Bioactive Knee Sleeve Garments After ACL Reconstruction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Swelling
研究概览
简要总结
This trial is studying the effectiveness of a bioactive knee sleeve to improve swelling and range of motion in the early postoperative ACL 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
- None
入排标准
- 年龄范围
- 16 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •MRI ACL-deficient knee and scheduled for ACLR surgery.
排除标准
- •Inflammatory rheumatic conditions
- •Previous ACLR on either knee
- •Multi-ligamentous knee repair/reconstruction required
- •Any autoimmune disease
- •Worker's compensation claims
- •Sickle cell anemia
- •Non-English speakers
结局指标
主要结局
Swelling
时间窗: Pre-operative/baseline, 1-week p/o, 1-month p/o, 2-month p/o, 3-month p/o
Circumferential girth measurements measured at 4 inches above mid-patellar region, mid-patellar region, and 4 inches below mid-patellar region on the tibia.
Range of Motion
时间窗: Pre-operative/baseline, 1-week p/o, 1-month p/o, 2-month p/o, 3-month p/o
Knee flexion and extension measured with standard goniometry.
Patient Reported Outcome (PRO) Measures
时间窗: Pre-operative/baseline, 1-week p/o, 1-month p/o, 2-month p/o, 3-month p/o
Questionnaires relevant to pain and perceived function.
次要结局
- Gait Speed(Pre-operative/baseline, 1-week p/o, 1-month p/o, 2-month p/o, 3-month p/o)
研究者
Christopher Brice
PT, DPT
Western Kentucky Heart and Lung Research Foundation and Educational Trust