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

Phase

N/A

Condition

N/A

Treatment

Pedicle fixation surgery

Clinical Study ID

NCT06342765

SV009

Ages > 18
All Genders

Study 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

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 datacollection, per local regulation

Exclusion

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 ofinstrumented surgery, such as the presence of a malignant tumor or serious congenitalabnormalities, 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 theexpected 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

Pedicle fixation surgery

September 22, 2022

May 30, 2028

Study 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.

Connect with a study center

DOSCEA Pôle Rachis
Bayonne, 64100
France
Active - Recruiting
Clinique du dos Bordeaux-Terrefort
Bruges, 33520
France
Active - Recruiting
Orthéo Neurochirurgie
Saint-Étienne, 42199
France
Active - Recruiting

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