Pediatric and Adolescent Patellar Instability
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: Medial patellofemoral ligament reconstruction surgery, Physical therapy and rehabilitation.
- Кому может быть актуально
- Состояния в реестре: Patellar Instability. Базовые параметры: 8 лет — 25 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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Обзор
This is a multi-center, randomized controlled clinical trial, the purpose of which is to determine if patients age 25 and younger who undergo medial patellofemoral ligament (MPFL) reconstruction have lower rates of recurrent instability compared to those treated non-operatively. The MPFL is a ligament that stabilizes the kneecap, and maintains its proper position in the groove on the femur (thighbone). Instability refers to a situation in which the kneecap moves out of place, or dislocates. When instability is recurrent, it occurs more than once in the same knee.
Подробное описание
A total of 240 patients will be enrolled across participating sites around the country. These sites currently include: The Hospital for Special Surgery, Oregon Health and Science University, Inova Sports Medicine, and Mayo Clinic. Patients are randomly assigned to one of two treatment groups. Patients assigned to the "stabilization" group will undergo surgery to reconstruct the MPFL using either a hamstring tendon that is your own or one obtained from a donor. Patients assigned to the "conservative" group will be treated with physical therapy, and possibly a simple knee arthroscopy if you are found to have a loose fragment on x-ray or MRI. All patients will be required to return for follow-up visits, which will continue over the course of 5 years. During these visits, patients will be examined, asked to answer questions about their surgery and general health, and have imaging (x-ray and MRI) performed on the knee. All patients enrolled in this study will undergo a standardized, intensive rehabilitation protocol. The investigators anticipate that all patients may benefit from extensive rehabilitation, including strengthening and return to sport training. The knowledge gained from this study may benefit others in the future.
Вмешательства
- Процедура Medial patellofemoral ligament reconstruction surgery
Medial patellofemoral ligament reconstruction surgery using hamstring autograft - Другое Physical therapy and rehabilitation
A standardized physical therapy and rehabilitation program to be administered and guided by rehab specialists
Первичные конечные точки
- Recurrence of patellar instability [Срок оценки: 5 years]
Вторичные конечные точки (5)
- Kujala Scoring Questionnaire [Срок оценки: Preoperatively and at 1 year, 2 years, 3 years, 4 years, and 5 years after treatment.]
- Knee Injury and Osteoarthritis Outcome Score (KOOS) [Срок оценки: Preoperatively and at 1 year, 2 years, 3 years, 4 years, and 5 years after treatment.]
- International Knee Documentation Committee (IKDC) Subjective Knee Evaluation [Срок оценки: Preoperatively and at 1 year, 2 years, 3 years, 4 years, and 5 years after treatment.]
- Hospital for Special Surgery Pediatric Functional Activity Brief Scale [Срок оценки: Preoperatively and at 1 year, 2 years, 3 years, 4 years, and 5 years after treatment.]
- Outerbridge grade of any cartilage lesions [Срок оценки: MRI taken at initial exam, and for patients randomized to surgery only at 1 year and 5 years after surgery as well]
Критерии участия
Критерии включения
- Patients must be age 25 or younger
- Patients must be first-time dislocators, meaning have had only one episode of patellar instability, during which they dislocated their patella (kneecap)
Критерии исключения
- Patients with more than one episode of patellofemoral instability
- Patients who have had prior patellofemoral surgery on the knee of interest
- Patients with large cartilage tears in the knee. These patients will undergo stabilization of the patellofemoral joint (MPFL reconstruction) as per standard of care, and will not be included in the study.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Основная цель
- Лечение
Центры проведения
Список центров уточняется — проверьте первичный протокол.
Идентификаторы
NCT: NCT02333825 · 2014-087