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Идёт набор NCT05299762

A Post Market Surveillance on INFUSE Bone Graft

— Наблюдательное Intervertebral Disc Degeneration Spinal Fusion Lumbar Disc Disease

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: INFUSE™ Bone Graft.
Кому может быть актуально
Состояния в реестре: Intervertebral Disc Degeneration, Spinal Fusion, Lumbar Disc Disease. 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
South Korea
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

This study aims to evaluate the safety and effectiveness of INFUSE™ Bone Graft in the real-world setting in Korea.

Подробное описание

This study is a prospective, observational, multi-center, post-market surveillance to collect patient data regarding on-label use of INFUSE™ Bone Graft for lumbar fusion via ALIF or OLIF. Commercially available device will be used within its intended use.

This study is supposed to be conducted during a period of 4 years with 600 or more cases after the product approval in Korea. According to the standard of care in Korea, the patients will be followed at least 12 months post-surgery.

Вмешательства

  • Устройство INFUSE™ Bone Graft
    Ministry of Food and Drug Safety (MFDS) has approved the INFUSE™ Bone Graft for anterior (ALIF) or oblique (OLIF) lumbar interbody spine fusion as a substitute for autogenous bone graft for patients with degenerative disc disease (DDD) who have had at least 6 months of non-operative treatment for this condition.

Первичные конечные точки

  • Adverse device effects by 12 months post-surgery [Срок оценки: Surgery to 12 months]
  • Fusion status at last assessment by 12 months post-surgery [Срок оценки: Surgery to 12 months]
Вторичные конечные точки (4)
  • Adverse events of interest up to 12 months post-surgery [Срок оценки: Surgery to 12 months]
  • Clinical outcome (ODI) at 6 weeks, 3, 6, 12 months post-surgery [Срок оценки: Baseline (pre-op) to 12 months]
  • Clinical outcome (VAS) at 6 weeks, 3, 6, 12 months post-surgery [Срок оценки: Baseline (pre-op) to 12 months]
  • Rate of neurological success at 6 weeks, 3, 6, 12 months post-surgery [Срок оценки: Baseline (pre-op) to 12 months]

Критерии участия

Критерии включения

  • Has degenerative disc disease and is indicated for lumbar interbody spine fusion from L2-S1 with INFUSE™ Bone Graft via ALIF or OLIF technique
  • Agrees to participate in the study and is able to understand and sign the Informed Consent
  • The procedure planned for the patient complies with the labeling of the devices that may be used in the surgical procedure
  • Has at least six months of nonoperative treatment prior to the study treatment
  • Is at least 18 years old at the time of informed consent

Критерии исключения

  • Has a known hypersensitivity to recombinant human Bone Morphogenetic Protein-2, bovine Type I collagen, or to other components of the formulation
  • Has any active malignancy or undergoes treatment for a malignancy, or operative site is in the vicinity of a resected or extant tumor
  • Is skeletally immature (<18 years of age or no radiographic evidence of epiphyseal closure)
  • Is pregnant or lactating
  • Has an active infection at the operative site or with an allergy to titanium, titanium alloy, or polyetheretherketone
  • The use of the Infuse™ Bone Graft component implanted at locations other than the lower lumbar spine (e.g., cervical spine)
  • Repeat applications of the Infuse™ Bone Graft component
  • Has up to Grade 1 retrolisthesis
  • Has hepatic or renal impairment
  • Has metabolic bone disease
  • Has autoimmune disease
  • Has immunosuppressive disease or suppressed immune systems resulting from radiation therapy, chemotherapy, steroid therapy, or other treatments
  • Is illiterate or vulnerable (e.g., the participant is incapable of judgment or is under tutelage) as per the investigator's assessment
  • Concurrent participation in another clinical study that may confound study results
  • Has a considerable risk for surgery
  • Has a condition that could compromise study (e.g., mentally incompetent, alcohol or drug abuse) as per the investigator's assessment

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

South Korea · 1 центр
  • Chung-Ang Gwangmyeong Hospital — Seoul

Идентификаторы

NCT: NCT05299762 · MDT21006

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗