Comparison of Methods in Post Operative Knee Arthroscopy Rehabilitation

Study Overview
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Brief Summary
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The aim of this study is to investigate the efficacy of blood flow restriction (BFR) therapy in post operative rehabilitation following knee arthroscopy.

Detailed Description
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The aim of this study is to investigate the efficacy of blood flow restriction (BFR) therapy in post operative rehabilitation following knee arthroscopy. The current standard of care and post-operative pain levels can limit patients from applying load necessary to increase muscle size and strength development due to partial weight baring after surgery. We hypothesize that immediate and consistent use of BFR augmenting our current standard post operative knee arthroscopy rehabilitation protocol will result in greater improvement in strength and quicker achievement of phase-based rehabilitation goals. We hypothesize that these objective improvements in strength will correlate with clinically meaningful improvement in Tegner activity scale, International Knee Documentation Committee (IKDC), return to sport, Lower Extremity Functional Scale (LEFS), pain and resiliency (patient reported outcome, PRO) scores indicative of greater functional recovery compared to our standard rehabilitation protocol alone.

Official Title
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Comparison of Methods in Post Operative Knee Arthroscopy Rehabilitation

Conditions
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Muscle Weakness, Muscle Atrophy

Intervention / Treatment
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* Device: BFR Cuff


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with ACL reconstruction with quadriceps, hamstring, bone-patellar-bone or allograft graft, with/without meniscectomies. Patients must also have access to a smartphone device in order to utilize the SAGA BFR application for use. The application is free to use. Exclusion Criteria: Bilateral knee surgeries to be performed within 12 weeks of each other, meniscus repairs, chondral lesion repair/transplants, ACL revisions that utilize contralateral autografts, MCL repairs, and the following BFR contraindications: deep vein thrombosis (DVT), pulmonary embolism, hemorrhagic/thrombolytic stroke, clotting disorders, hemophilia or taking blood thinners, pregnant or up to 6 months postpartum, untreated hypertension, untreated hypotension, rhabdomyolysis or recent traumatic injury, does not understand English, and the following BFR contraindications: Contraindications for BFR Deep Vein Thrombosis (DVT) Pulmonary Embolism Hemorrhagic/Thrombolytic Stroke Clotting Disorders Hemophilia or taking blood thinners Pregnant or up to 6 months post-partum Untreated Hypertension Untreated Hypotension Rhabdomyolysis or recent traumatic injury Exclusion criteria will be evaluated via the medical record as well as by the expert opinion of the physician. If at any point in the study a subject develops one of the above contraindications, they will be removed from the study. If a subject becomes pregnant while participating in the intervention portion of the study, they will be removed.

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 60 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Participants undergo standard post-operative physical therapy as prescribed by their surgeon. | |
| Active Comparator: BFR Cuff<br>Patients undergo standard post-operative physical therapy as prescribed by their surgeon with the addition of a Blood Flow Restriction (BFR) cuff that is used during their exercises. | Device: BFR Cuff<br>* The BFR cuff will be applied to the proximal thigh of the surgical leg while the patient completes specified physical therapy exercises.80% occlusion pressure will be determined by PT's in clinic through the use of a Delphi unit. Subjects will then be able to use the Saga Fitness app to adjust this pressure if it differs from the automatic calibrated pressure.<br>* Other names: Blood Flow Restriction Cuff;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee extensor strength | Strength of knee extensors via handheld dynamometry (HHD) and reported as a measure of limb symmetry index (LSI) comparing operative limb to non-operative lim | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hamstrings musculature strength | Strength of knee flexors via handheld dynamometry (HHD) and reported as a measure of limb symmetry index (LSI) comparing operative limb to non-operative limb. | 6 months | 
| single leg squat test | Performance on a Repeated Single Leg Squat test to 45 deg knee flexion over the course of 90 seconds reported as a measure of LSI | 6 months | 
| Tegner Activity Scale | Tegner Activity Scale: Range 0 (disability because of knee problems) - 10 (national or international level soccer) | 6 months | 
| LEFS | Range 0 (extreme difficulty) -100 (nodifficulty);MDIC = Δ 123 | 2 years | 
| Pain NPRS | Range 1 (low pain) -10 (high pain); MDC = Δ 34 | 2 Years | 
| PROMIS Pain | Range 0 (low pain) -100 (highpain); MDC = Δ 85 | 2 Years | 
| PROMIS Physical Function | Range 0 (low function) -100 (high function); MDC = Δ 85 | 2 Years | 
| Brief Resiliency Score (BRS) | Range 1(low resilience) -5 (high resilience); MDC = Δ low (1-2.99) to normal (3-4.3) to high (4.31-5) | 2 Years | 
| ACL-RSI | Range 1 (low function) -100 (high function); MDC = ∆15.1 for short form version | 2 Years | 
| IKDC | Range 1 (low function) -100 (high function); MDC = ∆8.8 low to ∆15.6 high | 2 Years |