Safety and Performance of the SpineVision Posterior Fixation Systems in Thoracolumbar Spinal Treatment
- Conditions
- Intervertebral Disc Degeneration
- Registration Number
- NCT06342765
- Lead Sponsor
- SPINEVISION SAS
- 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 330
- 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
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method Change of the back and leg Visual Analogue Score (VAS) Month 2, month 6, month 12 and month 24 Back and leg Visual Analogue Score (VAS) pain assessment will be analyzed.
Change of the Oswestry Disability Index (ODI) Month 2, month 6, month 12 and month 24 Mean Oswestry Disability Index (ODI) score evolution score will be analyzed.
Incidence of revision surgery at implant site Month 2, month 6, month 12 and month 24 Rate of revision surgery at implant site will be analyzed and compared to the state of the art.
Fusion success Month 2, month 6, month 12 and month 24 Fusion rate will be analyzed and compared to the state if the art.
Trial Locations
- Locations (3)
Orthéo Neurochirurgie
🇫🇷Saint-Étienne, France
Clinique du dos Bordeaux-Terrefort
🇫🇷Bruges, France
DOSCEA Pôle Rachis
🇫🇷Bayonne, France