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Recruiting NCT06342765

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

— Observational Intervertebral Disc Degeneration

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Pedicle fixation surgery.
Who it may be relevant to
Registry conditions: Intervertebral Disc Degeneration. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Safety and Performance of the SpineVision Posterior Fixation Systems Lumis®, Plus® and Ulis® in Thoracolumbar Spinal Degenerative Pathologies or Degenerative Disc Disease (DDD) Associated Pathologies Treatment - Fixed D3 Study

Overview

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.

Detailed description

The Fixed D3 study is a multicentric, non-randomized, ambispective, post market clinical follow-up study. This means that either subjects already implanted with one (1) of the Spinevision posterior fixations systems (Lumis, Plus or Ulis) - retrospective subjects - or subjects planned for treatment with one of the Spinevision posterior fixation system (prospective subjects) can be enrolled in the study.

Standard of care data up to twenty four (24) months post Spinevision posterior fixation system implant procedure will be collected; key data include back and leg Visual Analogue Score (VAS) pain, Oswestry Disability Index (ODI) score, and adverse events.

Data will be collected at pre-operative, per-operative, and post-operative Month 2, Month 6, Month 12 and Month 24.

Interventions

  • Device 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.

Primary outcome measures

  • Incidence of serious and non-serious device- and/or procedure-related adverse events [Time frame: Month 24]
  • Change of the Oswestry Disability Index (ODI) [Time frame: Month 12]
Secondary outcome measures (4)
  • Fusion success [Time frame: Month 2, month 6, month 12 and month 24]
  • Change of the Oswestry Disability Index (ODI) [Time frame: Month 2, month 6, month 12 and month 24]
  • Change of the back and leg Visual Analogue Score (VAS) [Time frame: Month 2, month 6, month 12 and month 24]
  • Incidence of revision surgery at implant site [Time frame: Month 2, month 6, month 12 and month 24]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 3 centers
  • DOSCEA Pôle Rachis — Bayonne
  • Clinique du dos Bordeaux-Terrefort — Bruges
  • Orthéo Neurochirurgie — Saint-Etienne

Identifiers

NCT: NCT06342765 · SV009

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗