Femoral Fracture, Humeral Fracture, Tibial Fracture
Conditions
Keywords
Magnesium-Titanium Hybrid Intramedullary Nail, Long Bone Fractures of the Extremities, Intramedullary Nailing, Biodegradable Magnesium Implant
Brief 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.
Detailed description
Intramedullary nailing, a common surgical procedure to fix broken long bones, has a long history. As early as the 16th century, anthropologist Bernardino documented that local physicians in Mexico used wooden rods inserted into the bone marrow cavity to treat patients with unhealed long bone fractures. Modern metallic intramedullary nails were widely adopted after 1939, when Dr. KÜNTSCHER successfully treated femoral shaft fractures with V-shaped stainless steel nails. This technique was introduced to China in the early 1950s, and has since become the first-line treatment for fractures of the arm and leg bones, especially with the advancement of minimally invasive and biological fixation principles. Traditional intramedullary nails rely on tight contact with the bone marrow cavity for stability. The later development of interlocking screws further improved stability, expanded clinical applications, and reduced complications. Compared with other fixation methods, intramedullary nails offer multiple advantages: they are inserted through small incisions to protect surrounding soft tissues, reduce infection risk, distribute stress evenly to avoid bone weakening, and allow early postoperative movement and weight-bearing, which speeds up recovery. Currently, biodegradable magnesium and magnesium-based materials are a major global focus in orthopedic implant research. Magnesium is a naturally occurring metal that the body can absorb safely. It has excellent biocompatibility and mechanical properties very similar to human bone, making it an ideal revolutionary implant material. Growing evidence shows that magnesium ions released during the gradual degradation of magnesium implants can actively promote new bone growth and blood vessel formation, which is highly beneficial for fracture healing. HuaMg Perfection Med Tech (Suzhou) Co., Ltd. has developed high-purity magnesium for orthopedic fixation implants. In preclinical animal studies conducted by qualified third-party institutions, a goat tibial fracture model experiment compared the company's magnesium-titanium hybrid intramedullary nail (experimental group) with conventional titanium alloy intramedullary nails (control group). The results demonstrated that the magnesium-titanium hybrid nail significantly promoted faster and more effective fracture healing than traditional titanium alloy nails. Based on these promising preclinical findings, this prospective, multicenter, randomized controlled clinical trial is designed to evaluate the safety and effectiveness of the magnesium-titanium hybrid intramedullary nail system for treating long bone fractures of the extremities, compared with the commercially available locked metallic intramedullary nail.
Interventions
DEVICEMagnesium-Titanium Hybrid Intramedullary Nail System
The 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.
DEVICECommercially Locked Metallic Intramedullary Nail
This 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.
Sponsors
HuaMg Perfection Med Tech (Suzhou) Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Aged ≥ 18 years and ≤ 80 years (inclusive), with skeletal maturity, regardless of gender; 2. Diagnosed with long bone fractures of the extremities (including femur, tibia, humerus) requiring surgical fixation with intramedullary nail; 3. Good treatment compliance, willing and able to complete follow-up and observation as required; 4. Voluntarily participate in this trial and sign the written informed consent form.
Exclusion criteria
1. Pregnant or lactating women, or individuals with family planning during the study period; 2. Pathological fractures (e.g., bone tumor, bone metastasis, osteomalacia), or patients with too narrow or occluded medullary cavity; 3. Patients complicated with osteomyelitis, osteofascial compartment syndrome, systemic infection or local infection at the surgical site; 4. Patients with severe bone defects requiring artificial bone or autologous bone grafting; 5. Patients with severe soft tissue or vascular injury, or previous surgical treatment at the fracture site, where intramedullary nailing may not provide stable fixation; 6. Patients without sufficient soft tissue coverage at the proposed surgical site; 7. Patients diagnosed with severe osteoporosis by the investigator based on medical history and X-ray films of the fracture site; 8. Patients requiring simultaneous use of both intramedullary nail and screw-plate system at the planned surgical site; 9. Patients with hypermagnesemia (serum magnesium \> 1.25 mmol/L (3.0 mg/dL)); 10. Patients with uncontrolled diabetes mellitus (glycated hemoglobin HbA1c ≥ 8.0%); 11. Patients with severe cardiovascular, hepatic, renal, pulmonary, hematological diseases or metabolic disorders who cannot tolerate surgery; 12. Patients with previous or concurrent malignant tumors (excluding those cured and disease-free survival for more than 5 years, such as basal cell carcinoma of the skin, cervical carcinoma in situ, and papillary thyroid carcinoma); 13. Patients who have received radiotherapy, chemotherapy, growth factors, immunosuppressants, systemic corticosteroids, long-term (continuous use for more than 3 months) sedative-hypnotics, non-steroidal anti-inflammatory drugs, or bisphosphonates within 6 months prior to screening; 14. Patients with constitutions allergic to the implanted materials or known allergies; 15. Patients who have participated or are participating in any drug clinical trials within 3 months, or other medical device clinical trials within 30 days; 16. Other conditions where the investigator determines the patient is unsuitable for inclusion (e.g., metabolic bone disease, poliomyelitis sequelae, etc.).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effective rate of the product at 180 days postoperatively | 180±14 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% |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fracture healing status | 42±7 days, 90±7 days, and 180±14 days postoperatively | 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% |
| Surgical duration | Intraoperative | 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. |
| Intraoperative estimated blood loss | Intraoperative | The estimated intraoperative blood loss (mL) will be recorded, based on the official operative record. |
| Evaluation of Device Operability | Day of Surgery | 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% |
| Occurrence of Adverse Events | Through study completion, with an average follow-up duration of 180 days (range: 166-194 days postoperatively) | Definition: Includes the incidence rate (%) and number of events for (serious) adverse events, as well as the incidence rate (%) and number of events for device-related (serious) adverse events. Adverse events include, but are not limited to, deformation, breakage, and loosening of the intramedullary nail and locking components, as well as infection, compartment syndrome, nerve injury, non-union, delayed union, and other complications. |
| Laboratory Examinations | Within 7 days after surgery, 42±7 days postoperatively (electrolytes only), 90±7 days postoperatively (electrolytes only), 180±14 days postoperatively (electrolytes only) | Routine blood tests (RBC, WBC, HGB, PLT), electrolyte tests (Ca²⁺, Mg²⁺), routine urine tests (RBC, PRO, WBC), and blood biochemistry tests (ALT, AST, TBIL, BUN/UREA, Cr) will be performed, and the laboratory findings of the experimental group and control group will be recorded. |
| Occurrence of Device Deficiencies | Through study completion, with an average follow-up duration of 180 days (range: 166-194 days postoperatively) | Investigators will observe and record any device deficiencies that occur with the medical device under normal use during the clinical trial, including labeling errors, quality issues, malfunctions, etc. The incidence rate (%) and number of device deficiency events will be calculated. |
Countries
China
Contacts
CONTACTYuantao Zhang, PhD
STUDY_DIRECTORLing Qin, PhD
Chinese University of Hong Kong
Outcome results
None listed