[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"HuaMg Perfection Med Tech (Suzhou) Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":47},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"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":19,"type":20},160,"ESTIMATED","INTERVENTIONAL",[23],"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.",[26,27,28],"Tibial Fracture","Femoral Fracture","Humeral Fracture",[30,31,32,33],"Magnesium-Titanium Hybrid Intramedullary Nail","Long Bone Fractures of the Extremities","Intramedullary Nailing","Biodegradable Magnesium Implant","NOT_YET_RECRUITING","2026-04-29",{"date":37,"type":38},"2026-05-06","ACTUAL",{"date":40,"type":20},"2026-05-01",{"date":42,"type":20},"2027-12-31",{"name":44,"class":45},"HuaMg Perfection Med Tech (Suzhou) Co., Ltd.","INDUSTRY",5,""]