Magnesium-Titanium Hybrid Intramedullary Nail System For Long Bone Fractures

Starting soon · Not applicable

Conditions studied: Tibial Fracture, Femoral Fracture, Humeral Fracture

In brief

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.

Key facts

Study ID

NCT07569575

Run by

HuaMg Perfection Med Tech (Suzhou) Co., Ltd.

People needed

160

Starts

2026-05-01

Expected to finish

2027-12-31

Last updated by the study team

2026-05-06

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Aged ≥ 18 years and ≤ 80 years (inclusive), with skeletal maturity, regardless of gender;
• Diagnosed with long bone fractures of the extremities (including femur, tibia, humerus) requiring surgical fixation with intramedullary nail;
• Good treatment compliance, willing and able to complete follow-up and observation as required;
• Voluntarily participate in this trial and sign the written informed consent form.

You may not qualify if…

• Pregnant or lactating women, or individuals with family planning during the study period;
• Pathological fractures (e.g., bone tumor, bone metastasis, osteomalacia), or patients with too narrow or occluded medullary cavity;
• Patients complicated with osteomyelitis, osteofascial compartment syndrome, systemic infection or local infection at the surgical site;
• Patients with severe bone defects requiring artificial bone or autologous bone grafting;
• Patients with severe soft tissue or vascular injury, or previous surgical treatment at the fracture site, where intramedullary nailing may not provide stable fixation;
• Patients without sufficient soft tissue coverage at the proposed surgical site;
• Patients diagnosed with severe osteoporosis by the investigator based on medical history and X-ray films of the fracture site;
• Patients requiring simultaneous use of both intramedullary nail and screw-plate system at the planned surgical site;
• Patients with hypermagnesemia (serum magnesium > 1.25 mmol/L (3.0 mg/dL));
• Patients with uncontrolled diabetes mellitus (glycated hemoglobin HbA1c ≥ 8.0%);
• Patients with severe cardiovascular, hepatic, renal, pulmonary, hematological diseases or metabolic disorders who cannot tolerate surgery;
• 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);
• 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;
• Patients with constitutions allergic to the implanted materials or known allergies;
• Patients who have participated or are participating in any drug clinical trials within 3 months, or other medical device clinical trials within 30 days;
• Other conditions where the investigator determines the patient is unsuitable for inclusion (e.g., metabolic bone disease, poliomyelitis sequelae, etc.).

Where it is running

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

Full record on ClinicalTrials.gov

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