The European Robotic Spinal Instrumentation (EUROSPIN) Study

NCT03398915 · tracked via the Priya Life Science Germany 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

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)

Facility	City	Region
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

Preoperative Stereotactic Radiotherapy for Treatment of Spinal Metastases Recruiting

PMCF Neo Pedicle Screw and Cage Systems Active, not recruiting

Post-Market Clinical Follow-Up Study on the Safety and Performance of Ennovate® Cervical Recruiting

Clinical Outcome and Fusion Rate of 3D Printed Interbody Fusion Cages and Titanium Coated PEEK Cages Active, not recruiting

LISA Post Market Clinical Follow-Up Study: Documentation of Clinical Outcomes After Surgery With LISA Implant Recruiting

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 Germany