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

May 5, 2025 updated by: University of Colorado, Denver
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

78

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Colorado
      • Centennial, Colorado, United States, 80111
        • Recruiting
        • UCHealth Steadman Hawkins Clinic
        • Sub-Investigator:
          • Stephanie Mayer, MD
        • Contact:
        • Principal Investigator:
          • James Genuario, MD
        • Sub-Investigator:
          • Braden Mayer, MD
        • Sub-Investigator:
          • Thomas Noonan, MD
        • Sub-Investigator:
          • Martin Boublik, MD
        • Sub-Investigator:
          • Jason Dragoo, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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 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

        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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Device: BFR 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.
Other Names:
  • Blood Flow Restriction Device
  • Blood Flow Restriction Cuff

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knee extensor strength
Time Frame: 6 months
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
Time Frame: 6 months
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
Time Frame: 6 months
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
Time Frame: 6 months
Tegner Activity Scale: Range 0 (disability because of knee problems) - 10 (national or international level soccer)
6 months
LEFS
Time Frame: 2 years
Range 0 (extreme difficulty) -100 (nodifficulty);MDIC = Δ 123
2 years
Pain NPRS
Time Frame: 2 Years
Range 1 (low pain) -10 (high pain); MDC = Δ 34
2 Years
PROMIS Pain
Time Frame: 2 Years
Range 0 (low pain) -100 (highpain); MDC = Δ 85
2 Years
PROMIS Physical Function
Time Frame: 2 Years
Range 0 (low function) -100 (high function); MDC = Δ 85
2 Years
Brief Resiliency Score (BRS)
Time Frame: 2 Years
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
Time Frame: 2 Years
Range 1 (low function) -100 (high function); MDC = ∆15.1 for short form version
2 Years
IKDC
Time Frame: 2 Years
Range 1 (low function) -100 (high function); MDC = ∆8.8 low to ∆15.6 high
2 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Investigators

  • Principal Investigator: James Genuario, MD, University of Colorado, Denver

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 8, 2022

Primary Completion (Estimated)

November 8, 2025

Study Completion (Estimated)

November 8, 2025

Study Registration Dates

First Submitted

January 18, 2023

First Submitted That Met QC Criteria

February 15, 2023

First Posted (Actual)

February 21, 2023

Study Record Updates

Last Update Posted (Actual)

May 8, 2025

Last Update Submitted That Met QC Criteria

May 5, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-1052

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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