Safety and Performance of the SpineVision Posterior Fixation Systems in Thoracolumbar Spinal Treatment
Recruiting now
Conditions studied: Intervertebral Disc Degeneration
In brief
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.
Key facts
- Study ID
- NCT06342765
- Run by
- SPINEVISION SAS
- People needed
- 330
- Starts
- 2022-09-22
- Expected to finish
- 2028-05-30
- Last updated by the study team
- 2026-03-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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 it is running
- DOSCEA Pôle Rachis — Bayonne, France (enrolling)
- Clinique du dos Bordeaux-Terrefort — Bruges, France (enrolling)
- Orthéo Neurochirurgie — Saint-Etienne, France (enrolling)
Full record on ClinicalTrials.gov
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