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

Not Applicable

Withdrawn

• Conditions: Anterior Cruciate Ligament Injuries; Knee Injuries
• Interventions: Other: Standard Postoperative Physical Therapy; Other: Blood Flow Restriction Therapy

• Registration Number: NCT04528992
• Lead Sponsor: Stanford University

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.

Study Timeline

• Study First Submitted: 2020-08-18
• Study First Submitted QC: 2020-08-24
• Study First Posted: 2020-08-27
• Study Start: 2024-09-20
• Primary Completion: 2024-09-20
• Study Completion: 2024-09-20
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-21
• Last Update Posted: 2024-11-25

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

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

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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 unable to lay still in an MRI scanner
• Patients with a torn ACL or previous ACL reconstruction in the contralateral knee

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Physical Therapy without BFR	Standard Postoperative Physical Therapy	Participants will undergo standard physical therapy following the surgeon's postoperative protocol.
Physical Therapy with BFR	Blood Flow Restriction Therapy	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Stanford; 🇺🇸 Redwood City, California, United States