<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/NCT02983357</url>
  </required_header>
  <id_info>
    <org_study_id>435-16-FB</org_study_id>
    <nct_id>NCT02983357</nct_id>
  </id_info>
  <brief_title>Long Term Outcomes Follow-up of Glenoid Anchor Peg Component Fixation</brief_title>
  <acronym>Glenoid</acronym>
  <official_title>Long Term Outcome Follow-up of Glenoid Anchor Peg Component Fixation Utilizing Autologous Bone Graft in Total Shoulder Arthroplasty.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Nebraska</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Nebraska</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate if the use of autologous bone graft around the&#xD;
      anchor-peg glenoid prosthesis correlates with (1.) bony apposition on computed tomography&#xD;
      scans, (2.) decreased radiolucent lines, (3.) a decrease in component loosening, and (4.)&#xD;
      better functional outcomes. Investigators hypothesize that a glenoid anchor peg component&#xD;
      fixation utilizing autologous bone graft in Total Shoulder Arthroplasty (TSA) will have a&#xD;
      lower incidence of glenoid loosening and that the absence of radiolucent lines will correlate&#xD;
      with excellent shoulder function. Glenoid component loosening remains a major concern&#xD;
      following total shoulder arthroplasty and is the man reason for failure. Despite positive&#xD;
      findings in the investigators previous study (same population at a minimum of 2 year post&#xD;
      operative follow up), it is reasonable that loosening rates could increase with longer&#xD;
      follow-up. This study will be a minimum of 7 year post operative follow up.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Long term outcome follow-up of glenoid anchor peg component fixation utilizing autologous&#xD;
      bone graft in total shoulder arthroplasty. This research will be a case series study to&#xD;
      evaluate the adequacy of fixation and functional outcome of the glenoid anchor peg following&#xD;
      autologous bone grafting around the prosthesis at the time of implant. Eligibility criteria&#xD;
      are subjects,who were treated at the Department of Orthopaedic Surgery at University of&#xD;
      Nebraska Medical Center and Nebraska Medicine, with a total shoulder replacement using an&#xD;
      anchor peg glenoid and autologous bone grafting, and who are now at least 9 years out from&#xD;
      surgery. Each subject will be evaluated and this will include having three plain radiographs&#xD;
      of the operated shoulder of which 2 will be true anterior-posterior (AP) radiographs of the&#xD;
      glenohumeral joint, one in internal rotation and the other in external rotation, along with&#xD;
      axillary lateral films. In addition, the subject will have a computed tomographic (CT) scan,&#xD;
      without contrast dye, to examine the shoulder. One of the study personnel will use the&#xD;
      Constant Score and Simple Shoulder Test to obtain specific shoulder functional, motion, and&#xD;
      strength outcomes as well as pain assessment. A patient completed questionnaire, Rand Short&#xD;
      Form Health Survey, (Rand SF-36) will be obtained to look at association with general health&#xD;
      status. Investigators hypothesize that there will be a low incidence of glenoid loosening&#xD;
      with a TSA (total shoulder arthroplasty) using an anchor peg glenoid and autologous bone&#xD;
      grafting. In addition, investigators suggest that the absence of radiolucent lines will&#xD;
      correlate with excellent shoulder function. A study was previously completed at our facility&#xD;
      on same population at a minimum of 2 year follow up. At that time, and despite more than 10&#xD;
      years of widespread clinical use, no radiographic or clinical data existed regarding this&#xD;
      unique component type. The findings from this prior study indicated that total shoulder&#xD;
      arthroplasty (TSA) utilizing minimal glenoid peripheral peg cement and autologous reamings&#xD;
      placed between radial fins of the central peg allowed host bone incorporation for the central&#xD;
      peg and that better bone incorporation imparted fewer overall peg lucencies. The study&#xD;
      findings were accepted for presentation at The American Academy of Orthopaedic Surgeons,&#xD;
      2010, New Orleans. Despite these positive findings, loosening rates could increase farther&#xD;
      out from surgery, hence the purpose for the current proposed longer follow up study which is&#xD;
      evaluation at a minimum of 9 years post surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2016</start_date>
  <completion_date type="Actual">May 11, 2018</completion_date>
  <primary_completion_date type="Actual">May 11, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of patients with bone presence between radial fins of the glenoid component's central peg measured by thin CT scans and using Yian CT-based radiolucency scores.</measure>
    <time_frame>Day One</time_frame>
    <description>CT</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of patients with glenoid component radiolucencies as measured by plain radiographs using Lazarus radiolucency scores for each.</measure>
    <time_frame>Day One</time_frame>
    <description>plain radiograph</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">15</enrollment>
  <condition>Arthritis</condition>
  <arm_group>
    <arm_group_label>Case Series Study</arm_group_label>
    <description>Subjects who received a total shoulder replacement with an anchor peg glenoid and autologous bone grafting at the department of Orthopaedic Surgery at University of Nebraska Medical Center / Nebraska Medicine and are now at least 9 years out from surgery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>CT, X-Ray</intervention_name>
    <description>2 anterior-posterior (AP) radiographs of the glenohumeral joint, one in internal rotation and the other in external rotation, along with axillary lateral films, will be completed of the affected operated shoulder. Also, a computed tomographic scan without contrast performed of same shoulder.</description>
    <arm_group_label>Case Series Study</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Physical assessment</intervention_name>
    <description>Physically evaluate for shoulder function and pain using American Shoulder Elbow Score (ASES) Constant score and the Simple Shoulder Test to obtain specific shoulder functional, motion,and strength outcomes.</description>
    <arm_group_label>Case Series Study</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire</intervention_name>
    <description>Rand Short Form Health Survey (Rand SF-36) which is a patient completed quality of life measurement</description>
    <arm_group_label>Case Series Study</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        This research is a case series study to evaluate the adequacy of fixation and functional&#xD;
        outcome of the glenoid anchor peg following autologous bone grafting around the prosthesis&#xD;
        at the time of implant.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects who received a total shoulder replacement with an anchor peg glenoid and&#xD;
             autologous bone grafting at the department of Orthopaedic Surgery at University of&#xD;
             Nebraska Medical Center / Nebraska Medicine and are now at least 9 years out from&#xD;
             surgery.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects who are unable to comprehend the consent form information. Pregnant women&#xD;
             will be excluded from the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>44 Years</minimum_age>
    <maximum_age>94 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Matthew Teusink, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Nebraska</affiliation>
  </overall_official>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>November 4, 2016</study_first_submitted>
  <study_first_submitted_qc>December 1, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 6, 2016</study_first_posted>
  <last_update_submitted>November 4, 2022</last_update_submitted>
  <last_update_submitted_qc>November 4, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 8, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Nebraska</investigator_affiliation>
    <investigator_full_name>Matthew Teusink</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>Shoulder Arthroplasty</keyword>
  <keyword>glenohumeral arthritis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthritis</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/NCT02983357
org study id: 435-16-FB
nct id: NCT02983357
lead sponsor: 
has dmc: No
The purpose of this study is to investigate if the use of autologous bone graft around the
      anchor-peg glenoid prosthesis correlates with (1.) bony apposition on computed tomography
      scans, (2.) decreased radiolucent lines, (3.) a decrease in component loosening, and (4.)
      better functional outcomes. Investigators hypothesize that a glenoid anchor peg component
      fixation utilizing autologous bone graft in Total Shoulder Arthroplasty (TSA) will have a
      lower incidence of glenoid loosening and that the absence of radiolucent lines will correlate
      with excellent shoulder function. Glenoid component loosening remains a major concern
      following total shoulder arthroplasty and is the man reason for failure. Despite positive
      findings in the investigators previous study (same population at a minimum of 2 year post
      operative follow up), it is reasonable that loosening rates could increase with longer
      follow-up. This study will be a minimum of 7 year post operative follow up.
Long term outcome follow-up of glenoid anchor peg component fixation utilizing autologous
      bone graft in total shoulder arthroplasty. This research will be a case series study to
      evaluate the adequacy of fixation and functional outcome of the glenoid anchor peg following
      autologous bone grafting around the prosthesis at the time of implant. Eligibility criteria
      are subjects,who were treated at the Department of Orthopaedic Surgery at University of
      Nebraska Medical Center and Nebraska Medicine, with a total shoulder replacement using an
      anchor peg glenoid and autologous bone grafting, and who are now at least 9 years out from
      surgery. Each subject will be evaluated and this will include having three plain radiographs
      of the operated shoulder of which 2 will be true anterior-posterior (AP) radiographs of the
      glenohumeral joint, one in internal rotation and the other in external rotation, along with
      axillary lateral films. In addition, the subject will have a computed tomographic (CT) scan,
      without contrast dye, to examine the shoulder. One of the study personnel will use the
      Constant Score and Simple Shoulder Test to obtain specific shoulder functional, motion, and
      strength outcomes as well as pain assessment. A patient completed questionnaire, Rand Short
      Form Health Survey, (Rand SF-36) will be obtained to look at association with general health
      status. Investigators hypothesize that there will be a low incidence of glenoid loosening
      with a TSA (total shoulder arthroplasty) using an anchor peg glenoid and autologous bone
      grafting. In addition, investigators suggest that the absence of radiolucent lines will
      correlate with excellent shoulder function. A study was previously completed at our facility
      on same population at a minimum of 2 year follow up. At that time, and despite more than 10
      years of widespread clinical use, no radiographic or clinical data existed regarding this
      unique component type. The findings from this prior study indicated that total shoulder
      arthroplasty (TSA) utilizing minimal glenoid peripheral peg cement and autologous reamings
      placed between radial fins of the central peg allowed host bone incorporation for the central
      peg and that better bone incorporation imparted fewer overall peg lucencies. The study
      findings were accepted for presentation at The American Academy of Orthopaedic Surgeons,
      2010, New Orleans. Despite these positive findings, loosening rates could increase farther
      out from surgery, hence the purpose for the current proposed longer follow up study which is
      evaluation at a minimum of 9 years post surgery.
observational model: Case-Only
time perspective: Prospective
measure: Number of patients with bone presence between radial fins of the glenoid component's central peg measured by thin CT scans and using Yian CT-based radiolucency scores.
time frame: Day One
description: CT
measure: Number of patients with glenoid component radiolucencies as measured by plain radiographs using Lazarus radiolucency scores for each.
time frame: Day One
description: plain radiograph
arm group label: Case Series Study
description: Subjects who received a total shoulder replacement with an anchor peg glenoid and autologous bone grafting at the department of Orthopaedic Surgery at University of Nebraska Medical Center / Nebraska Medicine and are now at least 9 years out from surgery.
intervention type: Radiation
intervention name: CT, X-Ray
description: 2 anterior-posterior (AP) radiographs of the glenohumeral joint, one in internal rotation and the other in external rotation, along with axillary lateral films, will be completed of the affected operated shoulder. Also, a computed tomographic scan without contrast performed of same shoulder.
arm group label: Case Series Study
intervention type: Other
intervention name: Physical assessment
description: Physically evaluate for shoulder function and pain using American Shoulder Elbow Score (ASES) Constant score and the Simple Shoulder Test to obtain specific shoulder functional, motion,and strength outcomes.
arm group label: Case Series Study
intervention type: Other
intervention name: Questionnaire
description: Rand Short Form Health Survey (Rand SF-36) which is a patient completed quality of life measurement
arm group label: Case Series Study
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 44 Years
maximum age: 94 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Matthew Teusink, MD
role: Principal Investigator
affiliation: University of Nebraska
responsible party type: Principal Investigator
investigator affiliation: University of Nebraska
investigator full name: Matthew Teusink
investigator title: MD
mesh term: Arthritis
sharing ipd: No