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.

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.

• Authors: Victor E Staartjes, Granit Molliqaj, Paulien M van Kampen, Hubert A J Eversdijk, Aymeric Amelot, Christoph Bettag, Jasper F C Wolfs, Sophie Urbanski, Farman Hedayat, Carsten G Schneekloth, Mike Abu Saris, Michel Lefranc, Johann Peltier, Duccio Boscherini, Ingo Fiss, Bawarjan Schatlo, Veit Rohde, Yu-Mi Ryang, Sandro M Krieg, Bernhard Meyer, Nikolaus Kögl, Pierre-Pascal Girod, Claudius Thomé, Jos W R Twisk, Enrico Tessitore, Marc L Schröder
• Journal: BMJ open (BMJ Open) Vol. 9 Issue 9 Pg. e030389 (09 08 2019) ISSN: 2044-6055 [Electronic] England
• PMID: 31501123 (Publication Type: Clinical Trial Protocol, Journal Article)
• Copyright: © Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Topics

• Europe (epidemiology)
• Female
• Humans
• Lumbar Vertebrae (diagnostic imaging, surgery)
• Male
• Middle Aged
• Multicenter Studies as Topic
• Observational Studies as Topic
• Outcome Assessment, Health Care
• Pedicle Screws (adverse effects)
• Postoperative Complications (diagnosis, etiology, surgery)
• Reoperation (methods, statistics & numerical data)
• Robotic Surgical Procedures (adverse effects, instrumentation, methods)
• Spinal Diseases (diagnostic imaging, epidemiology, surgery)
• Spinal Fusion (adverse effects, instrumentation, methods)
• Surgery, Computer-Assisted (adverse effects, instrumentation, methods)
• Thoracic Vertebrae (diagnostic imaging, surgery)