<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/NCT03011112</url>
  </required_header>
  <id_info>
    <org_study_id>GuangzhouGH003</org_study_id>
    <nct_id>NCT03011112</nct_id>
  </id_info>
  <brief_title>Can 3D Kinematic Parameters Assess the Symptomatic and Functional Severity of KOA?</brief_title>
  <official_title>Can Three Dimensional Kinematic Parameters Assess the Symptomatic and Functional Severity of Medial Knee Osteoarthritis?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Guangzhou General Hospital of Guangzhou Military Command</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Medical Center of Assessment, Prevention and Treatment of Bone &amp; Joint Diseases, Guangdong, China</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The First Affiliated Hospital of Guangzhou Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Guangzhou General Hospital of Guangzhou Military Command</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      There is little study focusing on kinematic parameters in the assessment of the symptomatic&#xD;
      and functional severity of knee osteoarthritis (KOA). The purpose of this study is to&#xD;
      evaluate the correlations between kinematic parameters and the severity of symptoms and&#xD;
      functions in patients with KOA.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2, 2017</start_date>
  <completion_date type="Actual">February 28, 2017</completion_date>
  <primary_completion_date type="Actual">February 20, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Knee flexion/extension angle at initial contact during gait.</measure>
    <time_frame>1 Day</time_frame>
    <description>The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Knee internal/external rotation angle at initial contact during gait.</measure>
    <time_frame>1 Day</time_frame>
    <description>The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Knee adduction/abduction angle at initial contact during gait.</measure>
    <time_frame>1 Day</time_frame>
    <description>The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>knee anterior/posterior translation at initial contact during gait.</measure>
    <time_frame>1 Day</time_frame>
    <description>The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Knee medial/lateral translation at initial contact during gait.</measure>
    <time_frame>1 Day</time_frame>
    <description>The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Knee proximal/distal translation at initial contact during gait.</measure>
    <time_frame>1 Day</time_frame>
    <description>The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>WOMAC</measure>
    <time_frame>1 Day</time_frame>
    <description>The Western Ontario and McMaster Universities Osteoarthritis Index</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Kellgren/Lawrence Score</measure>
    <time_frame>1 Day</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Knee flexion/extension angle at opposite toe off during gait.</measure>
    <time_frame>1 Day</time_frame>
    <description>The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Knee internal/external rotation angle at opposite toe off during gait.</measure>
    <time_frame>1 Day</time_frame>
    <description>The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Knee adduction/abduction angle at opposite toe off during gait.</measure>
    <time_frame>1 Day</time_frame>
    <description>The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Knee anterior/posterior translation at opposite toe off during gait.</measure>
    <time_frame>1 Day</time_frame>
    <description>The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Knee distal/proximal translation at opposite toe off during gait.</measure>
    <time_frame>1 Day</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Knee medial/lateral translation at opposite toe off during gait.</measure>
    <time_frame>1 Day</time_frame>
    <description>The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Knee flexion/extension angle at heel rise during gait.</measure>
    <time_frame>1 Day</time_frame>
    <description>The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Knee internal/external rotation angle at heel rise during gait.</measure>
    <time_frame>1 Day</time_frame>
    <description>The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Knee adduction/abduction angle at heel rise during gait.</measure>
    <time_frame>1 Day</time_frame>
    <description>The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Knee anterior/posterior translation at heel rise during gait.</measure>
    <time_frame>1 Day</time_frame>
    <description>The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Knee distal/proximal translation at heel rise during gait.</measure>
    <time_frame>1 Day</time_frame>
    <description>The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Knee medial/lateral translation at heel rise during gait.</measure>
    <time_frame>1 Day</time_frame>
    <description>The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Knee flexion/extension angle at opposite initial contact during gait.</measure>
    <time_frame>1 Day</time_frame>
    <description>The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Knee internal/external angle at opposite initial contact during gait.</measure>
    <time_frame>1 Day</time_frame>
    <description>The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Knee adduction/abduction angle at opposite initial contact during gait.</measure>
    <time_frame>1 Day</time_frame>
    <description>The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Knee anterior/posterior translation at opposite initial contact during gait.</measure>
    <time_frame>1 Day</time_frame>
    <description>The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Knee distal/proximal translation at opposite initial contact during gait.</measure>
    <time_frame>1 Day</time_frame>
    <description>The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Knee medial/lateral translation at opposite initial contact during gait.</measure>
    <time_frame>1 Day</time_frame>
    <description>The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Knee flexion/extension angle at toe off during gait.</measure>
    <time_frame>1 Day</time_frame>
    <description>The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Knee adduction/abduction angle at toe off during gait.</measure>
    <time_frame>1 Day</time_frame>
    <description>The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Knee internal/external rotation angle at toe off during gait.</measure>
    <time_frame>1 Day</time_frame>
    <description>The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Knee anterior/posterior translation at toe off during gait.</measure>
    <time_frame>1 Day</time_frame>
    <description>The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Knee distal/proximal translation at toe off during gait.</measure>
    <time_frame>1 Day</time_frame>
    <description>The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Knee medial/lateral translation at toe off during gait.</measure>
    <time_frame>1 Day</time_frame>
    <description>The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Knee flexion/extension angle at feet adjacent during gait.</measure>
    <time_frame>1 Day</time_frame>
    <description>The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Knee internal/external rotation angle at feet adjacent during gait.</measure>
    <time_frame>1 Day</time_frame>
    <description>The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Knee adduction/abduction angle at feet adjacent during gait.</measure>
    <time_frame>1 Day</time_frame>
    <description>The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Knee anterior/posterior translation at feet adjacent during gait.</measure>
    <time_frame>1 Day</time_frame>
    <description>The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Knee distal/proximal translation at feet adjacent during gait.</measure>
    <time_frame>1 Day</time_frame>
    <description>The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Knee medial/lateral translation at feet adjacent during gait.</measure>
    <time_frame>1 Day</time_frame>
    <description>The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Knee flexion/extension angle at tibia vertical during gait.</measure>
    <time_frame>1 Day</time_frame>
    <description>The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Knee adduction/abduction angle at tibia vertical during gait.</measure>
    <time_frame>1 Day</time_frame>
    <description>The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Knee internal/external rotation angle at tibia vertical during gait.</measure>
    <time_frame>1 Day</time_frame>
    <description>The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Knee anterior/posterior translation at tibia vertical during gait.</measure>
    <time_frame>1 Day</time_frame>
    <description>The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Knee distal/proximal translation at tibia vertical during gait.</measure>
    <time_frame>1 Day</time_frame>
    <description>The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Knee medial/lateral translation at tibia vertical during gait.</measure>
    <time_frame>1 Day</time_frame>
    <description>The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Range of motion of knee flexion/extension angle.</measure>
    <time_frame>1 Day</time_frame>
    <description>The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Range of motion of knee internal/external rotation angle.</measure>
    <time_frame>1 Day</time_frame>
    <description>The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Range of motion of knee adduction/abduction angle.</measure>
    <time_frame>1 Day</time_frame>
    <description>The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Range of motion of knee anterior/posterior translation.</measure>
    <time_frame>1 Day</time_frame>
    <description>The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Range of motion of knee distal/proximal translation.</measure>
    <time_frame>1 Day</time_frame>
    <description>The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Range of motion of knee medial/lateral translation.</measure>
    <time_frame>1 Day</time_frame>
    <description>The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.</description>
  </primary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Actual">186</enrollment>
  <condition>Osteoarthritis,Knee</condition>
  <arm_group>
    <arm_group_label>KL 1</arm_group_label>
    <description>All patients (&gt;50 years) are classified to be Kellgrence/Lawrence grade 1 according to Kellgrence/Lawrence score.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>KL 2</arm_group_label>
    <description>All patients (&gt;50 years) are classified to be Kellgrence/Lawrence grade 2 according to Kellgrence/Lawrence score.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>KL 3</arm_group_label>
    <description>All patients (&gt;50 years) are classified to be Kellgrence/Lawrence grade 3 according to Kellgrence/Lawrence score.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>KL 4</arm_group_label>
    <description>All patients (&gt;50 years) are classified to be Kellgrence/Lawrence grade 4 according to Kellgrence/Lawrence score.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Observational procedure</intervention_name>
    <description>All the patients will undergo a standard observational procedure: i) diagnosed with KOA; ii) take a radiographic examination (x-ray); iii) assessed by WOMAC; iv) take an physical examination to avoid other disease; iv) take a gait examination on a treadmill in barefoot.</description>
    <arm_group_label>KL 1</arm_group_label>
    <arm_group_label>KL 2</arm_group_label>
    <arm_group_label>KL 3</arm_group_label>
    <arm_group_label>KL 4</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All the patients diagnosed with KOA will be recruited via hospital advertisements in this&#xD;
        study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. age&gt; 50 years&#xD;
&#xD;
          2. body mass index&lt;30;&#xD;
&#xD;
          3. confirmed radiographically and assessed according to KL score;&#xD;
&#xD;
          4. knee pain in their knees at least three months;&#xD;
&#xD;
          5. absolute medial compartment KOA according to atlas criteria13;&#xD;
&#xD;
          6. able to walk unaided&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. history of knee surgery;&#xD;
&#xD;
          2. Corticosteroid or Sodium Hyaluronate injection within 6 months;&#xD;
&#xD;
          3. neuropathic arthropathy or rheumatoid arthritis;&#xD;
&#xD;
          4. any other muscular or neurological diseases that affected the condition of the lower&#xD;
             limbs;&#xD;
&#xD;
          5. any treatments or training (e.g. kneepad) to improve the symptoms of KOA;&#xD;
&#xD;
          6. history of foot/ankle/hip injury or disease;&#xD;
&#xD;
          7. unable to walk independently;&#xD;
&#xD;
          8. history of heart disease;&#xD;
&#xD;
          9. lateral KOA according to atlas criteria13;&#xD;
&#xD;
         10. body mass index&gt; 30;&#xD;
&#xD;
         11. age&gt; 90 years;&#xD;
&#xD;
         12. unable to finish the procedure&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yu Zhang, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital of Orthopedics, Guangzhou General Hospital of Guangzhou Military Command, 111 Liuhua Road, Guangzhou 510010, China</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital of Orthopedics, Guangzhou General Hospital of Guangzhou Military Command</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510010</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>January 3, 2017</study_first_submitted>
  <study_first_submitted_qc>January 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 5, 2017</study_first_posted>
  <last_update_submitted>March 1, 2017</last_update_submitted>
  <last_update_submitted_qc>March 1, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 3, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Guangzhou General Hospital of Guangzhou Military Command</investigator_affiliation>
    <investigator_full_name>Yu Zhang</investigator_full_name>
    <investigator_title>chief surgeon, associate professor</investigator_title>
  </responsible_party>
  <keyword>Osteoarthritis, Knee</keyword>
  <keyword>WOMAC</keyword>
  <keyword>gait</keyword>
  <keyword>kinematics</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>
  </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/NCT03011112
org study id: GuangzhouGH003
nct id: NCT03011112
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
There is little study focusing on kinematic parameters in the assessment of the symptomatic
      and functional severity of knee osteoarthritis (KOA). The purpose of this study is to
      evaluate the correlations between kinematic parameters and the severity of symptoms and
      functions in patients with KOA.
observational model: Case-Control
time perspective: Cross-Sectional
measure: Knee flexion/extension angle at initial contact during gait.
time frame: 1 Day
description: The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
measure: Knee internal/external rotation angle at initial contact during gait.
time frame: 1 Day
description: The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
measure: Knee adduction/abduction angle at initial contact during gait.
time frame: 1 Day
description: The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
measure: knee anterior/posterior translation at initial contact during gait.
time frame: 1 Day
description: The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
measure: Knee medial/lateral translation at initial contact during gait.
time frame: 1 Day
description: The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
measure: Knee proximal/distal translation at initial contact during gait.
time frame: 1 Day
description: The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
measure: WOMAC
time frame: 1 Day
description: The Western Ontario and McMaster Universities Osteoarthritis Index
measure: Kellgren/Lawrence Score
time frame: 1 Day
measure: Knee flexion/extension angle at opposite toe off during gait.
time frame: 1 Day
description: The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
measure: Knee internal/external rotation angle at opposite toe off during gait.
time frame: 1 Day
description: The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
measure: Knee adduction/abduction angle at opposite toe off during gait.
time frame: 1 Day
description: The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
measure: Knee anterior/posterior translation at opposite toe off during gait.
time frame: 1 Day
description: The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
measure: Knee distal/proximal translation at opposite toe off during gait.
time frame: 1 Day
measure: Knee medial/lateral translation at opposite toe off during gait.
time frame: 1 Day
description: The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
measure: Knee flexion/extension angle at heel rise during gait.
time frame: 1 Day
description: The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
measure: Knee internal/external rotation angle at heel rise during gait.
time frame: 1 Day
description: The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
measure: Knee adduction/abduction angle at heel rise during gait.
time frame: 1 Day
description: The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
measure: Knee anterior/posterior translation at heel rise during gait.
time frame: 1 Day
description: The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
measure: Knee distal/proximal translation at heel rise during gait.
time frame: 1 Day
description: The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
measure: Knee medial/lateral translation at heel rise during gait.
time frame: 1 Day
description: The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
measure: Knee flexion/extension angle at opposite initial contact during gait.
time frame: 1 Day
description: The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
measure: Knee internal/external angle at opposite initial contact during gait.
time frame: 1 Day
description: The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
measure: Knee adduction/abduction angle at opposite initial contact during gait.
time frame: 1 Day
description: The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
measure: Knee anterior/posterior translation at opposite initial contact during gait.
time frame: 1 Day
description: The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
measure: Knee distal/proximal translation at opposite initial contact during gait.
time frame: 1 Day
description: The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
measure: Knee medial/lateral translation at opposite initial contact during gait.
time frame: 1 Day
description: The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
measure: Knee flexion/extension angle at toe off during gait.
time frame: 1 Day
description: The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
measure: Knee adduction/abduction angle at toe off during gait.
time frame: 1 Day
description: The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
measure: Knee internal/external rotation angle at toe off during gait.
time frame: 1 Day
description: The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
measure: Knee anterior/posterior translation at toe off during gait.
time frame: 1 Day
description: The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
measure: Knee distal/proximal translation at toe off during gait.
time frame: 1 Day
description: The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
measure: Knee medial/lateral translation at toe off during gait.
time frame: 1 Day
description: The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
measure: Knee flexion/extension angle at feet adjacent during gait.
time frame: 1 Day
description: The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
measure: Knee internal/external rotation angle at feet adjacent during gait.
time frame: 1 Day
description: The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
measure: Knee adduction/abduction angle at feet adjacent during gait.
time frame: 1 Day
description: The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
measure: Knee anterior/posterior translation at feet adjacent during gait.
time frame: 1 Day
description: The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
measure: Knee distal/proximal translation at feet adjacent during gait.
time frame: 1 Day
description: The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
measure: Knee medial/lateral translation at feet adjacent during gait.
time frame: 1 Day
description: The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
measure: Knee flexion/extension angle at tibia vertical during gait.
time frame: 1 Day
description: The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
measure: Knee adduction/abduction angle at tibia vertical during gait.
time frame: 1 Day
description: The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
measure: Knee internal/external rotation angle at tibia vertical during gait.
time frame: 1 Day
description: The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
measure: Knee anterior/posterior translation at tibia vertical during gait.
time frame: 1 Day
description: The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
measure: Knee distal/proximal translation at tibia vertical during gait.
time frame: 1 Day
description: The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
measure: Knee medial/lateral translation at tibia vertical during gait.
time frame: 1 Day
description: The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
measure: Range of motion of knee flexion/extension angle.
time frame: 1 Day
description: The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
measure: Range of motion of knee internal/external rotation angle.
time frame: 1 Day
description: The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
measure: Range of motion of knee adduction/abduction angle.
time frame: 1 Day
description: The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
measure: Range of motion of knee anterior/posterior translation.
time frame: 1 Day
description: The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
measure: Range of motion of knee distal/proximal translation.
time frame: 1 Day
description: The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
measure: Range of motion of knee medial/lateral translation.
time frame: 1 Day
description: The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
arm group label: KL 1
description: All patients (>50 years) are classified to be Kellgrence/Lawrence grade 1 according to Kellgrence/Lawrence score.
arm group label: KL 2
description: All patients (>50 years) are classified to be Kellgrence/Lawrence grade 2 according to Kellgrence/Lawrence score.
arm group label: KL 3
description: All patients (>50 years) are classified to be Kellgrence/Lawrence grade 3 according to Kellgrence/Lawrence score.
arm group label: KL 4
description: All patients (>50 years) are classified to be Kellgrence/Lawrence grade 4 according to Kellgrence/Lawrence score.
intervention type: Procedure
intervention name: Observational procedure
description: All the patients will undergo a standard observational procedure: i) diagnosed with KOA; ii) take a radiographic examination (x-ray); iii) assessed by WOMAC; iv) take an physical examination to avoid other disease; iv) take a gait examination on a treadmill in barefoot.
arm group label: KL 1
arm group label: KL 2
arm group label: KL 3
arm group label: KL 4
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 50 Years
maximum age: 90 Years
healthy volunteers: No
last name: Yu Zhang, PhD
role: Principal Investigator
affiliation: Hospital of Orthopedics, Guangzhou General Hospital of Guangzhou Military Command, 111 Liuhua Road, Guangzhou 510010, China
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Guangzhou General Hospital of Guangzhou Military Command
investigator full name: Yu Zhang
investigator title: chief surgeon, associate professor
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee
sharing ipd: No