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Magnesium-Titanium Hybrid Intramedullary Nail System For Long Bone Fractures
Sponsor: HuaMg Perfection Med Tech (Suzhou) Co., Ltd.
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.
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
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
160
Start Date
2026-11-01
Completion Date
2028-12-31
Last Updated
2026-11-03
Healthy Volunteers
No
Interventions
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 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
Commercially available metallic intramedullary nails including the humeral intramedullary nail (NMPA Registration No. 20233130578) and locked intramedullary nail (NMPA Registration No. 20163131478) manufactured by Shandong Weigao Orthopaedic Device Co., Ltd. are selected as the control devices based on the following reasons: 1) Shandong Weigao Orthopaedic Device Co., Ltd. is a leading orthopaedic enterprise in China, and its products are widely used in clinical practice with well-established efficacy and safety profiles; 2) The indications of the control devices fully cover those of the investigational device.
Locations (5)
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
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Xuhui, Shanghai Municipality, China