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

Effects of Blood Flow Restriction (BFR) Therapy on Early Anterior Cruciate Ligament (ACL) Graft Maturation

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.

Study Overview

• Status: Recruiting
• Conditions: Anterior Cruciate Ligament Injuries; Knee Injuries
• Intervention / Treatment: Other: Blood Flow Restriction Therapy; Other: Standard Postoperative Physical Therapy

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Monica Vel; Phone Number: 650-721-6412; Email: msvel@stanford.edu
• Study Contact Backup: Name: Elizabeth Jameiro; Phone Number: 650-725-5978; Email: ejameiro@stanford.edu

Study Locations

• United States
  • California
    • Redwood City, California, United States, 94063
      • Recruiting
      • Stanford
      • Contact: Elizabeth Jameiro; Phone Number: 650-725-5978; Email: ejameiro@stanford.edu
      • Contact: Monica Vel; Phone Number: 650-721-7653; Email: msvel@stanford.edu
      • Principal Investigator: Seth Sherman, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Physical Therapy with BFR; 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.	Other: Blood Flow Restriction Therapy; 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.
Active Comparator: Physical Therapy without BFR; Participants will undergo standard physical therapy following the surgeon's postoperative protocol.	Other: Standard Postoperative Physical Therapy; This is the surgeon's standard postoperative physical therapy protocol after ACL reconstruction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in MRI imaging of Graft	Graft ligamentization or maturation on MRI using T2 mapping	2 weeks, 3 months, 6 months
Difference in Quadriceps Volume & Cross-sectional Area	Quadriceps muscle atrophy measured on MRI with quadriceps cross-sectional area	3 months, 6 months
Difference in Thigh Circumference Measurement	Muscle measurement determined with measuring tape for thigh circumference	3 months, 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Isokinetic Dynamometer	Measurement of knee extension and flexion torque at 180° and 300°/sec using the isokinetic dynamometer	2 weeks, 3 months, 6 months
Visual Analog Scale (VAS)	Patient reported assessment of current level of pain from no pain to worst imaginable	2 weeks, 3 months, 6 months
Single Assessment Numerical Evaluation (SANE)	Patient reported outcome measure of function. 0-100% scale with 100% being normal	2 weeks, 3 months, 6 months
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)	2 weeks, 3 months, 6 months

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Seth Sherman, MD, Stanford University

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: August 18, 2020
• First Submitted That Met QC Criteria: August 24, 2020
• First Posted (Actual): August 27, 2020

Study Record Updates

• Last Update Posted (Actual): April 23, 2024
• Last Update Submitted That Met QC Criteria: April 22, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Leg Injuries; Wounds and Injuries; Anterior Cruciate Ligament Injuries; Knee Injuries
• Other Study ID Numbers: IRB-56716

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No