Abstract
INTRODUCTION
For cementless TKA, highly crosslinked UHWMPE is traditionally used with modular components because of manufacturing and sterilization complexities of monoblock metal-backed components. However, it would be very useful to have a highly crosslinked UHMWPE monoblock metal-backed cementless component to address historical clinical issues. The purpose of this study was to evaluate the wear properties of a unique process for achieving a monoblock metal-backed cementless component featuring highly crosslinked polyethylene to standard highly crosslinked UHWMPE.
MATERIALS AND METHODS
The knee system used for testing consisted of cobalt chrome femoral components and tibial trays (Triathlon®, Stryker Orthopaedics, Mahwah, NJ). Modular tibial inserts were machined from GUR 1020 polyethylene that was irradiated to 30 kGy and annealed three times (Modular, n=5) (X3, Stryker Orthopaedics, Mahwah, NJ). Monoblock tibias were direct compression molded to a metal substrate and then irradiated to 30 kGy and annealed three times. For the purposes of this test, the polyethylene was removed from the monoblock component and machined into a standard tibial insert (Monoblock, n=5).
A 6-station knee simulator was utilized for testing (MTS, Eden Prairie, MN). All motion and loading was computer controlled and waveforms followed ISO 14243-3 [1]. Testing was conducted at a frequency of 1 Hz for 3 million cycles. The lubricant used was Alpha Calf Fraction serum (Hyclone Labs, Logan, UT) diluted to 50% with a pH-balanced 20-mMole solution of deionized water and EDTA [2]. The serum solution was replaced and inserts were weighed for gravimetric wear at least every 0.5 million cycles. Standard test protocols were used for cleaning, weighing and assessing the wear loss of the tibial inserts [3]. Soak control specimens were used to correct for fluid absorption with weight loss data converted to volumetric data (by material density). Statistical analysis was performed using the Student's t-test with significance determined at the 95% confidence level (p < 0.05).
RESULTS
The average volume loss and volumetric wear rates at 3 million cycles are represented in Figure 1 and Figure 2. Group 1: Highly Crosslinked UHMWPE had a wear rate of 2.8±0.6 mm3/mc, where the Group 2: Monoblock Highly Crosslinked UHMWPE was 2.8±0.2 mm3/mc. There was no statistical difference (p = 0.95).
CONCLUSION
The results of testing show that the Monoblock Highly Crosslinked UHMWPE material is the same in wear performance relative to Modular Highly Crosslinked UHMWPE material. These results suggest that this new material may have applications in monoblock implant design applications but further testing for specific applications is needed.
