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Идёт набор NCT05044767

Study to Evaluate the Performance and Safety of ATF Implants and Lapé Médical Devices Implanted During Hip Arthroplasty

— Наблюдательное Arthroplasty, 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: total hip arthroplasty.
Кому может быть актуально
Состояния в реестре: Arthroplasty, Hip, Replacement. 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
Франция
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

Observational and Prospective Multicenter Study to Evaluate the Long-term (10 Years) Performance and Safety (10 Years) of ATF Implants and Lapé Médical Devices Implanted During Total Hip Arthroplasty or Hemiarthroplasty.

Обзор

Observational and prospective multicenter study to evaluate the long-term (10 years) performance and safety (10 years) of ATF Implants and Lapé Médical devices implanted during total hip arthroplasty or hemiarthroplasty.

Подробное описание

Observational and prospective multicenter study to evaluate the long-term (10 years) performance and safety (10 years) of ATF Implants and Lapé Médical devices implanted during total hip arthroplasty or hemiarthroplasty.

The post-market clinical follow-up study to be conducted by ATF Implants following this plan aims to collect data from the follow-up of patients before and after hip replacement surgery with implants manufactured by ATF Implants and Lapé médical. In current practice, the surgeon-investigator evaluates the patient pre- and post-operatively according to predefined criteria used in orthopedic surgery and more particularly in hp replacement surgery. Complications and adverse effects observed are also recorded.

The main objective is to gather clinical evidence to evaluate the survival rate of ATP Implants and Lapé médical hip prostheses over the long-term, namely 10 years.

The secondary objectives are to evaluate the performance and safety of the prostheses over the same period (i.e. 10 years), as well as to obtain feedback on the performance /intended use and safety of the surgical instruments required for implant placement.

Вмешательства

  • Устройство total hip arthroplasty
    hip replacement surgery

Первичные конечные точки

  • Long-term survival rate [Срок оценки: 10 years]
Вторичные конечные точки (1)
  • hip joint function [Срок оценки: before and after surgery (6 month, 2 years, 5 years, 7 years, 10 years)]

Критерии участия

Критерии включения

  • Male or female indicated for hip replacement surgery with hip prosthesis manufactured by ATF Implants and/or Lapé médical;

There are different indications for hip replacement surgery. The main ones are listed below:

  • Dysplasia
  • Primary Coxarthrosis
  • Secondary Coxarthrosis
  • Perthes disease
  • Epiphysiolysis
  • Ankylosing spondylitis
  • Trochanteric bursitis
  • Arthritis
  • Degenerative arthritis
  • Post-traumatic arthritis
  • Rheumatoid arthritis
  • Femoral neck fracture
  • Osteonecrosis
  • Revision

Depending on the specificities of the devices (size, absence/presence of a coating, material), indications may vary. This information can be found in the instruction for use. It is the surgeon's responsibility to select the most appropriate prosthesis for a given patient according to the patient's medical records and the instruction for use in force at the time of the procedure accompanying the medical device.

Критерии исключения

  • There are various contraindications for hip arthroplasty. The main ones are listed below:
  • An acute or chronic, local or systemic infection
  • Severe muscular, neurological or vascular deficiency compromising the affected extremity
  • A bone defect or insufficient bone quality that may compromise the stability of the implant
  • Any concomitant disease (dysplastic coxarthrosis with extreme coxa valga, short neck and severe varus) that may affect the function of the implant
  • Sensitivity to the material (allergy) Depending on the specificities of the devices (size, absence/presence of a coating, material), contraindications may vary. This information can be found in the instruction for use of the devices.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Франция · 13 центров
  • CHU de Bordeaux - Hôpital Pellegrin — Bordeaux
  • Clinique des Cèdres — Cornebarrieu
  • Centre Ostéo-Articulaire des Cèdres — Échirolles
  • Hôpital privé Drôme Ardèche — Guilherand-Granges
  • Clinique du Croisé Laroche — Marcq-en-Barœul
  • Polyclinique Saint George — Nice
  • Groupe Hospitalier Diaconesses Croix Saint-Simon — Paris
  • CHU de Poitiers — Poitiers
  • … и ещё 5 центров

Идентификаторы

NCT: NCT05044767 · PEPS

Первоисточники (государственные реестры)

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