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Bioceramic vertebral augmentation with a calcium sulphate/hydroxyapatite composite (Cerament™ SpineSupport) in vertebral compression fractures due to osteoporosis

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Abstract

A prospective, non-randomized multicenter study was initiated to study efficacy and safety of a partly resorbable composite of calcium sulphate and hydroxyapatite (Cerament™ SpineSupport), a novel, injectable bioceramic, in osteoporotic patients with vertebral compression fractures during 18-month follow-up. Fifteen patients with low-energy trauma and 1–2 vertebral compression fractures verified by magnetic resonance imaging were recruited to undergo percutaneous bioceramic vertebral augmentation under fluoroscopy. The patients were treated with a highly flowable bioceramic containing calcium sulphate, hydroxyapatite and the non-ionic radiocontrast agent iohexol, with final setting time within 1 h. After the procedure, the patients were allowed to mobilize after 2 h. Pain (VAS), occurrence of remote and adjacent fractures, and Quality of Life (QoL; SF-36 and EQ-5D) was recorded during 18 months. The injected volume of the composite material ranged from 2.8 to 9 mL (mean 4.2 mL). Pre-operative VAS score was mean 70.3 (CI95% ±8.7) with an immediate post-operative pain relief, which was maintained at the 4-week visit (mean 26.4 with CI95% ±16.1) and 8-week visit (mean 18.0 with CI95% ±13.5 pain relief). Eighty percent of the patients demonstrated a clinical improvement. The pain relief was maintained over 18 months and no adjacent fractures were observed. There was a statistically significant improvement of physical components in the QoL assessment. No extra-vertebral leakage or neurological deficits were reported in this series. This first prospective multicenter study on a partly resorbable bioceramic material indicate that fracture healing can be achieved with sustained pain relief over a follow-up period of 18 months in an osteoporotic patient population with vertebral compression fractures.

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Acknowledgments

We are grateful for the support of this study by BoneSupport AB, Lund, Sweden.

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Authors and Affiliations

  1. Orthopädische Universitätsklinik Friedrichsheim gGmbH, 60528, Frankfurt/Main, Germany

    Michael Rauschmann & Sven Schmidt

  2. Klinik fur Diagnostische und Interventionelle Radiologie Johann Wolfgang Goethe, Universität Frankfurt/Main, Frankfurt/Main, Germany

    Thomas Vogl

  3. Ortenau Klinikum Lahr-Ettenheim, Lahr, Germany

    Akhil Verheyden

  4. Klinik und Poliklinik für Orthopädie und Unfallchirurgie, Universität Bonn, Bonn, Germany

    Robert Pflugmacher

  5. Department of Radiology, Klinikum Offenbach GmbH, Offenbach, Germany

    Thomas Werba

  6. Diagnostic and Interventional Radiology, Klinik Ernst von Bergmann gGmbH Potsdam, Potsdam, Germany

    Johannes Hierholzer

Authors
  1. Michael Rauschmann
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  2. Thomas Vogl
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  3. Akhil Verheyden
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  4. Robert Pflugmacher
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  5. Thomas Werba
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  6. Sven Schmidt
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  7. Johannes Hierholzer
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Correspondence to Michael Rauschmann.

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Rauschmann, M., Vogl, T., Verheyden, A. et al. Bioceramic vertebral augmentation with a calcium sulphate/hydroxyapatite composite (Cerament™ SpineSupport) in vertebral compression fractures due to osteoporosis. Eur Spine J 19, 887–892 (2010). https://doi.org/10.1007/s00586-010-1279-z

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  • DOI: https://doi.org/10.1007/s00586-010-1279-z

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