<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/NCT03797287</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00046834</org_study_id>
    <nct_id>NCT03797287</nct_id>
  </id_info>
  <brief_title>Arthroscopic Transosseous vs. Anchored Rotator Cuff Repair</brief_title>
  <official_title>Arthroscopic Transosseous vs. Anchored Rotator Cuff Repair: A Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Johns Hopkins University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will compare arthroscopic transosseous versus anchored rotator cuff repairs in&#xD;
      terms of clinical outcomes, rotator cuff integrity, and cost-effectiveness. With the&#xD;
      collection of patient-reported outcomes the health of patients undergoing each rotator cuff&#xD;
      repair technique will be assessed. The aims of this study will be achieved through a clinical&#xD;
      randomized controlled trial and a cost-effectiveness analysis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study Design: After the decision to proceed with arthroscopic rotator cuff repair, patients&#xD;
      will be asked to participate in this prospective randomized clinical trial.&#xD;
&#xD;
      Study Procedures:&#xD;
&#xD;
      Before Surgery: The Informed Consent process will be completed prior to any data collection.&#xD;
      Consent will be completed after explanation of each treatment group and the data to be&#xD;
      collected. Baseline and demographic data will be collected prior to surgery:&#xD;
&#xD;
      Randomization: Subjects will be randomized prior to surgery into one of the two rotator cuff&#xD;
      repair technique groups using REDCap software. Randomization will be stratified by gender.&#xD;
&#xD;
      Patient Visits:&#xD;
&#xD;
      Patients will complete their questionnaires and testing before surgery then within 2 weeks, 3&#xD;
      months, 6 months, 1 year, and 2 years After the first week of surgery, patients will be given&#xD;
      a pain diary to record all narcotic pain medications they consume during the 1st week&#xD;
      post-op.&#xD;
&#xD;
      An ultrasound will be done during their 6 month, 1 year, and 2 year follow up.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    IRB will be terminated&#xD;
  </why_stopped>
  <start_date type="Anticipated">February 1, 2020</start_date>
  <completion_date type="Anticipated">December 2025</completion_date>
  <primary_completion_date type="Anticipated">December 2025</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 (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in condition of the shoulder as assessed by American Shoulder and Elbow Surgeon (ASES) Score</measure>
    <time_frame>Before surgery, 2 weeks, 3 months, 6 months, and 1 year after surgery</time_frame>
    <description>10 separate questions is scored on an ordinal scale from 0-3 for a maximal raw functional score of 30 (no difficulties).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in shoulder pain as assessed by Visual Analog Pain Score</measure>
    <time_frame>Before surgery, 2 weeks, 3 months, 6 months, and 1 year after surgery</time_frame>
    <description>Patients are asked to identify whether they are having pain in the shoulder and are asked to record the location of their pain on a 10 cm line that ranges from 0(no pain at all) to 10 (pain as bad as it can be)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Range of Motion (ROM)</measure>
    <time_frame>Before surgery, within 1 month after surgery, 3 months, 6 months, 1 year</time_frame>
    <description>Total (combined glenohumeral and scapulothoracic) shoulder motion is measured. Both active and passive motion for both shoulders is recorded. Forward elevation is measured as the maximum arm-trunk angle viewed from any direction. External rotation is measured with the arm comfortably at the side and also with the arm at 90° of abduction. Internal rotation is measured by noting the highest segment of spinal anatomy reached with the thumb. Cross-body adduction is measured by measuring the distance of the antecubital fossa from the opposite acromion.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Strength Testing</measure>
    <time_frame>Before surgery, 2 weeks, 3 months, 6 months, and 1 year after surgery</time_frame>
    <description>Strength is graded according to the Medical Research Council grade. Strength is measured in forward elevation, abduction, external rotation with the arm comfortably at the side, and internal rotation with the arm comfortably at the side. A perfect score is a 5 in each category.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in quality of life as assessed by the Western Ontario Rotator Cuff (WORC) Index</measure>
    <time_frame>Before surgery, 1 year after surgery, 2 years after surgery</time_frame>
    <description>Quality of Life Measurement tool for patients with rotator cuff disease where patients mark a line on 21 visual analogue scale (VAS) lines labeled 0 (not affected) - 100 (affected). These items will ask about physical symptoms, sports and recreation, work, social function, and emotions. The maximum score is 2100 for worst possible symptoms and 0 represents no symptoms at all.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in health related quality of life as assessed by Short-Form Six-Dimension (SF-6D)</measure>
    <time_frame>Before surgery, 2 weeks, 3 months, 6 months, and 1 year after surgery</time_frame>
    <description>Measures of health related quality of life (HRQoL) using 11 items from the SF-36 or SF-12. Patients are asked about their physical functioning, role limitations, social functioning, pain, mental health, and vitality. A score of 1 represents full health.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Implant Cost</measure>
    <time_frame>Within 1 month after surgery</time_frame>
    <description>Review of costs through our billing department</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Shoulder Pain Chronic</condition>
  <condition>Shoulder Pain</condition>
  <condition>Rotator Cuff Tear</condition>
  <condition>Rotator Cuff Injury</condition>
  <arm_group>
    <arm_group_label>Tensor Tunnler</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The Tensor Tunneler (Chattanooga, TN) will be used to create the bone tunnels during the arthroscopic procedure. This is an FDA approved device and is used currently in routine clinical practice.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Smith and Nephew PEEK Helicoil Anchor</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The anchors used in this trial are FDA approved and are used currently in routine clinical practice (Anchor Rotator Cuff Repair).</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Tensor Tunnler</intervention_name>
    <description>Create the bone tunnels during the arthroscopic rotator cuff repair procedure</description>
    <arm_group_label>Tensor Tunnler</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Anchor Rotator Cuff Repair</intervention_name>
    <description>The suture anchors (Smith and Nephew PEEK Helicoil Anchor) are inserted in bone and the sutures are then used to sew the tendons to bone arthroscopically.</description>
    <arm_group_label>Smith and Nephew PEEK Helicoil Anchor</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults age 18-75 years old&#xD;
&#xD;
          -  Full thickness rotator cuff tears of any size (documented by MRI or ultrasound)&#xD;
&#xD;
          -  Patients planning surgical repair with Dr. Uma Srikumaran (PI of this study) at Johns&#xD;
             Hopkins Shoulder Service (Columbia, Odenton Clinic sites; Howard County General&#xD;
             Hospital/Bayview/Johns Hopkins Hospital operative sites)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with partial tears, massive rotator cuff tears that are irreparable, isolated&#xD;
             subscapularis tears, and associated pathology (advanced degenerative changes)&#xD;
&#xD;
          -  Patients undergoing revision rotator cuff tears will be excluded.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Uma Srikumaran, MD, MBA</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Johns Hopkins</name>
      <address>
        <city>Columbia</city>
        <state>Maryland</state>
        <zip>21044</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>January 7, 2019</study_first_submitted>
  <study_first_submitted_qc>January 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 9, 2019</study_first_posted>
  <last_update_submitted>May 29, 2019</last_update_submitted>
  <last_update_submitted_qc>May 29, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 30, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Shoulder Pain</mesh_term>
    <mesh_term>Rotator Cuff Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </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/NCT03797287
org study id: IRB00046834
nct id: NCT03797287
lead sponsor: 
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
This study will compare arthroscopic transosseous versus anchored rotator cuff repairs in
      terms of clinical outcomes, rotator cuff integrity, and cost-effectiveness. With the
      collection of patient-reported outcomes the health of patients undergoing each rotator cuff
      repair technique will be assessed. The aims of this study will be achieved through a clinical
      randomized controlled trial and a cost-effectiveness analysis.
Study Design: After the decision to proceed with arthroscopic rotator cuff repair, patients
      will be asked to participate in this prospective randomized clinical trial.

      Study Procedures:

      Before Surgery: The Informed Consent process will be completed prior to any data collection.
      Consent will be completed after explanation of each treatment group and the data to be
      collected. Baseline and demographic data will be collected prior to surgery:

      Randomization: Subjects will be randomized prior to surgery into one of the two rotator cuff
      repair technique groups using REDCap software. Randomization will be stratified by gender.

      Patient Visits:

      Patients will complete their questionnaires and testing before surgery then within 2 weeks, 3
      months, 6 months, 1 year, and 2 years After the first week of surgery, patients will be given
      a pain diary to record all narcotic pain medications they consume during the 1st week
      post-op.

      An ultrasound will be done during their 6 month, 1 year, and 2 year follow up.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change in condition of the shoulder as assessed by American Shoulder and Elbow Surgeon (ASES) Score
time frame: Before surgery, 2 weeks, 3 months, 6 months, and 1 year after surgery
description: 10 separate questions is scored on an ordinal scale from 0-3 for a maximal raw functional score of 30 (no difficulties).
measure: Change in shoulder pain as assessed by Visual Analog Pain Score
time frame: Before surgery, 2 weeks, 3 months, 6 months, and 1 year after surgery
description: Patients are asked to identify whether they are having pain in the shoulder and are asked to record the location of their pain on a 10 cm line that ranges from 0(no pain at all) to 10 (pain as bad as it can be)
measure: Change in Range of Motion (ROM)
time frame: Before surgery, within 1 month after surgery, 3 months, 6 months, 1 year
description: Total (combined glenohumeral and scapulothoracic) shoulder motion is measured. Both active and passive motion for both shoulders is recorded. Forward elevation is measured as the maximum arm-trunk angle viewed from any direction. External rotation is measured with the arm comfortably at the side and also with the arm at 90° of abduction. Internal rotation is measured by noting the highest segment of spinal anatomy reached with the thumb. Cross-body adduction is measured by measuring the distance of the antecubital fossa from the opposite acromion.
measure: Change in Strength Testing
time frame: Before surgery, 2 weeks, 3 months, 6 months, and 1 year after surgery
description: Strength is graded according to the Medical Research Council grade. Strength is measured in forward elevation, abduction, external rotation with the arm comfortably at the side, and internal rotation with the arm comfortably at the side. A perfect score is a 5 in each category.
measure: Change in quality of life as assessed by the Western Ontario Rotator Cuff (WORC) Index
time frame: Before surgery, 1 year after surgery, 2 years after surgery
description: Quality of Life Measurement tool for patients with rotator cuff disease where patients mark a line on 21 visual analogue scale (VAS) lines labeled 0 (not affected) - 100 (affected). These items will ask about physical symptoms, sports and recreation, work, social function, and emotions. The maximum score is 2100 for worst possible symptoms and 0 represents no symptoms at all.
measure: Change in health related quality of life as assessed by Short-Form Six-Dimension (SF-6D)
time frame: Before surgery, 2 weeks, 3 months, 6 months, and 1 year after surgery
description: Measures of health related quality of life (HRQoL) using 11 items from the SF-36 or SF-12. Patients are asked about their physical functioning, role limitations, social functioning, pain, mental health, and vitality. A score of 1 represents full health.
measure: Implant Cost
time frame: Within 1 month after surgery
description: Review of costs through our billing department
arm group label: Tensor Tunnler
arm group type: Experimental
description: The Tensor Tunneler (Chattanooga, TN) will be used to create the bone tunnels during the arthroscopic procedure. This is an FDA approved device and is used currently in routine clinical practice.
arm group label: Smith and Nephew PEEK Helicoil Anchor
arm group type: Active Comparator
description: The anchors used in this trial are FDA approved and are used currently in routine clinical practice (Anchor Rotator Cuff Repair).
intervention type: Device
intervention name: Tensor Tunnler
description: Create the bone tunnels during the arthroscopic rotator cuff repair procedure
arm group label: Tensor Tunnler
intervention type: Procedure
intervention name: Anchor Rotator Cuff Repair
description: The suture anchors (Smith and Nephew PEEK Helicoil Anchor) are inserted in bone and the sutures are then used to sew the tendons to bone arthroscopically.
arm group label: Smith and Nephew PEEK Helicoil Anchor
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Uma Srikumaran, MD, MBA
role: Principal Investigator
affiliation: Johns Hopkins University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Shoulder Pain
mesh term: Rotator Cuff Injuries
sharing ipd: Undecided