Actively Recruiting
Safety and Performance of the SpineVision Posterior Fixation Systems Lumis®, Plus® and Ulis® in Thoracolumbar Spinal Degenerative Pathologies or Degenerative Disc Disease Treatment - Fixed D3 Study
Led by SPINEVISION SAS · Updated on 2026-03-18
330
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
Sponsors
S
SPINEVISION SAS
Lead Sponsor
S
Slb Pharma
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and performance of three Spinevision posterior fixation systems—Lumis®, Plus®, and Ulis®—for 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 device's 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.
CONDITIONS
Brief Title
Safety and Performance of the SpineVision Posterior Fixation Systems in Thoracolumbar Spinal Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 data collection according to local regulation
You will not qualify if you...
- Trauma such as fracture or dislocation
- Known or suspected allergy or intolerance to implanted metals like cobalt, chromium, or nickel
- Medical or surgical conditions compromising surgery success, including malignant tumors or serious congenital abnormalities
- Cases not described in the indications
- Localized infection or inflammation at the surgical site
- Fever or abnormal white blood cell counts
- Pathological obesity
- Pregnancy
- Mental illness
- Rapidly evolving joint diseases, bone absorption, osteopenia, or osteoporosis
- Cases not requiring bone graft or fusion
- Absence or malformation of pedicles when screws are used
- Cases requiring a combination of different metals
- Non-compliance with post-operative instructions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Day of surgery and hospital recovery period
Participants undergo pedicle fixation surgery in the thoracic to sacral spine to support interbody fusion or correct spinal deformity, followed by immediate post-operative care.
1 surgery visit (in-person) and immediate post-operative care
Duration - Up to 24 months post-surgery
Participants are followed for up to 24 months after the surgery to monitor safety, fusion success, pain levels, disability scores, and any revision surgeries.
Visits at Month 2, Month 6, Month 12, and Month 24 (in-person)
Trial Site Locations
Total: 3 locations
1
DOSCEA Pôle Rachis
Bayonne, France, 64100
Actively Recruiting
2
Clinique du dos Bordeaux-Terrefort
Bruges, France, 33520
Actively Recruiting
3
Orthéo Neurochirurgie
Saint-Etienne, France, 42199
Actively Recruiting
Research Team
R
Renaud Duchenes
H
Hanta Ranaivoson
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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