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.
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
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
All patients eligible for treatment or already treated with one (1) of the SpineVision posterior fixation system (Lumis®, Plus® or Ulis®) will be offered to participate in the study; this applies to primary care clinic.
Cohort
Other
Pedicle fixation surgery
DevicePedicle 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.
Incidence of serious and non-serious device- and/or procedure-related adverse events
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)
Oswestry Disability Index (ODI) mean score at Month 12 will be compared to the ODI mean score at baseline.
Fusion success
Fusion rate will be analyzed and compared to the state if the art.
Change of the Oswestry Disability Index (ODI)
Mean Oswestry Disability Index (ODI) score evolution score will be analyzed.
Change of the back and leg Visual Analogue Score (VAS)
Back and leg Visual Analogue Score (VAS) pain assessment will be analyzed.
Incidence of revision surgery at implant site
Rate of revision surgery at implant site will be analyzed and compared to the state of the art.
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SPINEVISION SAS
Lead sponsor
Slb Pharma
Collaborator
