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Clinical Trials in France / NCT06342765
Recruiting Observational

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

NCT06342765 · tracked via the Priya Life Science France tracker
Sponsor
SPINEVISION SAS
Phase
Observational
Started
2022-09-22
Last updated
2026-03-18

Condition(s) studied

Intervertebral Disc Degeneration

Investigational drug(s) / intervention(s)

Pedicle fixation surgery

Pedicle fixation surgery: Pedicle fixation surgery indicates a surgical approach in the thoracic spine down to sacral spine to either support interbody fusion (fusion of the discal space between two vertebrae) , or to correct spinal deformity.

Study summary

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Incidence of serious and non-serious device- and/or procedure-related adverse events — Month 24
    Rate of the serious and non-serious device- and/or procedure-related adverse events will be analyzed and compared to the state of the art.
  • Change of the Oswestry Disability Index (ODI) — Month 12
    Oswestry Disability Index (ODI) mean score at Month 12 will be compared to the ODI mean score at baseline.

Trial sites (3)

FacilityCityRegionStatus
DOSCEA Pôle Rachis Bayonne France Recruiting
Clinique du dos Bordeaux-Terrefort Bruges France Recruiting
Orthéo Neurochirurgie Saint-Etienne France Recruiting

More SPINEVISION SAS trials in France

Safety and Performance of the Hexanium TLIF System in the Treatment of Degenerative Disc Disease Recruiting
Safety and Performance of the SPINEVISION Hexanium ACIF in the Treatment of Cervical Spine Degenerative Disc Disease Active, not recruiting

Other trials for the same condition

Safety and Performance of the Hexanium TLIF System in the Treatment of Degenerative Disc Disease Recruiting
Safety and Performance of the SPINEVISION Hexanium ACIF in the Treatment of Cervical Spine Degenerative Disc Disease Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06342765 on ClinicalTrials.gov ↗ ← All trials in France