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Идёт набор NCT07671729

Quadriceps Tendon vs Peroneus Longus Tendon in ACL Reconstruction

Без фазы С лечением Anterior Cruciate Ligament Injury Anterior Cruciate Ligament Rupture

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: Anterior Cruciate Ligament Reconstruction Using Quadriceps Tendon Autograft, Anterior Cruciate Ligament Reconstruction Using Peroneus Longus Tendon Autograft.
Кому может быть актуально
Состояния в реестре: Anterior Cruciate Ligament Injury, Anterior Cruciate Ligament Rupture. Базовые параметры: 18 лет — 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
Turkey (Türkiye)
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

A Prospective Randomized Clinical Trial Comparing Quadriceps Tendon and Peroneus Longus Tendon Autografts in Anterior Cruciate Ligament Reconstruction: Clinical, Functional, and Gait Analysis Outcomes

Обзор

This prospective randomized clinical trial aims to compare quadriceps tendon and peroneus longus tendon autografts in anterior cruciate ligament reconstruction. Patients with anterior cruciate ligament injury undergoing primary reconstruction surgery will be randomly assigned to one of the two graft groups. Clinical examination findings, return-to-sport outcomes, ankle muscle strength, ankle-related functional scores, and gait analysis parameters will be evaluated at 6 months and 12 months postoperatively. The study aims to investigate both knee-related functional outcomes and donor site morbidity associated with graft harvesting techniques.

Подробное описание

Anterior cruciate ligament (ACL) reconstruction is one of the most commonly performed orthopedic procedures for restoring knee stability and enabling return to sports activities after ACL injury. Various autograft options have been described for ACL reconstruction, including hamstring tendon, bone-patellar tendon-bone, quadriceps tendon, and more recently, peroneus longus tendon grafts. Each graft option has unique biomechanical characteristics, advantages, and potential donor site morbidities.

Quadriceps tendon autografts have gained increasing popularity because of their adequate graft diameter, favorable biomechanical properties, and relatively low donor site complications. Peroneus longus tendon autografts have also emerged as a promising alternative graft source with satisfactory clinical outcomes and sufficient graft size. However, concerns remain regarding donor site morbidity, particularly potential effects on ankle muscle strength and ankle function following peroneus longus tendon harvesting.

This prospective randomized study aims to compare quadriceps tendon and peroneus longus tendon autografts in patients undergoing primary ACL reconstruction. Patients will be randomly assigned into two groups according to graft type. Clinical evaluations, functional knee scores, return-to-sport outcomes, ankle muscle strength assessments, ankle-related functional scores, and gait analysis parameters will be assessed during postoperative follow-up.

Follow-up evaluations will be performed at 6 months and 12 months after surgery. The findings of this study are expected to contribute to graft selection strategies in ACL reconstruction by providing comparative data regarding clinical outcomes, functional recovery, gait characteristics, and donor site morbidity.

Вмешательства

  • Процедура Anterior Cruciate Ligament Reconstruction Using Quadriceps Tendon Autograft
    Anterior cruciate ligament reconstruction performed using quadriceps tendon autograft.
  • Процедура Anterior Cruciate Ligament Reconstruction Using Peroneus Longus Tendon Autograft
    Anterior cruciate ligament reconstruction performed using peroneus longus tendon autograft.

Первичные конечные точки

  • International Knee Documentation Committee (IKDC) Subjective Knee Score [Срок оценки: 12 months postoperatively]
Вторичные конечные точки (9)
  • Return to Sport Rate [Срок оценки: Assessment of return to pre-injury level of sports activity following anterior cruciate ligament reconstruction.]
  • Ankle Plantar Flexion Strength [Срок оценки: 6 and 12 months postoperatively]
  • Ankle Dorsiflexion Strength [Срок оценки: 6 and 12 months postoperatively]
  • Ankle Inversion Strength [Срок оценки: 6 and 12 months postoperatively]
  • Ankle Eversion Strength [Срок оценки: 6 and 12 months postoperatively]
  • Ankle Rotational Strength [Срок оценки: 6 and 12 months postoperatively]
  • Ground Reaction Force [Срок оценки: 6 and 12 months postoperatively]
  • Force Asymmetry [Срок оценки: 6 and 12 months postoperatively]
  • Weight Distribution [Срок оценки: 6 and 12 months postoperatively]

Критерии участия

Критерии включения

  • Patients diagnosed with anterior cruciate ligament rupture
  • Patients scheduled for primary anterior cruciate ligament reconstruction
  • Age between 18 and 50 years
  • Ability to provide informed consent
  • Willingness to comply with postoperative rehabilitation and follow-up evaluations

Критерии исключения

  • Previous ligament reconstruction surgery on the affected knee
  • Multi-ligament knee injuries requiring additional ligament reconstruction
  • Severe osteoarthritis of the knee
  • Revision anterior cruciate ligament reconstruction
  • Neuromuscular disorders affecting lower extremity function
  • Active infection
  • Inability to comply with follow-up protocol

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
Открытое
Основная цель
Лечение

Центры проведения

Turkey (Türkiye) · 1 центр
  • Acibadem Fulya Hospital, Sport Medicine Center — Istanbul

Идентификаторы

NCT: NCT07671729 · Quadriceps vs PL

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗