1. Scope

Keywords

Rationale

Contact Area and Contact Pressure testing has been recommended in FDA Guidance and ASTM F2083 Total Knee specification. This testing is recommended to understand potential for wear behavior in a total knee implant system and helps support worst case analysis for wear testing. Little guidance on the method is given in the standards currently, and only the angles of flexion are specifically recommended. These often do not match reported literature. Literature references are provided but no standard test method exists as a standard. Therefore published literature explores many methods (film vs digital film vs ultrasound etc.) and loading conditions and size combinations of implants, mostly undisclosed, and this offers a poor comparator between devices. Loading conditions, angles, and methods must be consistent to make a meaningful comparison. Additionally, the use of validated finite element models to characterize this contact can significantly streamline the testing by identifying worst-case combinations in a more comprehensive manner than a traditional engineering rationale without compromising the integrity of results and conclusions.