<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/NCT01676038</url>
  </required_header>
  <id_info>
    <org_study_id>2011/519/D</org_study_id>
    <nct_id>NCT01676038</nct_id>
  </id_info>
  <brief_title>Pinless-Navigated Versus Conventional Total Knee Arthroplasty</brief_title>
  <official_title>Radiographic Analysis Comparing Pinless-Navigated and Conventional Total Knee Arthroplasty: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Singapore General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Singapore General Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The success of total knee arthroplasty depends on a number of factors including pre-operative&#xD;
      range of movement, obesity, medical comorbidities, prosthesis design, preparation and&#xD;
      implantation of the prosthesis, soft tissue balancing, as well as implants alignment. Optimal&#xD;
      placement of the implants within 3° of the mechanical axis of the lower limb has been proven&#xD;
      to reduce wear and early implant failure.&#xD;
&#xD;
      Compared to conventional techniques, computer-Aided Navigation total knee arthroplasty has&#xD;
      been widely used in the last decade and have been proven to improve the accuracy of&#xD;
      prosthesis placement and lower limb alignment by reducing the number of outliers with more&#xD;
      than 3° deviation from the mechanical axis. However, its use also involves a steep learning&#xD;
      curve, high initial capital cost and longer duration of surgery.&#xD;
&#xD;
      Traditional computer-navigated TKA using optical tracking systems also requires fixation of&#xD;
      the femoral and tibial reference arrays to bone using anchoring pins. Complications reported&#xD;
      with the use of these pins include either femoral or tibial fracture, pin site pain, pin site&#xD;
      infection and osteomyelitis. The investigators study aims to investigate the accuracy of a&#xD;
      new pinless navigation system for TKA that will avoid these complications.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The duration of surgery and length of hospital stay were recorded for all patients. Three&#xD;
      radiographic measurements were recorded on the coronal films: 1) Hip-Knee-Ankle Angle (HKA),&#xD;
      the angle formed by the mechanical axis of the femur (line between the centre of the femoral&#xD;
      head and the centre of the knee) and the mechanical axis of the tibia (line between the&#xD;
      centre of the talus and the centre of the knee); 2) Coronal Femoral-Component Angle (CFA),&#xD;
      the angle formed by the femoral component and the mechanical axis of the femur; 3) Coronal&#xD;
      Tibia-Component Angle (CTA), the angle formed by the tibia base plate and the mechanical axis&#xD;
      of the tibia. The post-operative radiographic measurements were compared with the&#xD;
      intra-operative readings from the pinless navigation system. The accepted values used in our&#xD;
      study for normal alignment were: 1) 0° ± 3° varus/valgus for HKA; 2) perpendicular (± 3°) to&#xD;
      the mechanical axis of the femur; 3) perpendicular (± 3°) to the mechanical axis of the&#xD;
      tibia.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2011</start_date>
  <completion_date type="Actual">August 2014</completion_date>
  <primary_completion_date type="Actual">June 2012</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>Radiographic analysis</measure>
    <time_frame>Up till 1 year</time_frame>
    <description>The number of outliers and mean value of: 1) Hip-Knee-Ankle Angle (HKA), the angle formed by the mechanical axis of the femur (line between the centre of the femoral head and the centre of the knee) and the mechanical axis of the tibia (line between the centre of the talus and the centre of the knee); 2) Coronal Femoral-Component Angle (CFA), the angle formed by the femoral component and the mechanical axis of the femur; 3) Coronal Tibia-Component Angle (CTA), the angle formed by the tibia base plate and the mechanical axis of the tibia.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Duration of surgery</measure>
    <time_frame>Up till 1 year</time_frame>
    <description>Comparing the mean duration of surgery for both surgical arms.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Arthropathy of Knee</condition>
  <arm_group>
    <arm_group_label>Pinless-Navigated Total Knee Arthroplasty</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The patients underwent total knee arthroplasty using a Pinless-Navigated system that is designed to restore the mechanical alignment of the lower limb.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional Total Knee Arthroplasty</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The patients underwent total knee arthroplasty using conventional technique.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Pinless-Navigated Total Knee Arthroplasty</intervention_name>
    <description>Brainlab VectorVision Knee 2.5 Navigation System</description>
    <arm_group_label>Pinless-Navigated Total Knee Arthroplasty</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Conventional Total Knee Arthroplasty</intervention_name>
    <description>Conventional technique.</description>
    <arm_group_label>Conventional Total Knee Arthroplasty</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients between the ages of 45 and 90 diagnosed with osteoarthritis of the knee and&#xD;
             scheduled for unilateral total knee replacement.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients coming for revision total knee arthroplasty&#xD;
&#xD;
          -  Patients diagnosed with inflammatory arthritis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pak Lin Chin, FRCS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Singapore General Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Singapore General Hospital</name>
      <address>
        <city>Singapore</city>
        <zip>169608</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Singapore</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>August 3, 2012</study_first_submitted>
  <study_first_submitted_qc>August 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 30, 2012</study_first_posted>
  <last_update_submitted>April 16, 2018</last_update_submitted>
  <last_update_submitted_qc>April 16, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 18, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Total Knee Replacement, Computer-Assisted Surgery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Joint Diseases</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/NCT01676038
org study id: 2011/519/D
nct id: NCT01676038
lead sponsor: 
has dmc: Yes
The success of total knee arthroplasty depends on a number of factors including pre-operative
      range of movement, obesity, medical comorbidities, prosthesis design, preparation and
      implantation of the prosthesis, soft tissue balancing, as well as implants alignment. Optimal
      placement of the implants within 3° of the mechanical axis of the lower limb has been proven
      to reduce wear and early implant failure.

      Compared to conventional techniques, computer-Aided Navigation total knee arthroplasty has
      been widely used in the last decade and have been proven to improve the accuracy of
      prosthesis placement and lower limb alignment by reducing the number of outliers with more
      than 3° deviation from the mechanical axis. However, its use also involves a steep learning
      curve, high initial capital cost and longer duration of surgery.

      Traditional computer-navigated TKA using optical tracking systems also requires fixation of
      the femoral and tibial reference arrays to bone using anchoring pins. Complications reported
      with the use of these pins include either femoral or tibial fracture, pin site pain, pin site
      infection and osteomyelitis. The investigators study aims to investigate the accuracy of a
      new pinless navigation system for TKA that will avoid these complications.
The duration of surgery and length of hospital stay were recorded for all patients. Three
      radiographic measurements were recorded on the coronal films: 1) Hip-Knee-Ankle Angle (HKA),
      the angle formed by the mechanical axis of the femur (line between the centre of the femoral
      head and the centre of the knee) and the mechanical axis of the tibia (line between the
      centre of the talus and the centre of the knee); 2) Coronal Femoral-Component Angle (CFA),
      the angle formed by the femoral component and the mechanical axis of the femur; 3) Coronal
      Tibia-Component Angle (CTA), the angle formed by the tibia base plate and the mechanical axis
      of the tibia. The post-operative radiographic measurements were compared with the
      intra-operative readings from the pinless navigation system. The accepted values used in our
      study for normal alignment were: 1) 0° ± 3° varus/valgus for HKA; 2) perpendicular (± 3°) to
      the mechanical axis of the femur; 3) perpendicular (± 3°) to the mechanical axis of the
      tibia.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Radiographic analysis
time frame: Up till 1 year
description: The number of outliers and mean value of: 1) Hip-Knee-Ankle Angle (HKA), the angle formed by the mechanical axis of the femur (line between the centre of the femoral head and the centre of the knee) and the mechanical axis of the tibia (line between the centre of the talus and the centre of the knee); 2) Coronal Femoral-Component Angle (CFA), the angle formed by the femoral component and the mechanical axis of the femur; 3) Coronal Tibia-Component Angle (CTA), the angle formed by the tibia base plate and the mechanical axis of the tibia.
measure: Duration of surgery
time frame: Up till 1 year
description: Comparing the mean duration of surgery for both surgical arms.
arm group label: Pinless-Navigated Total Knee Arthroplasty
arm group type: Active Comparator
description: The patients underwent total knee arthroplasty using a Pinless-Navigated system that is designed to restore the mechanical alignment of the lower limb.
arm group label: Conventional Total Knee Arthroplasty
arm group type: Active Comparator
description: The patients underwent total knee arthroplasty using conventional technique.
intervention type: Procedure
intervention name: Pinless-Navigated Total Knee Arthroplasty
description: Brainlab VectorVision Knee 2.5 Navigation System
arm group label: Pinless-Navigated Total Knee Arthroplasty
intervention type: Procedure
intervention name: Conventional Total Knee Arthroplasty
description: Conventional technique.
arm group label: Conventional Total Knee Arthroplasty
criteria: 
gender: All
minimum age: 45 Years
maximum age: 90 Years
healthy volunteers: No
last name: Pak Lin Chin, FRCS
role: Principal Investigator
affiliation: Singapore General Hospital
facility: 
country: Singapore
responsible party type: Sponsor
mesh term: Joint Diseases