JuggerStitch™ for Meniscal Repair Post Market Clinical Follow-up Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 130
- 试验地点
- 12
- 主要终点
- Clinical Success
研究概览
简要总结
This study is a post-market follow-up study. The data collected from this study will serve the purpose of confirming the safety and performance of the JuggerStitch Device used for meniscal repair according to the product labelling (Instruction For Use).
详细描述
This study is a post-market follow-up study to fulfil the post-market surveillance obligations according to Medical Device Directive and MEDDEV 2.12/2 and the Medical Devices Regulation (MDR 2017/745). The data collected from this study will serve the purpose of confirming the safety and performance of the JuggerStitch Device used for meniscal repair according to the product labelling (IFU).
The objectives of the study are to calculate the overall clinical success rate and the performance, and confirm the safety of the JuggerStitch Meniscal Repair Device. The primary endpoint of this study is defined by the absence of reoperation due to meniscal tear. This will be measured against the success criteria of the absence of reoperation in 90.2% of the cases at one year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject qualifies for meniscal repair based on the physical exam and medical history and meets the approved indications for use of the study product;
- •Older than 18 years and skeletally mature;
- •Willing and able to comply with the study procedures;
- •Subject is capable of understanding the doctor's explanations, following his instructions and is able to participate in the follow-up program;
- •Subject is able to read and understand the informed consent form (ICF) and has voluntarily provided written informed consent.
排除标准
- •Meniscal tears in the avascular zone of meniscus;
- •Meniscal tears not suitable for repair because of the degree of damage(marked irregularity and complex tearing) to the meniscus body including degenerative, radial, horizontal cleavage and flap tears;
- •Presence of active infection;
- •If female, subject is pregnant;
- •Subject is vulnerable (prisoner, mentally incompetent or unable to understand what participation to the study entails, a known alcohol or drug abuser, anticipated to be non-compliant);
- •The subject is unwilling or unable to give consent or to comply with the follow-up program;
- •Subject meets any contraindications of the appropriate Instruction for Use.
结局指标
主要结局
Clinical Success
时间窗: 1 year
The absence of reoperation due to meniscal tear. This will be measured against the success criteria of the absence of reoperation in 90.2% of the cases at one year.
次要结局
- Monitoring of Adverse Events to confirm safety of the meniscal repair device(1 year)