Towards the simulation of bone-implant systems with a stratified material model

Area of Science:

• Biomechanical engineering
• Medical device development
• Computational modeling

Background:

• Clinical performance of medical devices is critical for regulatory approval.
• Evidence for device performance is often gathered late in development via clinical trials.
• Simulation offers a potential avenue for earlier performance evaluation.

Purpose of the Study:

• To demonstrate the feasibility of widespread healthcare utilization of bone-implant simulations.
• To highlight advancements in cloud-based execution, Virtual Clinical Trials, and material modeling.
• To emphasize the importance of careful data handling in virtual cohort construction.

Main Methods:

• Overview of Finite Element Method (FEM) based structural mechanical simulations for bone-implant systems.
• Utilizing clinical imaging data as the baseline for simulations.
• Presenting an enhancement method for improving accuracy and reliability of imaging data.

Main Results:

• Initial steps towards creating a virtual cohort for proximal femur implant evaluation.
• Demonstration of an enhancement methodology for clinical Computer Tomography data.
• Highlighting the necessity of using multiple image reconstructions for data accuracy.

Conclusions:

• Simulation methodologies are mature for daily use in healthcare.
• Minor variations in imaging and preprocessing significantly impact simulation outcomes.
• While virtual clinical trials are progressing, input data reliability requires further research.