Status:
RECRUITING
BFRT in Adolescents After ACL Reconstruction
Lead Sponsor:
Children's Healthcare of Atlanta
Conditions:
Anterior Cruciate Ligament Rupture
Eligibility:
All Genders
12-18 years
Phase:
NA
Brief Summary
This is an interventional study that will examine effects of blood flow restriction training (BFRT) in adolescents aged 12-18 after anterior cruciate ligament reconstruction surgery (ACLR). The study ...
Detailed Description
Background: Approximately 100,000 anterior cruciate ligament reconstructions (ACLR) are performed yearly, and rates of these surgeries in patients younger than 15 years increased by 924% between 1990...
Eligibility Criteria
Inclusion
- Adolescent male and female patients, age 12-18
- Skeletally mature at time of diagnosis, with closed growth plates, as determined via standard clinic x-ray imaging (this specification automatically excludes pre-pubescent children.
- Underwent transphyseal ACLR with quadriceps tendon autograft with one of three sports orthopedic surgeons at CHOA
- Completed pre-surgery strength assessment of bilateral quadriceps, hamstrings, hip abductor and hip adductor musculature.
- English-speaking adolescents and parents of all races and ethnicities (after preliminary data is achieved, PI will coordinate a larger multi-center study that will include all non-English speaking participants.
Exclusion
- Skeletally immature patients with open growth plates, as determined via standard clinic x-ray imaging
- Concomitant procedures performed during ACLR which require weight-bearing restrictions (i.e. meniscus repair, microfracture, multi-ligament knee reconstruction)
- History of previous knee surgery
- History of cardiovascular disease (e.g. coronary artery disease, unstable hypertension, vascular endothelial dysfunction, peripheral artery disease, varicose veins)
- ICD-10 diagnosis of bleeding disorder (e.g. hemophilia or blood clotting disorder) or use of anticoagulants or other medications that may affect blood clotting
- Inability to adhere to treatment protocol (as described in study procedures, BFR-LLT treatment requirements)
- Any adverse events intra-operatively or post-operatively that lead to delay in care, including infection
- Failure to adhere to attendance requirements as detailed below:
- Attend first PT visit (PTV) within 5 days post-surgery
- Attend a minimum of 20 total PTVs during weeks 1-16 post-surgery
Key Trial Info
Start Date :
September 23 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2023
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04390035
Start Date
September 23 2020
End Date
April 1 2023
Last Update
August 2 2021
Active Locations (1)
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1
Children's Healthcare of Atlanta Physical Therapy
Atlanta, Georgia, United States, 30342-3269