Purpose: A biodegradable magnesium alloy system has been developed as a substitute for conventional plates and screws made of titanium or absorbable polymer. However, previous studies were limited to small animal experiments using screws or wires. In the present study, we preliminarily evaluated the biocompatibility and effectiveness of human standard-size biodegradable magnesium-based plates and screws in facial fractures of beagles.
Materials and methods: Fracture lines were created bilaterally in the zygomatic arches of 6 beagles. They were fixed in situ with plates and screws made of magnesium alloy mixed with calcium and zinc (experimental group) or absorbable polymer (control group). Laboratory testing, radiologic imaging, histologic analysis, and mechanical testing were performed 4 weeks postoperatively.
Results: Inflammatory reactions were not significantly increased in any animal. Mechanical testing showed greater ultimate load and structural stiffness in the experimental group. In the histologic analysis, the void area and bone regeneration area were increased in the experimental, and the implant area and soft tissue area were increased in the control group. Radiologically, 3-dimensional micro-computed tomography showed no differences in the bone gap area between the 2 groups. A temporary increase in hydrogen gas around the magnesium implants regressed spontaneously and did not affect bone healing significantly.
Conclusions: Magnesium-based biodegradable plates and screws showed good biocompatibility and offered considerable stability for fixating facial bone fractures in the early bone-healing process. These results show the possibilities for the future development of magnesium alloy plates and screws for craniomaxillofacial fixation in humans.
Copyright © 2018. Published by Elsevier Inc.