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

Launched by SPINEVISION SAS · Mar 26, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the safety and effectiveness of three specific spinal fixation systems—Lumis®, Plus®, and Ulis®—designed to help patients with conditions related to degenerative disc disease, which is when the disks in the spine break down and cause pain. The trial aims to gather information on how well these devices work and if they cause any problems for patients after surgery. Participants who are at least 18 years old and have had one of these systems implanted can take part in the study. They will be asked about their back and leg pain, any difficulties they face in daily life, and whether they have experienced any side effects for up to two years after their surgery.

If you decide to join the study, you will be part of a group that helps researchers understand the outcomes of this treatment. However, not everyone can participate. For instance, if you have certain medical conditions like severe allergies to the materials used in the implants, recent infections, or specific types of bone diseases, you may not be eligible. It's important to discuss any concerns with your doctor to see if this trial is right for you. Your feedback will be valuable in determining the best approaches to treating spinal issues in the future.

Gender

ALL

Eligibility 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