Obtain Safety and Effectiveness of CT-ACL001, a Regenerative Ligament Using Biological Tissue, in ACLR

Официальное название

A Randomized, Multicenter Study Comparing the Safety and Efficacy of CT-ACL001, a Regenerative Ligament, With Standard Treatment in Anterior Cruciate Ligament Reconstruction

Обзор

A randomized, multicenter study comparing the safety and efficacy of CT-ACL001, a regenerative ligament, with standard treatment in anterior cruciate ligament reconstruction

Подробное описание

The study will target patients (18 years old or older and under 45 years old) who have suffered anterior cruciate ligament injuries that require reconstruction surgery, and will evaluate the safety and efficacy of the investigational device when used in reconstruction surgery, using patients who used autologous tendons (knee flexor tendons) as a comparison control.

Вмешательства

• Устройство Anterior cruciate ligament reconstruction
  Single-bundle anterior cruciate ligament reconstruction will be performed using the test device. In addition, single-bundle anterior cruciate ligament reconstruction will also be performed in the control group using autologous knee flexor tendons.
• Процедура Anterior cruciate ligament reconstruction
  Single-bundle anterior cruciate ligament reconstruction will be performed using the test device. In addition, single-bundle anterior cruciate ligament reconstruction will also be performed in the control group using autologous knee flexor tendons.

Первичные конечные точки

• Evaluation of IKDC Subjective Score using a dedicated evaluation form [Срок оценки: 12 months after surgery]

Вторичные конечные точки (8)

• Measurement of Tibial Anterior Translation using a measuring device [Срок оценки: 12 months after surgery]
• Evaluation of Donor Site Morbidity using a dedicated evaluation form [Срок оценки: 1 week, 1 month, 3 months and 6 months after surgery]
• Measurement of Knee Flexion Strength using a measuring device [Срок оценки: 3 months, 6 months and 12 months after surgery]
• Evaluation of TEGNER-Activity-Score using a dedicated evaluation form [Срок оценки: 6 months and 12 months after surgery]
• Incidence of additional surgery on the affected side [Срок оценки: Through 12 months after surgery]
• Graft rupture rate [Срок оценки: Through 12 months after surgery]
• Joint effusion [Срок оценки: 1 month, 3 months and 6 months and 12 months after surgery]
• Adverse events/malfunction rates [Срок оценки: Through 12 months after surgery]

Критерии участия

Критерии включения

• Age: 18 years old or older and under 45 years old.
• Patients with anterior cruciate ligament injury who are candidates for reconstruction surgery.

Критерии исключения

• Chronic anterior cruciate ligament injury (injury occurred more than 12 months ago).
• History of knee surgery, including anterior cruciate ligament surgery on the index side.
• Complication or history cruciate ligament injury on the opposite side, history of total knee arthroplasty, osteotomy around the knee, or osteosynthesis around the knee on the opposite side.
• Meniscus injury that requires extensive resection and is impossible to suture on the index side, collateral ligament injury or posterior cruciate ligament injury of 2° or more on the index side.
• Complication of osteoarthritis of the knee on the index side, KL classification 2° or higher.
• Complications of cartilage damage that cannot be treated by drilling or microfracture on the index side.
• Patients with infection in the index knee or inflammatory joint disease such as rheumatoid arthritis.
• Patients undergoing radiation therapy, chemotherapy, or both.
• Patients currently receiving treatment with systemic steroids, immunosuppressants, or both.
• Patients who are allergic to bovine products (e.g. meat).
• Patients who cannot discontinue returning to sports until 9 months after reconstruction surgery.
• Pregnant, breastfeeding and possibly pregnant patients.
• Female patients of childbearing potential and male patients who cannot agree to contraception for at least one year after reconstruction surgery.
• Patients who participated in other clinical trials within 4 weeks prior to reconstruction surgery.

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

Двойное слепое

Основная цель

Лечение

Центры проведения

Япония · 6 центров

• Hirosaki University Hospital — Hirosaki
• Hiroshima University Hospital — Hiroshima
• Hokkaido University Hospital — Sapporo
• Kobe University Hospital — Kobe
• Juntendo University Hospital — Bunkyo-ku
• Tokyo Women's Medical University Hospital — Shinjuku-ku

Идентификаторы

NCT: NCT07129694 · CT-ACL001 · jRCT2032240214

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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