Blood Flow Restriction Therapy to Prevent Muscle Atrophy Following Anterior Cruciate Ligament Reconstruction
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Change in Quadriceps Cross-Sectional Area
研究概览
简要总结
This study is a prospective, double-blinded, randomized control trial examining the effect of blood flow restriction (BFR) therapy on reducing post-operative quadriceps atrophy in patients undergoing anterior cruciate ligament reconstruction (ACLR). Following ACLR, patients will undergo a rehabilitation protocol either w/ BFR therapy or sham BFR therapy.
详细描述
Patients will be randomized to either BFR therapy or no BFR therapy. Randomization will be carried out using block randomization with blocks of 6.
Those undergoing BFR therapy will have a Delfi Personalized Tourniquet System (PTS) cuff applied to the proximal thigh of their operative leg and inflated to 80% limb occlusive pressure (LOP) calculated by the Delfi PTS device during physical therapy (PT) sessions from day 2 after surgery through day 7 after surgery. Those in the no BFR group will have the Delfi PTS cuff applied to their proximal thigh with inflation of the tourniquet to minimal pressure only. BFR therapy will be administered by health care providers who have undergone training and certification for BFR therapy with the Delfi PTS device.
Both groups will undergo the following PT regimen two times daily beginning on the day after the surgical procedure and lasting for 6 weeks post-operatively:
- Quad sets = x1 min isometric hold, 30 sec off, 3 sets
- Terminal knee extensions = 3x15, 30 sec rest or short arc quads sitting 1 x 30 + 3 x 15, 30 sec rest
- Once range of motion (ROM) allows: Bike 10 mins, low to no resistance
Each physical therapy visit will last approximately 60 minutes. During that time, there will be a total estimated time of 5-7 minutes during which the tourniquet cuff will be on the thigh, and the tourniquet will be inflated for a similar time period. The tourniquet will inflate for about 1 minute in order to find out the specific pressure for the patient's leg and then will remain inflated until exercises are completed, which should take 4-6 minutes. The cuff will then be deflated and is removed from the leg within about 30 seconds of being deflated.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Patients and outcomes assessors will be blinded to treatment group. Physical therapy providers will not be masked.
入排标准
- 年龄范围
- 14 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 14-70
- •Undergoing ACL reconstruction with patellar tendon autograft
- •Full weightbearing after surgery
- •Surgery performed within 14 days of ACL injury
- •No nerve catheter in place
排除标准
- •Meniscal root tears
- •radial meniscal tears
- •multi-ligament knee injury
- •revision ACL reconstruction
- •concomitant osteotomies
- •concomitant cartilage resurfacing procedures
- •fracture preventing full-weightbearing of operated extremity
- •previous history of deep vein thrombosis (DVT)
- •new nerve injury/findings affecting operative extremity
- •active femoral nerve catheter
- •nerve block lasting longer than day of surgery
- •patients unable to tolerate BFR treatment
- •untolerable post-operative pain due to absence of nerve catheter
- •proximal thigh girth greater than 34cm
- •time to surgery greater than 14 days
结局指标
主要结局
Change in Quadriceps Cross-Sectional Area
时间窗: Pre-op and 6-weeks post-operative
Change in quadriceps cross-sectional area measured on MRI pre-operatively compared to post-operatively
次要结局
- Numeric rating scale pain(Days 1, 14, and 6 weeks after surgery)
- Thigh girth(Days 1, 14, and 6 weeks after surgery)
- Knee joint range of motion(Days 1, 14, and 6 weeks after surgery)