Clinical trial NCT04528992: Effects of Blood Flow Restriction (BFR) Therapy on ACL Graft Maturation
Official title: Effects of Blood Flow Restriction (BFR) Therapy on Early Anterior Cruciate Ligament (ACL) Graft Maturation
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Knee Injuries
Anterior Cruciate Ligament Injuries
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2020-08-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Difference in MRI imaging of Graft
timeFrame: 2 weeks, 3 months, 6 months
measure: Difference in Quadriceps Volume & Cross-sectional Area
timeFrame: 3 months, 6 months
measure: Difference in Thigh Circumference Measurement
timeFrame: 3 months, 6 months
Secondary outcomes:
measure: Isokinetic Dynamometer
timeFrame: 2 weeks, 3 months, 6 months
measure: Visual Analog Scale (VAS)
timeFrame: 2 weeks, 3 months, 6 months
measure: Single Assessment Numerical Evaluation (SANE)
timeFrame: 2 weeks, 3 months, 6 months
measure: International Knee Documentation Committee (IKDC)
timeFrame: 2 weeks, 3 months, 6 months
Other outcomes:
Locations:
city: Redwood City
country: United States
facility: Stanford
state: California
Study officials:
affiliation: Stanford University
name: Seth Sherman, MD
role: PRINCIPAL_INVESTIGATOR
References: