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ACL TearACL BFRNCT05735236

Comparison of Methods in Post Operative Knee Arthroscopy Rehabilitation

A study testing BFR Cuff in people with ACL Tear, run by University of Colorado, Denver at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 16 to 60 years
Conditions the study is for
ACL Tear
What is being tested?
BFR Cuff
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
78 participants
Where
1 siteUnited States
Study dates
8 Nov 2022to 8 Nov 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 60 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 16Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • UCHealth Steadman Hawkins Clinic

    Centennial, Colorado, 80111

Other trials in 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 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.

Read the 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.

Conditions
ACL Tear
Being tested
BFR Cuff
Medical subject headings
Anterior Cruciate Ligament Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BFR CuffDevice

    Also called Blood Flow Restriction Device, Blood Flow Restriction 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.

Study groups in NCT05735236
Study groupRoleWhat they receive
ControlNo interventionParticipants undergo standard post-operative physical therapy as prescribed by their surgeon.
BFR CuffActive comparatorPatients 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.
Receives: Device: BFR Cuff

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Knee extensor strength

    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

    Measured: 6 months

Secondary outcomes (10)

  1. hamstrings musculature strength

    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.

    Measured: 6 months

  2. single leg squat test

    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

    Measured: 6 months

  3. Tegner Activity Scale

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

    Measured: 6 months

  4. LEFS

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

    Measured: 2 years

  5. Pain NPRS

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

    Measured: 2 Years

  6. PROMIS Pain

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

    Measured: 2 Years

  7. PROMIS Physical Function

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

    Measured: 2 Years

  8. Brief Resiliency Score (BRS)

    Range 1(low resilience) -5 (high resilience); MDC = Δ low (1-2.99) to normal (3-4.3) to high (4.31-5)

    Measured: 2 Years

  9. ACL-RSI

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

    Measured: 2 Years

  10. IKDC

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

    Measured: 2 Years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Feb 2023
  2. Study start8 Nov 2022
  3. Primary completion8 Nov 2026 (estimated)
  4. Study completion8 Nov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
78 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05735236
Sponsor's protocol ID
22-1052
Acronym
ACL BFR
Status last verified
Jul 2026
First submitted
18 Jan 2023
Last updated
13 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Bowman EN, Elshaar R, Milligan H, Jue G, Mohr K, Brown P, Watanabe DM, Limpisvasti O. Proximal, Distal, and Contralateral Effects of Blood Flow Restriction Training on the Lower Extremities: A Randomized Controlled Trial. Sports Health. 2019 Mar/Apr;11(2):149-156. doi: 10.1177/1941738118821929. Epub 2019 Jan 14.

    PubMed 30638439

  • Tabata S, Suzuki Y, Azuma K, Matsumoto H. Rhabdomyolysis After Performing Blood Flow Restriction Training: A Case Report. J Strength Cond Res. 2016 Jul;30(7):2064-8. doi: 10.1519/JSC.0000000000001295.

    PubMed 26677831

  • Slysz J, Stultz J, Burr JF. The efficacy of blood flow restricted exercise: A systematic review & meta-analysis. J Sci Med Sport. 2016 Aug;19(8):669-75. doi: 10.1016/j.jsams.2015.09.005. Epub 2015 Sep 28.

    PubMed 26463594

  • Yasuda T, Fukumura K, Fukuda T, Uchida Y, Iida H, Meguro M, Sato Y, Yamasoba T, Nakajima T. Muscle size and arterial stiffness after blood flow-restricted low-intensity resistance training in older adults. Scand J Med Sci Sports. 2014 Oct;24(5):799-806. doi: 10.1111/sms.12087. Epub 2013 Jun 3.

    PubMed 23730848

  • Charles D, White R, Reyes C, Palmer D. A SYSTEMATIC REVIEW OF THE EFFECTS OF BLOOD FLOW RESTRICTION TRAINING ON QUADRICEPS MUSCLE ATROPHY AND CIRCUMFERENCE POST ACL RECONSTRUCTION. Int J Sports Phys Ther. 2020 Dec;15(6):882-891. doi: 10.26603/ijspt20200882.

    PubMed 33344004

  • Hung M, Saltzman CL, Kendall R, Bounsanga J, Voss MW, Lawrence B, Spiker R, Brodke D. What Are the MCIDs for PROMIS, NDI, and ODI Instruments Among Patients With Spinal Conditions? Clin Orthop Relat Res. 2018 Oct;476(10):2027-2036. doi: 10.1097/CORR.0000000000000419.

    PubMed 30179950

  • Grzybowski JS, Malloy P, Stegemann C, Bush-Joseph C, Harris JD, Nho SJ. Rehabilitation Following Hip Arthroscopy - A Systematic Review. Front Surg. 2015 May 26;2:21. doi: 10.3389/fsurg.2015.00021. eCollection 2015.

    PubMed 26075208

  • Chahal J, Van Thiel GS, Mather RC 3rd, Lee S, Song SH, Davis AM, Salata M, Nho SJ. The Patient Acceptable Symptomatic State for the Modified Harris Hip Score and Hip Outcome Score Among Patients Undergoing Surgical Treatment for Femoroacetabular Impingement. Am J Sports Med. 2015 Aug;43(8):1844-9. doi: 10.1177/0363546515587739. Epub 2015 Jun 15.

    PubMed 26078452

  • Bronner S, Chodock E, Urbano IER, Smith T. Psychometric Properties of the Dance Functional Outcome Survey (DFOS): Reliability, Validity, and Responsiveness. J Orthop Sports Phys Ther. 2019 Feb;49(2):64-79. doi: 10.2519/jospt.2019.8247. Epub 2018 Jul 27.

    PubMed 30053790

  • Enseki K, Harris-Hayes M, White DM, Cibulka MT, Woehrle J, Fagerson TL, Clohisy JC; Orthopaedic Section of the American Physical Therapy Association. Nonarthritic hip joint pain. J Orthop Sports Phys Ther. 2014 Jun;44(6):A1-32. doi: 10.2519/jospt.2014.0302.

    PubMed 24881906

  • Luebbers PE, Witte EV, Oshel JQ, Butler MS. Effects of Practical Blood Flow Restriction Training on Adolescent Lower-Body Strength. J Strength Cond Res. 2019 Oct;33(10):2674-2683. doi: 10.1519/JSC.0000000000002302.

    PubMed 29084094

  • Lu Y, Patel BH, Kym C, Nwachukwu BU, Beletksy A, Forsythe B, Chahla J. Perioperative Blood Flow Restriction Rehabilitation in Patients Undergoing ACL Reconstruction: A Systematic Review. Orthop J Sports Med. 2020 Mar 25;8(3):2325967120906822. doi: 10.1177/2325967120906822. eCollection 2020 Mar.

    PubMed 32232065

  • Weatherholt AM, Vanwye WR, Lohmann J, Owens JG. The Effect of Cuff Width for Determining Limb Occlusion Pressure: A Comparison of Blood Flow Restriction Devices. Int J Exerc Sci. 2019 Jan 1;12(3):136-143. doi: 10.70252/RWVU7100. eCollection 2019.

    PubMed 30761200

  • Ingram JG, Fields SK, Yard EE, Comstock RD. Epidemiology of knee injuries among boys and girls in US high school athletics. Am J Sports Med. 2008 Jun;36(6):1116-22. doi: 10.1177/0363546508314400. Epub 2008 Mar 28.

    PubMed 18375784

  • Powell JW, Barber-Foss KD. Injury patterns in selected high school sports: a review of the 1995-1997 seasons. J Athl Train. 1999 Jul;34(3):277-84.

    PubMed 16558577

Questions about this trial

What is this clinical trial studying?

A study testing BFR Cuff in people with ACL Tear, run by University of Colorado, Denver at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Knee extensor strength (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05735236, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.

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