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In Vivo Oxidation and Surface Damage in Retrieved Ethylene Oxide-sterilized Total Knee Arthroplasties

  • Symposium: Retrieval Studies
  • Published:
Clinical Orthopaedics and Related Research®

Abstract

Background

Gas sterilization (eg, ethylene oxide [EtO] and gas plasma) was introduced for polyethylene to reduce oxidation due to free radicals occurring during radiation sterilization. Recently, oxidation has been observed in polyethylenes with undetectable levels of free radicals, which were expected to be oxidatively stable. It is unclear whether in vivo oxidation will occur in unirradiated inserts sterilized with EtO.

Questions/purposes

Methods

We collected 20 EtO-sterilized tibial inserts at revision surgeries. We assessed oxidative using Fourier transform infrared spectroscopy and mechanical properties using the small punch test. Surface damage was assessed using damage scoring techniques and micro-CT.

Results

Oxidation indexes were low and uniform between the regions. The subtle changes did not affect the mechanical properties of the polymer. The dominant surface damage modes included burnishing, abrasion, and third-body wear. There was no evidence of delamination in the retrievals.

Conclusions

The retrieved EtO-sterilized UHMWPE retrievals remained stable with respect to both oxidative and mechanical properties for up to 10 years in vivo. We did observe slight measurable amounts of oxidation in the inserts; however, it was far below levels that would be expected to compromise the strength of the polymer.

Clinical Relevance

Due to the stable oxidative and mechanical properties, EtO-sterilized tibial components appear to be an effective alternative to gamma-sterilized inserts, at least in short-term implantations.

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Acknowledgments

The authors thank Poonam Sharma and Genymphas Higgs of Drexel University for their assistance with the retrieval analysis in this study.

Author information

Authors and Affiliations

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

    Daniel MacDonald MS, Josa Hanzlik MS & Steven M. Kurtz PhD

  2. Exponent, Inc, Philadelphia, PA, USA

    Daniel MacDonald MS, Josa Hanzlik MS & Steven M. Kurtz PhD

  3. Rothman Institute at Jefferson, Philadelphia, PA, USA

    Peter Sharkey MD & Javad Parvizi MD

Authors
  1. Daniel MacDonald MS
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  2. Josa Hanzlik MS
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  3. Peter Sharkey MD
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  4. Javad Parvizi MD
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  5. Steven M. Kurtz PhD
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Corresponding author

Correspondence to Daniel MacDonald MS.

Additional information

The institution of one or more of the authors (DM, JH, SMK) has received, in any 1 year, funding from the NIH (NIAMS R01 AR47904); Stryker Orthopaedics, Inc (Mahwah, NJ, USA); Zimmer, Inc (Warsaw, IN, USA); and StelKast, Inc (McMurray, PA, USA). One of the authors (PS) certifies that he, or a member of his immediate family, receives royalties from StelKast, Inc. One of the authors (JP) certifies that he, or a member of his immediate family, has paid consultancies from Biomet, Inc (Warsaw, IN, USA), Zimmer, Inc, Stryker Orthopaedics, Inc, and Smith & Nephew, Inc (Memphis, TN), owns stock in SmarTech (Philadelphia, PA, USA), and has or may receive payments or benefits, in any 1 year, in excess of $10,000.

All ICMJE Conflict of Interest Forms for authors and Clinical Orthopaedics and Related Research editors and board members are on file with the publication and can be viewed on request.

Clinical Orthopaedics and Related Research neither advocates nor endorses the use of any treatment, drug, or device. Readers are encouraged to always seek additional information, including FDA approval status, of any drug or device before clinical use.

Each author certifies that his or her institution approved the human protocol for this investigation, that all investigations were conducted in conformity with ethical principles of research, and that informed consent for participation in the study was obtained.

This work was performed at the Implant Research Center, Drexel University.

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MacDonald, D., Hanzlik, J., Sharkey, P. et al. In Vivo Oxidation and Surface Damage in Retrieved Ethylene Oxide-sterilized Total Knee Arthroplasties. Clin Orthop Relat Res 470, 1826–1833 (2012). https://doi.org/10.1007/s11999-011-2184-4

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  • DOI: https://doi.org/10.1007/s11999-011-2184-4

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