Autologous Costal Osteochondral Transplantation for Talar Osteochondral Lesions

Официальное название

Evaluation of the Effectiveness and Safety of Autologous Costal Osteochondral Transplantation in the Treatment of Talar Osteochondral Lesions: a Randomized Controlled Clinical Trial

Обзор

The goal of this clinical trial is to evaluate the effectiveness and safety of autologous costal osteochondral transplantation in the treatment of Hepple Stage V talar osteochondral lesions, compared with autologous osteoperiosteal transplantation. The main question it aims to answer is: • Whether autologous costal osteochondral transplantation can achieve better clinical outcomes and cartilage repair quality with lower donor site morbidity than autologous osteoperiosteal transplantation in the treatment of Hepple Stage V talar osteochondral lesions. Participants will be randomly assigned to the intervention group (undergoing autologous costal osteochondral transplantation) or the control group (undergoing autologous osteoperiosteal transplantation). Both groups of participants will receive the same postoperative rehabilitation process and follow-up evaluation.

Вмешательства

• Процедура Autologous costal osteochondral transplantation
  Operating steps: 1. Arthroscopic examination of the size and location of the talar osteochondral lesion; 2. Make a transverse incision (approximately 4 cm long) at the osteochondral junction of the fifth or sixth rib, and harvest an osteochondral column from the rib; 3. Thoroughly remove the talar osteochonral lesion through arthrotomy or Chevron osteotomy of the medial malleolus; 4. Trim the autograft according to the size of the lesion; 5. Fill the peri-lesion cavity with cancellous bone, and
• Процедура Autologous iliac osteoperiosteal transplantation
  Operating steps: 1. Arthroscopic examination of the size and location of the talar osteochondral lesion; 2. Make an incision along the anterior iliac crest. At the time of exposure, pay attention not to damage the periosteum. Obtain a cylindrical osteoperiosteal column by an appropriate-sized harvester tube. 3. Thoroughly remove the talar osteochonral lesion through arthrotomy or Chevron osteotomy of the medial malleolus; 4. Fill the peri-lesion cavity with cancellous bone, and finally embed th

Первичные конечные точки

• American Orthopedic Foot and Ankle Society (AOFAS) ankle-hindfoot scale score [Срок оценки: 24 months after surgery]

Вторичные конечные точки (11)

• American Orthopedic Foot and Ankle Society (AOFAS) ankle-hindfoot scale score [Срок оценки: 3, 6, 12 months after surgery]
• International Cartilage Repair Society (ICRS) score [Срок оценки: 12 months after surgery]
• Numeric Rating Scale (NRS) for ankle pain during walking [Срок оценки: 3, 6, 12 and 24 months after surgery]
• Foot and Ankle Ability Measure (FAAM) ADL subscale [Срок оценки: 12 and 24 months after surgery]
• Foot and Ankle Ability Measure (FAAM) Sports subscale [Срок оценки: 12 and 24 months after surgery]
• Tegner score [Срок оценки: 12 and 24 months after surgery]
• Patients' satisfaction degree [Срок оценки: 24 months after surgery]
• Bone union [Срок оценки: 3 months after surgery or later]
• Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) score [Срок оценки: 12 and 24 months after surgery]
• Numeric Rating Scale (NRS) for donor-site pain [Срок оценки: 1, 2, 3, 6, 12 and 24 months after surgery]
• Any other complications [Срок оценки: 1, 2, 3, 6, 12 and 24 months after surgery]

Критерии участия

Критерии включения

• Symptomatic Hepple stage V talar osteochondral lesions with a lesion depth ≥5 mm and an AOFAS score ≤80 points;
• Failed conservative treatment for at least 6 months;
• Unilateral talar osteochondral lesions without corresponding lesions on the tibial side;
• Willingness to participate in this clinical trial and signing an informed consent form.

Критерии исключения

• Combined with lower limb deformity.
• Combined with hip or knee joint diseases.
• Combined with ipsilateral ankle arthritis with joint space narrowing .
• Diagnosis of gouty arthritis of the ankle joint.
• Combined with osteoporosis (T score <-2.5).
• Other conditions considered inappropriate for participation in this clinical trial by the researchers.

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

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The Third Affiliated Hospital of Southern Medical University — Гуанчжоу

Идентификаторы

NCT: NCT05942430 · 2023-Lunshen-017 · YL202203

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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