Comparison of Methods in Post Operative Knee Arthroscopy Rehabilitation

Part of paid clinical trials in Centennial, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT05735236
Status
Recruiting
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Conditions

  • ACL Tear

Eligibility Criteria

Sex
ALL
Age
16 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • BFR Cuff — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Nov 8, 2022
Status verified
Mar 2025
Primary completion
Nov 8, 2025
Completion
Nov 8, 2025

Study Design

Enrollment
78 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • No Intervention: Control
    Participants undergo standard post-operative physical therapy as prescribed by their surgeon.
  • Active Comparator: BFR Cuff
    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.

Primary Outcome Measure

Knee extensor strength [ Time Frame: 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UCHealth Steadman Hawkins ClinicCentennialColorado80111
Lauren M Heylmun, BS
[email protected]
720-516-9823
James Genuario, MD (PRINCIPAL_INVESTIGATOR)
Braden Mayer, MD (SUB_INVESTIGATOR)
Stephanie Mayer, MD (SUB_INVESTIGATOR)
Thomas Noonan, MD (SUB_INVESTIGATOR)
Martin Boublik, MD (SUB_INVESTIGATOR)
Jason Dragoo, MD (SUB_INVESTIGATOR)

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By research site
UCHealth Steadman Hawkins Clinic· Centennial, CO

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