Magnesium-Titanium Hybrid Intramedullary Nail System For Long Bone Fractures

NCT07569575 | Not Yet Recruiting

• 1 other identifier: HM-CT-MgIMN-001
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 5

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.

Conditions

Tibial Fracture; Femoral Fracture; Humeral Fracture

Keywords

Magnesium-Titanium Hybrid Intramedullary Nail; Long Bone Fractures of the Extremities; Intramedullary Nailing; Biodegradable Magnesium Implant

Outcome Measures

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%

  180±14 days postoperatively

Secondary Outcomes (7)

• Fracture healing status

  42±7 days, 90±7 days, and 180±14 days postoperatively

• Surgical duration

  Intraoperative

• Intraoperative estimated blood loss

  Intraoperative

• Evaluation of Device Operability

  Day of Surgery

• Occurrence of Adverse Events

  Through study completion, with an average follow-up duration of 180 days (range: 166-194 days postoperatively)

Study Arms (2)

Magnesium-Titanium Hybrid Intramedullary Nail System

EXPERIMENTAL

Indicated for intramedullary fixation and fracture healing promotion in humeral, femoral, and tibial diaphyseal, proximal, and distal extremity fractures during orthopedic surgery.

Device: Magnesium-Titanium Hybrid Intramedullary Nail System

Commercially Locked Metallic Intramedullary Nail

ACTIVE COMPARATOR

Indicated for internal fixation of long bone fractures of the extremities.

Device: Commercially Locked Metallic Intramedullary Nail

Interventions

Magnesium-Titanium Hybrid Intramedullary Nail System DEVICE

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.

Magnesium-Titanium Hybrid Intramedullary Nail System

Commercially Locked Metallic Intramedullary Nail DEVICE

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.

Commercially Locked Metallic Intramedullary Nail

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• HuaMg Perfection Med Tech (Suzhou) Co., Ltd.: lead

Study Sites (5)

Beijing Jishuitan Hospital, Capital Medical University

Xicheng, Beijing Municipality, China

Location

Henan Luoyang Orthopedic Hospital (Henan Orthopedic Hospital)

Luoyang, He'Nan, China

Location

Hebei Medical University Third Hospital

Shijiazhuang, Hebei, China

Location

Xi'an Honghui Hospital

Xi'an, Shaanxi, China

Location

Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Xuhui, Shanghai Municipality, China

Location

MeSH Terms

Conditions

Tibial Fractures; Femoral Fractures; Humeral Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries; Arm Injuries

Study Officials

• Ling Qin, PhD

  Chinese University of Hong Kong

  STUDY DIRECTOR

Central Study Contacts

Yuantao Zhang, PhD

CONTACT

+86 13421870043; ytzhang2008@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2026
• First Posted: May 6, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): March 29, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-04

Locations

CN (5)