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BFR Therapy for Post-Op Rehab of ACL Reconstruction With Quadriceps Tendon Autograft

NCT04519801 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-08-27

No results posted yet for this study

Summary

The overall objective of the proposed research is to conduct a prospective, randomized controlled trial to investigate whether the addition of BFR therapy to standard post-operative rehabilitation regimen significantly improves clinical outcomes following anterior cruciate ligament reconstruction (ACLR) standardized with respect to both surgical technique and graft selection. Patients indicated for ACLR will be screened and offered enrollment into this prospective, randomized controlled trial. MRI of bilateral thighs will be performed within 7 days of ACLR. Patients will be randomized to either REHAB or REHAB + BFR (study intervention) using a block randomization scheme. Patients will undergo repeat MRI of bilateral thighs pre-surgery, at 12 weeks, and at 52 weeks post-operatively (primary outcome measure.) Patient reported outcome (PRO) instruments will be administered pre-operatively to establish pre-operative debility related to ACL injury and subsequently after ACLR at 24 weeks, 36 weeks, and 52 weeks post-operative (secondary outcome measures).

Conditions

  • ACL Injury

Interventions

OTHER

Blood Flow Restriction (BFR) therapy

BFR therapy beginning after first MD follow up appointment after ACL reconstruction with quadriceps tendon autograft and the following functional criteria have been met: 1.) incisions healing or healed without signs of infection or dehiscence. 2.) ROM to at least 90 degree flexion. 3.) Able to perform unilateral weight bearing for 5 seconds. 4.) Pain under control and minimal knee effusion.

OTHER

Standard REHAB

Standard post-operative rehabilitation regimen (REHAB) beginning after first MD follow up appointment ACL reconstruction with quadriceps tendon autograft and the following functional criteria have been met: 1.) incisions healing or healed without signs of infection or dehiscence. 2.) ROM to at least 90 degree flexion. 3.) Able to perform unilateral weight bearing for 5 seconds. 4.) Pain under control and minimal knee effusion

Sponsors & Collaborators

  • American Orthopaedic Society for Sports Medicine

    collaborator OTHER

  • Congressionally Directed Medical Research Programs

    collaborator FED

  • Brooke Army Medical Center

    lead FED

Principal Investigators

  • Andrew J Sheean, MD · Brooke Army Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-09
Primary Completion
2026-02-28
Completion
2026-04-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04519801 on ClinicalTrials.gov