<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/NCT04494932</url>
  </required_header>
  <id_info>
    <org_study_id>20-01027</org_study_id>
    <nct_id>NCT04494932</nct_id>
  </id_info>
  <brief_title>SLAP Repair vs. Biceps Tenodesis in Patients Under 30: A Randomized Clinical Trial</brief_title>
  <official_title>SLAP Repair vs. Biceps Tenodesis in Patients Under 30: A Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NYU Langone Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>NYU Langone Health</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>
      One of the common complaints after SLAP repair is pain and stiffness. However, the more&#xD;
      recently-described Biceps Tenodesis for SLAP tears improves upon this by addressing the long&#xD;
      head of biceps which is thought to be the pain sources. However, only one small prior RCT has&#xD;
      evaluated this, finding minimal difference. Both procedures are currently considered standard&#xD;
      of care, and are decided upon based on patient and surgeon preference.&#xD;
&#xD;
      This will be a single-center randomized controlled trial. The study is comparing SLAP repair&#xD;
      and biceps tenodesis in patients under 30 undergoing surgery for SLAP tears. The purpose of&#xD;
      the proposed study is to evaluate the effect of SLAP repair versus biceps tenodesis in the&#xD;
      management of SLAP tears in patients under 30 years old.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Superior-labrum anterior to posterior (SLAP) tears were first described by Andrews et al. in&#xD;
      1985, and have been reported to be present in up to 26% of shoulder arthroscopies. While the&#xD;
      exact cause of SLAP tears is unknown, they are often related to traumatic events and sports&#xD;
      activity, particularly overhead sports such as baseball. Type II SLAP tears, which are&#xD;
      characterized by superior labral fraying with a detached biceps anchor, are the most common&#xD;
      subtype, based on the classification by Snyder et al. Treatment options include SLAP repair,&#xD;
      biceps tenodesis, biceps tenotomy, and debridement.&#xD;
&#xD;
      One of the common complaints after SLAP repair is pain and stiffness. However, the more&#xD;
      recently-described Biceps Tenodesis for SLAP tears improves upon this by addressing the long&#xD;
      head of biceps which is thought to be the pain sources. However, only one small prior RCT has&#xD;
      evaluated this, finding minimal difference. Both procedures are currently considered standard&#xD;
      of care, and are decided upon based on patient and surgeon preference.&#xD;
&#xD;
      This will be a single-center randomized controlled trial. The study is comparing SLAP repair&#xD;
      and biceps tenodesis in patients under 30 undergoing surgery for SLAP tears. The purpose of&#xD;
      the proposed study is to evaluate the effect of SLAP repair versus biceps tenodesis in the&#xD;
      management of SLAP tears in patients under 30 years old.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">September 1, 2020</start_date>
  <completion_date type="Anticipated">September 1, 2024</completion_date>
  <primary_completion_date type="Actual">September 1, 2023</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>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Score on Visual Analogue Scale (VAS) Scale</measure>
    <time_frame>3 months post-op, 24 months post-op</time_frame>
    <description>The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between &quot;no pain&quot; and &quot;worst pain possible.&quot; The total score range is 0-10. The higher the score, the higher the pain level experienced.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Score on American Shoulder &amp; Elbow Surgeons (ASES) Scale</measure>
    <time_frame>3 months post-op, 24 months post-op</time_frame>
    <description>The ASES scale consists of two subscales: pain (0-50 points) and function/disability (0-50 points), with a total score range of 0-100 points. The lower the score, the greater the pain and disability.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Score on Kerlan-Jobe Orthopaedic Clinical Shoulder &amp; Elbow (KJOC) Questionnaire</measure>
    <time_frame>3 months post-op, 24 months post-op</time_frame>
    <description>The KJOC Score includes 10 questions with an 11-point Likert scale in the form of blocks to be ticked from 0 to 10. The total score is equal to the sum of the values of the 10 responses. The higher the score, the greater the shoulder function.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Score on Shoulder Instability-Return to Sport after Injury (SIRSI) Questionnaire</measure>
    <time_frame>3 months post-op, 24 months post-op</time_frame>
    <description>The SIRSI includes 12 questions with an 11-point Likert scale in the form of blocks to be ticked from 0 to 10. The total score is equal to the sum of the values of the 12 responses then determined in relation to 100 to obtain a percentage (0-100%). The higher the score (%), the more positive the psychological response.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average timing of return to work/sport</measure>
    <time_frame>up to 24 months post-op</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of re-operations</measure>
    <time_frame>up to 24 months post-op</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>SLAP Tear</condition>
  <arm_group>
    <arm_group_label>Biceps Tenodesis</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>SLAP Repair (Control)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Self-Locking Tenotomy</intervention_name>
    <description>Self-locking Tenotomy describes the surgical procedure that will be performed to treat SLAP tears.</description>
    <arm_group_label>SLAP Repair (Control)</arm_group_label>
    <other_name>SLAP Repair</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Biceps Tenodesis</intervention_name>
    <description>Biceps tenodesis describes the surgical procedure that will be performed to treat SLAP tears.</description>
    <arm_group_label>Biceps Tenodesis</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Primary indication is for SLAP tear&#xD;
&#xD;
          -  Age 18-30&#xD;
&#xD;
          -  Willing and able to provide consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Associated rotator cuff tear requiring arthroscopic repair&#xD;
&#xD;
          -  Pregnant patient&#xD;
&#xD;
          -  Previous shoulder surgery&#xD;
&#xD;
          -  Age &gt; 30, or &lt; 18&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Laith Jazrawi, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>NYU Langone Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>NYU Langone Health</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>July 28, 2020</study_first_submitted>
  <study_first_submitted_qc>July 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2020</study_first_posted>
  <last_update_submitted>September 14, 2023</last_update_submitted>
  <last_update_submitted_qc>September 14, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 15, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>SLAP Repair</keyword>
  <keyword>Biceps Tenodesis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Shoulder Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_time_frame>Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.</ipd_time_frame>
    <ipd_access_criteria>The investigator who proposed to use the data will have access to use the data upon reasonable request. Requests should be directed to laith.jazrawi@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.</ipd_access_criteria>
  </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/NCT04494932
org study id: 20-01027
nct id: NCT04494932
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
One of the common complaints after SLAP repair is pain and stiffness. However, the more
      recently-described Biceps Tenodesis for SLAP tears improves upon this by addressing the long
      head of biceps which is thought to be the pain sources. However, only one small prior RCT has
      evaluated this, finding minimal difference. Both procedures are currently considered standard
      of care, and are decided upon based on patient and surgeon preference.

      This will be a single-center randomized controlled trial. The study is comparing SLAP repair
      and biceps tenodesis in patients under 30 undergoing surgery for SLAP tears. The purpose of
      the proposed study is to evaluate the effect of SLAP repair versus biceps tenodesis in the
      management of SLAP tears in patients under 30 years old.
Superior-labrum anterior to posterior (SLAP) tears were first described by Andrews et al. in
      1985, and have been reported to be present in up to 26% of shoulder arthroscopies. While the
      exact cause of SLAP tears is unknown, they are often related to traumatic events and sports
      activity, particularly overhead sports such as baseball. Type II SLAP tears, which are
      characterized by superior labral fraying with a detached biceps anchor, are the most common
      subtype, based on the classification by Snyder et al. Treatment options include SLAP repair,
      biceps tenodesis, biceps tenotomy, and debridement.

      One of the common complaints after SLAP repair is pain and stiffness. However, the more
      recently-described Biceps Tenodesis for SLAP tears improves upon this by addressing the long
      head of biceps which is thought to be the pain sources. However, only one small prior RCT has
      evaluated this, finding minimal difference. Both procedures are currently considered standard
      of care, and are decided upon based on patient and surgeon preference.

      This will be a single-center randomized controlled trial. The study is comparing SLAP repair
      and biceps tenodesis in patients under 30 undergoing surgery for SLAP tears. The purpose of
      the proposed study is to evaluate the effect of SLAP repair versus biceps tenodesis in the
      management of SLAP tears in patients under 30 years old.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in Score on Visual Analogue Scale (VAS) Scale
time frame: 3 months post-op, 24 months post-op
description: The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain possible." The total score range is 0-10. The higher the score, the higher the pain level experienced.
measure: Change in Score on American Shoulder & Elbow Surgeons (ASES) Scale
time frame: 3 months post-op, 24 months post-op
description: The ASES scale consists of two subscales: pain (0-50 points) and function/disability (0-50 points), with a total score range of 0-100 points. The lower the score, the greater the pain and disability.
measure: Change in Score on Kerlan-Jobe Orthopaedic Clinical Shoulder & Elbow (KJOC) Questionnaire
time frame: 3 months post-op, 24 months post-op
description: The KJOC Score includes 10 questions with an 11-point Likert scale in the form of blocks to be ticked from 0 to 10. The total score is equal to the sum of the values of the 10 responses. The higher the score, the greater the shoulder function.
measure: Change in Score on Shoulder Instability-Return to Sport after Injury (SIRSI) Questionnaire
time frame: 3 months post-op, 24 months post-op
description: The SIRSI includes 12 questions with an 11-point Likert scale in the form of blocks to be ticked from 0 to 10. The total score is equal to the sum of the values of the 12 responses then determined in relation to 100 to obtain a percentage (0-100%). The higher the score (%), the more positive the psychological response.
measure: Average timing of return to work/sport
time frame: up to 24 months post-op
measure: Incidence of re-operations
time frame: up to 24 months post-op
arm group label: Biceps Tenodesis
arm group type: Experimental
arm group label: SLAP Repair (Control)
arm group type: Active Comparator
intervention type: Procedure
intervention name: Self-Locking Tenotomy
description: Self-locking Tenotomy describes the surgical procedure that will be performed to treat SLAP tears.
arm group label: SLAP Repair (Control)
other name: SLAP Repair
intervention type: Procedure
intervention name: Biceps Tenodesis
description: Biceps tenodesis describes the surgical procedure that will be performed to treat SLAP tears.
arm group label: Biceps Tenodesis
criteria: 
gender: All
minimum age: 18 Years
maximum age: 30 Years
healthy volunteers: No
last name: Laith Jazrawi, MD
role: Principal Investigator
affiliation: NYU Langone Health
facility: 
country: United States
responsible party type: Sponsor
mesh term: Shoulder Injuries
sharing ipd: Yes
ipd description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd time frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
ipd access criteria: The investigator who proposed to use the data will have access to use the data upon reasonable request. Requests should be directed to laith.jazrawi@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.