<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/NCT01672320</url>
  </required_header>
  <id_info>
    <org_study_id>2012P000809</org_study_id>
    <nct_id>NCT01672320</nct_id>
  </id_info>
  <brief_title>Outcomes of Robotic Total Hip Arthroplasty</brief_title>
  <official_title>Outcomes of Robotic Total Hip Arthroplasty: A Prospective Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>MAKO Surgical Corp.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Massachusetts General Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objectives of this study are to evaluate the clinical value of robotic-assisted total hip&#xD;
      arthroplasty with respect to acetabular cup implantation, and to document the long-term&#xD;
      clinical outcome of patients with Total Hip Arthroplasty (THA). IRB approval will be obtained&#xD;
      at every study site to evaluate the basic clinical outcomes and post-operative component&#xD;
      placement accuracy of each MAKO® THA patient.&#xD;
&#xD;
      The hypothesis is that robotic preparation of the acetabulum will significantly reduce the&#xD;
      variability and inaccuracy in the component alignment parameters that lead to post-operative&#xD;
      complications, including implant failure.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    No patients will be recruited at Massachsetts General hospital. IRB approval changed to core&#xD;
    center.&#xD;
  </why_stopped>
  <start_date>January 2013</start_date>
  <completion_date type="Anticipated">January 2023</completion_date>
  <primary_completion_date type="Anticipated">January 2023</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>Survivorship of Components</measure>
    <time_frame>10 Years</time_frame>
    <description>Defined as implant remaining in subject.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Adverse Events</measure>
    <time_frame>10 Years</time_frame>
    <description>Protocol deviations, complications, &quot;lost to follow-up&quot;</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Retrieval Analysis of implants from revision surgery</measure>
    <time_frame>Up to 10 Years</time_frame>
    <description>When possible, analysis of the THR components that are removed at revision surgery will be anlaysed for signs of component impingment or signs of damage related to component position. These observations will be correlated to the clinical reason for revision.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Assessment/questionaire HOOS</measure>
    <time_frame>Pre-op, 1, 3, 5, 7, 10 years after surgery</time_frame>
    <description>Hip Disability and Osteoarthritis Outcome</description>
  </other_outcome>
  <other_outcome>
    <measure>Assessment/Questionaire UCLA Activty Score</measure>
    <time_frame>Pre-op, 1, 3, 5, 7, 10 years after surgery</time_frame>
    <description>Assesses level of activity</description>
  </other_outcome>
  <other_outcome>
    <measure>Assessment/Questionaire EQ-5D</measure>
    <time_frame>Pre-op, 1, 3, 5, 7, 10 years after surgery</time_frame>
    <description>General health and cost effective analysis</description>
  </other_outcome>
  <other_outcome>
    <measure>Assessment/questionaire</measure>
    <time_frame>Pre-op, 1, 3, 5, 7, 10 years after surgery</time_frame>
    <description>Hip desease specific questionaire</description>
  </other_outcome>
  <other_outcome>
    <measure>Assessment/Questionaire Case Mix Indicator</measure>
    <time_frame>Pre-op, 1, 3, 5, 7, 10 years after surgery</time_frame>
    <description>Identifies comorbidities</description>
  </other_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Osteoarthritis</condition>
  <arm_group>
    <arm_group_label>Phase II</arm_group_label>
    <description>An evaluation of long-term outcomes, patient reported outcomes, and radiographic analysis will be conducted prospectively on 500 patients</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Phase I</arm_group_label>
    <description>An analysis of post-operative component positioning will be evaluated for 500 patients, retrospectively.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Adults requiring a total hip arthroplasty procedure.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female&#xD;
&#xD;
          -  20 to 75 years of age&#xD;
&#xD;
          -  Subjects requiring primary total hip replacement&#xD;
&#xD;
          -  Contralateral hip should be relatively free from arthritis for comparison purposes,&#xD;
             specifically with less than a grade of 2 on the Kellgren-Lawrence Scale.&#xD;
&#xD;
          -  Subjects diagnosed with osteoarthritis or traumatic arthritis&#xD;
&#xD;
          -  Subjects with avascular necrosis&#xD;
&#xD;
          -  Subjects who demonstrate the ability to return for follow-up for the next 10 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with difficulty understanding protocol for any reason&#xD;
&#xD;
          -  Subjects with a limited life span&#xD;
&#xD;
          -  Subjects with inflammatory hip disease, previous joint infection, or those requiring&#xD;
             hip revision surgery&#xD;
&#xD;
          -  Female subjects who are pregnant, or who plan to get pregnant while enrolled in the&#xD;
             study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2013</verification_date>
  <study_first_submitted>August 10, 2012</study_first_submitted>
  <study_first_submitted_qc>August 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 24, 2012</study_first_posted>
  <last_update_submitted>November 4, 2013</last_update_submitted>
  <last_update_submitted_qc>November 4, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 5, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
    <investigator_full_name>Charles R. Bragdon</investigator_full_name>
    <investigator_title>Research Scientist</investigator_title>
  </responsible_party>
  <keyword>Robotic</keyword>
  <keyword>Arthroplasty</keyword>
  <keyword>Total Hip Arthroplasty</keyword>
  <keyword>Cup Positioning</keyword>
  <keyword>Outcomes</keyword>
  <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/NCT01672320
org study id: 2012P000809
nct id: NCT01672320
lead sponsor: 
collaborator: 
has dmc: No
The objectives of this study are to evaluate the clinical value of robotic-assisted total hip
      arthroplasty with respect to acetabular cup implantation, and to document the long-term
      clinical outcome of patients with Total Hip Arthroplasty (THA). IRB approval will be obtained
      at every study site to evaluate the basic clinical outcomes and post-operative component
      placement accuracy of each MAKO® THA patient.

      The hypothesis is that robotic preparation of the acetabulum will significantly reduce the
      variability and inaccuracy in the component alignment parameters that lead to post-operative
      complications, including implant failure.
observational model: Cohort
time perspective: Prospective
measure: Survivorship of Components
time frame: 10 Years
description: Defined as implant remaining in subject.
measure: Adverse Events
time frame: 10 Years
description: Protocol deviations, complications, "lost to follow-up"
measure: Retrieval Analysis of implants from revision surgery
time frame: Up to 10 Years
description: When possible, analysis of the THR components that are removed at revision surgery will be anlaysed for signs of component impingment or signs of damage related to component position. These observations will be correlated to the clinical reason for revision.
measure: Assessment/questionaire HOOS
time frame: Pre-op, 1, 3, 5, 7, 10 years after surgery
description: Hip Disability and Osteoarthritis Outcome
measure: Assessment/Questionaire UCLA Activty Score
time frame: Pre-op, 1, 3, 5, 7, 10 years after surgery
description: Assesses level of activity
measure: Assessment/Questionaire EQ-5D
time frame: Pre-op, 1, 3, 5, 7, 10 years after surgery
description: General health and cost effective analysis
measure: Assessment/questionaire
time frame: Pre-op, 1, 3, 5, 7, 10 years after surgery
description: Hip desease specific questionaire
measure: Assessment/Questionaire Case Mix Indicator
time frame: Pre-op, 1, 3, 5, 7, 10 years after surgery
description: Identifies comorbidities
arm group label: Phase II
description: An evaluation of long-term outcomes, patient reported outcomes, and radiographic analysis will be conducted prospectively on 500 patients
arm group label: Phase I
description: An analysis of post-operative component positioning will be evaluated for 500 patients, retrospectively.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Massachusetts General Hospital
investigator full name: Charles R. Bragdon
investigator title: Research Scientist
mesh term: Osteoarthritis