Abstract
Introduction
Ideally, standardized wear testing protocols replicate the in vivo motions and forces of TKR patients. In a previous study with 30 TKR patients, two distinct in vivo gait patterns emerged, one characterized as having low anteroposterior (AP-L) motion and the other high anteroposterior (AP-H) motion. The aim of this study was to determine the effect of the two in vivo-determined gait patterns on total and backside insert wear in comparison with the ISO standard 14243-3. In order to differentiate and accurately quantify topside and backside wear, a novel technique was employed where different lanthanide tracers are incorporated into the polyethylene during manufacture.
Materials and Methods
Components from the Zimmer NexGen CR Knee Replacement System were used. Europium (Eu) and Gadolinium (Gd)-stearates were mechanically mixed with GUR1050 UHMWPE resin to obtain two tracer-UHMWPE resins containing 49.1±1.5 ppm Eu and 68.8±1.6 ppm Gd, respectively. 12 grams of the Eu-doped resin was placed on the bottom, 10 grams of virgin GUR1050 resin was placed in the middle, and 10 grams of Gd-doped resin was placed on the top to mold NexGen CR tibial inserts. The backside was then machined to interlock with the tibial baseplate. The minimum insert thickness was 10 mm. All inserts were packaged in nitrogen and gamma sterilized.
The wear test was conducted on a 4-station knee simulator in displacement-control mode. Simulator input was obtained from ISO 14243-3 and from gait of 30 NexGen TKR subjects, previously categorized into low (AP-L) and high (AP-H) anteroposterior motion groups. Per station, each insert was sequentially subjected to ISO, AP-L, AP-H motion for 2 Mc at 1 Hz. Subsequently, the ISO profile was repeated. Tibial inserts were weighed and lubricant samples were taken after every 0.5 Mc interval. Knowing the Eu and Gd concentrations from ICP-MS analysis, and normalizing those to the concentrations in the polyethylene inserts, the localized (Eu – backside; Gd – topside) wear was calculated. Wear particle analysis was conducted following established protocols.
Results
For all tested liners (n=4 + soak) during the three tested motion profiles, the chemically calculated wear correlated closely with the gravimetrically determined wear (R2»0.8), with slopes not different from 1. Both in vivo motion groups displayed higher wear rates than the ISO group following the order of the AP motion amplitudes (Figure). Backside wear for ISO constituted 2.76% ± 0.90% (mean ± SE) of the total wear, increasing significantly to 15.8 ± 3.2% for AP-L and further increasing to 19.3 ± 0.95% for AP-H (p<.001). The mean wear particle sizes were under 200 nm for all three motion patterns, being largest for the AP-H gait protocol (Table).
Discussion
Both in vivo motion groups displayed higher wear rates than the group tested per ISO standard 14243-3. Interestingly backside wear was affected the most and increased 4.5 to 6-fold over ISO. Testing for the proportion of backside wear across various activities of daily living may therefore be an important consideration in evaluating knee prostheses wear and could be facilitated by this new tracer technology.
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