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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Magnesium-Titanium Hybrid Intramedullary Nail System
DeviceThe magnesium-titanium hybrid intramedullary nail system is inserted into the medullary canal through the proximal or distal end of the bone via standard intramedullary fixation surgical procedures, achieving fixation of the fracture site through intramedullary stabilization. This device provides load-sharing fixation for the fracture. The titanium alloy main body of the product delivers continuous, reliable mechanical support to ensure the overall stability of fracture fixation. The biodegradable magnesium components gradually degrade in vivo, releasing magnesium ions that participate in regulating the local bone repair microenvironment, thereby synergistically supporting the fracture healing process.
Commercially Locked Metallic Intramedullary Nail
DeviceThis is a commercially available locked metallic intramedullary nail manufactured by Double Medical Technology Inc., with the National Medical Products Administration (NMPA) registration certificate number: NMPA 20153131195. It is selected as the control device based on the following: 1) Double Medical is a leading orthopedic enterprise in China, and its products are widely used clinically with proven efficacy and safety; 2) The indications of the control device fully cover those of the investigational device.
Treatment groups
160 Participants
are divided into 2 treatment groupsGroup A: Magnesium-Titanium Hybrid Intramedullary Nail SystemExperimental treatment 1 intervention
Group B: Commercially Locked Metallic Intramedullary NailActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Effective rate of the product at 180 days postoperatively
"Product effectiveness" is defined as the simultaneous fulfillment of the following criteria: (a) Fracture healing assessment criteria: no local tenderness or longitudinal percussion pain, no abnormal local movement; on radiographs of the fracture site, the fracture line is obscured or obliterated, or continuous callus or trabecular bone crossing the fracture line is visible. (b) No deformation, loosening, or breakage of the implanted product. Calculation formula: Product effectiveness rate at 180 days postoperatively = (Number of cases with effective product at 180 days postoperatively ÷ Total number of cases in the group) × 100%
Time frame
180±14 days postoperativelySecondary outcomes
1
Fracture healing status
Fracture healing status will be documented at various follow-up time points after surgical reduction and internal fixation, and the fracture healing rate will be calculated. Fracture healing assessment criteria: No local tenderness or longitudinal percussion pain, and no abnormal local mobility; On radiographs of the fracture site, the fracture line is obscured or obliterated, or continuous callus or trabecular bone crossing the fracture line is visible. Calculation formula: Fracture healing rate = (Number of cases with fracture healing ÷ Total number of cases in the group) × 100%
Time frame
42±7 days, 90±7 days, and 180±14 days postoperatively2
Surgical duration
The duration from the start of skin incision to the completion of wound closure and suture. Calculation method: The mean operative time will be calculated separately for the investigational group and the control group.
Time frame
Intraoperative3
Intraoperative estimated blood loss
The estimated intraoperative blood loss (mL) will be recorded, based on the official operative record.
Time frame
Intraoperative4
Evaluation of Device Operability
Device operability will be evaluated according to the following criteria, and the excellent-good rate will be calculated. Evaluation Criteria: Excellent: Complete configuration, simple operation, strong operability, and excellent compatibility of all components; Good: Complete configuration, acceptable operation, acceptable operability, and acceptable compatibility of all components; Fair: Average configuration, average operation, average operability, and average compatibility of all components; Poor: Incomplete configuration, cumbersome operation, poor operability, and poor compatibility of all components. Calculation Formula: Device Operability Excellent-Good Rate = (Number of cases rated Excellent or Good) ÷ (Total number of cases in the group) × 100%
Time frame
Day of SurgerySponsors and contacts
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Source ClinicalTrials.gov
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