<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/NCT01697865</url>
  </required_header>
  <id_info>
    <org_study_id>061217B</org_study_id>
    <nct_id>NCT01697865</nct_id>
  </id_info>
  <brief_title>Reverse Shoulder Arthroplasty With or Without Concomitant Latissimus and Teres Major Transfer for Shoulder Pseudoparalysis With Teres Minor Dysfunction</brief_title>
  <official_title>Reverse Shoulder Arthroplasty With or Without Concomitant Latissimus and Teres Major Transfer for Shoulder Pseudoparalysis With Teres Minor Dysfunction: A Prospective, Randomized Investigation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>OrthoCarolina Research Institute, Inc.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>OrthoCarolina Research Institute, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The overall objective of this study is to compare the clinical benefit and safety of two&#xD;
      different surgical techniques of primary reverse total shoulder arthroplasty for the&#xD;
      treatment of shoulder pseudoparalysis from chronic rotator cuff disease with associated teres&#xD;
      minor dysfunction. The first surgical technique includes a concomitant latissimus and teres&#xD;
      major transfer (transfer group) and the second technique does not include a concomitant&#xD;
      latissimus and teres major transfer (control group).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 21, 2012</start_date>
  <completion_date type="Actual">September 21, 2020</completion_date>
  <primary_completion_date type="Actual">February 12, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>ADLER Score</measure>
    <time_frame>2 Year</time_frame>
    <description>Activities of Daily Living and External Rotation (ADLER) Score: This tool measures patients' ability to do various tasks on a daily basis.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>DASH Score</measure>
    <time_frame>1 Year, 2 Year</time_frame>
    <description>Disabilities of the Arm, Shoulder, and Hand score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ASES score</measure>
    <time_frame>1 Year, 2 Year</time_frame>
    <description>American Shoulder and Elbow Surgeons Score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SF-12 Score</measure>
    <time_frame>1 Year, 2 Year</time_frame>
    <description>General Health Outcome score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Range of Motion</measure>
    <time_frame>1 Year, 2 Year</time_frame>
    <description>Shoulder range of motion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>X-Ray Measurements</measure>
    <time_frame>1 Year, 2 Year</time_frame>
    <description>X-ray measurements from the anteroposterior (AP) and axillary views of the shoulder.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">33</enrollment>
  <condition>Osteoarthritis of the Shoulder</condition>
  <arm_group>
    <arm_group_label>Transfer group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The first surgical technique includes a concomitant latissimus and teres major transfer (transfer group).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The second technique does not include a concomitant latissimus and teres major transfer (control group).</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Transfer group</intervention_name>
    <arm_group_label>Transfer group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Control group</intervention_name>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Shoulder pseudoparalysis due to chronic rotator cuff dysfunction with or without&#xD;
             glenohumeral arthritis.&#xD;
&#xD;
          -  Chronic rotator cuff tear with severe retraction, atrophy, fatty infiltration.&#xD;
&#xD;
          -  Active forward elevation of less than 90 degrees&#xD;
&#xD;
          -  Teres minor dysfunction&#xD;
&#xD;
          -  Positive lag and hornblower sign&#xD;
&#xD;
          -  Grade 2 or greater fatty infiltration of the teres minor and infraspinatous seen on&#xD;
             MRI&#xD;
&#xD;
          -  Able to attend scheduled office visits&#xD;
&#xD;
          -  Meet all criteria to have a latissimus and teres major transfer&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Revision arthroplasty&#xD;
&#xD;
          -  Previous shoulder infection&#xD;
&#xD;
          -  Neuro-muscular disorder (ie: Parkinson's)&#xD;
&#xD;
          -  Advanced dementia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>OrthoCarolina Research Institute</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>September 27, 2012</study_first_submitted>
  <study_first_submitted_qc>October 1, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2012</study_first_posted>
  <last_update_submitted>January 22, 2021</last_update_submitted>
  <last_update_submitted_qc>January 22, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 25, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Reverse total shoulder</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
  </condition_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/NCT01697865
org study id: 061217B
nct id: NCT01697865
lead sponsor: 
has dmc: Yes
The overall objective of this study is to compare the clinical benefit and safety of two
      different surgical techniques of primary reverse total shoulder arthroplasty for the
      treatment of shoulder pseudoparalysis from chronic rotator cuff disease with associated teres
      minor dysfunction. The first surgical technique includes a concomitant latissimus and teres
      major transfer (transfer group) and the second technique does not include a concomitant
      latissimus and teres major transfer (control group).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: ADLER Score
time frame: 2 Year
description: Activities of Daily Living and External Rotation (ADLER) Score: This tool measures patients' ability to do various tasks on a daily basis.
measure: DASH Score
time frame: 1 Year, 2 Year
description: Disabilities of the Arm, Shoulder, and Hand score
measure: ASES score
time frame: 1 Year, 2 Year
description: American Shoulder and Elbow Surgeons Score
measure: SF-12 Score
time frame: 1 Year, 2 Year
description: General Health Outcome score
measure: Range of Motion
time frame: 1 Year, 2 Year
description: Shoulder range of motion
measure: X-Ray Measurements
time frame: 1 Year, 2 Year
description: X-ray measurements from the anteroposterior (AP) and axillary views of the shoulder.
arm group label: Transfer group
arm group type: Active Comparator
description: The first surgical technique includes a concomitant latissimus and teres major transfer (transfer group).
arm group label: Control group
arm group type: Active Comparator
description: The second technique does not include a concomitant latissimus and teres major transfer (control group).
intervention type: Procedure
intervention name: Transfer group
arm group label: Transfer group
intervention type: Procedure
intervention name: Control group
arm group label: Control group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Osteoarthritis