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Safety and Performance of the SpineVision Posterior Fixation Systems in Thoracolumbar Spinal Treatment — FixedD3  

Intervertebral Disc Degeneration Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

The Fixed D3 study is a multicentric, non-randomized, ambispective, post market clinical follow-up study. This means that either subjects already implanted with one (1) of the Spinevision posterior fixations systems (Lumis, Plus or Ulis) - retrospective subjects - or subjects planned for treatment with one of the Spinevision posterior fixation system (prospective subjects) can be enrolled in the study. Standard of care data up to twenty four (24) months post Spinevision posterior fixation system implant procedure will be collected; key data include back and leg Visual Analogue Score (VAS) pain, Oswestry Disability Index (ODI) score, and adverse events. Data will be collected at pre-operative, per-operative, and post-operative Month 2, Month 6, Month 12 and Month 24. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06342765
Study type Observational
Source SpineVision
Contact Renaud Duchenes
Phone +33 6 86 16 61 91
Email r.duchenes@spinevision.com
Status Recruiting
Phase
Start date September 22, 2022
Completion date May 30, 2028
View Details
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