Comparison of Methods in Post Operative Knee Arthroscopy Rehabilitation (ACL BFR)

University of Colorado Denver (CU Denver)

Status: Enrolling

Conditions: Muscle Atrophy; Muscle Weakness

Treatments: Device: BFR Cuff

Study type: Interventional

Funder types: Other

Identifiers

NCT05735236

22-1052

Details and patient eligibility

About

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

Full description

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.

Enrollment: 78 estimated patients

Sex: All

Ages: 16 to 60 years old

Volunteers: No Healthy Volunteers

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:

  1. 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

  2. Exclusion criteria will be evaluated via the medical record as well as by the expert opinion of the physician.

  3. If at any point in the study a subject develops one of the above contraindications, they will be removed from the study.

  4. If a subject becomes pregnant while participating in the intervention portion of the study, they will be removed.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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78 participants in 2 patient groups

Control

No Intervention group

Description:

Participants undergo standard post-operative physical therapy as prescribed by their surgeon.

BFR Cuff

Active Comparator group

Description:

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.

Treatment:

Device: BFR Cuff