Evaluating the safety and performance of SpineVision's posterior fixation systems for spinal treatment
Safety and Performance of the SpineVision Posterior Fixation Systems Lumis®, Plus® and Ulis® in Thoracolumbar Spinal Degenerative Pathologies or Degenerative Disc Disease (DDD) Associated Pathologies Treatment - Fixed D3 Study
This study is testing how safe and effective three different SpineVision devices are for treating people with spinal problems in their lower back.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 330 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Spinevision Sas Industry-sponsored |
| Locations | 3 sites (Bayonne and 2 other locations) |
| Trial ID | NCT06342765 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the safety and effectiveness of three SpineVision posterior fixation systems—Lumis®, Plus®, and Ulis®—in treating patients with thoracolumbar spinal degenerative conditions. Participants, either already implanted with these systems or scheduled for surgery, will be monitored for up to 24 months post-implantation. Data collected will include pain levels, disability scores, and any adverse events experienced. The study employs a multicentric, non-randomized design to gather comprehensive insights into patient outcomes.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who have been implanted with the Lumis®, Plus®, or Ulis® posterior fixation systems.
Not a fit: Patients with contraindications such as trauma, known allergies to the implant materials, or other serious medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance treatment protocols for patients suffering from intervertebral disc degeneration by confirming the safety and effectiveness of these fixation systems.
How similar studies have performed: While this study builds on existing knowledge of spinal fixation systems, its specific focus on the SpineVision systems in a multicentric observational context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Bayonne and 2 other locations
- DOSCEA Pôle Rachis — Bayonne, France (Recruiting)
- Clinique du dos Bordeaux-Terrefort — Bruges, France (Recruiting)
- Orthéo Neurochirurgie — Saint-Etienne, France (Recruiting)
Study contacts
- Principal investigator: Benjamin Pommier — Orthéo Neurochirurgie
- Study coordinator: Renaud Duchenes
- Email: r.duchenes@spinevision.com
- Phone: +33 6 86 16 61 91
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.