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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Device
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patient implanted with Lumis®, Plus® or Ulis® posterior fixation system

• Patient of 18 years old and more

• Patient has provided signed informed consent or did not oppose to his/her data collection, per local regulation

Locations
Other Locations
France
DOSCEA Pôle Rachis
RECRUITING
Bayonne
Clinique du dos Bordeaux-Terrefort
RECRUITING
Bruges
Orthéo Neurochirurgie
RECRUITING
Saint-etienne
Contact Information
Primary
Renaud Duchenes
r.duchenes@spinevision.com
+33 6 86 16 61 91
Backup
Hanta Ranaivoson
h.ranaivoson@spinevision.com
Time Frame
Start Date: 2022-09-22
Estimated Completion Date: 2028-05-30
Participants
Target number of participants: 330
Related Therapeutic Areas
Sponsors
Leads: SPINEVISION SAS
Collaborators: Slb Pharma

This content was sourced from clinicaltrials.gov