Effects of e-beam radiation, storage, and hydration on osteoinductivity of DBM/AM composite.

Abstract

E-beam irradiation is often used to sterilize medical devices including demineralized bone matrix (DBM) products. In this study, the effect of e-beam on osteoinductivity of a DBM product in hydrous and anhydrous configurations has been evaluated at 0-, 6- and 12-month ambient storage using a nude rat muscle pouch model. The thermal and structural stabilities of DBM and acellular dermal matrix (AM) composites were analyzed using differential scanning calorimetry (DSC) and trypsin digestion assay. Both hydrous and anhydrous DBM/AM composites exhibited osteoinductivity after e-beam irradiation of 15 kGy. After 12-month ambient storage, the osteoinductivity of hydrous DBM/AM was diminished, whereas the anhydrous DBM/AM retained its osteoinductive potential. However, the DSC and trypsin analysis revealed that the DBM in anhydrous DBM/AM was more vulnerable to damage from e-beam irradiation than its hydrous counterpart. This study has found that although the anhydrous DBM has more structural damage than hydrous DBM from e-beam irradiation, it has retained its osteoinductivity better after 1-year ambient storage.