RecruitingNot ApplicableNCT05735236

Comparison of Methods in Post Operative Knee Arthroscopy Rehabilitation


Sponsor

University of Colorado, Denver

Enrollment

78 participants

Start Date

Nov 8, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 16 YearsMax Age: 60 Years

Inclusion Criteria3

  • Patients undergoing primary knee arthroscopy for ACL reconstruction without meniscus repair
  • Completing initial 12 weeks of physical therapy at the Steadman Hawkins Clinic in Denver
  • Patients with access to smartphone device

Exclusion Criteria15

  • 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
  • \. 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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Interventions

DEVICEBFR Cuff

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.


Locations(1)

UCHealth Steadman Hawkins Clinic

Centennial, Colorado, United States

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NCT05735236


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