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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

2026-11-01

Completion Date

2028-12-31

Last Updated

2026-11-03

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

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