<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/NCT02185365</url>
  </required_header>
  <id_info>
    <org_study_id>20140371-01H</org_study_id>
    <nct_id>NCT02185365</nct_id>
  </id_info>
  <brief_title>Evaluation of T1rho Magnetic Resonance Imaging for Diagnosis of Cartilage Lesions in Hips With Developmental Dysplasia</brief_title>
  <official_title>Evaluation of T1rho Magnetic Resonance Imaging for Diagnosis of Cartilage Lesions in Hips With Developmental Dysplasia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ottawa Hospital Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Zimmer Biomet</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Ottawa Hospital Academic Medical Association</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </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>
      One of the leading causes of hip arthritis is developmental dysplasia of the hip (DDH). DDH&#xD;
      can lead to major damage in the hip joint and may result in hip arthritis later in life.&#xD;
      Patients recruited into this study will be undergoing corrective hip surgery within the next&#xD;
      6 months with a goal of preventing further hip problems down the road. This study is being&#xD;
      done to see how well a newer type of Magnetic Resonance Imaging (MRI) detects hip cartilage&#xD;
      damage compared to an older but well validated MRI method.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The start of arthritis can first be detected in certain molecules in the joint. Proteoglycan&#xD;
      is a molecule that is important to cartilage structure, and is lost as arthritis develops.&#xD;
      Magnetic resonance imaging (MRI) is one of the best ways to image cartilage, and an&#xD;
      investigational MRI technique that has shown great promise in detecting proteoglycan amounts&#xD;
      is called T1-rho.&#xD;
&#xD;
      In this study, patients with hip dysplasia will undergo this investigational MRI in addition&#xD;
      to a well validated MRI method (called dGEMRIC) to see if T1-rho is as good as dGEMRIC at&#xD;
      detecting cartilage damage. The dGEMRIC MRI requires an injection of a contrast agent, while&#xD;
      the T1-rho MRI does not. If the T1-rho is shown to be as useful as the dGEMRIC method it can&#xD;
      then be used to look at cartilage damage in the hip without having to have an injection.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 25, 2017</start_date>
  <completion_date type="Anticipated">December 2021</completion_date>
  <primary_completion_date type="Anticipated">December 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Assess proteoglycan amounts in hip cartilage</measure>
    <time_frame>Within the 6 months prior to surgery</time_frame>
    <description>Our aim is to correlate T1-rho with dGEMRIC values in painful hips with underlying DDH. To achieve this, we will assess whether T1-rho MRI values correlate with dGEMRIC MRI values in hips with DDH.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in WOMAC Questionnaire</measure>
    <time_frame>12 months</time_frame>
    <description>The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is widely used as a standard assessment of arthritis in the hip joint. The Index is self-administered and assesses the three dimensions of pain (5 items), joint stiffness (2 items), and Physical Function (17 items) in hip osteoarthritis using 24 questions. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme. These correspond to an ordinal scale of 0-4. Scores are summed with higher scores indicating worse pain, stiffness, and function.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in iHOT 12 Questionnaire</measure>
    <time_frame>12 months</time_frame>
    <description>The International Hip Outcome Tool (iHOT-12) is a questionnaire that has recently been validated in young active patients with early hip disease. The questionnaire is self-administered and assesses across 4 domains: symptoms and functional limitations; sport and recreational activities; job-related concerns; and social, emotional, and lifestyle concerns. Questions are answered by marking a visual analog scale between 2 anchor statements (100-mm scale). The total score is calculated as a simple mean of these responses ranging from 0 to 100, with 100 representing the best possible quality-of-life score.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">25</enrollment>
  <condition>Developmental Dysplasia of the Hip</condition>
  <arm_group>
    <arm_group_label>Developmental dysplasia of the hip (DDH)</arm_group_label>
    <description>Patients will complete 2 magnetic resonance imaging (MRI): T1-rho and dGEMRIC. The T1-rho MRI does not require the injection of a contrast agent, while the dGEMRIC MRI requires a gadolinium injection to visualize cartilage in the hip.</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Magnetic Resonance Imaging (MRI)</intervention_name>
    <description>Patients will undergo 2 different MRIs of the affected hip. Both MRIs assess hip cartilage degeneration. A contrast agent, Gadolinium, will be used to visualize cartilage during the MRI. The contrast agent is injected through an intravenous (a small plastic tube inserted into a vein in the patients' arm) before the MRI.</description>
    <arm_group_label>Developmental dysplasia of the hip (DDH)</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study group will consist of patients diagnosed with developmental dysplasia of the hip&#xD;
        (DDH), and who are scheduled to undergo surgery to correct this.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with a diagnosis of developmental dysplasia of the hip (DDH)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients under the age of 18&#xD;
&#xD;
          -  pregnancy and/or lactation&#xD;
&#xD;
          -  non-MRI compatible implants (stents, electronic devices, cardiac pacers or wires)&#xD;
&#xD;
          -  severe claustrophobia&#xD;
&#xD;
          -  prior contrast allergic reaction&#xD;
&#xD;
          -  kidney impairment&#xD;
&#xD;
          -  previous hip surgery&#xD;
&#xD;
          -  osteoarthritis on conventional radiographs (Tönnis Grade&gt;0)&#xD;
&#xD;
          -  additional underlying hip diseases such as posttraumatic arthritis,&#xD;
             Legg-Calvé-Perthes-Disease (LCPD), or slipped capital femoral epiphysis (SCFE)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Paul Beaule, MD, FRCSC</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ottawa Hospital Research Institute</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Paul Beaule, MD, FRCSC</last_name>
    <phone>613-737-8899</phone>
    <phone_ext>73265</phone_ext>
    <email>pbeaule@toh.ca</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Cheryl Kreviazuk</last_name>
    <phone>613-737-8920</phone>
    <email>ckreviazuk@ohri.ca</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Ottawa Hospital - General Campus</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1H8L6</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Orthopaedic Research</last_name>
      <phone>613-737-8920</phone>
    </contact>
    <investigator>
      <last_name>Paul Beaule, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>June 2, 2014</study_first_submitted>
  <study_first_submitted_qc>July 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 9, 2014</study_first_posted>
  <last_update_submitted>June 22, 2021</last_update_submitted>
  <last_update_submitted_qc>June 22, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 23, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>T1-rho MRI</keyword>
  <keyword>dGEMRIC MRI</keyword>
  <keyword>DDH</keyword>
  <keyword>Developmental dysplasia of the hip</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Developmental Dysplasia of the Hip</mesh_term>
    <mesh_term>Hip Dislocation, Congenital</mesh_term>
    <mesh_term>Hyperplasia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT02185365
org study id: 20140371-01H
nct id: NCT02185365
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
One of the leading causes of hip arthritis is developmental dysplasia of the hip (DDH). DDH
      can lead to major damage in the hip joint and may result in hip arthritis later in life.
      Patients recruited into this study will be undergoing corrective hip surgery within the next
      6 months with a goal of preventing further hip problems down the road. This study is being
      done to see how well a newer type of Magnetic Resonance Imaging (MRI) detects hip cartilage
      damage compared to an older but well validated MRI method.
The start of arthritis can first be detected in certain molecules in the joint. Proteoglycan
      is a molecule that is important to cartilage structure, and is lost as arthritis develops.
      Magnetic resonance imaging (MRI) is one of the best ways to image cartilage, and an
      investigational MRI technique that has shown great promise in detecting proteoglycan amounts
      is called T1-rho.

      In this study, patients with hip dysplasia will undergo this investigational MRI in addition
      to a well validated MRI method (called dGEMRIC) to see if T1-rho is as good as dGEMRIC at
      detecting cartilage damage. The dGEMRIC MRI requires an injection of a contrast agent, while
      the T1-rho MRI does not. If the T1-rho is shown to be as useful as the dGEMRIC method it can
      then be used to look at cartilage damage in the hip without having to have an injection.
observational model: Cohort
time perspective: Prospective
measure: Assess proteoglycan amounts in hip cartilage
time frame: Within the 6 months prior to surgery
description: Our aim is to correlate T1-rho with dGEMRIC values in painful hips with underlying DDH. To achieve this, we will assess whether T1-rho MRI values correlate with dGEMRIC MRI values in hips with DDH.
measure: Change in WOMAC Questionnaire
time frame: 12 months
description: The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is widely used as a standard assessment of arthritis in the hip joint. The Index is self-administered and assesses the three dimensions of pain (5 items), joint stiffness (2 items), and Physical Function (17 items) in hip osteoarthritis using 24 questions. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme. These correspond to an ordinal scale of 0-4. Scores are summed with higher scores indicating worse pain, stiffness, and function.
measure: Change in iHOT 12 Questionnaire
time frame: 12 months
description: The International Hip Outcome Tool (iHOT-12) is a questionnaire that has recently been validated in young active patients with early hip disease. The questionnaire is self-administered and assesses across 4 domains: symptoms and functional limitations; sport and recreational activities; job-related concerns; and social, emotional, and lifestyle concerns. Questions are answered by marking a visual analog scale between 2 anchor statements (100-mm scale). The total score is calculated as a simple mean of these responses ranging from 0 to 100, with 100 representing the best possible quality-of-life score.
arm group label: Developmental dysplasia of the hip (DDH)
description: Patients will complete 2 magnetic resonance imaging (MRI): T1-rho and dGEMRIC. The T1-rho MRI does not require the injection of a contrast agent, while the dGEMRIC MRI requires a gadolinium injection to visualize cartilage in the hip.
intervention type: Radiation
intervention name: Magnetic Resonance Imaging (MRI)
description: Patients will undergo 2 different MRIs of the affected hip. Both MRIs assess hip cartilage degeneration. A contrast agent, Gadolinium, will be used to visualize cartilage during the MRI. The contrast agent is injected through an intravenous (a small plastic tube inserted into a vein in the patients' arm) before the MRI.
arm group label: Developmental dysplasia of the hip (DDH)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Paul Beaule, MD, FRCSC
role: Principal Investigator
affiliation: Ottawa Hospital Research Institute
last name: Paul Beaule, MD, FRCSC
phone: 613-737-8899
phone ext: 73265
email: pbeaule@toh.ca
last name: Cheryl Kreviazuk
phone: 613-737-8920
email: ckreviazuk@ohri.ca
facility: 
status: Recruiting
contact: 
investigator: 
country: Canada
responsible party type: Sponsor
mesh term: Developmental Dysplasia of the Hip
mesh term: Hip Dislocation, Congenital
mesh term: Hyperplasia
sharing ipd: No