In Silico Clinical Trials in the Orthopedic Device Industry: From Fantasy to Reality?

The orthopedic device industry relies heavily on clinical evaluation to confirm the safety, performance, and clinical benefits of its implants. Limited sample size often prevents these studies from capturing the full spectrum of patient variability and real-life implant use. The device industry is accustomed to simulating benchtop tests with numerical methods and recent developments now enable virtual "in silico clinical trials" (ISCT).

Modeling and finite element analysis of a new revision implant for the elbow.

Failed total elbow arthroplasties often are associated with significant bone loss, especially at the level of both humeral condyles. Regular implants might not be ideal for those revision cases and either custom-made implants or complex bone reconstruction procedures with grafts are needed. The goal of the current study was to develop a new revision implant, based on an existing total elbow system (GSB III).