Andres Annchristin, Wickert Kerstin, Gneiting Elena, Binmoeller Franziska, Diebels Stefan, Roland Michael
Applied Mechanics, Saarland University, Campus A4 2, 1. OG, 66123 Saarbrücken, Germany.
KLS Martin SE & Co. KG, 78532 Tuttlingen, Germany.
Bioengineering (Basel). 2025 May 20;12(5):545. doi: 10.3390/bioengineering12050545.
Temporomandibular joint replacement is a critical intervention for severe temporomandibular joint disorders, enhancing pain levels, jaw function and overall quality of life. In this study, we compare two finite element method-based simulation workflows from both academic and industrial perspectives, focusing on a patient-specific case involving a custom-made temporomandibular joint prosthesis. Using computed tomography data and computer-aided design data, we generated different 3D models and performed mechanical testing, including wear and static compression tests. Our results indicate that the academic workflow, which is retrospective, purely image-based and applied post-operatively, produced peak stress values within 9-20% of those obtained from the industrial workflow. The industrial workflow is prospective, pre-operative, computer-aided design-based and guided by stringent regulatory standards and approval protocols. Observed differences between workflows were attributed primarily to distinct modelling assumptions, simplifications and constraints inherent in each method. To explicitly quantify these differences, multiple additional models were generated within the academic workflow using partial data from the industrial process, revealing specific sources of variation in stress distribution and implant performance. The findings underscore the potential of patient-specific simulations not only to refine temporomandibular joint prosthesis design and enhance patient outcomes, but also to highlight the interplay between academic research methodologies and industrial standards in the development of medical devices.
颞下颌关节置换是治疗严重颞下颌关节疾病的关键干预措施,可改善疼痛程度、下颌功能及整体生活质量。在本研究中,我们从学术和行业角度比较了两种基于有限元方法的模拟工作流程,重点关注一个涉及定制颞下颌关节假体的特定患者案例。利用计算机断层扫描数据和计算机辅助设计数据,我们生成了不同的三维模型并进行了力学测试,包括磨损和静态压缩测试。我们的结果表明,学术工作流程具有回顾性、完全基于图像且在术后应用,其产生的峰值应力值在工业工作流程所得结果的9%-20%范围内。工业工作流程具有前瞻性、术前进行、基于计算机辅助设计且受严格的监管标准和审批协议指导。观察到的工作流程之间的差异主要归因于每种方法固有的不同建模假设、简化和约束。为了明确量化这些差异,在学术工作流程中使用工业流程的部分数据生成了多个额外模型,揭示了应力分布和植入物性能变化的具体来源。研究结果强调了特定患者模拟的潜力,不仅可以优化颞下颌关节假体设计并改善患者预后,还能突出学术研究方法与医疗设备开发中的行业标准之间的相互作用。