Effect of Chemical Sterilization on the Mechanical Properties of Human Cortical Bone Allografts

Introduction Musculoskeletal allografts are increasingly being utilized in a variety of orthopedic procedures. However, they pose the serious risk of viral or bacterial disease transmission as highlighted by the 2001 death of a young man from Clostridium sordellii sepsis after receiving a contaminated allograft. Gamma irradiation has been widely used to minimize this risk, but has been shown to weaken musculoskeletal allografts. Therefore, the need exists for sterilization techniques that do not diminish allograft biomechanical properties. BioCleanseTM (Regeneration Technologies Inc., Alachua, FL) is a fully-automated, low-temperature, chemical sterilization process that removes endogenous donor material such as blood and lipids, and has been validated to consistently eliminate bacteria, bacterial spores, fungi, and viruses. The objective of this study was to evaluate the effects of this sterilization technique on bone strength.