ARE THERE DIFFERENCES BETWEEN THE OLD AND NEW INTERNATIONAL STANDARDS FOR TKR PRE-CLINICAL WEAR TESTING? AN FEA ANALYSIS USING ADAPTIVE REMESHING

Abstract

Generic walking profiles applied to mechanical knee simulators are the gold standard in wear testing of total knee replacements (TKRs). Recently, there was a change in the international standard (ISO) for knee wear testing (ISO 14243-3): the direction of motion in the anterior/posterior (AP) and internal/external (IE) directions were reversed. The effects of this change have not been investigated, therefore it is not known whether results generated by following this new standard can be compared to historical wear tests which used the old standard. Using a finite element analysis (FEA) model of a TKR in parallel with an energy based wear model and adaptive remeshing, we investigated differences in wear between the newest ISO standard developed in 2014, and the previous ISO standard developed in 2004.

CAD models of a left sided NexGen Cruciate Retaining (CR) TKR (Zimmer, Warsaw, IN) were used to create the FEA model (Figure 1). The loads and motions specified by simulator standards ISO 14243-3(2004) and ISO 14243-3(2014) were applied to the model. Analyses were run using ABAQUS v6.13-2 Standard (Dassault Systèmes, Waltham, MA). 8 node hexahedral elements were used to model the UHMWPE component. The contact was modeled as penalty contact, with the friction coefficient set to 0.04 on the articular surface. The cobalt chromium molybdenum femoral component was modeled as a rigid surface, utilizing a mix of 2^nd order quadrilaterals and tetrahedrons. Wear of the polyethylene (PE) component was predicted to 1,000,000 cycles using a previously published frictional energy-based wear model. The wear model, developed from data generated in wheel-on-flat tests, utilizes two parameters defining the frictional energy required to remove a unit volume of material both parallel (3.86E8 J/mm³) and perpendicular (3.55E7 J/mm³) to the primary polyethylene fibril direction. Primary fibril direction for the analysis was set to the AP direction. Wear for each simulation of a gait cycle was scaled to 500,000 cycles. Two gait cycles were simulated representing 1,000,000 cycles in total. Adaptive remeshing was driven by the wear model, with the mesh being updated every time increment to simulate material ablation. The time step size was variable with a maximum of 0.01s.

The FEA predicted higher wear rates for the newest ISO standard (7.34mg/million cycles) compared to the previous standard (6.04mg/million cycles) (Figure 2). Comparing the predicted wear scars (Figure 3), the new version of the standard covered a larger percentage of the total articular surface, with wear being more spread out as opposed to localized. This is more similar to what is seen in patient retrievals.

The results of the study suggest that major differences between the old and the new ISO standard exist and therefore historical wear results are not comparable to newly obtained results. In addition, this study demonstrates the utility of FEA in wear analysis, though the wear model needs further work and validation before it can be used as a supplement to simulator testing. Validation of the wear model against simulator tests and pin-on-disk experiments is currently underway.

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