Osteochondritis Dissecans of Knee Prospective Cohort
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: Other: observational only- no intervention.
- Кому может быть актуально
- Состояния в реестре: Osteochondritis Dissecans. Базовые параметры: Без ограничений · 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
- США
- 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
ROCK Comprehensive Prospective Cohort for Osteochondritis Dissecans of the Knee
Обзор
The Cohort is a multi-site prospective data collection study that will enroll any patient with diagnosis of knee OCD (confirmed by a standard of care x-ray or MRI). Patients will be followed for up to the next 50 years of their lives to study courses of care, disease progression, treatment/surgical options/results, and specific sports-related outcomes in athletic patients. Subjects will complete quality of life surveys as part of the Cohort. Course of care will not be affected.
Подробное описание
Patients will be recruited and consented at the visit in which their eligibility is determined. Once a patient is eligible and provides informed consent, he or she will be in the study for up to 50 years, or until his or her OCD lesion is healed successfully.
At the initial visit, a subject will complete a basic medical history form, and three questionnaires: the IKDC Subjective questionnaire (ages over 18) or the PEDI-IKDC Subjective questionnaire (ages under 18); the KOOS questionnaire; and the Marx Activity Scale (adult) or Pedi-FABS Scale (pediatric). Patients will then continue with their normal course of care as determined by their surgeon and care team.
Mandatory surveys (same as above) will be collected from patients at 2 years, 5 years, 10 years, and 25 years. Patients who cannot return to clinic will have the option to complete the assessments and return in pre-stamped and addressed return envelopes provided by the clinical site the subject is a patient at. Any other follow-up visits between these time intervals will also be options for patients to complete these assessments, however patients will not complete them any closer than intervals 12 weeks apart in order to prevent redundancy.
Additionally, at the initial visit, the surgeon will complete a routine patient history and physical exam, which will be collected. Any surgical procedures or physical therapy a patient undergoes for treatment of his or her OCD lesion will also be documented and collected. At follow-up visits, surgeons will complete their own physical exam follow-up assessment forms, which will be collected.
Вмешательства
- Другое Other: observational only- no intervention
Other: observational only- no intervention
Первичные конечные точки
- IKDC questionnaire [Срок оценки: baseline up to 50 years]
- PEDI-IKDC questionnaire [Срок оценки: baseline up to 50 years]
Вторичные конечные точки (4)
- KOOS Knee score [Срок оценки: baseline up to 50 years]
- Marx Activity Score questionnaire [Срок оценки: baseline up to 50 years]
- Pedi-FABS Score [Срок оценки: baseline up to 50 years]
- Radiographic Healing [Срок оценки: baseline up to 50 years]
Критерии участия
Критерии включения
- Diagnosis of osteochondritis dissecans or focal articular cartilage defects as confirmed by x-ray or MRI
Критерии исключения
- Non-confirmed diagnosis (i.e. patient does not yet have imaging confirmation)
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
США · 1 центр
- University of Pennsylvania — Philadelphia
Публикации
- ROCK Group; Nissen CW, Albright JC, Anderson CN, Busch MT, Carey JL, Carlson C, Carsen S, Chambers HG, Crepeau A, Edmonds EW, Ellermann JM, Ellis HB Jr, Erickson JB, Fabricant PD, Godin J, Ganley TJ, Green DW, Grimm NL, Heyworth BE, Hui Hoi Po J, Kocher MS, Koehler R, Krych AJ, Latz KH, Loveland DM, Lyon RM, Meenen NM, Milewski MD, Myer GD, Nelson BJ, Nepple JJ, Nguyen JC, Pace JL, Paterno MV, Pen PMID 41981903
Идентификаторы
NCT: NCT02771496 · 820147