Clinical trial · Observational
The European Robotic Spinal Instrumentation (EUROSPIN) Study
The European Robotic Spinal Instrumentation (EUROSPIN) Study: A European Prospective Multicenter Multinational Pragmatic Trial on Robot-guided Versus Navigated Versus Freehand Pedicle Screw Fixation
NCT03398915CI-TRIAL-00106863EUROSPINactive not recruitingResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
In a multinational prospective study, preoperative, intraoperative, perioperative and follow-up data on patients receiving thoracolumbar pedicle screw placement for degenerative disease or infections or tumors will be collected. The three arms consist of robot-guided (RG), navigated (NV), or freehand (FH) screw insertion.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Degenerative Disc Disease | — | UNRESOLVED | — |
| Recurrent Disc Herniation | — | UNRESOLVED | — |
| Spinal Metastases | — | UNRESOLVED | — |
| Spinal Stenosis | — | UNRESOLVED | — |
| Spinal Tumor | — | UNRESOLVED | — |
| Spondylodiskitis | — | UNRESOLVED | — |
| Spondylolisthesis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Transpedicular Instrumentation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Robot-Guided Transpedicular Instrumentation
- description
- This arm will comprise all patients that receive transpedicular instrumentation by use of a robotic guidance system (SpineAssist or Renaissance, Mazor Robotics, Ltd., Caesarea, Israel or ROSA Spine, Medtech, Montpellier, France).
- interventionNames
- Procedure: Transpedicular Instrumentation
- label
- Navigated Transpedicular Instrumentation
- description
- This arm will comprise all patients that receive transpedicular instrumentation by use of navigation (computer assistance using CT, O-arm or 3D-fluoroscopic imaging).
- interventionNames
- Procedure: Transpedicular Instrumentation
- label
- Freehand Transpedicular Instrumentation
- description
- This arm will comprise all patients that receive transpedicular instrumentation by use of the conventional freehand technique.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria * Informed consent * Thoracolumbar pedicle screw placement * Indication for surgery: Degenerative pathologies (stenosis, spondylolisthesis, degenerative disc disease, recurrent disc herniation), infections, tumors, fractures, trauma * Age ≥ 18 Exclusion Criteria * Deformity surgery * \>5 index levels
References
Publications (14)
- BACKGROUNDGoldstein CL, Phillips FM, Rampersaud YR. Comparative Effectiveness and Economic Evaluations of Open Versus Minimally Invasive Posterior or Transforaminal Lumbar Interbody Fusion: A Systematic Review. Spine (Phila Pa 1976). 2016 Apr;41 Suppl 8:S74-89. doi: 10.1097/BRS.0000000000001462. PMID 26825793
- BACKGROUNDHu X, Lieberman IH. What is the learning curve for robotic-assisted pedicle screw placement in spine surgery? Clin Orthop Relat Res. 2014 Jun;472(6):1839-44. doi: 10.1007/s11999-013-3291-1. PMID 24048889
- BACKGROUNDSchatlo B, Martinez R, Alaid A, von Eckardstein K, Akhavan-Sigari R, Hahn A, Stockhammer F, Rohde V. Unskilled unawareness and the learning curve in robotic spine surgery. Acta Neurochir (Wien). 2015 Oct;157(10):1819-23; discussion 1823. doi: 10.1007/s00701-015-2535-0. Epub 2015 Aug 19. PMID 26287268
- BACKGROUNDMarcus HJ, Cundy TP, Nandi D, Yang GZ, Darzi A. Robot-assisted and fluoroscopy-guided pedicle screw placement: a systematic review. Eur Spine J. 2014 Feb;23(2):291-7. doi: 10.1007/s00586-013-2879-1. Epub 2013 Jun 26. PMID 23801017
- BACKGROUNDSchroder ML, Staartjes VE. Revisions for screw malposition and clinical outcomes after robot-guided lumbar fusion for spondylolisthesis. Neurosurg Focus. 2017 May;42(5):E12. doi: 10.3171/2017.3.FOCUS16534. PMID 28463610
- BACKGROUNDMolliqaj G, Schatlo B, Alaid A, Solomiichuk V, Rohde V, Schaller K, Tessitore E. Accuracy of robot-guided versus freehand fluoroscopy-assisted pedicle screw insertion in thoracolumbar spinal surgery. Neurosurg Focus. 2017 May;42(5):E14. doi: 10.3171/2017.3.FOCUS179. PMID 28463623
- BACKGROUNDSchatlo B, Molliqaj G, Cuvinciuc V, Kotowski M, Schaller K, Tessitore E. Safety and accuracy of robot-assisted versus fluoroscopy-guided pedicle screw insertion for degenerative diseases of the lumbar spine: a matched cohort comparison. J Neurosurg Spine. 2014 Jun;20(6):636-43. doi: 10.3171/2014.3.SPINE13714. Epub 2014 Apr 11.