Magnesium-Titanium Hybrid Intramedullary Nail System For Long Bone Fractures
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorHuaMg Perfection Med Tech (Suzhou) Co., Ltd.
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Magnesium-Titanium Hybrid Intramedullary Nail System
- Commercially Locked Metallic Intramedullary Nail
Treatment groups
160 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov