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Идёт набор NCT07049484

Clinical and Biomechanical Outcomes of Anterior Cruciate Ligament (ACL) Reconstruction Associated With Lateral Extra-articular Tenodesis (LET)

— Наблюдательное ACL Reconstruction Tenodesis ACL Injuries

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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: ACL Reconstruction, Tenodesis, ACL Injuries. 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
Италия
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

Clinical and Biomechanical Outcomes of Anterior Cruciate Ligament (ACL) Reconstruction Associated With Lateral Extra-articular Tenodesis (LET): a Short-term Prospective Arthrometric Study

Обзор

The anterior cruciate ligament (ACL) is one of the main stabilizers of the knee joint, and its injury is among the most common soft tissue injuries of the knee. Several surgical reconstruction techniques are available, utilizing various tissues as a graft for the neo-ligament, including both autografts and allografts. The "Over-the-top single-bundle technique with gracilis and semitendinosus tendons combined with lateral extra-articular tenodesis (LET)" was developed in 1998 by Prof. Marcacci and Prof. Zaffagnini, and it is still the preferred method for ACL reconstruction at the Second Clinic of the Rizzoli Orthopaedic Institute. Cadaveric biomechanical studies have shown that combining LET with ACL reconstruction improves knee joint stability in both the anteroposterior and rotational planes. However, a recent in vivo study has challenged this hypothesis, showing that in patients undergoing surgery, the addition of LET enhances knee stability only in the anteroposterior direction and only for a limited period of six months. At twelve months postoperatively, joint laxity appeared similar to that of patients who did not undergo the additional procedure. Furthermore, the same study did not assess rotational instability using the pivot-shift test, an essential parameter as it is closely linked to knee stability and the patient's subjective perception of surgical success. Despite the increasing use of LET in conjunction with ACL reconstruction, few studies have analyzed the short-term postoperative effects of lateral extra-articular tenodesis and its potential benefits during the early stages of rehabilitation and return to sport. This study was conceived in response to this clinical question, with the goal of evaluating anteroposterior and rotational laxity in a group of patients who underwent ACL reconstruction combined with LET, in order to analyze clinical outcomes and, most importantly, any changes in stability during the early postoperative period. The results aim to improve understanding of knee stability in the initial phase following surgery, providing valuable information for rehabilitation teams to optimize recovery protocols and more effectively guide return-to-sport decisions for patients undergoing both procedures.

Первичные конечные точки

  • KYRA accelerometer [Срок оценки: 12 months]
Вторичные конечные точки (10)
  • KT-1000 Arthrometer [Срок оценки: 12 months]
  • Physical Examination [Срок оценки: 12 months]
  • Anterior Drawer Test [Срок оценки: 12 months]
  • Lachman Test [Срок оценки: 12 months]
  • Pivot Shift Test [Срок оценки: 12 months]
  • Knee Injury and Osteoarthritis Outcome Score (KOOS) [Срок оценки: 12 months]
  • Lysholm Knee Score [Срок оценки: 12 months]
  • VAS (Visual Analog Scale) [Срок оценки: 12 months]
  • Tegner Score [Срок оценки: 12 months]
  • Complications or Subsequent Interventions [Срок оценки: 12 months]

Критерии участия

Критерии включения

  • Patients undergoing isolated ACL reconstruction using gracilis and semitendinosus tendons with the over-the-top technique and LET.
  • Both male and female patients.
  • Patients who have given consent to participate in the study.
  • Age between 18 and 50 years at the time of surgery.

Критерии исключения

  • Previous surgery on the same limb (meniscectomy, prior ACL reconstruction, displaced fractures).
  • Surgical technique different from Over-the-Top with LET using autologous gracilis and semitendinosus tendons.
  • Other concomitant ligament injuries requiring surgical treatment.
  • Patients undergoing additional procedures at the same time as ACL reconstruction and LET (e.g., concomitant osteotomy, meniscus transplant, cartilage procedure…).
  • Patients who did not provide informed consent.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Италия · 1 центр
  • IRCCS Istituto Ortopedico Rizzoli — Bologna

Идентификаторы

NCT: NCT07049484 · LETOTT

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗