Cerasorb


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When a material is used to augment a bone defect, the material must fulfil different requirements for each phase of bone regeneration. In particular the resorption characteristics are determined by the phase purity, primary particle size, structure, porosity, and solubility. Only an ideal combination of these properties leads to an optimal bone regeneration material. 


Phase purity: Phase purity is the determinant for a homogeneous and complete resorption of the bone resorption material. Phase impurities can either be non-resorbable phases (e.g. hydroxyapatite) or phases that resorb too quickly and cause a premature breakdown of the scaffold (e.g. calcium pyrophosphate). The American Society for Testing and Materials (ASTM) requires implantable ß-TCP to have a phase purity of 95 %. 

Due to the unique manufacturing technique, Cerasorb Ortho and Cerasorb M Ortho have a phase purity of over 99% and are, in fact, the testing standard that all other formulations are compared to. 


Primary particle size: A primary particle size of greater 10μm is optimal to prevent a cellular degradation process. The larger size particles provide a stronger overall structure while allowing an inter-connective, open porosity. Particle sizes under 10 μm can stimulate phagocytosis by macrophages (Shimizu, 1988) and lead to a premature volume loss of the material in the defect and a particular decomposition, so that complete biological bone regeneration is not achieved. 

The tightly bound and sufficiently large primary particles of Cerasorb Ortho/Cerasorb M Ortho prevent the undesired premature degradation and phagocytosis. 


Structure: In the early healing phase, there is an acute inflammatory and immune reaction. In this phase, the bone regeneration material must remain stable and must not lose stability either by disintegration during the application or by accelerated solubility. A premature disntegration into micro particles elicits the activity of phagocytotic macrophages and polymorphic multinucleated cells. The resulting increased non-specific immune reaction disrupts the bone regeneration. 

The sufficiently strong structure of Cerasorb Ortho / Cerasorb M Ortho prevents early degradation into micro particles and therefore avoids the undesired macrophage activity. 


Porosity: From a biomedical standpoint a bone regeneration material must have an interconnecting open porosity in order to support a deep, uniform connection between the implant material and the blood supply. The porosity is also important for the resorption process, which is accelerated by the interconnectivity. The open porosity increases the surface area and allows vascularization when the pores are of sufficient size. In order to achieve the ingrowth of vascularized, mineralized tissue within the implant, a pore diameter of at least 100 μm is required. In addition to these macro pores, meso pores, which support the ingrowth and adhesion of the newly forming tissue, as well as micro pores (< 5 μm), which allow for the absorption of extracellular fluid, are of key importance. 

All Cerasorb products provide a multi-porosity profile to allow an indication specific resorption process. 


Solubility: Bone regeneration material should dissolve in a homogeneous manner so that micro particles are not released from the structure prematurely, which elicit phagocytosis by macrophages, particularly when they are 10 μm or smaller. Through a homogeneous controlled dissolution, calcium and phosphate are supplied in physiological concentrations, so that they can be taken up by the osteoblasts and can be anabolically metabolized for the synthesis of new bone. 

With the phase purity of over 99% in combination with the structural characteristics and homogeneous solubility, Cerasorb Ortho and Cerasorb M Ortho optimally support the healing process for bone regeneration.