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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 weeks, 3 months, 6 months
Awards & highlights
Study Summary
This trial found that BFR may improve ACL graft maturation compared to physical therapy alone.
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.Check my eligibility
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.See study design
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 belowSelect...
I am receiving an ACL graft, either from my body or a donor.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Difference in MRI imaging of Graft
Difference in Quadriceps Volume & Cross-sectional Area
Difference in Thigh Circumference Measurement
Secondary outcome measures
International Knee Documentation Committee (IKDC)
Isokinetic Dynamometer
Single Assessment Numerical Evaluation (SANE)
+1 moreTrial 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.
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Who is running the clinical trial?
Stanford UniversityLead Sponsor
2,395 Previous Clinical Trials
17,341,580 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am undergoing a revision procedure.I am receiving an ACL graft, either from my body or a donor.I am having other ligament repairs besides the main surgery.I cannot stay still in an MRI machine.My knee surgery involves extra steps that may delay my walking recovery.I am 18 years old or older.I cannot stay still in an MRI machine.I have a torn ACL or had ACL surgery on the opposite knee.
Research Study Groups:
This trial has the following groups:- Group 1: Physical Therapy with BFR
- Group 2: Physical Therapy without BFR
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the foremost goals of this clinical investigation?
"This clinical trial, which is set to be conducted over a three month period with assessments for six months after that, aims to measure the difference in thigh circumference. Additionally, it seeks to evaluate patient reported outcomes using Single Assessment Numerical Evaluation (SANE) on 0-100% scale and International Knee Documentation Committee (IKDC) yielding scores from 0-100 points; as well as assessing current pain levels via Visual Analogue Scale (VAS)."
Answered by AI
Are there any available openings in this research program for potential participants?
"According to the details listed on clinicaltrials.gov, this trial is still searching for potential participants. The initial posting was made October 1st 2022 with a recent update occurring June 7th 2022."
Answered by AI
How many participants is the research team recruiting for this investigation?
"Affirmative. Clinicaltrials.gov attests that, as of June 7th 2022, this clinical trial is actively seeking subjects - with an initial posting date of October 1st 2022. 40 participants must be sourced from a single site to complete the study's recruitment requirements."
Answered by AI
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