Conrad Bryan P, Rappé Matthew, Horodyski MaryBeth, Farmer Kevin W, Indelicato Peter A
Department of Orthopaedics and Rehabilitation, Orthopaedics and Sports Medicine Institute, University of Florida, 3450 Hull Rd., Gainesville, FL 32607, USA.
Cell Tissue Bank. 2013 Sep;14(3):359-66. doi: 10.1007/s10561-012-9340-2. Epub 2012 Sep 13.
One major concern regarding soft tissue allograft use in surgical procedures is the risk of disease transmission. Current techniques of tissue sterilization, such as irradiation have been shown to adversely affect the mechanical properties of soft tissues. Grafts processed using Biocleanse processing (a proprietary technique developed by Regeneration Technologies to sterilize human tissues) will have better biomechanical characteristics than tissues that have been irradiated. Fifteen pairs of cadaveric Achilles tendon allografts were obtained and separated into three groups of 10 each. Three treatment groups were: Biocleanse, Irradiated, and Control (untreated). Each specimen was tested to determine the biomechanical properties of the tissue. Specimens were cyclically preloaded and then loaded to failure in tension. During testing, load, displacement, and optical strain data were captured. Following testing, the cross sectional area of the tendons was determined. Tendons in the control group were found to have a higher extrinsic stiffness (slope of the load-deformation curve, p = .005), have a higher ultimate stress (force/cross sectional area, p = .006) and higher ultimate failure load (p = .003) than irradiated grafts. Biocleanse grafts were also found to be stiffer than irradiated grafts (p = .014) yet were not found to be statistically different from either irradiated or non-irradiated grafts in terms of load to failure. Biocleanse processing seems to be a viable alternative to irradiation for Achilles tendon allografts sterilization in terms of their biomechanical properties.
在外科手术中使用软组织同种异体移植物的一个主要担忧是疾病传播的风险。目前的组织灭菌技术，如辐照，已被证明会对软组织的机械性能产生不利影响。使用生物净化处理（Regeneration Technologies开发的一种用于对人体组织进行灭菌的专有技术）处理的移植物将比经过辐照的组织具有更好的生物力学特性。获取了15对尸体跟腱同种异体移植物，并将其分成三组，每组10个。三个治疗组分别为：生物净化组、辐照组和对照组（未处理组）。对每个标本进行测试以确定组织的生物力学性能。标本先进行循环预加载，然后进行拉伸直至破坏。在测试过程中，采集载荷、位移和光学应变数据。测试后，确定肌腱的横截面积。发现对照组的肌腱比辐照移植物具有更高的外在刚度（载荷-变形曲线的斜率，p = 0.005）、更高的极限应力（力/横截面积，p = 0.006）和更高的极限破坏载荷（p = 0.003）。还发现生物净化移植物比辐照移植物更硬（p = 0.014），但在破坏载荷方面与辐照或未辐照的移植物相比没有统计学差异。就生物力学性能而言，生物净化处理似乎是跟腱同种异体移植物灭菌中辐照的一种可行替代方法。
