NCT05735236 · University of Colorado, Denver
Comparison of Methods in Post Operative Knee Arthroscopy Rehabilitation
(ACL BFR)
What this study is about
The aim of this study is to investigate the effectiveness of blood flow restriction (BFR) therapy in post-operative rehabilitation following knee arthroscopy for primary ACL reconstruction. BFR has been shown to effect time to return to activity and strength postoperatively.
View original scientific description
The aim of this study is to investigate the efficacy of blood flow restriction (BFR) therapy in post-operative rehabilitation following knee arthroscopy for primary ACL reconstruction. BFR has been shown to effect time to return to activity and strength postoperatively. This study aims to analyze the effects of BFR therapy in patients who underwent primary ACL reconstruction surgery compared to controls. Participants will be randomized into either a treatment (BFR Cuff) or control (no BFR cuff) group. All participants will follow standard of care (SOC) physical therapy protocol for 12 weeks after surgery according to their treatment group. Strength and patient outcome measures will be recorded throughout the 2 year study period.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Patients undergoing primary knee arthroscopy for ACL reconstruction without meniscus repair
- Completing initial 12 weeks of physical therapy at the Steadman Hawkins Clinic in Denver
- Patients with access to smartphone device
Exclusion criteria
- Bilateral knee surgeries to be performed within 12 weeks of each other
- Patients received meniscus repairs, chondral lesion repair/transplants,
- Prior surgery on the same knee
- Anyone who meets the following contraindications for BFR therapy:
- Deep Vein Thrombosis (DVT)
- Pulmonary Embolism
- Hemorrhagic/Thrombolytic Stroke
- Clotting Disorders
- Hemophilia or taking blood thinners
- Pregnant or up to 6 months post-partum
- Untreated Hypertension
- Untreated Hypotension
- Rhabdomyolysis or recent traumatic injury 2\. Exclusion criteria will be evaluated via the medical record as well as by the expert opinion of the physician. 3\. If at any point in the study a subject develops one of the above contraindications, they will be removed from the study. 4\. If a subject becomes pregnant while participating in the intervention portion of the study, they will be removed.
Where
- Centennial, Colorado
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 8, 2025 · Source of record for eligibility and locations