The European Robotic Spinal Instrumentation (EUROSPIN) Study

NCT03398915 | Active Not Recruiting Results

• 1 other identifier: EUROSPIN
• Study Type: observational
• Target: 932
• Locations: 7 countries
• Sites: 12

Brief Summary

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

Spondylolisthesis; Degenerative Disc Disease; Spinal Stenosis; Recurrent Disc Herniation; Spondylodiskitis; Spinal Tumor; Spinal Metastases

Keywords

robotic; robot-guided; navigated; computer-assisted; pedicle screw; instrumentation; thoracolumbar

Outcome Measures

Primary Outcomes (1)

• Revision Surgery for a Malpositioned Pedicle Screw

  We defined the primary endpoint as required revision surgery for a malpositioned or loosened pedicle screw within the first postoperative year.

  12 months

Secondary Outcomes (12)

• Intraoperative Screw Revision

  Intraoperative

• Duration of Surgery

  Intraoperative

• Length of Hospital Stay

  Through hospital stay (From admission to discharge of the hospital stay in which the primary surgery was carried out)

• Radiation Dose (DAP)

  Intraoperative

• Estimated Blood Loss

  Intraoperative

Other Outcomes (6)

• Frequency of Use of Analgetics

  2 years

• Satisfaction With Symptoms

  2 years

• Smoking Status

  2 years

Study Arms (3)

Robot-Guided Transpedicular Instrumentation

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).

Procedure: Transpedicular Instrumentation

Navigated Transpedicular Instrumentation

This arm will comprise all patients that receive transpedicular instrumentation by use of navigation (computer assistance using CT, O-arm or 3D-fluoroscopic imaging).

Procedure: Transpedicular Instrumentation

Freehand Transpedicular Instrumentation

This arm will comprise all patients that receive transpedicular instrumentation by use of the conventional freehand technique.

Procedure: Transpedicular Instrumentation

Interventions

Transpedicular Instrumentation PROCEDURE

Transpedicular screw placement and instrumentation

Freehand Transpedicular Instrumentation; Navigated Transpedicular Instrumentation; Robot-Guided Transpedicular Instrumentation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients receiving thoracolumbar transpedicular screw placement for degenerative pathologies (stenosis, spondylolisthesis, degenerative disc disease, recurrent disc herniation), infections, fractures, trauma, or tumors.

You may qualify if:

• 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

You may not qualify if:

• Deformity surgery
• \>5 index levels

Sponsors & Collaborators

• Marc Schröder: lead
• University Hospital, Zürich: collaborator

Study Sites (12)

Medical University of Innsbruck

Innsbruck, Austria

Location

La Pitié Salpetrière Hospital

Paris, France

Location

Ortho-Klinik Dortmund

Dortmund, Germany

Location

Universitätsmedizin Göttingen

Göttingen, Germany

Location

Klinikum Rechts der Isar

Munich, Germany

Location

M. Bufalini Hospital

Cesena, 47521, Italy

Location

Azienda Ospedaliero Universitaria di Ferrara

Ferrara, 44124, Italy

Location

Azienda Ospedaliera Papardo

Messina, 98158, Italy

Location

Azienda Ospedaliera Sant'Andrea di Roma

Roma, 00189, Italy

Location

Bergman Clinics

Naarden, GE, Netherlands

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

HUG Geneva

Geneva, Canton of Geneva, Switzerland

Location

Related Publications (14)

• Goldstein 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 BACKGROUND

• Hu 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 BACKGROUND

• Schatlo 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 BACKGROUND

• Marcus 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 BACKGROUND

• Schroder 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 BACKGROUND

• Molliqaj 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 BACKGROUND

• Schatlo 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.

  PMID: 24725180 BACKGROUND

• Rabin R, de Charro F. EQ-5D: a measure of health status from the EuroQol Group. Ann Med. 2001 Jul;33(5):337-43. doi: 10.3109/07853890109002087.

  PMID: 11491192 BACKGROUND

• Fairbank JC, Couper J, Davies JB, O'Brien JP. The Oswestry low back pain disability questionnaire. Physiotherapy. 1980 Aug;66(8):271-3. No abstract available.

  PMID: 6450426 BACKGROUND

• Roland M, Morris R. A study of the natural history of back pain. Part I: development of a reliable and sensitive measure of disability in low-back pain. Spine (Phila Pa 1976). 1983 Mar;8(2):141-4. doi: 10.1097/00007632-198303000-00004. No abstract available.

  PMID: 6222486 BACKGROUND

• Ostelo RW, Deyo RA, Stratford P, Waddell G, Croft P, Von Korff M, Bouter LM, de Vet HC. Interpreting change scores for pain and functional status in low back pain: towards international consensus regarding minimal important change. Spine (Phila Pa 1976). 2008 Jan 1;33(1):90-4. doi: 10.1097/BRS.0b013e31815e3a10.

  PMID: 18165753 BACKGROUND

• R Core Team. R: A Language and Environment for Statistical Computing. (R Foundation for Statistical Computing, 2017).

  BACKGROUND

• Staartjes VE, Klukowska AM, Schroder ML. Pedicle Screw Revision in Robot-Guided, Navigated, and Freehand Thoracolumbar Instrumentation: A Systematic Review and Meta-Analysis. World Neurosurg. 2018 Aug;116:433-443.e8. doi: 10.1016/j.wneu.2018.05.159. Epub 2018 May 31.

  PMID: 29859354 BACKGROUND

• Staartjes VE, Molliqaj G, van Kampen PM, Eversdijk HAJ, Amelot A, Bettag C, Wolfs JFC, Urbanski S, Hedayat F, Schneekloth CG, Abu Saris M, Lefranc M, Peltier J, Boscherini D, Fiss I, Schatlo B, Rohde V, Ryang YM, Krieg SM, Meyer B, Kogl N, Girod PP, Thome C, Twisk JWR, Tessitore E, Schroder ML. 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. BMJ Open. 2019 Sep 8;9(9):e030389. doi: 10.1136/bmjopen-2019-030389.

  PMID: 31501123 DERIVED

MeSH Terms

Conditions

Intervertebral Disc Degeneration; Spondylolisthesis; Spinal Stenosis; Intervertebral Disc Displacement; Discitis; Spinal Cord Neoplasms

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Spondylolysis; Spondylosis; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Spondylitis; Bone Diseases, Infectious; Infections; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Victor Staartjes
• Organization: University Hospital Zurich

victoregon.staartjes@usz.ch

+41 44 255 2660

Study Officials

• Victor E Staartjes, MD, PhD

  Department of Neurosurgery, University Hospital Zurich

  STUDY DIRECTOR

• Granit Molliqaj, MD

  Department of Neurosurgery, Hôpitaux Universitaires de Genève

  PRINCIPAL INVESTIGATOR

• Enrico Tessitore, MD

  Department of Neurosurgery, Hôpitaux Universitaires de Genève

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Department

Study Record Dates

• First Submitted: January 7, 2018
• First Posted: January 16, 2018
• Study Start: January 1, 2019
• Primary Completion: January 30, 2026
• Study Completion: May 1, 2026
• Last Updated: March 31, 2026
• Results First Posted: March 31, 2026

Record last verified: 2026-03

Locations

NL (1); CH (1); DE (3); AU (1); FR (1); IT (4); ES (1)