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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
160
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.
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.
Beijing Jishuitan Hospital, Capital Medical University
Xicheng, Beijing Municipality, China
Henan Luoyang Orthopedic Hospital (Henan Orthopedic Hospital)
Luoyang, He'Nan, China
Hebei Medical University Third Hospital
Shijiazhuang, Hebei, China
Xi'an Honghui Hospital
Xi'an, Shaanxi, China
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 postoperatively
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 postoperatively
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: Intraoperative
Intraoperative estimated blood loss
The estimated intraoperative blood loss (mL) will be recorded, based on the official operative record.
Time frame: Intraoperative
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Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Xuhui, Shanghai Municipality, China
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 Surgery
Occurrence of Adverse Events
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.
Time frame: Through study completion, with an average follow-up duration of 180 days (range: 166-194 days postoperatively)
Laboratory Examinations
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.
Time frame: Within 7 days after surgery, 42±7 days postoperatively (electrolytes only), 90±7 days postoperatively (electrolytes only), 180±14 days postoperatively (electrolytes only)
Occurrence of Device Deficiencies
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.
Time frame: Through study completion, with an average follow-up duration of 180 days (range: 166-194 days postoperatively)