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NCT03398915: EUROSPIN

The European Robotic Spinal Instrumentation (EUROSPIN) Study

Active, enrolled Results posted Last updated 31 March 2026
What this trial tests

trial testing Transpedicular Instrumentation in Degenerative Disc Disease in 932 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline
1 January 2019
Primary endpoint
30 January 2026
1 May 2026

Quick facts

Lead sponsorMarc Schröder
StatusActive, enrolled
Study typeOBSERVATIONAL
Enrollment932
Start date1 January 2019
Primary completion30 January 2026
Estimated completion1 May 2026
Sites12 locations across France, Italy, Netherlands, Austria, Germany, Switzerland, Spain

Drugs / interventions tested

Conditions studied

Sponsor

Marc Schröder

Who can join

18 and older, any sex, with Degenerative Disc Disease or Spondylolisthesis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Revision Surgery for a Malpositioned Pedicle Screw Primary · 12 months

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

GroupValue95% CI
Robot Guided4
Navigated7
Freehand4

Adverse events — posted to ClinicalTrials.gov

Time frame: 1 year. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Robot-Guided Transpedicular Instrumentation
Serious: 4/389 (1%)
Deaths: 1/389
Navigated Transpedicular Instrumentation
Serious: 7/198 (4%)
Deaths: 11/198
Freehand Transpedicular Instrumentation
Serious: 4/315 (1%)
Deaths: 8/315

Serious adverse events (1 terms)

ReactionSystemRobot-Guided Transpedicula…Navigated Transpedicular I…Freehand Transpedicular In…
Revision Surgery for Malposition/LooseningMusculoskeletal and connective tissue disorders
Other adverse events (1 terms — click to expand)

ReactionSystemRobot-Guided Transpedicula…Navigated Transpedicular I…Freehand Transpedicular In…
Surgical ComplicationsSurgical and medical procedures

Most-reported serious reactions: Revision Surgery for Malposition/Loosening.

Data from ClinicalTrials.gov NCT03398915 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. 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, Molliqaj G, van Kampen PM, Eversdijk HAJ, et al · · 2019 · cited 14× · PMID 31501123 · DOI 10.1136/bmjopen-2019-030389

Verify or expand the search:

Other recruiting trials for Degenerative Disc Disease

Currently open trials in the same condition.

Other Marc Schröder trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03398915.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing