Preclinical evaluation of posterior spine stabilization devices: can the current standards represent basic everyday life activities?
Preclinical evaluation of posterior spine stabilization devices: can the current standards represent basic everyday life activities?
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DOI：
10.1007/s00586-016-4622-1
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发表时间：
2016-09-01
影响因子：
2.8
通讯作者：
Villa, Tomaso
中科院分区：
文献类型：
--
作者：
La Barbera, Luigi;Galbusera, Fabio;Villa, Tomaso
为了探讨现有的后路脊柱稳定装置临床前评估的标准方法是否能代表基本的日常生活活动，以及如何比较不同方法获得的结果。一项比较有限元研究比较了ASTMF1717和ISO 12189标准与经验证的L2-L4节段内固定的站立、上半身屈曲和伸展。分析了脊柱棒上的内部载荷和植入物上的最大应力。ISO推荐的前支撑刚度和力允许在上半身屈曲时重现在器械生理节段上测得的弯矩。尽管ASTM模型在工程学上具有重要意义，但过于保守的椎体切除模型代表了一种不切实际的最坏情况。提出了一种确定施加在具有不同前支承刚度的组件上的载荷的方法，以保证可比较的弯矩并再现特定的日常生活活动。这项研究提高了我们对使用现有标准以获得易于比较和解释的有意义结果的认识。
To discuss whether the available standard methods for preclinical evaluation of posterior spine stabilization devices can represent basic everyday life activities and how to compare the results obtained with different procedures.A comparative finite element study compared ASTM F1717 and ISO 12189 standards to validated instrumented L2-L4 segments undergoing standing, upper body flexion and extension. The internal loads on the spinal rod and the maximum stress on the implant are analysed.ISO recommended anterior support stiffness and force allow for reproducing bending moments measured in vivo on an instrumented physiological segment during upper body flexion. Despite the significance of ASTM model from an engineering point of view, the overly conservative vertebrectomy model represents an unrealistic worst case scenario. A method is proposed to determine the load to apply on assemblies with different anterior support stiffnesses to guarantee a comparable bending moment and reproduce specific everyday life activities.The study increases our awareness on the use of the current standards to achieve meaningful results easy to compare and interpret.