<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/NCT03248934</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00082395</org_study_id>
    <nct_id>NCT03248934</nct_id>
  </id_info>
  <brief_title>Patient Performed Examination for Patients With Intra-articular Hip Pain</brief_title>
  <official_title>Delineating the Concurrent Validity and Diagnostic Accuracy of a Patient Performed Examination for Patients With Intra-Articular Hip Pain: A Proof of Concept Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Duke University</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 primary objective of this study is evaluate the diagnostic accuracy of a patient&#xD;
      self-administered clinical examination of the hip compared with a traditional clinical&#xD;
      examination (i.e. index test).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 18, 2017</start_date>
  <completion_date type="Actual">March 13, 2018</completion_date>
  <primary_completion_date type="Actual">March 13, 2018</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Sensitivity</measure>
    <time_frame>End of clinician examination, 20 minutes</time_frame>
    <description>As measured by a questionnaire evaluating the diagnostic test's ability to identify a positive finding when the targeted diagnosis is actually present (i.e. true positive).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Specificity</measure>
    <time_frame>End of clinician examination, 20 minutes</time_frame>
    <description>As measured by the discriminatory ability of the diagnostic test to identify if the disease or condition is absent when in actuality it is truly absent (i.e. true negative).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diagnostic accuracy measure of positive likelihood ratio</measure>
    <time_frame>End of clinician examination, 20 minutes</time_frame>
    <description>As measured by sensitivity and specificity values.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diagnostic accuracy measure of negative likelihood ratio</measure>
    <time_frame>End of clinician examination, 20 minutes</time_frame>
    <description>As measured by sensitivity and specificity values.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diagnostic accuracy measure of post-test probabilities</measure>
    <time_frame>End of clinician examination, 20 minutes</time_frame>
    <description>As measured by analysis of the pre-test prevalence of the condition and determination of the post-test shift in probability of the condition.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Hip Pain Chronic</condition>
  <condition>Hip Disease</condition>
  <arm_group>
    <arm_group_label>Patient Self-Administered Exam Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with hip pain presenting in the hip preservation clinics will be asked to complete two diagnostic exams. Participants with hip pain will first complete a patient self-administered diagnostic exam.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Clinician-Performed Exam Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants with hip pain presenting in the hip preservation clinics will be asked to complete two diagnostic exams. Participants with hip pain will next complete a clinician-performed diagnostic exam.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Patient Self-Administered Diagnostic Exam</intervention_name>
    <description>Participants will complete a patient self-administered diagnostic exam. A physician will be available to monitor the patient and record findings but will not physically assist the participants.</description>
    <arm_group_label>Patient Self-Administered Exam Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Clinician-Performed Diagnostic Exam</intervention_name>
    <description>A clinician-performed diagnostic exam will be completed on the patients.</description>
    <arm_group_label>Clinician-Performed Exam Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age: 18-80 years&#xD;
&#xD;
          -  Seeking care for hip related pain and/or clicking, catching, giving way or stiffness&#xD;
&#xD;
          -  Able to sign or verbalize study consent&#xD;
&#xD;
          -  No other medical conditions (e.g. gynecological or urinary pathology) that may affect&#xD;
             study results&#xD;
&#xD;
          -  English speaking&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with primary lumbar spine, sacro-iliac or other non-hip related pain as&#xD;
             determined with clinical examination&#xD;
&#xD;
          -  Previous hip surgery&#xD;
&#xD;
          -  Previous hip injury that would normally exclude from examination as standard practice&#xD;
&#xD;
          -  Unable to sign or verbalize consent&#xD;
&#xD;
          -  Other non-musculoskeletal pathology that may affect study results (e.g. gynecological&#xD;
             or urinary pathology)&#xD;
&#xD;
          -  Non-English speaking&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Richard C. Mather</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Duke University Health System</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>August 10, 2017</study_first_submitted>
  <study_first_submitted_qc>August 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 15, 2017</study_first_posted>
  <last_update_submitted>December 16, 2019</last_update_submitted>
  <last_update_submitted_qc>December 16, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 17, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT03248934
org study id: Pro00082395
nct id: NCT03248934
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The primary objective of this study is evaluate the diagnostic accuracy of a patient
      self-administered clinical examination of the hip compared with a traditional clinical
      examination (i.e. index test).
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Sensitivity
time frame: End of clinician examination, 20 minutes
description: As measured by a questionnaire evaluating the diagnostic test's ability to identify a positive finding when the targeted diagnosis is actually present (i.e. true positive).
measure: Specificity
time frame: End of clinician examination, 20 minutes
description: As measured by the discriminatory ability of the diagnostic test to identify if the disease or condition is absent when in actuality it is truly absent (i.e. true negative).
measure: Diagnostic accuracy measure of positive likelihood ratio
time frame: End of clinician examination, 20 minutes
description: As measured by sensitivity and specificity values.
measure: Diagnostic accuracy measure of negative likelihood ratio
time frame: End of clinician examination, 20 minutes
description: As measured by sensitivity and specificity values.
measure: Diagnostic accuracy measure of post-test probabilities
time frame: End of clinician examination, 20 minutes
description: As measured by analysis of the pre-test prevalence of the condition and determination of the post-test shift in probability of the condition.
arm group label: Patient Self-Administered Exam Group
arm group type: Experimental
description: Participants with hip pain presenting in the hip preservation clinics will be asked to complete two diagnostic exams. Participants with hip pain will first complete a patient self-administered diagnostic exam.
arm group label: Clinician-Performed Exam Group
arm group type: Active Comparator
description: Participants with hip pain presenting in the hip preservation clinics will be asked to complete two diagnostic exams. Participants with hip pain will next complete a clinician-performed diagnostic exam.
intervention type: Other
intervention name: Patient Self-Administered Diagnostic Exam
description: Participants will complete a patient self-administered diagnostic exam. A physician will be available to monitor the patient and record findings but will not physically assist the participants.
arm group label: Patient Self-Administered Exam Group
intervention type: Other
intervention name: Clinician-Performed Diagnostic Exam
description: A clinician-performed diagnostic exam will be completed on the patients.
arm group label: Clinician-Performed Exam Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Richard C. Mather
role: Principal Investigator
affiliation: Duke University
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No