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Active, Not Recruiting

NCT Number: NCT05735236

Comparison of Methods in Post Operative Knee Arthroscopy Rehabilitation

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

ACL Tear Anterior Cruciate Ligament Injuries Knee Injuries Leg Injuries Wounds and Injuries

Age range

16 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCHealth Steadman Hawkins Clinic

Centennial, Colorado, 80111, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • 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.

Treatment and study plan

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.

Other names: Blood Flow Restriction Device, Blood Flow Restriction Cuff

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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

  3. Tegner Activity Scale

    Time frame: 6 months

    Tegner Activity Scale: Range 0 (disability because of knee problems) - 10 (national or international level soccer)

  4. LEFS

    Time frame: 2 years

    Range 0 (extreme difficulty) -100 (nodifficulty);MDIC = Δ 123

  5. Pain NPRS

    Time frame: 2 Years

    Range 1 (low pain) -10 (high pain); MDC = Δ 34

  6. PROMIS Pain

    Time frame: 2 Years

    Range 0 (low pain) -100 (highpain); MDC = Δ 85

  7. PROMIS Physical Function

    Time frame: 2 Years

    Range 0 (low function) -100 (high function); MDC = Δ 85

  8. 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)

  9. ACL-RSI

    Time frame: 2 Years

    Range 1 (low function) -100 (high function); MDC = ∆15.1 for short form version

  10. IKDC

    Time frame: 2 Years

    Range 1 (low function) -100 (high function); MDC = ∆8.8 low to ∆15.6 high

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Acronym: ACL BFR

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Feb 21, 2023
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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