<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/NCT03272672</url>
  </required_header>
  <id_info>
    <org_study_id>17-0831</org_study_id>
    <nct_id>NCT03272672</nct_id>
  </id_info>
  <brief_title>Effects of a Valgus Unloader Brace on Medial Femoral Cartilage</brief_title>
  <official_title>Effects of a Valgus Unloader Brace on Medial Femoral Cartilage Changes Following Walking Protocol</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of North Carolina, Chapel Hill</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of North Carolina, Chapel Hill</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the effect of a valgus unloader brace condition on&#xD;
      the acute change in medial femoral condyle cartilage morphology using Ultrasound following a&#xD;
      standardized walking protocol.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants will report to an initial screening session during which knee alignment will be&#xD;
      determined using a long-lever goniometer. For the assessment of baseline knee alignment, the&#xD;
      participant will stand with feet facing forward directly underneath corresponding acromion&#xD;
      processes and weight evenly distributed. The first axis will be measured from ASIS to&#xD;
      midpoint of the patella and the second axis will be measured from the midpoint of the patella&#xD;
      to the tibial tuberosity. The valgus angle will be used to determine eligibility for the&#xD;
      study. To be eligible for this study, participants must present with a valgus knee alignment&#xD;
      angle of ≥180° on the dominant limb defined as the limb the participant would use to kick a&#xD;
      ball. Weight and height measurements will also be measured and used to calculate BMI. Once&#xD;
      eligible, participants will determine a self-selected walking speed by walking between 2 sets&#xD;
      of infrared timing gates (TF100, TracTronix). Starting approximately 5 steps before the first&#xD;
      timing gate, participants will be instructed to walk at a speed described as &quot;comfortable&#xD;
      walking over a sidewalk&quot;. Each participant will complete 3 trials and the average walking&#xD;
      speed will be calculated.&#xD;
&#xD;
      Pre-loading Protocol&#xD;
&#xD;
      Participants will report to the laboratory at the same time of day (±2 hours) for both&#xD;
      sessions to account for diurnal variations within the cartilage. Upon arrival, participants&#xD;
      will sit on a treatment table in the long-sit position with knees fully extended for 45 mins&#xD;
      to allow time for cartilage reformation.&#xD;
&#xD;
      Ultrasonographic Assessment of the Femoral Articular Cartilage While seated with their back&#xD;
      up against the wall, participants will flex their knee to 140° measured using a manual&#xD;
      goniometer while. A measuring tape will be secured to the length of the table so that the&#xD;
      position of the posterior calcaneus can be recorded to allow for consistent positioning&#xD;
      across trials 15. A LOGIQe US system (General Electric Co., Fairfield, CT) with a 12MHz&#xD;
      linear probe will be used to image both the medial and lateral femoral cartilage. The probe&#xD;
      will be placed transversely in line between the medial and lateral femoral condyles just&#xD;
      superior to the patella and rotated to maximize reflection off the articular cartilage. A&#xD;
      transparent grid will be placed over the US screen to improve reproducibility of the US&#xD;
      image. The midpoint of the intercondylar groove will be aligned with the center of the grid.&#xD;
&#xD;
      The level of the cartilage-bone interface at the edge of the image on either side will be&#xD;
      recorded in order to ensure consistent positioning across US assessments. Three images will&#xD;
      be collected of each knee at each time point. Following each loading condition, the&#xD;
      participant will be placed in the same position as the pre-loading US assessment using the&#xD;
      tape measure. Three images of the femoral cartilage will be recorded from each knee. All&#xD;
      post-walking images will be captured within 5 minutes of the loading protocol.&#xD;
&#xD;
      Ultrasonographic Image Analysis All US images will be analyzed with the ImageJ software&#xD;
      (National Institutes of Health, Bethesda, MD). Values for all measurement types will be&#xD;
      obtained for each of the three images of the dominant limb at each time point (pre and&#xD;
      post-walking) and averaged for statistical analysis.&#xD;
&#xD;
      Cartilage Thickness&#xD;
&#xD;
      Cartilage thickness (in millimeters) will be determined at the most inferior point of the&#xD;
      intercondylar groove, the midpoint of the medial condyle, and the midpoint of the lateral&#xD;
      condyle by drawing a line from the cartilage-bone interface to the synovial space-cartilage&#xD;
      interface.&#xD;
&#xD;
      Cartilage Area The femoral cartilage will be divided into medial and lateral sections by&#xD;
      identifying the midline at the most inferior point of the intercondylar groove. Each section&#xD;
      of the cartilage will be outlined with a polygon function (Figure 1). The area (in square&#xD;
      millimeters) of each section will be measured.&#xD;
&#xD;
      Average Cartilage Thickness The area (in square millimeters) of each section as determined in&#xD;
      the cartilage area measure will then be divided by the length (in millimeters) of the section&#xD;
      measured via a segmented line along the cartilage-bone interface (Figure 2). Average&#xD;
      cartilage thickness (in millimeters) measures will be determined for the medial and lateral&#xD;
      condyles. Values will be obtained for each of the three images per limb at each time point&#xD;
      (pre and post-walking) and averaged for statistical analysis.&#xD;
&#xD;
      Cartilage Loading Protocol Immediately following pre-test ultrasound assessments,&#xD;
      participants will be transferred from the table to a wheelchair in order to minimize knee&#xD;
      loading not related to the walking condition. During the braced walking condition, a valgus&#xD;
      unloader brace (Össür Unloader One®, Össur Americas, Orange County, CA) will be fitted by a&#xD;
      certified athletic trainer per manufacturer instructions to the dominant limb while the&#xD;
      participant is seated with knee flexed to approximately 80°.&#xD;
&#xD;
      The brace will be maximally adjusted to unload the medial compartment. The participant will&#xD;
      take 30 steps to adjust to the brace. Adjustments will then be made as needed if the&#xD;
      participant determines the fit is uncomfortable or too loose. The participant will take 30&#xD;
      more steps. Any final adjustments can be made at that point. The participant will then be&#xD;
      transferred to and from the treadmill via wheelchair to control the amount of cartilage&#xD;
      loading.&#xD;
&#xD;
      Control Protocol In the unbraced condition, the participant will repeat the brace protocol&#xD;
      except that the participant will not be fitted with an unloader brace while seated. The&#xD;
      participant will take 60 steps to keep the number of steps consistent across trials before&#xD;
      being transferred to the treadmill. The participant will remain unbraced for the entire&#xD;
      trial.&#xD;
&#xD;
      Loading Protocol Participants will maintain the self-selected walking speed for 5000 steps on&#xD;
      a treadmill (4Front, WOODWAY, Waukesha, WI). Self-selected speed will be kept the same across&#xD;
      both conditions. Participant will walk for 1 minute to adjust to treadmill. Steps will then&#xD;
      be counted for 1 minute, and the time necessary to complete 5000 steps will be calculated&#xD;
      (5000 divided by number of steps per minute).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2017</start_date>
  <completion_date type="Actual">November 1, 2019</completion_date>
  <primary_completion_date type="Actual">November 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>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>A blinded investigator will segment all Ultrasound images.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Pre walking - Thickness (mm) of the Medial Femoral Articular Cartilage as measured by ultrasound</measure>
    <time_frame>Prior to the walking protocol</time_frame>
    <description>Thickness of the articular cartilage on the Medial Femoral condyle will be measured in millimeters</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Post walking - Thickness (mm) of the Medial Femoral Articular Cartilage as measured by ultrasound</measure>
    <time_frame>Immediately following the walking protocol (the post-test will be finished within approximately 5 minutes of concluding the walking protocol)</time_frame>
    <description>Thickness of the articular cartilage on the Medial Femoral condyle will be measured in millimeters</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Braced</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Össür Unloading Knee Brace used during walking protocol</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Unbraced</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Walking protocol without the use of brace</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Össür Unloading Knee Brace</intervention_name>
    <description>During the braced walking condition, a valgus unloader brace (Össür Unloader One®, Össur Americas, Orange County, CA) will be fitted by a certified athletic trainer per manufacturer instructions to the dominant limb while the participant is seated with knee flexed to approximately 80°.&#xD;
The brace will be maximally adjusted to unload the medial compartment.</description>
    <arm_group_label>Braced</arm_group_label>
    <other_name>Össür Unloader One®</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Uninjured participants. There will be no exclusion based on race, gender or ethnicity.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  congenital or degenerative joint condition, orthopedic implants, current joint pain&#xD;
             (quantified as less than 2 on a 10cm visual analog scale),&#xD;
&#xD;
          -  cartilage injury of any joint, lower extremity fracture, or upper extremity fracture&#xD;
             within the last year.&#xD;
&#xD;
          -  any major ligamentous or cartilage injury of the knee or hip joints, or reported of&#xD;
             cartilage injury at the ankle.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joshua Valentine</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of North Carolina, Chapel Hill</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Brian Pietrosimone, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>University of North Carolina, Chapel Hill</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of North Carolina at Chapel Hill</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>August 28, 2017</study_first_submitted>
  <study_first_submitted_qc>September 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 5, 2017</study_first_posted>
  <last_update_submitted>March 24, 2020</last_update_submitted>
  <last_update_submitted_qc>March 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 25, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </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/NCT03272672
org study id: 17-0831
nct id: NCT03272672
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to determine the effect of a valgus unloader brace condition on
      the acute change in medial femoral condyle cartilage morphology using Ultrasound following a
      standardized walking protocol.
Participants will report to an initial screening session during which knee alignment will be
      determined using a long-lever goniometer. For the assessment of baseline knee alignment, the
      participant will stand with feet facing forward directly underneath corresponding acromion
      processes and weight evenly distributed. The first axis will be measured from ASIS to
      midpoint of the patella and the second axis will be measured from the midpoint of the patella
      to the tibial tuberosity. The valgus angle will be used to determine eligibility for the
      study. To be eligible for this study, participants must present with a valgus knee alignment
      angle of ≥180° on the dominant limb defined as the limb the participant would use to kick a
      ball. Weight and height measurements will also be measured and used to calculate BMI. Once
      eligible, participants will determine a self-selected walking speed by walking between 2 sets
      of infrared timing gates (TF100, TracTronix). Starting approximately 5 steps before the first
      timing gate, participants will be instructed to walk at a speed described as "comfortable
      walking over a sidewalk". Each participant will complete 3 trials and the average walking
      speed will be calculated.

      Pre-loading Protocol

      Participants will report to the laboratory at the same time of day (±2 hours) for both
      sessions to account for diurnal variations within the cartilage. Upon arrival, participants
      will sit on a treatment table in the long-sit position with knees fully extended for 45 mins
      to allow time for cartilage reformation.

      Ultrasonographic Assessment of the Femoral Articular Cartilage While seated with their back
      up against the wall, participants will flex their knee to 140° measured using a manual
      goniometer while. A measuring tape will be secured to the length of the table so that the
      position of the posterior calcaneus can be recorded to allow for consistent positioning
      across trials 15. A LOGIQe US system (General Electric Co., Fairfield, CT) with a 12MHz
      linear probe will be used to image both the medial and lateral femoral cartilage. The probe
      will be placed transversely in line between the medial and lateral femoral condyles just
      superior to the patella and rotated to maximize reflection off the articular cartilage. A
      transparent grid will be placed over the US screen to improve reproducibility of the US
      image. The midpoint of the intercondylar groove will be aligned with the center of the grid.

      The level of the cartilage-bone interface at the edge of the image on either side will be
      recorded in order to ensure consistent positioning across US assessments. Three images will
      be collected of each knee at each time point. Following each loading condition, the
      participant will be placed in the same position as the pre-loading US assessment using the
      tape measure. Three images of the femoral cartilage will be recorded from each knee. All
      post-walking images will be captured within 5 minutes of the loading protocol.

      Ultrasonographic Image Analysis All US images will be analyzed with the ImageJ software
      (National Institutes of Health, Bethesda, MD). Values for all measurement types will be
      obtained for each of the three images of the dominant limb at each time point (pre and
      post-walking) and averaged for statistical analysis.

      Cartilage Thickness

      Cartilage thickness (in millimeters) will be determined at the most inferior point of the
      intercondylar groove, the midpoint of the medial condyle, and the midpoint of the lateral
      condyle by drawing a line from the cartilage-bone interface to the synovial space-cartilage
      interface.

      Cartilage Area The femoral cartilage will be divided into medial and lateral sections by
      identifying the midline at the most inferior point of the intercondylar groove. Each section
      of the cartilage will be outlined with a polygon function (Figure 1). The area (in square
      millimeters) of each section will be measured.

      Average Cartilage Thickness The area (in square millimeters) of each section as determined in
      the cartilage area measure will then be divided by the length (in millimeters) of the section
      measured via a segmented line along the cartilage-bone interface (Figure 2). Average
      cartilage thickness (in millimeters) measures will be determined for the medial and lateral
      condyles. Values will be obtained for each of the three images per limb at each time point
      (pre and post-walking) and averaged for statistical analysis.

      Cartilage Loading Protocol Immediately following pre-test ultrasound assessments,
      participants will be transferred from the table to a wheelchair in order to minimize knee
      loading not related to the walking condition. During the braced walking condition, a valgus
      unloader brace (Össür Unloader One®, Össur Americas, Orange County, CA) will be fitted by a
      certified athletic trainer per manufacturer instructions to the dominant limb while the
      participant is seated with knee flexed to approximately 80°.

      The brace will be maximally adjusted to unload the medial compartment. The participant will
      take 30 steps to adjust to the brace. Adjustments will then be made as needed if the
      participant determines the fit is uncomfortable or too loose. The participant will take 30
      more steps. Any final adjustments can be made at that point. The participant will then be
      transferred to and from the treadmill via wheelchair to control the amount of cartilage
      loading.

      Control Protocol In the unbraced condition, the participant will repeat the brace protocol
      except that the participant will not be fitted with an unloader brace while seated. The
      participant will take 60 steps to keep the number of steps consistent across trials before
      being transferred to the treadmill. The participant will remain unbraced for the entire
      trial.

      Loading Protocol Participants will maintain the self-selected walking speed for 5000 steps on
      a treadmill (4Front, WOODWAY, Waukesha, WI). Self-selected speed will be kept the same across
      both conditions. Participant will walk for 1 minute to adjust to treadmill. Steps will then
      be counted for 1 minute, and the time necessary to complete 5000 steps will be calculated
      (5000 divided by number of steps per minute).
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Single (Outcomes Assessor)
masking description: A blinded investigator will segment all Ultrasound images.
measure: Pre walking - Thickness (mm) of the Medial Femoral Articular Cartilage as measured by ultrasound
time frame: Prior to the walking protocol
description: Thickness of the articular cartilage on the Medial Femoral condyle will be measured in millimeters
measure: Post walking - Thickness (mm) of the Medial Femoral Articular Cartilage as measured by ultrasound
time frame: Immediately following the walking protocol (the post-test will be finished within approximately 5 minutes of concluding the walking protocol)
description: Thickness of the articular cartilage on the Medial Femoral condyle will be measured in millimeters
arm group label: Braced
arm group type: Experimental
description: Össür Unloading Knee Brace used during walking protocol
arm group label: Unbraced
arm group type: No Intervention
description: Walking protocol without the use of brace
intervention type: Other
intervention name: Össür Unloading Knee Brace
description: During the braced walking condition, a valgus unloader brace (Össür Unloader One®, Össur Americas, Orange County, CA) will be fitted by a certified athletic trainer per manufacturer instructions to the dominant limb while the participant is seated with knee flexed to approximately 80°.
The brace will be maximally adjusted to unload the medial compartment.
arm group label: Braced
other name: Össür Unloader One®
criteria: 
gender: All
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Joshua Valentine
role: Principal Investigator
affiliation: University of North Carolina, Chapel Hill
last name: Brian Pietrosimone, PhD
role: Study Chair
affiliation: University of North Carolina, Chapel Hill
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: Undecided