Идёт набор NCT06628336

Post-Market Observational Study of the HARMONY® Evolution Implants and Instruments

— Наблюдательное Total Hip Replacement

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: HARMONY EVOLUTION.
Кому может быть актуально: Состояния в реестре: Total Hip Replacement. Базовые параметры: 18 лет — 99 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: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Обзор

The purpose of this study is to evaluate the safety and performance of the HARMONY® Evolution implants in a series of operated subjects treated in THR. The objective is to demonstrate that the evaluated implants are compliant with the state of the art and the performance (PMA score \> 15 points) \& safety claims (The expected acceptable revision rate (state of the art with a confidence interval of 95%) is 3% at 3 years, 5% at 5 years, 7% at 7 years and 10% at 10 years). The endpoint of this study is to validate the expected performance of the HARMONY® Evolution implants with the PMA score at 10 years and to validate the safety claim with the expected acceptable revision rate at 10 years.

Подробное описание

The study is prospective, multi-centric, observational, non-comparative, non-randomized and post market. About 264 subjects will be enrolled in this study to evaluate the safety and performance of the HARMONY® Evolution implants.

Patients will be included in the study during 12 months and followed-up during 10 years.

Вмешательства

Устройство HARMONY EVOLUTION
It is planned to include consecutive eligible subjects which will be treated with the HARMONY EVOLUTION devices.

Первичные конечные точки

Evaluate safety by means of measuring Adverse event recurrences [Срок оценки: 2 months, 1, 3, 5 and 10 years follow-up]
Evaluate performance by means of clinical and quality of life scores [Срок оценки: 2 months, 1, 3, 5 and 10 years follow-up]

Вторичные конечные точки (1)

Evaluate performance by means of surgeon satisfaction questionnaire [Срок оценки: 2 months, 1, 3, 5 and 10 years follow-up]

Критерии участия

Критерии включения

Subjects of 18 years of age and older
Each subject who is willing to give informed consent
Clinically indicated for a Total Hip Replacement
Women of childbearing age who are not pregnant and do not expect to become pregnant within 12 months. A pregnancy test should be performed for women of childbearing age
Geographically stable and willing to return to the implanting site for all follow-up visits

Критерии исключения

Acute or chronic, local or systemic infection
Muscular, neurological, psychological or vascular deficits
Poor bone density and quality likely to affect implant stability (severe osteoporosis)
Any concomitant condition likely to affect implant integration or function
Allergy or hypersensitivity to any of the materials used

Specific: