Comparison of Methods in Post Operative Knee Arthroscopy Rehabilitation (NCT05735236) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Comparison of Methods in Post Operative Knee Arthroscopy Rehabilitation
United States78 participantsStarted 2022-11-08
Plain-language summary
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
Age range
16 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.