Clinical trial NCT06342765: Safety and Performance of the SpineVision Posterior Fixation Systems in Thoracolumbar Spinal Treatment
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Intervertebral Disc Degeneration
Keywords: Lumbar
Spine
Fusion
Posterior fixation
Oswestry disability index
Visual Analogue Score
Lead sponsor: SPINEVISION SAS
Sponsor class: INDUSTRY
Collaborators: name: Slb Pharma
First posted: 2024-04-02
Enrollment: 330
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

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

Primary outcomes:
measure: Incidence of serious and non-serious device- and/or procedure-related adverse events
timeFrame: Month 24
measure: Change of the Oswestry Disability Index (ODI)
timeFrame: Month 12
Secondary outcomes:
measure: Fusion success
timeFrame: Month 2, month 6, month 12 and month 24
measure: Change of the Oswestry Disability Index (ODI)
timeFrame: Month 2, month 6, month 12 and month 24
measure: Change of the back and leg Visual Analogue Score (VAS)
timeFrame: Month 2, month 6, month 12 and month 24
measure: Incidence of revision surgery at implant site
timeFrame: Month 2, month 6, month 12 and month 24
Other outcomes:
Locations:
city: Bayonne
country: France
facility: DOSCEA Pôle Rachis
city: Bruges
country: France
facility: Clinique du dos Bordeaux-Terrefort
city: Saint-Étienne
country: France
facility: Orthéo Neurochirurgie
Study officials:
affiliation: Orthéo Neurochirurgie
name: Benjamin Pommier
role: PRINCIPAL_INVESTIGATOR
References: