<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/NCT01671176</url>
  </required_header>
  <id_info>
    <org_study_id>Wide04262012</org_study_id>
    <nct_id>NCT01671176</nct_id>
  </id_info>
  <brief_title>Wide Diameter Bone Anchored Implant Study</brief_title>
  <official_title>A Clinical Study of the Oticon Medical Ponto 4.5mm Wide Implant</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oticon Medical</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Oticon Medical</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To assess implant stability, implant loss, adverse skin reactions, and Quality of Life&#xD;
      Benefit following implantation of the Ponto 4.5mm Wide Diameter implant. Secondary: to&#xD;
      determine the feasibility of fitting the sound processor 3 weeks after surgical implantation,&#xD;
      and to investigate if the type of skin reactions following implantation could be related to&#xD;
      the demographic data of subjects and the type of surgical technique used&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Bone-anchored hearing systems have been an amplification choice for conductive, mixed, and&#xD;
      profound, unilateral, sensorineural hearing loss for over three decades. So far, about 75,000&#xD;
      patients worldwide have received this surgical intervention (bone-anchored hearing system),&#xD;
      since its first successful implantation in 1977. In 2009, Oticon Medical, LLC launched its&#xD;
      bone-anchored hearing system called Ponto. In just over two years, the Ponto has been&#xD;
      successfully implanted in over 3,000 patients by leading otolaryngologists and neurotologists&#xD;
      in 18 countries worldwide.&#xD;
&#xD;
      The Ponto implant has previously been available with a 3.75mm diameter and comes in two&#xD;
      lengths: 3mm and 4mm. Anew Ponto implant that is 4.5mm wide in diameter is now available in&#xD;
      both 3mm and 4mm lengths. This Wide Diameter implant is designed to maximize bone-to-implant&#xD;
      contact area and enhance implant stability which can potentially allow loading of the sound&#xD;
      processor as early as 3 weeks after surgery. The abutment screw incorporates external threads&#xD;
      at the screw head to make it possible to connect a SmartPeg (Osstell, Goteborg, Sweden) for&#xD;
      stability measurements. All Ponto implants have the same universal implant-abutment&#xD;
      interface. Therefore, they are fully compatible with existing instruments and abutments. Two&#xD;
      new countersinks have been developed for the new Ponto Wide Diameter implant. The drill size&#xD;
      of the countersink is 3.80mm. It is marked with a &quot;W&quot; to separate them from existing drills.&#xD;
      All products are CE-marked and cleared for the US market by the FDA.&#xD;
&#xD;
      Objectives The present study will attempt to show that the Ponto 4.5mm Wide Diameter implant&#xD;
      has similar or better outcomes in terms of Quality of Life (QoL) benefit; implant extrusion&#xD;
      and revision surgery when compared to the 3.75mm diameter implant. Secondary objectives to be&#xD;
      studied will include adverse skin reactions, the feasibility of fitting the sound processor&#xD;
      three weeks after surgical implantation, and investigation to see if the type of skin&#xD;
      reactions observed following implantation could be related to the demographic data of&#xD;
      subjects or the type of surgical technique used.&#xD;
&#xD;
      Study Design This study is a prospective, multicenter study of subjects' demographic and&#xD;
      implant data. Subjects will be enrolled at two US sites.&#xD;
&#xD;
      Subject Population Twenty adult subjects 18 years or older will be included in the study from&#xD;
      each participating partner site.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2012</start_date>
  <completion_date type="Actual">November 2014</completion_date>
  <primary_completion_date type="Actual">November 2014</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>Holger's Scale</measure>
    <time_frame>1 week, 3 weeks, 6 weeks, 3 months, 6 months and 12 months</time_frame>
    <description>Holger's Scale is a 5 point that ranges from 0 - 4 scale that assesses skin reactions at the implant site where 0 means no reaction and 4 means excessive granulation, skin overgrowth, or scar formation requiring revision surgery</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Implant Stability as Measured by the Osstell Implant Stability Quotient in the Vertical and Horizontal Plane</measure>
    <time_frame>At surgery, 1 week, 3 weeks, 6 weeks, 12 weeks, 6 months and 12 months</time_frame>
    <description>Presently, the recommendations to load the sound processor on a bone anchored implant is 3 months (for adults). Using outcome measures, i.e., OSSTELL ISQ ranges from 0 -100 where 0 is least stable and 100 being the most stable.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Conductive Hearing Loss</condition>
  <condition>Conductive and Sensori-neural Hearing Loss in the Same Ear</condition>
  <condition>Unilateral, Profound Sensori-neural Hearing Loss</condition>
  <arm_group>
    <arm_group_label>Wide diameter bone anchored implant</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Intervention: Implantation of a wide diameter bone anchored auditory implant either 3 or 4 mm in length, into the skull on the side of the ear where intervention is intended in order to restore hearing. In the case of a conductive or mixed hearing loss, that side is chosen. In patients with unilateral, profound sensori-neural hearing loss the implant is implanted on that side but the sound is transmitted to the side with the normal hearing ear via bone conduction stimulation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Wide diameter bone anchored implant</intervention_name>
    <description>4.5 mm wide diameter bone anchored implant</description>
    <arm_group_label>Wide diameter bone anchored implant</arm_group_label>
    <other_name>Oticon Medical Ponto Pro</other_name>
    <other_name>Oticon Medical Ponto Pro Power</other_name>
    <other_name>Osstell ISQ</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  conductive, mixed or single sided deafness&#xD;
&#xD;
          -  18 years of age or older&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  younger than 18 years of age&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jack Wazen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sarasota Ear Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Silverstein Institute</name>
      <address>
        <city>Sarasota</city>
        <state>Florida</state>
        <zip>34239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Michigan Ear Institute</name>
      <address>
        <city>Farmington Hills</city>
        <state>Michigan</state>
        <zip>48833</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Wazen JJ, Babu S, Daugherty J, Metrailer A. Three-week loading of the 4.5mm wide titanium implant in bone anchored hearing systems. Am J Otolaryngol. 2016 Mar-Apr;37(2):132-5. doi: 10.1016/j.amjoto.2015.08.005. Epub 2015 Aug 18.</citation>
    <PMID>26954868</PMID>
  </results_reference>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>August 15, 2012</study_first_submitted>
  <study_first_submitted_qc>August 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 23, 2012</study_first_posted>
  <results_first_submitted>April 3, 2018</results_first_submitted>
  <results_first_submitted_qc>April 3, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">May 7, 2018</results_first_posted>
  <last_update_submitted>April 3, 2018</last_update_submitted>
  <last_update_submitted_qc>April 3, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 7, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Wide diameter implant</keyword>
  <keyword>ISQ</keyword>
  <keyword>Ponto</keyword>
  <keyword>Bone anchored implant</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hearing Loss</mesh_term>
    <mesh_term>Deafness</mesh_term>
    <mesh_term>Hearing Loss, Conductive</mesh_term>
    <mesh_term>Retrocochlear Diseases</mesh_term>
    <mesh_term>Hearing Loss, Sensorineural</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Wide Diameter Bone Anchored Implant</title>
          <description>Intervention: Implantation of a wide diameter bone anchored auditory implant either 3 or 4 mm in length, into the skull on the side of the ear where intervention is intended in order to restore hearing. In the case of a conductive or mixed hearing loss, that side is chosen. In patients with unilateral, profound sensori-neural hearing loss the implant is implanted on that side but the sound is transmitted to the side with the normal hearing ear via bone conduction stimulation.&#xD;
Wide diameter bone anchored implant: 4.5 mm wide diameter bone anchored implant</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Wide Diameter Bone Anchored Implant</title>
          <description>Intervention: Implantation of a wide diameter bone anchored auditory implant either 3 or 4 mm in length, into the skull on the side of the ear where intervention is intended in order to restore hearing. In the case of a conductive or mixed hearing loss, that side is chosen. In patients with unilateral, profound sensori-neural hearing loss the implant is implanted on that side but the sound is transmitted to the side with the normal hearing ear via bone conduction stimulation.&#xD;
Wide diameter bone anchored implant: 4.5 mm wide diameter bone anchored implant</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="30"/>
          </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="60.83" spread="16.07"/>
                  </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="22"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Smoking status</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>no</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Diabetes</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>no</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Abutment length</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>6 mm</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>9 mm</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 mm</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight</title>
          <units>kilogram</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="76.72" spread="19.61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>BMI</title>
          <units>kilogram/M^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="28.56" spread="7.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Height</title>
          <units>centimeters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="163.79" spread="8.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Holger's Scale</title>
        <description>Holger's Scale is a 5 point that ranges from 0 - 4 scale that assesses skin reactions at the implant site where 0 means no reaction and 4 means excessive granulation, skin overgrowth, or scar formation requiring revision surgery</description>
        <time_frame>1 week, 3 weeks, 6 weeks, 3 months, 6 months and 12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Wide Diameter Bone Anchored Implant</title>
            <description>Intervention: Implantation of a wide diameter bone anchored auditory implant either 3 or 4 mm in length, into the skull on the side of the ear where intervention is intended in order to restore hearing. In the case of a conductive or mixed hearing loss, that side is chosen. In patients with unilateral, profound sensori-neural hearing loss the implant is implanted on that side but the sound is transmitted to the side with the normal hearing ear via bone conduction stimulation.&#xD;
Wide diameter bone anchored implant: 4.5 mm wide diameter bone anchored implant</description>
          </group>
        </group_list>
        <measure>
          <title>Holger's Scale</title>
          <description>Holger's Scale is a 5 point that ranges from 0 - 4 scale that assesses skin reactions at the implant site where 0 means no reaction and 4 means excessive granulation, skin overgrowth, or scar formation requiring revision surgery</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Holger score 0 at 1 week</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Holger score of 1 at one week</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Holger score of 2 at one week</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Holger score of 0 at 3 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Holger score of 1 at 3 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Holger score of 2 at 3 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Holger score of 0 at 6 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Holger score of 1 at 6 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Holger score of 2 at 6 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Holger score of 0 at 3 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Holger score of 1 at 3 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Holger score of 2 at 3 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Holger score of 0 at 6 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Holger score of 1 at 6 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Holger score of 2 at 6 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Holger score of 0 at 12 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>olger score of 1 at 12 months 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Holger score of 2 at 12 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Implant Stability as Measured by the Osstell Implant Stability Quotient in the Vertical and Horizontal Plane</title>
        <description>Presently, the recommendations to load the sound processor on a bone anchored implant is 3 months (for adults). Using outcome measures, i.e., OSSTELL ISQ ranges from 0 -100 where 0 is least stable and 100 being the most stable.</description>
        <time_frame>At surgery, 1 week, 3 weeks, 6 weeks, 12 weeks, 6 months and 12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Wide Diameter Bone Anchored Implant</title>
            <description>Intervention: Implantation of a wide diameter bone anchored auditory implant either 3 or 4 mm in length, into the skull on the side of the ear where intervention is intended in order to restore hearing. In the case of a conductive or mixed hearing loss, that side is chosen. In patients with unilateral, profound sensori-neural hearing loss the implant is implanted on that side but the sound is transmitted to the side with the normal hearing ear via bone conduction stimulation.&#xD;
Wide diameter bone anchored implant: 4.5 mm wide diameter bone anchored implant</description>
          </group>
        </group_list>
        <measure>
          <title>Implant Stability as Measured by the Osstell Implant Stability Quotient in the Vertical and Horizontal Plane</title>
          <description>Presently, the recommendations to load the sound processor on a bone anchored implant is 3 months (for adults). Using outcome measures, i.e., OSSTELL ISQ ranges from 0 -100 where 0 is least stable and 100 being the most stable.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>ISQ vertical at surgery</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="58.43" spread="8.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ISQ horizontal at surgery</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="58.58" spread="7.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ISQ vertical at one week</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59.70" spread="7.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ISQ horizontal at one week</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59.77" spread="7.88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ISQ vertical at 3 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60.53" spread="7.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ISQ horizontal at 3 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60.30" spread="7.78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ISQ vertical at 6 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61.28" spread="5.81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ISQ horizontal at 6 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61.02" spread="6.56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ISQ vertical at 12 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61.97" spread="5.91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ISQ horizontal at 12 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="62.00" spread="6.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ISQ vertical at 6 month</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63.62" spread="5.26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ISQ horizontal at 6 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63.27" spread="5.48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ISQ vertical at 12 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63.73" spread="5.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ISQ horizontal at 12 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63.62" spread="5.26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Wide Diameter Bone Anchored Implant</title>
          <description>Intervention: Implantation of a wide diameter bone anchored auditory implant either 3 or 4 mm in length, into the skull on the side of the ear where intervention is intended in order to restore hearing. In the case of a conductive or mixed hearing loss, that side is chosen. In patients with unilateral, profound sensori-neural hearing loss the implant is implanted on that side but the sound is transmitted to the side with the normal hearing ear via bone conduction stimulation.&#xD;
Wide diameter bone anchored implant: 4.5 mm wide diameter bone anchored implant</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Skin revision</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
              </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>
    <point_of_contact>
      <name_or_title>Ravi Sockalingam</name_or_title>
      <organization>Oticon Medical LLC</organization>
      <phone>9082023524</phone>
      <email>rsoc@oticomedical.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/NCT01671176
org study id: Wide04262012
nct id: NCT01671176
lead sponsor: 
has dmc: No
To assess implant stability, implant loss, adverse skin reactions, and Quality of Life
      Benefit following implantation of the Ponto 4.5mm Wide Diameter implant. Secondary: to
      determine the feasibility of fitting the sound processor 3 weeks after surgical implantation,
      and to investigate if the type of skin reactions following implantation could be related to
      the demographic data of subjects and the type of surgical technique used
Bone-anchored hearing systems have been an amplification choice for conductive, mixed, and
      profound, unilateral, sensorineural hearing loss for over three decades. So far, about 75,000
      patients worldwide have received this surgical intervention (bone-anchored hearing system),
      since its first successful implantation in 1977. In 2009, Oticon Medical, LLC launched its
      bone-anchored hearing system called Ponto. In just over two years, the Ponto has been
      successfully implanted in over 3,000 patients by leading otolaryngologists and neurotologists
      in 18 countries worldwide.

      The Ponto implant has previously been available with a 3.75mm diameter and comes in two
      lengths: 3mm and 4mm. Anew Ponto implant that is 4.5mm wide in diameter is now available in
      both 3mm and 4mm lengths. This Wide Diameter implant is designed to maximize bone-to-implant
      contact area and enhance implant stability which can potentially allow loading of the sound
      processor as early as 3 weeks after surgery. The abutment screw incorporates external threads
      at the screw head to make it possible to connect a SmartPeg (Osstell, Goteborg, Sweden) for
      stability measurements. All Ponto implants have the same universal implant-abutment
      interface. Therefore, they are fully compatible with existing instruments and abutments. Two
      new countersinks have been developed for the new Ponto Wide Diameter implant. The drill size
      of the countersink is 3.80mm. It is marked with a "W" to separate them from existing drills.
      All products are CE-marked and cleared for the US market by the FDA.

      Objectives The present study will attempt to show that the Ponto 4.5mm Wide Diameter implant
      has similar or better outcomes in terms of Quality of Life (QoL) benefit; implant extrusion
      and revision surgery when compared to the 3.75mm diameter implant. Secondary objectives to be
      studied will include adverse skin reactions, the feasibility of fitting the sound processor
      three weeks after surgical implantation, and investigation to see if the type of skin
      reactions observed following implantation could be related to the demographic data of
      subjects or the type of surgical technique used.

      Study Design This study is a prospective, multicenter study of subjects' demographic and
      implant data. Subjects will be enrolled at two US sites.

      Subject Population Twenty adult subjects 18 years or older will be included in the study from
      each participating partner site.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Holger's Scale
time frame: 1 week, 3 weeks, 6 weeks, 3 months, 6 months and 12 months
description: Holger's Scale is a 5 point that ranges from 0 - 4 scale that assesses skin reactions at the implant site where 0 means no reaction and 4 means excessive granulation, skin overgrowth, or scar formation requiring revision surgery
measure: Implant Stability as Measured by the Osstell Implant Stability Quotient in the Vertical and Horizontal Plane
time frame: At surgery, 1 week, 3 weeks, 6 weeks, 12 weeks, 6 months and 12 months
description: Presently, the recommendations to load the sound processor on a bone anchored implant is 3 months (for adults). Using outcome measures, i.e., OSSTELL ISQ ranges from 0 -100 where 0 is least stable and 100 being the most stable.
arm group label: Wide diameter bone anchored implant
arm group type: Other
description: Intervention: Implantation of a wide diameter bone anchored auditory implant either 3 or 4 mm in length, into the skull on the side of the ear where intervention is intended in order to restore hearing. In the case of a conductive or mixed hearing loss, that side is chosen. In patients with unilateral, profound sensori-neural hearing loss the implant is implanted on that side but the sound is transmitted to the side with the normal hearing ear via bone conduction stimulation.
intervention type: Device
intervention name: Wide diameter bone anchored implant
description: 4.5 mm wide diameter bone anchored implant
arm group label: Wide diameter bone anchored implant
other name: Oticon Medical Ponto Pro
other name: Oticon Medical Ponto Pro Power
other name: Osstell ISQ
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Jack Wazen, MD
role: Principal Investigator
affiliation: Sarasota Ear Institute
facility: 
facility: 
country: United States
citation: Wazen JJ, Babu S, Daugherty J, Metrailer A. Three-week loading of the 4.5mm wide titanium implant in bone anchored hearing systems. Am J Otolaryngol. 2016 Mar-Apr;37(2):132-5. doi: 10.1016/j.amjoto.2015.08.005. Epub 2015 Aug 18.
PMID: 26954868
responsible party type: Sponsor
mesh term: Hearing Loss
mesh term: Deafness
mesh term: Hearing Loss, Conductive
mesh term: Retrocochlear Diseases
mesh term: Hearing Loss, Sensorineural
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 