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
|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|
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|
|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.|
|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|
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
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
- 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
- Patient reported visual analog pain [ Time Frame: Days 1, 14, and 6 weeks after surgery ]Patient reported pain levels using visual analog scale
- Thigh girth [ Time Frame: Days 1, 14, and 6 weeks after surgery ]Measured thigh girth 15cm above knee joint line
- Knee joint range of motion [ Time Frame: Days 1, 14, and 6 weeks after surgery ]Measure knee range of motion
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
|Contact: David Bernholt, MDfirstname.lastname@example.org|
|United States, Colorado|
|The Steadman Clinic||Recruiting|
|Vail, Colorado, United States, 81657|
|Contact: David Bernholt, MD 937-423-3522 email@example.com|
|Principal Investigator: Robert F LaPrade, MD, PhD|