<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03794570</url>
  </required_header>
  <id_info>
    <org_study_id>2018-35</org_study_id>
    <nct_id>NCT03794570</nct_id>
  </id_info>
  <brief_title>BFR Therapy After ACL Reconstruction</brief_title>
  <acronym>BFR</acronym>
  <official_title>Blood Flow Restriction Therapy to Prevent Muscle Atrophy Following Anterior Cruciate Ligament Reconstruction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Steadman Philippon Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Steadman Philippon Research Institute</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a prospective, double-blinded, randomized control trial examining the effect of&#xD;
      blood flow restriction (BFR) therapy on reducing post-operative quadriceps atrophy in&#xD;
      patients undergoing anterior cruciate ligament reconstruction (ACLR). Following ACLR,&#xD;
      patients will undergo a rehabilitation protocol either w/ BFR therapy or sham BFR therapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients will be randomized to either BFR therapy or no BFR therapy. Randomization will be&#xD;
      carried out using block randomization with blocks of 6.&#xD;
&#xD;
      Those undergoing BFR therapy will have a Delfi Personalized Tourniquet System (PTS) cuff&#xD;
      applied to the proximal thigh of their operative leg and inflated to 80% limb occlusive&#xD;
      pressure (LOP) calculated by the Delfi PTS device during physical therapy (PT) sessions from&#xD;
      day 2 after surgery through day 7 after surgery. Those in the no BFR group will have the&#xD;
      Delfi PTS cuff applied to their proximal thigh with inflation of the tourniquet to minimal&#xD;
      pressure only. BFR therapy will be administered by health care providers who have undergone&#xD;
      training and certification for BFR therapy with the Delfi PTS device.&#xD;
&#xD;
      Both groups will undergo the following PT regimen two times daily beginning on the day after&#xD;
      the surgical procedure and lasting for 6 weeks post-operatively:&#xD;
&#xD;
        -  Quad sets = x1 min isometric hold, 30 sec off, 3 sets&#xD;
&#xD;
        -  Terminal knee extensions = 3x15, 30 sec rest or short arc quads sitting 1 x 30 + 3 x 15,&#xD;
           30 sec rest&#xD;
&#xD;
        -  Once range of motion (ROM) allows: Bike 10 mins, low to no resistance&#xD;
&#xD;
      Each physical therapy visit will last approximately 60 minutes. During that time, there will&#xD;
      be a total estimated time of 5-7 minutes during which the tourniquet cuff will be on the&#xD;
      thigh, and the tourniquet will be inflated for a similar time period. The tourniquet will&#xD;
      inflate for about 1 minute in order to find out the specific pressure for the patient's leg&#xD;
      and then will remain inflated until exercises are completed, which should take 4-6 minutes.&#xD;
      The cuff will then be deflated and is removed from the leg within about 30 seconds of being&#xD;
      deflated.&#xD;
&#xD;
      Patients will have MRI performed pre-operatively and at 6 weeks post-operatively with axial&#xD;
      cuts to 50% femoral length above joint line. Quadriceps cross-sectional area will be measured&#xD;
      by a blinded observer using MRI. Patients will have clinical measurements including thigh&#xD;
      girth, Lachman test, knee joint range of motion, and knee joint swelling performed&#xD;
      pre-operatively, at post-op day 1, post-op day 14, and 6 weeks post-operatively. All clinical&#xD;
      measurements will be performed by a blinded observer. Additionally, patient reported pain&#xD;
      level will be obtained at the same timepoints in which clinical measurements are performed&#xD;
      using visual analog scale.&#xD;
&#xD;
      In order to ensure there are no nerve injuries present in patients prior to undergoing&#xD;
      application and inflation of thigh tourniquet, all patients in the study will have single&#xD;
      shot adductor and/or sciatic nerve blocks to ensure 24 hour period without nerve block prior&#xD;
      to initiation of BFR therapy. Patients included in the study cannot have a nerve block&#xD;
      lasting longer than the day of surgery. To ensure no new nerve deficits are present, the&#xD;
      patients will undergo a physical examination during morning rounding on post-operative day 1&#xD;
      to assess for new nerve deficits.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Investigator separated from institution&#xD;
  </why_stopped>
  <start_date type="Actual">December 18, 2018</start_date>
  <completion_date type="Actual">June 1, 2019</completion_date>
  <primary_completion_date type="Actual">June 1, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Double blinded randomized control trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    <masking_description>Patients and outcomes assessors will be blinded to treatment group. Physical therapy providers will not be masked.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Quadriceps Cross-Sectional Area</measure>
    <time_frame>Pre-op and 6-weeks post-operative</time_frame>
    <description>Change in quadriceps cross-sectional area measured on MRI pre-operatively compared to post-operatively</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Numeric rating scale pain</measure>
    <time_frame>Days 1, 14, and 6 weeks after surgery</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Thigh girth</measure>
    <time_frame>Days 1, 14, and 6 weeks after surgery</time_frame>
    <description>Measured thigh girth 15cm above knee joint line</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Knee joint range of motion</measure>
    <time_frame>Days 1, 14, and 6 weeks after surgery</time_frame>
    <description>Measure knee range of motion</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>ACL Injury</condition>
  <condition>Quadriceps Muscle Atrophy</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Patients in this group will have BFR tourniquet applied but inflated to only minimal pressure.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Blood Flow Restriction (BFR) Therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in this group will have BFR tourniquet applied and inflated to 80% limb occlusion pressure</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Blood flow restriction therapy - with Delfi Personalized Tourniquet System</intervention_name>
    <description>Physical therapy performed with Blood flow restriction therapy tourniquet inflated to 80% limb occlusion pressure</description>
    <arm_group_label>Blood Flow Restriction (BFR) Therapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sham blood flow restriction therapy - with Delfi Personalized Tourniquet System</intervention_name>
    <description>Physical therapy performed with Blood flow restriction therapy tourniquet inflated to only minimal pressure</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 14-70&#xD;
&#xD;
          -  Undergoing ACL reconstruction with patellar tendon autograft&#xD;
&#xD;
          -  Full weightbearing after surgery&#xD;
&#xD;
          -  Surgery performed within 14 days of ACL injury&#xD;
&#xD;
          -  No nerve catheter in place&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Meniscal root tears&#xD;
&#xD;
          -  radial meniscal tears&#xD;
&#xD;
          -  multi-ligament knee injury&#xD;
&#xD;
          -  revision ACL reconstruction&#xD;
&#xD;
          -  concomitant osteotomies&#xD;
&#xD;
          -  concomitant cartilage resurfacing procedures&#xD;
&#xD;
          -  fracture preventing full-weightbearing of operated extremity&#xD;
&#xD;
          -  previous history of deep vein thrombosis (DVT)&#xD;
&#xD;
          -  new nerve injury/findings affecting operative extremity&#xD;
&#xD;
          -  active femoral nerve catheter&#xD;
&#xD;
          -  nerve block lasting longer than day of surgery&#xD;
&#xD;
          -  patients unable to tolerate BFR treatment&#xD;
&#xD;
          -  untolerable post-operative pain due to absence of nerve catheter&#xD;
&#xD;
          -  proximal thigh girth greater than 34cm&#xD;
&#xD;
          -  time to surgery greater than 14 days&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>The Steadman Clinic</name>
      <address>
        <city>Vail</city>
        <state>Colorado</state>
        <zip>81657</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>December 20, 2018</study_first_submitted>
  <study_first_submitted_qc>January 2, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 7, 2019</study_first_posted>
  <last_update_submitted>December 2, 2019</last_update_submitted>
  <last_update_submitted_qc>December 2, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 4, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Muscular Atrophy</mesh_term>
    <mesh_term>Atrophy</mesh_term>
    <mesh_term>Anterior Cruciate Ligament Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No sharing</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03794570
org study id: 2018-35
nct id: NCT03794570
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Double blinded randomized control trial
primary purpose: Treatment
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.
measure: Change in Quadriceps Cross-Sectional Area
time frame: Pre-op and 6-weeks post-operative
description: Change in quadriceps cross-sectional area measured on MRI pre-operatively compared to post-operatively
measure: Numeric rating scale pain
time frame: Days 1, 14, and 6 weeks after surgery
description: 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
measure: Thigh girth
time frame: Days 1, 14, and 6 weeks after surgery
description: Measured thigh girth 15cm above knee joint line
measure: Knee joint range of motion
time frame: Days 1, 14, and 6 weeks after surgery
description: Measure knee range of motion
arm group label: Control
arm group type: Sham Comparator
description: Patients in this group will have BFR tourniquet applied but inflated to only minimal pressure.
arm group label: Blood Flow Restriction (BFR) Therapy
arm group type: Experimental
description: Patients in this group will have BFR tourniquet applied and inflated to 80% limb occlusion pressure
intervention type: Device
intervention name: Blood flow restriction therapy - with Delfi Personalized Tourniquet System
description: Physical therapy performed with Blood flow restriction therapy tourniquet inflated to 80% limb occlusion pressure
arm group label: Blood Flow Restriction (BFR) Therapy
intervention type: Device
intervention name: Sham blood flow restriction therapy - with Delfi Personalized Tourniquet System
description: Physical therapy performed with Blood flow restriction therapy tourniquet inflated to only minimal pressure
arm group label: Control
criteria: 
gender: All
minimum age: 14 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Muscular Atrophy
mesh term: Atrophy
mesh term: Anterior Cruciate Ligament Injuries
sharing ipd: No
ipd description: No sharing