<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/NCT04468906</url>
  </required_header>
  <id_info>
    <org_study_id>20-01026</org_study_id>
    <nct_id>NCT04468906</nct_id>
  </id_info>
  <brief_title>Tenodesis vs. Self-locking Tenotomy in Long Head of the Biceps Tendon Lesions: A Randomized Clinical Trial</brief_title>
  <official_title>Tenodesis vs. Self-locking Tenotomy in Long Head of the Biceps Tendon Lesions: 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>Yes</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 long head of the biceps brachii tendon (LHBT) surgery is a&#xD;
      Popeye deformity, which can occur with both the tenodesis and tenotomy. Tenotomy using the&#xD;
      traditional technique has a higher incidence of Popeye deformity as the residual stump is not&#xD;
      fixated in place. However, the more recently-described self-locking tenotomy improves upon&#xD;
      this by having a wider stump base to theoretically prevent reduce the incidence of tendon&#xD;
      retraction down the bicipital groove. If this technique is shown to result in a similar&#xD;
      incidence of Popeye deformity, then it may be preferable to tenodesis due to its advantages&#xD;
      of reduced postoperative pain, more rapid return to activity, and reduced surgical time and&#xD;
      cost. The purpose of the proposed study is to evaluate the effect of biceps tenodesis versus&#xD;
      self-locking T tenotomy in the management of lesions involving the LHBT.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Long head of the biceps brachii tendon (LHBT) lesions are a common pathology and can be a&#xD;
      significant source of pain in the shoulder due to the large number of free nerve endings&#xD;
      around the tendon. There are 3 main subtypes of LHBT lesions 1) LHBT degeneration, 2) LHBT&#xD;
      anchor disorders, and 3) LHBT instability. These lesions can occur both in isolation or in&#xD;
      conjunction with rotator cuff disease. Treatment options include tenotomy and tenodesis, and&#xD;
      while both are utilized there exists a lack of consensus treatment choice.&#xD;
&#xD;
      The optimal management of LHBT lesions remains controversial, with surgeons typically&#xD;
      treating younger patients with tenodesis and older patients with tenotomy. Previous RCTs have&#xD;
      failed to discern a clinical difference between tenodesis and tenotomy, apart from the&#xD;
      reduced incidence of Popeye deformity in the tenodesis cohorts. However, all previous&#xD;
      literature has utilized the traditional biceps tenotomy technique of transecting the tendon&#xD;
      just lateral to its insertion on the superior labrum. This results in a narrow tendon stump&#xD;
      that usually slips through the transverse humeral ligament and retracts down the arm,&#xD;
      resulting in the aforementioned deformity. A newer tenotomy technique, termed the&#xD;
      self-locking tenotomy, consists of preserving the attachment of the LHBT on the superior&#xD;
      labrum and instead releasing the superior labrum off the glenoid from the 11 o'clock to 1&#xD;
      o'clock positions. As a result, the residual LHBT stump is broad and &quot;T-shaped&quot;, which has a&#xD;
      lower incidence of retracting down the arm. Using this technique, LHBT tenotomy has been&#xD;
      shown to result in similar rates of Popeye deformity as the tenodesis in a number of recent&#xD;
      case series.&#xD;
&#xD;
      This will be a single-center randomized controlled trial. The study is comparing biceps&#xD;
      tenodesis and self-locking tenotomy in patients undergoing arthroscopic shoulder surgery for&#xD;
      lesions involving the LHBT.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 1, 2020</start_date>
  <completion_date type="Anticipated">June 6, 2025</completion_date>
  <primary_completion_date type="Anticipated">June 6, 2024</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>Rate of Reverse Popeye Deformity</measure>
    <time_frame>up to 24 months post-op</time_frame>
    <description>Reverse popeye deformity is the loss of the theoretical LHBT stabilizing effect on the humeral head, which can be determined with a physical exam.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Score on American Shoulder &amp; Elbow Surgeons (ASES) Scale</measure>
    <time_frame>6 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 Visual Analogue Scale (VAS)</measure>
    <time_frame>6 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>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of fatigue, cramping, biceps groove tenderness</measure>
    <time_frame>up to 24 months post-op</time_frame>
  </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>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">110</enrollment>
  <condition>Tenodesis</condition>
  <condition>Tenotomy</condition>
  <arm_group>
    <arm_group_label>Biceps self-locking &quot;T&quot; tenotomy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Biceps tenodesis (control)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <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 LHBT lesions.</description>
    <arm_group_label>Biceps tenodesis (control)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Self-locking &quot;T&quot; Tenotomy</intervention_name>
    <description>Self-locking &quot;T&quot; Tenotomy describes the surgical procedure that will be performed to treat LHBT lesions.</description>
    <arm_group_label>Biceps self-locking &quot;T&quot; tenotomy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Primary indication is for pathology of the LHBT or biceps-labrum complex&#xD;
&#xD;
          -  Age 40-80&#xD;
&#xD;
          -  Ability to comply with a standardized postoperative protocol&#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;
          -  Age &lt;40 years&#xD;
&#xD;
          -  Previous shoulder surgery&#xD;
&#xD;
          -  Unable to speak English or perform informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>80 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>
  <overall_contact>
    <last_name>Laith Jazrawi, MD</last_name>
    <phone>646-501-7223</phone>
    <email>laith.jazrawi@nyulangone.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Dhruv Shankar</last_name>
    <phone>240-848-8645</phone>
    <email>dhruv.shankar@nyulangone.org</email>
  </overall_contact_backup>
  <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>
    <status>Recruiting</status>
    <contact>
      <last_name>Dhruv Shankar</last_name>
      <phone>240-848-8645</phone>
      <email>dhruv.shankar@nyulangone.org</email>
    </contact>
    <investigator>
      <last_name>Laith Jawrawi, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>July 9, 2020</study_first_submitted>
  <study_first_submitted_qc>July 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 13, 2020</study_first_posted>
  <last_update_submitted>July 20, 2023</last_update_submitted>
  <last_update_submitted_qc>July 20, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>LHBT</keyword>
  <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/NCT04468906
org study id: 20-01026
nct id: NCT04468906
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
One of the common complaints after long head of the biceps brachii tendon (LHBT) surgery is a
      Popeye deformity, which can occur with both the tenodesis and tenotomy. Tenotomy using the
      traditional technique has a higher incidence of Popeye deformity as the residual stump is not
      fixated in place. However, the more recently-described self-locking tenotomy improves upon
      this by having a wider stump base to theoretically prevent reduce the incidence of tendon
      retraction down the bicipital groove. If this technique is shown to result in a similar
      incidence of Popeye deformity, then it may be preferable to tenodesis due to its advantages
      of reduced postoperative pain, more rapid return to activity, and reduced surgical time and
      cost. The purpose of the proposed study is to evaluate the effect of biceps tenodesis versus
      self-locking T tenotomy in the management of lesions involving the LHBT.
Long head of the biceps brachii tendon (LHBT) lesions are a common pathology and can be a
      significant source of pain in the shoulder due to the large number of free nerve endings
      around the tendon. There are 3 main subtypes of LHBT lesions 1) LHBT degeneration, 2) LHBT
      anchor disorders, and 3) LHBT instability. These lesions can occur both in isolation or in
      conjunction with rotator cuff disease. Treatment options include tenotomy and tenodesis, and
      while both are utilized there exists a lack of consensus treatment choice.

      The optimal management of LHBT lesions remains controversial, with surgeons typically
      treating younger patients with tenodesis and older patients with tenotomy. Previous RCTs have
      failed to discern a clinical difference between tenodesis and tenotomy, apart from the
      reduced incidence of Popeye deformity in the tenodesis cohorts. However, all previous
      literature has utilized the traditional biceps tenotomy technique of transecting the tendon
      just lateral to its insertion on the superior labrum. This results in a narrow tendon stump
      that usually slips through the transverse humeral ligament and retracts down the arm,
      resulting in the aforementioned deformity. A newer tenotomy technique, termed the
      self-locking tenotomy, consists of preserving the attachment of the LHBT on the superior
      labrum and instead releasing the superior labrum off the glenoid from the 11 o'clock to 1
      o'clock positions. As a result, the residual LHBT stump is broad and "T-shaped", which has a
      lower incidence of retracting down the arm. Using this technique, LHBT tenotomy has been
      shown to result in similar rates of Popeye deformity as the tenodesis in a number of recent
      case series.

      This will be a single-center randomized controlled trial. The study is comparing biceps
      tenodesis and self-locking tenotomy in patients undergoing arthroscopic shoulder surgery for
      lesions involving the LHBT.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Rate of Reverse Popeye Deformity
time frame: up to 24 months post-op
description: Reverse popeye deformity is the loss of the theoretical LHBT stabilizing effect on the humeral head, which can be determined with a physical exam.
measure: Change in Score on American Shoulder & Elbow Surgeons (ASES) Scale
time frame: 6 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 Visual Analogue Scale (VAS)
time frame: 6 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: Incidence of fatigue, cramping, biceps groove tenderness
time frame: up to 24 months post-op
measure: Average timing of return to work/sport
time frame: up to 24 months post-op
arm group label: Biceps self-locking "T" tenotomy
arm group type: Experimental
arm group label: Biceps tenodesis (control)
arm group type: Active Comparator
intervention type: Procedure
intervention name: Biceps Tenodesis
description: Biceps tenodesis describes the surgical procedure that will be performed to treat LHBT lesions.
arm group label: Biceps tenodesis (control)
intervention type: Procedure
intervention name: Self-locking "T" Tenotomy
description: Self-locking "T" Tenotomy describes the surgical procedure that will be performed to treat LHBT lesions.
arm group label: Biceps self-locking "T" tenotomy
criteria: 
gender: All
minimum age: 40 Years
maximum age: 80 Years
healthy volunteers: No
last name: Laith Jazrawi, MD
role: Principal Investigator
affiliation: NYU Langone Health
last name: Laith Jazrawi, MD
phone: 646-501-7223
email: laith.jazrawi@nyulangone.org
last name: Dhruv Shankar
phone: 240-848-8645
email: dhruv.shankar@nyulangone.org
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Sponsor
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.