Autologous Osteoperiosteal Transplantation for the Treatment of Severe Osteochondral Lesions of the Talus

Официальное название

A Multicenter Prospective Cohort Study of Autologous Osteoperiosteal Transplantation for the Treatment of Severe Osteochondral Lesions of the Talus

Обзор

The goal of this clinical trial is to establish a multicenter prospective cohort of patients with severe osteochondral lesion of the talus (OLT), evaluate the clinical efficacy of autologous osteoperiosteal transplantation and the incidence of postoperative donor-site morbidity. The main questions it aims to answer are: Does autologous osteoperiosteal transplantation have good clinical outcomes in the treatment of severe OLT? Does autologous osteoperiosteal transplantation treat severe OLT with fewer postoperative complications? Participants will: Undergo autologous osteoperiosteal transplantation for OLT Receive clinical follow-up 3, 6, 12, and 24 months after surgery and answer scales of ankle function assessment Take CT and MRI preoperatively and 12 and 24 months after surgery

Вмешательства

• Процедура Autologous Osteoperiosteal Transplantation
  After full exposure of the lesion, the center of the cystic lesion was determined and drilled perpendicularly using a 2-mm pin. Then, a 4.5-mm cannulated bore was used to drill the lesion until the cyst was reached, and a small bone socket was created. A harvester tube matching the diameter of the cyst was used to enlarge the bone socket with care to avoid damage to the adjacent normal cartilage. The cystic lesion was debrided thoroughly, and the sclerotic wall of the cyst was freshened using a

Первичные конечные точки

• Foot and Ankle Outcome Score (FAOS) [Срок оценки: Pre-surgery and 6 weeks and 3, 6, 12 and 24 months after surgery]

Вторичные конечные точки (6)

• American Orthopedic Foot and Ankle Society Score (AOFAS) [Срок оценки: Pre-surgery and 6 weeks and 3, 6, 12 and 24 months after surgery]
• Visual Analogue Scale (VAS) [Срок оценки: Pre-surgery and 6 weeks and 3, 6, 12 and 24 months after surgery]
• Ankle Activity Score (AAS) [Срок оценки: Pre-surgery and 6 weeks and 3, 6, 12 and 24 months after surgery]
• Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) [Срок оценки: 12 and 24 months after surgery]
• International Cartilage Repair Society (ICRS) [Срок оценки: 12 months after surgery]
• Complications [Срок оценки: Final follow-up (48 months after surgery)]

Критерии участия

Критерии включения

• Chronic ankle pain, diagnosed as Osteochondral Lesions of the Talus (OLT);
• Hepple V OLT on the medial side of the talus or the diameter of the lesion ≥ 8 mm;
• Conservative treatment of at least 3 months fails to relieve symptoms;
• Willingness to voluntarily participate in the trial and to sign informed consent.

Критерии исключения

• Varus or valgus deformity of the ankle of more than 5 degrees;
• Grade III injury of the lateral collateral ligament of ankle;
• Chronic synovitis (rheumatoid arthritis, pigmented villous nodular synovitis, etc.);
• Joint fibrosis, stiffness, and significantly restricted range of motion;
• Evidence of moderate to severe knee osteoarthritis on plain radiographs;
• Failure to complete the rehabilitation protocol as required;
• Patient medically not fit for surgery, radiographs or MRI;
• For women, pregnant, planning to be pregnant or lactating.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• Peking University Third Hospital — Пекин

Идентификаторы

NCT: NCT06527482 · M2023418

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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