In silico medical device testing of anatomically and mechanically conforming patient-specific spinal fusion cages designed by full-scale topology optimisation

Thijs Smit*, Niels Aage, Daniel Haschtmann, Stephen J. Ferguson, Benedikt Helgason

*Corresponding author for this work

Research output: Contribution to journalJournal articleResearchpeer-review

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Abstract

A full-scale topology optimisation formulation has been developed to automate the design of cages used in instrumented transforaminal lumbar interbody fusion. The method incorporates the mechanical response of the adjacent bone structures in the optimisation process, yielding patient-specific spinal fusion cages that both anatomically and mechanically conform to the patient, effectively mitigating subsidence risk compared to generic, off-the-shelf cages and patient-specific devices. In this study, in silico medical device testing on a cohort of seven patients was performed to investigate the effectiveness of the anatomically and mechanically conforming devices using titanium and PEEK implant materials. A median reduction in the subsidence risk by 89% for titanium and 94% for PEEK implant materials was demonstrated compared to an off-the-shelf implant. A median reduction of 75% was achieved for a PEEK implant material compared to an anatomically conforming implant. A credibility assessment of the computational model used to predict the subsidence risk was provided according to the ASME V&V40–2018 standard.

Original languageEnglish
Article number1347961
JournalFrontiers in Bioengineering and Biotechnology
Volume12
Number of pages13
ISSN2296-4185
DOIs
Publication statusPublished - 2024

Keywords

  • ASME V&V40
  • Finite element analysis
  • In silico
  • Lumbar spinal fusion implant
  • Medical device testing
  • Model credibility
  • Patient-specific
  • Topology optimisation

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