Credibility assessment of patient-specific biomechanical models to investigate proximal junctional failure in clinical cases with adult spine deformity using ASME V&V40 standard

Abstract

Computational models are increasingly used to assess spine biomechanics and support surgical planning. However, varying levels of model verification and validation, along with characterization of uncertainty effects limit the level of confidence in their predictive potential. The objective was to assess the credibility of an adult spine deformity instrumentation model for proximal junction failure (PJF) analysis using the ASME V&V40:2018 framework. To assess model applicability, the surgery, erected posture, and flexion movement of actual clinical cases were simulated. The loads corresponding to PJF indicators for a group of asymptomatic patients and a group of PJF patients were compared. Model consistency was demonstrated by finding PJF indicators significantly higher for the simulated PJF vs. asymptomatic patients. A detailed sensitivity analysis and uncertainty quantification were performed to further establish the model credibility.

Keywords:

• Proximal junctional failure
• spine
• biomechanics
• verification and validation
• scoliosis

Acknowledgments

The authors want to thank: Nathalie Bourassa for her help with the 3D reconstruction of the patients.

Disclosure statement

Maeva Lopez Poncelas: financed by the Natural Sciences and Engineering Research Council of Canada (Industrial Research chair with Medtronic of Canada)

Luigi La Barbera: financed by Canada First Research Excellence Fund through TransMedTech Institute Postdoctoral Fellowship.

Carl-Eric Aubin: NSERC Industrial Research Chair with Medtronic of Canada, and Consultant (Medtronic)

Jeremy Rawlinson: industry scientist employed by Medtronic, Inc.

Dennis Crandall: SpineWave – Consultant and Royalties; Medtronic – Royalties; U&I – Consultant; GS Medical – Consultant; Helia Care – Stock; Handel – Stock; Auctus – Stock and Consultant. Sonoran Spine Research Foundation – Research Support. None of the work contained in this study is related to any of these consulting/royalty/stockholder/research support activities.

Additional information

Funding

This work was supported by the Natural Sciences and Engineering Research Council of Canada (Industrial Research chair with Medtronic of Canada) under Grant [31-001-39]; Canada First Research Excellence Fund through TransMedTech Institute Postdoctoral Fellowship awarded to Luigi La Barbera.