Kienle Annette, Wilke Hans-Joachim, Schröder Christian, Pietsch Andrea
SpineServ GmbH & Co. KG Ulm Germany.
Institute of Orthopaedic Research and Biomechanics University Hospital Ulm Ulm Germany.
JOR Spine. 2024 Dec 25;7(4):e70026. doi: 10.1002/jsp2.70026. eCollection 2024 Dec.
Spinal implant failure is associated with prolonged patient suffering, high costs for the medical device industry, and a high economic burden for the health care system. Pre-clinical mechanical testing has great potential to reduce the risk of such failure. However, there are no binding regulations for planning and interpretation of mechanical testing. Therefore, different strategies exist. Mainly for novel implants an option is to start with a structured scientific literature search that forms an objective background for the definition of an implant-specific test plan, the derivation of acceptance criteria and interpretation of the test results.
This paper describes, how a literature-based approach can look like from the initial literature search through the derivation of the test plan and the acceptance criteria, to the final test result evaluation and how this approach can support the proof that the device meets all necessary safety and performance standards.
The main advantage of this literature-based approach is that testing and test result interpretation are linked with the loads acting on the individual implant in vivo. In an ideal case, testing is focused on the individual implant in a way that ensures maximum efficiency during the development and approval process combined with maximum insight in safety and effectiveness of the implant. Even comparative implant testing may become obsolete, which is a big advantage if comparative implant and related data are not available.
This approach to pre-clinical mechanical testing offers the potential to create a chain of arguments, from literature review through testing to the interpretation of test results. This methodology can significantly enhance testing efficiency, reduce risk of failure, and ultimately prevent unnecessary patient suffering and healthcare costs. By synthesizing scientific insights with regulatory requirements, this review aims to guide clinicians and researchers in improving patient care and advancing device technologies.
脊柱植入物失败会给患者带来长期痛苦，给医疗器械行业带来高昂成本，并给医疗保健系统带来沉重经济负担。临床前机械测试在降低此类失败风险方面具有巨大潜力。然而，对于机械测试的规划和解释尚无具有约束力的法规。因此，存在不同的策略。主要针对新型植入物，一种选择是从结构化的科学文献检索开始，这为定义特定植入物的测试计划、推导验收标准以及解释测试结果形成客观背景。
本文描述了基于文献的方法从最初的文献检索到测试计划和验收标准的推导，再到最终测试结果评估的过程，以及这种方法如何支持证明该设备符合所有必要的安全和性能标准。
这种基于文献的方法的主要优点是测试和测试结果解释与体内作用于单个植入物的负荷相关联。在理想情况下，测试以一种确保在开发和审批过程中实现最高效率，同时对植入物的安全性和有效性有最大程度洞察的方式聚焦于单个植入物。甚至比较植入物测试可能也会过时，如果没有比较植入物及相关数据，这是一个很大的优势。
这种临床前机械测试方法有可能创建一个从文献综述到测试再到测试结果解释的论证链。这种方法可以显著提高测试效率，降低失败风险，并最终防止不必要的患者痛苦和医疗成本。通过将科学见解与监管要求相结合，本综述旨在指导临床医生和研究人员改善患者护理并推动设备技术发展。
