Evaluating the safety and performance of SpineVision's posterior fixation systems for spinal treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.