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BFR Therapy After ACL Reconstruction (BFR)

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ClinicalTrials.gov Identifier: NCT03794570
Recruitment Status : Recruiting
First Posted : January 7, 2019
Last Update Posted : January 7, 2019
Sponsor:
Information provided by (Responsible Party):
Steadman Philippon Research Institute

Brief Summary:
This study is a prospective, double-blinded, randomized control trial examining the effect of blood flow restriction (BFR) therapy on reducing post-operative quadriceps atrophy in patients undergoing anterior cruciate ligament reconstruction (ACLR). Following ACLR, patients will undergo a rehabilitation protocol either w/ BFR therapy or sham BFR therapy.

Condition or disease Intervention/treatment Phase
Blood Flow Restriction Therapy ACL Injury Quadriceps Muscle Atrophy Device: Blood flow restriction therapy - with Delfi Personalized Tourniquet System Device: Sham blood flow restriction therapy - with Delfi Personalized Tourniquet System Not Applicable

Detailed Description:

Patients will be randomized to either BFR therapy or no BFR therapy. Randomization will be carried out using block randomization with blocks of 6.

Those undergoing BFR therapy will have a Delfi Personalized Tourniquet System (PTS) cuff applied to the proximal thigh of their operative leg and inflated to 80% limb occlusive pressure (LOP) calculated by the Delfi PTS device during physical therapy (PT) sessions from day 2 after surgery through day 7 after surgery. Those in the no BFR group will have the Delfi PTS cuff applied to their proximal thigh with inflation of the tourniquet to minimal pressure only. BFR therapy will be administered by health care providers who have undergone training and certification for BFR therapy with the Delfi PTS device.

Both groups will undergo the following PT regimen two times daily beginning on the day after the surgical procedure and lasting for 6 weeks post-operatively:

  • Quad sets = x1 min isometric hold, 30 sec off, 3 sets
  • Terminal knee extensions = 3x15, 30 sec rest or short arc quads sitting 1 x 30 + 3 x 15, 30 sec rest
  • Once range of motion (ROM) allows: Bike 10 mins, low to no resistance

Each physical therapy visit will last approximately 60 minutes. During that time, there will be a total estimated time of 5-7 minutes during which the tourniquet cuff will be on the thigh, and the tourniquet will be inflated for a similar time period. The tourniquet will inflate for about 1 minute in order to find out the specific pressure for the patient's leg and then will remain inflated until exercises are completed, which should take 4-6 minutes. The cuff will then be deflated and is removed from the leg within about 30 seconds of being deflated.

Patients will have MRI performed pre-operatively and at 6 weeks post-operatively with axial cuts to 50% femoral length above joint line. Quadriceps cross-sectional area will be measured by a blinded observer using MRI. Patients will have clinical measurements including thigh girth, Lachman test, knee joint range of motion, and knee joint swelling performed pre-operatively, at post-op day 1, post-op day 14, and 6 weeks post-operatively. All clinical measurements will be performed by a blinded observer. Additionally, patient reported pain level will be obtained at the same timepoints in which clinical measurements are performed using visual analog scale.

In order to ensure there are no nerve injuries present in patients prior to undergoing application and inflation of thigh tourniquet, all patients in the study will have single shot adductor and/or sciatic nerve blocks to ensure 24 hour period without nerve block prior to initiation of BFR therapy. Patients included in the study cannot have a nerve block lasting longer than the day of surgery. To ensure no new nerve deficits are present, the patients will undergo a physical examination during morning rounding on post-operative day 1 to assess for new nerve deficits.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double blinded randomized control trial
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Patients and outcomes assessors will be blinded to treatment group. Physical therapy providers will not be masked.
Primary Purpose: Treatment
Official Title: Blood Flow Restriction Therapy to Prevent Muscle Atrophy Following Anterior Cruciate Ligament Reconstruction
Actual Study Start Date : December 18, 2018
Estimated Primary Completion Date : June 1, 2019
Estimated Study Completion Date : June 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Sham Comparator: Control
Patients in this group will have BFR tourniquet applied but inflated to only minimal pressure.
Device: Sham blood flow restriction therapy - with Delfi Personalized Tourniquet System
Physical therapy performed with Blood flow restriction therapy tourniquet inflated to only minimal pressure

Experimental: BFR
Patients in this group will have BFR tourniquet applied and inflated to 80% limb occlusion pressure
Device: Blood flow restriction therapy - with Delfi Personalized Tourniquet System
Physical therapy performed with Blood flow restriction therapy tourniquet inflated to 80% limb occlusion pressure




Primary Outcome Measures :
  1. Change in Quadriceps Cross-Sectional Area [ Time Frame: Pre-op and 6-weeks post-operative ]
    Change in quadriceps cross-sectional area measured on MRI pre-operatively compared to post-operatively


Secondary Outcome Measures :
  1. Patient reported visual analog pain [ Time Frame: Days 1, 14, and 6 weeks after surgery ]
    Patient reported pain levels using visual analog scale

  2. Thigh girth [ Time Frame: Days 1, 14, and 6 weeks after surgery ]
    Measured thigh girth 15cm above knee joint line

  3. Knee joint range of motion [ Time Frame: Days 1, 14, and 6 weeks after surgery ]
    Measure knee range of motion



Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 14-70
  • Undergoing ACL reconstruction with patellar tendon autograft
  • Full weightbearing after surgery
  • Surgery performed within 14 days of ACL injury
  • No nerve catheter in place

Exclusion Criteria:

  • Meniscal root tears
  • radial meniscal tears
  • multi-ligament knee injury
  • revision ACL reconstruction
  • concomitant osteotomies
  • concomitant cartilage resurfacing procedures
  • fracture preventing full-weightbearing of operated extremity
  • previous history of deep vein thrombosis (DVT)
  • new nerve injury/findings affecting operative extremity
  • active femoral nerve catheter
  • nerve block lasting longer than day of surgery
  • patients unable to tolerate BFR treatment
  • untolerable post-operative pain due to absence of nerve catheter
  • proximal thigh girth greater than 34cm
  • time to surgery greater than 14 days

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03794570


Contacts
Contact: David Bernholt, MD 9374233522 david.bernholt@gmail.com

Locations
United States, Colorado
The Steadman Clinic Recruiting
Vail, Colorado, United States, 81657
Contact: David Bernholt, MD    937-423-3522    david.bernholt@gmail.com   
Principal Investigator: Robert F LaPrade, MD, PhD         
Sponsors and Collaborators
Steadman Philippon Research Institute

Responsible Party: Steadman Philippon Research Institute
ClinicalTrials.gov Identifier: NCT03794570     History of Changes
Other Study ID Numbers: 2018-35
First Posted: January 7, 2019    Key Record Dates
Last Update Posted: January 7, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No sharing

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Atrophy
Muscular Atrophy
Anterior Cruciate Ligament Injuries
Pathological Conditions, Anatomical
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Knee Injuries
Leg Injuries
Wounds and Injuries