<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/NCT04487535</url>
  </required_header>
  <id_info>
    <org_study_id>Karadeniz Technique Unıversty</org_study_id>
    <nct_id>NCT04487535</nct_id>
  </id_info>
  <brief_title>The Relationship Between Preoperative Serum Cytokine Level and Lenght of Stay in Hospital, Postoperative Pain Intensity, Functional Status, Joint Position Sense and X Ray Findings</brief_title>
  <official_title>The Relationship Between Preoperative Serum Cytokine Level and Lenght of Stay in Hospital, Postoperative Pain Intensity, Functional Status, Joint Position Sense and X Ray Findings</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hacettepe University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Karadeniz Technical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hacettepe University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Serum cytokines was assosiated with symptoms and progression of osteoartritis. It is unknown&#xD;
      whether these cytokines have a predictive role on severity of symptoms after total knee&#xD;
      arthroplasty (TKA) or not. The aim of this study is to investigate the relationships between&#xD;
      the preoperative serum cytokine level (SCL) and lenght of stay in hospital, postoperative&#xD;
      pain intensity, functional status, joint position sense and X ray.&#xD;
&#xD;
      Grade 4 osteoartritis degeneration who intern the hospital for total knee arthroplasty&#xD;
      surgery. Serum Cytokine Levels (IL-6, TNFα, IL-1β) will be assessed before surgery. Pain&#xD;
      intensity at rest/activity and valgite angle will be evaluated before surgery, postoperative&#xD;
      72 hour and postoperative 6 weeks. Functional status and joint position sense will be&#xD;
      assessed before surgery and 6 weeks after surgery. Lenght of stay in hospital (LOS) will be&#xD;
      recorded.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2018</start_date>
  <completion_date type="Actual">February 1, 2020</completion_date>
  <primary_completion_date type="Actual">January 1, 2020</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>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain intensty</measure>
    <time_frame>pain intensity will be evaluated. It will determined pain intensity alteration from 2 weeks before surgery and at 72 hours and at 6 weeks following surgery</time_frame>
    <description>Rest and activity pain intensity will be evaluated by using 100 mm vertical line Visual Anolog Scale (VAS). Zero meet no pain, 10 unbearable pain</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Functional Status</measure>
    <time_frame>Functional status will be assessed before surgery and 6 weeks after surgery</time_frame>
    <description>Turkish version of Western Ontario McMaster University Osteoarthritis Index (WOMAC) scale will be used to evaluate functional status. The WOMAC is a self reported funtional assessment scale consisting of 24 items which responded on Likert type scale (0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = extreme), with higher score indicating more difficulty</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Joint Position Sense</measure>
    <time_frame>It will be evaluated before surgery and 6 weeks after surgery</time_frame>
    <description>Joint positon sense will be evaluated by using a digital goniometer. Each patient will be asked to sat in a erect pack position on the chair with knee relaxed in 90 º flexion noticing that popliteal fossa was not in contact with end edge of the chair. A digital goniometer will be placed at the lateral aspect of the knee, with moveable arm in the course of midline of the lateral malleolus and stationary arm along the midline of the femur. The knee will be moved passively by examiner slowly from initial position (90º flexion) to final predetermined three angle (35º, 55º, 70º), hold final positon for 5 second and then return to initial position with same speed. After instruction the procedure, patients will be ask to extend the knee actively for each angle. This procedure will be repeated three times for each angle.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>X-Ray</measure>
    <time_frame>X-ray evaluated before surgery, 72 hour after surgery and 6 weeks ater surgery</time_frame>
    <description>To measure valgus angle, standart anteroposterior (AP) X ray view was obtained from patients in standing position and without shoes. The angle between femoral axis which indicate a line drawn from femoral head to femoral intercondylar notch and tibial axis which describe a line from the center of the talus bone to the center of the tibial spine was measured by orthopedics</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum Cytokine Level</measure>
    <time_frame>Venous blood sample was collected 2 weeks before surgery</time_frame>
    <description>Five-milliliter blood samples from each individual were placed into vacutainer tubes without anticoagulant. These were then centrifuged at 1800 g for 10 minutes. Serum samples were stored at -80°C until being used for measurements. Serum IL- 6, TNF-α ve IL-1β levels were determined using commercial sandwich-ELISA kits. The absorbance of the samples was measured at a 450 nm wavelength on a VERSA (designed by Molecular Devices in California, USA) micro plate reader. The results were expressed as pg/ mL. The coefficients of variation (CV) of this ELISA method were6.69% for IL-6, 6.62% for TNF alfa and 6.72% for IL-1beta.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">29</enrollment>
  <condition>Total Knee Arthroplasty</condition>
  <arm_group>
    <arm_group_label>Standard Total Knee Arthroplasty Surgery</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Surgery performed by one orthopedic surgeon</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Cytokine level</intervention_name>
    <description>Serum cytokine level will be measured before surgery, 72nd after surgery and 6 weeks after surgery</description>
    <arm_group_label>Standard Total Knee Arthroplasty Surgery</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. aged between 45-75&#xD;
&#xD;
          2. were scheduled for unilateral or bilateral TKA&#xD;
&#xD;
          3. were diagnosed of OA with a severity Grade 4 according to the Kellgren-Lawrence (KL)&#xD;
             classification.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. neuropathic pain&#xD;
&#xD;
          2. presurgery for same lower extremity&#xD;
&#xD;
          3. vascular disease&#xD;
&#xD;
          4. any chronic disease related to kidney, heart, liver&#xD;
&#xD;
          5. cancer&#xD;
&#xD;
          6. chronic inflammatory disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hacettepe Universty</name>
      <address>
        <city>Ankara</city>
        <state>Sıhhıye</state>
        <zip>06100</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>July 16, 2020</study_first_submitted>
  <study_first_submitted_qc>July 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2020</study_first_posted>
  <last_update_submitted>July 22, 2020</last_update_submitted>
  <last_update_submitted_qc>July 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Karadeniz Technical University</investigator_affiliation>
    <investigator_full_name>Kübra Canli</investigator_full_name>
    <investigator_title>Karadeniz Technical University</investigator_title>
  </responsible_party>
  <keyword>Total knee arthroplasty</keyword>
  <keyword>Cytokines</keyword>
  <keyword>Proprioception</keyword>
  <keyword>Pain</keyword>
  <keyword>Functional Status</keyword>
  <keyword>Lenght of Stay in hospital</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</mesh_term>
    <mesh_term>Pain</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/NCT04487535
org study id: Karadeniz Technique Unıversty
nct id: NCT04487535
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
Serum cytokines was assosiated with symptoms and progression of osteoartritis. It is unknown
      whether these cytokines have a predictive role on severity of symptoms after total knee
      arthroplasty (TKA) or not. The aim of this study is to investigate the relationships between
      the preoperative serum cytokine level (SCL) and lenght of stay in hospital, postoperative
      pain intensity, functional status, joint position sense and X ray.

      Grade 4 osteoartritis degeneration who intern the hospital for total knee arthroplasty
      surgery. Serum Cytokine Levels (IL-6, TNFα, IL-1β) will be assessed before surgery. Pain
      intensity at rest/activity and valgite angle will be evaluated before surgery, postoperative
      72 hour and postoperative 6 weeks. Functional status and joint position sense will be
      assessed before surgery and 6 weeks after surgery. Lenght of stay in hospital (LOS) will be
      recorded.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Pain intensty
time frame: pain intensity will be evaluated. It will determined pain intensity alteration from 2 weeks before surgery and at 72 hours and at 6 weeks following surgery
description: Rest and activity pain intensity will be evaluated by using 100 mm vertical line Visual Anolog Scale (VAS). Zero meet no pain, 10 unbearable pain
measure: Functional Status
time frame: Functional status will be assessed before surgery and 6 weeks after surgery
description: Turkish version of Western Ontario McMaster University Osteoarthritis Index (WOMAC) scale will be used to evaluate functional status. The WOMAC is a self reported funtional assessment scale consisting of 24 items which responded on Likert type scale (0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = extreme), with higher score indicating more difficulty
measure: Joint Position Sense
time frame: It will be evaluated before surgery and 6 weeks after surgery
description: Joint positon sense will be evaluated by using a digital goniometer. Each patient will be asked to sat in a erect pack position on the chair with knee relaxed in 90 º flexion noticing that popliteal fossa was not in contact with end edge of the chair. A digital goniometer will be placed at the lateral aspect of the knee, with moveable arm in the course of midline of the lateral malleolus and stationary arm along the midline of the femur. The knee will be moved passively by examiner slowly from initial position (90º flexion) to final predetermined three angle (35º, 55º, 70º), hold final positon for 5 second and then return to initial position with same speed. After instruction the procedure, patients will be ask to extend the knee actively for each angle. This procedure will be repeated three times for each angle.
measure: X-Ray
time frame: X-ray evaluated before surgery, 72 hour after surgery and 6 weeks ater surgery
description: To measure valgus angle, standart anteroposterior (AP) X ray view was obtained from patients in standing position and without shoes. The angle between femoral axis which indicate a line drawn from femoral head to femoral intercondylar notch and tibial axis which describe a line from the center of the talus bone to the center of the tibial spine was measured by orthopedics
measure: Serum Cytokine Level
time frame: Venous blood sample was collected 2 weeks before surgery
description: Five-milliliter blood samples from each individual were placed into vacutainer tubes without anticoagulant. These were then centrifuged at 1800 g for 10 minutes. Serum samples were stored at -80°C until being used for measurements. Serum IL- 6, TNF-α ve IL-1β levels were determined using commercial sandwich-ELISA kits. The absorbance of the samples was measured at a 450 nm wavelength on a VERSA (designed by Molecular Devices in California, USA) micro plate reader. The results were expressed as pg/ mL. The coefficients of variation (CV) of this ELISA method were6.69% for IL-6, 6.62% for TNF alfa and 6.72% for IL-1beta.
arm group label: Standard Total Knee Arthroplasty Surgery
arm group type: Other
description: Surgery performed by one orthopedic surgeon
intervention type: Other
intervention name: Cytokine level
description: Serum cytokine level will be measured before surgery, 72nd after surgery and 6 weeks after surgery
arm group label: Standard Total Knee Arthroplasty Surgery
criteria: 
gender: All
minimum age: 45 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Karadeniz Technical University
investigator full name: Kübra Canli
investigator title: Karadeniz Technical University
mesh term: Pain, Postoperative
mesh term: Pain
sharing ipd: No