<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/NCT01677416</url>
  </required_header>
  <id_info>
    <org_study_id>UNIFESP/2011</org_study_id>
    <nct_id>NCT01677416</nct_id>
  </id_info>
  <brief_title>Joint Ultrasound Evaluation of Asymptomatic Rheumatic Feet</brief_title>
  <official_title>Joint Ultrasound Evaluation of Asymptomatic Feet in Patients With Rheumatoid Arthritis: A Controlled Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Federal University of São Paulo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Federal University of São Paulo</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Objectives: The aims of the present study were to compare ultrasound on asymptomatic feet of&#xD;
      patients with rheumatoid arthritis (RA) and normal controls, determine the association&#xD;
      between ultrasound and global disease activity, function and goniometric measures in patients&#xD;
      with RA and determine the correlation between ultrasound and radiography in the detection of&#xD;
      bone erosion.&#xD;
&#xD;
      Methods: The foot joints (talocrural, talocalcaneal, talonavicular, naviculocuneiform,&#xD;
      calcaneocuboid, 5th tarsometatarsal and 1st to 5th metatarsophalangeal [MTP] joints) of 50&#xD;
      healthy subjects and 50 patients with RA (all with asymptomatic feet) were evaluated&#xD;
      bilaterally regarding quantitative/semi-quantitative synovitis, semi-quantitative Power&#xD;
      Doppler (PD) signals and erosion using ultrasound. Statistical significance was set to 5%.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2011</start_date>
  <completion_date type="Actual">March 2012</completion_date>
  <primary_completion_date type="Actual">March 2012</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Presence of synovial effusion and/or synovial hypertrophy</measure>
    <time_frame>Baseline</time_frame>
    <description>Ultrasound evaluation - quantitative measurement considered the distance between the joint capsule and subchondral bone of the joints studied (talocrural, talocalcaneal (medial, lateral and posterior windows); dorsal face of calcaneocuboid, talonavicular, medial naviculocuneiform, 5th tarsometatarsal and metatarsophalangeal (MTP) (dorsal and volar faces of 1st to 5th MTP joints and lateral face of 1st and 5th MTP joints). A modified score was used for the semi-quantitative measurement, ranging from 0 to 3: 0-no synovial thickening; 1-minimal synovial thickening in joint recess; 2-synovial thickening in entire joint recess causing bulging of joint capsule; and 3-synovial thickening in joint recess with bulging of joint capsule and extending to at least one bone diaphysis. &quot;Presence of synovitis&quot; was defined as synovial hypertrophy of at least Grade 1 in the semi-quantitative analysis (gray scale - ultrasound)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Presence of bone erosion</measure>
    <time_frame>Baseline</time_frame>
    <description>defined based on the preliminary OMERACT criteria: intra-articular discontinuity of the bone surface observed on two perpendicular planes. A previously established semi-quantitative score (0-3) was employed: 0-uniform bone surface; 1-irregular bone surface; 2-bone surface defect on two planes; 3-bone defect causing extensive bone destruction. The &quot;presence of erosion&quot; was defined as the presence of at least Grade 2 erosion.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Radiographic evaluation</measure>
    <time_frame>Baseline</time_frame>
    <description>A blinded radiologist analysed the presence of erosion in each joint studied. For such, ankle (AP and profile) and foot (AP and profile with load) radiographs were taken.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intraobserver and interobserver agreement</measure>
    <time_frame>Baseline</time_frame>
    <description>The patients with RA were submitted to clinical and ultrasound evaluations of the feet and ankles on the same day. The ultrasound measurements intraobserver/interobserver agreement was performed on the talocrural, talonavicular and 5th MTP joints, using 20% of the sample. For this, the ultrasound exams were performed by another rheumatologist.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Presence of synovial blood flow</measure>
    <time_frame>Baseline</time_frame>
    <description>The presence of Power Doppler (PD) signals was evaluated in the bone margins, joint spaces, and peri-articular tissues (frequency of 8 MHz and pulse repetition rate of 750 MHz). A semi-quantitative score (0-3) was employed[14]: 0-no signal; 1-minimal signal, presence of simple vessels; 2-moderate signal, presence of confluent vessels with signal in less than 50% of the area evaluated; 3-intense signal (more than 50% of area evaluated). &quot;Active synovitis&quot; or &quot;presence of PD signal&quot; was defined as the presence of intra-articular synovitis with a positive PD signal (at least Grade 1).</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">100</enrollment>
  <condition>Rheumatoid Arthritis</condition>
  <arm_group>
    <arm_group_label>Rheumatoid Arthritis Group</arm_group_label>
    <description>RA with at least one year since diagnosis, asymptomatic feet, and age between 18 and 65 years</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <description>Absence of known osteoarticular disease</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Rheumatoid Arthritis&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Rheumatoid Arthritis Group:&#xD;
&#xD;
          -  RA with at least one year since diagnosis&#xD;
&#xD;
          -  Asymptomatic feet&#xD;
&#xD;
          -  Age between 18 and 65 years Control group&#xD;
&#xD;
          -  absence of known osteoarticular disease&#xD;
&#xD;
        Exclusion Criteria for both groups:&#xD;
&#xD;
          -  Peripheral venous insufficiency with retrograde venous flow and/or ochre dermatitis&#xD;
&#xD;
          -  Previous surgical intervention and/or fracture in feet/ankles&#xD;
&#xD;
          -  Intra-articular corticosteroid injection in previous three months in any of the joints&#xD;
             evaluated&#xD;
&#xD;
          -  Foot neuropathy&#xD;
&#xD;
          -  Pain and swelling in feet or ankles&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rita Furtado, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Federal University of São Paulo</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Universidade Federal de Sao Paulo</name>
      <address>
        <city>Sao Paulo</city>
        <state>SP - Sao Paulo</state>
        <zip>04023-062</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 27, 2012</study_first_submitted>
  <study_first_submitted_qc>August 29, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 3, 2012</study_first_posted>
  <last_update_submitted>August 29, 2012</last_update_submitted>
  <last_update_submitted_qc>August 29, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 3, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Federal University of São Paulo</investigator_affiliation>
    <investigator_full_name>Anamaria Jones</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Rheumatoid arthritis</keyword>
  <keyword>Ultrasonography</keyword>
  <keyword>Synovitis</keyword>
  <keyword>Foot joints</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthritis</mesh_term>
    <mesh_term>Arthritis, Rheumatoid</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/NCT01677416
org study id: UNIFESP/2011
nct id: NCT01677416
lead sponsor: 
has dmc: No
Objectives: The aims of the present study were to compare ultrasound on asymptomatic feet of
      patients with rheumatoid arthritis (RA) and normal controls, determine the association
      between ultrasound and global disease activity, function and goniometric measures in patients
      with RA and determine the correlation between ultrasound and radiography in the detection of
      bone erosion.

      Methods: The foot joints (talocrural, talocalcaneal, talonavicular, naviculocuneiform,
      calcaneocuboid, 5th tarsometatarsal and 1st to 5th metatarsophalangeal [MTP] joints) of 50
      healthy subjects and 50 patients with RA (all with asymptomatic feet) were evaluated
      bilaterally regarding quantitative/semi-quantitative synovitis, semi-quantitative Power
      Doppler (PD) signals and erosion using ultrasound. Statistical significance was set to 5%.
time perspective: Cross-Sectional
measure: Presence of synovial effusion and/or synovial hypertrophy
time frame: Baseline
description: Ultrasound evaluation - quantitative measurement considered the distance between the joint capsule and subchondral bone of the joints studied (talocrural, talocalcaneal (medial, lateral and posterior windows); dorsal face of calcaneocuboid, talonavicular, medial naviculocuneiform, 5th tarsometatarsal and metatarsophalangeal (MTP) (dorsal and volar faces of 1st to 5th MTP joints and lateral face of 1st and 5th MTP joints). A modified score was used for the semi-quantitative measurement, ranging from 0 to 3: 0-no synovial thickening; 1-minimal synovial thickening in joint recess; 2-synovial thickening in entire joint recess causing bulging of joint capsule; and 3-synovial thickening in joint recess with bulging of joint capsule and extending to at least one bone diaphysis. "Presence of synovitis" was defined as synovial hypertrophy of at least Grade 1 in the semi-quantitative analysis (gray scale - ultrasound)
measure: Presence of bone erosion
time frame: Baseline
description: defined based on the preliminary OMERACT criteria: intra-articular discontinuity of the bone surface observed on two perpendicular planes. A previously established semi-quantitative score (0-3) was employed: 0-uniform bone surface; 1-irregular bone surface; 2-bone surface defect on two planes; 3-bone defect causing extensive bone destruction. The "presence of erosion" was defined as the presence of at least Grade 2 erosion.
measure: Radiographic evaluation
time frame: Baseline
description: A blinded radiologist analysed the presence of erosion in each joint studied. For such, ankle (AP and profile) and foot (AP and profile with load) radiographs were taken.
measure: Intraobserver and interobserver agreement
time frame: Baseline
description: The patients with RA were submitted to clinical and ultrasound evaluations of the feet and ankles on the same day. The ultrasound measurements intraobserver/interobserver agreement was performed on the talocrural, talonavicular and 5th MTP joints, using 20% of the sample. For this, the ultrasound exams were performed by another rheumatologist.
measure: Presence of synovial blood flow
time frame: Baseline
description: The presence of Power Doppler (PD) signals was evaluated in the bone margins, joint spaces, and peri-articular tissues (frequency of 8 MHz and pulse repetition rate of 750 MHz). A semi-quantitative score (0-3) was employed[14]: 0-no signal; 1-minimal signal, presence of simple vessels; 2-moderate signal, presence of confluent vessels with signal in less than 50% of the area evaluated; 3-intense signal (more than 50% of area evaluated). "Active synovitis" or "presence of PD signal" was defined as the presence of intra-articular synovitis with a positive PD signal (at least Grade 1).
arm group label: Rheumatoid Arthritis Group
description: RA with at least one year since diagnosis, asymptomatic feet, and age between 18 and 65 years
arm group label: Control group
description: Absence of known osteoarticular disease
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Rita Furtado, MD
role: Principal Investigator
affiliation: Federal University of São Paulo
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Federal University of São Paulo
investigator full name: Anamaria Jones
investigator title: Principal Investigator
mesh term: Arthritis
mesh term: Arthritis, Rheumatoid