AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

← Trials
🧪

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

Recruitingn/aAges 18 Years - anyAllSPINEVISION SAS
💬

In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Exclusion Criteria: contra-indication * trauma (i.e., fracture or dislocation) * Known or suspected allergy or intolerance to the implanted material, mainly to metal (e.g., cobalt, chromium, nickel, etc.) * Any other medical or surgical condition likely to compromise the success of instrumented surgery, such as the presence of a malignant tumor or serious congenital abnormalities, raised erythrocyte sedimentation rate not explained by other diseases, high white blood cell count or a tendency to low white blood cell count * All cases not described in the indications * Localized infection of the operative site * All patients with insufficient tissue cover of the operative site * Local signs of inflammation * Fever or leukocytosis * Pathological obesity * Pregnancy * Mental illness * Rapidly evolving joint diseases, bone absorption, osteopenia and/or osteoporosis. Osteoporosis is a relative contraindication, as this medical condition can limit the expected correction gain and stability of mechanical fixation * All cases not requiring bone graft or bone fusion * When pedicular screws are used, absence or malformation of pedicles * All cases requiring a combination of different metals * All patients not agreeing to comply with post-operative instructions
💊

What it tests

  • Pedicle fixation surgery
📍

Where

3 sites
DOSCEA Pôle Rachis
Bayonne, France
Clinique du dos Bordeaux-Terrefort
Bruges, France
Orthéo Neurochirurgie
Saint-Etienne, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
🛡️

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it — not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use · Privacy