jRCT2032240214招募中不适用
A randomized, multicenter study comparing the safety and efficacy of CT-ACL001, a regenerative ligament, with standard treatment in anterior cruciate ligament reconstruction
CoreTissue BioEngineering Inc.0 个研究点目标入组 64 人开始时间: 2024年11月25日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 64
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Single Blind
入排标准
- 年龄范围
- 18age old over 至 45age old not（—）
- 性别
- All
入选标准
- •Age: 18 years old or older and under 45 years old.
- •Patients with anterior cruciate ligament injury who are candidates for reconstruction surgery.
排除标准
- •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.
结局指标
主要结局
-
IKDC Subjective Score
次要结局
未报告次要终点
研究者
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