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

Primary Purpose

Muscle Weakness, Muscle Atrophy

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
BFR Cuff
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Muscle Weakness

Eligibility Criteria

16 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients with ACL reconstruction with quadriceps, hamstring, bone-patellar-bone or allograft graft, with/without meniscectomies. Patients must also have access to a smartphone device in order to utilize the SAGA BFR application for use. The application is free to use. Exclusion Criteria: Bilateral knee surgeries to be performed within 12 weeks of each other, meniscus repairs, chondral lesion repair/transplants, ACL revisions that utilize contralateral autografts, MCL repairs, and the following BFR contraindications: deep vein thrombosis (DVT), pulmonary embolism, hemorrhagic/thrombolytic stroke, clotting disorders, hemophilia or taking blood thinners, pregnant or up to 6 months postpartum, untreated hypertension, untreated hypotension, rhabdomyolysis or recent traumatic injury, does not understand English, and the following BFR contraindications: Contraindications for BFR 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.

Sites / Locations

  • UCHealth Steadman Hawkins ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Control

BFR Cuff

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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
Tegner Activity Scale
Tegner Activity Scale: Range 0 (disability because of knee problems) - 10 (national or international level soccer)
LEFS
Range 0 (extreme difficulty) -100 (nodifficulty);MDIC = Δ 123
Pain NPRS
Range 1 (low pain) -10 (high pain); MDC = Δ 34
PROMIS Pain
Range 0 (low pain) -100 (highpain); MDC = Δ 85
PROMIS Physical Function
Range 0 (low function) -100 (high function); MDC = Δ 85
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)
ACL-RSI
Range 1 (low function) -100 (high function); MDC = ∆15.1 for short form version
IKDC
Range 1 (low function) -100 (high function); MDC = ∆8.8 low to ∆15.6 high

Full Information

First Posted
January 18, 2023
Last Updated
February 15, 2023
Sponsor
University of Colorado, Denver
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1. Study Identification

Unique Protocol Identification Number
NCT05735236
Brief Title
Comparison of Methods in Post Operative Knee Arthroscopy Rehabilitation
Acronym
ACL BFR
Official Title
Comparison of Methods in Post Operative Knee Arthroscopy Rehabilitation
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 8, 2022 (Actual)
Primary Completion Date
November 8, 2024 (Anticipated)
Study Completion Date
November 8, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Weakness, Muscle Atrophy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
78 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants undergo standard post-operative physical therapy as prescribed by their surgeon.
Arm Title
BFR Cuff
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
BFR Cuff
Other Intervention Name(s)
Blood Flow Restriction Device, Blood Flow Restriction Cuff
Intervention Description
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.
Primary Outcome Measure Information:
Title
Knee extensor strength
Description
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
Time Frame
6 months
Secondary Outcome Measure Information:
Title
hamstrings musculature strength
Description
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.
Time Frame
6 months
Title
single leg squat test
Description
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
Time Frame
6 months
Title
Tegner Activity Scale
Description
Tegner Activity Scale: Range 0 (disability because of knee problems) - 10 (national or international level soccer)
Time Frame
6 months
Title
LEFS
Description
Range 0 (extreme difficulty) -100 (nodifficulty);MDIC = Δ 123
Time Frame
2 years
Title
Pain NPRS
Description
Range 1 (low pain) -10 (high pain); MDC = Δ 34
Time Frame
2 Years
Title
PROMIS Pain
Description
Range 0 (low pain) -100 (highpain); MDC = Δ 85
Time Frame
2 Years
Title
PROMIS Physical Function
Description
Range 0 (low function) -100 (high function); MDC = Δ 85
Time Frame
2 Years
Title
Brief Resiliency Score (BRS)
Description
Range 1(low resilience) -5 (high resilience); MDC = Δ low (1-2.99) to normal (3-4.3) to high (4.31-5)
Time Frame
2 Years
Title
ACL-RSI
Description
Range 1 (low function) -100 (high function); MDC = ∆15.1 for short form version
Time Frame
2 Years
Title
IKDC
Description
Range 1 (low function) -100 (high function); MDC = ∆8.8 low to ∆15.6 high
Time Frame
2 Years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with ACL reconstruction with quadriceps, hamstring, bone-patellar-bone or allograft graft, with/without meniscectomies. Patients must also have access to a smartphone device in order to utilize the SAGA BFR application for use. The application is free to use. Exclusion Criteria: Bilateral knee surgeries to be performed within 12 weeks of each other, meniscus repairs, chondral lesion repair/transplants, ACL revisions that utilize contralateral autografts, MCL repairs, and the following BFR contraindications: deep vein thrombosis (DVT), pulmonary embolism, hemorrhagic/thrombolytic stroke, clotting disorders, hemophilia or taking blood thinners, pregnant or up to 6 months postpartum, untreated hypertension, untreated hypotension, rhabdomyolysis or recent traumatic injury, does not understand English, and the following BFR contraindications: Contraindications for BFR 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lauren Heylmun, BS
Phone
720-516-9823
Email
lauren.heylmun@cuanschutz.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Alexandra Orahovats, BS, MS
Phone
720-516-9824
Email
alexandra.orahovats@cuanshutz.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Genuario, MD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCHealth Steadman Hawkins Clinic
City
Centennial
State/Province
Colorado
ZIP/Postal Code
80111
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lauren M Heylmun, BS
Phone
720-516-9823
Email
lauren.heylmun@cuanschutz.edu
First Name & Middle Initial & Last Name & Degree
Alexandra Orahovats, BS, MS
Phone
720-516-9824
Email
alexandra.orahovats@cuanschutz.edu
First Name & Middle Initial & Last Name & Degree
James Genuario, MD
First Name & Middle Initial & Last Name & Degree
Braden Mayer, MD
First Name & Middle Initial & Last Name & Degree
Stephanie Mayer, MD
First Name & Middle Initial & Last Name & Degree
Thomas Noonan, MD
First Name & Middle Initial & Last Name & Degree
Martin Boublik, MD
First Name & Middle Initial & Last Name & Degree
Jason Dragoo, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30638439
Citation
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.
Results Reference
background
PubMed Identifier
26677831
Citation
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.
Results Reference
result
PubMed Identifier
26463594
Citation
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.
Results Reference
result
PubMed Identifier
23730848
Citation
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.
Results Reference
result
PubMed Identifier
33344004
Citation
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.
Results Reference
result
PubMed Identifier
30179950
Citation
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.
Results Reference
result
PubMed Identifier
26075208
Citation
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.
Results Reference
result
PubMed Identifier
26078452
Citation
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.
Results Reference
result
PubMed Identifier
30053790
Citation
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.
Results Reference
result
PubMed Identifier
24881906
Citation
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.
Results Reference
result
PubMed Identifier
29084094
Citation
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.
Results Reference
result
PubMed Identifier
32232065
Citation
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.
Results Reference
result
PubMed Identifier
30761200
Citation
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. eCollection 2019.
Results Reference
result
PubMed Identifier
18375784
Citation
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.
Results Reference
result
PubMed Identifier
16558577
Citation
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.
Results Reference
result
PubMed Identifier
24143905
Citation
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.
Results Reference
result
PubMed Identifier
35391873
Citation
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.
Results Reference
result

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Comparison of Methods in Post Operative Knee Arthroscopy Rehabilitation

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