Safety and Effectiveness of SpineVision Posterior Fixation Systems Lumis, Plus, and Ulis for Treating Thoracolumbar Spine Degeneration or Degenerative Disc Disease

What this Trial Is About

Researchers are evaluating the safety and performance of three Spinevision posterior fixation systemsLumis, Plus, and Ulisfor treating patients with thoracolumbar spinal degenerative conditions, including degenerative disc disease. This observational study includes both patients who have already received one of these implants and those planned for treatment, aiming to understand outcomes up to 24 months after surgery. The study follows participants who have undergone pedicle fixation surgery, a procedure supporting spinal fusion or correcting deformities from the thoracic spine to the sacral spine. Data collection occurs at key timepoints before surgery, during surgery, and post-operatively at 2, 6, 12, and 24 months. The focus is on assessing pain levels, disability, fusion success, and any adverse events related to the device or procedure. Participants will be asked about their back and leg pain using the Visual Analogue Score VAS, disability through the Oswestry Disability Index ODI, and any complications or need for revision surgery. These assessments help measure the devices safety and effectiveness over two years. The study also monitors for serious and non-serious device- or procedure-related adverse events throughout the follow-up period.

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