<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/NCT04481711</url>
  </required_header>
  <id_info>
    <org_study_id>2018-91</org_study_id>
    <nct_id>NCT04481711</nct_id>
  </id_info>
  <brief_title>Total Knee Arthroplasty and Clinical Findings</brief_title>
  <official_title>Investigation of the Effect of Total Knee Arthroplasty on Proinflammatory Cytokine Level, Pain Severity, Functional Status, Joint Position Sense and Radiographic Findings</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Karadeniz Technical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Karadeniz Technical University</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>
      Knee osteoarthritis is a common disease that causes pain and loss of function. Total Knee&#xD;
      Arthroplasty (TKA) is a frequently used surgical method in the treatment of severe knee&#xD;
      osteoarthritis. The aim of this study was to investigate the effect of TKA on IL-6, TNF-α and&#xD;
      IL-1β cytokine levels, pain intensity at rest and walking, knee joint valgity&#xD;
      angle,malaligment, functional status and knee joint position sense.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Twenty-nine patients (female/male: 24/5) with grade 4 osteoarthritis were included in the TKA&#xD;
      group (study group) and 22 patients (female/male:13/9) with &lt;grade 4 osteoarthritis were&#xD;
      included in the control group. Systemic venous blood samples of the patients were taken to&#xD;
      evaluate the cytokine level (IL-6, TNF-α, IL-1). The Visual Analogue Scale was used to assess&#xD;
      pain intensity, and the WOMAC (Western Ontario and McMaster Universities Osteoarthritis&#xD;
      Index) score was used to evaluate the functional status. Valgity and malaligment measurements&#xD;
      were calculated using antero-posterior X ray Digital goniometer was used to evaluate the knee&#xD;
      joint position sense (at 35, 55 and 70 degrees knee flexion angles). Measurements were taken&#xD;
      once from patients in the control group, and twice in pre-op and post-op sixth weeks from&#xD;
      study group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 8, 2018</start_date>
  <completion_date type="Actual">May 8, 2020</completion_date>
  <primary_completion_date type="Actual">February 8, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proinflammatory cytokine level</measure>
    <time_frame>30 minutes</time_frame>
    <description>Systemic venous blood samples were taken. IL-6, TNF-α and IL-1β cytokine levels were examined.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain severity</measure>
    <time_frame>15 minutes</time_frame>
    <description>The pain intensity were evaluated by the Visuel Analog Scale.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Functional status</measure>
    <time_frame>30 minutes</time_frame>
    <description>The Western Ontario and McMaster Universities Arthritis Index was used for functional status.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Joint position sense</measure>
    <time_frame>30 minutes</time_frame>
    <description>Electro-goniometer was used for proprioception evaluation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Valgity angle and amount of malaligment</measure>
    <time_frame>30 minutes</time_frame>
    <description>In this evaluation, the valgity angle and the malalingement amount were calculated on the knee antero-posterior direct X-ray imageby an experienced orthopedist</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">51</enrollment>
  <condition>Orthopedic Disorder</condition>
  <condition>Arthropathy of Knee</condition>
  <condition>Pain, Joint</condition>
  <condition>Proprioception</condition>
  <condition>Radiography</condition>
  <arm_group>
    <arm_group_label>Study group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Twenty-nine patients (female/male: 24/5) with grade 4 osteoarthritis were included in the study group. These patients underwent total knee arthroplasty</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Twenty-two patients (female/male:13/9) with &lt;grade 4 osteoarthritis were included in the control group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Total Knee Arthroplasty</intervention_name>
    <description>Osteoarthritis (OA) is one of the most common chronic peripheral joint diseases increasing among the aging population.Pathogenesis is not fully known.One of the most common risk factors and causes are loss of pain and function. Knee joint osteoarthritis adversly affects the person's life quality. Total Knee Arthroplasty (TKA) is a surgical approach to restore tibiofemoral joint alignment, especially in the severe level of knee OA.</description>
    <arm_group_label>Study group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with grade 4 degeneration levels who had surgical indications between the&#xD;
             ages of 45-75 were placed in the study group.&#xD;
&#xD;
          -  Patients without surgical indication, lower than 4 OA severity included in the control&#xD;
             group&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with surgical history of the ipsilateral side, neuropathic pain, loss of&#xD;
             sensation, systemic, chronic and infectious disease were excluded from the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Murat Emirzeoğlu</last_name>
    <role>Study Chair</role>
    <affiliation>Karadeniz Technical University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Arzu Erden</last_name>
    <role>Study Director</role>
    <affiliation>Karadeniz Technical University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Kübra Canlı</last_name>
    <role>Study Chair</role>
    <affiliation>Hacettepe University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Serap Özer Yaman</last_name>
    <role>Study Chair</role>
    <affiliation>Karadeniz Technical University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>İbrahim Pekşen</last_name>
    <role>Study Chair</role>
    <affiliation>Karadeniz Technical University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Osman Aynacı</last_name>
    <role>Study Chair</role>
    <affiliation>Karadeniz Technical University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Süleyman Caner Karahan</last_name>
    <role>Study Chair</role>
    <affiliation>Karadeniz Technical University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Karadeniz Technical Üniversitesi</name>
      <address>
        <city>Trabzon</city>
        <state>Türkiye</state>
        <zip>61080</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 17, 2020</study_first_submitted>
  <study_first_submitted_qc>July 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 22, 2020</study_first_posted>
  <last_update_submitted>July 23, 2020</last_update_submitted>
  <last_update_submitted_qc>July 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Karadeniz Technical University</investigator_affiliation>
    <investigator_full_name>Murat EMİRZEOĞLU</investigator_full_name>
    <investigator_title>Karadeniz Technical University</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Musculoskeletal Diseases</mesh_term>
    <mesh_term>Arthralgia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04481711
org study id: 2018-91
nct id: NCT04481711
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Knee osteoarthritis is a common disease that causes pain and loss of function. Total Knee
      Arthroplasty (TKA) is a frequently used surgical method in the treatment of severe knee
      osteoarthritis. The aim of this study was to investigate the effect of TKA on IL-6, TNF-α and
      IL-1β cytokine levels, pain intensity at rest and walking, knee joint valgity
      angle,malaligment, functional status and knee joint position sense.
Twenty-nine patients (female/male: 24/5) with grade 4 osteoarthritis were included in the TKA
      group (study group) and 22 patients (female/male:13/9) with <grade 4 osteoarthritis were
      included in the control group. Systemic venous blood samples of the patients were taken to
      evaluate the cytokine level (IL-6, TNF-α, IL-1). The Visual Analogue Scale was used to assess
      pain intensity, and the WOMAC (Western Ontario and McMaster Universities Osteoarthritis
      Index) score was used to evaluate the functional status. Valgity and malaligment measurements
      were calculated using antero-posterior X ray Digital goniometer was used to evaluate the knee
      joint position sense (at 35, 55 and 70 degrees knee flexion angles). Measurements were taken
      once from patients in the control group, and twice in pre-op and post-op sixth weeks from
      study group.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Proinflammatory cytokine level
time frame: 30 minutes
description: Systemic venous blood samples were taken. IL-6, TNF-α and IL-1β cytokine levels were examined.
measure: Pain severity
time frame: 15 minutes
description: The pain intensity were evaluated by the Visuel Analog Scale.
measure: Functional status
time frame: 30 minutes
description: The Western Ontario and McMaster Universities Arthritis Index was used for functional status.
measure: Joint position sense
time frame: 30 minutes
description: Electro-goniometer was used for proprioception evaluation
measure: Valgity angle and amount of malaligment
time frame: 30 minutes
description: In this evaluation, the valgity angle and the malalingement amount were calculated on the knee antero-posterior direct X-ray imageby an experienced orthopedist
arm group label: Study group
arm group type: Experimental
description: Twenty-nine patients (female/male: 24/5) with grade 4 osteoarthritis were included in the study group. These patients underwent total knee arthroplasty
arm group label: Control group
arm group type: No Intervention
description: Twenty-two patients (female/male:13/9) with <grade 4 osteoarthritis were included in the control group.
intervention type: Procedure
intervention name: Total Knee Arthroplasty
description: Osteoarthritis (OA) is one of the most common chronic peripheral joint diseases increasing among the aging population.Pathogenesis is not fully known.One of the most common risk factors and causes are loss of pain and function. Knee joint osteoarthritis adversly affects the person's life quality. Total Knee Arthroplasty (TKA) is a surgical approach to restore tibiofemoral joint alignment, especially in the severe level of knee OA.
arm group label: Study group
criteria: 
gender: All
minimum age: 45 Years
maximum age: 70 Years
healthy volunteers: No
last name: Murat Emirzeoğlu
role: Study Chair
affiliation: Karadeniz Technical University
last name: Arzu Erden
role: Study Director
affiliation: Karadeniz Technical University
last name: Kübra Canlı
role: Study Chair
affiliation: Hacettepe University
last name: Serap Özer Yaman
role: Study Chair
affiliation: Karadeniz Technical University
last name: İbrahim Pekşen
role: Study Chair
affiliation: Karadeniz Technical University
last name: Osman Aynacı
role: Study Chair
affiliation: Karadeniz Technical University
last name: Süleyman Caner Karahan
role: Study Chair
affiliation: Karadeniz Technical University
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Karadeniz Technical University
investigator full name: Murat EMİRZEOĞLU
investigator title: Karadeniz Technical University
mesh term: Musculoskeletal Diseases
mesh term: Arthralgia
sharing ipd: Undecided