<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/NCT04459858</url>
  </required_header>
  <id_info>
    <org_study_id>2020-01201; ch20Taha2</org_study_id>
    <nct_id>NCT04459858</nct_id>
  </id_info>
  <brief_title>The Influence of the Greater Tuberosity Angle on the Clinical Outcome One Year Postoperative in Patients With a Rotator Cuff Tear</brief_title>
  <acronym>GTA</acronym>
  <official_title>GTA-The Influence of the Greater Tuberosity Angle on the Clinical Outcome One Year Postoperative in Patients With a Rotator Cuff Tear - a Comparative Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Basel, Switzerland</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Basel, Switzerland</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>
      This retrospective study is to investigate the influence of the Greater Tuberosity Angle&#xD;
      (GTA) in addition to CSA on patient outcome in patients with rotator cuff tear.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A tear of the rotator cuff is one of the most common disorders of the shoulder. It is assumed&#xD;
      that a large Critical Shoulder Angle (CSA) is associated with the occurrence of rotator cuff&#xD;
      tears. This retrospective study is to investigate the influence of the Greater Tuberosity&#xD;
      Angle (GTA) in addition to CSA on patient outcome in patients with rotator cuff tear.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 3, 2020</start_date>
  <completion_date type="Actual">October 31, 2020</completion_date>
  <primary_completion_date type="Actual">October 31, 2020</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>Change in Constant Score</measure>
    <time_frame>1 year (before surgery and 1 year after surgery)</time_frame>
    <description>This scoring system consists of four variables that are used to assess the function of the shoulder. The right and left shoulders are assessed separately.&#xD;
The subjective variables are pain and activity of daily life (ADL) (sleep, work, recreation / sport) which give a total of 35 points. The objective variables are range of motion and strength which give a total of 65 Points (the higher the score the better the shoulder function).</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">60</enrollment>
  <condition>Rotator Cuff Tear</condition>
  <arm_group>
    <arm_group_label>rotator cuff lesion</arm_group_label>
    <description>patients treated for traumatic or degenerative rotator cuff lesion</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>data analysis</intervention_name>
    <description>Data is extracted from the existing medical records and from the Rotator Cuff Repair Database (RCR_USB). The GTA (determined as the angle between a &quot;line parallel to the humerus diaphysis passing through the humeral head center of rotation and a line connecting the upper border of the humeral head to the most superolateral edge of the greater tuberosity&quot;) is determined.</description>
    <arm_group_label>rotator cuff lesion</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients treated for traumatic or degenerative rotator cuff lesion at the University&#xD;
        Hospital Basel between January 2015 and January 2019.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient after an arthroscopic rotator cuff repair&#xD;
&#xD;
          -  1 to 4 years postoperative&#xD;
&#xD;
          -  Presence of pre-operative radiography of the shoulder&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Massive irreparable cuff tear&#xD;
&#xD;
          -  Chronically retracted tendons and atrophic rotator cuff muscles Partial arthroscopic&#xD;
             repair&#xD;
&#xD;
          -  Absence of pre-operative radiography in neutral rotation&#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>Mohy Taha, Dr. med.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Orthopaedics and Traumatology, University Hospital Basel</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Orthopaedics and Traumatology, University Hospital Basel</name>
      <address>
        <city>Basel</city>
        <zip>4031</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>July 1, 2020</study_first_submitted>
  <study_first_submitted_qc>July 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>December 14, 2020</last_update_submitted>
  <last_update_submitted_qc>December 14, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Critical Shoulder Angle (CSA)</keyword>
  <keyword>Greater Tuberosity Angle (GTA)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rotator Cuff Injuries</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/NCT04459858
org study id: 2020-01201; ch20Taha2
nct id: NCT04459858
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This retrospective study is to investigate the influence of the Greater Tuberosity Angle
      (GTA) in addition to CSA on patient outcome in patients with rotator cuff tear.
A tear of the rotator cuff is one of the most common disorders of the shoulder. It is assumed
      that a large Critical Shoulder Angle (CSA) is associated with the occurrence of rotator cuff
      tears. This retrospective study is to investigate the influence of the Greater Tuberosity
      Angle (GTA) in addition to CSA on patient outcome in patients with rotator cuff tear.
observational model: Cohort
time perspective: Retrospective
measure: Change in Constant Score
time frame: 1 year (before surgery and 1 year after surgery)
description: This scoring system consists of four variables that are used to assess the function of the shoulder. The right and left shoulders are assessed separately.
The subjective variables are pain and activity of daily life (ADL) (sleep, work, recreation / sport) which give a total of 35 points. The objective variables are range of motion and strength which give a total of 65 Points (the higher the score the better the shoulder function).
arm group label: rotator cuff lesion
description: patients treated for traumatic or degenerative rotator cuff lesion
intervention type: Other
intervention name: data analysis
description: Data is extracted from the existing medical records and from the Rotator Cuff Repair Database (RCR_USB). The GTA (determined as the angle between a "line parallel to the humerus diaphysis passing through the humeral head center of rotation and a line connecting the upper border of the humeral head to the most superolateral edge of the greater tuberosity") is determined.
arm group label: rotator cuff lesion
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Mohy Taha, Dr. med.
role: Principal Investigator
affiliation: Department of Orthopaedics and Traumatology, University Hospital Basel
facility: 
country: Switzerland
responsible party type: Sponsor
mesh term: Rotator Cuff Injuries