Use of Blood Flow Restriction Therapy Following ACL Tear

Study Overview
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Brief Summary
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Evaluating the use of peri-operative blood flow restriction therapy surrounding anterior cruciate ligament tear

Detailed Description
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The purpose of this study is to examine the effect of utilizing blood flow restriction (BFR) therapy both before and after anterior cruciate ligament reconstruction (ACLR) following a tear. BFR has been proposed to work by restricting arterial inflow leading to an oxygen depleted environment and the ability to induce muscle adaption at lower maximum repetition via reactive hyperemia. Muscle atrophy occurs following ACL tear and reconstruction. Thus, physical therapy is used in the peri-operative period to regain strength with the ultimate goal of returning to activity. The goal of this investigation is to determine if using BFR during perioperative therapy would lead to increased and expedited strength gains. Additionally we would like to determine if BFR helps patients to pass the standard rehabilitative functional tests and return to play sooner. We will also look at patient reported outcomes metrics and pain scores to determine if BFR has a significant impact on the patient experience surrounding ACL tear and reconstruction.

Official Title
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Use of Blood Flow Restriction (BFR) Therapy in Peri-operative Rehabilitation Following Anterior Cruciate Ligament Tear

Conditions
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Anterior Cruciate Ligament Tear, Knee Injuries, Sport Injury

Intervention / Treatment
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* Device: Blood flood restriction cuff


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ACL tear undergoing reconstruction Exclusion Criteria: History of pulmonary embolism History of deep vein thrombosis Family history of PE/DVT Hypercoaguable disorder Multiligamentous knee injury Neurovascular injury Peripheral vascular disease Unable to complete physical therapy Unable to tolerate blood flow restriction

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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
Interventional Model Description: Parallel randomized controlled trial with a treatment and control group
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BFR Treatment<br>Patients will be recruited following ACL tear and medical screening for history of DVT/PE. Patients allocated to the BFR intervention group will undergo physical therapy with the use of a blood flow restriction cuff. Rehabilitation will consist of a structured home exercise program prior to surgery. We will instruct patients on how to perform home BFR and test them in the office to ensure competence. Following surgery patients will immediately be started in physical therapy. Therapy will consist of a structured program progressing from range of motion, to strength training and then functional tests. Both arms will use the same protocol with the only difference being use of BFR. | Device: Blood flood restriction cuff<br>* Blood flow restriction cuffs will be used as an augment to physical therapy<br>|
| No Intervention: Control<br>The control arm will undergo the same pre and post operative physical therapy as the BFR group. They will undergo a structure home therapy program prior to surgery and an outpatient physical therapy program under the guidance of a therapist following surgery. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quadriceps Strength | Quadriceps strength via handheld dynamometer | Three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quadriceps Strength | Quadriceps strength via handheld dynamometer | six months | 
| Knee range of motion | Knee range of motion via goniometer | three months | 
| Knee range of motion | Knee range of motion via goniometer | six months | 
| Patient reported outcome measurement information system | Patient reported outcomes measurement information system score on patient physical function, scale 0-100 with higher scores better | Three months | 
| Patient reported outcomes measurement information system | Patient reported outcomes measurement information system score on patient physical function, scale 0-100 with higher scores better | Six months | 
| international knee documentation committee questionnaire | international knee documentation committee questionnaire, scale 0-100 with higher scores better | three months | 
| international knee documentation committee questionnaire | international knee documentation committee questionnaire, scale 0-100 with higher scores better | six months | 
| Pain scores | Visual analog scale pain scores, scale 0-10 higher is more pain | three months | 
| Pain scores | Visual analog scale pain scores, scale 0-10 higher is more pain | six months |