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Gamma inert sterilization: a solution to polyethylene oxidation?

Francisco J Medel¹, Steven M Kurtz, William J Hozack

¹Implant Research Center, School of Biomedical Engineering, Science and Health Systems, Drexel University, 3401 Market Street, Suite 300, Philadelphia, PA 19104, USA. fjm33@drexel.edu

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|April 3, 2009

Summary

This summary is machine-generated.

Orthopaedic polyethylene components sterilized in inert gas show less oxidation than those sterilized in air. However, both methods result in similar in vivo oxidation and wear, except for reduced delamination in tibial inserts sterilized in inert gas.

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Area of Science:

Biomaterials Science
Orthopaedic Surgery
Polymer Chemistry

Background:

Oxidation in ultra-high molecular weight polyethylene (UHMWPE) total joint replacement components was identified in the 1990s after gamma irradiation and air exposure.
Barrier packaging was developed to mitigate oxidation in radiation-sterilized components.
This study investigates if low-oxygen sterilization affects in vivo oxidation and wear compared to air sterilization.

Purpose of the Study:

To test the hypothesis that polyethylene components sterilized in a low-oxygen environment exhibit similar in vivo oxidative mechanisms as those sterilized in air.
To evaluate the influence of different sterilization methods (gamma in air vs. gamma in inert gas) on the wear performance of polyethylene joint replacement components.

Main Methods:

Analysis of oxidation, wear, and surface damage in 48 acetabular liners and 123 tibial inserts.
Comparison of components with varying implantation times: gamma-in-air vs. gamma-in-inert gas sterilization.
Characterization of oxidation and hydroperoxide levels in loaded and unloaded regions.

Main Results:

All polyethylene cohorts exhibited measurable oxidation and oxidation potential, with higher levels on surfaces exposed to body fluids.
Oxidation variations were more pronounced in historical gamma-in-air-sterilized components.
Acetabular liners showed similar wear rates regardless of sterilization; tibial inserts sterilized in inert gas had a lower incidence of delamination within the first decade.

Conclusions:

Gamma sterilization in inert gas resulted in lower oxidation and oxidation potential compared to gamma sterilization in air.
Conventional components sterilized in inert gas still undergo in vivo oxidation mechanisms similar to air-sterilized components.
Inert gas sterilization did not significantly improve wear resistance, except for a reduced delamination rate in tibial inserts within the first 10 years.