<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/NCT02239406</url>
  </required_header>
  <id_info>
    <org_study_id>HK025</org_study_id>
    <nct_id>NCT02239406</nct_id>
  </id_info>
  <brief_title>Acetabular Bone Vascularity in Metal-on-Metal Revisions</brief_title>
  <official_title>Acetabular Bone Vascularity in Metal-on-Metal Revisions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>OrthoCarolina Research Institute, Inc.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Presbyterian Pathology Group</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>OrthoCarolina Research Institute, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine if avascular necrosis of the acetabulum is present&#xD;
      in metal-on-metal revisions and to what depth this dead avascular bone occurs.&#xD;
&#xD;
      A convenient sample of a consecutive series of 15 patients treated for metal on metal&#xD;
      acetabular revision surgery will be included.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients being treated for metal on metal acetabular revision surgery by a physician at&#xD;
      OrthoCarolina, PA will be screened for eligibility. These patients will be approached by&#xD;
      their surgeon and asked to volunteer their participation in the study. Potential subjects&#xD;
      will meet with a research coordinator to discuss details of the study and those you volunteer&#xD;
      participation will be asked to sign an informed consent prior to the collection of study&#xD;
      data. . Basic demographic information (initials, age, gender, height, weight, BMI), dates of&#xD;
      original index surgery, reason for revision, type of implant being removed, and standard of&#xD;
      care cobalt and chromium metal ion levels will be collected via chart review.&#xD;
&#xD;
      Patients who meet all eligibility criteria will have three biopsies performed at the time of&#xD;
      their revision surgery. A pathologist will note the presence or absence of bone necrosis and&#xD;
      will measure the length (mm) of necrosis, acute inflammation, chronic inflammation, normal&#xD;
      bone, and entire bone specimen in order to obtain a ratio.&#xD;
&#xD;
      Biopsy Protocol:&#xD;
&#xD;
      A bone biopsy is a procedure in which bone samples are removed (with a special instrument&#xD;
      during surgery) and looked at under a microscope for necrosis (tissue death), infection, or&#xD;
      other bone disorders. Once the acetabular hip replacement implants have been removed the&#xD;
      following steps will occur:&#xD;
&#xD;
        -  The biopsy needle will be inserted into the bone (3 locations; 2 from ilium, 1 from&#xD;
           pubis or ischium = 3 total).&#xD;
&#xD;
        -  The biopsy needle will be withdrawn and firm pressure will be applied to the biopsy site&#xD;
           for a few minutes, until the bleeding has stopped.&#xD;
&#xD;
        -  Each bone biopsy sample will be labeled sequentially and by anatomic location (i.e.,&#xD;
           ilium #1, ilium #2)&#xD;
&#xD;
        -  The normal bone will be marked on the bone sample.&#xD;
&#xD;
        -  The bone biopsy sample will be sent to the lab for examination.&#xD;
&#xD;
        -  The acetabulum bone will be reamed so the new implant can be seated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Lack of enrollment interest.&#xD;
  </why_stopped>
  <start_date>November 2014</start_date>
  <completion_date type="Actual">April 2016</completion_date>
  <primary_completion_date type="Actual">April 2016</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>The depth (mm) of avascular bone from the acetabular surface per each patient</measure>
    <time_frame>participants will be followed for the duration of their surgery, an expected average of 2 hours</time_frame>
    <description>A bone biopsy is a procedure in which bone samples are removed (with a special instrument during surgery) and looked at under a microscope for necrosis (tissue death), infection, or other bone disorders. Once the acetabular hip replacement implants have been removed the following steps will occur:&#xD;
The biopsy needle will be inserted into the bone (3 locations; 2 from ilium, 1 from pubis or ischium = 3 total).&#xD;
The biopsy needle will be withdrawn and firm pressure will be applied to the biopsy site for a few minutes, until the bleeding has stopped.&#xD;
Each bone biopsy sample will be labeled sequentially and by anatomic location (i.e., ilium #1, ilium #2)&#xD;
The normal bone will be marked on the bone sample.&#xD;
The bone biopsy sample will be sent to the lab for examination.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The ratio of necrotic bone per each patient</measure>
    <time_frame>paricipants will be followed for the duration of their surgery, an expected average of 2 hours</time_frame>
    <description>The ratio of each bone type (necrotic, acute inflammation, chronic inflammation, and normal bone) in relation to the length of the entire bone specimen will be measured.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">7</enrollment>
  <condition>Failure of Total Hip</condition>
  <arm_group>
    <arm_group_label>Metal-on-Metal Revision</arm_group_label>
    <description>Patients who have a failed metal on metal total hip implant and are presenting for revision surgery</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        A convenience sample of a total of 15 patients will be enrolled at OrthoCarolina.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients being revised for an aseptic metal on metal acetabular revision.&#xD;
&#xD;
          -  Patient is greater than one year postoperative.&#xD;
&#xD;
          -  Patient has had cobalt and chromium metal ion levels tested within 6 months of the&#xD;
             planned revision surgery.&#xD;
&#xD;
          -  Understands the local language and is willing and able to follow the requirements of&#xD;
             the protocol.&#xD;
&#xD;
          -  Understands the informed consent and signs the institutional review board or&#xD;
             independent ethics committee (IRB/IEC) approved informed consent form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of infection&#xD;
&#xD;
          -  Evidence of current substance or alcohol abuse&#xD;
&#xD;
          -  Being treated with radiation, chemotherapy, immunosupression, or chronic steroid&#xD;
             therapy (prednisone use up to 5 mg/qd or its equivalent is allowed)&#xD;
&#xD;
          -  Is a prisoner&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Thomas Fehring, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>OrthoCarolina Research Institute, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>OrthoCarolina</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2016</verification_date>
  <study_first_submitted>September 10, 2014</study_first_submitted>
  <study_first_submitted_qc>September 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2014</study_first_posted>
  <last_update_submitted>July 21, 2016</last_update_submitted>
  <last_update_submitted_qc>July 21, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 22, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>metal on metal total hip</keyword>
  <keyword>avasuclar necrosis</keyword>
  <keyword>acetabular revision</keyword>
  <keyword>bone vascularity</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02239406
org study id: HK025
nct id: NCT02239406
lead sponsor: 
collaborator: 
has dmc: Yes
The purpose of this study is to determine if avascular necrosis of the acetabulum is present
      in metal-on-metal revisions and to what depth this dead avascular bone occurs.

      A convenient sample of a consecutive series of 15 patients treated for metal on metal
      acetabular revision surgery will be included.
Patients being treated for metal on metal acetabular revision surgery by a physician at
      OrthoCarolina, PA will be screened for eligibility. These patients will be approached by
      their surgeon and asked to volunteer their participation in the study. Potential subjects
      will meet with a research coordinator to discuss details of the study and those you volunteer
      participation will be asked to sign an informed consent prior to the collection of study
      data. . Basic demographic information (initials, age, gender, height, weight, BMI), dates of
      original index surgery, reason for revision, type of implant being removed, and standard of
      care cobalt and chromium metal ion levels will be collected via chart review.

      Patients who meet all eligibility criteria will have three biopsies performed at the time of
      their revision surgery. A pathologist will note the presence or absence of bone necrosis and
      will measure the length (mm) of necrosis, acute inflammation, chronic inflammation, normal
      bone, and entire bone specimen in order to obtain a ratio.

      Biopsy Protocol:

      A bone biopsy is a procedure in which bone samples are removed (with a special instrument
      during surgery) and looked at under a microscope for necrosis (tissue death), infection, or
      other bone disorders. Once the acetabular hip replacement implants have been removed the
      following steps will occur:

        -  The biopsy needle will be inserted into the bone (3 locations; 2 from ilium, 1 from
           pubis or ischium = 3 total).

        -  The biopsy needle will be withdrawn and firm pressure will be applied to the biopsy site
           for a few minutes, until the bleeding has stopped.

        -  Each bone biopsy sample will be labeled sequentially and by anatomic location (i.e.,
           ilium #1, ilium #2)

        -  The normal bone will be marked on the bone sample.

        -  The bone biopsy sample will be sent to the lab for examination.

        -  The acetabulum bone will be reamed so the new implant can be seated.
observational model: Cohort
time perspective: Prospective
measure: The depth (mm) of avascular bone from the acetabular surface per each patient
time frame: participants will be followed for the duration of their surgery, an expected average of 2 hours
description: A bone biopsy is a procedure in which bone samples are removed (with a special instrument during surgery) and looked at under a microscope for necrosis (tissue death), infection, or other bone disorders. Once the acetabular hip replacement implants have been removed the following steps will occur:
The biopsy needle will be inserted into the bone (3 locations; 2 from ilium, 1 from pubis or ischium = 3 total).
The biopsy needle will be withdrawn and firm pressure will be applied to the biopsy site for a few minutes, until the bleeding has stopped.
Each bone biopsy sample will be labeled sequentially and by anatomic location (i.e., ilium #1, ilium #2)
The normal bone will be marked on the bone sample.
The bone biopsy sample will be sent to the lab for examination.
measure: The ratio of necrotic bone per each patient
time frame: paricipants will be followed for the duration of their surgery, an expected average of 2 hours
description: The ratio of each bone type (necrotic, acute inflammation, chronic inflammation, and normal bone) in relation to the length of the entire bone specimen will be measured.
arm group label: Metal-on-Metal Revision
description: Patients who have a failed metal on metal total hip implant and are presenting for revision surgery
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Thomas Fehring, MD
role: Principal Investigator
affiliation: OrthoCarolina Research Institute, Inc.
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No