Abstract
INTRODUCTION
Since the early 2000s, highly cross-linked (HXL) UHMWPE's have become a popular option with multiple experimental and clinical studies showing that gamma or electron radiation doses between 50–100kGY reduce wear and potentially extend the bearing life of UHMWPE. However, the increased wear resistance came at a compromise to mechanical properties due to the cross-linking process. Vitamin E has been added to some HXL UHMWPE materials to offer a solution to the compromise by increasing oxidation resistance and maintaining sufficient fatigue strength. However, limited data is available on the effect of the fabrication process, especially the method of irradiation, on the properties of the Vitamin E blended HXL UHMWPE. The purpose of this study was to evaluate the effects of adding the antioxidant vitamin E to highly crosslinked UHMWPE on wear rates.
METHODS
Wear testing was performed on six highly crosslinked UHMWPE acetabular liners containing vitamin E (0.1% wt. alpha tocopherol) fabricated using the Cold Irradiation Mechanically Annealed (CIMA) process, initially cross-linked with approximately 100 kGy gamma irradiation, and terminally gamma sterilized. The liners were paired with three 40mm CoCr femoral heads and 40mm three ceramic femoral heads. Testing was completed per ASTM F1714 and ISO 14242 on an orbital hip joint wear simulator (Shore Western, California) and lubricated with 90% bovine calf serum, 20mM EDTA, 0.2% wt. NaN3 and DI water. A 1.1Hz Paul-type loading waveform with a peak of 2kN was used for a total of 5E6 wear cycles. Three loaded soak controls were used in parallel to adjust for fluid absorption. Samples were weighed every 5E5 wear cycles.
RESULTS
The wear rates for the HXL blended vitamin-E liners were calculated using the slope of the linear regression over the steady state and resulted in a wear rate of 0.49mg/Mc. This is a decrease of approximately 95% compared to the 9.54 mg/Mc 28mm ID conventional UHMWPE wear rates as well as a notable difference for the other HXL UHMWPE liner wear rates discussed in the review.
DISCUSSION
HXL blended vitamin-E 40mm liners demonstrated an approximate 95% reduction in wear rates compared to a 28mm ID conventional UHMWPE. The reduced wear rate confirmed the design expectation that a higher irradiation dose in the fabrication process resulted in an increased amount of polymer crosslinking. Additionally, the wear rate of the HXL blended vitamin-E liners studied was well below 20mg/Mc, which was shown by Dowd et al. to be the threshold of osteolysis in THA.
SIGNIFICANCE
The HXL vitamin E blended UHMWPE liner tested in this study demonstrated reduced wear rates by approximately 95% compared to conventional polyethylene. Osteolysis-causing wear debris is reduced while maintaining other mechanical properties. This liner material and manufacturing process is a promising alternative to conventional polyethylene, but long-term clinical results are warranted.
