Clinical and Radiological Outcomes of M-ARS ACL
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 3
- 主要终点
- Survival rate
研究概览
简要总结
The goal of this study is to evaluate the performance of Medacta Anatomic Ribbon Surgery (M-ARS) in patients requiring anterior cruciate ligament (ACL) reconstruction.
The main goal is to evaluate the survival rate of M-ARS ACL at 6 months post-operatively. The secondary goals are to assess the survival rate, clinical and functional outcomes, the quality of life, and the rate of complications at 1 month, 1 year and 2 years post-operatively.
详细描述
This s a prospective, multicenter, non-controlled, observational study to evaluate the outcomes of Medacta Anatomic Ribbon Surgery (M-ARS) in the reconstruction of the anterior cruciate ligament (ACL).
Participants will be informed about the study, both orally and in writing, during a preoperative visit. The investigator will answer any questions that may arise and will collect the informed consent. During the study, enrolled participants will be able to withdraw at any time and for any reason.
The study is conducted according to the following schedule:
- V1 : Inclusion during a preoperative visit
- V2: Surgery
- V3: Follow-up visit at 1 month ± 15 days post-surgery
- V4: Follow-up visit at 6 months ± 30 days post-surgery
- V5: Follow-up visit at 12 months ± 60 days post-surgery
- V6: Follow-up visit at 24 months ± 90 days post-surgery
The following data will be collected:
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients older than 18 years
- •Patients with ACL rupture requiring ACL reconstruction
排除标准
- •Patients with malignant diseases (at the time of surgery)
- •Patients with proven or suspected infections (at the time of surgery)
- •Patients with functional deficits of the affected extremity (at the time of surgery)
- •Patients with known incompatibility or allergy to products materials (at the time of surgery)
结局指标
主要结局
Survival rate
时间窗: 6 months
Kaplan Meier method
次要结局
- Functional outcome(1, 6, 12, 24 months)
- Quality of Life outcome(1, 6, 12, 24 months)
- Complication rate(intraoperative, 1, 6, 12, 24 months)
- Survival rate(1, 12, 24 months)
- Radiological outcome (optional)(1, 6, 12, 24 months)