Biocompatibility evaluation of bioabsorbable osteofixation devices: A scoping review

Abstract

The quest of performing biocompatibility study for biodegradable material remains to be abstruse. Numerous studies have been conducted to investigate the biocompatibility of a biodegradable material for bone fixation devices. However, they rarely follow any known standard, making it difficult to compare, draw a conclusion, or extrapolate the data. Therefore, this study aims to evaluate the biocompatibility tests performed in those studies in order to take note of their underlying concept and present the key points investigated. A database search of PubMed, Embase, and Cochrane Central Register of Controlled Trials (CENTRAL) was conducted, and PRISMA-ScR guideline was used. Twenty-six studies were included in the review, and all of the studies utilize the preclinical animal model as their biocompatibility assessment. The biocompatibility tests are cytotoxicity, sensitization, irritation, systemic toxicity, genotoxicity, implantation, and hemocompatibility tests. It was found that only one study performed all of the biocompatibility tests. However, this study did not provide comparative animal control. Most of the studies conducted implantation tests, evaluating inflammatory reaction, bone healing, and implant degradation. Only three studies referred to International Standard Operation (ISO) for conduction biocompatibility test. Although renowned standardization bodies such as ISO have published an international standard on biocompatibility studies, it was found that most researchers were not able to follow the standard thoroughly.