Anterior Cruciate Ligament Injuries Clinical Trial
Official title:
Effects of Blood Flow Restriction (BFR) Therapy on Early Anterior Cruciate Ligament (ACL) Graft Maturation
NCT number | NCT04528992 |
Other study ID # | IRB-56716 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | May 2024 |
Est. completion date | April 2025 |
Verified date | April 2024 |
Source | Stanford University |
Contact | Monica Vel |
Phone | 650-721-6412 |
msvel[@]stanford.edu | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a study comparing the effects of blood flow restriction (BFR) therapy on the maturation of the Anterior Cruciate Ligament (ACL) graft after reconstruction surgery compared to physical therapy without the use of BFR.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | April 2025 |
Est. primary completion date | April 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Ages 18 or older, all gender - Patients receiving any type of ACL graft, either autograft or allograft, and any type of tissue Exclusion Criteria: - Patients who do not meet the the comprehensive BFR screening criteria based on predetermined contraindications and precautions - Patients undergoing any additional concomitant ligament repair or reconstruction at the same surgery - Revision procedures - Patients unable to lay still in an MRI scanner - Patients receiving treatment outside Stanford - Patients undergoing concomitant meniscus treatment that restricts patients' weight bearing or prolongs their immobilization compared to their surgeons standard postoperative ACL reconstruction protocol - Patients who are unble to lay still in an MRI scanner - Patients with a torn ACL or previous ACL reconstruction in the contralateral knee |
Country | Name | City | State |
---|---|---|---|
United States | Stanford | Redwood City | California |
Lead Sponsor | Collaborator |
---|---|
Stanford University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Difference in MRI imaging of Graft | Graft ligamentization or maturation on MRI using T2 mapping | 2 weeks, 3 months, 6 months | |
Primary | Difference in Quadriceps Volume & Cross-sectional Area | Quadriceps muscle atrophy measured on MRI with quadriceps cross-sectional area | 3 months, 6 months | |
Primary | Difference in Thigh Circumference Measurement | Muscle measurement determined with measuring tape for thigh circumference | 3 months, 6 months | |
Secondary | Isokinetic Dynamometer | Measurement of knee extension and flexion torque at 180° and 300°/sec using the isokinetic dynamometer | 2 weeks, 3 months, 6 months | |
Secondary | Visual Analog Scale (VAS) | Patient reported assessment of current level of pain from no pain to worst imaginable | 2 weeks, 3 months, 6 months | |
Secondary | Single Assessment Numerical Evaluation (SANE) | Patient reported outcome measure of function. 0-100% scale with 100% being normal | 2 weeks, 3 months, 6 months | |
Secondary | International Knee Documentation Committee (IKDC) | Patient reported outcome measure of symptoms, sports activity & knee function. 0-100 points with 0 (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms) | 2 weeks, 3 months, 6 months |
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