Anterior Cruciate Ligament Injuries, Knee Injuries
Conditions
Brief summary
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.
Detailed description
The study will be a randomized controlled trial to compare outcomes between physical therapy with BFR and physical therapy without BFR on the ACL graft maturation following reconstruction surgery. BFR therapy will begin as early as 2 weeks after surgery. The initial 2 weeks after surgery, or prior to initiation of BFR, will consist of the physical therapy following the surgeon's postoperative protocol. To be considered for participation in this study, patients must be 18 years and older undergoing primary ACL reconstruction. In addition, patients must meet several inclusion/exclusion criteria to be randomized and included in this study.
Interventions
OTHERBlood Flow Restriction Therapy
BFR is a rehabilitation method that involves wearing a tight band around the exercising extremity to briefly limit blood flow while doing light weight exercises. The response is similar to heavy weight training or lifting but without the stress on the extremity that is still healing from surgery. Will be given after 2 weeks standard postoperative physical therapy per surgeon's ACL reconstruction protocol following surgery.
OTHERStandard Postoperative Physical Therapy
This is the surgeon's standard postoperative physical therapy protocol after ACL reconstruction.
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 unable to lay still in an MRI scanner * Patients with a torn ACL or previous ACL reconstruction in the contralateral knee
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in MRI imaging of Graft | 2 weeks, 3 months, 6 months | Graft ligamentization or maturation on MRI using T2 mapping |
| Difference in Quadriceps Volume & Cross-sectional Area | 3 months, 6 months | Quadriceps muscle atrophy measured on MRI with quadriceps cross-sectional area |
| Difference in Thigh Circumference Measurement | 3 months, 6 months | Muscle measurement determined with measuring tape for thigh circumference |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Isokinetic Dynamometer | 2 weeks, 3 months, 6 months | Measurement of knee extension and flexion torque at 180° and 300°/sec using the isokinetic dynamometer |
| International Knee Documentation Committee (IKDC) | 2 weeks, 3 months, 6 months | 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) |
| Visual Analog Scale (VAS) | 2 weeks, 3 months, 6 months | Patient reported assessment of current level of pain from no pain to worst imaginable |
| Single Assessment Numerical Evaluation (SANE) | 2 weeks, 3 months, 6 months | Patient reported outcome measure of function. 0-100% scale with 100% being normal |
Countries
United States
Outcome results
None listed