Overview of polyethylene as a bearing material: comparison of sterilization methods.
Polyethylene has been used for more than 30 years as an orthopaedic bearing material; however, there has been recent concern regarding the early failure of a small percentage of the polyethylene bearings. The damage seen in some retrieved polyethylene components has been linked to gamma radiation sterilization in air, which was widely used by the industry for years. Gamma radiation in air has been documented to cause an increase in oxidation and degradation of mechanical properties with time. The degradation of polyethylene initiated by gamma sterilization in air has led the orthopaedic industry toward alternative sterilization methods, including gamma radiation in an inert gas or vacuum environment, ethylene oxide gas sterilization, and gas plasma sterilization. For many of these alternative techniques, little clinical performance data exist. This study is a comparative evaluation of sterilization methods using the same analytic techniques that have been used to document the effects of gamma sterilization in air on polyethylene. Fourier transform infrared spectroscopy, electron spin resonance, and uniaxial tensile testing are used to compare, respectively, the oxidation levels, free radical concentration, and mechanical properties of material sterilized by each method. The polyethylene is evaluated before sterilization, poststerilization, and postartificial aging. All examined alternative sterilization methods, when compared with gamma sterilization in air, caused less material degradation during a component's preimplantation shelf life.
Collier
J P
JP
Dartmouth Biomedical Engineering Center, Thayer School of Engineering, Dartmouth College, Hanover, NH 03755-8000, USA.
Sutula
L C
LC
Currier
B H
BH
Currier
J H
JH
Wooding
R E
RE
Williams
I R
IR
Farber
K B
KB
Mayor
M B
MB
D004578:Electron Spin Resonance Spectroscopy; D005027:Ethylene Oxide; D005720:Gamma Rays; D006801:Humans; D008422:Materials Testing; D010084:Oxidation-Reduction; D011095:Polyethylenes / Q000627:therapeutic use*; D017550:Spectroscopy, Fourier Transform Infrared; D013242:Sterilization; D013718:Tensile Strength; D016474:Weight-Bearing
D011095:Polyethylenes; D005027:Ethylene Oxide