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Идёт набор NCT06462040

Evaluation of Clinical and Radiological Outcomes in Patients Undergoing Fixation of Osteochondral Fragments With Reasorbable Screws in the Knee Joint

— Наблюдательное Osteochondral Defect Osteochondritis Dissecans Osteochondral Fracture Osteochondral Fracture of Patella

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: Fixation of osteochdral fragments with reabsorbable screws.
Кому может быть актуально
Состояния в реестре: Osteochondral Defect, Osteochondritis Dissecans, Osteochondral Fracture, Osteochondral Fracture of Patella. Базовые параметры: 12 лет — 35 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
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Обзор

Various techniques for the fixation of unstable osteochondral fragments have been used over the years, each with associated advantages and disadvantages, and differing clinical outcomes. However, the literature on the treatment of this type of injury in the adolescent and young adult population is scarce and involves small case series. Failure to treat these injuries can lead to serious consequences such as chronic pain, residual joint stiffness, and the development of early osteoarthritis, necessitating more invasive and burdensome interventions for the national health system, such as prosthetic replacements or osteotomies. Due to the lack of real consensus within the scientific community regarding the ideal treatment for these patients and the insufficient medium/long-term follow-up data on the effects of these injuries on articular cartilage in young patients, this study aims to evaluate the clinical and radiological conditions of patients undergoing osteochondral fragment fixation using the same surgical technique (fixation with resorbable screws performed arthroscopically or via open surgery depending on the lesion's location) in order to clarify preventive measures against cartilage degeneration following these injuries, which are very common in adolescence.

Вмешательства

  • Процедура Fixation of osteochdral fragments with reabsorbable screws
    Arthroscopic or mini-open fixation of free-intrarticular or unstable osteochondral fragments due to osteochondritis dissecans or osteochondral fractures with reabsorbable screws

Первичные конечные точки

  • KOOS (Knee Injury and Ostearthritis Outcome Score) score [Срок оценки: At least 24 months after surgery]
Вторичные конечные точки (12)
  • Kujala Anterior Knee Pain Scale [Срок оценки: At least 24 months after surgery]
  • International Knee Documentation Committee (IKDC) Score [Срок оценки: At least 24 months after surgery]
  • Objective IKDC (IKDC standard evaluation form) [Срок оценки: At least 24 months after surgery]
  • MARX Activity Rating Scale [Срок оценки: At least 24 months after surgery]
  • VAS (Visual Analog Scale) for pain [Срок оценки: At least 24 months after surgery]
  • Radiological evaluation (MRI, magnetic resonance imaging) throughout ICRS Cartilage Score [Срок оценки: 24 months after surgery]
  • Radiological evaluation (MRI, magnetic resonance imaging) throughout Outerbridge Classification [Срок оценки: 24 months after surgery]
  • Sports Activity Level, Tegner Score [Срок оценки: At least 24 months after surgery]
  • Thigh circumference [Срок оценки: At least 24 months after surgery]
  • Anterior knee pain / pain during knee flexion [Срок оценки: At least 24 months after surgery]
  • Likert scale [Срок оценки: At least 24 months after surgery]
  • Complications, subsequent interventions, or surgical failures [Срок оценки: At least 24 months after surgery]

Критерии участия

Критерии включения

  • Patients undergoing surgical fixation of osteochondral fragment using resorbable screw technique, either arthroscopically or via mini-open procedure depending on the lesion's location, from 01/01/2017, and all new patients eligible for this type of intervention until 31/12/2025.
  • Patients aged between 12 and 35 years at the time of the surgical intervention.
  • Patients with the presence of osteochondral fragments confirmed by magnetic resonance imaging.
  • Patients with osteochondral lesions observed on imaging and symptoms attributable to the presence of osteochondral fragments.
  • Patients diagnosed with osteochondritis dissecans or recent contusion/sprain trauma.

Критерии исключения

  • Patients with concomitant complex ligamentous injuries or fractures at the time of the intervention;
  • Patients who are no longer reachable;
  • Women of childbearing age who cannot exclude pregnancy;
  • Patients who are unable to provide informed consent or patients who are unwilling to sign the informed consent form.

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 Rizzoli Orthopedic Institute — Bologna

Идентификаторы

NCT: NCT06462040 · OC-FIX

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗