<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/NCT02220478</url>
  </required_header>
  <id_info>
    <org_study_id>ORTHO.CR.GH24</org_study_id>
    <nct_id>NCT02220478</nct_id>
  </id_info>
  <brief_title>Signature Acetabular Posterior/Lateral Data Collection</brief_title>
  <official_title>A Prospective Controlled Study on Signature Anterior Posterior/Lateral Acetabular Cup Placement System in Total Hip Arthroplasty</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zimmer Biomet</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zimmer Biomet</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary purpose of this pilot study is to evaluate the accuracy of cup placement between&#xD;
      two instrumentation technologies: Cutting Guide and Conventional Instrumentation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Using a more advanced surgical technique may assist surgeons and patients in a variety of&#xD;
      ways including identifying a specific-size for the prosthesis prior to surgery, increasing&#xD;
      operating room efficiency, and reducing the number of traditional instruments needed. This&#xD;
      may reduce cost associated with the instrument inventory and instrument sterilization.&#xD;
      Operating time may also be reduced, potentially decreasing the patient's risk of infection.&#xD;
      However, before these hypotheses can be tested, it is important to fully understand the&#xD;
      efficacy and accuracy of Signature Custom Guides and their use in Total Hip Arthroplasty.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Unable to engage surgeons to participate in the study&#xD;
  </why_stopped>
  <start_date>November 2014</start_date>
  <completion_date type="Actual">July 2016</completion_date>
  <primary_completion_date type="Actual">July 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Operative Room Time</measure>
    <time_frame>Surgery</time_frame>
    <description>Average operative time</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Noninflammatory Degenerative Joint Disease</condition>
  <condition>Avascular Necrosis</condition>
  <condition>Rheumatoid Arthritis</condition>
  <arm_group>
    <arm_group_label>Signature Cutting Guides</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients indicated for a Posterior Lateral THA utilizing non implantable Signature Cutting Guides during surgery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional Instrumentation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients indicated for a Posterior Lateral THA utilizing non implantable Conventional Instrumentation during surgery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Posterior Lateral Approach Total Hip Arthroplasty</intervention_name>
    <description>All patients enrolled in the study are indicated for a total hip replacement, and will receive this replacement from the surgeon via a Posterior Lateral surgical approach.</description>
    <arm_group_label>Conventional Instrumentation</arm_group_label>
    <arm_group_label>Signature Cutting Guides</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects with one of the following indication:&#xD;
&#xD;
          -  Noninflammatory degenerative joint disease including osteoarthritis and avascular&#xD;
             necrosis.&#xD;
&#xD;
          -  Rheumatoid arthritis.&#xD;
&#xD;
          -  Correction of functional deformity.&#xD;
&#xD;
          -  Treatment of non-union, femoral neck fracture, and trochanteric fractures of the&#xD;
             proximal femur with head involvement, unmanageable by other techniques.&#xD;
&#xD;
        Additional inclusion criteria include:&#xD;
&#xD;
          -  Subjects requiring primary total hip arthroplasty&#xD;
&#xD;
          -  20 to 75 years of age&#xD;
&#xD;
          -  Subjects with a diagnosis of osteoarthritis or traumatic arthritis&#xD;
&#xD;
          -  Subjects willing to return for follow-up evaluations.&#xD;
&#xD;
          -  Subjects who can read, understand study information and give written consent without&#xD;
             representation of a legally authorized representative.&#xD;
&#xD;
          -  Bilateral patients are included if staged.&#xD;
&#xD;
          -  Only Posterior Lateral Approach can be used for inclusion in this study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - Exclusion criteria should be in accordance with Contraindications for the Biomet primary&#xD;
        acetabular cup.&#xD;
&#xD;
        Absolute contraindications include: infection, sepsis, osteomyelitis, and failure of a&#xD;
        previous joint replacement.&#xD;
&#xD;
        Additional contraindications include:&#xD;
&#xD;
          -  Subjects whose bony structure deviates substantially from the general norm&#xD;
             sufficiently to require non-standard implants. Specific examples of these are total&#xD;
             dislocation of the hip, severe coxa vera deformity, and severe forms of multiple&#xD;
             epiphyseal dysplasia&#xD;
&#xD;
          -  Subjects unable to cooperate with and complete the study&#xD;
&#xD;
          -  Dementia and inability to understand and follow instructions&#xD;
&#xD;
          -  Neurological conditions affecting movement&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
        Additional exclusion criteria include:&#xD;
&#xD;
          -  Surgical approach other than posterior lateral.&#xD;
&#xD;
          -  Simultaneous bilateral procedures&#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>
  <overall_official>
    <last_name>Russell Schenck, Ph.D.</last_name>
    <role>Study Director</role>
    <affiliation>Zimmer Biomet</affiliation>
  </overall_official>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>August 18, 2014</study_first_submitted>
  <study_first_submitted_qc>August 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 20, 2014</study_first_posted>
  <results_first_submitted>September 30, 2022</results_first_submitted>
  <results_first_submitted_qc>September 30, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">October 25, 2022</results_first_posted>
  <last_update_submitted>September 30, 2022</last_update_submitted>
  <last_update_submitted_qc>September 30, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 25, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>hip</keyword>
  <keyword>Signature</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Joint Diseases</mesh_term>
    <mesh_term>Osteoarthritis</mesh_term>
    <mesh_term>Necrosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Signature Cutting Guides</title>
          <description>Patients indicated for a Posterior Lateral THA utilizing non implantable Signature Cutting Guides during surgery.&#xD;
Posterior Lateral Approach Total Hip Arthroplasty: All patients enrolled in the study are indicated for a total hip replacement, and will receive this replacement from the surgeon via a Posterior Lateral surgical approach.</description>
        </group>
        <group group_id="P2">
          <title>Conventional Instrumentation</title>
          <description>Patients indicated for a Posterior Lateral THA utilizing non implantable Conventional Instrumentation during surgery.&#xD;
Posterior Lateral Approach Total Hip Arthroplasty: All patients enrolled in the study are indicated for a total hip replacement, and will receive this replacement from the surgeon via a Posterior Lateral surgical approach.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Signature Cutting Guides</title>
          <description>Patients indicated for a Posterior Lateral THA utilizing non implantable Signature Cutting Guides during surgery.&#xD;
Posterior Lateral Approach Total Hip Arthroplasty: All patients enrolled in the study are indicated for a total hip replacement, and will receive this replacement from the surgeon via a Posterior Lateral surgical approach.</description>
        </group>
        <group group_id="B2">
          <title>Conventional Instrumentation</title>
          <description>Patients indicated for a Posterior Lateral THA utilizing non implantable Conventional Instrumentation during surgery.&#xD;
Posterior Lateral Approach Total Hip Arthroplasty: All patients enrolled in the study are indicated for a total hip replacement, and will receive this replacement from the surgeon via a Posterior Lateral surgical approach.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="14"/>
            <count group_id="B2" value="10"/>
            <count group_id="B3" value="24"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="57.9" spread="9.9"/>
                    <measurement group_id="B2" value="68.8" spread="6.4"/>
                    <measurement group_id="B3" value="62.1" spread="10.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>France</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Operative Room Time</title>
        <description>Average operative time</description>
        <time_frame>Surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Signature Cutting Guides</title>
            <description>Patients indicated for a Posterior Lateral THA utilizing non implantable Signature Cutting Guides during surgery.&#xD;
Posterior Lateral Approach Total Hip Arthroplasty: All patients enrolled in the study are indicated for a total hip replacement, and will receive this replacement from the surgeon via a Posterior Lateral surgical approach.</description>
          </group>
          <group group_id="O2">
            <title>Conventional Instrumentation</title>
            <description>Patients indicated for a Posterior Lateral THA utilizing non implantable Conventional Instrumentation during surgery.&#xD;
Posterior Lateral Approach Total Hip Arthroplasty: All patients enrolled in the study are indicated for a total hip replacement, and will receive this replacement from the surgeon via a Posterior Lateral surgical approach.</description>
          </group>
        </group_list>
        <measure>
          <title>Operative Room Time</title>
          <description>Average operative time</description>
          <units>minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="84.7" spread="12.0"/>
                    <measurement group_id="O2" value="78.3" spread="3.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>6 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Signature Cutting Guides</title>
          <description>Patients indicated for a Posterior Lateral THA utilizing non implantable Signature Cutting Guides during surgery.&#xD;
Posterior Lateral Approach Total Hip Arthroplasty: All patients enrolled in the study are indicated for a total hip replacement, and will receive this replacement from the surgeon via a Posterior Lateral surgical approach.</description>
        </group>
        <group group_id="E2">
          <title>Conventional Instrumentation</title>
          <description>Patients indicated for a Posterior Lateral THA utilizing non implantable Conventional Instrumentation during surgery.&#xD;
Posterior Lateral Approach Total Hip Arthroplasty: All patients enrolled in the study are indicated for a total hip replacement, and will receive this replacement from the surgeon via a Posterior Lateral surgical approach.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Early termination leading to small numbers of subjects analyzed</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Hillary Overholser</name_or_title>
      <organization>Zimmer Biomet</organization>
      <phone>574-933-4180</phone>
      <email>hillary.overholser@zimmerbiomet.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02220478
org study id: ORTHO.CR.GH24
nct id: NCT02220478
lead sponsor: 
has dmc: No
The primary purpose of this pilot study is to evaluate the accuracy of cup placement between
      two instrumentation technologies: Cutting Guide and Conventional Instrumentation.
Using a more advanced surgical technique may assist surgeons and patients in a variety of
      ways including identifying a specific-size for the prosthesis prior to surgery, increasing
      operating room efficiency, and reducing the number of traditional instruments needed. This
      may reduce cost associated with the instrument inventory and instrument sterilization.
      Operating time may also be reduced, potentially decreasing the patient's risk of infection.
      However, before these hypotheses can be tested, it is important to fully understand the
      efficacy and accuracy of Signature Custom Guides and their use in Total Hip Arthroplasty.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Operative Room Time
time frame: Surgery
description: Average operative time
arm group label: Signature Cutting Guides
arm group type: Active Comparator
description: Patients indicated for a Posterior Lateral THA utilizing non implantable Signature Cutting Guides during surgery.
arm group label: Conventional Instrumentation
arm group type: Active Comparator
description: Patients indicated for a Posterior Lateral THA utilizing non implantable Conventional Instrumentation during surgery.
intervention type: Device
intervention name: Posterior Lateral Approach Total Hip Arthroplasty
description: All patients enrolled in the study are indicated for a total hip replacement, and will receive this replacement from the surgeon via a Posterior Lateral surgical approach.
arm group label: Conventional Instrumentation
arm group label: Signature Cutting Guides
criteria: 
gender: All
minimum age: 20 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Russell Schenck, Ph.D.
role: Study Director
affiliation: Zimmer Biomet
responsible party type: Sponsor
mesh term: Joint Diseases
mesh term: Osteoarthritis
mesh term: Necrosis
sharing ipd: Undecided
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Early termination leading to small numbers of subjects analyzed
point of contact: 