Self Hardening Macroporous Biphasic Calcium Phosphate Bone Void Filler for Bone Reconstruction; Animal Study and Human Data

Abstract

Due to the lack of macroporosity in current available Calcium Phosphate cement used in osteoarticular surgery, Micro and Macroporous Biphasic CaP Cement (MCPC™) was developed. The MCPC™ concept was the association of a settable and a fast resorbable matrix and a sieved fraction of microporous biphasic calcium phosphate (BCP) granules, recognized for the high osteoconductive and osteogenic properties. During the resorption of the matrix, a porous structure is created and the osteoconductive effect of the granules promotes the bone ingrowth. A goat preclinical study was realized to evaluate the efficacy of MCPC™ for C3 and C4 vertebral body filling defects during 6 months. Bone remodelling was evidenced demonstrating bone ingrowth at the expense of the cement and surrounding the residual BCP granules. Bone trabeculae were observed coming from the spongious bone to the implant site. Human vertebral body filling cases demonstrated the biocompatibility and the safety of MCPC™ for bone reconstruction. Results of this study demonstrated the importance of special combination of calcium phosphate granules in the MCPC™ to provide macroporosity and scaffolding for newly formed bone.