[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100636737":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":34,"locations":40,"responsibleParty":120,"collaborators":25,"id":122,"slug":123,"hasResults":124,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":25,"eligibilityCriteria":128,"healthyVolunteers":124,"sex":129,"minAge":130,"maxAge":131,"enrollmentInfo":132,"targetDuration":25,"studyType":135,"phases":136,"briefSummary":138,"conditions":139,"keywords":143,"overallStatus":148,"whyStopped":25,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":158},{"fullName":5,"class":6},"HuaMg Perfection Med Tech (Suzhou) Co., Ltd.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Magnesium-Titanium Hybrid Intramedullary Nail System","EXPERIMENTAL","Indicated for intramedullary fixation and fracture healing promotion in humeral, femoral, and tibial diaphyseal, proximal, and distal extremity fractures during orthopedic surgery.",[13],"Device: Magnesium-Titanium Hybrid Intramedullary Nail System",{"label":15,"type":16,"description":17,"interventionNames":18},"Commercially Locked Metallic Intramedullary Nail","ACTIVE_COMPARATOR","Indicated for internal fixation of long bone fractures of the extremities.",[19],"Device: Commercially Locked Metallic Intramedullary Nail",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","The magnesium-titanium hybrid intramedullary nail system is inserted into the medullary canal through the proximal or distal end of the bone via standard intramedullary fixation surgical procedures, achieving fixation of the fracture site through intramedullary stabilization. This device provides load-sharing fixation for the fracture. The titanium alloy main body of the product delivers continuous, reliable mechanical support to ensure the overall stability of fracture fixation. The biodegradable magnesium components gradually degrade in vivo, releasing magnesium ions that participate in regulating the local bone repair microenvironment, thereby synergistically supporting the fracture healing process.",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"This is a commercially available locked metallic intramedullary nail manufactured by Double Medical Technology Inc., with the National Medical Products Administration (NMPA) registration certificate number: NMPA 20153131195. It is selected as the control device based on the following: 1) Double Medical is a leading orthopedic enterprise in China, and its products are widely used clinically with proven efficacy and safety; 2) The indications of the control device fully cover those of the investigational device.",[15],[30],{"name":31,"affiliation":32,"role":33},"Ling Qin, PhD","Chinese University of Hong Kong","STUDY_DIRECTOR",[35],{"name":36,"role":37,"phone":38,"phoneExt":25,"email":39},"Yuantao Zhang, PhD","CONTACT","+86 13421870043","ytzhang2008@163.com",[41,55,72,88,104],{"facility":42,"status":25,"city":43,"state":44,"zip":25,"country":45,"countryCode":46,"cosmosGeoPoint":25,"geoPoint":25,"contacts":47},"Beijing Jishuitan Hospital, Capital Medical University","Xicheng","Beijing Municipality","China","CN",[48,52],{"name":49,"role":37,"phone":50,"phoneExt":25,"email":51},"Maoqi Gong, PhD","+86 10 58517080","jst2603@126.com",{"name":53,"role":54,"phone":25,"phoneExt":25,"email":25},"Xieyuan Jiang, PhD","PRINCIPAL_INVESTIGATOR",{"facility":56,"status":25,"city":57,"state":58,"zip":25,"country":45,"countryCode":46,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"Henan Luoyang Orthopedic Hospital (Henan Orthopedic Hospital)","Luoyang","He'Nan",{"type":60,"coordinates":61},"Point",[62,63],112.43684,34.67345,{"lat":63,"lon":62},[66,70],{"name":67,"role":37,"phone":68,"phoneExt":25,"email":69},"Yunlong Liu, MD","+86 18037786581","liuyunlongboa@163.com",{"name":71,"role":54,"phone":25,"phoneExt":25,"email":25},"Yanchun Shang, PhD",{"facility":73,"status":25,"city":74,"state":75,"zip":25,"country":45,"countryCode":46,"cosmosGeoPoint":76,"geoPoint":80,"contacts":81},"Hebei Medical University Third Hospital","Shijiazhuang","Hebei",{"type":60,"coordinates":77},[78,79],114.47861,38.04139,{"lat":79,"lon":78},[82,86],{"name":83,"role":37,"phone":84,"phoneExt":25,"email":85},"Kuo Zhao, MD","+86 18033832759","surgeonchenwei@126.com",{"name":87,"role":54,"phone":25,"phoneExt":25,"email":25},"Wei Chen, PhD",{"facility":89,"status":25,"city":90,"state":91,"zip":25,"country":45,"countryCode":46,"cosmosGeoPoint":92,"geoPoint":96,"contacts":97},"Xi'an Honghui Hospital","Xi'an","Shaanxi",{"type":60,"coordinates":93},[94,95],108.92861,34.25833,{"lat":95,"lon":94},[98,102],{"name":99,"role":37,"phone":100,"phoneExt":25,"email":101},"Pengfei Wang, MD","+86 13759994007","pengfei_wang@163.com",{"name":103,"role":54,"phone":25,"phoneExt":25,"email":25},"Kun Zhang, PhD",{"facility":105,"status":25,"city":106,"state":107,"zip":25,"country":45,"countryCode":46,"cosmosGeoPoint":108,"geoPoint":112,"contacts":113},"Shanghai Jiao Tong University Affiliated Sixth People's Hospital","Xuhui","Shanghai Municipality",{"type":60,"coordinates":109},[110,111],121.44709,31.19594,{"lat":111,"lon":110},[114,118],{"name":115,"role":37,"phone":116,"phoneExt":25,"email":117},"Hongyi Zhu, PhD","+86 021 64369181","420308955@qq.com",{"name":119,"role":54,"phone":25,"phoneExt":25,"email":25},"Changqing Zhang, PhD",{"type":121,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","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":133,"type":134},160,"ESTIMATED","INTERVENTIONAL",[137],"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.",[140,141,142],"Tibial Fracture","Femoral Fracture","Humeral Fracture",[144,145,146,147],"Magnesium-Titanium Hybrid Intramedullary Nail","Long Bone Fractures of the Extremities","Intramedullary Nailing","Biodegradable Magnesium Implant","NOT_YET_RECRUITING","2026-04-29",{"date":151,"type":152},"2026-05-06","ACTUAL",{"date":154,"type":134},"2026-05-01",{"date":156,"type":134},"2027-12-31",{"name":5,"class":6},5]