<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/NCT03778463</url>
  </required_header>
  <id_info>
    <org_study_id>12370677</org_study_id>
    <nct_id>NCT03778463</nct_id>
  </id_info>
  <brief_title>Synovectomy in Primary Total Knee Arthrplasty</brief_title>
  <official_title>Synovectomy Versus no Synovectomy in Primary Total Knee Arthrplasty : A Randomized Control Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ain Shams University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ain Shams University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of total knee arthroplasty is to achieve best patient functional outcomes, improve&#xD;
      patient pain score and satisfaction. Synovial proliferation is a common finding in arthritic&#xD;
      knees. Surgeons can't decide if synovectomy is a crucial step in the operation. Studies&#xD;
      didn't prove the clear benefits of synovectomy. We are aiming to perform a randomized&#xD;
      clinical trial trying to reach the best evidence in that matter.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">December 2018</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">December 2019</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>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Functional outcome scores. e.g. knee society score (KSS)</measure>
    <time_frame>one year</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>knee pain e.g. visual analogue score (VAS) score</measure>
    <time_frame>immediate postoperative</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Health related quality of life e.g. short form (SF12) scale</measure>
    <time_frame>one year</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Revision rate</measure>
    <time_frame>one year</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Reoperation rate</measure>
    <time_frame>one year</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Range of motion</measure>
    <time_frame>immediate postoperative</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Range of motion</measure>
    <time_frame>6 month</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Range of motion</measure>
    <time_frame>One year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Postoperative blood loss</measure>
    <time_frame>immediate postoperative</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative hemoglobin level</measure>
    <time_frame>immediate postoperative</time_frame>
    <description>gram/dl</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infection rate</measure>
    <time_frame>in first three month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Wound complications</measure>
    <time_frame>in first 3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients requiring transfusion</measure>
    <time_frame>immediate postoperative</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">70</enrollment>
  <condition>Arthroplasty, Replacement, Knee</condition>
  <condition>Synovectomy</condition>
  <arm_group>
    <arm_group_label>Synovectomy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>No synovectomy</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Synovectomy</intervention_name>
    <description>Removal of the synovium during total knee arthroplasty</description>
    <arm_group_label>Synovectomy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with primary osteoarthritis undergoing primary total knee arthroplasty&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inflammatory arthritis&#xD;
&#xD;
          -  Revision knee arthroplasty&#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>Ahmed Saeed Younis, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ain Shams University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Amr Amal Elsayed Amin, Dr.</last_name>
    <role>Study Director</role>
    <affiliation>Ain Shams University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Wael Samir Osman, Professor</last_name>
    <role>Study Chair</role>
    <affiliation>Ain Shams University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ahmed Saeed Younis, Dr.</last_name>
    <phone>201012370677</phone>
    <email>ahmed.s.younis@med.asu.edu.eg</email>
  </overall_contact>
  <location>
    <facility>
      <name>Ain Shams Univrsity</name>
      <address>
        <city>Cairo</city>
        <zip>11566</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ain Shams</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 14, 2018</study_first_submitted>
  <study_first_submitted_qc>December 14, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>December 14, 2018</last_update_submitted>
  <last_update_submitted_qc>December 14, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 19, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ain Shams University</investigator_affiliation>
    <investigator_full_name>Ahmed Saeed Younis</investigator_full_name>
    <investigator_title>Principle investigator</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/NCT03778463
org study id: 12370677
nct id: NCT03778463
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: Yes
The aim of total knee arthroplasty is to achieve best patient functional outcomes, improve
      patient pain score and satisfaction. Synovial proliferation is a common finding in arthritic
      knees. Surgeons can't decide if synovectomy is a crucial step in the operation. Studies
      didn't prove the clear benefits of synovectomy. We are aiming to perform a randomized
      clinical trial trying to reach the best evidence in that matter.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Functional outcome scores. e.g. knee society score (KSS)
time frame: one year
measure: knee pain e.g. visual analogue score (VAS) score
time frame: immediate postoperative
measure: Health related quality of life e.g. short form (SF12) scale
time frame: one year
measure: Revision rate
time frame: one year
measure: Reoperation rate
time frame: one year
measure: Range of motion
time frame: immediate postoperative
measure: Range of motion
time frame: 6 month
measure: Range of motion
time frame: One year
measure: Postoperative blood loss
time frame: immediate postoperative
measure: Postoperative hemoglobin level
time frame: immediate postoperative
description: gram/dl
measure: Infection rate
time frame: in first three month
measure: Wound complications
time frame: in first 3 months
measure: Number of patients requiring transfusion
time frame: immediate postoperative
arm group label: Synovectomy
arm group type: Experimental
arm group label: No synovectomy
arm group type: No Intervention
intervention type: Other
intervention name: Synovectomy
description: Removal of the synovium during total knee arthroplasty
arm group label: Synovectomy
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Ahmed Saeed Younis, Dr.
role: Principal Investigator
affiliation: Ain Shams University
last name: Amr Amal Elsayed Amin, Dr.
role: Study Director
affiliation: Ain Shams University
last name: Wael Samir Osman, Professor
role: Study Chair
affiliation: Ain Shams University
last name: Ahmed Saeed Younis, Dr.
phone: 201012370677
email: ahmed.s.younis@med.asu.edu.eg
facility: 
status: Recruiting
contact: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Ain Shams University
investigator full name: Ahmed Saeed Younis
investigator title: Principle investigator