BFR Therapy After ACL Reconstruction (BFR)

• ClinicalTrials.gov Identifier: NCT03794570
• Recruitment Status: Withdrawn
• First Posted: January 7, 2019
• Last Update Posted: December 4, 2019
• Sponsor: Steadman Philippon Research Institute
• Information provided by (Responsible Party): Steadman Philippon Research Institute

Study Description

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
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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 0 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
• Actual Primary Completion Date: June 1, 2019
• Actual Study Completion Date: June 1, 2019

Arms and Interventions

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: Blood Flow Restriction (BFR) Therapy; 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

Outcome Measures

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. Numeric rating scale pain [ Time Frame: Days 1, 14, and 6 weeks after surgery ]
   Patient reported pain levels using numeric rating scale (NRS) on a scale of 1-10 where 10 represents maximal pain and 1 represents minimal pain
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

Eligibility Criteria

• 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

Contacts and Locations

Locations

United States, Colorado

The Steadman Clinic

Vail, Colorado, United States, 81657

Sponsors and Collaborators

Steadman Philippon Research Institute

More Information

• Responsible Party: Steadman Philippon Research Institute
• ClinicalTrials.gov Identifier: NCT03794570
• Other Study ID Numbers: 2018-35
• First Posted: January 7, 2019
• Last Update Posted: December 4, 2019
• Last Verified: December 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
• Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:

Muscular Atrophy; Atrophy; Anterior Cruciate Ligament Injuries; Pathological Conditions, Anatomical; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Knee Injuries; Leg Injuries; Wounds and Injuries