A computational design of experiments based method for evaluation of off-the-shelf total knee replacement implants.

A methodology to explore the design space of off-the-shelf total knee replacement implant designs is outlined. Generic femur component and tibia plate designs were scaled to thousands of sizes and virtually fitted to 244 test subjects. Various implant designs and sizing requirements between genders and ethnicities were evaluated. 5 sizes optimised via the methodology produced a good global fit for most subjects. However, clinically significant over/underhang was present in 19% of subjects for tibia plates and 25% for femur components, reducing to 11/20% with 8 sizes. The analysis highlighted subtly better fit performance was obtained using sizes with unequal spacing.