In vitro & in vivo investigation of the silicon nitride ceramic hip implant’s safety and effectiveness evaluation

BACKGROUND: With regard to the ceramic hip joint implant, given the concerns in ceramic about the alumina brittleness and zirconia instability, is there any alternative material solution for the orthopedic implant? Beyond the metastable oxide ceramics, along the echelon of advanced technical ceramics, looking at the non-oxide ceramic, the silicon nitride could be an excellent candidate for the joint implant’s application. The purpose of this study is to investigate the safety, effectiveness and to demonstrate the potential of this silicon nitride hip implant. METHODS: According to the related ISO (International Organization for Standardization) standards, a series of in vitro (nine) & in vivo (five) tests, which had been accomplished for the aforementioned aim. Especially, the total hip replacement in pigs had been achieved, as per the authors’ knowledge, this is the first time to apply the THA (Total Hip Arthroplasty) in the big animal. RESULTS: Refer to the ISO 6474-2, in comparison with the current monopolized German product, this silicon nitride ceramic hip implant has high strength, high hardness, excellent fracture toughness, lower density, better wear resistance, good biocompatibility, inherent stability, corrosion resistance and bioactivity, bone integration capability. CONCLUSIONS: This silicon nitride ceramic will be an admirable alternative solution with superior comprehensive property that can withstand the toughest conditions in the most demanding applications like in orthopedic and beyond.