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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 for primary ACL reconstruction. BFR has been shown to effect time to return to activity and strength postoperatively. This study aims to analyze the effects of BFR therapy in patients who underwent primary ACL reconstruction surgery compared to controls. Participants will be randomized into either a treatment (BFR Cuff) or control (no BFR cuff) group. All participants will follow standard of care (SOC) physical therapy protocol for 12 weeks after surgery according to their treatment group. Strength and patient outcome measures will be recorded throughout the 2 year study period.
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.
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Inclusion criteria
Exclusion criteria
Bilateral knee surgeries to be performed within 12 weeks of each other
Patients received meniscus repairs, chondral lesion repair/transplants,
Prior surgery on the same knee
Anyone who meets the following contraindications for BFR therapy:
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.
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Interventional model
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78 participants in 2 patient groups
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Central trial contact
Lauren Heylmun, BS
Data sourced from clinicaltrials.gov
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