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Blood Flow Restriction Therapy for ACL Injury

N/A

Waitlist Available

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

No Placebo-Only Group

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.

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I cannot stay still in an MRI machine.

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My knee surgery involves extra steps that may delay my walking recovery.

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I cannot stay still in an MRI machine.

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I have a torn ACL or had ACL surgery on the opposite knee.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 weeks, 3 months, 6 months

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 6Eligibility criteria met