Autologous Osteo-periosteal Cylinder Graft Transplantation for Hepple V Osteochondral Lesions of the Talus
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: autologous osteo-periosteal cylinder graft transplantation, autologous osteochondral graft transplantation, autologous osteo-periosteal cylinder graft.
- Кому может быть актуально
- Состояния в реестре: Osteochondral; Defect. Базовые параметры: 18 лет — 60 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
- Китай
- 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 Study of Autologous Osteo-periosteal Cylinder Graft Transplantation for Hepple V Osteochondral Lesions of the Talus
Обзор
The trial evaluates the clinical efficacy and safety of autologous osteo-periosteal cylinder graft transplantation for Hepple V osteochondral lesions of the talus. Half of participants will receive autologous osteo-periosteal cylinder graft transplantation, while the other will receive osteochondral graft transplantation as a control group.
Подробное описание
Autologous osteo-periosteal cylinder graft surface is a periosteal structure, with the ability of repairment to cartilage, periosteum is closely connected to the cortical bone, then the deep loose cancellous bone.The objective of the study is to evaluate the clinical efficacy of autologous osteo-periosteal cylinder graft transplantation for Hepple V osteochondral lesions of the talus by randomized controlled trial. 70 patients with clinically diagnosed Hepple V talus osteochondral lesions according to 1: 1 were divided into experimental group and control group. The experimental group will be treated with autologous osteo-periosteal cylinder graft transplantation under arthroscopy. The control group will be treated with autologous osteochondral graft under arthroscopy. The patients will be treated by the same surgeon in this study group. Postoperative MRI MOCART evaluation, clinical AOFAS score, VAS score, Tegner score, and the secondary arthroscopy ICRS score will be selected as the measures of outcome. The incidence of adverse events will be recorded.
Вмешательства
- Процедура autologous osteo-periosteal cylinder graft transplantation
Autologous osteo-periosteal cylinder graft transplantation is a novel treatment for Hepple V osteochondral lesions of the talus. - Процедура autologous osteochondral graft transplantation
Autologous osteochondral graft transplantation is the most common treatment for Hepple V osteochondral lesions of the talus. - Устройство autologous osteo-periosteal cylinder graft
Autologous osteo-periosteal cylinder graft is taken from ilium.
Первичные конечные точки
- American Orthopaedic Foot & Ankle Society(AOFAS) ankle-hindfoot score [Срок оценки: 4 years]
Вторичные конечные точки (4)
- International Cartilage Repair Society(ICRS) score [Срок оценки: 4 years]
- Magnetic Resonance Observation of cartilage repair tissue(MOCART) score [Срок оценки: 4 years]
- Tegner activity level score [Срок оценки: 4 years]
- Visual analogue scale [Срок оценки: 4 years]
Критерии участия
Критерии включения
- 18-50 years old, male or female
- Chronic pain in the ankle, confirmed by ankle joint MRI as Hepple V osteo-chondral lesions of the talus
- Using rest/external use/oral non-steroidal anti-inflammatory drugs and other conservative treatment for more than 3 months ineffective
- Patients voluntarily participated in clinical trials, signed informed consent, with clinical follow-up
Критерии исключения
- In the last 6 months patients participated in other drug or medical device clinical trials
- Line of force in ankle is not correct (varus or valgus> 5 degrees)
- Grade III ankle collateral ligament injury
- Chronic specific synovitis (rheumatoid, pigmented villonodular synovitis, etc.)
- Joint fibrosis, ankylosis, activity was significantly limited
- Moderate and severe osteoarthritis
- There are MRI contraindications
- Hemophilia patients
- The general condition of patients can not tolerate surgery
- Pregnant or planned pregnant women and lactating women
- Abnormal mental capacity without autonomy
- Other conditions in which the doctor can not decide to participate in the trial
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
Китай · 1 центр
- Institute of Sports Medicine — Пекин
Публикации
- Yang S, Hu F, Shao Q, Zhang Z, Liu X, Jiang Y, Jiang D, Xie X, Jiao C, Hu Y, Shi W, Guo Q. Autologous Osteoperiosteal Transplantation Versus Autologous Osteochondral Transplantation for Large Cystic Osteochondral Lesions of the Medial Talus: 2-Year Results From a Prospective Randomized Controlled Trial. Am J Sports Med. 2025 Sep;53(11):2642-2651. doi: 10.1177/03635465251361505. Epub 2025 Aug 19. PMID 40828751
- Deng E, Shi W, Jiang Y, Guo Q. Comparison of autologous osteoperiosteal cylinder and osteochondral graft transplantation in the treatment of large cystic osteochondral lesions of the talus (OLTs): a protocol for a non-inferiority randomised controlled trial. BMJ Open. 2020 Feb 9;10(2):e033850. doi: 10.1136/bmjopen-2019-033850. PMID 32041859
Идентификаторы
NCT: NCT03347877 · PKU-GUO-01