<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/NCT04430829</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY00145012</org_study_id>
    <nct_id>NCT04430829</nct_id>
  </id_info>
  <brief_title>Diagnostic Value of Weight Bearing CT for Detecting Meniscal Tears</brief_title>
  <official_title>Comparison of Weight Bearing CT Arthrography With MRI for Detection of Knee Meniscal and Cartilage Lesions.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Kansas Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Kansas Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This observational study will compare the clinical value of weight-bearing CT arthrography&#xD;
      (WBCTa) with that for MRI in evaluating meniscal and cartilage lesions of the knee joint. The&#xD;
      MRI Osteoarthritis Knee Score (MOAKS) and modified MOAKS for WBCTa will be used to compare&#xD;
      findings between MRI and WBCTa of the knee while comparing with surgical measurements using&#xD;
      the ICRS scoring system.&#xD;
&#xD;
      The study hypothesis is that meniscal and cartilage lesions may be missed by&#xD;
      non-weight-bearing MRI, but detected by WBCTa.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study Objectives:&#xD;
&#xD;
      Aim 1 Establish the accuracy of WBCTa and MRI for diagnosing knee cartilage and meniscal&#xD;
      lesions in both surgical and non-surgical participants.&#xD;
&#xD;
      Hypothesis 1: Pre-operative cartilage and meniscal scoring on WBCTa is more accurate than&#xD;
      MRI, in comparison with arthroscopic assessment.&#xD;
&#xD;
      Aim 2 Establish the accuracy of WBCTa for detecting persistent and recurrent meniscal root&#xD;
      and radial tears not detected by MRI 6 months after meniscal repair (defined by diastasis of&#xD;
      the repair or meniscal extrusion ≥3mm).&#xD;
&#xD;
      Hypothesis 2: Six months following meniscal repair, WBCTa detects persistent and recurrent&#xD;
      meniscal root and radial re-tears not detected by MRI.&#xD;
&#xD;
      Study Type and Design: This cross-sectional, observational study will compare WBCTa with MRI&#xD;
      to evaluate rate of detection of meniscal and cartilage lesions. The inter-rater reliability&#xD;
      of WBCTa readings also will be assessed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 8, 2020</start_date>
  <completion_date type="Anticipated">November 14, 2023</completion_date>
  <primary_completion_date type="Anticipated">November 14, 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>To determine the agreement between weight-bearing CT arthrography (WBCTa) and MRI in evaluation of meniscal tears.</measure>
    <time_frame>Baseline</time_frame>
    <description>Pre-operative cartilage lesion scoring of meniscal lesions on WBCTa (modified MOAKS score) and MRI (modified MOAKS score) will be compared with arthroscopic visual MOAKS scoring of meniscal lesions.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To determine the agreement between weight-bearing CT arthrography and MRI in evaluation of cartilage lesions.</measure>
    <time_frame>Baseline</time_frame>
    <description>Musculoskeletal radiologists, each with greater than 10 years of experience will assess the morphology of the medial and lateral tibiofemoral cartilage on MRI and WBCTa using the MOAKS scoring system. Area of cartilage damage per subregion will be graded according to the MOAKS classification from 0-3: 0= no cartilage damage, 1=cartilage damage involving &lt;10% of the subregion area, 2= cartilage damage involving 10%-75% of the subregion area and 3=cartilage damage involving &gt;75% of the subregion area. The scores will be compared by dichotomizing into lesion present/absent (primary) and also compared using the full ranges of ordinal scores.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To determine the extent to which WBCTa identifies meniscal re-tears or failed repairs 6 months following meniscal root or radial tear surgical repairs</measure>
    <time_frame>6 months</time_frame>
    <description>Participants who undergo a meniscal repair for radial meniscal tears and posterior root tears will undergo 6-month post-operative MRI and WBCTa and each of these 2 imaging modalities will be assessed for visualization of the presence or absence of a meniscal tear..</description>
  </secondary_outcome>
  <enrollment type="Anticipated">125</enrollment>
  <condition>Meniscus Tear, Tibial</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Weight-Bearing CT arthrography</intervention_name>
    <description>A 20ml mixture of 5ml 0.5% ropivacaine, 5ml preservative-free sterile saline, and 10ml of non-ionic iodinated contrast media (e.g. iohexol 240) will be instilled into the knee joint of each patient prior to WBCTa imaging of the knee (LineUp, CurveBeam, LLC).</description>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Knee MRI</intervention_name>
    <description>MRI will be acquired (in-plane 0.25mm x 0.25mm, and 1.00mm slab thickness/separation and In-plane 0.25mm x 0.25mm, and 2.00mm slab thickness/separation)</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Participants will be recruited from orthopedic clinics as well as other musculoskeletal&#xD;
        clinics that request knee MRI. Special efforts will be made to recruit the majority from&#xD;
        orthopedic sports medicine clinical practices to include patients who are scheduled for&#xD;
        arthroscopic meniscal repair of full-thickness radial tears of the posterior horn or body&#xD;
        or root tears of the posterior horn after clinical MRI. There will be no exclusions based&#xD;
        on sex or ethnic group.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female over 18 years of age with a knee MRI acquired in the previous 10 days&#xD;
             to evaluate for suspected meniscal or cartilage pathology.&#xD;
&#xD;
          -  Body mass index (BMI) ≤ 45 kg/m2&#xD;
&#xD;
          -  Ability to stand with support without moving for at least 2 minutes.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  End stage kidney disease&#xD;
&#xD;
          -  Allergic to iodinated contrast material.&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Skin breakdown or rash at the knee joint which would prevent injection of the&#xD;
             contrast.&#xD;
&#xD;
          -  Any clinically significant degree of cognitive impairment or other condition, finding,&#xD;
             or psychiatric illness at screening which, in the opinion of the investigator, affects&#xD;
             their ability to ambulate to a sufficient degree and could compromise patient safety&#xD;
             or interfere with the assessment of the safety of the study injection.&#xD;
&#xD;
          -  Superficial or deep infection in or around the index knee joint or allergy to&#xD;
             iodinated contrast media.&#xD;
&#xD;
          -  History of inflammatory arthritis, meniscectomy, or end-stage OA&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Neil A Segal, MD, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Kansas Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jeannine Nilges, MD</last_name>
    <phone>913-574-0961</phone>
    <email>jnilges@kumc.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Mairenn Mancina, BS</last_name>
    <phone>913-574-0949</phone>
    <email>m268m752@kumc.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of Kansas Medical Center</name>
      <address>
        <city>Kansas City</city>
        <state>Kansas</state>
        <zip>66160</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jennifer Bedard, BA, CCRC</last_name>
      <phone>913-574-0961</phone>
      <email>jbedard@kumc.edu</email>
    </contact>
    <investigator>
      <last_name>Neil Segal, MD, MS</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>May 26, 2020</study_first_submitted>
  <study_first_submitted_qc>June 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 12, 2020</study_first_posted>
  <last_update_submitted>May 15, 2023</last_update_submitted>
  <last_update_submitted_qc>May 15, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 17, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Kansas Medical Center</investigator_affiliation>
    <investigator_full_name>Neil Segal, MD, MS</investigator_full_name>
    <investigator_title>Director of Clinical Research</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tibial Meniscus Injuries</mesh_term>
  </condition_browse>
  <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/NCT04430829
org study id: STUDY00145012
nct id: NCT04430829
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
This observational study will compare the clinical value of weight-bearing CT arthrography
      (WBCTa) with that for MRI in evaluating meniscal and cartilage lesions of the knee joint. The
      MRI Osteoarthritis Knee Score (MOAKS) and modified MOAKS for WBCTa will be used to compare
      findings between MRI and WBCTa of the knee while comparing with surgical measurements using
      the ICRS scoring system.

      The study hypothesis is that meniscal and cartilage lesions may be missed by
      non-weight-bearing MRI, but detected by WBCTa.
Study Objectives:

      Aim 1 Establish the accuracy of WBCTa and MRI for diagnosing knee cartilage and meniscal
      lesions in both surgical and non-surgical participants.

      Hypothesis 1: Pre-operative cartilage and meniscal scoring on WBCTa is more accurate than
      MRI, in comparison with arthroscopic assessment.

      Aim 2 Establish the accuracy of WBCTa for detecting persistent and recurrent meniscal root
      and radial tears not detected by MRI 6 months after meniscal repair (defined by diastasis of
      the repair or meniscal extrusion ≥3mm).

      Hypothesis 2: Six months following meniscal repair, WBCTa detects persistent and recurrent
      meniscal root and radial re-tears not detected by MRI.

      Study Type and Design: This cross-sectional, observational study will compare WBCTa with MRI
      to evaluate rate of detection of meniscal and cartilage lesions. The inter-rater reliability
      of WBCTa readings also will be assessed.
observational model: Other
time perspective: Other
measure: To determine the agreement between weight-bearing CT arthrography (WBCTa) and MRI in evaluation of meniscal tears.
time frame: Baseline
description: Pre-operative cartilage lesion scoring of meniscal lesions on WBCTa (modified MOAKS score) and MRI (modified MOAKS score) will be compared with arthroscopic visual MOAKS scoring of meniscal lesions.
measure: To determine the agreement between weight-bearing CT arthrography and MRI in evaluation of cartilage lesions.
time frame: Baseline
description: Musculoskeletal radiologists, each with greater than 10 years of experience will assess the morphology of the medial and lateral tibiofemoral cartilage on MRI and WBCTa using the MOAKS scoring system. Area of cartilage damage per subregion will be graded according to the MOAKS classification from 0-3: 0= no cartilage damage, 1=cartilage damage involving <10% of the subregion area, 2= cartilage damage involving 10%-75% of the subregion area and 3=cartilage damage involving >75% of the subregion area. The scores will be compared by dichotomizing into lesion present/absent (primary) and also compared using the full ranges of ordinal scores.
measure: To determine the extent to which WBCTa identifies meniscal re-tears or failed repairs 6 months following meniscal root or radial tear surgical repairs
time frame: 6 months
description: Participants who undergo a meniscal repair for radial meniscal tears and posterior root tears will undergo 6-month post-operative MRI and WBCTa and each of these 2 imaging modalities will be assessed for visualization of the presence or absence of a meniscal tear..
intervention type: Diagnostic Test
intervention name: Weight-Bearing CT arthrography
description: A 20ml mixture of 5ml 0.5% ropivacaine, 5ml preservative-free sterile saline, and 10ml of non-ionic iodinated contrast media (e.g. iohexol 240) will be instilled into the knee joint of each patient prior to WBCTa imaging of the knee (LineUp, CurveBeam, LLC).
intervention type: Diagnostic Test
intervention name: Knee MRI
description: MRI will be acquired (in-plane 0.25mm x 0.25mm, and 1.00mm slab thickness/separation and In-plane 0.25mm x 0.25mm, and 2.00mm slab thickness/separation)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Neil A Segal, MD, MS
role: Principal Investigator
affiliation: University of Kansas Medical Center
last name: Jeannine Nilges, MD
phone: 913-574-0961
email: jnilges@kumc.edu
last name: Mairenn Mancina, BS
phone: 913-574-0949
email: m268m752@kumc.edu
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Kansas Medical Center
investigator full name: Neil Segal, MD, MS
investigator title: Director of Clinical Research
mesh term: Tibial Meniscus Injuries
sharing ipd: Undecided