<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/NCT02992613</url>
  </required_header>
  <id_info>
    <org_study_id>Ultra-Congruent(UC) insert</org_study_id>
    <nct_id>NCT02992613</nct_id>
  </id_info>
  <brief_title>Ultra-Congruent(UC) Versus Posterior-stabilized(PS) Insert in Bilateral Total Knee Arthroplasty</brief_title>
  <official_title>Comparison of Ultra-Congruent(UC) and Posterior-stabilized(PS) Insert in Bilateral Total Knee Arthroplasty</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Catholic University of Korea</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Catholic University of Korea</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Numerous studies have echoed the superior clinical outcomes of posterior-stabilized (PS)&#xD;
      total knee arthroplasty compared to posterior cruciate-retaining (CR) total knee&#xD;
      arthroplasty. The post-cam mechanism of posterior-stabilized (PS) total knee arthroplasty has&#xD;
      been postulated to provide reproducible femoral rollback and increased flexion. However,&#xD;
      posterior-stabilized (PS) total knee arthroplasty systems are purportedly limited due to&#xD;
      several post-cam related problems, including post-cam dislocation, wear and breakage of post,&#xD;
      and patellar clunk syndrome. Moreover, the post-cam mechanism requires additional bone&#xD;
      resection and poses a risk for intercondylar fracture of the distal femur during box&#xD;
      preparation. To overcome these issues, a fixed-bearing highly conforming ultra-congruent (UC)&#xD;
      total knee arthroplasty was introduced.&#xD;
&#xD;
      This study aims to compare the clinical results of Ultra-Congruent(UC) and&#xD;
      posterior-stabilized(PS) insert in bilateral total knee arthroplasty.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objective of this work was to compare pain, stiffness, function and accuracy between&#xD;
      groups at minimum 2 year postoperatively. The investigators hypothesized that the&#xD;
      Ultra-Congruent(UC) insert would provide similar functional outcomes without increasing the&#xD;
      incidence of adverse events.&#xD;
&#xD;
      The study design is a double-blind randomized controlled trial. Fifty patients planed to&#xD;
      undergo simultaneously bilateral total knee arthroplasty are randomised to be used&#xD;
      Ultra-Congruent(UC) insert on one leg and posterior-stabilized(PS) insert on the other. The&#xD;
      clinical outcome is comparative preoperative, postoperative 6weeks, 3months, 6months and&#xD;
      1years. And clinical score consists of Range of Motion (ROM), WOMAC (Western Ontario and&#xD;
      McMaster University Arthritis Index ) pain scale, Knee Society Score, Anterior and posterior&#xD;
      stress view on X-ray.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">December 2018</completion_date>
  <primary_completion_date type="Anticipated">December 2017</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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Western Ontario and McMaster Universities Index(WOMAC index)</measure>
    <time_frame>Change from baseline score to score of postoperative1 year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Knee Society Score</measure>
    <time_frame>Change from baseline score to score of postoperative1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Range of Motion</measure>
    <time_frame>Change from baseline Range of Motion at postoperative1 year</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Osteoarthritis, Ultra-Congruent(UC) Insert</condition>
  <arm_group>
    <arm_group_label>Ultra-Congruent(UC) group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ultra-Congruent(UC) insert will be used in total knee arthroplasty.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>posterior-stabilized(PS) group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Posterior-stabilized(PS) insert will be used in total knee arthroplasty.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>total knee arthroplasty with ultra-congruent (UC) insert</intervention_name>
    <arm_group_label>Ultra-Congruent(UC) group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>total knee arthroplasty with posterior-stabilized (PS) insert</intervention_name>
    <arm_group_label>posterior-stabilized(PS) group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  over 19 year old&#xD;
&#xD;
          -  Patients for total knee arthroplasty of both knee&#xD;
&#xD;
          -  having medicare insurance&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Rheumatoid arthritis&#xD;
&#xD;
          -  Other inflammatory arthritis&#xD;
&#xD;
          -  Neuropsychiatric patients&#xD;
&#xD;
          -  Hepatic insufficiency&#xD;
&#xD;
          -  Renal insufficiency&#xD;
&#xD;
          -  over 40 of body mass index&#xD;
&#xD;
          -  Chronic opioid use (taking opioids for longer than 3 months)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 12, 2016</study_first_submitted>
  <study_first_submitted_qc>December 12, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 14, 2016</study_first_posted>
  <last_update_submitted>December 12, 2016</last_update_submitted>
  <last_update_submitted_qc>December 12, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 14, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Catholic University of Korea</investigator_affiliation>
    <investigator_full_name>Yong In</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
  </condition_browse>
  <!-- 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/NCT02992613
org study id: Ultra-Congruent(UC) insert
nct id: NCT02992613
lead sponsor: 
has dmc: No
Numerous studies have echoed the superior clinical outcomes of posterior-stabilized (PS)
      total knee arthroplasty compared to posterior cruciate-retaining (CR) total knee
      arthroplasty. The post-cam mechanism of posterior-stabilized (PS) total knee arthroplasty has
      been postulated to provide reproducible femoral rollback and increased flexion. However,
      posterior-stabilized (PS) total knee arthroplasty systems are purportedly limited due to
      several post-cam related problems, including post-cam dislocation, wear and breakage of post,
      and patellar clunk syndrome. Moreover, the post-cam mechanism requires additional bone
      resection and poses a risk for intercondylar fracture of the distal femur during box
      preparation. To overcome these issues, a fixed-bearing highly conforming ultra-congruent (UC)
      total knee arthroplasty was introduced.

      This study aims to compare the clinical results of Ultra-Congruent(UC) and
      posterior-stabilized(PS) insert in bilateral total knee arthroplasty.
The objective of this work was to compare pain, stiffness, function and accuracy between
      groups at minimum 2 year postoperatively. The investigators hypothesized that the
      Ultra-Congruent(UC) insert would provide similar functional outcomes without increasing the
      incidence of adverse events.

      The study design is a double-blind randomized controlled trial. Fifty patients planed to
      undergo simultaneously bilateral total knee arthroplasty are randomised to be used
      Ultra-Congruent(UC) insert on one leg and posterior-stabilized(PS) insert on the other. The
      clinical outcome is comparative preoperative, postoperative 6weeks, 3months, 6months and
      1years. And clinical score consists of Range of Motion (ROM), WOMAC (Western Ontario and
      McMaster University Arthritis Index ) pain scale, Knee Society Score, Anterior and posterior
      stress view on X-ray.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Change in Western Ontario and McMaster Universities Index(WOMAC index)
time frame: Change from baseline score to score of postoperative1 year
measure: Change in Knee Society Score
time frame: Change from baseline score to score of postoperative1 year
measure: Change in Range of Motion
time frame: Change from baseline Range of Motion at postoperative1 year
arm group label: Ultra-Congruent(UC) group
arm group type: Experimental
description: Ultra-Congruent(UC) insert will be used in total knee arthroplasty.
arm group label: posterior-stabilized(PS) group
arm group type: Active Comparator
description: Posterior-stabilized(PS) insert will be used in total knee arthroplasty.
intervention type: Procedure
intervention name: total knee arthroplasty with ultra-congruent (UC) insert
arm group label: Ultra-Congruent(UC) group
intervention type: Procedure
intervention name: total knee arthroplasty with posterior-stabilized (PS) insert
arm group label: posterior-stabilized(PS) group
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: The Catholic University of Korea
investigator full name: Yong In
investigator title: Professor
mesh term: Osteoarthritis