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Developing and Validating a Model of Humeral Stem Primary Stability, Intended for In Silico Clinical Trials

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Abstract

In silico clinical trials (ISCT) can contribute to demonstrating a device’s performance via credible computational models applied on virtual cohorts. Our purpose was to establish the credibility of a model for assessing the risk of humeral stem loosening in total shoulder arthroplasty, based on a twofold validation scheme involving both benchtop and clinical validation activities, for ISCT applications. A finite element model computing bone-implant micromotion (benchtop model) was quantitatively compared to a bone foam micromotion test (benchtop comparator) to ensure that the physics of the system was captured correctly. The model was expanded to a population-based approach (clinical model) and qualitatively evaluated based on its ability to replicate findings from a published clinical study (clinical comparator), namely that grit-blasted stems are at a significantly higher risk of loosening than porous-coated stems, to ensure that clinical performance of the stem can be predicted appropriately. Model form sensitivities pertaining to surgical variation and implant design were evaluated. The model replicated benchtop micromotion measurements (52.1 ± 4.3 µm), without a significant impact of the press-fit (“Press-fit”: 54.0 ± 8.5 µm, “No press-fit”: 56.0 ± 12.0 µm). Applied to a virtual population, the grit-blasted stems (227 ± 78µm) experienced significantly larger micromotions than porous-coated stems (162 ± 69µm), in accordance with the findings of the clinical comparator. This work provides a concrete example for evaluating the credibility of an ISCT study. By validating the modeling approach against both benchtop and clinical data, model credibility is established for an ISCT application aiming to enrich clinical data in a regulatory submission.

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Acknowledgments

The authors thank Sandeep Mani (Zimmer Biomet, Warsaw, Indiana USA) for his support with the benchtop testing.

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Authors and Affiliations

  1. Zimmer Biomet, Sulzerallee 8, 8404, Winterthur, Switzerland

    Ghislain Maquer, Christine Mueri & Adam Henderson

  2. Zimmer Biomet, 1800 West Center St., Warsaw, IN, 46580, USA

    Jeff Bischoff

  3. Zimmer Biomet, Zählerweg 4, 6300, Zug, Switzerland

    Philippe Favre

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  1. Ghislain Maquer
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  2. Christine Mueri
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  3. Adam Henderson
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Contributions

All authors contributed to the study conception and design. Material preparation, data collection, and analysis were performed by GM, CM, and AH. The first draft of the manuscript was written by GM, PF, and CM. Revisions were done by GM, JB, and PF. All authors read and approved the final manuscript.

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Correspondence to Ghislain Maquer.

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The authors are employees of Zimmer Biomet, and therefore, they have received/will receive benefits for personal or professional use from Zimmer Biomet related directly or indirectly to the subject of this manuscript. The authors did not receive support from any organization for the submitted work.

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Appendix – Mesh convergence

Appendix – Mesh convergence

The mesh convergence was conducted according to the ASME V&V40 standard [32] on a representative bone model for the Abduction 60 load case. First, the element size on the contact surfaces between stem and bone, then the element size on the outer surface of the humerus, and finally, the element size of the volumes, were varied. For every level, the element size was reduced by half until mesh convergence was achieved, i.e., when the change in micromotion (QOI) compared to the next mesh iteration (Δ) reached 5% or less. The regions of the model whose element size was varied independently are presented in Fig.

Fig. 9.
figure 9

Several regions of the model were refined during the mesh convergence analysis: a face outer humerus (surface), b face inner humerus (surface), c Body Humerus (volume), d face implant (surface), e body implant (volume)

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9 and the impact of the element size on the QOI (micromotion) is presented in in Table

Table 2 Mesh convergence analysis
Full size table

2.

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Maquer, G., Mueri, C., Henderson, A. et al. Developing and Validating a Model of Humeral Stem Primary Stability, Intended for In Silico Clinical Trials. Ann Biomed Eng 52, 1280–1296 (2024). https://doi.org/10.1007/s10439-024-03452-w

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