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NOT YET RECRUITING
NCT07569575
NA

Magnesium-Titanium Hybrid Intramedullary Nail System For Long Bone Fractures

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

View on ClinicalTrials.gov

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

2026-05-01

Completion Date

2027-12-31

Last Updated

2026-05-06

Healthy Volunteers

No

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 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.

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 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