Clinical Research Directory

Magnesium Alloy Scaffold With Controlled Degradation for Periarticular Bone Defects

Sponsor: Peking University Third Hospital

Summary

This prospective, multi-center, randomized controlled clinical trial is designed to evaluate the effectiveness and safety of a biodegradable magnesium alloy scaffold with controlled degradation for the treatment of periarticular bone defects of the extremities. Adults with proximal humeral fractures, distal radius fractures, or tibial plateau fractures associated with bone defects and requiring surgical treatment will be enrolled. A total of 120 participants will be randomly assigned in a 1:1 ratio to the experimental group or the control group. Participants in the experimental group will undergo open reduction and internal fixation with implantation of a customized magnesium alloy scaffold into the bone defect. Participants in the control group will undergo conventional open reduction and internal fixation with calcium sulfate bone graft substitute used to fill the bone defect. Participants will be followed for up to 48 weeks after surgery. The study will primarily evaluate bone healing, and will also assess joint function, wound healing, degradation of the magnesium alloy scaffold, device performance, laboratory parameters, and adverse events.

Official title: Clinical Study of a Magnesium Alloy Scaffold With Controlled Degradation for the Treatment of Periarticular Bone Defects of the Extremities

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