Product Overview – βGran

βGran is a synthetic osteoconductive scaffold material. It has a three dimensional porous ceramic matrix which has been designed to mimic the function of human cancellous bone. Conventionally when a surgeon needs bone to repair the skeleton, bone is removed from another site within the patient (usually from the area of the pelvis around the hip) using a technique called autograft harvest. This is time consuming, involves a second surgical procedure and is associated with a high degree (>50%) of post-operative complications. Also, in many cases there is simply insufficient bone volume available to be safely harvested to meet the demand of the surgical technique being performed.

As an alternative, surgeons may use allograft bone which is bone harvested from living or deceased donors. Although allograft removes the complications related to autograft harvest, the challenge of significantly inactivating pathogens in the donated bone is an important safety concern.



βGran can be used by surgeons as an alternative to autograft or allograft bone. βGran functions because the chemistry and porous geometry of the phase pure beta tri-calcium phosphate exactly mimics the same parameters of human bone. The body accepts βGran and responds physiologically to the material, exactly as it would to autograft bone, being converted by the body into its elements which are then used to build new bone which replaces the βGran.



Indications for using βGran

βGran synthetic osteoconductive scaffold is intended to be used as a bone void filler in the treatment of osseous defects which occur as a result of trauma or in surgically created defects. βGran has been successfully used to treat bone loss resulting from trauma to resolve conduction defects in non-unions and to restore conduction across osteotomy sites. In spinal fusion βGran has proved extremely effective at expanding the volume of available fusion material as it can be combined with any autograft harvested during the surgical procedure.



Properties of βGran

The chemical composition of βGran is tricalcium phosphate, consistent with the international standard ASTM F-1088:87. The tricalcium phosphate contains calcium (35%) and phosphorous (20%) in a molar ratio of 1.5 and provides the essential elements for bone growth. Trace metal impurities are extremely low and are regularly evaluated to ensure the specification is met, using inductively coupled plasma emission spectroscopy (ICP) and cold vapour atomic absorption Chemical and crystal structural purity are also evaluated on every βGran batch using x-ray diffraction (XRD), x-ray fluorescence spectrometry (XRF) and Fourier transform infrared spectroscopy (FTIR).

βGran synthetic bone substitute granules are supplied in convenient pre-packed volumes as an irregularly shaped granule in three sizes. When mixed with blood or combined with marrow the granules form a cohesive matrix.

The interconnected porosity of βGran has been calculated and is controlled during manufacture to achieve a balance between pore size, surface area and material volume to achieve an optimum physiologic response. The overall porosity of the material is 70% by volume with a pore geometry producing macropores >200μm down to micro-pores of <1μm.



The material is supplied sterile which is achieved using a gamma irradiation technique to ensure a sterility assurance level of 10^-6.