<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/NCT03247335</url>
  </required_header>
  <id_info>
    <org_study_id>17-341</org_study_id>
    <nct_id>NCT03247335</nct_id>
  </id_info>
  <brief_title>Follow-up of Arthrosurface HemiCAP Implants</brief_title>
  <official_title>Follow-up of Arthrosurface HemiCAP Implants</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Cleveland Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Arthrosurface, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>The Cleveland Clinic</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Follow-up of Arthrosurface HemiCAP shoulder implants.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In summary, the investigators would like to contact all patients who have had HemiCAP&#xD;
      implants done at CCF with at least 2 years of follow-up after their procedure. The&#xD;
      investigators will use electronic or written means to alert the patients that they will be&#xD;
      contacted by our team to discuss their surgery and any related issues. Once the appropriate&#xD;
      consent is obtained, the investigators will use a brief telephone interview to ask the&#xD;
      patients several questions regarding any re-operations or complications the patients have had&#xD;
      since the index procedure.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 31, 2018</start_date>
  <completion_date type="Actual">August 1, 2019</completion_date>
  <primary_completion_date type="Actual">August 1, 2019</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <target_duration>1 Year</target_duration>
  <primary_outcome>
    <measure>Arthrosurface</measure>
    <time_frame>2 year</time_frame>
    <description>survival curve for the implant</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of revision surgeries</measure>
    <time_frame>2 year</time_frame>
    <description>rate of revision surgeries</description>
  </secondary_outcome>
  <enrollment type="Actual">75</enrollment>
  <condition>Orthopedic Disorder</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who had Arthrosurface (Franlin, MA) HemiCAP implants placed into their shoulders&#xD;
        at the Cleveland Clinic&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        -Patients who had Arthrosurface (Franlin, MA) HemiCAP implants placed into their shoulders&#xD;
        at the Cleveland Clinic&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Anyone who has not had ARthrosurface (Franlin, MA) HeiCAP implants placed into their&#xD;
             shoulders at the Cleveland Clinic&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kurt Spindler, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Cleveland Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cleveland Clinic</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44125</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>August 9, 2017</study_first_submitted>
  <study_first_submitted_qc>August 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 2017</study_first_posted>
  <last_update_submitted>March 4, 2021</last_update_submitted>
  <last_update_submitted_qc>March 4, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 8, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Musculoskeletal Diseases</mesh_term>
  </condition_browse>
  <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/NCT03247335
org study id: 17-341
nct id: NCT03247335
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Follow-up of Arthrosurface HemiCAP shoulder implants.
In summary, the investigators would like to contact all patients who have had HemiCAP
      implants done at CCF with at least 2 years of follow-up after their procedure. The
      investigators will use electronic or written means to alert the patients that they will be
      contacted by our team to discuss their surgery and any related issues. Once the appropriate
      consent is obtained, the investigators will use a brief telephone interview to ask the
      patients several questions regarding any re-operations or complications the patients have had
      since the index procedure.
observational model: Other
time perspective: Other
measure: Arthrosurface
time frame: 2 year
description: survival curve for the implant
measure: Rate of revision surgeries
time frame: 2 year
description: rate of revision surgeries
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Kurt Spindler, MD
role: Principal Investigator
affiliation: The Cleveland Clinic
facility: 
country: United States
responsible party type: Sponsor
mesh term: Musculoskeletal Diseases
sharing ipd: No