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Effects of Blood Flow Restriction (BFR) Therapy on ACL Graft Maturation

Primary Purpose

Knee Injuries, Anterior Cruciate Ligament Injuries

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Blood Flow Restriction Therapy
Standard Postoperative Physical Therapy
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Injuries

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Ages 18 or older, all gender
  • Patients receiving any type of ACL graft, either autograft or allograft, and any type of tissue

Exclusion Criteria:

  • Patients who do not meet the the comprehensive BFR screening criteria based on predetermined contraindications and precautions
  • Patients undergoing any additional concomitant ligament repair or reconstruction at the same surgery
  • Revision procedures
  • Patients unable to lay still in an MRI scanner
  • Patients receiving treatment outside Stanford
  • Patients undergoing concomitant meniscus treatment that restricts patients' weight bearing or prolongs their immobilization compared to their surgeons standard postoperative ACL reconstruction protocol
  • Patients who are unble to lay still in an MRI scanner
  • Patients with a torn ACL or previous ACL reconstruction in the contralateral knee

Sites / Locations

  • StanfordRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Physical Therapy with BFR

Physical Therapy without BFR

Arm Description

Participants will begin BFR therapy as early as 2 weeks after surgery. The initial 2 weeks after surgery, or prior to initiation of BFR will consist of the physical therapy following the surgeon's postoperative protocol.

Participants will undergo standard physical therapy following the surgeon's postoperative protocol.

Outcomes

Primary Outcome Measures

Difference in MRI imaging of Graft
Graft ligamentization or maturation on MRI using T2 mapping
Difference in Quadriceps Volume & Cross-sectional Area
Quadriceps muscle atrophy measured on MRI with quadriceps cross-sectional area
Difference in Thigh Circumference Measurement
Muscle measurement determined with measuring tape for thigh circumference

Secondary Outcome Measures

Isokinetic Dynamometer
Measurement of knee extension and flexion torque at 180° and 300°/sec using the isokinetic dynamometer
Visual Analog Scale (VAS)
Patient reported assessment of current level of pain from no pain to worst imaginable
Single Assessment Numerical Evaluation (SANE)
Patient reported outcome measure of function. 0-100% scale with 100% being normal
International Knee Documentation Committee (IKDC)
Patient reported outcome measure of symptoms, sports activity & knee function. 0-100 points with 0 (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms)

Full Information

First Posted
August 18, 2020
Last Updated
May 24, 2023
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT04528992
Brief Title
Effects of Blood Flow Restriction (BFR) Therapy on ACL Graft Maturation
Official Title
Effects of Blood Flow Restriction (BFR) Therapy on Early Anterior Cruciate Ligament (ACL) Graft Maturation
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 5, 2023 (Anticipated)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

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

5. Study Description

Brief Summary
This is a study comparing the effects of blood flow restriction (BFR) therapy on the maturation of the Anterior Cruciate Ligament (ACL) graft after reconstruction surgery compared to physical therapy without the use of BFR.
Detailed Description
The study will be a randomized controlled trial to compare outcomes between physical therapy with BFR and physical therapy without BFR on the ACL graft maturation following reconstruction surgery. BFR therapy will begin as early as 2 weeks after surgery. The initial 2 weeks after surgery, or prior to initiation of BFR, will consist of the physical therapy following the surgeon's postoperative protocol. To be considered for participation in this study, patients must be 18 years and older undergoing primary ACL reconstruction. In addition, patients must meet several inclusion/exclusion criteria to be randomized and included in this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Injuries, Anterior Cruciate Ligament Injuries

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Physical Therapy with BFR
Arm Type
Experimental
Arm Description
Participants will begin BFR therapy as early as 2 weeks after surgery. The initial 2 weeks after surgery, or prior to initiation of BFR will consist of the physical therapy following the surgeon's postoperative protocol.
Arm Title
Physical Therapy without BFR
Arm Type
Active Comparator
Arm Description
Participants will undergo standard physical therapy following the surgeon's postoperative protocol.
Intervention Type
Other
Intervention Name(s)
Blood Flow Restriction Therapy
Intervention Description
BFR is a rehabilitation method that involves wearing a tight band around the exercising extremity to briefly limit blood flow while doing light weight exercises. The response is similar to heavy weight training or lifting but without the stress on the extremity that is still healing from surgery. Will be given after 2 weeks standard postoperative physical therapy per surgeon's ACL reconstruction protocol following surgery.
Intervention Type
Other
Intervention Name(s)
Standard Postoperative Physical Therapy
Intervention Description
This is the surgeon's standard postoperative physical therapy protocol after ACL reconstruction.
Primary Outcome Measure Information:
Title
Difference in MRI imaging of Graft
Description
Graft ligamentization or maturation on MRI using T2 mapping
Time Frame
2 weeks, 3 months, 6 months
Title
Difference in Quadriceps Volume & Cross-sectional Area
Description
Quadriceps muscle atrophy measured on MRI with quadriceps cross-sectional area
Time Frame
3 months, 6 months
Title
Difference in Thigh Circumference Measurement
Description
Muscle measurement determined with measuring tape for thigh circumference
Time Frame
3 months, 6 months
Secondary Outcome Measure Information:
Title
Isokinetic Dynamometer
Description
Measurement of knee extension and flexion torque at 180° and 300°/sec using the isokinetic dynamometer
Time Frame
2 weeks, 3 months, 6 months
Title
Visual Analog Scale (VAS)
Description
Patient reported assessment of current level of pain from no pain to worst imaginable
Time Frame
2 weeks, 3 months, 6 months
Title
Single Assessment Numerical Evaluation (SANE)
Description
Patient reported outcome measure of function. 0-100% scale with 100% being normal
Time Frame
2 weeks, 3 months, 6 months
Title
International Knee Documentation Committee (IKDC)
Description
Patient reported outcome measure of symptoms, sports activity & knee function. 0-100 points with 0 (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms)
Time Frame
2 weeks, 3 months, 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Ages 18 or older, all gender Patients receiving any type of ACL graft, either autograft or allograft, and any type of tissue Exclusion Criteria: Patients who do not meet the the comprehensive BFR screening criteria based on predetermined contraindications and precautions Patients undergoing any additional concomitant ligament repair or reconstruction at the same surgery Revision procedures Patients unable to lay still in an MRI scanner Patients receiving treatment outside Stanford Patients undergoing concomitant meniscus treatment that restricts patients' weight bearing or prolongs their immobilization compared to their surgeons standard postoperative ACL reconstruction protocol Patients who are unble to lay still in an MRI scanner Patients with a torn ACL or previous ACL reconstruction in the contralateral knee
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Monica Vel
Phone
650-721-6412
Email
msvel@stanford.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Elizabeth Jameiro
Phone
650-725-5978
Email
ejameiro@stanford.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seth Sherman, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford
City
Redwood City
State/Province
California
ZIP/Postal Code
94063
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Monica Vel
Phone
650-721-7653
Email
msvel@stanford.edu
First Name & Middle Initial & Last Name & Degree
Elizabeth Jameiro
Phone
650-725-5978
Email
ejameiro@stanford.edu
First Name & Middle Initial & Last Name & Degree
Seth Sherman, MD

12. IPD Sharing Statement

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Effects of Blood Flow Restriction (BFR) Therapy on ACL Graft Maturation

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