Background: The clinical performance of medical devices is becoming increasingly important for the requirements of modern development processes and the associated regulations. However, the evidence for this performance can often only be obtained very late in the development process via clinical trials or studies.
Objective: The purpose of the presented work is to show that the simulation of bone-implant systems has advanced in various aspects, including cloud-based execution, Virtual Clinical Trials, and material modeling towards a point where and widespread utilization in healthcare for procedure planning and enhancing practices seems feasible. But this will only hold true if the virtual cohort data build from clinical Computer Tomography data are collected and analysed with care.
Methods: An overview of the principal steps necessary to perform Finite Element Method based structural mechanical simulations of bone-implant systems based on clinical imaging data is presented. Since these data form the baseline for virtual cohort construction, we present an enhancement method to make them more accurate and reliable.
Results: The findings of our work comprise the initial step towards a virtual cohort for the evaluation of proximal femur implants. In addition, results of our proposed enhancement methodology for clinical Computer Tomography data that demonstrate the necessity for the usage of multiple image reconstructions are presented.
Conclusion: Simulation methodologies and pipelines nowadays are mature and have turnaround times that allow for a day-to-day use. However, small changes in the imaging and the preprocessing of data can have a significant impact on the obtaind results. Consequently, first steps towards virtual clinical trials, like collecting bone samples, are done, but the reliability of the input data remains subject to further research and development.
Keywords: Simulation; bone-implant systems; computed tomography; finite element method; high-performance computing; in silicio; virtual clinical trials.