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Related Experiment Videos

Current sterilization and packaging methods for polyethylene.

L S Bargmann1, B C Bargmann, J P Collier

  • 1Dartmouth Biomedical Engineering Center, Thayer School of Engineering, Dartmouth College, Hanover, NH 03755, USA.

Clinical Orthopaedics and Related Research
|December 28, 1999
PubMed
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New sterilization methods for polyethylene reduce oxidation, improving mechanical properties and clinical performance in orthopaedic implants. Long-term outcomes require further study.

Area of Science:

  • Biomaterials Science
  • Orthopaedic Engineering
  • Polymer Chemistry

Background:

  • Gamma sterilization in air causes polyethylene oxidation, leading to embrittlement and compromised performance of orthopaedic bearings.
  • This oxidation issue necessitates alternative sterilization and packaging methods by orthopaedic manufacturers.

Purpose of the Study:

  • To evaluate the clinical performance prognosis of polyethylene bearings sterilized using novel methods.
  • To assess material properties (oxidation, mechanical strength, crosslink density) of new and retrieved polyethylene implants.

Main Methods:

  • Analysis of material properties including oxidation levels, mechanical properties (ductility, tensile strength), and crosslink density (swell ratio).
  • Examination of both never-implanted (shelf-aged up to 3 years) and retrieved polyethylene bearings.

Related Experiment Videos

  • Comparison of properties across different sterilization techniques (non-radiation, gamma irradiation in inert environments).

    • Main Results:

    • Never-implanted bearings sterilized with new methods show negligible oxidation and excellent mechanical properties (ductility >400%, UTS ~50 MPa), exceeding ASTM standards.
    • Significant variations in crosslink density were observed based on the sterilization method.
    • Retrieved bearings indicate good clinical performance and stability over time with these new methods.

    Conclusions:

    • New sterilization techniques effectively address the shelf oxidation problem in polyethylene orthopaedic bearings.
    • Clinical performance at short follow-up is acceptable for polyethylene sterilized with these advanced methods.
    • Long-term clinical performance necessitates continued evaluation to fully understand the benefits of these new sterilization approaches.