NCT07777458尚未招募不适用
The Effect of Lateral Extra-Articular Tenodesis on Lower-Extremity Lean Mass Recovery Following Anterior Cruciate Ligament Reconstruction: A Randomized Controlled Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in operative-leg lean mass (LM)
研究概览
简要总结
The purpose of this study is to determine whether the addition of Lateral Extra-Articular Tenodesis (LET) influences postoperative lower-extremity LM recovery following bone-patellar tendon-bone (BTB) Anterior Cruciate Ligament Reconstruction (ACLR). We hypothesize that patients undergoing ACLR BTB with LET will demonstrate greater loss of operative-leg LM at 9 months postoperatively compared with patients undergoing isolated ACLR BTB.
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
- None
入排标准
- 年龄范围
- 16 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Skeletally mature patients less than or equal to 60 years of age with ACL insufficiency scheduled to undergo primary BTB ACL reconstruction with or without LET.
- •Patients presenting with acute ACL injuries. Patients presenting with acute ACL injuries will be eligible for enrollment.
- •Acute injuries will be defined as injuries occurring within 6 weeks of presentation.
排除标准
- •undergoing multi ligamentous reconstruction (PCL, MCL, or PLC)
- •revision ACL reconstruction
- •neuromuscular disorders
- •contralateral ACL injury
- •pregnant or nursing
- •unable to read or write in English
- •possessing a high likelihood of remaining non-compliant
- •desire to return to sport prior to 6 months.
结局指标
主要结局
Change in operative-leg lean mass (LM)
时间窗: Baseline to 9 months
次要结局
未报告次要终点
研究者
Amit Momaya
Associate Professor
University of Alabama at Birmingham
研究点 (1)
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