<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/NCT02192073</url>
  </required_header>
  <id_info>
    <org_study_id>13081402</org_study_id>
    <nct_id>NCT02192073</nct_id>
  </id_info>
  <brief_title>Analysis of Suprapectoral and Subpectoral Biceps Tenodesis</brief_title>
  <official_title>Prospective Analysis of Arthroscopic Suprapectoral and Open Subpectoral Biceps Tenodesis: 1 Year Follow-Up</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rush University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rush University Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Biceps pathology typically includes pain in the anterior shoulder that is reproduced with&#xD;
      provocative maneuvers. However, optimal treatment of patient with this diagnosis is not clear&#xD;
      and can include tenotomy (cutting the biceps) or various forms of tenodesis (cutting then&#xD;
      reattaching). As tenotomy can lead to cosmetic deformity and anterior humeral discomfort from&#xD;
      spasms, many surgeons perform tenodesis. There are various techniques for tenodesis. This&#xD;
      study will compare 2 methods: suprapectoral (doing the surgery using an incision higher in&#xD;
      the shoulder) versus subpectoral fixation (surgery which involves making an incision lower in&#xD;
      the shoulder).&#xD;
&#xD;
      Purpose of the study is to prospectively determine whether arthroscopic suprapectoral or open&#xD;
      subpectoral biceps tenodesis results in better function.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <start_date>May 2014</start_date>
  <completion_date type="Actual">September 1, 2020</completion_date>
  <primary_completion_date type="Actual">September 1, 2018</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>American Shoulder and Elbow Surgeons (ASES) Shoulder Score</measure>
    <time_frame>1 year</time_frame>
    <description>Validated outcome score assessing pain and function of shoulder</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Constant Score</measure>
    <time_frame>1 year</time_frame>
    <description>Validated score to assess shoulder pain and function</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Biceps Tendonitis</condition>
  <arm_group>
    <arm_group_label>Suprapectoral Biceps Tenodesis</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Suprapectoral Biceps Tenodesis involves detaching the long head of biceps from it's origin and reattaching it to humerus in the superior border of the pectoralis major insertion</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Subpectoral Biceps Tenodesis</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subpectoral Biceps Tenodesis involves detaching the long head of biceps from it's origin and reattaching it to humerus in the inferior border of the pectoralis major insertion</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Suprapectoral Biceps tenodesis</intervention_name>
    <arm_group_label>Suprapectoral Biceps Tenodesis</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Subpectoral biceps tenodesis</intervention_name>
    <arm_group_label>Subpectoral Biceps Tenodesis</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Scheduled to undergo biceps tenodesis&#xD;
&#xD;
          -  Pain at intertubercular groove&#xD;
&#xD;
          -  Anterior Humeral pain&#xD;
&#xD;
          -  Patient agrees to follow up and consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Biceps Tenotomy&#xD;
&#xD;
          -  Revision biceps procedure&#xD;
&#xD;
          -  Prior SLAP or labral repair&#xD;
&#xD;
          -  Concomitant subscapularis repair&#xD;
&#xD;
          -  More than 1 rotator cuff repair at time of surgery&#xD;
&#xD;
          -  Concomitant arthroplasty&#xD;
&#xD;
          -  Prior infection&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nikhil N Verma, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rush Univeristy Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rush University Medical Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>May 21, 2014</study_first_submitted>
  <study_first_submitted_qc>July 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 16, 2014</study_first_posted>
  <last_update_submitted>September 8, 2021</last_update_submitted>
  <last_update_submitted_qc>September 8, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 16, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Rush University Medical Center</investigator_affiliation>
    <investigator_full_name>Carla Edwards</investigator_full_name>
    <investigator_title>Clinical Research Manger</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tendinopathy</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/NCT02192073
org study id: 13081402
nct id: NCT02192073
lead sponsor: 
has dmc: No
Biceps pathology typically includes pain in the anterior shoulder that is reproduced with
      provocative maneuvers. However, optimal treatment of patient with this diagnosis is not clear
      and can include tenotomy (cutting the biceps) or various forms of tenodesis (cutting then
      reattaching). As tenotomy can lead to cosmetic deformity and anterior humeral discomfort from
      spasms, many surgeons perform tenodesis. There are various techniques for tenodesis. This
      study will compare 2 methods: suprapectoral (doing the surgery using an incision higher in
      the shoulder) versus subpectoral fixation (surgery which involves making an incision lower in
      the shoulder).

      Purpose of the study is to prospectively determine whether arthroscopic suprapectoral or open
      subpectoral biceps tenodesis results in better function.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: American Shoulder and Elbow Surgeons (ASES) Shoulder Score
time frame: 1 year
description: Validated outcome score assessing pain and function of shoulder
measure: Constant Score
time frame: 1 year
description: Validated score to assess shoulder pain and function
arm group label: Suprapectoral Biceps Tenodesis
arm group type: Active Comparator
description: Suprapectoral Biceps Tenodesis involves detaching the long head of biceps from it's origin and reattaching it to humerus in the superior border of the pectoralis major insertion
arm group label: Subpectoral Biceps Tenodesis
arm group type: Active Comparator
description: Subpectoral Biceps Tenodesis involves detaching the long head of biceps from it's origin and reattaching it to humerus in the inferior border of the pectoralis major insertion
intervention type: Procedure
intervention name: Suprapectoral Biceps tenodesis
arm group label: Suprapectoral Biceps Tenodesis
intervention type: Procedure
intervention name: Subpectoral biceps tenodesis
arm group label: Subpectoral Biceps Tenodesis
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Nikhil N Verma, MD
role: Principal Investigator
affiliation: Rush Univeristy Medical Center
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Rush University Medical Center
investigator full name: Carla Edwards
investigator title: Clinical Research Manger
mesh term: Tendinopathy