- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03794570
BFR Therapy After ACL Reconstruction (BFR)
Blood Flow Restriction Therapy to Prevent Muscle Atrophy Following Anterior Cruciate Ligament Reconstruction
Study Overview
Status
Conditions
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
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Colorado
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Vail, Colorado, United States, 81657
- The Steadman Clinic
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
SHAM_COMPARATOR: Control
Patients in this group will have BFR tourniquet applied but inflated to only minimal pressure.
|
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
|
Physical therapy performed with Blood flow restriction therapy tourniquet inflated to 80% limb occlusion pressure
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Pre-op and 6-weeks post-operative
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Days 1, 14, and 6 weeks after surgery
|
Thigh girth
Time Frame: Days 1, 14, and 6 weeks after surgery
|
Measured thigh girth 15cm above knee joint line
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Days 1, 14, and 6 weeks after surgery
|
Knee joint range of motion
Time Frame: Days 1, 14, and 6 weeks after surgery
|
Measure knee range of motion
|
Days 1, 14, and 6 weeks after surgery
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018-35
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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