Набор скоро начнётся NCT07594639

GRACE II (General Retrospective Analysis of Commercial Experience With AGN1 LOEP)

— Наблюдательное Osteoporosis

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: AGN1 LOEP.
Кому может быть актуально: Состояния в реестре: Osteoporosis. Базовые параметры: Без ограничений · 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: Бельгия
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

Retrospective Study of OSSURE LOEP in Osteopenic and Osteoporotic Subjects in the Commercial European Market

Обзор

The study is designed as a retrospective, multicenter study for subjects previously treated with the AGN1 LOEP Kit in the proximal femur as part of standard hospital practice. This will be a non-randomized and non-blinded study. The study will collect retrospective data on the safety and performance of AGN1 LOEP of all subjects treated between September 2019 and January 2026. Subjects treated as part of an AgNovos prior protocoled study are excluded. Investigators are asked to reach out to all subjects that were previously treated with the AGN1 LOEP Kit in the proximal femur. Subject informed consent is obtained before a subject is enrolled into the study. Subjects treated but not enrolled are documented in a log with the reason why a subject did not participate. This log is kept on site. Enrolled subjects will be contacted per telephone to collect information about any fractures sustained post-AGN1 LOEP treatment.

Вмешательства

Устройство AGN1 LOEP
Patients treated with AGN1 LOEP

Первичные конечные точки

Incidence of fragility fractures of AGN1 LOEP treated hip [Срок оценки: Through study completion, an average of 6 months.]
Incidence of all adverse events and serious adverse events occurring intraoperative and post-AGN1 LOEP determined to be at least possibly related to the procedure and/or device [Срок оценки: Through study completion, an average of 6 months.]

Критерии участия

Критерии включения

Subject has previously received AGN1 LOEP treatment in the proximal femur after September 2019 and before January 2026.
Subject can give written informed consent to allow for data collection. Obtaining informed consent is not required for deceased subjects.