<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/NCT04429997</url>
  </required_header>
  <id_info>
    <org_study_id>COA 057/2563</org_study_id>
    <nct_id>NCT04429997</nct_id>
  </id_info>
  <brief_title>Incidence of Patellar Crepitus in Removal and Non-removal of Fibrosynovial Tissue at Superior Pole of Patella</brief_title>
  <official_title>Prospective Randomized Controlled Trial: Comparison of Incidence of Patellar Crepitus Between Removal and Non-removal of Fibrosynovial Tissue at the Border of the Superior Pole of the Patellar</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Navamindradhiraj University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Navamindradhiraj 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>
      The purpose of this study is to compare the incidence of patellar crepitus complication and&#xD;
      the clinical outcome between remove and not remove fibrosynovial tissue at the border of the&#xD;
      superior pole of the patellar in posterior stabilized total knee arthroplasty.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">June 10, 2020</start_date>
  <completion_date type="Anticipated">December 2022</completion_date>
  <primary_completion_date type="Anticipated">July 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of patellar crepitus complication</measure>
    <time_frame>Change from baseline patellar crepitus complication 3 months, 6 months, and 12 months after surgery</time_frame>
    <description>Incidence of patellar crepitus complication (present, absent)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Knee Society and Knee Society function score</measure>
    <time_frame>Change from baseline Knee Society and Knee Society function score at 3 months, 6 months, and 12 months after surgery</time_frame>
    <description>Knee Society and Knee Society function score (minimum 0, maximum 200)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>New patellar score</measure>
    <time_frame>Change from baseline new patellar score at 3 months, 6 months, and 12 months after surgery</time_frame>
    <description>New patellar score (minimum 0, maximum 30)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oxford knee score</measure>
    <time_frame>Change from baseline Oxford knee score 3 months, 6 months, and 12 months after surgery</time_frame>
    <description>Oxford knee score (minimum 0, maximum 48)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of post-operative anterior knee pain</measure>
    <time_frame>Change from baseline Visual Analog Scale for anterior knee pain at 3 months, 6 months, and 12 months after surgery</time_frame>
    <description>Visual Analog Scale for anterior knee pain (minimum 0, maximum 10) Do higher values represent a worse outcome</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">138</enrollment>
  <condition>Removal of Fibrosynovial Tissue</condition>
  <condition>Non-removal of Fibrosynovial Tissue</condition>
  <condition>Patellar Non-resurfacing</condition>
  <arm_group>
    <arm_group_label>Removal of fibrosynovial tissue</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Removal of fibrosynovial tissue in patellar non-resurfacing TKA</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-removal of fibrosynovial tissue</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Non-removal of fibrosynovial tissue in patellar non-resurfacing TKA</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Removal of fibrosynovial tissue</intervention_name>
    <description>Remove of fibrosynovial tissue at the superior border of patella</description>
    <arm_group_label>Removal of fibrosynovial tissue</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Non-removal of fibrosynovial tissue</intervention_name>
    <description>Do not remove of fibrosynovial tissue at the superior border of patella</description>
    <arm_group_label>Non-removal of fibrosynovial tissue</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Primary osteoarthritis of knee who were scheduled for a primary total knee&#xD;
             arthroplasty&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Valgus deformity&#xD;
&#xD;
          -  History of inflammatory arthroplathy&#xD;
&#xD;
          -  Previous fracture or open surgery on the same knee&#xD;
&#xD;
          -  History of patellar instability&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Satit Thiengwittayaporn, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Orthopaedics, Faculty of Medicine Vajira Hospital, Navamindradhiraj University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Navamindradhiraj University</name>
      <address>
        <city>Dusit</city>
        <state>Bangkok,</state>
        <zip>10300</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Thailand</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>June 10, 2020</study_first_submitted>
  <study_first_submitted_qc>June 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 12, 2020</study_first_posted>
  <last_update_submitted>August 30, 2021</last_update_submitted>
  <last_update_submitted_qc>August 30, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 31, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Navamindradhiraj University</investigator_affiliation>
    <investigator_full_name>Satit Thiengwittayaporn</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <!-- 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/NCT04429997
org study id: COA 057/2563
nct id: NCT04429997
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to compare the incidence of patellar crepitus complication and
      the clinical outcome between remove and not remove fibrosynovial tissue at the border of the
      superior pole of the patellar in posterior stabilized total knee arthroplasty.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Double (Participant, Outcomes Assessor)
measure: Incidence of patellar crepitus complication
time frame: Change from baseline patellar crepitus complication 3 months, 6 months, and 12 months after surgery
description: Incidence of patellar crepitus complication (present, absent)
measure: Knee Society and Knee Society function score
time frame: Change from baseline Knee Society and Knee Society function score at 3 months, 6 months, and 12 months after surgery
description: Knee Society and Knee Society function score (minimum 0, maximum 200)
measure: New patellar score
time frame: Change from baseline new patellar score at 3 months, 6 months, and 12 months after surgery
description: New patellar score (minimum 0, maximum 30)
measure: Oxford knee score
time frame: Change from baseline Oxford knee score 3 months, 6 months, and 12 months after surgery
description: Oxford knee score (minimum 0, maximum 48)
measure: Change of post-operative anterior knee pain
time frame: Change from baseline Visual Analog Scale for anterior knee pain at 3 months, 6 months, and 12 months after surgery
description: Visual Analog Scale for anterior knee pain (minimum 0, maximum 10) Do higher values represent a worse outcome
arm group label: Removal of fibrosynovial tissue
arm group type: Experimental
description: Removal of fibrosynovial tissue in patellar non-resurfacing TKA
arm group label: Non-removal of fibrosynovial tissue
arm group type: Experimental
description: Non-removal of fibrosynovial tissue in patellar non-resurfacing TKA
intervention type: Procedure
intervention name: Removal of fibrosynovial tissue
description: Remove of fibrosynovial tissue at the superior border of patella
arm group label: Removal of fibrosynovial tissue
intervention type: Procedure
intervention name: Non-removal of fibrosynovial tissue
description: Do not remove of fibrosynovial tissue at the superior border of patella
arm group label: Non-removal of fibrosynovial tissue
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Satit Thiengwittayaporn, M.D.
role: Principal Investigator
affiliation: Department of Orthopaedics, Faculty of Medicine Vajira Hospital, Navamindradhiraj University
facility: 
country: Thailand
responsible party type: Principal Investigator
investigator affiliation: Navamindradhiraj University
investigator full name: Satit Thiengwittayaporn
investigator title: Associate Professor