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 range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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.
. 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;