Biodegradable Magnesium Alloy (ZK60) with a Poly(l-lactic)-Acid Polymer Coating for Maxillofacial Surgery

The purpose of this study was to evaluate the mechanical strength and biodegradation of a ZK60 plate coated with poly(l-lactic)-acid polymer (PLLA) in a LeFort I osteotomy canine model for maxillofacial applications. The PLLA-coated ZK60 plate and screw were evaluated using a LeFort I osteotomy canine model based on five beagles. The presence of wound dehiscence, plate exposure, gas formation, inflammation, pus formation, occlusion, food intake, and fistula formation were evaluated. After 12 weeks, these dogs were sacrificed, and an X-ray micro-computed tomography (µCT) was conducted. Plate exposure, gas formation, and external fistula were not observed, and the occlusion remained stable. Wound dehiscence did not heal for 12 weeks. CT images did not show plates in all the five dogs. A few screw bodies fixed in the bone remained, and screw heads were completely absorbed after 12 weeks. These findings may be attributed to the inability to optimize the absorption rate with PLLA coating. Rapid biodegradation of the PLLA-coated ZK60 occurred due to the formation of microcracks during the bending process. Further improvement to the plate system with PLLA-coated ZK60 is required using other surface coating methods or alternative Mg alloys.