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Experimental validation of adaptive pedicle screws—a novel implant concept using shape memory alloys

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Abstract

Pedicle screw fixation is a standard procedure in spine surgery. A secure anchoring in deficient (e.g., osteoporotic) bone or in a secondary supply after a revision is a major challenge. This study aimed to test the primary stability of a new self-expanding shape memory actuator screw concept with the traditional screw design. The actuator part braces itself against the osseous environment after implantation by heating to body temperature. Thirty screws and twenty-four actuator sheets were manufactured and tested in vertebrae from seven human cadavers in vitro. The pullout force and mechanical work for the pullout were evaluated. Bone quality was determined from μCT. The mean actuator sheet compression force of the used shape memory alloy (SMA) sheets averaged − 8.2 ± 0.6 N. Seven of the SMA screws activated correctly after the implantation, four activated unilaterally only. The pullout force averaged 868 ± 392 N for the standard screws and 828 ± 353 N for the SMA screws. The mechanical work was conducted after the first 100 N, and the loss of strain resistance of 40% of the pullout force averaged 2.2 ± 1.6 Nm for the standard screws, and 1.7 ± 0.9 Nm for the SMA screws. Consequently, the novel concept showed non-inferiority compared with the traditional screw designs.

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Acknowledgments

Ms. Aqeeda Singh kindly proofread the article as a native speaker.

Funding

Parts of the work were funded by the Saxon Ministry for Science and Arts: 4-7531.50-02-876-10/1.

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Authors and Affiliations

  1. Department of Medical Engineering, Fraunhofer Institute for Machine Tools and Forming Technology IWU, Nöthnitzer Straße 44, 01187, Dresden, Germany

    Michael Werner, Niels Hammer, Christian Rotsch & Isabell Berthold

  2. Department of Clinical and Macroscopic Anatomy, Medical University of Graz, Graz, Austria

    Niels Hammer

  3. Department of Orthopedic and Trauma Surgery, University of Leipzig, Leipzig, Germany

    Niels Hammer & Christian Rotsch

  4. Department of Spinal Center, Orthopädische Klinik Hohwald-Asklepios, Neustadt in Sachsen, Germany

    Isabell Berthold

  5. Department of Neurosurgery and Spine Surgery, Sächsische Schweiz Klinik Sebnitz, Senftenberg, Germany

    Mario Leimert

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  1. Michael Werner
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  2. Niels Hammer
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  3. Christian Rotsch
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  4. Isabell Berthold
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Correspondence to Michael Werner.

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As part of the donation regulated by the Saxonian Death and Funeral Act of 1994, institutional approval for the use of the post-mortem tissues of human body donors was obtained from the Institute of Anatomy, University of Leipzig, Germany.

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While alive, all body donors gave their informed and written consent to the donation of their bodies for teaching and research purposes.

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Werner, M., Hammer, N., Rotsch, C. et al. Experimental validation of adaptive pedicle screws—a novel implant concept using shape memory alloys. Med Biol Eng Comput 58, 55–65 (2020). https://doi.org/10.1007/s11517-019-02059-x

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  • DOI: https://doi.org/10.1007/s11517-019-02059-x

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