Идёт набор NCT04244942

CERAMENT™| Bone Void Filler Device Registry

— Наблюдательное Orthopedic Disorder

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: CERAMENT BVF.
Кому может быть актуально: Состояния в реестре: Orthopedic Disorder. 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: США
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

A device registry to compile data on the performance of CERAMENT BONE VOID FILLER in normal use.

Подробное описание

A device registry to compile data on the performance of CERAMENT BONE VOID FILLER in normal use.

Вмешательства

Устройство CERAMENT BVF
CERAMENT BONE VOID FILLER is a synthetic biphasic bone graft substitute.

Первичные конечные точки

Unexpected device performance will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months [Срок оценки: 12 months]
Unexpected device performance will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months [Срок оценки: 18 months]
Complaints will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months [Срок оценки: 12 months]
Complaints will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months [Срок оценки: 18 months]
Adverse events will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months [Срок оценки: 12 and 18 months]
Adverse events will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months [Срок оценки: 12 months]
adverse device events will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months [Срок оценки: 18 months]
SAEs will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months [Срок оценки: 12 months]
SAEs will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months [Срок оценки: 18 months]

Вторичные конечные точки (4)

Radiological assessment at 6 and 12 months. Objective assessment of regeneration [Срок оценки: 6 Months]
Radiological assessment at 6 and 12 months. Objective assessment of regeneration [Срок оценки: 12 Months]
Pain VAS score [Срок оценки: 6, 12, and 18 Months]
EQ-5D-3L [Срок оценки: 6, 12, and 18 months]

Критерии участия

Критерии включения

18 years and over (on the day of surgery)
Receive CERAMENT BVF as a component of their treatment at a participating, contracted center or healthcare provider, in accordance with the IFU for the implanted product
In receipt of patient information leaflet and have signed appropriately designed informed consent