NCT04114708撤回不适用
MRI Review of ACLR With and Without Lateral Extra-articular Tenodesis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Determine if ACLR supplementation with LET results in superior MRI findings relative to ACLR alone
研究概览
简要总结
The purpose of the proposed study is to evaluate the effect of lateral extra-articular tenodesis (LET) on anterior cruciate ligament reconstruction through evaluation of postoperative magnetic resonance imaging (MRI). This will be a single-center non-randomized controlled study. The study is comparing postoperative graft MRI findings in two cohorts: patients undergoing isolated ACLR and patients undergoing ACLR with lateral extra-articular tenodesis (LET). Postoperative MRIs will be obtained at 6, 9 and 12 months postoperatively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ACL deficient knee
- •skeletally mature (as defined by closed growth plates on plain radiograph)
- •at least 13 years of age
- •less than 26 years of age
- •not pregnant
- •two or more of following criteria: competitive pivoting sport, grade 2 pivot shift or - greater, generalized ligament laxity (beighton score of 4 or greater )
- •no concomitant lateral meniscus tear
排除标准
- •knee with intact ACL
- •skeletally immature (as defined by open physis on plain radiograph)
- •less than two of following criteria: competitive pivoting sport, grade 2 pivot shift or - greater, generalized ligament laxity (beighton score of 4 or greater )
- •less than 13 years of age
- •older than age 25
- •previous ACL repair
- •concomitant lateral meniscus tear
- •unable to speak english or perform informed consent
- •multiligamentous knee injury (two or more ligaments requiring surgical attention)
- •varus or valgus malalignment greater than 3 degrees
结局指标
主要结局
Determine if ACLR supplementation with LET results in superior MRI findings relative to ACLR alone
时间窗: 1 Year
MRI findings will be compared in patients receiving ACLR+LET versus just ACLR
次要结局
- Graft Failure(1 Year)
研究者
研究点 (1)
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