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Safety and Performance of the SpineVision Posterior Fixation Systems in Thoracolumbar Spinal Treatment

NCT06342765 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 330

Last updated 2026-03-18

No results posted yet for this study

Summary

The goal of this observational study is to confirm the safety and performance of the three (3) Spinevision posterior fixations systems Lumis®, Plus® and Ulis® , in the treatment of patient suffering from thoracolumbar spinal degenerative pathologies, or degenerative disc disease (disease that occurs when the spinal disk break down) associated pathologies.

Part of their standard of care, participants will be questioned on their back and leg pains, their disability and if they have encountered any adverse effects since the Spinevision posterior fixation system implant surgery. Those data will be collected up to twenty four (24) months after the Spinevision posterior fixation system implant surgery.

Conditions

  • Intervertebral Disc Degeneration

Interventions

DEVICE

Pedicle fixation surgery

Pedicle fixation surgery indicates a surgical approach in the thoracic spine down to sacral spine to either support interbody fusion (fusion of the discal space between two vertebrae) , or to correct spinal deformity.

Sponsors & Collaborators

  • Slb Pharma

    collaborator OTHER

  • SPINEVISION SAS

    lead INDUSTRY

Principal Investigators

  • Benjamin Pommier · Orthéo Neurochirurgie

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-22
Primary Completion
2028-05-30
Completion
2028-05-30
FDA Device
Yes

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06342765 on ClinicalTrials.gov