RecruitingNCT06342765

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

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

Sponsor

SPINEVISION SAS

Enrollment

330 participants

Start Date

Sep 22, 2022

Study Type

OBSERVATIONAL

Conditions

Intervertebral disc degeneration

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

Min Age: 18 Years

Inclusion Criteria3

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 Criteria16

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

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Interventions

DEVICEPedicle 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.