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RECRUITING
NCT06342765

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

Sponsor: SPINEVISION SAS

View on ClinicalTrials.gov

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.

Official title: Safety and Performance of the SpineVision Posterior Fixation Systems Lumis®, Plus® and Ulis® in Thoracolumbar Spinal Degenerative Pathologies or Degenerative Disc Disease (DDD) Associated Pathologies Treatment - Fixed D3 Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

330

Start Date

2022-09-22

Completion Date

2028-05-30

Last Updated

2026-03-18

Healthy Volunteers

No

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.

Locations (3)

DOSCEA Pôle Rachis

Bayonne, France

Clinique du dos Bordeaux-Terrefort

Bruges, France

Orthéo Neurochirurgie

Saint-Etienne, France