Comparison of Methods in Post Operative Knee Arthroscopy Rehabilitation

NCT05735236 | Recruiting FDA Device

• 1 other identifier: 22-1052
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

ACL Tear

Outcome Measures

Primary Outcomes (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

  6 months

Secondary Outcomes (10)

• hamstrings musculature strength

  6 months

• single leg squat test

  6 months

• Tegner Activity Scale

  6 months

• LEFS

  2 years

• Pain NPRS

  2 Years

Study Arms (2)

Control

NO INTERVENTION

Participants undergo standard post-operative physical therapy as prescribed by their surgeon.

BFR Cuff

ACTIVE COMPARATOR

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

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.

Also known as: Blood Flow Restriction Device, Blood Flow Restriction Cuff

BFR Cuff

Eligibility Criteria

• Age: 16 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

UCHealth Steadman Hawkins Clinic

Centennial, Colorado, 80111, United States

RECRUITING

Related Publications (17)

• 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.

  PMID: 30638439 BACKGROUND

• 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.

  PMID: 26677831 RESULT

• 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.

  PMID: 26463594 RESULT

• 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.

  PMID: 23730848 RESULT

• 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.

  PMID: 33344004 RESULT

• 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.

  PMID: 30179950 RESULT

• 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.

  PMID: 26075208 RESULT

• 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.

  PMID: 26078452 RESULT

• 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.

  PMID: 30053790 RESULT

• 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.

  PMID: 24881906 RESULT

• 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.

  PMID: 29084094 RESULT

• 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.

  PMID: 32232065 RESULT

• 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.

  PMID: 30761200 RESULT

• 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.

  PMID: 18375784 RESULT

• 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.

  PMID: 16558577 RESULT

• Joseph AM, Collins CL, Henke NM, Yard EE, Fields SK, Comstock RD. A multisport epidemiologic comparison of anterior cruciate ligament injuries in high school athletics. J Athl Train. 2013 Nov-Dec;48(6):810-7. doi: 10.4085/1062-6050-48.6.03. Epub 2013 Oct 23.

  PMID: 24143905 RESULT

• Prue J, Roman DP, Giampetruzzi NG, Fredericks A, Lolic A, Crepeau A, Pace JL, Weaver AP. Side Effects and Patient Tolerance with the Use of Blood Flow Restriction Training after ACL Reconstruction in Adolescents: A Pilot Study. Int J Sports Phys Ther. 2022 Apr 2;17(3):347-354. doi: 10.26603/001c.32479. eCollection 2022.

  PMID: 35391873 RESULT

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Study Officials

• James Genuario, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lauren Heylmun, BS

CONTACT

720-516-9823; lauren.heylmun@cuanschutz.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2023
• First Posted: February 21, 2023
• Study Start: November 8, 2022
• Primary Completion: November 8, 2025
• Study Completion: November 8, 2025
• Last Updated: May 8, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)