<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/NCT02966613</url>
  </required_header>
  <id_info>
    <org_study_id>SC2900</org_study_id>
    <nct_id>NCT02966613</nct_id>
  </id_info>
  <brief_title>Fully Disposable Patient-Specific Instrumentation</brief_title>
  <acronym>MyKnee</acronym>
  <official_title>Primary TKA Using a Fully Disposable Patient-Specific Instrumentation: A Multicenter Controlled Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cochin Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cochin Hospital, India</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate the lower limb alignment following total knee arthroplasty (TKA) performed with&#xD;
      fully disposable patient-specific instrumentation versus conventional, versus patient&#xD;
      specific instrumentation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators performed a controlled multicenter trial comparing the clinical and&#xD;
      radiologic results and resources consumption of primary TKA using patient-specific cutting&#xD;
      guides (PSCG) versus conventional instrumentation (CI), and compared the results to those&#xD;
      obtained with a fully disposable patient-specific instrumentation (PSCG-D).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2013</start_date>
  <completion_date type="Actual">September 2016</completion_date>
  <primary_completion_date type="Actual">December 2015</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 (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>HKA angle</measure>
    <time_frame>3 months</time_frame>
    <description>Lower limb mechanical axis was measured on a bipodal standing leg-length anteroposterior radiograph with the patella oriented straight made three months postoperatively, using Roman software version 1.70 (Oswestry, United Kingdom). Postoperative lower limb mechanical axis was calculated from the Hip-Knee-Ankle (HKA) angle between the femoral and tibial mechanical axes, respectively. An HKA angle greater than 180° was indicative of valgus, whereas values lower than 180° indicated varus.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>% outliers</measure>
    <time_frame>3 months</time_frame>
    <description>% of patients with an HKA angle outside 180°+/- 3°</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Knee Society Score</measure>
    <time_frame>3 months</time_frame>
    <description>Validated pain and function score following TKA</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oxford Knee Score</measure>
    <time_frame>3 months</time_frame>
    <description>Patients self assessment of knee function</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">210</enrollment>
  <condition>Osteoarthritis,Knee</condition>
  <arm_group>
    <arm_group_label>CI</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>TKA using conventional instrumentation (CI)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PSCG</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>TKA performed using Patient specific cutting guides (PSCG)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PSCG-D</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>TKA performed using fully disposable Patient specific cutting guides (PSCG-D)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>GMK Medacta Total Knee arthroplasty</intervention_name>
    <description>Total Knee arthroplasty</description>
    <arm_group_label>CI</arm_group_label>
    <arm_group_label>PSCG</arm_group_label>
    <arm_group_label>PSCG-D</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients aged between 18 and 85 years&#xD;
&#xD;
          -  able to understand information&#xD;
&#xD;
          -  affiliated to social security&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  active or suspected sepsis&#xD;
&#xD;
          -  tumor around the knee&#xD;
&#xD;
          -  previous partial or total knee replacement&#xD;
&#xD;
          -  extra-articular deformation requiring osteotomy around the knee in conjunction with&#xD;
             TKA&#xD;
&#xD;
          -  social situation that could impair follow-up&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>September 26, 2016</study_first_submitted>
  <study_first_submitted_qc>November 15, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 17, 2016</study_first_posted>
  <last_update_submitted>November 15, 2016</last_update_submitted>
  <last_update_submitted_qc>November 15, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 17, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cochin Hospital</investigator_affiliation>
    <investigator_full_name>Moussa Hamadouche</investigator_full_name>
    <investigator_title>MD, PhD, Professor of Orthopaedic Surgery</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis, Knee</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/NCT02966613
org study id: SC2900
nct id: NCT02966613
lead sponsor: 
has dmc: No
To evaluate the lower limb alignment following total knee arthroplasty (TKA) performed with
      fully disposable patient-specific instrumentation versus conventional, versus patient
      specific instrumentation.
The investigators performed a controlled multicenter trial comparing the clinical and
      radiologic results and resources consumption of primary TKA using patient-specific cutting
      guides (PSCG) versus conventional instrumentation (CI), and compared the results to those
      obtained with a fully disposable patient-specific instrumentation (PSCG-D).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: HKA angle
time frame: 3 months
description: Lower limb mechanical axis was measured on a bipodal standing leg-length anteroposterior radiograph with the patella oriented straight made three months postoperatively, using Roman software version 1.70 (Oswestry, United Kingdom). Postoperative lower limb mechanical axis was calculated from the Hip-Knee-Ankle (HKA) angle between the femoral and tibial mechanical axes, respectively. An HKA angle greater than 180° was indicative of valgus, whereas values lower than 180° indicated varus.
measure: % outliers
time frame: 3 months
description: % of patients with an HKA angle outside 180°+/- 3°
measure: Knee Society Score
time frame: 3 months
description: Validated pain and function score following TKA
measure: Oxford Knee Score
time frame: 3 months
description: Patients self assessment of knee function
arm group label: CI
arm group type: Active Comparator
description: TKA using conventional instrumentation (CI)
arm group label: PSCG
arm group type: Experimental
description: TKA performed using Patient specific cutting guides (PSCG)
arm group label: PSCG-D
arm group type: Experimental
description: TKA performed using fully disposable Patient specific cutting guides (PSCG-D)
intervention type: Device
intervention name: GMK Medacta Total Knee arthroplasty
description: Total Knee arthroplasty
arm group label: CI
arm group label: PSCG
arm group label: PSCG-D
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Cochin Hospital
investigator full name: Moussa Hamadouche
investigator title: MD, PhD, Professor of Orthopaedic Surgery
mesh term: Osteoarthritis, Knee