TY - JOUR
T1 - Mechanical strength of bone allografts subjected to chemical sterilization and other terminal processing methods
AU - Mikhael, Mark M.
AU - Huddleston, Paul M.
AU - Zobitz, Mark E.
AU - Chen, Quingshan
AU - Zhao, Kristin D.
AU - An, Kai Nan
N1 - Funding Information:
Funding for this study and specimens were provided by Regeneration Technologies, Inc. (Alachua, FL). There is no proprietary relationship between any of the authors and Regeneration Technologies, Inc.
PY - 2008/9/18
Y1 - 2008/9/18
N2 - Infectious disease transmission through the use of human donor allografts can be a catastrophic complication in an otherwise straightforward surgical procedure. The use of bone allograft in reconstructive orthopedic surgeries is increasing, yet severe complications, including death, can result if the transplanted tissues transmit a communicable disease to the tissue recipient. The BioCleanse® tissue sterilization process is a fully automated, low-temperature chemical sterilization process that renders allograft tissue sterile. The purpose of this study was to evaluate the effect of a chemical tissue sterilization process on the mechanical strength of cortical bone allografts prior to implantation. Cylindrical cortical bone specimens were harvested from seven human cadaver donors and treated either by: chemical sterilization alone; chemical sterilization and terminal sterilization by gamma irradiation; chemical sterilization, lyophilization, terminal sterilization by STERRAD and rehydration; or untreated. The specimens were tested to failure in axial compression, diametral compression, shear, or bending. There were no significant differences in ultimate stress, strain, or fracture energy between the chemically sterilized and control groups in any of the testing modes.
AB - Infectious disease transmission through the use of human donor allografts can be a catastrophic complication in an otherwise straightforward surgical procedure. The use of bone allograft in reconstructive orthopedic surgeries is increasing, yet severe complications, including death, can result if the transplanted tissues transmit a communicable disease to the tissue recipient. The BioCleanse® tissue sterilization process is a fully automated, low-temperature chemical sterilization process that renders allograft tissue sterile. The purpose of this study was to evaluate the effect of a chemical tissue sterilization process on the mechanical strength of cortical bone allografts prior to implantation. Cylindrical cortical bone specimens were harvested from seven human cadaver donors and treated either by: chemical sterilization alone; chemical sterilization and terminal sterilization by gamma irradiation; chemical sterilization, lyophilization, terminal sterilization by STERRAD and rehydration; or untreated. The specimens were tested to failure in axial compression, diametral compression, shear, or bending. There were no significant differences in ultimate stress, strain, or fracture energy between the chemically sterilized and control groups in any of the testing modes.
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U2 - 10.1016/j.jbiomech.2008.07.012
DO - 10.1016/j.jbiomech.2008.07.012
M3 - Article
C2 - 18760413
AN - SCOPUS:51049093782
VL - 41
SP - 2816
EP - 2820
JO - Journal of Biomechanics
JF - Journal of Biomechanics
SN - 0021-9290
IS - 13
ER -