NCT06878794Enrolling By Invitation不适用
IIT Study on the Use of Medical Bio Glue for Repairing Meniscus Tears
First Affiliated Hospital of Ningbo University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年12月25日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- MOCART score
研究概览
简要总结
To evaluate the safety and effectiveness of water triggered medical bioadhesive for meniscus tear repair
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
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient is aged between 18 and 60 years old (including 18 and 60 years old), regardless of gender;
- •Unilateral meniscus tear of the knee joint;
- •Normal joint range of motion;
- •The subjects agree to participate in this trial and sign the "Subject Informed Consent Form".
排除标准
- •Body mass index BMI>32 kg/m2 (BMI=weight divided by height squared);
- •Patients with abnormal lower limb force lines that require correction;
- •Patients with multiple ligament injuries or complete meniscectomy;
- •Individuals with a history of allergies to biological glue as the chief complaint;
- •Patients with more than 2 or extensive cartilage defects in a single knee joint, and patients with bilateral knee joint cartilage defects;
- •Those who have undergone open knee surgery within the past 6 months;
- •Pregnant or lactating women, or those who plan to conceive during the trial period, and those whose blood HCG test results are positive before the trial;
- •Patients with infectious, immune, or metabolic arthritis in the knee joint;
- •Patients who participated in any other clinical trial or did not reach the trial endpoint within the first 3 months prior to enrollment;
- •Other circumstances determined by the researcher to be unsuitable for inclusion in this study.
结局指标
主要结局
MOCART score
时间窗: Baseline (Before treatment), 6 and 12 months after treatment
Lysholm score
时间窗: Baseline (Before treatment), 3、 6 and 12 months after treatment
IKDC score
时间窗: Baseline (Before treatment), 3、 6 and 12 months after treatment
次要结局
- T2 mapping(Baseline (Before treatment),12 months after treatment)
- Equipment use and evaluation(During operation)
- The occurrence of adverse events related to the test device(12 months after treatment)
- Equipment defect incidence rate(During operation)
- The incidence of device related SAE requiring further surgical intervention within 12 months after surgical(12 months after treatment)
研究者
研究点 (1)
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