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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSPINEVISION SAS

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Pedicle fixation surgery

Treatment groups

No treatment groups listed

Sponsors and collaborators

SPINEVISION SAS

Lead sponsor

Slb Pharma

Collaborator