Long-term in vivo evolution of high-purity Mg screw degradation - Local and systemic effects of Mg degradation products

Magnesium (Mg) based materials are the focus of research for use as degradable materials in orthopedics and cranio-maxillofacial surgery. However, corrosion rate control and biosecurity are still the key issues that need to be solved prior to their clinical applications. In the present study, as-rolled high-purity magnesium (HP Mg, 99.99 wt%) screws were implanted in rabbit tibiae for up to 52 weeks in order to investigate their long-term in vivo degradation and the local and systemic effects of their degradation products. A series of long-term monitoring were performed at various time points (4w, 12w, 26w and 52w) after implantation using numerous investigations such as micro-CT assay, histomorphometric analysis, local micro-environment testing and biochemical analysis of serum and urine. It was revealed that HP Mg screws had a uniform degradation morphology and a slow degradation rate in vivo during the period of 52 weeks. Their degradation products not only increased the local pH values but also changed the local Mg2+ ions concentration and gas cavity area in the peri-implant tissues in a dynamic manner. More importantly, both the new bone formation and bone-implant contact rate were increased at bone implant interfaces at 26 weeks and 52 weeks post-implantation. Furthermore, neither abnormal elevation of serum magnesium and urine magnesium level, nor liver and kidney dysfunction were detected during the monitoring period of 26 weeks. All these results of long-term investigation suggest that HP Mg screws possess a slow degradation rate, desirable bone repair capacity and long-term local/systemic biosafety, and consequently may have good potential for application as bone fixation devices. (C) 2018 Acta Materialia Inc. Published by Elsevier Ltd. All rights reserved.