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(iv) Enhancing the safety and reliability of joint replacement implants
Louise M Jennings1, Mazen Al-Hajjar, Claire L Brockett
1Principal Research and Innovation Fellow, Institute of Medical and Biological Engineering iMBE, University of Leeds, Leeds, UK and Leeds Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospital Trust, Leeds, UK. Conflict of interest: none.
A new Stratified Approach For Enhanced Reliability (SAFER) method improves pre-clinical joint prosthesis testing. This approach simulates a wider range of clinical conditions for more accurate wear performance assessment.
Area of Science:
- Biomedical Engineering
- Materials Science
- Orthopedic Surgery
Background:
- Current pre-clinical testing for joint prostheses relies on limited standard conditions.
- This fails to capture the wide range of factors influencing in-vivo performance and longevity.
- Existing clinical data highlights the need for more comprehensive simulation.
Purpose of the Study:
- To introduce a novel Stratified Approach For Enhanced Reliability (SAFER) for pre-clinical joint prosthesis testing.
- To expand testing beyond standard conditions to encompass a wider clinical envelope.
- To improve the reliability and predictive accuracy of pre-clinical wear performance assessments.
Main Methods:
- Incorporation of variations in surgical delivery techniques.
- Inclusion of diverse kinematic profiles representative of patient populations.
- Simulation of biomaterial property degradation over time.
- Validation of in-vitro methods using clinical experience from existing prostheses.
Main Results:
- The SAFER approach systematically evaluates wear performance under a broader spectrum of conditions.
- It accounts for variability in surgical procedures, patient movement, and material aging.
- Validation against clinical data confirms the enhanced reliability of the SAFER simulation methods.
Conclusions:
- The SAFER approach offers a more robust and clinically relevant method for pre-clinical joint prosthesis evaluation.
- It enhances the reliability of wear performance testing by simulating a wider range of real-world conditions.
- This improved simulation can lead to better-designed and longer-lasting joint implants.
