A Multi-Center Open Study to Evaluate the SeriACL™ Device for Primary Anterior Cruciate Ligament Repair
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- KT-1000 Arthrometer
研究概览
简要总结
The SeriACL device was developed as an alternative to an autograft (i.e., tissue that is taken from a patient's own body) or an allograft (i.e., tissue that is taken from a cadaver) for ACL reconstruction. The SeriACL device is made of silk yarns, knit and processed with SeriCoat™ surface treatment which makes it easier to wet the material. The SeriACL device is designed to be a temporary support structure to replace the torn ACL and to stabilize the knee joint following surgical repair. It is designed to use the body's own healing process to regenerate the patient's own new ligament tissue. As the new tissue grows and the support structure is needed less over time, the SeriACL device is bioresorbed (i.e., broken down) by the patient's body. The SeriACL device is designed to be installed with standard surgical techniques for ACL repair.
This study is designed to test the safety of the SeriACL device in primary total ACL repair in patients with a torn ACL. The study will evaluate whether repair of the ACL with the SeriACL device will return the knee to normal function and what, if any, side effects will occur.
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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Complete ACL rupture
- •Injured knee range of motion >= 75% of contralateral knee
- •MCL tear grading <= 2
- •Sign informed consent.
排除标准
- •Prior ACL reconstruction
- •Complete PCL tear
- •Locked bucket handle tear or complex tears of the menisci.
- •Contralateral knee ligament injury
- •Known joint disease
- •Known allergy to silk
- •Active drug or alcohol abuse
结局指标
主要结局
KT-1000 Arthrometer
时间窗: 12 months
Safety - measured by device related SAEs
时间窗: 12 months
次要结局
- Knee Surveys(12 months)
- Return to Work(12 months)