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Набор по приглашению NCT03576573

Post Market Clinical Follow-Up Study Protocol for PROCOTYL® C Acetabular Components

— Наблюдательное Joint Disease

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: PROCOTYL® C.
Кому может быть актуально
Состояния в реестре: Joint Disease. Базовые параметры: от 21 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
Германия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

MicroPort Orthopedics (MPO) is conducting this post market clinical follow-up (PMCF) study to evaluate the safety and efficacy of its total hip arthroplasty (THA) components marketed in the European Union (EU). These types of studies are required by regulatory authorities for all THA devices that do not have medium to long-term clinical evidence available at the time of gaining approval to market in Europe. This study has been designed in accordance with the medial device directives (MEDDEV) 2.12/2 rev 2.

Вмешательства

  • Устройство PROCOTYL® C
    Hip Arthroplasty

Первичные конечные точки

  • Component Survivorship [Срок оценки: 10 years post-operative]
Вторичные конечные точки (3)
  • To determine the cumulative incidence of component revision at specified intervals out to 10 years follow-up; [Срок оценки: 2-5 years, 5-7 years, and 10 years]
  • To characterize functional scores, as assessed by Oxford Hip. [Срок оценки: 2-5 years, 5-7 years, and 10 years]
  • To characterize functional scores, as assessed by EQ-5D-3L scores. [Срок оценки: 2-5 years, 5-7 years, and 10 years]

Критерии участия

Критерии включения

To be included in the study, subjects must meet all of the following criteria:

  • Has previously undergone primary Total Hip Arthroscopy for any of the following:
  • Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, or painful hip dysplasia;
  • Inflammatory degenerative joint disease such as rheumatoid arthritis;
  • Correction of functional deformity
  • Subject was implanted with the specified combination of components, namely, any MicroPort Orthopedics or Wright Medical Technology femoral stem and PROCOTYL C Acetabular Components
  • Subject is willing and able to complete required study visits or assessments

Previously implanted bilateral subjects can have both THAs (Total Hip Arthroscopy) enrolled in the study provided:

  • the specified combination of components were implanted in both,
  • all other aspects of the Inclusion/Exclusion Criteria are satisfied,
  • enrollment does not exceed the subject count specified in the Clinical Trial Agreement, and
  • the subject agrees to a second Informed Consent document specific to the second THA. Prospective enrolment of a previously unimplanted hip is not permitted in this study.

Критерии исключения

Subjects will be excluded if they meet any of the following criteria:

  • Subject was skeletally immature (less than 21 years of age) at time of implantation
  • Subject has a non-MicroPort or non-Wright Medical Technology component implanted (femoral heads, acetabular shells, acetabular liners) in the enrolled Total Hip Arthroscopy
  • Subject is currently enrolled in another clinical investigation which could affect the endpoints of this protocol
  • Subject is unwilling or unable to sign the Informed Consent document
  • Subject has documented substance abuse issues
  • Subject has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study
  • Subject is currently incarcerated or has impending incarceration

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Германия · 1 центр
  • Elbe Kliniken Buxtehude — Buxtehude

Идентификаторы

NCT: NCT03576573 · 12-LJH-002N

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗