NCT06342765

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

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
• Phase: —
• Study type: Observational
• Enrollment: 330 (estimated)
• Sponsor: SPINEVISION SAS · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Intervertebral Disc Degeneration

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-09-22
• Primary completion: 2028-05-30
• Completion: 2028-05-30
• First posted: 2024-04-02
• Last updated: 2026-03-18

Locations

3 sites across 1 country: France

Regulatory

• FDA-regulated device study