Magnesium-Titanium Hybrid Intramedullary Nail System For Long Bone Fractures (NCT07569575) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Magnesium-Titanium Hybrid Intramedullary Nail System For Long Bone Fractures
China160 participantsStarted 2026-05-01
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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;
What they're measuring
1
Effective rate of the product at 180 days postoperatively
Timeframe: 180±14 days postoperatively
Trial details
NCT IDNCT07569575
SponsorHuaMg Perfection Med Tech (Suzhou) Co., Ltd.