<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/NCT01668160</url>
  </required_header>
  <id_info>
    <org_study_id>2012P000925</org_study_id>
    <secondary_id>216494</secondary_id>
    <nct_id>NCT01668160</nct_id>
  </id_info>
  <brief_title>Stability of Revision Total Hip Arthroplasty Implants Using Radiostereometric Analysis</brief_title>
  <official_title>Analysis of the Stability of Total Hip Arthroplasty Implants Used in Revision Surgery Using Radiostereometric Analysis (RSA)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Massachusetts General Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The specific aim is to quantify the stability of the acetabular and femoral components of a&#xD;
      revision total hip arthroplasty (THA) in vivo as currently performed at our institution. In&#xD;
      this way, the investigators will gain insight into the outcome of the current state of the&#xD;
      art of revision arthroplasty surgery. In the past, acetabular and femoral component stability&#xD;
      has been measured using radiostereometric analysis (RSA) and when patients having revision&#xD;
      total hip operations were compared to patients undergoing primary total hip operations it was&#xD;
      possible to determine differences in stability and this was predictive of the intermediate to&#xD;
      long-term performance of the acetabular and femoral reconstruction. The investigators propose&#xD;
      to use this established, high resolution technique to assess and compare the stability of the&#xD;
      revision implants.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <start_date>February 2012</start_date>
  <completion_date type="Anticipated">January 2020</completion_date>
  <primary_completion_date type="Anticipated">January 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Stability of Acetabular and femoral components</measure>
    <time_frame>1, 2, 3, 5 years after surgery</time_frame>
    <description>RSA films will be taken at the prescribed time intervals to measure component mothion over time.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Wear of the polyethlene component</measure>
    <time_frame>1, 2, 3, 5 years after surgery</time_frame>
    <description>The movement of the femoral head into the polyethylenen, (wear), will be measured at the prescribed time intervals.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Assessment/questionaire HOOS</measure>
    <time_frame>Pre-op, 1, 2, 3, 5 years after surgery</time_frame>
    <description>Hip disability and Osteoarthritis Outcome Score</description>
  </other_outcome>
  <other_outcome>
    <measure>Assessment/Questionaires Harris Hip Score</measure>
    <time_frame>Pre-op, 1, 2, 3, 5 years after surgery</time_frame>
    <description>Hip specific questionaire</description>
  </other_outcome>
  <other_outcome>
    <measure>Assessment/Questionaire UCLA Activity Score</measure>
    <time_frame>Pre-op, 1, 2, 3, 5 years after surgery</time_frame>
    <description>Measure of activity level</description>
  </other_outcome>
  <other_outcome>
    <measure>Assessment/Questionaire EQ-5D</measure>
    <time_frame>Pre-op, 1, 2, 3, 5 years after surgery</time_frame>
    <description>General health and cost effectiveness measure</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>Determines comorbidities</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Osteoarthritis of Hip</condition>
  <condition>Failure of Primary THA</condition>
  <arm_group>
    <arm_group_label>Revision Total Hip</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patients recieving a revision total hip replacement will be assessed for implant stability and wear using RSA. Tantalum beads will be placed in the polyethylene and surrounding pelvic and femoral bone.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Bead placement during revision hip replacement surgery</intervention_name>
    <description>Tantalum beads will be placed in the surrounding pelvic and femoral bone and the polyethylene component during surgical treatment of failed primary THA components</description>
    <arm_group_label>Revision Total Hip</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female.&#xD;
&#xD;
          2. 25 to 75 years of age.&#xD;
&#xD;
          3. Subjects requiring revision total hip replacement.&#xD;
&#xD;
          4. Subjects who demonstrate the ability to return to MGH for follow-up for the next five&#xD;
             years.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subjects with limited life span.&#xD;
&#xD;
          2. Subjects with difficulty in comprehending study protocol for any reason.&#xD;
&#xD;
          3. Subjects with complex disease entities which significantly increase the risks of the&#xD;
             surgery such as any major platelet abnormality, hematological disorder, or any other&#xD;
             major medical complication which could substantially reduce longevity, put them at&#xD;
             further risk due to immunocompromisation or increase the risk of infection.&#xD;
&#xD;
          4. Female subjects that are pregnant or who may suspect they are pregnant or who plan to&#xD;
             become pregnant while participating in this study.&#xD;
&#xD;
               -  A urine HCG will be done in all women of child bearing potential prior to RSA&#xD;
                  imaging at each follow-up visit. The result will be recorded in the research&#xD;
                  record.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 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 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 17, 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>Reseach scientist</investigator_title>
  </responsible_party>
  <keyword>clinical outcomes</keyword>
  <keyword>radiographic outcomes</keyword>
  <keyword>total hip arthroplasty</keyword>
  <keyword>survivorship</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis, Hip</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/NCT01668160
org study id: 2012P000925
secondary id: 216494
nct id: NCT01668160
lead sponsor: 
has dmc: Yes
The specific aim is to quantify the stability of the acetabular and femoral components of a
      revision total hip arthroplasty (THA) in vivo as currently performed at our institution. In
      this way, the investigators will gain insight into the outcome of the current state of the
      art of revision arthroplasty surgery. In the past, acetabular and femoral component stability
      has been measured using radiostereometric analysis (RSA) and when patients having revision
      total hip operations were compared to patients undergoing primary total hip operations it was
      possible to determine differences in stability and this was predictive of the intermediate to
      long-term performance of the acetabular and femoral reconstruction. The investigators propose
      to use this established, high resolution technique to assess and compare the stability of the
      revision implants.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Stability of Acetabular and femoral components
time frame: 1, 2, 3, 5 years after surgery
description: RSA films will be taken at the prescribed time intervals to measure component mothion over time.
measure: Wear of the polyethlene component
time frame: 1, 2, 3, 5 years after surgery
description: The movement of the femoral head into the polyethylenen, (wear), will be measured at the prescribed time intervals.
measure: Assessment/questionaire HOOS
time frame: Pre-op, 1, 2, 3, 5 years after surgery
description: Hip disability and Osteoarthritis Outcome Score
measure: Assessment/Questionaires Harris Hip Score
time frame: Pre-op, 1, 2, 3, 5 years after surgery
description: Hip specific questionaire
measure: Assessment/Questionaire UCLA Activity Score
time frame: Pre-op, 1, 2, 3, 5 years after surgery
description: Measure of activity level
measure: Assessment/Questionaire EQ-5D
time frame: Pre-op, 1, 2, 3, 5 years after surgery
description: General health and cost effectiveness measure
measure: Assessment/Questionaire Case Mix indicator
time frame: Pre-op, 1, 3, 5, 7, 10 years after surgery
description: Determines comorbidities
arm group label: Revision Total Hip
arm group type: Experimental
description: patients recieving a revision total hip replacement will be assessed for implant stability and wear using RSA. Tantalum beads will be placed in the polyethylene and surrounding pelvic and femoral bone.
intervention type: Procedure
intervention name: Bead placement during revision hip replacement surgery
description: Tantalum beads will be placed in the surrounding pelvic and femoral bone and the polyethylene component during surgical treatment of failed primary THA components
arm group label: Revision Total Hip
criteria: 
gender: All
minimum age: 25 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: Reseach scientist
mesh term: Osteoarthritis, Hip