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.
- Staartjes VE Department of Neurosurgery, Bergman Clinics Amsterdam, Amsterdam, The Netherlands victor.staartjes@gmail.com.
- Molliqaj G Department of Neurosurgery, Geneva University Hospitals, Geneva, Switzerland.
- van Kampen PM Department of Epidemiology, Bergman Clinics Amsterdam, Amsterdam, The Netherlands.
- Eversdijk HAJ Department of Neurosurgery, Bergman Clinics Amsterdam, Amsterdam, The Netherlands.
- Amelot A Department of Neurosurgery, La Pitié Salpétrière Hospital, Paris, France.
- Bettag C Department of Neurosurgery, Medical Center, Georg August University of Göttingen, Göttingen, Germany, Göttingen, Germany.
- Wolfs JFC Department of Neurosurgery, Bergman Clinics Amsterdam, Amsterdam, The Netherlands.
- Urbanski S Center for Spinal Surgery and Pain Therapy, Ortho-Klinik Dortmund, Dortmund, Germany.
- Hedayat F Center for Spinal Surgery and Pain Therapy, Ortho-Klinik Dortmund, Dortmund, Germany.
- Schneekloth CG Department of Spinal Surgery, St. Josef Brothers Hospital, Paderborn, Germany.
- Abu Saris M Department of Neurosurgery, Martini Hospital, Groningen, Groningen, Netherlands.
- Lefranc M Department of Neurosurgery, Amiens University Hospital, Amiens, Picardie, France.
- Peltier J Department of Neurosurgery, Amiens University Hospital, Amiens, Picardie, France.
- Boscherini D Department of Neurosurgery, Clinique de la Source, Lausanne, Switzerland.
- Fiss I Department of Neurosurgery, Medical Center, Georg August University of Göttingen, Göttingen, Germany, Göttingen, Germany.
- Schatlo B Department of Neurosurgery, Medical Center, Georg August University of Göttingen, Göttingen, Germany, Göttingen, Germany.
- Rohde V Department of Neurosurgery, Medical Center, Georg August University of Göttingen, Göttingen, Germany, Göttingen, Germany.
- Ryang YM Department of Neurosurgery, Klinikum rechts der Isar, Technical University Munich, Munich, Germany.
- Krieg SM Department of Neurosurgery, Klinikum rechts der Isar, Technical University Munich, Munich, Germany.
- Meyer B Department of Neurosurgery, Klinikum rechts der Isar, Technical University Munich, Munich, Germany.
- Kögl N Department of Neurosurgery, Medical University of Innsbruck, Innsbruck, Austria.
- Girod PP Department of Neurosurgery, Medical University of Innsbruck, Innsbruck, Austria.
- Thomé C Department of Neurosurgery, Medical University of Innsbruck, Innsbruck, Austria.
- Twisk JWR Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Epidemiology and Biostatistics, Amsterdam, The Netherlands.
- Tessitore E Department of Neurosurgery, Geneva University Hospitals, Geneva, Switzerland.
- Schröder ML Department of Neurosurgery, Bergman Clinics Amsterdam, Amsterdam, The Netherlands.
- 2019-09-11
Published in:
- BMJ open. - 2019
instrumentation
neurosurgery
orthopaedic and trauma surgery
pedicle screw
robotics
spine
Europe
Female
Humans
Lumbar Vertebrae
Male
Middle Aged
Multicenter Studies as Topic
Observational Studies as Topic
Outcome Assessment, Health Care
Pedicle Screws
Postoperative Complications
Reoperation
Robotic Surgical Procedures
Spinal Diseases
Spinal Fusion
Surgery, Computer-Assisted
Thoracic Vertebrae
English
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.
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.
- Language
-
- English
- Open access status
- gold
- Identifiers
-
- DOI 10.1136/bmjopen-2019-030389
- PMID 31501123
- Persistent URL
- https://sonar.ch/global/documents/29610
Export to…
Statistics
Document views: 72
File downloads:
- Full-text: 0