<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/NCT02993016</url>
  </required_header>
  <id_info>
    <org_study_id>patient-specific instruments</org_study_id>
    <nct_id>NCT02993016</nct_id>
  </id_info>
  <brief_title>Conventional Versus Patient-specific Instruments in Total Knee Arthroplasty</brief_title>
  <official_title>Comparison of Conventional Versus Patient-specific Instruments in Total Knee Arthroplasty: A Randomized Controlled Trial</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>
      Total knee arthroplasty (TKA) has a high success rate for addressing pain and improving&#xD;
      function. However, in instances where incorrect positioning and malignment of the TKA&#xD;
      components are observed, patients can experience a range of negative postoperative outcomes&#xD;
      such as loss of thickness of polyethylene tibial bearings, eccentric loading, implant&#xD;
      loosening, and eventual early revision. To avoid these complications, achieving a&#xD;
      postoperative alignment within the range of 0°±3° of the mechanical axis is recommended.&#xD;
      Manual intramedullary/extramedullary guides are not thought to be capable of consistently&#xD;
      achieving axes in this range, and though computer-assisted navigation has shown superior&#xD;
      results in comparison with conventional instrumentation, it is also limited by increased&#xD;
      surgical times and no clear superiority in improving short-term clinical outcomes. Thus,&#xD;
      there has been in a push in the orthopaedic community to create more precise technologies to&#xD;
      aid in the reconstruction of the knee's mechanical axis. Patient-specific instrumentation&#xD;
      (PSI), which uses anatomical data obtained primarily from pre-operative axial computed&#xD;
      tomography (CT) or magnetic resonance imaging (MRI) to create disposable cutting jigs&#xD;
      individualized to the patient's unique anatomy, was created with this goal.&#xD;
&#xD;
      This study aims to compare the clinical results of conventional and patient-specific&#xD;
      instruments in 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 PSI would lead&#xD;
      to a neutral mechanical axis on average more frequently than conventional instrumentation.&#xD;
&#xD;
      The study design is a double-blind randomized controlled trial. Randomly, fifty patients&#xD;
      planed to undergo total knee arthroplasty using conventional instruments and other fifty&#xD;
      patients undergo total knee arthroplasty using patient-specific instruments. The clinical&#xD;
      outcome is comparative preoperative, postoperative 6weeks, 3months, 6months and 1years. And&#xD;
      clinical score consists of Range of Motion (ROM), WOMAC (Western Ontario and McMaster&#xD;
      University Arthritis Index) pain scale (preoperative and postoperative 6, 12, 24 months),&#xD;
      Knee Society Score (preoperative and postoperative 6, 12, 24 months), Anterior and posterior&#xD;
      stress view on X-ray (preoperative and postoperative 6, 12, 24 months).&#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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in Range of Motion (ROM)</measure>
    <time_frame>Changes from Baseline Range of Motion at postoperative 1 year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in WOMAC (Western Ontario and McMaster University Arthritis Index)</measure>
    <time_frame>Changes from Baseline score to score of postoperative 1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Knee Society Score</measure>
    <time_frame>Changes from Baseline score to score of postoperative 1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Anterior and posterior stress view on X-ray</measure>
    <time_frame>Changes from Baseline Anterior and posterior stress view on X-ray at postoperative 1 year</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Osteoarthritis, Patient-specific Instruments</condition>
  <arm_group>
    <arm_group_label>patient-specific instruments group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>procedure: PSI (patient-specific instruments) will be used as the cutting guide in total knee arthroplasty.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>conventional instruments group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>procedure: Conventional instruments will be used as the cutting guide in total knee arthroplasty.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>patient-specific instruments</intervention_name>
    <arm_group_label>patient-specific instruments group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>The Signature™ Vanguard</intervention_name>
    <arm_group_label>patient-specific instruments group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>conventional instruments</intervention_name>
    <arm_group_label>conventional instruments group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Vanguard PS(posterior stabilized)</intervention_name>
    <arm_group_label>conventional instruments 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;
          -  over 5 degree in lateral bowing of femur&#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>
  <overall_official>
    <last_name>Yong In, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>the Catholic Univerisity of Korea Seoul St Mary's hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yong In, MD, PhD</last_name>
    <phone>8290445228</phone>
    <email>iy1000@catholic.ac.kr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Youngjun Choi, MD</last_name>
    <phone>8258985857</phone>
    <email>wogur79@naver.com</email>
  </overall_contact_backup>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 8, 2016</study_first_submitted>
  <study_first_submitted_qc>December 13, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 14, 2016</study_first_posted>
  <last_update_submitted>December 13, 2016</last_update_submitted>
  <last_update_submitted_qc>December 13, 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/NCT02993016
org study id: patient-specific instruments
nct id: NCT02993016
lead sponsor: 
has dmc: No
Total knee arthroplasty (TKA) has a high success rate for addressing pain and improving
      function. However, in instances where incorrect positioning and malignment of the TKA
      components are observed, patients can experience a range of negative postoperative outcomes
      such as loss of thickness of polyethylene tibial bearings, eccentric loading, implant
      loosening, and eventual early revision. To avoid these complications, achieving a
      postoperative alignment within the range of 0°±3° of the mechanical axis is recommended.
      Manual intramedullary/extramedullary guides are not thought to be capable of consistently
      achieving axes in this range, and though computer-assisted navigation has shown superior
      results in comparison with conventional instrumentation, it is also limited by increased
      surgical times and no clear superiority in improving short-term clinical outcomes. Thus,
      there has been in a push in the orthopaedic community to create more precise technologies to
      aid in the reconstruction of the knee's mechanical axis. Patient-specific instrumentation
      (PSI), which uses anatomical data obtained primarily from pre-operative axial computed
      tomography (CT) or magnetic resonance imaging (MRI) to create disposable cutting jigs
      individualized to the patient's unique anatomy, was created with this goal.

      This study aims to compare the clinical results of conventional and patient-specific
      instruments in 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 PSI would lead
      to a neutral mechanical axis on average more frequently than conventional instrumentation.

      The study design is a double-blind randomized controlled trial. Randomly, fifty patients
      planed to undergo total knee arthroplasty using conventional instruments and other fifty
      patients undergo total knee arthroplasty using patient-specific instruments. 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 (preoperative and postoperative 6, 12, 24 months),
      Knee Society Score (preoperative and postoperative 6, 12, 24 months), Anterior and posterior
      stress view on X-ray (preoperative and postoperative 6, 12, 24 months).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Changes in Range of Motion (ROM)
time frame: Changes from Baseline Range of Motion at postoperative 1 year
measure: Changes in WOMAC (Western Ontario and McMaster University Arthritis Index)
time frame: Changes from Baseline score to score of postoperative 1 year
measure: Changes in Knee Society Score
time frame: Changes from Baseline score to score of postoperative 1 year
measure: Changes in Anterior and posterior stress view on X-ray
time frame: Changes from Baseline Anterior and posterior stress view on X-ray at postoperative 1 year
arm group label: patient-specific instruments group
arm group type: Experimental
description: procedure: PSI (patient-specific instruments) will be used as the cutting guide in total knee arthroplasty.
arm group label: conventional instruments group
arm group type: Active Comparator
description: procedure: Conventional instruments will be used as the cutting guide in total knee arthroplasty.
intervention type: Procedure
intervention name: patient-specific instruments
arm group label: patient-specific instruments group
intervention type: Device
intervention name: The Signature™ Vanguard
arm group label: patient-specific instruments group
intervention type: Procedure
intervention name: conventional instruments
arm group label: conventional instruments group
intervention type: Device
intervention name: Vanguard PS(posterior stabilized)
arm group label: conventional instruments group
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Yong In, MD, PhD
role: Study Chair
affiliation: the Catholic Univerisity of Korea Seoul St Mary's hospital
last name: Yong In, MD, PhD
phone: 8290445228
email: iy1000@catholic.ac.kr
last name: Youngjun Choi, MD
phone: 8258985857
email: wogur79@naver.com
responsible party type: Principal Investigator
investigator affiliation: The Catholic University of Korea
investigator full name: Yong In
investigator title: Professor
mesh term: Osteoarthritis