We defined the primary endpoint as required revision surgery for a malpositioned or loosened pedicle screw within the first postoperative year.
| Group | Value | 95% CI |
|---|---|---|
| Robot Guided | 4 | |
| Navigated | 7 | |
| Freehand | 4 |
Last reviewed · How we verify
The European Robotic Spinal Instrumentation (EUROSPIN) Study
trial testing Transpedicular Instrumentation in Degenerative Disc Disease in 932 participants. Participants enrolled and being followed up; not accepting new ones.
| Lead sponsor | Marc Schröder |
|---|---|
| Status | Active, enrolled |
| Study type | OBSERVATIONAL |
| Enrollment | 932 |
| Start date | 1 January 2019 |
| Primary completion | 30 January 2026 |
| Estimated completion | 1 May 2026 |
| Sites | 12 locations across France, Italy, Netherlands, Austria, Germany, Switzerland, Spain |
Marc Schröder
18 and older, any sex, with Degenerative Disc Disease or Spondylolisthesis. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
We defined the primary endpoint as required revision surgery for a malpositioned or loosened pedicle screw within the first postoperative year.
| Group | Value | 95% CI |
|---|---|---|
| Robot Guided | 4 | |
| Navigated | 7 | |
| Freehand | 4 |
Time frame: 1 year. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Robot-Guided Transpedicula… | Navigated Transpedicular I… | Freehand Transpedicular In… |
|---|---|---|---|---|
| Revision Surgery for Malposition/Loosening | Musculoskeletal and connective tissue disorders | — | — | — |
| Reaction | System | Robot-Guided Transpedicula… | Navigated Transpedicular I… | Freehand Transpedicular In… |
|---|---|---|---|---|
| Surgical Complications | Surgical and medical procedures | — | — | — |
Most-reported serious reactions: Revision Surgery for Malposition/Loosening.
Data from ClinicalTrials.gov NCT03398915 adverse events section.
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.
1 peer-reviewed publication reference this trial (live from Europe PMC):
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