School of Biological Science and Medical Engineering, Beihang University, No. 37, XueYuan Road, HaiDian District, Beijing 100083, China; Beijing Advanced Innovation Center for Biomedical Engineering, Beihang University, Beijing 100083, China.
School of Biological Science and Medical Engineering, Beihang University, No. 37, XueYuan Road, HaiDian District, Beijing 100083, China.
Med Eng Phys. 2019 Oct;72:49-54. doi: 10.1016/j.medengphy.2019.08.006.
The market for orthopedic implants is growing rapidly with the increasing prevalence of orthopedic diseases in an aging society. Different designs and materials have been developed over the years and have, in general, shown excellent results in pre-clinical testing. However, there have been incidences of serious complications when novel implants or materials are put into clinical use, with some well-known cases being metallosis in patients implanted with metal-on-metal hip replacements and osteolysis from polyethylene wear debris generated in hip and knee joint replacements. Unforeseen factors related to new designs, materials and surgical techniques can lead to different outcomes for pre-clinical testing and clinical use. While often an excellent indicator of a device's performance in clinical settings, pre-clinical testing does sometime fail to predict critical flaws in implant development. This article aims to explore the gaps in the current approach to testing. The ISO international standard of pre-clinical testing should be modified to more adequately capture actual clinical use of the implant and simulate daily activities. This article will also introduce modern methods for implant development, such as FEM, 3D printing and computer-aided orthopedic surgery, which can be widely applied to improve pre-clinical testing procedures and reduce the incidence of surgical malalignment by analyzing biomechanical performance, planning surgical procedure and providing surgical guide.
随着老龄化社会中骨科疾病的日益增多，骨科植入物市场发展迅速。多年来，已经开发出不同的设计和材料，并且通常在临床前测试中显示出优异的结果。然而，当新型植入物或材料投入临床使用时，会出现一些严重的并发症，一些著名的例子是金属对金属髋关节置换患者的金属中毒和髋关节和膝关节置换中聚乙烯磨损颗粒引起的骨溶解。与新型设计、材料和手术技术相关的不可预见因素可能导致临床前测试和临床使用的结果不同。虽然临床前测试通常是设备在临床环境中性能的出色指标，但有时未能预测植入物开发中的关键缺陷。本文旨在探讨当前测试方法的差距。应该修改临床前测试的 ISO 国际标准，以更充分地捕捉植入物的实际临床使用情况并模拟日常活动。本文还将介绍植入物开发的现代方法，如有限元法、3D 打印和计算机辅助骨科手术，这些方法可以广泛应用于通过分析生物力学性能、规划手术程序和提供手术指导来改进临床前测试程序并降低手术对线不良的发生率。
