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

Study acronym: FixedD3
StatusRecruiting
PhaseNot specified
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv3
  2. Secondary endpoints: details revised at 2 of 4 entries
    • Primary endpoints revised (2)
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06342765
Lead Sponsor SPINEVISION SAS
Collaborators: Slb Pharma
Conditions
(from sponsor)		 Intervertebral Disc Degeneration
Related terms Intervertebral Disc Degeneration
Enrollment 330 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov