<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/NCT03294408</url>
  </required_header>
  <id_info>
    <org_study_id>CHRO-2016-01</org_study_id>
    <secondary_id>2016-A00552-49</secondary_id>
    <nct_id>NCT03294408</nct_id>
  </id_info>
  <brief_title>Multimodal Imaging of Subchondral Bone in Knee Osteoarthritis : Predictive Model</brief_title>
  <acronym>MOSART</acronym>
  <official_title>Capacity of Multimodal Imaging of Subchondral Bone for the Prediction of Structural Evolution in Knee Osteoarthritis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Régional d'Orléans</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Nancy</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Centre Hospitalier Régional d'Orléans</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>
      Predictive factors of osteoarthritis progression are not yet well understood. However, a&#xD;
      growing role attaches importance to the subchondral bone. The aim of the present project is&#xD;
      to determine predictive factors of progression of osteoarthritis at the knee by a multimodal&#xD;
      characterization of subchondral bone by Medical Resonnance Imaging, direct high resolution&#xD;
      digitization radiographs and bone texture analysis. At the end of the project, an innovative&#xD;
      imaging device, combining semi-automatic softwares for texture analysis, control detection&#xD;
      and image registration would be supplied. This will enable on the one hand a more accurate&#xD;
      and reproducible way to measure the joint space width of the affected compartment and on the&#xD;
      other hand, an assistance to better detect patients at risk of progression of their knee&#xD;
      osteoarthritis. Identifying These &quot;progressors&quot; patients might permit their selection in&#xD;
      clinical trials at baseline adapted to their severe disease, using for example biologic&#xD;
      treatments targeting knee osteoarthritis. The main objective of this study is to analyze the&#xD;
      predictive capacities of bone texture parameters measured on the high-resolution radiography&#xD;
      of the knee on the structural evolution of the knee osteoarthritis at 3 years.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 29, 2016</start_date>
  <completion_date type="Anticipated">November 28, 2023</completion_date>
  <primary_completion_date type="Anticipated">November 28, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Interventional study among patients suffering from knee osteoarthritis for at least six months. All the patients will benefit from a multimodal imaging and clinical assessment.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of patients who have one-point increase in the quality score of OARSI</measure>
    <time_frame>3 years</time_frame>
    <description>Patients who over the 3-year follow-up period will have a one-point increase in the quality score of OARSI compared to the initial pinch score (Altman RD et al, Osteoarthritis and Cartilage 1995).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Proportion of patients whose joint space reduction is greater than the smallest reliable detectable difference.</measure>
    <time_frame>3 years</time_frame>
    <description>Patients whose joint space reduction is greater than the smallest reliable detectable difference.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Proportion of patients who have a decrease in joint space of 0.5 mm</measure>
    <time_frame>3 years</time_frame>
    <description>Patients who have a decrease in joint space of 0.5 mm or more over the 3-year period (Cooper C et al, CMRO 2012).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients who have evolution of medial femoral tibial joint space</measure>
    <time_frame>3 years</time_frame>
    <description>Evolution of medial femoral-tibial joint space</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of particpants who will have evolution of strucutral lesion score</measure>
    <time_frame>3 years</time_frame>
    <description>Evolution structural lesion score is OARSI (OsteoArthritis Research Society International score)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evolution of algo-functional scores (OAKHQOL)</measure>
    <time_frame>3 years</time_frame>
    <description>OAKHQOL (OsteoArthritis of Knee and Hip Quality Of Life) scores</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evolution of algo-functional scores (WOMAC)</measure>
    <time_frame>3 years</time_frame>
    <description>WOMAC (McMaster Western Ontario questionnaire ) scores</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in quality of life Scores</measure>
    <time_frame>3 years</time_frame>
    <description>Short Form 36</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Pain Scores on the Visual Analog Scale</measure>
    <time_frame>3 years</time_frame>
    <description>Pain visual analogical score</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">425</enrollment>
  <condition>Knee Osteoarthritis</condition>
  <condition>Joint Disease</condition>
  <condition>Arthritis</condition>
  <condition>Musculoskeletal Disease</condition>
  <arm_group>
    <arm_group_label>Imaging</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>multimodal imaging and clinical assessment</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>multimodal imaging</intervention_name>
    <arm_group_label>Imaging</arm_group_label>
    <other_name>clinical assessment</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  knee osteoarthritis according to the criteria of knee osteoarthritis of American&#xD;
             College of Rheumatology.&#xD;
&#xD;
          -  Having felt a painful push in the last 6 months.&#xD;
&#xD;
          -  Visual Analogic Scale pain &gt; 4 on a 0 to 10 scale.&#xD;
&#xD;
          -  having a Radiographic score of OARSI (Osteoarthritis Research Society International&#xD;
             Score) from 2 to 3 whether it is for the presence of a joint space narrowing or the&#xD;
             presence of an osteophyte&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patello-femoral degenerative osteoarthritis isolated.&#xD;
&#xD;
          -  Incapacitated to consider the position in schuss for the realization of the&#xD;
             radiography.&#xD;
&#xD;
          -  Valgus &gt; in 5 °&#xD;
&#xD;
          -  Secondary degenerative osteoarthritis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eric LESPESSAILLES, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHR Orléans</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Aurélie DESPUJOLS</last_name>
    <phone>33 2 38 74 40 71</phone>
    <email>aurelie.despujols@chr-orleans.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Elodie TATSI TOTOUOM</last_name>
    <phone>33 2 38 74 40 86</phone>
    <email>elodie.tatsi-totouom@chr-orleans.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Chu Brabois</name>
      <address>
        <city>Nancy</city>
        <zip>54511</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Damien LOEUILLE, Pr</last_name>
      <phone>33 3 83 15 36 26</phone>
      <email>d.loeuille@chru-nancy.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHR Orléans</name>
      <address>
        <city>Orléans</city>
        <zip>45067</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Eric LESPESSAILLES, Dr</last_name>
      <phone>33 2 38 74 42 01</phone>
      <email>eric.lespessailles@chr-orleans.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <reference>
    <citation>Janvier T, Jennane R, Valery A, Harrar K, Delplanque M, Lelong C, Loeuille D, Toumi H, Lespessailles E. Subchondral tibial bone texture analysis predicts knee osteoarthritis progression: data from the Osteoarthritis Initiative: Tibial bone texture &amp; knee OA progression. Osteoarthritis Cartilage. 2017 Feb;25(2):259-266. doi: 10.1016/j.joca.2016.10.005. Epub 2016 Oct 11.</citation>
    <PMID>27742531</PMID>
  </reference>
  <reference>
    <citation>Arden N, Richette P, Cooper C, Bruyere O, Abadie E, Branco J, Brandi ML, Berenbaum F, Clerc C, Dennison E, Devogelaer JP, Hochberg M, D'Hooghe P, Herrero-Beaumont G, Kanis JA, Laslop A, Leblanc V, Maggi S, Mautone G, Pelletier JP, Petit-Dop F, Reiter-Niesert S, Rizzoli R, Rovati L, Tajana Messi E, Tsouderos Y, Martel-Pelletier J, Reginster JY. Can We Identify Patients with High Risk of Osteoarthritis Progression Who Will Respond to Treatment? A Focus on Biomarkers and Frailty. Drugs Aging. 2015 Jul;32(7):525-35. doi: 10.1007/s40266-015-0276-7.</citation>
    <PMID>26085027</PMID>
  </reference>
  <reference>
    <citation>Woloszynski T, Podsiadlo P, Stachowiak GW, Kurzynski M, Lohmander LS, Englund M. Prediction of progression of radiographic knee osteoarthritis using tibial trabecular bone texture. Arthritis Rheum. 2012 Mar;64(3):688-95. doi: 10.1002/art.33410.</citation>
    <PMID>21989629</PMID>
  </reference>
  <reference>
    <citation>Guermazi A, Roemer FW, Felson DT, Brandt KD. Motion for debate: osteoarthritis clinical trials have not identified efficacious therapies because traditional imaging outcome measures are inadequate. Arthritis Rheum. 2013 Nov;65(11):2748-58. doi: 10.1002/art.38086. No abstract available.</citation>
    <PMID>23861096</PMID>
  </reference>
  <reference>
    <citation>Kraus VB, Feng S, Wang S, White S, Ainslie M, Brett A, Holmes A, Charles HC. Trabecular morphometry by fractal signature analysis is a novel marker of osteoarthritis progression. Arthritis Rheum. 2009 Dec;60(12):3711-22. doi: 10.1002/art.25012.</citation>
    <PMID>19950282</PMID>
  </reference>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>July 4, 2017</study_first_submitted>
  <study_first_submitted_qc>September 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 27, 2017</study_first_posted>
  <last_update_submitted>February 16, 2023</last_update_submitted>
  <last_update_submitted_qc>February 16, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 17, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>fractal analysis</keyword>
  <keyword>trabecular bone texture</keyword>
  <keyword>knee osteoarthritis</keyword>
  <keyword>subchondral bone</keyword>
  <keyword>Medical Resonnance Imaging</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
    <mesh_term>Osteoarthritis, Knee</mesh_term>
    <mesh_term>Joint Diseases</mesh_term>
    <mesh_term>Musculoskeletal Diseases</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/NCT03294408
org study id: CHRO-2016-01
secondary id: 2016-A00552-49
nct id: NCT03294408
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Predictive factors of osteoarthritis progression are not yet well understood. However, a
      growing role attaches importance to the subchondral bone. The aim of the present project is
      to determine predictive factors of progression of osteoarthritis at the knee by a multimodal
      characterization of subchondral bone by Medical Resonnance Imaging, direct high resolution
      digitization radiographs and bone texture analysis. At the end of the project, an innovative
      imaging device, combining semi-automatic softwares for texture analysis, control detection
      and image registration would be supplied. This will enable on the one hand a more accurate
      and reproducible way to measure the joint space width of the affected compartment and on the
      other hand, an assistance to better detect patients at risk of progression of their knee
      osteoarthritis. Identifying These "progressors" patients might permit their selection in
      clinical trials at baseline adapted to their severe disease, using for example biologic
      treatments targeting knee osteoarthritis. The main objective of this study is to analyze the
      predictive capacities of bone texture parameters measured on the high-resolution radiography
      of the knee on the structural evolution of the knee osteoarthritis at 3 years.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Interventional study among patients suffering from knee osteoarthritis for at least six months. All the patients will benefit from a multimodal imaging and clinical assessment.
primary purpose: Prevention
masking: None (Open Label)
measure: Proportion of patients who have one-point increase in the quality score of OARSI
time frame: 3 years
description: Patients who over the 3-year follow-up period will have a one-point increase in the quality score of OARSI compared to the initial pinch score (Altman RD et al, Osteoarthritis and Cartilage 1995).
measure: Proportion of patients whose joint space reduction is greater than the smallest reliable detectable difference.
time frame: 3 years
description: Patients whose joint space reduction is greater than the smallest reliable detectable difference.
measure: Proportion of patients who have a decrease in joint space of 0.5 mm
time frame: 3 years
description: Patients who have a decrease in joint space of 0.5 mm or more over the 3-year period (Cooper C et al, CMRO 2012).
measure: Proportion of patients who have evolution of medial femoral tibial joint space
time frame: 3 years
description: Evolution of medial femoral-tibial joint space
measure: Number of particpants who will have evolution of strucutral lesion score
time frame: 3 years
description: Evolution structural lesion score is OARSI (OsteoArthritis Research Society International score)
measure: Evolution of algo-functional scores (OAKHQOL)
time frame: 3 years
description: OAKHQOL (OsteoArthritis of Knee and Hip Quality Of Life) scores
measure: Evolution of algo-functional scores (WOMAC)
time frame: 3 years
description: WOMAC (McMaster Western Ontario questionnaire ) scores
measure: Change From Baseline in quality of life Scores
time frame: 3 years
description: Short Form 36
measure: Change From Baseline in Pain Scores on the Visual Analog Scale
time frame: 3 years
description: Pain visual analogical score
arm group label: Imaging
arm group type: Other
description: multimodal imaging and clinical assessment
intervention type: Diagnostic Test
intervention name: multimodal imaging
arm group label: Imaging
other name: clinical assessment
criteria: 
gender: All
minimum age: 45 Years
maximum age: 80 Years
healthy volunteers: No
last name: Eric LESPESSAILLES, Dr
role: Principal Investigator
affiliation: CHR Orléans
last name: Aurélie DESPUJOLS
phone: 33 2 38 74 40 71
email: aurelie.despujols@chr-orleans.fr
last name: Elodie TATSI TOTOUOM
phone: 33 2 38 74 40 86
email: elodie.tatsi-totouom@chr-orleans.fr
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: France
citation: Janvier T, Jennane R, Valery A, Harrar K, Delplanque M, Lelong C, Loeuille D, Toumi H, Lespessailles E. Subchondral tibial bone texture analysis predicts knee osteoarthritis progression: data from the Osteoarthritis Initiative: Tibial bone texture & knee OA progression. Osteoarthritis Cartilage. 2017 Feb;25(2):259-266. doi: 10.1016/j.joca.2016.10.005. Epub 2016 Oct 11.
PMID: 27742531
citation: Arden N, Richette P, Cooper C, Bruyere O, Abadie E, Branco J, Brandi ML, Berenbaum F, Clerc C, Dennison E, Devogelaer JP, Hochberg M, D'Hooghe P, Herrero-Beaumont G, Kanis JA, Laslop A, Leblanc V, Maggi S, Mautone G, Pelletier JP, Petit-Dop F, Reiter-Niesert S, Rizzoli R, Rovati L, Tajana Messi E, Tsouderos Y, Martel-Pelletier J, Reginster JY. Can We Identify Patients with High Risk of Osteoarthritis Progression Who Will Respond to Treatment? A Focus on Biomarkers and Frailty. Drugs Aging. 2015 Jul;32(7):525-35. doi: 10.1007/s40266-015-0276-7.
PMID: 26085027
citation: Woloszynski T, Podsiadlo P, Stachowiak GW, Kurzynski M, Lohmander LS, Englund M. Prediction of progression of radiographic knee osteoarthritis using tibial trabecular bone texture. Arthritis Rheum. 2012 Mar;64(3):688-95. doi: 10.1002/art.33410.
PMID: 21989629
citation: Guermazi A, Roemer FW, Felson DT, Brandt KD. Motion for debate: osteoarthritis clinical trials have not identified efficacious therapies because traditional imaging outcome measures are inadequate. Arthritis Rheum. 2013 Nov;65(11):2748-58. doi: 10.1002/art.38086. No abstract available.
PMID: 23861096
citation: Kraus VB, Feng S, Wang S, White S, Ainslie M, Brett A, Holmes A, Charles HC. Trabecular morphometry by fractal signature analysis is a novel marker of osteoarthritis progression. Arthritis Rheum. 2009 Dec;60(12):3711-22. doi: 10.1002/art.25012.
PMID: 19950282
responsible party type: Sponsor
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee
mesh term: Joint Diseases
mesh term: Musculoskeletal Diseases
sharing ipd: No