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NCT04519801 · ClinicalTrials.gov registry record · NA
BFR Therapy for Post-Op Rehab of ACL Reconstruction With Quadriceps Tendon Autograft
A NA study of ACL Injury, sponsored by Brooke Army Medical Center.
- Active
- Registry status
- NA
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT04519801 is a NA study of ACL Injury that is active but no longer recruiting, run by Brooke Army Medical Center. The registered enrollment target is 60 participants, below the 499-participant average among 12 other ACL Injury trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04519801, a NA study of ACL Injury, is active but no longer recruiting, sponsored by Brooke Army Medical Center.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
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 Studied
Interventions
- OTHER Blood Flow Restriction (BFR) therapy
- OTHER Standard REHAB
Study Locations (1)
Texas
- Brooke Army Medical Center- Clinical Research Center - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2022-09-09 |
| Est. Completion | 2026-04-01 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04519801
The ClinicalTrials.gov registry entry for NCT04519801 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 499-participant average among 12 other ACL Injury trials with a reported enrollment target (88% lower). The listed sponsor is Brooke Army Medical Center, which has 54 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with ACL Injury appearing as the primary indexed condition, and to 2 interventions - of which Blood Flow Restriction (BFR) therapy is the first listed.
NCT04519801 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT04519801 about?
NCT04519801 is a clinical study titled "BFR Therapy for Post-Op Rehab of ACL Reconstruction With Quadriceps Tendon Autograft". 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 (A...
What is the current status of trial NCT04519801?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 60 participants. The study started on 2022-09-09. Estimated completion is 2026-04-01.
What conditions does trial NCT04519801 study?
This clinical trial studies the following conditions: ACL Injury.
What interventions are being tested in trial NCT04519801?
The interventions under investigation include: Blood Flow Restriction (BFR) therapy (OTHER), Standard REHAB (OTHER).
Who is sponsoring clinical trial NCT04519801?
This trial is sponsored by Brooke Army Medical Center, which has 54 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04519801 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Related
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