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BFR Therapy for Post-Knee Arthroscopy Recovery (ACL BFR Trial)
N/A
Recruiting
Led By James Genuario, MD
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with ACL reconstruction with quadriceps, hamstring, bone-patellar-bone or allograft graft, with/without meniscectomies
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
ACL BFR Trial Summary
This trial will study if a therapy using reduced blood flow helps recovery from knee surgery.
Who is the study for?
This trial is for patients who've had knee arthroscopy and are rehabilitating from ACL reconstruction. They must be able to use a smartphone with the SAGA BFR app. It's not for those with MCL repairs, clotting disorders, recent severe cardiovascular or brain events, untreated blood pressure issues, pregnancy/postpartum within 6 months, poor English understanding, recent major injuries or surgeries on both knees close together.Check my eligibility
What is being tested?
The study tests how effective blood flow restriction (BFR) therapy is when used in rehabilitation after knee surgery. Participants will use a BFR cuff along with an application that guides them through the process.See study design
What are the potential side effects?
Potential side effects of using the BFR cuff may include discomfort at the site of application, temporary numbness or tingling in the limb due to restricted blood flow, muscle fatigue during exercise and possible bruising.
ACL BFR Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I had ACL surgery using tissue from my body or a donor, with or without meniscus removal.
ACL BFR Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Knee extensor strength
Secondary outcome measures
ACL-RSI
Brief Resiliency Score (BRS)
IKDC
+7 moreACL BFR Trial Design
2Treatment groups
Active Control
Group I: ControlActive Control1 Intervention
Participants undergo standard post-operative physical therapy as prescribed by their surgeon.
Group II: BFR CuffActive Control1 Intervention
Patients undergo standard post-operative physical therapy as prescribed by their surgeon with the addition of a Blood Flow Restriction (BFR) cuff that is used during their exercises.
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Who is running the clinical trial?
University of Colorado, DenverLead Sponsor
1,734 Previous Clinical Trials
2,148,805 Total Patients Enrolled
1 Trials studying Muscle Weakness
70 Patients Enrolled for Muscle Weakness
James Genuario, MDPrincipal InvestigatorUniversity of Colorado, Denver
3 Previous Clinical Trials
131 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have high blood pressure that hasn't been treated.I have low blood pressure that hasn't been treated.I have had a recent severe muscle injury or trauma.I have had a deep vein thrombosis.I have hemophilia or am on blood thinners.I have had a pulmonary embolism.I will have surgery on both knees within 12 weeks.I do not understand English.I have a blood clotting disorder.I have had surgery to repair my meniscus.I have had surgery to repair or transplant cartilage.My ACL surgery will use tissue from the opposite side of my body.I have had a stroke caused by bleeding in the brain.I had ACL surgery using tissue from my body or a donor, with or without meniscus removal.I have had surgery to repair my MCL.
Research Study Groups:
This trial has the following groups:- Group 1: Control
- Group 2: BFR Cuff
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.
Does this experiment allow elderly persons to participate?
"As mentioned in the conditions for eligibility, participants must be 16 or older and no more than 60 years of age."
Answered by AI
Are there vacancies remaining for this research trial?
"Current information hosted on clinicaltrials.gov indicates that this investigation is actively seeking participants; the protocol was initially published on November 8th 2022 and last revised on February 15th 2023."
Answered by AI
How many participants can the trial accommodate at its maximum capacity?
"Affirmative. The clinicaltrials.gov website indicates that this trial, initially posted on November 8th 2022, is now accepting participants. 78 individuals are required to be recruited from a single medical site."
Answered by AI
Who is an appropriate candidate to participate in this experiment?
"This trial is seeking 78 volunteers, aged 16 to 60 years old, who present with muscular weakness. Moreover, they must have had ACL reconstruction surgery that involved quadriceps, hamstrings, bone-patellar-bone or allograft grafts and may also possess meniscectomies. Access to a smartphone device on which the SAGA BFR application can be installed is essential; thankfully this app is free of charge."
Answered by AI
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