Development and Preclinical Trials of Castomized Porous Titanium Implants with Bioactive Coatings in Model Systems

Abstract

This paper presents a technology for creating customized porous titanium implants with bioactive coatings, manufactured using additive technologies. The stages of creating an implant include obtaining primary data from the bone defect area using computed tomography; 3D modeling of the defect area and the corresponding implant; production of a customized implant from titanium alloys using selective laser fusion technology; application of bioactive coatings. The as-created customized implant can have several functional structures. Samples of titanium implants with bioactive coatings were subjected to extensive testing. Mathematical modeling and experiments were used to verify the correspondence of the mechanical properties of the developed structures to natural bone tissue. In vitro tests of the studied samples showed the absence of acute toxicity along with high levels of biocompatibility. In vivo tests of the studied samples on Soviet chinchilla rabbits and Anubis baboon monkeys approved by local ethical committees showed their adequate biomechanical and high osteoinductive properties. The successful results of preclinical studies, as well as toxicological and technical tests in certified laboratories, made it possible to create a registration dossier for state registration of customized porous titanium implants with bioactive coatings, manufactured using additive technologies.