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Идёт набор NCT05607966

A Post-market Observational ORIGIN® CR Clinical Study

— Наблюдательное Total Knee 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: ORIGIN® CR devices.
Кому может быть актуально
Состояния в реестре: Total Knee 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
Бельгия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

The study objective is to evaluate safety and performance of the ORIGIN® CR (cruciate retaining) devices and associated instruments, more precisely to evaluate safety by the proportion of patients requiring a revision (i.e. revision rate) at 1-year post procedure and to evaluate performance by means of a Knee Society Score (KSS) Knee Score at 1 year post procedure and by means of a KSS Function Score also at 1 year post procedure. The hypothesis raised for this study, regarding the scoring, is that patients will experience a marked improvement in the natural feel of the prosthesis during the first year after the surgery, and slightly significant improvement at the following interval of 2 years. The overall patient satisfaction is expected to be improved after 2 years follow-up with ORIGIN® CR.

Подробное описание

The study is a prospective, non-comparative, non-randomized, single-arm, observational, post market study in which 199 patients will be enrolled to evaluate the safety and performance of the ORIGIN® CR devices and associated instruments.

Patients will be included in the study during 18 months (inclusion window) and followed-up for 24 months.

Вмешательства

  • Устройство ORIGIN® CR devices
    It is planned to include consecutive eligible subjects which will be treated with the ORIGIN® CR devices.

Первичные конечные точки

  • Evaluate safety by the proportion of required revisions [Срок оценки: 1 year post-procedure]
  • Evaluate performance [Срок оценки: 1 year post-procedure]
Вторичные конечные точки (4)
  • Evaluate safety by the proportion of required revisions [Срок оценки: 2 years post procedure]
  • Performance on patient satisfaction [Срок оценки: 1- and 2-years post-procedure]
  • Quality of Life post-procedure measured by the Knee Society score and Knee Society function questionnaire [Срок оценки: 1- and 2-years post-procedure]
  • Quality of Life post-procedure measured by the Forgotten Joint Score questionnaire [Срок оценки: 1- and 2- years post-procedure]

Критерии участия

Критерии включения

  • Male and female over 18 years of age
  • Each patient who is willing to give informed consent.
  • Clinically indicated for a total knee replacement
  • Females who are not pregnant and not planning to become pregnant ≤ 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 at 1 year and 2 years.

Критерии исключения

  • Acute or chronic, local or systemic infection
  • Muscular, ligamental, neurological, psychological or vascular deficits
  • Bone destruction or poor bone quality likely to affect implant stability (requiring a femoral and/or a tibial stem and/or a thick insert)
  • Any concomitant condition likely to affect implant integration or function
  • Allergy or hypersensitivity to any of the materials used
  • For devices in CoCrMo (ISO 5832/4): renal and hepatic impairment
  • Hip Knee Ankle (HKA) angle < 165° or > 195°
  • Severe collateral ligaments deficiency (requiring a more constrained prosthesis)
  • Posterior cruciate ligament deficiency
  • Major anatomical deformities
  • Severe flexion contracture or severe recurvatum
  • Revision of a partial or total knee prosthesis
  • Non-extractible material (e.g. screws, plate, intramedullary nail, osteosynthesis material…) which can create a conflict with any component of the prosthesis
  • Distal and/or posterior and/or anterior femoral bone loss which exceeds the femoral component thickness
  • Proximal tibial bone loss which exceeds the tibial component thickness (tibial tray + tibial insert)
  • Bone degradation requiring an anchoring stem for femoral component

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Бельгия · 2 центра
  • GZA Ziekenhuizen - campus Sint-Augustinus — Antwerp
  • AZ Voorkempen — Malle

Идентификаторы

NCT: NCT05607966 · CLIN-G-014

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗