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Набор по приглашению NCT04145401

Post Market Clinical Follow-Up Study- EVOLUTION® Revision CCK

— Наблюдательное Knee Osteoarthritis

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: Revision Knee implants.
Кому может быть актуально
Состояния в реестре: Knee Osteoarthritis. 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
США
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

Post Market Clinical Follow-Up Study for EVOLUTION® Revision Tibial System and EVOLUTION® Revision Constrained Condylar Knee (CCK) Femur With the EVOLUTION® CCK Tibial Insert

Обзор

Sponsor is conducting this post market clinical follow-up (PMCF) study to evaluate the safety and efficacy of its EVOLUTION® Revision CCK Tibia and EVOLUTION® Revision CCK Femur with EVOLUTION® CCK Tibial inserts. These type of studies are required by regulatory authorities for all devices that have been approved in Europe (EU) to evaluate the medium and long term clinical evidence. This study has been designed in accordance with MEDDEV2.12/2 rev 2 (European Medical Device Vigilance System) and ISO (International Organization for Standardization) 14155:2011 guidelines.

Подробное описание

The objectives of this study are:

1. To estimate the individual component survivorship of EVOLUTION® Revision Tibia, EVOLUTION® Revision CCK Femur, and EVOLUTION® CCK Tibial Insert. 2. To find out the cumulative incidence of component revision of each component in this combination. 3. To find out the functional outcome scores at early, midterm, and long-term follow-up.

Вмешательства

  • Устройство Revision Knee implants
    Primary knee arthroplasty or a revision knee that requires a revision procedure.

Первичные конечные точки

  • Individual component survivorship [Срок оценки: 10 years post-operative]
Вторичные конечные точки (4)
  • Patient Reported Outcomes- Questionnaires [Срок оценки: 10 years post-operative]
  • Incidence of component revision [Срок оценки: 10 years post-operative]
  • Radiolucencies [Срок оценки: 10 years post-operative]
  • Adverse Events and Adverse Device Effects [Срок оценки: 10 years post-operative]

Критерии участия

Критерии включения

  • Has previously undergone or currently has been determined to undergo a revision knee arthroplasty that requires the study (EVOLUTION® Revision Tibial System and EVOLUTION® Revision CCK Femur with the EVOLUTION® CCK Tibial Insert)
  • Decision to perform the study index surgery with the required study components (EVOLUTION® Revision Tibial System and EVOLUTION® Revision CCK Femur with the EVOLUTION® CCK Tibial Insert) is pre-determined regardless of the research.
  • Previously implanted subjects must be enrolled within 3 years (+6 months) of their study index surgery
  • Willing and able to complete required study visits and assessments through the 10 year post-operative follow-up visit.

Bilateral subjects can have both TKAs enrolled in the study provided:

  • the specified combination of components (EVOLUTION® Revision Tibial System and EVOLUTION® Revision CCK Femur with the EVOLUTION® CCK Tibial Insert) were implanted in both
  • all other aspects of the Inclusion/Exclusion Criteria are satisfied
  • enrollment does not exceed the subject count specified
  • the subject agrees to a second Informed Consent document and data collection specific to the second TKA.

Критерии исключения

  • Skeletally immature (less than 21 years of age) at time of implantation.
  • Has an overt infection at the time of implantation.
  • Has inadequate neuromuscular status (e.g., prior paralysis, fusion, and/or inadequate abductor strength), poor bone stock, poor skin coverage around the joint which would make the procedure unjustifiable.
  • Currently enrolled in another clinical investigation which would affect the endpoints of this protocol.
  • Has documented substance abuse issues.
  • Has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study.
  • Currently incarcerated or has impending incarceration.
  • Has a medical condition, as judged by the Investigator, that would interfere with the subject's ability to comply with the requirements of the protocol.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 1 центр
  • HCA Research Institute, OrthoONE at Swedish Medical Center — Englewood

Идентификаторы

NCT: NCT04145401 · 18K001

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗