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Набор по приглашению NCT03610789

A Multicenter, Post-Market Clinical Follow-up Study of Subjects With the REDAPT™ System Monolithic Sleeveless/Sleeved Stem and/or Fully Porous Acetabular Shell With XLPE Liner and/or Modular Shell Components Previously Implanted

— Наблюдательное 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: REDAPT.
Кому может быть актуально
Состояния в реестре: Hip Replacement. Базовые параметры: от 18 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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Обзор

The primary purpose of this study is to demonstrate cumulative revision rate of the REDAPT System Monolithic Sleeveless/Sleeved Stem, Fully Porous Acetabular Shell with XLPE liner, and Modular Shell Components (with or without Staple, Slice and Blade Augments) at 10 years.

Подробное описание

Retrospective-prospective, single arm, multicenter study of subjects previously implanted with the REDAPT System Monolithic Sleeveless/Sleeved Stem and/or Fully Porous Acetabular Shell with XLPE liner and/or Modular Shell Components (with or without Staple, Slice and Blade Augments).

Вмешательства

  • Устройство REDAPT
    REDAPT Monolithic Sleeveless Stems and Acetabular Cup Components

Первичные конечные точки

  • Revision rate [Срок оценки: 10 years post-op]
Вторичные конечные точки (3)
  • EuroQul Five Dimensions Questionnaire EQ-5D-5L [Срок оценки: Collect retrospectively from medical records preoperatively and at 1 year, and prospectively at 2, 5, and 10 years post-operatively]
  • Functional outcomes as determined by the Hip Disability Osteoarthritis Outcome (HOOS) score [Срок оценки: Collect retrospectively from medical records preoperatively and at 1 year, and prospectively at 2, 5, and 10 years post-operatively]
  • Radiographic assessments [Срок оценки: Collect retrospectively from medical records preoperatively and at 1 year, and prospectively at 2, 5, and 10 years post-operatively]

Критерии участия

Критерии включения

Subjects must meet all of the inclusion criteria to enroll in the study:

  • Subject was considered skeletally mature at the time of surgery and was at least 18 years of age.
  • Subject has undergone hip arthroplasty with the REDAPT Fully Porous Acetabular Shell with XLPE liner or REDAPT Modular Cup Components (with or without Staple, Slice and Blade Augments), and/or Monolithic Sleeveless Stem, and/or Monolithic Sleeved Stem and are at least 3 months post-implantation at this site.
  • Subject required surgery with REDAPT device chosen for one of the following indications:
  • Advanced degeneration of the hip joint as result of osteoarthritis, avascular necrosis, posttraumatic arthritis, rheumatoid arthritis, or dysplasia (or any of the composites of these conditions).
  • Fracture-dislocation of the hip, femoral neck fracture or trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
  • Revision THA
  • Subject is willing to consent to and to follow the study visit schedule (as defined in the study protocol and ICF), by signing the IRB/IEC approved ICF.
  • Subject is willing and able to participate in required follow-up visits at the investigational site and to complete study procedures.

Критерии исключения

Subjects meeting any of the following exclusion criteria will be excluded from study participation:

  • Subject had an active infection - systemic or at the site of surgery.
  • Subject, in the opinion of the PI, has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study including mental illness, mental retardation, drug or alcohol abuse.
  • Subject is known to be at risk for loss to follow-up or failure to return for scheduled visits.
  • Subject is incarcerated or is pending incarceration.
  • Subject is enrolled in another clinical study that would affect the endpoints of the study.

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 · 4 центра
  • Eisenhower Medical Center-Hospital — Rancho Mirage
  • Scripps Mercy — San Diego
  • NYU Langone Health Orthopedic Hospital — New York
  • Hospital for Surgery- New York — New York

Идентификаторы

NCT: NCT03610789 · REDAPT 17-4538-02

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗