio to 1) standard of care (no dietary intervention) or 2) EAA-based supplementation.",[28,62,63],"Fragility Fracture","Muscle Atrophy","RECRUITING","2026-04-14",{"date":67,"type":39},"2026-04-15",{"date":69,"type":39},"2024-06-17",{"date":71,"type":21},"2026-12",{"name":73,"class":74},"Michael C Willey","OTHER",2,{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":16,"minAge":83,"maxAge":84,"enrollmentInfo":85,"targetDuration":4,"studyType":22,"phases":87,"briefSummary":88,"conditions":89,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":99},"100400472","a-study-to-verify-if-the-surgery-for-the-proximal-femur-fracture-can-be-improved-with-the-help-of-a-navigation-system-100400472","NCT04494672","A Study to Verify if the Surgery for the Proximal Femur Fracture Can be Improved With the Help of a Navigation System","Improving Intramedullary Nailing of Proximal Femoral Fractures Through a Navigation Assisted Technique: a Double Blinded Randomized Control Trial","Inclusion Criteria:\n\n* Patients undergoing unilateral primary intramedullary nailing at the Ospedale Regionale di Lugano.\n* Patients aged 50-85 years old.\n* Patients with a BMI \\>18 and \\\u003C35.\n* Patients able to provide informed consent and follow all the study procedures as indicated by the protocol.\n* Radiological evidence of proximal fracture of the femur, AO classified as 31 A1.3, 31 A2.1, 31 A2.2, 31 A2.3, 31 A3.1, 31 A3.2, 31 A3.3.\n\nExclusion Criteria:\n\n* Other clinically significant concomitant disease states (e.g. renal failure, major hepatic dysfunction, life-threatening cardiovascular disease, etc..).\n* Known or suspected non-compliance, drug or alcohol abuse.\n* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant.\n* Previous enrolment into the current study.\n* Enrolment of the investigator, his\u002Fher family members, employees and other dependent persons.","50 Years","85 Years",{"count":86,"type":21},96,[24],"The ADAPT system is a software that calculate a virtual 3D reconstruction of the femoral head without additional radiation. It automatically detects the used implant and its position relative to the femoral head, helping the surgeon to achieve an optimal proximal screw positioning in the femoral head. The investigators want to verify if with the addition of the ADAPT system the investigators can improve screw placement and reduce surgery time and radiation exposure.",[28],"2026-03-03",{"date":92,"type":39},"2026-03-05",{"date":94,"type":39},"2020-09-28",{"date":96,"type":21},"2026-08-01",{"name":98,"class":74},"Christian Candrian",1,{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":4,"eligibilityCriteria":106,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":107,"targetDuration":4,"studyType":108,"phases":4,"briefSummary":109,"conditions":110,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":99},"100490596","a-case-series-trumatch-graft-cage-for-segmental-long-bone-defects-100490596","NCT05668182","A Case Series: TRUMATCH Graft Cage for Segmental Long Bone Defects","Early Outcomes Utilizing the TRUMATCH Graft Cage for Segmental Long Bone Defects: A Case Series","Inclusion Criteria:\n\n* Humerus, femur, or tibia segmental defects requiring surgery\n* Evaluation and treatment at UCSD\n* Ages 18 year and older\n* Abiltiy to understand the content of the patient information\u002Finformed consent form\n\nExclusion Criteria:\n\n* Any not medically managed severe systemic disease\n* Their doctor has decided that it is in the patient's best interest to receive a different method of repair\n* Their doctor has determined that the patient has a condition that would make them unsuitable for participation in the study\n* Pregnancy or women planning to conceive within the subject participation period (1 year) note: pregnancy will be self-reported and no test will be performed to test for it\n* Prisoner\n* Participation in any other pharmacologic or medicinal product study within the previous month that could influence the results of this study.",{"count":47,"type":21},"OBSERVATIONAL","This project consists of a prospective case design. Study candidates will include all patients ages 18 and over who were evaluated at UCSD and found to have a critical-sized humerus, femur, or tibia segmental defect that would be fixed through surgery. Patients who consent to study participation will receive the TRUMATCH Graft Cage for their long bone segmental defect repair. Data on healing rates, complication rates, re-operation rates, time to return to normal activity, and pain levels will be collected for each participation. After 3 years of data collection, we will analyze this data to provide further insight on the utility of the TRUMATCH Graft Cage. Given the significant difficulty with repairing segmental long bone defects, it is imperative to evaluate novel systems to appropriately manage these injuries.",[111,112,28,113],"Tibia Fracture","Humerus Fracture","Long Bone Segmental Defect","2026-02-05",{"date":116,"type":39},"2026-02-09",{"date":118,"type":39},"2021-06-29",{"date":120,"type":21},"2026-06-29",{"name":122,"class":74},"University of California, San Diego",{"id":124,"slug":125,"hasResults":11,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":4,"eligibilityCriteria":129,"healthyVolunteers":130,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":131,"targetDuration":4,"studyType":22,"phases":133,"briefSummary":134,"conditions":135,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":136,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":99},"100491581","retrograde-femoral-nail-advanced-outcomes-for-fixation-of-distal-femur-and-femoral-shaft-fractures-100491581","NCT05680987","Retrograde Femoral Nail-Advanced Outcomes for Fixation of Distal Femur and Femoral Shaft Fractures","Utilizing the Retrograde Femoral Nail-Advanced for Fixation of Distal Femur and Femoral Shaft Fractures: A Prospective Case Series","Inclusion Criteria:\n\n* Distal femur or femoral shaft fracture requiring surgery\n* Evaluation and treatment at UCSD\n* Age 18 years or older\n* Ability to understand the content of the patient information\u002FInformed Consent Form\n* Signed and dated IRB-approved written informed consent\n\nExclusion Criteria:\n\n* Any not medically managed severe systemic disease\n* their doctor has decided that it is in the patient's best interest to receive a different method of fixation\n* Their doctor has determined that the patient has a condition that would make them unsuitable for participation in the study\n* Pregnancy or women planning to conceive within the subject participation period (1 year) note: pregnancy will be self-reported and no test will be performed to test for it\n* Prisoner\n* Participation in any other pharmacologic or medicinal product study within the previous month that could influence the results of this study",true,{"count":132,"type":21},40,[24],"This project consists of a prospective and retrospective case series design. Study candidates will include all patients 18 years or older, who were evaluated at UCSD and found to have a distal femur or femoral shaft fracture requiring surgical fixation. Patients who consent to study participation will recieve the RFN-advanced Retrograde Femoral Nailing System implant for fracture fixation. Data on functional status, healing rates, complication rates, and pain levels will be collected for each participant. After 3 years of data collection, investigators will analyze this data to provide further insight on the utility of this new design of retrograde femoral nails. Given the relatively high rate of complications, such as malalignment, with current femoral nail designs, it is imperative to evaluate novel systems to appropriately manage distal femur or femoral shaft fractures.",[28],{"date":116,"type":39},{"date":138,"type":39},"2021-06-23",{"date":140,"type":21},"2026-06-23",{"name":122,"class":74},{"id":143,"slug":144,"hasResults":11,"nctId":145,"briefTitle":146,"officialTitle":147,"acronym":4,"eligibilityCriteria":148,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":149,"targetDuration":4,"studyType":108,"phases":4,"briefSummary":151,"conditions":152,"keywords":153,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":159,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":165,"locationsCount":167},"100460518","znn-bactiguard-retrograde-femoral-nails-pmcf-study-100460518","NCT05276674","ZNN Bactiguard Retrograde Femoral Nails PMCF Study","Post-Market Clinical Follow-up Study on the ZNN™ Bactiguard ® Retrograde Femoral Nails (Implants and Instrumentation)","Inclusion Criteria:\n\n* Patients must be 18 years or older.\n* Patient must have a femoral fracture (open, closed, monolateral or bilateral) requiring surgical intervention and be eligible for fixation by intramedullary nailing. Patients with delayed treatment (initial treatment by external fixation due to swelling \u002F high energy trauma followed by definitive treatment by intramedullary nail) can also be included.\n* Patient has been or is scheduled to be treated with the ZNN Bactiguard System Retrograde Femoral Nail.\n* Patient must be able and willing to complete the protocol required follow-up.\n* Patient must have a signed EC approved consent.\n* Patients capable of understanding the surgeon's explanations and following his instructions.\n\nExclusion Criteria:\n\n* Skeletally immature patients\n* A medullary canal obliterated by a previous fracture or tumor\n* Bone shaft having excessive bow or a deformity\n* Lack of bone substance or bone quality, which makes stable seating of the implant impossible\n* All concomitant diseases that can impair the operation, functioning or the success of the implant\n* Insufficient blood circulation\n* Infection\n* Patient is unwilling or unable to give consent.\n* Patient is a vulnerable subject (prisoner, mentally incompetent or unable to understand what participation to the study entails, alcohol\u002Fdrug addiction, known to be pregnant or breast feeding).\n* Patient anticipated to be non-compliant and\u002For likely to have problems with maintaining follow-up program (e.g. patient with no fixed address, long distance, plans to move during course of study).\n* Not expected to survive the duration of the follow-up program",{"count":150,"type":21},100,"Post-market clinical follow-up (PMCF) study to confirm the safety, performance, and clinical benefits of the intra-medullary retrograde femoral nail Zimmer Natural Nail (ZNN) Bactiguard (implants and instrumentation) when used for the temporary internal fixation and stabilization of femoral fractures.",[28],[154,155,156,157],"Bactiguard","Femur fracture","Intramedullary nailing","Infection control","2026-02-02",{"date":160,"type":39},"2026-02-03",{"date":162,"type":39},"2023-10-23",{"date":164,"type":21},"2027-12",{"name":166,"class":46},"Zimmer Biomet",4,{"id":169,"slug":170,"hasResults":11,"nctId":171,"briefTitle":172,"officialTitle":173,"acronym":174,"eligibilityCriteria":175,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":176,"targetDuration":4,"studyType":22,"phases":178,"briefSummary":179,"conditions":180,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":181,"lastUpdatePostDateStruct":182,"startDateStruct":184,"completionDateStruct":186,"leadSponsor":188,"locationsCount":190},"100445994","study-of-the-effectiveness-of-a-polymer-cerclage-system-compared-to-cerclages-used-in-standard-care-cercpmcf--100445994","NCT05087667","Study of the Effectiveness of a Polymer Cerclage System Compared to Cerclages Used in Standard Care (CERCPMCF) )","Outcomes of Adjuvant \"Polymer Cerclage System \"OrthoLoop\" to Manage Prosthetic Rehabilitation, Per Prosthetic or Primary Femoral and Humeral Fractures. A Prospective , Multicentric, Simple Blind , Comparative, Non-inferiority Study, Compared to Cerclage Systems Used in Standard Care.","SERRE","Inclusion Criteria:\n\n* patient with femoral or humeral fracture requiring the installation of one or more cerclage(s) and respecting at least one of the criteria below:\n* Primary femoral or humeral fractures (diaphyseal, metaphyseal, epiphyseal proximal or distal) with osteosynthesis by plate and screw or osteosynthesis by Intramedullary nailing associated with the installation of one or more cerclage(s)\n* Patients with traumatic fracture of femur or humerus that required prosthetic rehabilitation associated with the installation of one or more cerclage(s)\n* Peri-prosthetic fracture of the femur or humerus\n* Resumption of prosthesis (hip, knee, shoulder, elbow) requiring the installation of one or more cerclages\n* who underwent fixation with cerclage wiring (Sterile Self Locking Polymer Cerclage System or other cerclage systems used in standard care)\n* age ≥18 years\n* Who have given free, informed and written consent to participate in the study\n* Patient able to communicate in French\n* Patient affiliated to a social security system or entitled to a social security system\n\nExclusion Criteria:\n\n* high-energy injury,\n* associated damage to other long bones,\n* fracture extension to the articular surface with displacement\n* Severe disease that could interfere with the study results or be life threatening\n* Patients with an infection\n* Allergy to any component of the medical products\n* Pregnant or breastfeeding women\n* Anticipated unavailability during the study\n* Participation in a clinical trial within 3 months prior to the inclusion visit.\n* Patient with linguistic or psychological incapacity to understand and sign the informed consent.\n* Patient deprived of liberty by administrative or judicial decision, or being under guardianship.",{"count":177,"type":21},202,[24],"The use of cerclage wiring in the management of long bone fractures is common. With the increase in the placement of total hip ans shoulder prostheses, the occurrence of peri-prosthetic hip an shoulder fractures is also increasing, notably due to an older population.\n\nWhether it is for a fracture on a native femur or humerus, or on a periprosthetic hip or shoulder fracture, the use of cerclage wiring is an adjuvant additional but not the main means to ensure stable osteosynthesis, allowing re-loading and early rehabilitation of patients. This method has demonstrated its ability to improve the fixation of this fracture type, associated with osteosynthesis or hip\u002Fshoulder prosthesis revision surgery. However, metal cerclage expose to a risk of metallosis which can compromise bone fusion, injury to neighboring soft parts causing pain and also injury to the surgical team when handling them. More recently, non-metallic cerclage have been developed and could overcome certain risks associated with metallic cerclage, while ensuring their bone fixing capacity and therefore bone consolidation. Indeed, non-metallic cerclage could withstand similar or even greater stresses than metallic cables, in particular concerning their resistance to rupture.\n\nThe \"Sterile Self Locking Polymer Cerclage System\" named OrthoLoop is a polymer cerclage which has been developed and could be used in these indications.\n\nThus, this study (SERRE) aims to investigate the clinical results and sequelae of adjuvant cerclage wires OrthoLoop Cerclage in the management of rehabilitation, per prosthetic or primary femoral or humeral fractures compared with cerclages system used in standard care.\n\nSERRE is a 36 months follow up study in two arms :\n\n* Experimental group: \"OrthoLoop cercalge\"\n* Control group: \"cerclages used in standard care\" After each surgery, the patient follow-up period is 36 months. with 4 planned consultation visits after surgery at 6-8 weeks, 3, 6 and 36 months, with collection and measurement of the endpoints.\n\nThe main objective of this study is to assess the role of \"OrthoLoop cerclage\" of COUSIN Biotech in comparison with cerclages (metallic for the majority) used in standard care ; in the optimization of the consolidation of primary and periprosthetic femoral or humeral fractures, 6 months after surgery.",[28],"2025-03-18",{"date":183,"type":39},"2025-03-20",{"date":185,"type":39},"2022-03-08",{"date":187,"type":21},"2028-12",{"name":189,"class":46},"Quanta Medical",15,{"id":192,"slug":193,"hasResults":11,"nctId":194,"briefTitle":195,"officialTitle":196,"acronym":4,"eligibilityCriteria":197,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":198,"targetDuration":4,"studyType":22,"phases":200,"briefSummary":201,"conditions":202,"keywords":203,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":207,"lastUpdatePostDateStruct":208,"startDateStruct":210,"completionDateStruct":212,"leadSponsor":214,"locationsCount":167},"100470801","fracture-monitor---femur-100470801","NCT05410587","Fracture Monitor - Femur","Prospective First in Human Clinical Investigation to Evaluate the Safety of the Fracture Monitor T1 in Patients with Femur Fractures Treated with a Locking Compression Plate","Inclusion Criteria:\n\n* Age 18 years or older\n* Closed growth plates at time of injury\n* Femoral fracture requiring osteosynthesis and treated with one of the following plates:\n\n  * DePuy Synthes LCP® 4.5\u002F5, Broad\n  * DePuy Synthes LCP® 4.5\u002F5, Broad Curved\n  * DePuy Synthes LCP® Condylar Plate 4.5\u002F5.0\n  * DePuy Synthes VA-LCP® Condylar Plate 4.5\u002F5.0\n  * DePuy Synthes LCP® Distal Femur\n  * DePuy Synthes LCP® Proximal Femoral Plate 4.5\u002F5.0\n  * DePuy Synthes LCP® Proximal Femur Hook Plate\n  * 41medical AG, Biphasic Plate DF\n* ASA score 1-3\n* Full weight-bearing capacity prior to the injury\n* The patient is foreseen to be capable of postoperative weight bearing of at least 15 kg\n* Willingness to undergo an additional surgery to remove the Fracture Monitor T1 if its removal is not done together with the fixation plate within two years according to standard of care\n* Ability to provide written informed consent\n\nPreoperative exclusion Criteria:\n\n* Concomitant fractures in the contralateral leg\n* Electromagnetic hypersensitivity\n* Implanted electromagnetic bone stimulators\n* Pregnancy (determined by pregnancy test)\n* Prisoner\n* Known history of substance abuse (eg, recreational drugs and alcohol) that would preclude reliable assessments\n* Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present clinical investigation\n\nIntraoperative exclusion criteria:\n\n* Use of compression lag screw across fracture fragment\n* Compression osteosynthesis\n* Precontouring of implant at the area of the attachment of Fracture Monitor T1\n* Double-plating technique\n* Soft-tissue coverage \\> 6 cm above the data logger\n* Concurrent use of intramedullary nail\n* Patients foreseen to require magnetic resonance imaging scanning at any part of the body or shockwave therapy at the proximity of the Fracture Monitor T1\n* Fracture Monitor T1 not functional according to the instruction for use (IFU, section 24, A) and no functional replacement implant available",{"count":199,"type":21},37,[24],"Thirty-seven patients diagnosed with femoral fracture to be treated with a compatible plate will be enrolled for this multicenter prospective interventional study. The Fracture Monitor T1 will be attached to the locking plate during osteosynthesis. Prior to discharge, it will be connected to an app installed either on the patients' smartphone or on the smartphone provided by the sponsor. The device will continuously collect and process data, which can automatically be downloaded via Bluetooth through the smartphone app and transferred in encrypted form to a dedicated cloud server. The smartphones will be equipped with a basic app version with rudimentary user interface that has no data visualization function. During the rehabilitation phase, data collected by the device will not be accessible to the surgeon nor the patient to ensure that no therapeutic decision will be made based on the acquired data. Every patient is treated as per standard of care.\n\nThe primary objective of the study is to collect safety information of the Fracture Monitor T1. The secondary objectives are to collect information on device performance, device handling, and usability.\n\nAll adverse events (AEs) and serious AEs (SAEs) will be recorded during the study. These will be reviewed and evaluated for their potential relationship to the device.\n\nAll patients will be followed up for 6 months after the surgery according to the local standard of care. Given that the removal of the Fracture Monitor T1 may occur beyond 6 months, a safety follow-up will take place at the time point when the Fracture Monitor T1 is removed as per the instructions for use if it has not been removed within the 6 months.\n\nThe results will be compiled into a clinical evaluation report to be submitted as part of the technical documentation for the conformity assessment procedure.",[28],[204,205,206],"Fracture fixation, internal","Femur","Fracture healing","2025-01-30",{"date":209,"type":39},"2025-02-03",{"date":211,"type":39},"2023-10-03",{"date":213,"type":21},"2026-07",{"name":215,"class":74},"AO Innovation Translation Center",{"id":217,"slug":218,"hasResults":11,"nctId":219,"briefTitle":220,"officialTitle":221,"acronym":4,"eligibilityCriteria":222,"healthyVolunteers":130,"sex":16,"minAge":223,"maxAge":224,"enrollmentInfo":225,"targetDuration":4,"studyType":108,"phases":4,"briefSummary":227,"conditions":228,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":232,"lastUpdatePostDateStruct":233,"startDateStruct":235,"completionDateStruct":237,"leadSponsor":239,"locationsCount":4},"100433020","prospective-post-market-study-examining-the-effectiveness-of-the-ecofit-100433020","NCT04918680","Prospective Post-market Study Examining the Effectiveness of the EcoFit®","Prospective Post-market Study Examining the Effectiveness of the EcoFit® Total Hip System With Implacross® E Polyethylene","Inclusion Criteria:\n\n* Subject must be a candidate for a total primary hip replacement.\n* Subject must have degenerative joint disease, including osteoarthritis or traumatic arthritis, OR a femoral fracture which can be treated by a primary hip replacement and no other hardware\n* Subject has a BMI of 40.00 kg\u002Fm2 or less at the time of enrollment\n* Subject is likely to be available for evaluation for the duration of the study\n* Subject is able and willing to sign the informed consent and follow study procedures\n* Subject is not pregnant\n\nExclusion Criteria:\n\n* Subject has had a prior hip replacement in the subject hip\n* Subject has an active cancer or is a survivor for \\\u003C5 years except for squamous cell or basal cell skin cancer\n* Subject has a chronic disease(s) where, in the opinion of the investigator, the disease will interfere with the patient's ability to follow the protocol\n* Subject is currently a documented substance abuser (alcohol or other addictions)\n* Subject has an infection, or history of infection (within the last 3 months), acute or chronic, local or systemic\n* Subject has a history of muscular, neurological or vascular deficiencies which compromise the affected extremity\n* Subject has a BMI \\> 40.00 kg\u002Fm2\n* Subject has a mental condition that may interfere with the subject's ability to give an informed consent or willingness to fulfill the study requirements (i.e., severe mental retardation such that the Subject cannot understand the informed consent process, global dementia, prior strokes that interfere with the Subject's cognitive abilities, senile dementia, and Alzheimer's Disease)\n* Subject is a prisoner\n* Subject is pregnant\n* Subject has known materials sensitivity (to metals)","40 Years","75 Years",{"count":226,"type":21},500,"The purpose of this study is to evaluate the safety and effectiveness of the EcoFit Hip with implacross E polyethylene for total hip replacement surgery.",[229,28,230,231],"Degenerative Joint Disease","Osteoarthritis, Hip","Traumatic Arthritis","2021-06-01",{"date":234,"type":39},"2021-06-09",{"date":236,"type":21},"2021-06-21",{"date":238,"type":21},"2027-03-30",{"name":240,"class":46},"Implantcast North America, LLC"]