In vitro and in vivo biocompatibility of Ti-6Al-4V titanium alloy and Chirulen 1020 polymer for total hip replacements

Introductions: Joint replacements have considerably improved the quality of life of patients with damaged joints. Over the past 30 years, there has been much effort and investigations in ways to repair damages in joints, including knee and hip joints. Materials for joint production have also been developed. Many improvements have been made in the joint replacement materials to increase their biocompatibility and longevity. This study is aimed at evaluating the in vitro and in vivo biocompatibility of Ti-6Al-4V titanium alloy and UHMWPE polymer used in total hip replacements. Methods: Ti-6Al-4V titanium alloy and UHMWPE polymer were carefully washed with sterile distilled water then autoclaved. The materials were used directly or indirectly to evaluate pyrogens, endotoxins, animal cell cytotoxicity, gene mutation, animal cell transformation, DNA synthesis, immunogenicity, histology reactions, and immune response.  All assays were performed according to ISO10993 guidelines. Results: The results showed that Ti-6Al-4V titanium alloy and Chirulen 1020 UHMWPE polymer satisfied all criteria for implantable materials.