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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

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

NCT ID

NCT05735236

First Posted

January 18, 2023

Last Updated

February 15, 2023

Sponsor

University of Colorado, Denver

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

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

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

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Lauren Heylmun, BS

Phone

720-516-9823

lauren.heylmun@cuanschutz.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Alexandra Orahovats, BS, MS

Phone

720-516-9824

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

lauren.heylmun@cuanschutz.edu

First Name & Middle Initial & Last Name & Degree

Alexandra Orahovats, BS, MS

Phone

720-516-9824

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

Citations:

PubMed Identifier

30638439

Citation

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Comparison of Methods in Post Operative Knee Arthroscopy Rehabilitation

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