Actively Recruiting
Safety and Performance of the SpineVision Posterior Fixation Systems in Thoracolumbar Spinal Treatment
Led by SPINEVISION SAS · Updated on 2026-03-18
330
Participants Needed
3
Research Sites
296 weeks
Total Duration
On this page
Sponsors
S
SPINEVISION SAS
Lead Sponsor
S
Slb Pharma
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 Lumis4, Plus4 or Ulis4 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
You will not qualify if you...
- Trauma such as fracture or dislocation
- Known or suspected allergy or intolerance to the implanted material, mainly to metal (e.g., cobalt, chromium, nickel)
- Any medical or surgical condition compromising instrumented surgery success, including malignant tumor or serious congenital abnormalities
- Raised erythrocyte sedimentation rate unexplained by other diseases
- High or low white blood cell count
- Cases not described in the indications
- Localized infection of the operative site
- 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, or osteoporosis (osteoporosis is a relative contraindication)
- Cases not requiring bone graft or bone fusion
- Absence or malformation of pedicles when pedicular screws are used
- Cases requiring a combination of different metals
- Patients not agreeing to comply with post-operative instructions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
H
Hanta Ranaivoson
CONTACT
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
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here