Test protocols for evaluation of spinal implants
Test protocols for evaluation of spinal implants
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DOI：
10.2106/jbjs.e.01363
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发表时间：
2006-01-01
影响因子：
5.3
通讯作者：
Serhan, H
中科院分区：
文献类型：
--
作者：
Goel, VK;Panjabi, MM;Serhan, H
在植入之前，医疗器械要经过严格的测试，以确保安全性和有效性。植入式脊柱器械的全套测试方案可能包括许多步骤。生物相容性测试是必要的第一步。在选择材料时，评价方案应说明器械的生物力学和临床性能。在机械测试之前和期间，有限元建模可用于优化设计，预测性能，并在一定程度上预测器械的耐久性和有效性。在台架型评价之后，器械的生物力学特性（例如，运动、载荷分配和椎间盘内压力）可以使用新鲜的人类尸体脊柱来评估。从尸体测试中获得的信息可以通过基于有限元模型的分析进行补充。在成功完成这些测试后，进行利用动物模型的研究以评估结构、功能、组织学，目前用于脊柱器械测试的方案反映了过去三十年在骨科生物力学领域的基础和应用研究经验，一般情况下，尤其是脊柱。脊柱植入物行业内的创新（例如，过去的融合装置与目前的运动保持装置）表明测试协议代表了必须与变化的期望保持同步的动态过程。除了随机临床试验外，没有任何单一的测试可以完全评估器械的所有特性。由于每个测试的固有局限性，必须在适当的背景下查看数据。最后，一个案例是医学界向标准化的测试协议，这将使我们能够比较大量的目前可用的设备，无论是在市场上还是仍在开发中，在一个系统的，独立于实验室的方式。
Prior to implantation, medical devices are subjected to rigorous testing to ensure safety and efficacy. A full battery of testing protocols for implantable spinal devices may include many steps. Testing for biocompatibility is a necessary first step. On selection of the material, evaluation protocols should address both the biomechanical and clinical performance of the device. Before and during mechanical testing, finite element modeling can be used to optimize the design, predict performance, and, to some extent, predict durability and efficacy of the device. Following bench-type evaluations, the biomechanical characteristics of the device (e.g., motion, load-sharing, and intradiscal pressure) can be evaluated with use of fresh human cadaveric spines. The information gained from cadaveric testing may be supplemented by the finite element model-based analyses. Upon the successful completion of these tests, studies that make use of an animal model are performed to assess the structure, function, histology, and biomechanics of the device in situ and as a final step before clinical investigations are initiated.The protocols that are presently being used for the testing of spinal devices reflect the basic and applied research experience of the last three decades in the field of orthopaedic biomechanics in general and the spine in particular. The innovation within the spinal implant industry (e.g., fusion devices in the past versus motion-preservation devices at present) suggests that test protocols represent a dynamic process that must keep pace with changing expectations. Apart from randomized clinical trials, no single test can fully evaluate all of the characteristics of a device. Due to the inherent limitations of each test, data must be viewed in a proper context. Finally, a case is made for the medical community to converge toward standardized test protocols that will enable us to compare the vast number of currently available devices, whether on the market or still under development, in a systematic, laboratory-independent manner.