NCT07129694Enrolling By Invitation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.8 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2024年11月25日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 64
- 试验地点
- 8
- 主要终点
- Evaluation of IKDC Subjective Score using a dedicated evaluation form
研究概览
简要总结
A randomized, multicenter study comparing the safety and efficacy of CT-ACL001, a regenerative ligament, with standard treatment in anterior cruciate ligament reconstruction
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 44 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
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.
研究组 & 干预措施
Safety evaluation cohort; CT-ACL001 treatment group
Experimental
An acute safety evaluation group that will receive treatment with the test device without randomization: 7 cases
干预措施: Anterior cruciate ligament reconstruction (Device)
Randomization cohort; CT-ACL001 treatment group
Experimental
Treatment with the test device (test device group): 38 cases
干预措施: Anterior cruciate ligament reconstruction (Device)
Randomization cohort; autologous tendon treatment group
Active Comparator
Anterior cruciate ligament reconstruction with autologous tendon (knee flexor tendon) (control group): 19 cases
干预措施: Anterior cruciate ligament reconstruction (Procedure)
结局指标
主要结局
Evaluation of IKDC Subjective Score using a dedicated evaluation form
时间窗: 12 months after surgery
The non-inferiority of the test device group to the control group will be evaluated 12 months after surgery using the IKDC Subjective Score. (maximum score: 100 and minimum score: 0, higher scores mean a better outcome)
次要结局
- Measurement of Tibial Anterior Translation using a measuring device(12 months after surgery)
- Evaluation of Donor Site Morbidity using a dedicated evaluation form(1 week, 1 month, 3 months and 6 months after surgery)
- Measurement of Knee Flexion Strength using a measuring device(3 months, 6 months and 12 months after surgery)
- Evaluation of TEGNER-Activity-Score using a dedicated evaluation form(6 months and 12 months after surgery)
- Incidence of additional surgery on the affected side(Through 12 months after surgery)
- Graft rupture rate(Through 12 months after surgery)
- Joint effusion(1 month, 3 months and 6 months and 12 months after surgery)
- Adverse events/malfunction rates(Through 12 months after surgery)
研究者
研究点 (8)
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