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

Last updated: November 21, 2024
Sponsor: Stanford University
Overall Status: Trial Not Available

Phase

N/A

Condition

Knee Injuries

Treatment

Blood Flow Restriction Therapy

Standard Postoperative Physical Therapy

Clinical Study ID

NCT04528992
IRB-56716
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Ages 18 or older, all gender

  • Patients receiving any type of ACL graft, either autograft or allograft, and anytype of tissue

Exclusion

Exclusion Criteria:

  • Patients who do not meet the the comprehensive BFR screening criteria based onpredetermined contraindications and precautions

  • Patients undergoing any additional concomitant ligament repair or reconstruction atthe 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' weightbearing or prolongs their immobilization compared to their surgeons standardpostoperative 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

Study Design

Treatment Group(s): 2
Primary Treatment: Blood Flow Restriction Therapy
Phase:
Study Start date:
September 20, 2024
Estimated Completion Date:
September 20, 2024

Study 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.

Connect with a study center

  • Stanford

    Redwood City, California 94063
    United States

    Site Not Available

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