Magnesium-Titanium Hybrid Intramedullary Nail System For Long Bone Fractures

Official title

A Prospective, Multicenter, Randomized, Controlled, Non-inferiority Clinical Trial to Evaluate the Safety and Effectiveness of the Magnesium-titanium Hybrid Intramedullary Nail System in Treating Long Bone Fractures of the Extremities

Overview

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

• Device Magnesium-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 biodegradab
• Device Commercially 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 investig

Primary outcome measures

• Effective rate of the product at 180 days postoperatively [Time frame: 180±14 days postoperatively]

Secondary outcome measures (7)

• Fracture healing status [Time frame: 42±7 days, 90±7 days, and 180±14 days postoperatively]
• Surgical duration [Time frame: Intraoperative]
• Intraoperative estimated blood loss [Time frame: Intraoperative]
• Evaluation of Device Operability [Time frame: Day of Surgery]
• Occurrence of Adverse Events [Time frame: Through study completion, with an average follow-up duration of 180 days (range: 166-194 days postoperatively)]
• Laboratory Examinations [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 [Time frame: Through study completion, with an average follow-up duration of 180 days (range: 166-194 days postoperatively)]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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;
• Patients with severe soft tissue or vascular injury, or previous surgical treatment at the fracture site, where intramedullary nailing may not provide stable fixation;
• Patients without sufficient soft tissue coverage at the proposed surgical site;
• Patients diagnosed with severe osteoporosis by the investigator based on medical history and X-ray films of the fracture site;
• Patients requiring simultaneous use of both intramedullary nail and screw-plate system at the planned surgical site;
• Patients with hypermagnesemia (serum magnesium > 1.25 mmol/L (3.0 mg/dL));
• Patients with uncontrolled diabetes mellitus (glycated hemoglobin HbA1c ≥ 8.0%);
• Patients with severe cardiovascular, hepatic, renal, pulmonary, hematological diseases or metabolic disorders who cannot tolerate surgery;
• 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);
• 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;
• Patients with constitutions allergic to the implanted materials or known allergies;
• Patients who have participated or are participating in any drug clinical trials within 3 months, or other medical device clinical trials within 30 days;
• Other conditions where the investigator determines the patient is unsuitable for inclusion (e.g., metabolic bone disease, poliomyelitis sequelae, etc.).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 5 centers

• Beijing Jishuitan Hospital, Capital Medical University — Xicheng
• Henan Luoyang Orthopedic Hospital (Henan Orthopedic Hospital) — Luoyang
• Hebei Medical University Third Hospital — Shijiazhuang
• Xi'an Honghui Hospital — Xi'an
• Shanghai Jiao Tong University Affiliated Sixth People's Hospital — Xuhui

Identifiers

NCT: NCT07569575 · HM-CT-MgIMN-001

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗