<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/NCT01672086</url>
  </required_header>
  <id_info>
    <org_study_id>344-01</org_study_id>
    <nct_id>NCT01672086</nct_id>
  </id_info>
  <brief_title>Active Surveillance Post-Approval Atudy of the Stelkast Surpass Acetabular System</brief_title>
  <official_title>Active Surveillance Post-Approval Atudy of the Stelkast Surpass Acetabular System</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>StelKast, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>StelKast, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The active surveillance post-approval study of the Stelkast Surpass Acetabular System is a&#xD;
      retrospective, multi-center, single-arm study intended to collect data on the survivorship&#xD;
      and long-term safety and effectiveness of the device.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This active surveillance study is intended to evaluate the survivorship and long-term safety&#xD;
      and effectiveness of the Stelkast Surpass Acetabular System. Neither the patient nor the&#xD;
      surgeon are blinded to treatment. The study will compare the Surpass' survivorship to the&#xD;
      survivorship observed in a historical control group established by a meta-analysis. The&#xD;
      evaluation will be conducted for a period of ten years. These evaluations will be recorded&#xD;
      through onsite visits and/or mailings sent to physicians requesting deidentified&#xD;
      patient-level data for subjects implanted with the Surpass system.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Product is no longer being manufactured and marketed.&#xD;
  </why_stopped>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">June 2016</completion_date>
  <primary_completion_date type="Actual">June 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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Survivorship</measure>
    <time_frame>10 Years</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">347</enrollment>
  <condition>Survivorship and Long-term Safety and Effectiveness of the Stelkast Surpass Acetabular System</condition>
  <arm_group>
    <arm_group_label>Stelkast Surpass Patients</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Stelkast Surpass Acetabular System implant</intervention_name>
    <arm_group_label>Stelkast Surpass Patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients treated with the Stelkast Surpass Acetabular System at the participating&#xD;
        siteswill be included in the evaluation.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Primary hip arthroplasty&#xD;
&#xD;
          -  Skeletal maturity&#xD;
&#xD;
          -  Non-inflammatory degenerative joint disease such as osteoarthritis, avascular&#xD;
             necrosis, congenital hip dysplasia, and traumatic arthritis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The Stelkast Surpass Acetabular System is contraindicated in patients with the&#xD;
             following conditions: Overt or latent infection in or around the hip joint,&#xD;
             insufficient bone stock to allow appropriate insertion and fixation of the prosthesis,&#xD;
             insufficient soft tissue integrity to provide adequate stability, muscle laxity or&#xD;
             inadequate soft tissue for proper function and healing, mental or neuromuscular&#xD;
             disorders that do not allow control of the affected joint, revision hip arthroplasty,&#xD;
             inflammatory hip joint disease, and neuropathic hip joint disease.&#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>Abigail Allen</last_name>
    <role>Study Director</role>
    <affiliation>MCRA</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Gill Orthopedic Clinic</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mutschler Orthopedic Institute</name>
      <address>
        <city>Canonsburg</city>
        <state>Pennsylvania</state>
        <zip>15317</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Premier Orthopedics and SPM Associates</name>
      <address>
        <city>Glen Mills</city>
        <state>Pennsylvania</state>
        <zip>19342</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Rothman Institute</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2016</verification_date>
  <study_first_submitted>August 21, 2012</study_first_submitted>
  <study_first_submitted_qc>August 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 24, 2012</study_first_posted>
  <last_update_submitted>October 12, 2016</last_update_submitted>
  <last_update_submitted_qc>October 12, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 13, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Calcium Carbonate</mesh_term>
  </intervention_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/NCT01672086
org study id: 344-01
nct id: NCT01672086
lead sponsor: 
has dmc: No
The active surveillance post-approval study of the Stelkast Surpass Acetabular System is a
      retrospective, multi-center, single-arm study intended to collect data on the survivorship
      and long-term safety and effectiveness of the device.
This active surveillance study is intended to evaluate the survivorship and long-term safety
      and effectiveness of the Stelkast Surpass Acetabular System. Neither the patient nor the
      surgeon are blinded to treatment. The study will compare the Surpass' survivorship to the
      survivorship observed in a historical control group established by a meta-analysis. The
      evaluation will be conducted for a period of ten years. These evaluations will be recorded
      through onsite visits and/or mailings sent to physicians requesting deidentified
      patient-level data for subjects implanted with the Surpass system.
observational model: Cohort
time perspective: Retrospective
measure: Survivorship
time frame: 10 Years
arm group label: Stelkast Surpass Patients
intervention type: Device
intervention name: Stelkast Surpass Acetabular System implant
arm group label: Stelkast Surpass Patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Abigail Allen
role: Study Director
affiliation: MCRA
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Calcium Carbonate