Prevention of Skeletal Muscle Adaptations to Traumatic Knee Injury and Surgery
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Cross-sectional Area of Skeletal Muscle Fibers (All Fibers)
研究概览
简要总结
Traumatic knee injury is common and highly debilitating. Surgical reconstruction/repair improves knee biomechanics and function, but neuromuscular dysfunction persist for years despite rehabilitation, hindering resumption of normal activities, increasing risk of further injury and, in a majority of patients, hastening the development of knee osteoarthritis (OA). Our goal in this research study is to evaluate the utility of neuromuscular electrical stimulation (NMES), initiated following injury and maintained through the early post-surgical period, to prevent muscle atrophy and intrinsic contractile dysfunction compared to active control intervention of micro-electrical stimulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-50 yrs
- •BMI <35 kg/m2
- •acute, first-time, ACL rupture with or without meniscus injury
- •scheduled to undergo reconstruction with a BPTB autograft
排除标准
- •history of prior knee/lower extremity surgery or non-surgical intervention (eg, intra-articular injection) on either leg
- •abnormal laxity of any lower extremity ligament other than the injured ACL
- •signs or symptoms of arthritis, autoimmune or inflammatory disease or diabetes
- •grade IIIb or greater articular cartilage lesions (ICRS criteria)
- •women who are/plan on becoming pregnant
结局指标
主要结局
Cross-sectional Area of Skeletal Muscle Fibers (All Fibers)
时间窗: Difference between injured and non-injured leg at 3 weeks post-surgery
Cross-sectional area of skeletal muscle fibers will be evaluated using immunohistochemistry, with specification of all relevant muscle fiber types
Maximal Single Muscle Fiber Shortening Velocity (Myosin Heavy Chain (MHC) IIA Fibers)
时间窗: Difference between injured and non-injured leg at 3 weeks post-surgery
Maximal shortening velocity from segments of chemically-skinned single human muscle fibers will be assessed, with muscle fiber type determined post-measurement by gel electrophoresis
Cross-sectional Area of Skeletal Muscle Fibers (MHC IIA)
时间窗: Difference between injured and non-injured leg at 3 weeks post-surgery
Cross-sectional area of skeletal muscle fibers will be evaluated using immunohistochemistry, with specification of all relevant muscle fiber types
Cross-sectional Area of Skeletal Muscle Fibers (Myosin Heavy Chain (MHC) I Fibers)
时间窗: Difference between injured and non-injured leg at 3 weeks post-surgery
Cross-sectional area of skeletal muscle fibers will be evaluated using immunohistochemistry, with specification of all relevant muscle fiber types
Maximal Calcium-activated Tension Single Muscle Fiber Tension (Myosin Heavy Chain (MHC) IIA Fibers)
时间窗: Difference between injured and non-injured leg at 3 weeks post-surgery
Tension (force per unit muscle fiber cross-sectional area) from segments of chemically-skinned single human muscle fibers will be assessed under maximal calcium-activated condition, with muscle fiber type determined post-measurement by gel electrophoresis
次要结局
- Knee Extensor Peak Isokinetic Torque(Difference between injured and non-injured leg at 6 months post-surgery)
研究者
Michael J. Toth, Ph.D.
Associate Professor of Medicine
University of Vermont