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 groupsLocations
5Beijing Jishuitan Hospital, Capital Medical University XichengBeijing Municipality, China
Henan Luoyang Orthopedic Hospital (Henan Orthopedic Hospital) LuoyangHe'Nan, China
Hebei Medical University Third Hospital ShijiazhuangHebei, China
Xi'an Honghui Hospital Xi'anShaanxi, China
Sponsors and collaborators
HuaMg Perfection Med Tech (Suzhou) Co., Ltd.
Lead sponsor
Source ClinicalTrials.gov