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Идёт набор NCT06176183

A Comparative Prospective Study of the Arthroscopic Meniscal Repair Methods

Без фазы С лечением Meniscus Tear Caused by a Traumatic Event Fibrin Clot Augmentation Meniscal Repair

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: Arthroscopic meniscus repair.
Кому может быть актуально
Состояния в реестре: Meniscus Tear Caused by a Traumatic Event, Fibrin Clot Augmentation, Meniscal Repair. Базовые параметры: 0 лет — 19 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
Литва
Следующий шаг
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Официальное название

A Comparative Prospective Study of Meniscal Repair Methods in Young Patients With Traumatic Meniscal Tears.

Обзор

Performing arthroscopic meniscus repair following a traumatic meniscus tear as an alternative to a meniscectomy is now an acceptable choice. Preserving meniscus tissues is crucial due to the significant role they play as an essential part of the knee joint. It is essential to comprehend the additional tools that can impact the recovery of the meniscus after suturing. Patients have been randomly assigned into two groups using the computer "www.randomiser.org," and the treatment outcomes were compared after one year. One group of patients has received a standard meniscus suturing technique, whereas another group has experienced the meniscus suturing treatment with an additional fibrin clot approach. Data pertaining to demographics, clinical characteristics, radiological findings, and survey responses have been carefully collected prospectively.

Вмешательства

  • Процедура Arthroscopic meniscus repair
    A traditional two-portal arthroscopic approach is utilized. The meniscal edges are examined using a probe, and any meniscal tears that are not stable are evaluated for potential repair. For meniscus repair, sutures have been made using the "all-inside" or "outside-inside" and "inside-outside" techniques. If the procedure involving the addition of a fibrin clot is being carried out, a volume of approximately 60 milliliters of blood is taken and thereafter transferred into a basin. An assistant i

Первичные конечные точки

  • Pediatric International Documentation Committee Subjective (Pedi-IKDC) Knee Form. [Срок оценки: before treatment, after 12 months and 24 months following treatment]
  • Lysholm knee scale [Срок оценки: before treatment, after 12 months and 24 months following treatment]
  • Health-related paediatric quality of life (PedsQL) [Срок оценки: before treatment, after 12 months and 24 months following treatment]
Вторичные конечные точки (3)
  • Clinical evaluation at 12 and 24 months postoperatively. The clinical assessment involves evaluating of pain, swelling and estimating and comparing the range of motion of the knee with the contralateral side. [Срок оценки: 12 and 24 months postoperatively.]
  • magnetic resonance imaging (MRI scan) of the knee [Срок оценки: before treatment, after 12 months and 24 months following treatment]
  • Revision rates (secondary arthroscopies) [Срок оценки: 12 and 24 month following primary surgery]

Критерии участия

Критерии включения

  • Individuals who provide consent to participate in the study, including patients and their care providers. The inclusion criteria for this study are as follows: being under the age of 19, having a traumatic isolated full-thickness meniscal tear longer than 1cm that has been confirmed by both preoperative MRI and arthroscopy, and not having undergone any previous surgery on the affected knee.

Критерии исключения

  • This investigation excludes patients with developmental disabilities who are unable to read or interpret in their native language.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Лечение

Центры проведения

Литва · 2 центра
  • Vilnius University, Medical faculty — Vilnius
  • Vilnius University Hospital Santaros Klinikos — Vilnius

Идентификаторы

NCT: NCT06176183 · 2021/5-1353-825

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗