Kettler A, Liakos L, Haegele B, Wilke H-J
Institute for Orthopaedic Research and Biomechanics, University of Ulm, Helmholtzstrasse 14, 89081, Ulm, Germany.
Eur Spine J. 2007 Dec;16(12):2186-92. doi: 10.1007/s00586-007-0485-9. Epub 2007 Aug 25.
Pre-clinical in vitro tests are needed to evaluate the biomechanical performance of new spinal implants. For such experiments large animal models are frequently used. Whether these models allow any conclusions concerning the implant's performance in humans is difficult to answer. The aim of the present study was to investigate whether calf, pig or sheep spine specimens may be used to replace human specimens in in vitro flexibility and cyclic loading tests with two different implant types. First, a dynamic and a rigid fixator were tested using six human, six calf, six pig and six sheep thoracolumbar spine specimens. Standard flexibility tests were carried out in a spine tester in flexion/extension, lateral bending and axial rotation in the intact state, after nucleotomy and after implantation. Then, the Coflex interspinous implant was tested for flexibility and intradiscal pressure using another six human and six calf lumbar spine segments. Loading was carried out as described above in the intact condition, after creation of a defect and after implantation. The fixators were most easily implantable into the calf. Qualitatively, they had similar effects on ROM in all species, however, the degree of stability achieved differed. Especially in axial rotation, the ROM of sheep, pig and calf was partially less than half the human ROM. Similarly, implantation of the Coflex interspinous implant caused the ROM to either increase in both species or to decrease in both of them, however, quantitatively, differences were observed. This was also the case for the intradiscal pressure. In conclusion, animal species, especially the calf, may be used to get a first idea of how a new pedicle screw system or an interspinous implant behaves in in vitro flexibility tests. However, the effects on ROM and intradiscal pressure have to be expected to differ in magnitude between animal and human. Therefore, the last step in pre-clinical implant testing should always be an experiment with human specimens.
需要进行临床前体外测试以评估新型脊柱植入物的生物力学性能。对于此类实验,经常使用大型动物模型。很难回答这些模型是否能得出有关植入物在人体中性能的任何结论。本研究的目的是调查在使用两种不同植入物类型的体外柔韧性和循环加载测试中,小牛、猪或羊的脊柱标本是否可用于替代人类标本。首先,使用六个人类、六个小牛、六个猪和六个羊的胸腰椎脊柱标本对一个动态固定器和一个刚性固定器进行测试。在完整状态下、髓核摘除术后和植入后,在脊柱测试仪中进行屈伸、侧弯和轴向旋转的标准柔韧性测试。然后,使用另外六个人类和六个小牛的腰椎节段对Coflex棘突间植入物进行柔韧性和椎间盘内压力测试。在完整状态下、制造缺损后和植入后,按照上述方法进行加载。固定器最容易植入小牛体内。定性地说,它们对所有物种的ROM有相似的影响,然而,实现的稳定程度不同。特别是在轴向旋转方面,羊、猪和小牛的ROM部分不到人类ROM的一半。同样,Coflex棘突间植入物的植入导致两个物种的ROM要么增加要么减少,然而,在数量上观察到了差异。椎间盘内压力也是如此。总之,动物物种,尤其是小牛,可用于初步了解新型椎弓根螺钉系统或棘突间植入物在体外柔韧性测试中的表现。然而,预计动物和人类之间对ROM和椎间盘内压力的影响在程度上会有所不同。因此,临床前植入物测试的最后一步应该始终是用人标本进行实验。