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Идёт набор NCT05997121

Safety and Performance of the Hexanium TLIF System in the Treatment of Degenerative Disc Disease

— 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: Transforaminal lumbar interbody fusion.
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, Швейцария
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Safety and Performance of the Hexanium TLIF System in the Treatment of Skeletally Mature Patients Suffering From Degenerative Disc Disease - Hexanium TLIF Study

Обзор

The goal of this observational study is to confirm the safety and efficacy of the Hexanium TLIF system in the treatment of skeletally mature patients suffering from degenerative disc disease (disease that occurs when the spinal disk break down). 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 Hexanium TLIF system implant surgery. Those data will be collected up to twenty four (24) months after the Hexanium TLIF system implant surgery.

Подробное описание

The Hexanium TLIF study is a multicentric, international, ambispective, post market clinical follow-up study. This means that either subjects already implanted with the Hexanium TLIF system (retrospective subjects) or subjects planned for treatment with the Hexanium TLIF (prospective subjects) can be enrolled in the study.

Standard of care subjects data up to twenty four (24) months post Hexanium TLIF system implant procedure will be collected; key data include back and leg Visual Analogue Score (VAS), Oswestry Disability Index (ODI) score, and adverse events.

Data will be collected at Month 2, Month 6, Month 12 and Month 24 post surgery.

Вмешательства

  • Устройство Transforaminal lumbar interbody fusion
    Transforaminal Lumbar Interbody Fusion indicates a surgical approach in the lumbar spine to fuse the discal space between two vertebrae. These are joined by removing the disc and placing a cage in its place to restore the vertebral height. Screws and rods are also added to maintain the level secure while the bones fuse together.

Первичные конечные точки

  • Incidence of serious adverse device and/or procedure related 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, 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 planned for Hexanium TLIF system implant or patient implant with Hexanium TLIF system (not prior to July 2021)
  • Patient of 18 years old or more
  • Patient has provided signed informed consent, or did not oppose to his/her data collection, per local regulation

Exclusion Criteria: contra-indication

  • Infection, local to the operative site
  • Signed of local inflammation
  • Fever or leukocytosis
  • Morbid obesity
  • Pregnancy
  • Paediatric cases, or patient still having general skeletal growth
  • Spondylolisthesis unable to be reduced to Grade I
  • Suspected or documented allergy or intolerance to metal
  • Any case where the implant components selected for use would be too large or too small to achieve a successful result
  • Any patient having inadequate tissue coverage over the operative site or inadequate bone stock or quality
  • Any patient in which implant utilization would interfere with anatomical structures or expected physiological performance
  • Prior fusion at the level to be treated
  • Any case not needing a bone graft or fusion
  • Any abnormality present which affects the normal process of bone remodelling including, but not limited to severe osteoporosis involving spine, bone absorption, osteopenia, primary or metastasis tumours involving the spine, active infection at the site or certain metabolic disorders affecting osteogenesis
  • Any other condition which would preclude the potential benefit of spinal implant surgery, such as the presence of tumours or congenital abnormalities, fracture local to operating site, elevation of segmentation rate unexplained by other diseases, elevation of white blood count (WBC), or marked left shift in the WBC differential count
  • Mental illness
  • Any patient unwilling to cooperate with post-operative instructions

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

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Франция · 5 центров
  • Clinique du dos Terrefort — Bruges
  • Clinique Saint Charles — Lyon
  • Hopital privé Clairval — Marseille
  • CHRU Nancy — Nancy
  • Polyclinique Majorelle — Nancy
Швейцария · 1 центр
  • Clinicque Générale Beaulieu — Geneva

Идентификаторы

NCT: NCT05997121 · SV005

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗