Mroz Thomas E, Lin Eric L, Summit Matthew C, Bianchi John R, Keesling Jim E, Roberts Michael, Vangsness C Thomas, Wang Jeffrey C
The Spine Institute, Cleveland Clinic Foundation, 9500 Euclid Avenue, S-80, Cleveland, OH 44195, USA.
Spine J. 2006 Jan-Feb;6(1):34-9. doi: 10.1016/j.spinee.2005.10.007.
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.
To analyze the mechanical properties, compared with nontreated controls, of a novel sterilization process for allograft cortical bone.
STUDY DESIGN/SETTING: A controlled biomechanical evaluation of allograft bone under various types of loading after a novel sterilization treatment.
Not applicable; basic science.
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.
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.
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.
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.
存在多种对同种异体骨进行灭菌的方法，包括伽马射线辐照和冻干，这些方法可能会改变移植物的力学性能。目前正在努力开发一种能保持结构完整性的同种异体骨处理方法。本文介绍了这样一种方法。
分析一种新型同种异体皮质骨灭菌工艺的力学性能，并与未处理的对照进行比较。
研究设计/地点：对经过新型灭菌处理的同种异体骨在各种加载类型下进行控制性生物力学评估。
不适用；基础科学研究。
记录研究组和对照组的破坏载荷，并对这些结果进行统计分析。显著性水平（α）和检验效能（β）分别设定为０.０５和０.９０。采用单因素方差分析（ANOVA）检测处理组和未处理组之间的显著差异。对每个反应变量进行实验后效能分析。
取自７名尸体供体（平均年龄６８.７岁）的胫骨和股骨皮质样本用Biocleanse处理，并在密度和强度方面与未处理样本进行比较。所有样本在直径和双轴压缩、剪切及三点弯曲下加载直至破坏。
对所有加载模式下的密度和破坏应力进行了统计分析。除轴向和双轴样本外（ｐ＜０.０５），ANOVA未显示处理对密度有显著（ｐ＞０.０５）影响。破坏应力的ANOVA分析表明，在所有四种机械加载下，用Biocleanse处理的皮质骨与未处理样本之间无显著差异（ｐ＞０.０５）。实验后效能分析显示每次测试的效能均大于０.９。
与未处理样本相比，用Biocleanse对同种异体骨进行灭菌不会显著改变其力学性能。必须确定这种灭菌工艺对同种异体骨骨传导性和骨诱导性的影响。
