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Идёт набор NCT06342765

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

— Наблюдательное Intervertebral Disc Degeneration

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Pedicle fixation surgery.
Кому может быть актуально
Состояния в реестре: Intervertebral Disc Degeneration. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Франция
Следующий шаг
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Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Устройство Pedicle 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.

Первичные конечные точки

  • Incidence of serious and non-serious device- and/or procedure-related adverse events [Срок оценки: Month 24]
  • Change of the Oswestry Disability Index (ODI) [Срок оценки: Month 12]
Вторичные конечные точки (4)
  • Fusion success [Срок оценки: Month 2, month 6, month 12 and month 24]
  • Change of the Oswestry Disability Index (ODI) [Срок оценки: Month 2, month 6, month 12 and month 24]
  • Change of the back and leg Visual Analogue Score (VAS) [Срок оценки: Month 2, month 6, month 12 and month 24]
  • Incidence of revision surgery at implant site [Срок оценки: Month 2, month 6, month 12 and month 24]

Критерии участия

Критерии включения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Франция · 3 центра
  • DOSCEA Pôle Rachis — Bayonne
  • Clinique du dos Bordeaux-Terrefort — Bruges
  • Orthéo Neurochirurgie — Saint-Etienne

Идентификаторы

NCT: NCT06342765 · SV009

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗