Effects of Blood Flow Restriction (BFR) Therapy on Early Anterior Cruciate Ligament (ACL) Graft Maturation
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Difference in Thigh Circumference Measurement
研究概览
简要总结
This is a study comparing the effects of blood flow restriction (BFR) therapy on the maturation of the Anterior Cruciate Ligament (ACL) graft after reconstruction surgery compared to physical therapy without the use of BFR.
详细描述
The study will be a randomized controlled trial to compare outcomes between physical therapy with BFR and physical therapy without BFR on the ACL graft maturation following reconstruction surgery. BFR therapy will begin as early as 2 weeks after surgery. The initial 2 weeks after surgery, or prior to initiation of BFR, will consist of the physical therapy following the surgeon's postoperative protocol.
To be considered for participation in this study, patients must be 18 years and older undergoing primary ACL reconstruction. In addition, patients must meet several inclusion/exclusion criteria to be randomized and included in this study.
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 (Investigator)
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
- •Ages 18 or older, all gender
- •Patients receiving any type of ACL graft, either autograft or allograft, and any type of tissue
排除标准
- •Patients who do not meet the the comprehensive BFR screening criteria based on predetermined contraindications and precautions
- •Patients undergoing any additional concomitant ligament repair or reconstruction at the same surgery
- •Revision procedures
- •Patients unable to lay still in an MRI scanner
- •Patients receiving treatment outside Stanford
- •Patients undergoing concomitant meniscus treatment that restricts patients' weight bearing or prolongs their immobilization compared to their surgeons standard postoperative ACL reconstruction protocol
- •Patients who are unable to lay still in an MRI scanner
- •Patients with a torn ACL or previous ACL reconstruction in the contralateral knee
结局指标
主要结局
Difference in Thigh Circumference Measurement
时间窗: 3 months, 6 months
Muscle measurement determined with measuring tape for thigh circumference
Difference in MRI imaging of Graft
时间窗: 2 weeks, 3 months, 6 months
Graft ligamentization or maturation on MRI using T2 mapping
Difference in Quadriceps Volume & Cross-sectional Area
时间窗: 3 months, 6 months
Quadriceps muscle atrophy measured on MRI with quadriceps cross-sectional area
次要结局
- Visual Analog Scale (VAS)(2 weeks, 3 months, 6 months)
- Single Assessment Numerical Evaluation (SANE)(2 weeks, 3 months, 6 months)
- Isokinetic Dynamometer(2 weeks, 3 months, 6 months)
- International Knee Documentation Committee (IKDC)(2 weeks, 3 months, 6 months)
研究者
Seth Sherman
Associate Professor
Stanford University