Biomechanical analysis of allograft bone treated with a novel tissue sterilization process.
BACKGROUND
Several methods to sterilize allograft bone exist, including gamma irradiation and freeze-drying, which can alter the mechanical properties of the graft. Efforts are under way to develop a method for processing osseous allograft that maintains structural integrity. Herein is presented one such method.


OBJECTIVE
To analyze the mechanical properties, compared with nontreated controls, of a novel sterilization process for allograft cortical bone.


METHODS
A controlled biomechanical evaluation of allograft bone under various types of loading after a novel sterilization treatment.


METHODS
Not applicable; basic science.


METHODS
The load to failure was recorded for both the study and control groups, and statistical analysis of these results was performed. Significance level (alpha) and power (beta) were set to 0.05 and 0.90, respectively. Single-factor analysis of variance (ANOVA) was used to detect significant differences between the treated and untreated groups. A post-experimental power analysis was performed for each of the response variables.


METHODS
Cortical tibia and femur samples from seven cadaveric donors (mean age 68.7 years) were treated with Biocleanse and compared with untreated samples with regard to density and strength. All samples were loaded to failure under diametral and biaxial compression, shear, and three-point bending.


RESULTS
Statistical analysis was done on the density and failure stress for all modes of loading. ANOVA did not indicate a significant (p>.05) effect of treatment on the density except for the axial and biaxial specimens (p<.05). ANOVA analysis of failure stress demonstrated no significant differences (p>.05) between cortical bone treated with Biocleanse and untreated specimens under all four types of mechanical loading. Post-experimental power analysis revealed power to be greater than 0.9 for each test.


CONCLUSIONS
Sterilization of allograft bone with Biocleanse does not significantly alter the mechanical properties when compared with untreated samples. The effect of this sterilization process on the osteoconductive and osteoinductive properties of allograft bone must be determined.
Mroz
Thomas E
TE
The Spine Institute, Cleveland Clinic Foundation, 9500 Euclid Avenue, S-80, Cleveland, OH 44195, USA.
Lin
Eric L
EL
Summit
Matthew C
MC
Bianchi
John R
JR
Keesling
Jim E
JE
Roberts
Michael
M
Vangsness
C Thomas
CT
Wang
Jeffrey C
JC
D000368:Aged; D000704:Analysis of Variance; D001696:Biomechanical Phenomena; D016025:Bone Transplantation; D002102:Cadaver; D005269:Femur; D005612:Freeze Drying; D005720:Gamma Rays / Q000627:therapeutic use*; D006084:Graft Rejection / Q000517:prevention & control*; D006801:Humans; D008875:Middle Aged; D011336:Probability; D012016:Reference Values; D012307:Risk Factors; D012680:Sensitivity and Specificity; D013048:Specimen Handling / Q000379:methods; D013242:Sterilization / Q000379:methods*; D013314:Stress, Mechanical; D013977:Tibia; D014184:Transplantation, Homologous