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[脊柱椎间融合器的力学研究——标准化测试的特点与局限性]

[Mechanical study of spinal interbody implants--characteristics and limits of standardized testing].

作者信息

Steinhauser E, Bader R, Rechl H, Bertagnoli R, Mittelmeier W, Gradinger R

机构信息

Klinik für Orthopädie und Sportorthopädie, Technische Universität München.

出版信息

Biomed Tech (Berl). 2001 Nov;46(11):325-32.

Abstract

Spinal interbody fusion has proved to be a useful procedure for the surgical stabilization of spinal segments, for which fusion cases made of metal or reinforced polymers are increasingly being used. For the mechanical testing of spinal interbody implants, a test setup has been developed on the basis of an ASTM proposal. Initially, testing of lumbar fusion cages made of CFRP (carbon fibre reinforced polymer) was carried out. The implants (UNION Cages, Medtronic Sofamor Danek), which are characterised by their radiolucency on radiography, NMR and CT scans, have a cube-shaped body with three table-tracks on the under and upper surfaces. The cages were tested at different loads. Modifications of the proposed standardized method were carried out to enable implementation of implant-oriented testing. The tested cages were shown to have adequate axial compression, shear and torsional strengths with regard to the implant body. The maximum axial compression force tolerated by the table-tracks was less than the maximal potential loading of the lumbar spine, and, with account being taken of implant design, consequences with regard to surgical technique were drawn. As dictated by the geometry of the table-tracks, parallel grooves have to be made intra-operatively in the vertebral end plates. Axial compressive loads then act on the implant body, and the table-tracks are protected from damage. To avoid in vivo failure, the tested cages should be implanted only when this specific surgical technique is employed. Using supplementary anterior or posterior instrumentation, in vivo failure of the table-tracks under physiological spinal loading is not to be expected.

摘要

脊柱椎间融合术已被证明是一种用于脊柱节段手术稳定的有效方法,越来越多地使用由金属或增强聚合物制成的融合病例。对于脊柱椎间植入物的力学测试,已根据ASTM提案开发了一种测试装置。最初,对由CFRP(碳纤维增强聚合物)制成的腰椎融合器进行了测试。这些植入物(美敦力索法莫丹尼克公司的UNION融合器)在X射线、核磁共振成像和CT扫描中具有透X线性,其主体呈立方体形状,上下表面有三条平台轨道。这些融合器在不同载荷下进行了测试。对提议的标准化方法进行了修改,以实现针对植入物的测试。测试结果表明,就植入物主体而言,这些融合器具有足够的轴向压缩、剪切和扭转强度。平台轨道所能承受的最大轴向压缩力小于腰椎的最大潜在载荷,并考虑到植入物设计,得出了有关手术技术的结论。根据平台轨道的几何形状,术中必须在椎体终板上制作平行凹槽。然后轴向压缩载荷作用于植入物主体,从而保护平台轨道不受损坏。为避免体内失效,只有采用这种特定手术技术时才能植入测试过的融合器。使用辅助前路或后路器械,在生理脊柱载荷下,平台轨道在体内不应出现失效。

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