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Clinical Trials in Italy / NCT03398915
Active, not recruiting Observational

The European Robotic Spinal Instrumentation (EUROSPIN) Study

NCT03398915 · tracked via the Priya Life Science Italy tracker
Sponsor
Marc Schröder
Phase
Observational
Started
2019-01-01
Last updated
2026-03-31

Condition(s) studied

Degenerative Disc DiseaseSpondylolisthesisSpinal StenosisRecurrent Disc HerniationSpondylodiskitisSpinal TumorSpinal Metastases

Investigational drug(s) / intervention(s)

Transpedicular Instrumentation

Transpedicular Instrumentation: Transpedicular screw placement and instrumentation

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Revision Surgery for a Malpositioned Pedicle Screw — 12 months
    We defined the primary endpoint as required revision surgery for a malpositioned or loosened pedicle screw within the first postoperative year.

Trial sites (12)

FacilityCityRegionStatus
Medical University of Innsbruck Innsbruck Austria
La Pitié Salpetrière Hospital Paris France
Ortho-Klinik Dortmund Dortmund Germany
Universitätsmedizin Göttingen Göttingen Germany
Klinikum Rechts der Isar Munich Germany
M. Bufalini Hospital Cesena Italy
Azienda Ospedaliero Universitaria di Ferrara Ferrara Italy
Azienda Ospedaliera Papardo Messina Italy
Azienda Ospedaliera Sant'Andrea di Roma Roma Italy
Bergman Clinics Naarden Netherlands
Hospital Universitario La Paz Madrid Spain
HUG Geneva Geneva Canton of Geneva

Other trials for the same condition

Carbofix Pedicle Screw System: Evaluation of the Clinical and Radiographic Outcomes of the Use of a Carbon Fiber Device Compared to Titanium Devices in Patients Undergoing Spinal Arthrodesis for Degenerative Spinal Diseases Recruiting
Effects of a Single Session of Physiotherapy on Patients Operated for Lumbar Spondylolisthesis Starting soon
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03398915 on ClinicalTrials.gov ↗ ← All trials in Italy