Comparative in vitro study on the long term performance of cemented hip stems: validation of a protocol to discriminate between "good" and "bad" designs.

The long-term clinical success of cemented hip stems is influenced both by the implant design, and by the surgical procedure. A methodology is proposed for discriminating between implant designs with different clinical outcomes. The protocol was designed with industrial pre-clinical validation in mind. Two cemented stem types were tested, one (Lubinus SPII) having good and the other (Müller Curved) having poor clinical outcomes. Three implants for each type were subjected to a mechanical in vitro test of one million loading cycles. Each cycle reproduced the load components of stair climbing. Interface shear micromotion was measured during the test in the direction of rotation and along the stem axis. The stem roughness before and after the test was compared. After the test, the cement mantles were retrieved and inspected through dye penetrants to detect evidences of micro-damage. For each specimen, the events of the loosening process were examined, based on the in vitro data available, so as to analyze the whole failure mechanism. The protocol developed was sensitive to the implant design, with significantly different results being found for the two stem types, both in terms of stem-cement micromotions, surface roughness alteration, and cement mantle damage. The information yielded by the three different investigation techniques was consistent for each of the two groups of specimens tested, allowing a better understanding of the failure process. In vitro inducible micromotion and permanent migration measurements, together with cement-stem interface fretting damage and cement fatigue damage, can help predicting the clinical performance of cemented stems.