Calcium Phosphate Bone Cement (CPBC): Development, Commercialization and Future Challenges

Abstract

The first generation of synthetic bone substitute materials, hydroxyapatite (or HA), was initially investigated as a “non self-hardening” biomaterial for remodeling of bone defects. CPBCs concepts were used as a platform to initiate a second generation of injectable, self-hardening cement. The variety of CPBC’s chemical composition leads to a better understanding of their mechanism of reaction and their proposed classification: acid-base, mono-component and hydrolysable. After hydration, mixing, and full chemical reaction, these cements have the ability to precipitate different end products (e.g. HA, calcium deficient apatite, carbonated apatite, brushite, etc.). In fact, the initial idea of having higher mechanical performance (>50 MPa in compression) for a bone void filler application was abandoned and has led to a greater focus on cement fast-hardening (<15 min), higher total porosity (>60%), extended performance of injectability (8 to 22 G), fast resorbability (< 2 years) and user-friendliness for the clinicians. A new CPBC combination (cement plus additives) has particularly improved rheological and biointegrity performance. A hybrid of CPBC-DBM (Demineralized Bone Matrix) has also added an osteoinductivity performance to the initial osteoconductive CPBC.This paper will propose a comparison of the chemical composition, reaction, and performance characteristics of major commercially available CPBC products. Furthermore, it will describe today’s surgeon’s CPBC needs as bone substitute materials for different clinical applications. Finally, we will discuss what we learned so far, how we can resolve several clinical impacts & product recall, and how we believe CPBC designers can meet development challenges, and users’ specific requirements.