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Understanding the differences in wear testing method standards for total knee replacement.

A Abdelgaied1, J Fisher2, L M Jennings2

  • 1Department of Engineering, Nottingham Trent University, Nottingham, UK.

Journal of the Mechanical Behavior of Biomedical Materials
|May 24, 2022
PubMed
Summary
This summary is machine-generated.

Different preclinical testing methods for total knee replacements (TKR) significantly impact wear predictions. Standardized ISO tests and a Leeds gait cycle show varied outcomes, highlighting the need for diverse testing conditions to reflect clinical variability.

Keywords:
Computational simulationExperimental simulationISO test MethodsPreclinical studiesTotal knee replacements

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Area of Science:

  • Biomaterials Science
  • Orthopedic Engineering
  • Tribology

Background:

  • Preclinical wear evaluation of total knee replacements (TKR) typically employs International Standards Organization (ISO) test methods.
  • Existing ISO standards utilize either force or displacement control for wear simulation.
  • A University of Leeds gait cycle (displacement control) predates the ISO displacement standard and is based on measured healthy subject kinematics.

Purpose of the Study:

  • To investigate the effects of different control regimes (force vs. displacement) and input conditions on TKR kinematics, contact mechanics, and wear.
  • To compare outcomes from ISO force control (ISO-14243-1-2009), ISO displacement control (ISO-14243-3-2004, ISO-14243-3-2014), and Leeds gait cycle inputs.
  • To understand the mechanical and tribological results predicted by various standard test conditions for a specific TKR design.

Main Methods:

  • Computational simulation and experimental methods were used to analyze a mid-size Sigma curved TKR with moderately cross-linked UHMWPE inserts.
  • Four distinct test conditions were evaluated: ISO-14243-3-2004, ISO-14243-3-2014, ISO-14243-1-2009, and the Leeds displacement control gait cycle.
  • Analysis focused on kinematics, contact mechanics (stress), and predicted wear rates under each condition.

Main Results:

  • Reversing polarity in ISO-2014 compared to ISO-2004 led to high stress (>65 MPa) at the insert's posterior edge and a >10% wear rate increase.
  • The Leeds gait cycle produced femoral rollback without high-stress edge loading, attributed to different input kinematics and centers of rotation.
  • Force control (ISO-2009) predicted over double the wear rate compared to displacement control standards due to increased anterior-posterior displacement and tibial rotation.

Conclusions:

  • Significant differences in mechanics and wear exist between different TKR test methods, precluding direct comparison of results across standards.
  • Test method selection should consider the specific TKR design, and results should be validated against predicate devices with known clinical performance.
  • A portfolio of representative testing conditions, including varied kinematics and alignments, is necessary to capture clinical wear variability.