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Идёт набор NCT05966519

ROSA Knee Intraoperative Planning Flexibility Study

— Наблюдательное Osteo Arthritis Knee Rheumatoid Arthritis

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: Total Knee Replacement (TKR).
Кому может быть актуально
Состояния в реестре: Osteo Arthritis Knee, Rheumatoid Arthritis. Базовые параметры: от 20 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
Япония
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

ROSA Knee Intraoperative Planning Flexibility on Japan Preferred Surgical Technique, A Single Center Prospective Study

Обзор

The purpose of this study is to verify that an orthopedic surgical assist robot (ROSA Knee System) can provide intraoperative adjustment of osteotomy angle and volume for total knee arthroplasty (TKA) based on feedbacks obtained from intraoperative soft tissue conditions. A total 80 cases will be enrolled at one study site with a postoperative follow-up period of 2 years.

Подробное описание

The objectives of the study are to document that ROSA Knee System can provide intraoperative planning adjustment based on feedbacks obtained by laxity as well as gaps to locally preferred surgeon's operative philosophy. This will also provide accuracy, intraoperative soft tissue release as well as patient outcome on locally preferred surgical technique.

The primary endpoint is defined as the mean absolute difference between X-Atlas image-based pre-op plan \& intra-op final plan.

The secondary endpoints include Kinematic Analysis, EuroQol 5 dimensions (EQ-5D), Rehabilitation record, Knee Society Score (KSS) 2011, image assessment and Safety up to 2 years postoperatively.

Вмешательства

  • Устройство Total Knee Replacement (TKR)
    Damaged cartilage of knee due to degenerative disease is replaced with metallic and plastic protheses

Первичные конечные точки

  • The mean absolute difference between X-Atlas image based pre-op plan & intra-op final plan [Срок оценки: Immediate post-operative]
Вторичные конечные точки (5)
  • Pain, range of knee motion and functional performance [Срок оценки: Preoperative, Postoperative 1.5 months (option), 3 months, 6 months, 12 months and 24 months]
  • QOL [Срок оценки: Preoperative, Postoperative 1.5 months (option), 3 months, 6 months, 12 months and 24 months]
  • Rehabilitation record [Срок оценки: Preoperative, Postoperative 1.5 months (option), 3 months, 6 months, 12 months and 24 months]
  • Kinematic analysis [Срок оценки: Postoperative 12 months or 24 months]
  • Image review (CT/Radiograph) [Срок оценки: Preoperative, Discharge, Postoperative 1.5 months (option), 3 months, 6 months, 12 months and 24 months]

Критерии участия

Критерии включения

  • 20 years and over
  • Skeletally matured
  • Decision to have Total Knee Arthroplasty with ROSA Knee System being made independently and prior to recruitment into study
  • Willing and able to complete scheduled follow-up evaluations as described in the study protocol
  • Has participated in the informed consent process and is willing and able to sign an Institutional Review Board (IRB)/Ethics Committee (EC) approved informed consent form

Критерии исключения

  • Has serious bone defect(s), which require(s) metallic augment, synthetic bone or allograft
  • Is septic, has an active infection or has osteomyelitis at the affected joint
  • Has vascular insufficiency, muscular atrophy at the implant site or neuromuscular disease which might jeopardize the outcome of the surgery
  • Has any concomitant disease which is likely to jeopardize the functioning or success of the implant
  • Is known to be pregnant
  • Is a prisoner, known alcohol or drug abuser or mentally incompetent or unable to understand what participation in this study entails
  • Has a known sensitivity or allergy to one or more of the implanted materials

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Только случаи

Центры проведения

Япония · 1 центр
  • Kyushu University Hospital — Fukuoka

Идентификаторы

NCT: NCT05966519 · CSA2022-29TDS

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗