NCT06342765 Safety and Performance of the SpineVision Posterior Fixation Systems in Thoracolumbar Spinal Treatment
| NCT ID | NCT06342765 |
| Status | Recruiting |
| Phase | — |
| Sponsor | SPINEVISION SAS |
| Condition | Intervertebral Disc Degeneration |
| Study Type | OBSERVATIONAL |
| Enrollment | 330 participants |
| Start Date | 2022-09-22 |
| Primary Completion | 2028-05-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 330 participants in total. It began in 2022-09-22 with a primary completion date of 2028-05-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Benjamin Pommier
PRINCIPAL INVESTIGATOR
Orthéo Neurochirurgie
Frequently Asked Questions
Who can join the NCT06342765 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Intervertebral Disc Degeneration. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06342765 currently recruiting?
Yes, NCT06342765 is actively recruiting participants. Contact the research team at r.duchenes@spinevision.com for enrollment information.
Where is the NCT06342765 trial being conducted?
This trial is being conducted at Bayonne, France, Bruges, France, Saint-Etienne, France.
Who is sponsoring the NCT06342765 clinical trial?
NCT06342765 is sponsored by SPINEVISION SAS. The principal investigator is Benjamin Pommier at Orthéo Neurochirurgie. The trial plans to enroll 330 participants.