Long-term implant—bone fixation of the femoral component in total knee replacement

Success of total knee replacement (TKR) depends on the prosthetic design. Aseptic loosening of the femoral component is a significant failure mode that has received little attention. Despite the clinical relevance of failures, no protocol is available to test long-term implant—bone fixation of TKR in vitro. The scope of this work was to develop and validate a protocol to assess pre-clinically the fixation of TKR femoral components. An in vitro protocol was designed to apply a simplified but relevant loading profile using a 6-degrees-of-freedom knee simulator for 1 000 000 cycles. Implant—bone inducible micromotions and permanent migrations were measured at three locations throughout the test. After test completion, fatigue damage in the cement was quantified. The developed protocol was successfully applied to a commercial TKR. Additional tests were performed to exclude artefacts due to swelling or creep of the composite femur models. The components migrated distally; they tilted towards valgus in the frontal plane and in extension in the sagittal plane. The migration patterns were consistent with clinical roentgen-stereophotogrammetric recordings with TKR. Additional indicators were proposed that could quantify the tendency to loosen/stabilize. The type and amount of damage found in the cement, as well as the migration patterns, were consistent with clinical experience with the specific TKR investigated. The proposed pre-clinical test yielded repeatable results, which were consistent with the clinical literature. Therefore, its relevance and reliability was proved.