Effects of Blood Flow Restriction (BFR) Therapy on ACL Graft Maturation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effects of Blood Flow Restriction (BFR) Therapy on Early Anterior Cruciate Ligament (ACL) Graft Maturation

Conditions
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Knee Injuries, Anterior Cruciate Ligament Injuries

Intervention / Treatment
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* Other: Blood Flow Restriction Therapy
* Other: Standard Postoperative Physical Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ages 18 or older, all gender Patients receiving any type of ACL graft, either autograft or allograft, and any type of tissue Exclusion Criteria: 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 unble to lay still in an MRI scanner Patients with a torn ACL or previous ACL reconstruction in the contralateral knee

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Physical Therapy with BFR<br>Participants will begin BFR therapy 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. | Other: Blood Flow Restriction Therapy<br>* BFR is a rehabilitation method that involves wearing a tight band around the exercising extremity to briefly limit blood flow while doing light weight exercises. The response is similar to heavy weight training or lifting but without the stress on the extremity that is still healing from surgery. Will be given after 2 weeks standard postoperative physical therapy per surgeon's ACL reconstruction protocol following surgery.<br>|
| Active Comparator: Physical Therapy without BFR<br>Participants will undergo standard physical therapy following the surgeon's postoperative protocol. | Other: Standard Postoperative Physical Therapy<br>* This is the surgeon's standard postoperative physical therapy protocol after ACL reconstruction.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in MRI imaging of Graft | Graft ligamentization or maturation on MRI using T2 mapping | 2 weeks, 3 months, 6 months | 
| Difference in Quadriceps Volume & Cross-sectional Area | Quadriceps muscle atrophy measured on MRI with quadriceps cross-sectional area | 3 months, 6 months | 
| Difference in Thigh Circumference Measurement | Muscle measurement determined with measuring tape for thigh circumference | 3 months, 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Isokinetic Dynamometer | Measurement of knee extension and flexion torque at 180° and 300°/sec using the isokinetic dynamometer | 2 weeks, 3 months, 6 months | 
| Visual Analog Scale (VAS) | Patient reported assessment of current level of pain from no pain to worst imaginable | 2 weeks, 3 months, 6 months | 
| Single Assessment Numerical Evaluation (SANE) | Patient reported outcome measure of function. 0-100% scale with 100% being normal | 2 weeks, 3 months, 6 months | 
| International Knee Documentation Committee (IKDC) | Patient reported outcome measure of symptoms, sports activity & knee function. 0-100 points with 0 (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms) | 2 weeks, 3 months, 6 months |