Abstract
The purpose of this study was to examine the effect of ultrahigh molecular weight polyethylene resin type and manufacturing method on wear of Miller-Galante I and II tibial knee components. Thirteen Miller-Galante I and 10 Miller-Galante II components were retrieved at revision surgery. The Miller-Galante I tibial components were made by direct compression molding of Hi-fax 1900 resin and the Miller-Galante II tibial components were made by machining from ram extruded rod of GUR 415 resin. Both generations were gamma radiation sterilized in air. The Miller-Galante I retrievals had significantly more wear damage in the form of scratching and embedded metallic debris, whereas the Miller-Galante II retrievals had significantly more wear damage in the form of delamination. For the implants with an implantation time of 5 years or more, the Miller-Galante II polyethylene had a significantly greater maximum density value than did the Miller-Galante I polyethylene. Examination of thin sections of the Miller-Galante II components revealed that delamination occurred through a subsurface region of severely oxidatively degraded polyethylene; no such subsurface degraded region was observed for the Miller-Galante I components. The results of this study suggest that delamination of polyethylene tibial components that have been gamma radiation sterilized (in air) is influenced by resin type or manufacturing method or both.
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