Меню
Идёт набор NCT05917028

Transcatheter Arterial Micro-Embolization (TAME) Using Nexsphere-F in Patients With Knee Degenerative Osteoarthritis

Без фазы С лечением 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: Transcatheter Arterial Micro-Embolization.
Кому может быть актуально
Состояния в реестре: Osteoarthritis. Базовые параметры: от 50 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
South Korea
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

A Single Arm, Single Center, Open Label , Pilot Clinical Study to Evaluate the Efficacy and Safety of Transcatheter Arterial Micro Embolization (TAME) Using Nexsphere F in Patients With Knee Degenerative Osteoarthritis

Обзор

Among knee degenerative osteoarthritis patients aged 50 or older, it will prove the therapeutic effect and safety of Nexsphere-F embolization for patients who need additional treatment because pain is not controlled even if conventional treatments are taken.

Подробное описание

This clinical trial is a single arm, single center, open label, and pilot clinical trial to prove the performance and safety of Nexsphere-F in patients over the age of 50 who need additional treatment because pain is not controlled even after conventional treatments are taken.

Since consent cannot be obtained during surgery from a subject who meets the inclusion and exclusion criteria, a written consent is obtained in advance between four weeks before the procedure and the day. As one of the usual orthopedic evaluations, baseline MRI will be performed and WORMS will be evaluated. In addition, the WOMAC score and the VAS score will be measured before the procedure and used as a baseline for evaluation variables. Since it is a pilot study to evaluate the validity, all subjects will undergo a Transcatheter Arterial Micro-Embolization (TAME).

Вмешательства

  • Устройство Transcatheter Arterial Micro-Embolization
    Participants will undergo TAME with Nexsphere-F.

Первичные конечные точки

  • Rate of WOMAC Score Reduction [Срок оценки: 1 day, 14 days, 1 month, 3 months, 6 months]
  • Rate of VAS Score (patient pain intensity) Reduction [Срок оценки: 1 day, 14 days, 1 month, 3 months, 6 months]
Вторичные конечные точки (3)
  • Rate of change in WORMS (Whole-Organ Magnetic Resonance Imaging Score) [Срок оценки: 1 month]
  • The rate of reduction of medication [Срок оценки: 6 months]
  • The rate of discontinuation of combination treatment [Срок оценки: 6 months]

Критерии участия

Критерии включения

  • Those who fall under Kellgren-Lawrence grade 2 to 3 according to the criteria in accordance with ACR guidelines and X-ray findings used within 12 months
  • VAS score exceeding 50mm
  • An adult male and female over 50 years of age
  • Preservative therapy Glucosamine chondroitin sulfate/physiological therapy and rehabilitation exercises, and joint injections of hyaluronic acid for more than 12 weeks
  • A person who agrees to maintain existing medication treatments during the clinical trial period but does not receive additional medication or new conservative treatments for knee osteoarthritis pain management.

Критерии исключения

  • A locally infected patient
  • A person whose life expectancy is less than six months
  • A person with symptoms of lower extremities that are considered secondary to atherosclerosis or arterial vascular disease (ex: claudication ischemic rest pain)
  • A person diagnosed with rheumatism or infectious arthritis
  • A person who has undergone knee arthroplasty
  • A person who has not had knee microfracture surgery for more than 10 years
  • INR 2.5 or less than 30,000 platelets
  • Anaphylaxis-causing iodine allergy
  • Patients with renal dysfunction or impaired renal function who have been diagnosed with less than 45 GFR (eGFR) within the last 60 days
  • Those who have a taboo on MR videos
  • Pregnant women
  • Other cases where it is deemed inappropriate to participate in this clinical trial at the discretion of the researcher

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

South Korea · 1 центр
  • Severance Hospital — Seoul

Идентификаторы

NCT: NCT05917028 · NS-F TAME001

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗