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

NCT04528992 | Withdrawn

• 1 other identifier: IRB-56716
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Injuries; Anterior Cruciate Ligament Injuries

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Isokinetic Dynamometer

  2 weeks, 3 months, 6 months

• Visual Analog Scale (VAS)

  2 weeks, 3 months, 6 months

• Single Assessment Numerical Evaluation (SANE)

  2 weeks, 3 months, 6 months

• International Knee Documentation Committee (IKDC)

  2 weeks, 3 months, 6 months

Study Arms (2)

Physical Therapy with BFR

EXPERIMENTAL

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

Physical Therapy without BFR

ACTIVE COMPARATOR

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

Other: Standard Postoperative Physical Therapy

Interventions

Blood Flow Restriction Therapy OTHER

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.

Physical Therapy with BFR

Standard Postoperative Physical Therapy OTHER

This is the surgeon's standard postoperative physical therapy protocol after ACL reconstruction.

Physical Therapy without BFR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford

Redwood City, California, 94063, United States

Location

MeSH Terms

Conditions

Knee Injuries; Anterior Cruciate Ligament Injuries

Interventions

Blood Flow Restriction Therapy

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• Seth Sherman, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 18, 2020
• First Posted: August 27, 2020
• Study Start: September 20, 2024
• Primary Completion: September 20, 2024
• Study Completion: September 20, 2024
• Last Updated: November 25, 2024

Record last verified: 2024-11

Locations

US (1)