Status:
WITHDRAWN
Blood Flow Restriction Following ACLR
Lead Sponsor:
Rush University Medical Center
Conditions:
Anterior Cruciate Ligament Injuries
ACL
Eligibility:
All Genders
18-40 years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate the the ability of BFR to reduce muscle loss and improve strength after ACL reconstruction. It is hypothesized that BFR training will significantly reduce musc...
Detailed Description
Following anterior cruciate ligament (ACL) reconstruction, many patients experience weakness of the quadriceps (thigh muscles) and loss of muscle mass due to inactivity following surgery. Recent resea...
Eligibility Criteria
Inclusion
- Adult patients 18-40
- English-speaking
- Primary ACL Reconstruction
- No associated procedures (meniscal repair, other ligamentous pathology), or history of deep vein thrombosis.
- Clinical and radiographic examination (MRI) consistent with an acute full thickness ACL tear and surgical consent for ACL reconstruction with a patellar tendon autograft
- Written and informed consent for study participation
Exclusion
- Patients younger than 18 or older than 40 years of age
- Non-native English speaker
- Revision surgery or prior history of knee surgery
- Concomitant ligamentous, meniscal, or cartilage injury that would alter postoperative weight bearing status or rehabilitation protocol
- Inability to comply with the proposed follow-up clinic visits
- Patients lacking decisional capacity
- Patients with a history of deep vein thrombosis, pulmonary embolism, or known clotting disorder or hypercoagulable state
- Pregnant or breast-feeding women. Pregnancy as determined by a positive pregnancy test prior to procedure. Females of childbearing potential must agree to use an acceptable birth control method during study participation.
- Worker's compensation patients
- Any clinically significant finding that would place the patient at health risk, impact the study, or affect the completion of the study
- Any psychiatric illness that would prevent comprehension of the details and nature of the study and interfere with follow-up clinic visits
Key Trial Info
Start Date :
December 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04086030
Start Date
December 1 2023
End Date
December 1 2024
Last Update
August 7 2023
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