Study of Surgical Methods for Anterior Cruciate Ligament Tearing
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 202
- 试验地点
- 2
- 主要终点
- quality of life
研究概览
简要总结
The purpose of this study is to determine which surgical method is better for anterior cruciate ligament teas in outcomes.
详细描述
The anterior cruciate ligament (ACL) is one of the most commonly injured ligaments of the knee. This study was conducted to determine whether the outcome of treatment is superior in early surgical reconstruction compared with optional delay reconstruction.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 36 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •a. patients with confirmed anterior cruciate ligament tearing
排除标准
- •One of the following associated injuries to the index knee as visualized on MRI and/or arthroscopy:
- •An unstable longitudinal meniscus tear that requires repair and where the following postoperative treatment (i.e. bracing and limited ROM) interferes with the rehabilitation protocol
- •Bi-compartmental extensive meniscus resections
- •A cartilage injury representing a full thickness loss down to bone
- •A total rupture of MCL/LCL as visualized on MRI
研究组 & 干预措施
early
patients underwent < 8 weeks reconstruction after injury
干预措施: early reconstruction (Procedure)
delay
patients underwent > 8 weeks reconstruction after injury
干预措施: delay reconstruction (Procedure)
结局指标
主要结局
quality of life
时间窗: at 6 months post-operatively
SF-36 questionnaire consists of 36 questions (two main components: physical and mental), each of which was assigned a score ranging from 0 to 100.
次要结局
- Tegner activity score(at 6 months post-operatively)
- Knee injury and Osteoarthritis Outcome Score(at 6 months post-operatively)
研究者
Hamidreza Shemshaki
principle
Isfahan University of Medical Sciences