<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/NCT02206321</url>
  </required_header>
  <id_info>
    <org_study_id>IRB 100-0038A3</org_study_id>
    <secondary_id>ChangGungMH</secondary_id>
    <nct_id>NCT02206321</nct_id>
  </id_info>
  <brief_title>Effects of Computer Navigation Versus Conventional Total Knee Arthroplasty on Endothelial Damage Marker Levels</brief_title>
  <official_title>Comparison of Navigation and Conventional Total Knee Arthroplasties</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chang Gung Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chang Gung Memorial Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      1. Prospective follow-up and comparative analysis of early, midterm, and long-term surgical&#xD;
           results and complications between navigation assisted TKA and conventional TKA.&#xD;
&#xD;
        2. Prospective comparative analysis of cytokines (including ICAM, VCAM, and PECAM) from&#xD;
           blood, tissues, and drainage between navigation assisted TKA and conventional TKA.&#xD;
&#xD;
        3. Prospective follow-up of surgical results of navigation-assisted TKA.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Total knee arthroplasty (TKA) is one of the most successful surgery in orthopaedic field.&#xD;
      However, occasional outliner from perfect alignment after prosthesis implantation and&#xD;
      unavoidable complications are still concerns. The usage of navigation-assisted system on&#xD;
      total knee arthroplasty has provided better accuracy of the component alignment and quantity&#xD;
      in knee kinematics, which theoretically affords better and consistent functional outcome.&#xD;
&#xD;
      In addition to better alignment, the design of navigation system avoids violation of the&#xD;
      medullary canal. This less invasive environment might be contributable to the less blood loss&#xD;
      in the drainage bottle, less blood transfusion more stable hemodynamic status, fewer&#xD;
      hospitalization days, and fewer complications.&#xD;
&#xD;
      Systemic emboli phenomena during preparation of the femur and tibia are well recognized&#xD;
      during total knee arthroplasty. They are widely believed to be the cause of intraoperative&#xD;
      hypotension and reduced cardiac output, which may lead to circulatory collapse, change of&#xD;
      mental status or cerebral infarction. Kalairajah et al reported that navigation-assisted&#xD;
      total knee arthroplasty, when compared with conventional jig-based surgery, significantly&#xD;
      reduces systemic emboli as detected by transcranial Doppler ultrasonography. Church et al&#xD;
      undertook a prospective, double-blind, randomized study to compare the cardiac emboli load by&#xD;
      tranesophageal echocardiography and demonstrated that computer-assisted TKA resulted in the&#xD;
      release of significant fewer systemic emboli than the conventional procedure using&#xD;
      intramedullary alignment. The increased blood loss in conventional TKA may be due to&#xD;
      intramedullary jigging of both femur and tibia, bleeding from sinusoids at the cut cancellous&#xD;
      bone surfaces with continuous suction drainage and more soft tissue dissection during&#xD;
      balancing of the prosthesis. The investigators have underwent more than 730 computer-assisted&#xD;
      TKA since 2005. The investigators data shows less bleeding and fewer transfusion after&#xD;
      navigation assisted TKA. The investigators wish to further follow-up and delineate the&#xD;
      differential clinical outcomes and perioperative markers (including ICAM, VCAM, and PECAM and&#xD;
      other cytokines )between computer-assisted TKA and conventional TKA.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>March 2011</start_date>
  <completion_date type="Anticipated">December 31, 2019</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>ELISA analysis to compare concentrations of target molecules in serum and hemovac drainage between two groups</measure>
    <time_frame>24 hours after surgery</time_frame>
    <description>We collect the serum and sample from hemovac drainage 24 hours after the surgery, to measure the concentrations of target molecules (ICAM, VCAM, PECAM).</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Computer-assisted Navigation Versus Conventional Total Knee Replacement</condition>
  <arm_group>
    <arm_group_label>Navigation total knee arthroplasty</arm_group_label>
    <description>Navigation total knee arthroplasty</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional total knee arthroplasty</arm_group_label>
    <description>Conventional total knee arthroplasty</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Navigation total knee arthroplasty</intervention_name>
    <description>computer assisted navigation total knee arthroplasty without femur intramedullary involvement</description>
    <arm_group_label>Navigation total knee arthroplasty</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Conventional total knee arthroplasty</intervention_name>
    <description>conventional technique with femur intramedullary violation</description>
    <arm_group_label>Conventional total knee arthroplasty</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Obtain the serum and hemovac drainage from the patients, and analyze the concentrations of&#xD;
      the markers&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        All the patients were recruited from the patient undergoing scheduled total knee&#xD;
        arthroplasty in our hospitals (Chang Gung Memorial Hospital, Kaohsiung medical center).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  degenerative osteoarthritis of the knee&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  autoimmune diseases, rheumatoid arthritis, malignancies, previous knee surgery or&#xD;
             post-traumatic arthritis&#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>Jih-Yang Ko, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chang Gung Memorial Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jih-Yang Ko, MD</last_name>
    <phone>886-7-731-7123</phone>
    <phone_ext>8003</phone_ext>
    <email>kojy@cgmh.org.tw</email>
  </overall_contact>
  <location>
    <facility>
      <name>Chang Gung Memorial Hospital</name>
      <address>
        <city>Kaohsiung city</city>
        <zip>833</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jih-Yang Ko, MD</last_name>
      <phone>886-7-731-7123</phone>
      <phone_ext>8003</phone_ext>
      <email>kojy@cgmh.org.tw</email>
    </contact>
    <investigator>
      <last_name>Jih-Yang Ko, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>July 29, 2014</study_first_submitted>
  <study_first_submitted_qc>July 30, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 1, 2014</study_first_posted>
  <last_update_submitted>February 2, 2017</last_update_submitted>
  <last_update_submitted_qc>February 2, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chang Gung Memorial Hospital</investigator_affiliation>
    <investigator_full_name>Jih-Yang Ko</investigator_full_name>
    <investigator_title>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/NCT02206321
org study id: IRB 100-0038A3
secondary id: ChangGungMH
nct id: NCT02206321
lead sponsor: 
has dmc: Yes
1. Prospective follow-up and comparative analysis of early, midterm, and long-term surgical
           results and complications between navigation assisted TKA and conventional TKA.

        2. Prospective comparative analysis of cytokines (including ICAM, VCAM, and PECAM) from
           blood, tissues, and drainage between navigation assisted TKA and conventional TKA.

        3. Prospective follow-up of surgical results of navigation-assisted TKA.
Total knee arthroplasty (TKA) is one of the most successful surgery in orthopaedic field.
      However, occasional outliner from perfect alignment after prosthesis implantation and
      unavoidable complications are still concerns. The usage of navigation-assisted system on
      total knee arthroplasty has provided better accuracy of the component alignment and quantity
      in knee kinematics, which theoretically affords better and consistent functional outcome.

      In addition to better alignment, the design of navigation system avoids violation of the
      medullary canal. This less invasive environment might be contributable to the less blood loss
      in the drainage bottle, less blood transfusion more stable hemodynamic status, fewer
      hospitalization days, and fewer complications.

      Systemic emboli phenomena during preparation of the femur and tibia are well recognized
      during total knee arthroplasty. They are widely believed to be the cause of intraoperative
      hypotension and reduced cardiac output, which may lead to circulatory collapse, change of
      mental status or cerebral infarction. Kalairajah et al reported that navigation-assisted
      total knee arthroplasty, when compared with conventional jig-based surgery, significantly
      reduces systemic emboli as detected by transcranial Doppler ultrasonography. Church et al
      undertook a prospective, double-blind, randomized study to compare the cardiac emboli load by
      tranesophageal echocardiography and demonstrated that computer-assisted TKA resulted in the
      release of significant fewer systemic emboli than the conventional procedure using
      intramedullary alignment. The increased blood loss in conventional TKA may be due to
      intramedullary jigging of both femur and tibia, bleeding from sinusoids at the cut cancellous
      bone surfaces with continuous suction drainage and more soft tissue dissection during
      balancing of the prosthesis. The investigators have underwent more than 730 computer-assisted
      TKA since 2005. The investigators data shows less bleeding and fewer transfusion after
      navigation assisted TKA. The investigators wish to further follow-up and delineate the
      differential clinical outcomes and perioperative markers (including ICAM, VCAM, and PECAM and
      other cytokines )between computer-assisted TKA and conventional TKA.
observational model: Cohort
time perspective: Prospective
measure: ELISA analysis to compare concentrations of target molecules in serum and hemovac drainage between two groups
time frame: 24 hours after surgery
description: We collect the serum and sample from hemovac drainage 24 hours after the surgery, to measure the concentrations of target molecules (ICAM, VCAM, PECAM).
arm group label: Navigation total knee arthroplasty
description: Navigation total knee arthroplasty
arm group label: Conventional total knee arthroplasty
description: Conventional total knee arthroplasty
intervention type: Procedure
intervention name: Navigation total knee arthroplasty
description: computer assisted navigation total knee arthroplasty without femur intramedullary involvement
arm group label: Navigation total knee arthroplasty
intervention type: Procedure
intervention name: Conventional total knee arthroplasty
description: conventional technique with femur intramedullary violation
arm group label: Conventional total knee arthroplasty
Obtain the serum and hemovac drainage from the patients, and analyze the concentrations of
      the markers
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Jih-Yang Ko, MD
role: Principal Investigator
affiliation: Chang Gung Memorial Hospital
last name: Jih-Yang Ko, MD
phone: 886-7-731-7123
phone ext: 8003
email: kojy@cgmh.org.tw
facility: 
status: Recruiting
contact: 
investigator: 
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: Chang Gung Memorial Hospital
investigator full name: Jih-Yang Ko
investigator title: Professor