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

Anterior Cruciate Ligament Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04528992
• Other study ID #: IRB-56716
• Status: Recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: April 2025

Study information

• Verified date: April 2024
• Source: Stanford University
• Contact: Monica Vel
• Phone: 650-721-6412
• Email: msvel[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: April 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Injuries
• Knee Injuries
• Wounds and Injuries

Intervention

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.
• Standard Postoperative Physical Therapy
This is the surgeon's standard postoperative physical therapy protocol after ACL reconstruction.

Locations

Country	Name	City	State
United States	Stanford	Redwood City	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in MRI imaging of Graft	Graft ligamentization or maturation on MRI using T2 mapping	2 weeks, 3 months, 6 months
Primary	Difference in Quadriceps Volume & Cross-sectional Area	Quadriceps muscle atrophy measured on MRI with quadriceps cross-sectional area	3 months, 6 months
Primary	Difference in Thigh Circumference Measurement	Muscle measurement determined with measuring tape for thigh circumference	3 months, 6 months
Secondary	Isokinetic Dynamometer	Measurement of knee extension and flexion torque at 180° and 300°/sec using the isokinetic dynamometer	2 weeks, 3 months, 6 months
Secondary	Visual Analog Scale (VAS)	Patient reported assessment of current level of pain from no pain to worst imaginable	2 weeks, 3 months, 6 months
Secondary	Single Assessment Numerical Evaluation (SANE)	Patient reported outcome measure of function. 0-100% scale with 100% being normal	2 weeks, 3 months, 6 months
Secondary	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