<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/NCT02260726</url>
  </required_header>
  <id_info>
    <org_study_id>20140318-01H</org_study_id>
    <nct_id>NCT02260726</nct_id>
  </id_info>
  <brief_title>Evaluation of Ultrasound for Detecting Hip Impingement</brief_title>
  <official_title>Diagnosing Deformities of the Hip Associated With Arthritis: MRI vs Ultrasound</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ottawa Hospital Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ottawa Hospital Research Institute</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>
      Patients are being asked to participate in this study because a previous research MRI of&#xD;
      their hips showed that the shape of the head of their thigh bone may indicate FAI of the hip.&#xD;
      We have already collected cartilage imaging data and data on how the hip joint moves on&#xD;
      people with painful/symptomatic FAI and people with normal hip function. We would now like to&#xD;
      compare the motion of the hip joint to those with painful FAI using ultrasound.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hip impingement is thought to be a leading cause of hip osteoarthritis, and occurs due to&#xD;
      deformities in the hip joint. However some individuals have these deformities but do not&#xD;
      exhibit symptoms. Using the standard magnetic resonance imaging and clinical tests it is not&#xD;
      clear which deformities will cause degeneration, requiring surgical intervention. We propose&#xD;
      to evaluate the deformity and impingement between the femur and acetabulum using dynamic&#xD;
      ultrasound imaging. Ultrasound does not involve radiation and can acquire video of the hip&#xD;
      joint and is thus suitable for such diagnostic purposes. In this pilot study we will evaluate&#xD;
      the feasibility of ultrasound in diagnosing hip impingement.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    No funding available&#xD;
  </why_stopped>
  <start_date type="Anticipated">October 2014</start_date>
  <completion_date type="Anticipated">October 2016</completion_date>
  <primary_completion_date type="Anticipated">October 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Ultrasound grade</measure>
    <time_frame>Upon enrollment</time_frame>
    <description>Ultrasound grade evaluated on a four point scale following ultrasound imaging session</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Ultrasound parameters</measure>
    <time_frame>Upon enrollment</time_frame>
    <description>Morphometry of hip measured in ultrasound images: alpha angle, clearance angle</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MRI parameters</measure>
    <time_frame>Upon enrollment</time_frame>
    <description>Standard MRI measures of impingement from images. Used as gold standard for comparative purposes.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Femoroacetabular Impingement</condition>
  <arm_group>
    <arm_group_label>Surgical group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects already scheduled to undergo surgical correction of a symptomatic cam-type hip impingement deformity. Subjects will undergo magnetic resonance imaging (MRI) and ultrasound investigation prior to surgery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Asymptomatic subjects with normal hip morphometry, as determined by MRI. Subjects will undergo magnetic resonance imaging (MRI) and ultrasound imaging.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Magnetic resonance imaging</intervention_name>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Surgical group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Ultrasound</intervention_name>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Surgical group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Surgical group:&#xD;
&#xD;
          -  Hip pain longer than 6 months referred to the groin/lateral aspect of the hip&#xD;
&#xD;
          -  Positive Impingement Sign&#xD;
&#xD;
        Plain radiographs:&#xD;
&#xD;
          -  Absence of arthritis (Tonnis Grade 0 or 1)&#xD;
&#xD;
          -  Absence of dysplasia (center edge &gt;25 degrees) on anterior-posterior radiograph&#xD;
&#xD;
          -  α-angle greater than 60 degrees on MRI.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who don't meet inclusion criteria&#xD;
&#xD;
          -  Control group: subjects with hip pain or with alpha angle &gt; 50 degrees on MRI&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Paul E Beaule, MD, FRCSC</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Ottawa / The Ottawa Hospital</affiliation>
  </overall_official>
  <removed_countries>
    <country>Canada</country>
  </removed_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>October 6, 2014</study_first_submitted>
  <study_first_submitted_qc>October 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 9, 2014</study_first_posted>
  <last_update_submitted>April 13, 2018</last_update_submitted>
  <last_update_submitted_qc>April 13, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 17, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>femoroacetabular impingement</keyword>
  <keyword>morphometry</keyword>
  <keyword>dynamic</keyword>
  <keyword>magnetic resonance imaging</keyword>
  <keyword>ultrasound</keyword>
  <keyword>screening</keyword>
  <keyword>diagnosis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Femoracetabular Impingement</mesh_term>
  </condition_browse>
  <!-- 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/NCT02260726
org study id: 20140318-01H
nct id: NCT02260726
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Patients are being asked to participate in this study because a previous research MRI of
      their hips showed that the shape of the head of their thigh bone may indicate FAI of the hip.
      We have already collected cartilage imaging data and data on how the hip joint moves on
      people with painful/symptomatic FAI and people with normal hip function. We would now like to
      compare the motion of the hip joint to those with painful FAI using ultrasound.
Hip impingement is thought to be a leading cause of hip osteoarthritis, and occurs due to
      deformities in the hip joint. However some individuals have these deformities but do not
      exhibit symptoms. Using the standard magnetic resonance imaging and clinical tests it is not
      clear which deformities will cause degeneration, requiring surgical intervention. We propose
      to evaluate the deformity and impingement between the femur and acetabulum using dynamic
      ultrasound imaging. Ultrasound does not involve radiation and can acquire video of the hip
      joint and is thus suitable for such diagnostic purposes. In this pilot study we will evaluate
      the feasibility of ultrasound in diagnosing hip impingement.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Screening
masking: None (Open Label)
measure: Ultrasound grade
time frame: Upon enrollment
description: Ultrasound grade evaluated on a four point scale following ultrasound imaging session
measure: Ultrasound parameters
time frame: Upon enrollment
description: Morphometry of hip measured in ultrasound images: alpha angle, clearance angle
measure: MRI parameters
time frame: Upon enrollment
description: Standard MRI measures of impingement from images. Used as gold standard for comparative purposes.
arm group label: Surgical group
arm group type: Experimental
description: Subjects already scheduled to undergo surgical correction of a symptomatic cam-type hip impingement deformity. Subjects will undergo magnetic resonance imaging (MRI) and ultrasound investigation prior to surgery.
arm group label: Control
arm group type: Other
description: Asymptomatic subjects with normal hip morphometry, as determined by MRI. Subjects will undergo magnetic resonance imaging (MRI) and ultrasound imaging.
intervention type: Procedure
intervention name: Magnetic resonance imaging
arm group label: Control
arm group label: Surgical group
intervention type: Procedure
intervention name: Ultrasound
arm group label: Control
arm group label: Surgical group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Paul E Beaule, MD, FRCSC
role: Principal Investigator
affiliation: University of Ottawa / The Ottawa Hospital
country: Canada
responsible party type: Sponsor
mesh term: Femoracetabular Impingement