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Clinical Trials in China / NCT07569575
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Magnesium-Titanium Hybrid Intramedullary Nail System For Long Bone Fractures

NCT07569575 · tracked via the Priya Life Science China tracker
Sponsor
HuaMg Perfection Med Tech (Suzhou) Co., Ltd.
Phase
Not applicable
Started
2026-05-01
Last updated
2026-05-06

Condition(s) studied

Tibial FractureFemoral FractureHumeral Fracture

Investigational drug(s) / intervention(s)

Magnesium-Titanium Hybrid Intramedullary Nail SystemCommercially Locked Metallic Intramedullary Nail

Magnesium-Titanium Hybrid Intramedullary Nail System: 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.

Commercially Locked Metallic Intramedullary Nail: 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.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: 1. Aged ≥ 18 years and ≤ 80 years (inclusive), with skeletal maturity, regardless of gender; 2. Diagnosed with long bone fractures of the extremities (including femur, tibia, humerus) requiring surgical fixation with intramedullary nail; 3. Good treatment compliance, willing and able to complete follow-up and observation as required; 4. Voluntarily participate in this trial and sign the written informed consent form. Exclusion Criteria: 1. Pregnant or lactating women, or individuals with family planning during the study period; 2. Pathological fractures (e.g., bone tumor, bone metastasis, osteomalacia), or patients with too narrow or occluded medullary cavity; 3. Patients complicated with osteomyelitis, osteofascial compartment syndrome, systemic infection or local infection at the surgical site; 4. Patients with severe bone defects requiring artificial bone or autologous bone grafting; 5. Patients with severe soft tissue or vascular injury, or previous surgical treatment at the fracture site, where intramedullary nailing may not provide stable fixation; 6. Patients without sufficient soft tissue coverage at the proposed surgical site; 7. Patients diagnosed with severe osteoporosis by the investigator based on medical history and X-ray films of the fracture site; 8. Patients requiring simultaneous use of both intramedullary nail and screw-plate system at the planned surgical site; 9. Patients with hypermagnesemia (serum magnesium \> 1.25 mmol/L (3.0 mg/dL)); 10. Patients with uncontrolled diabetes mellitus (glycated hemoglobin HbA1c ≥ 8.0%); 11. Patients with severe cardiovascular, hepatic, renal, pulmonary, hematological diseases or metabolic disorders who cannot tolerate surgery; 12. 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); 13. 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; 14. Patients with constitutions allergic to the implanted materials or known allergies; 15. Patients who have participated or are participating in any drug clinical trials within 3 months, or other medical device clinical trials within 30 days; 16. Other conditions where the investigator determines the patient is unsuitable for inclusion (e.g., metabolic bone disease, poliomyelitis sequelae, etc.).

Primary outcome measure(s)

Trial sites (5)

FacilityCityRegionStatus
Beijing Jishuitan Hospital, Capital Medical University Xicheng Beijing Municipality
Henan Luoyang Orthopedic Hospital (Henan Orthopedic Hospital) Luoyang He'Nan
Hebei Medical University Third Hospital Shijiazhuang Hebei
Xi'an Honghui Hospital Xi'an Shaanxi
Shanghai Jiao Tong University Affiliated Sixth People's Hospital Xuhui Shanghai Municipality
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07569575 on ClinicalTrials.gov ↗ ← All trials in China