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Набор скоро начнётся NCT07553975

Randomized Arthrex Nano Arthroscopy in Arthroscopic ACL vs Conventional Arthroscopy

Без фазы С лечением Anterior Cruciate Ligament

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: ACL surgery using Arthrex NanoScope, ACL surgery using conventional arthroscopy.
Кому может быть актуально
Состояния в реестре: Anterior Cruciate Ligament. Базовые параметры: 18 лет — 60 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
Список центров уточняется — проверьте первичный протокол.
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

Randomized Study Evaluating Cost of Arthrex Nano Arthroscopy Products in Arthroscopic Knee ACL Surgery Versus Conventional Arthroscopy

Обзор

The study is a pilot study designed to generate preliminary data regarding the cost of ACL surgery using NanoScope versus conventional arthroscopy in a traditional operating room (OR) setting.

Вмешательства

  • Устройство ACL surgery using Arthrex NanoScope
    The rod-lens arthroscope has been the standard of care in the operating room for more than 40 years. Arthrex's all-in-one disposable, 2 mm, chip-on-tip camera system now allows surgeons to miniaturize their treatment solutions.
  • Процедура ACL surgery using conventional arthroscopy
    Conventional arthroscopy using standard of care equipment

Первичные конечные точки

  • Compare patient satisfaction for Anterior Cruciate Ligament (ACL) surgery when using either Arthrex Nanoscope 2.0 or conventional arthroscopy. [Срок оценки: From enrollment to 2 years]
  • Compare patient satisfaction for Anterior Cruciate Ligament (ACL) surgery when using either Arthrex Nanoscope 2.0 or conventional arthroscopy. [Срок оценки: From enrollment to 2 years]
  • Compare patient satisfaction for Anterior Cruciate Ligament (ACL) surgery when using either Arthrex Nanoscope 2.0 or conventional arthroscopy. [Срок оценки: From enrollment to 2years]
  • Compare patient satisfaction for Anterior Cruciate Ligament (ACL) surgery when using either Arthrex Nanoscope 2.0 or conventional arthroscopy. [Срок оценки: From enrollment to 2 years]
  • Compare patient satisfaction for Anterior Cruciate Ligament (ACL) surgery when using either Arthrex Nanoscope 2.0 or conventional arthroscopy. [Срок оценки: From enrollment to 2 years]
  • Compare patient satisfaction for Anterior Cruciate Ligament (ACL) surgery when using either Arthrex Nanoscope 2.0 or conventional arthroscopy. [Срок оценки: From enrollment to 2 years]
Вторичные конечные точки (7)
  • Operating Room (OR) metrics that may be correlated with staff satisfaction and operating team satisfaction. [Срок оценки: immediately postoperatively]
  • Operating Room (OR) metrics that may be correlated with staff satisfaction and operating team satisfaction. [Срок оценки: immediately postoperatively]
  • Operating Room (OR) metrics that may be correlated with staff satisfaction and operating team satisfaction. [Срок оценки: immediately postoperatively]
  • Operating Room (OR) metrics that may be correlated with staff satisfaction and operating team satisfaction. [Срок оценки: immediately postoperatively]
  • Operating Room (OR) metrics that may be correlated with staff satisfaction and operating team satisfaction. [Срок оценки: immediately postoperatively]
  • Operating Room (OR) metrics that may be correlated with staff satisfaction and operating team satisfaction. [Срок оценки: immediately postoperatively]
  • Operating Room (OR) metrics that may be correlated with staff satisfaction and operating team satisfaction. [Срок оценки: 1 month postoperatively]

Критерии участия

Критерии включения

  • Subject is 18 - 60 years of age.
  • Subject body mass index (BMI) is 40 or lower (BMI ≤ 40).
  • Subject signed informed consent and is willing and able to comply with all study requirements and follow-up visits.
  • Confirmed ACL injury by MRI and physical exam as per standard of care.
  • Subjects not excluded for having meniscal pathology that requires resection or repair.
  • Subjects not excluded for having lateral-extra-articular tenodesis

Критерии исключения

  • Revision ACL case.
  • Current bilateral knee injury.
  • Insufficient quantity or quality of bone.
  • Blood supply limitations and previous infections which may retard healing.
  • Subjects that are skeletally immature.
  • Advanced Osteoarthritis; Kellgren Lawrence ≥ 2
  • Fracture of the lower extremities within 6 months prior to screening.
  • Previous surgery on the affected knee within 12 months related to the ACL reconstruction, prior to screening.
  • Sensitivity to silicone, polyester, nylon, FD\&C Blue No. 2 dye and beeswax.
  • Other concomitant disease that would interfere with study outcomes.
  • Subject is included in a vulnerable population (child, prisoner, etc.).
  • Conditions that tend to limit the patient's ability or willingness to restrict activities, follow directions, or perform online subject assessments during the healing period.
  • Subject is requesting or receiving Worker's compensation related to the knee injury.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07553975 · 25-2232

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗