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Blood Flow Restriction Therapy for ACL Injury

N/A
Recruiting
Led By Seth Sherman, MD
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients receiving any type of ACL graft, either autograft or allograft, and any type of tissue
Be older than 18 years old
Must not have
Patients undergoing any additional concomitant ligament repair or reconstruction at the same surgery
Patients unable to lay still in an MRI scanner
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 weeks, 3 months, 6 months
Awards & highlights

Summary

This trial is studying how using Blood Flow Restriction (BFR) therapy affects recovery. It targets patients aged 18 and older who have had ACL reconstruction. BFR helps muscles grow stronger by temporarily reducing blood flow during exercise. Blood Flow Restriction (BFR) therapy is a relatively new method for post-operative rehabilitation, particularly following knee surgeries like ACL reconstruction.

Who is the study for?
This trial is for adults of any gender who are undergoing ACL graft surgery, using either their own tissue or donor tissue. It's not suitable for those with conditions that make BFR unsafe, anyone having additional ligament repairs at the same time, revision surgeries, or if they can't stay still in an MRI scanner.
What is being tested?
The study compares two post-surgery treatments for ACL injuries: one group receives Blood Flow Restriction (BFR) Therapy along with standard physical therapy; the other just gets standard physical therapy without BFR to see which helps the ACL graft heal better.
What are the potential side effects?
Potential side effects of BFR may include discomfort from restricted blood flow, muscle fatigue, and possible numbness or tingling during treatment. Standard physical therapy risks are generally low but may include muscle soreness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am receiving an ACL graft, either from my body or a donor.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am having other ligament repairs besides the main surgery.
Select...
I cannot stay still in an MRI machine.
Select...
My knee surgery involves extra steps that may delay my walking recovery.
Select...
I cannot stay still in an MRI machine.
Select...
I have a torn ACL or had ACL surgery on the opposite knee.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 weeks, 3 months, 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 weeks, 3 months, 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Difference in MRI imaging of Graft
Difference in Quadriceps Volume & Cross-sectional Area
Difference in Thigh Circumference Measurement
Secondary study objectives
International Knee Documentation Committee (IKDC)
Isokinetic Dynamometer
Single Assessment Numerical Evaluation (SANE)
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Physical Therapy with BFRExperimental Treatment1 Intervention
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.
Group II: Physical Therapy without BFRActive Control1 Intervention
Participants will undergo standard physical therapy following the surgeon's postoperative protocol.

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,448 Previous Clinical Trials
17,492,354 Total Patients Enrolled
1 Trials studying Anterior Cruciate Ligament Injury
60 Patients Enrolled for Anterior Cruciate Ligament Injury
Seth Sherman, MDPrincipal InvestigatorStanford University
1 Previous Clinical Trials
40 Total Patients Enrolled

Media Library

Blood Flow Restriction Therapy (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04528992 — N/A
Anterior Cruciate Ligament Injury Research Study Groups: Physical Therapy with BFR, Physical Therapy without BFR
Anterior Cruciate Ligament Injury Clinical Trial 2023: Blood Flow Restriction Therapy Highlights & Side Effects. Trial Name: NCT04528992 — N/A
Blood Flow Restriction Therapy (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04528992 — N/A
~22 spots leftby Apr 2025
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