You are here

  • Home
  • Archive
  • Volume 9, Issue 9
  • The European Robotic Spinal Instrumentation (EUROSPIN) study: protocol for a multicentre prospective observational study of pedicle screw revision surgery after robot-guided, navigated and freehand thoracolumbar spinal fusion

Article Text

Article menu

Download PDFPDF

XML
Surgery
Protocol
The European Robotic Spinal Instrumentation (EUROSPIN) study: protocol for a multicentre prospective observational study of pedicle screw revision surgery after robot-guided, navigated and freehand thoracolumbar spinal fusion
  1. Victor E Staartjes1,2,3,
  2. Granit Molliqaj4,
  3. Paulien M van Kampen5,
  4. Hubert A J Eversdijk1,
  5. Aymeric Amelot6,
  6. Christoph Bettag7,
  7. Jasper F C Wolfs1,8,
  8. Sophie Urbanski9,
  9. Farman Hedayat9,
  10. Carsten G Schneekloth10,
  11. Mike Abu Saris11,
  12. Michel Lefranc12,
  13. Johann Peltier12,
  14. Duccio Boscherini13,
  15. Ingo Fiss7,
  16. Bawarjan Schatlo7,
  17. Veit Rohde7,
  18. Yu-Mi Ryang14,15,
  19. Sandro M Krieg14,
  20. Bernhard Meyer14,
  21. Nikolaus Kögl16,
  22. Pierre-Pascal Girod16,
  23. Claudius Thomé16,
  24. Jos W R Twisk17,
  25. Enrico Tessitore4,
  26. Marc L Schröder1
  1. 1 Department of Neurosurgery, Bergman Clinics Amsterdam, Amsterdam, The Netherlands
  2. 2 Department of Neurosurgery, Clinical Neuroscience Center, University Hospital Zurich, University of Zurich, Zurich, Switzerland
  3. 3 Amsterdam UMC, Vrije Universiteit Amsterdam, Neurosurgery, Amsterdam Movement Sciences, Amsterdam, The Netherlands
  4. 4 Department of Neurosurgery, Geneva University Hospitals, Geneva, Switzerland
  5. 5 Department of Epidemiology, Bergman Clinics Amsterdam, Amsterdam, The Netherlands
  6. 6 Department of Neurosurgery, La Pitié Salpétrière Hospital, Paris, France
  7. 7 Department of Neurosurgery, Medical Center, Georg August University of Göttingen, Göttingen, Germany, Göttingen, Germany
  8. 8 Department of Neurosurgery, Haaglanden Medical Center, Den Haag, The Netherlands
  9. 9 Center for Spinal Surgery and Pain Therapy, Ortho-Klinik Dortmund, Dortmund, Germany
  10. 10 Department of Spinal Surgery, St. Josef Brothers Hospital, Paderborn, Germany
  11. 11 Department of Neurosurgery, Martini Hospital, Groningen, Groningen, Netherlands
  12. 12 Department of Neurosurgery, Amiens University Hospital, Amiens, Picardie, France
  13. 13 Department of Neurosurgery, Clinique de la Source, Lausanne, Switzerland
  14. 14 Department of Neurosurgery, Klinikum rechts der Isar, Technical University Munich, Munich, Germany
  15. 15 Department of Neurosurgery, HELIOS Klinikum Berlin-Buch, Berlin, Germany
  16. 16 Department of Neurosurgery, Medical University of Innsbruck, Innsbruck, Austria
  17. 17 Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Epidemiology and Biostatistics, Amsterdam, The Netherlands
  1. Correspondence to Dr Victor E Staartjes; victor.staartjes{at}gmail.com

Abstract

Introduction Robotic guidance (RG) and computer-assisted navigation (NV) have seen increased adoption in instrumented spine surgery over the last decade. Although there exists some evidence that these techniques increase radiological pedicle screw accuracy compared with conventional freehand (FH) surgery, this may not directly translate to any tangible clinical benefits, especially considering the relatively high inherent costs. As a non-randomised, expertise-based study, the European Robotic Spinal Instrumentation Study aims to create prospective multicentre evidence on the potential comparative clinical benefits of RG, NV and FH in a real-world setting.

Methods and analysis Patients are allocated in a non-randomised, non-blinded fashion to the RG, NV or FH arms. Adult patients that are to undergo thoracolumbar pedicle screw instrumentation for degenerative pathologies, infections, vertebral tumours or fractures are considered for inclusion. Deformity correction and surgery at more than five levels represent exclusion criteria. Follow-up takes place at 6 weeks, as well as 12 and 24 months. The primary endpoint is defined as the time to revision surgery for a malpositioned or loosened pedicle screw within the first postoperative year. Secondary endpoints include patient-reported back and leg pain, as well as Oswestry Disability Index and EuroQOL 5-dimension questionnaires. Use of analgesic medication and work status are recorded. The primary analysis, conducted on the 12-month data, is carried out according to the intention-to-treat principle. The primary endpoint is analysed using crude and adjusted Cox proportional hazards models. Patient-reported outcomes are analysed using baseline-adjusted linear mixed models. The study is monitored according to a prespecified monitoring plan.

Ethics and dissemination The study protocol is approved by the appropriate national and local authorities. Written informed consent is obtained from all participants. The final results will be published in an international peer-reviewed journal.

Trial registration number Clinical Trials.gov registry NCT03398915; Pre-results, recruiting stage.

  • robotics
  • neurosurgery
  • spine
  • instrumentation
  • pedicle screw
  • orthopaedic and trauma surgery

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/bmjopen-2019-030389

Statistics from Altmetric.com

    Request Permissions

    If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.

    View Full Text

    Footnotes

    • ET and MLS are joint senior authors.

    • VES and GM are joint first authors.

    • VES and GM contributed equally.

    • Twitter @staartjesneuro

    • Contributors VES, GM, PMvK, ET and MLS conceived and designed the study. VES, PMvK and JWRT conceived the statistical analysis plan. VES, GM, PMvK, ET and MLS prepared the first draft of the study protocol. VES, GM, PMvK, HAJE, AA, CB, JFCW, SU, FH, CGS, MAS, ML, JP, DB, IF, BS, VR, Y-MR, SMK, BM, NK, P-PG, CT, JWRT, ET and MLS contributed to the final design of this study protocol, assisted with drafting the manuscript and carried out a critical revision of the manuscript. VES, GM, PMvK, HAJE, AA, CB, JFCW, SU, FH, CGS, MAS, ML, JP, DB, IF, BS, VR, Y-MR, SMK, BM, NK, P-PG, CT, JWRT, ET and MLS approved the final version of the manuscript and agree to be accountable for the accuracy of the work. MLS supervised the work and is the guarantor.

    • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

    • Competing interests VES, GM, PMvK, ET and MLS conceived and designed the study. VES, PMvK and JT conceived the statistical analysis plan. VES, GM, PMvK, ET and MLS prepared the first draft of the study protocol. VES, GM, PMvK, HAJE, AA, CB, JFCW, SU, FH, CGS, MAS, ML, JP, DB, IF, BS, VR, Y-MR, SMK, BM, NK, P-PG, CT, JT, ET and MLS contributed to the final design of this study protocol, assisted with drafting the manuscript and carried out a critical revision of the manuscript. VES, GM, PMvK, HAJE, AA, CB, JFCW, SU, FH, CGS, MAS, ML, JP, DB, IF, BS, VR, Y-MR, SMK, BM, NK, P-PG, CT, JT, ET and MLS approved the final version of the manuscript and agree to be accountable for the accuracy of the work. MLS supervised the work and is the guarantor.

    • Ethics approval The study protocol is approved by the appropriate national and local authorities.

    • Provenance and peer review Not commissioned; externally peer reviewed.