Goel Vijay K, Panjabi Manohar M, Patwardhan Avinash G, Dooris Andrew P, Serhan Hassan
Department of Bioengineering, 5051 C Nitschke Hall, College of Engineering, University of Toledo, Toledo, OH 43606, USA.
J Bone Joint Surg Am. 2006 Apr;88 Suppl 2:103-9. doi: 10.2106/JBJS.E.01363.
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.
在植入前,医疗设备要经过严格测试以确保安全性和有效性。用于可植入脊柱设备的一整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,评估方案应兼顾设备的生物力学性能和临床性能。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设备的耐用性和有效性。在进行台式评估之后,可使用新鲜的人体尸体脊柱来评估设备的生物力学特性(例如,运动、负荷分担和椎间盘内压力)。尸体测试获得的信息可通过基于有限元模型的分析进行补充。在这些测试成功完成后,进行利用动物模型的研究,以原位评估设备的结构、功能、组织学和生物力学,这是启动临床研究之前的最后一步。目前用于脊柱设备测试的方案反映了过去三十年在骨科生物力学领域,尤其是脊柱领域的基础和应用研究经验。脊柱植入行业的创新(例如,过去的融合设备与目前的运动保留设备)表明,测试方案是一个动态过程,必须跟上不断变化的期望。除了随机临床试验外,没有单一测试能全面评估设备的所有特性。由于每项测试都有其固有局限性,必须在适当的背景下看待数据。最后,有人提出医疗界应趋向于采用标准化测试方案,这将使我们能够以系统的、独立于实验室的方式比较大量目前可用的设备,无论它们是已上市还是仍在研发中。
J Bone Joint Surg Am. 2006-4
Spine (Phila Pa 1976). 2011-8-1
Clin Orthop Relat Res. 1997-2
J Bone Joint Surg Am. 2006-4
Bioengineering (Basel). 2024-8-1
OTA Int. 2021-4-15