Intraoperative Laxity Evaluation of Anterior Cruciate Ligament Reconstruction, Anterior Cruciate Ligament Revision and Meniscus Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Laxity Evaluation
研究概览
简要总结
Intraoperative knee laxity evaluation of patiente undergoing ACL reconstruction, ACL revision, MAT
详细描述
The study aims to include all thise patients who will undergo anterior cruciate ligament reconstruction, anterior cruciate ligament revision or meniscus transplantation. These patients will undergo an intraoperative kinematic evaluation (pre- and post-ligament reconstruction / meniscal transplantation). There is no follow-up because all the data necessary to carry out the study are obtained during the operating session. In particular, the pre- and post-intervention values (acquired intraoperatively) will be compared using both the surgical navigator and the KiRA system in order to evaluate the effect of the surgical procedure on the value of both static and dynamic laxity of the knee joint. Moreover, limited to the data acquired with the KiRA system, a comparison will be also made with the controlateral limb.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 14 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have provided written informed written consent
- •Patients aged 14 to 65
- •Patients undergoing reconstructive surgery of the anterior cruciate ligament or revision of anterior cruciate ligament surgery or meniscus transplantation. Patients unable to understand and want patients who have not signed informed consent
排除标准
- •Patients unable to understand and to want
- •Patients who have not signed informed consent
结局指标
主要结局
Laxity Evaluation
时间窗: intraoperative
Laxity Evaluation will be performed using the intraoperative navigation system
次要结局
- Dynamic Laxity Evaluation(intraoperative)
研究者
Stefano Zaffagnini
Prof
Istituto Ortopedico Rizzoli