Post Market Clinical Follow-up of Hip Surgery Using FH ORTHO Company Medical Devices.

Официальное название

Post Market Clinical Follow-up of Hip Surgery Using FH ORTHO Company Medical Devices (FH ORTHO Company Hip Observatory).

Обзор

The objective of this observatory is to generate additional real life clinical data in accordance with local regulation (i.e. Post-Market Clinical Follow-up (PMCF) study, a study carried out following the European Conformity (CE) marking of a device and intended to answer specific questions relating to clinical safety or performance (i.e. residual risks) of a device when used in accordance with its approved labelling). The difficulty of such an observatory is to be able to collect data on the different versions of the devices, on the different possible combinations of implants of an arthroplasty. The observatory must also be able to cover devices used in surgery to repair osteoarticular trauma. The observatory will be based on the principle of a "dynamic" cohort during the inclusion period, i.e. with possible inclusions to replace the premature exits. Technical solutions will be implemented to facilitate data collection from surgeons (electronic Case Report Form (eCRF) and from patients (Electronic Patient Reported Outcome (ePRO) on phone/tablet/computer).

Вмешательства

• Устройство Hip surgery with FH Ortho devices
  This study is a real-life observatory designed to collect long-term clinical data on patients who have undergone hip joint replacement or repair following hip trauma. In this type of intervention, one or more medical devices distributed by FH ORTHO Company may be used by surgeons.

Первичные конечные точки

• Survival rate (revision) of the medical device over the long term (maximum 15 years). [Срок оценки: maximum 15 years.]

Критерии участия

Критерии включения

• Any patient undergoing or having undergone implantation of medical devices distributed by FH ORTHO Company for hip arthroplasty and traumatology, used in accordance with their approved Instruction For Use, in one of the centers participating in the Observatory.
• Patient is at least 18 years of age.
• Patient agreeing to participate after having been informed orally and in writing (with written consent if required locally).
• In some countries, such as France, the patient will have to be socially insured to be included in the study.

Критерии исключения

• An infection, or latent infection.
• A mental or neuromuscular disorder that would create an unacceptable risk of prosthetic instability, failure of prosthetic fixation, or post-operative complications (except for the HIP\&GO Double mobility cemented cup and, if applicable, the associated stems and heads when assembled together).
• Known Insufficient bone quality and/or bone stock.
• Known allergy to any component of the material listed on the product label.
• Metabolic diseases that could compromise bone regrowth.
• Metabolic and/or vascular treatment or disease that may compromise bone healing or consolidation.
• Drug dependency.
• Uncooperative patient unable to follow recommendations.
• Protected adult

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Франция · 5 центров

• Clinique Pasteur — Guilherand-Granges
• Centre Hospitalier Du Haut Bugey — Oyonnax
• Polyclinique Reims-Courlancy — Reims
• Clinique Mutualiste La Sagesse — Rennes
• Clinique de l'Atlantique — Saint-Herblain

Идентификаторы

NCT: NCT05966220 · 2021-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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