xml: <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/NCT05988541</url>
    </required_header>
    <id_info>
      <org_study_id>Tikk2023</org_study_id>
      <nct_id>NCT05988541</nct_id>
    </id_info>
    <brief_title>Rotator Cuff Integrity and Clinical Outcomes 5 Years After Repair.</brief_title>
    <official_title>Overview of Surgically Treated Rotator Cuff Injury Patients and Rotator Cuff Integrity 5 Years After Atraumatic Rotator Cuff Tendon Repair.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Tartu University Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>University of Tartu</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Tartu University Hospital</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>
        The study gives an overview of surgically treated rotator cuff injury patients in Tartu&#xD;
        University Hospital Sports Traumatology Centre during 2013-2019 and evaluates the integrity&#xD;
        of rotator cuff at minimum 5 years after atraumatic rotator cuff tendon repair.&#xD;
  &#xD;
        First stage of the study describes the study population, etiology of the injury&#xD;
        (traumatic/atraumatic) and aims to answer the question whether the arthroscopic findings are&#xD;
        in line with the preoperative imaging studies or not.&#xD;
  &#xD;
        Second stage of the study focuses on atraumatic tendon tears assessing structural integrity&#xD;
        of the tendons 5 years after repair using ultrasound imaging. The main question is - does the&#xD;
        findings correlate with clinical outcomes and patient satisfaction.&#xD;
  &#xD;
        Participants of the second phase of the study will be asked for an appointment to have their&#xD;
        shoulders examined with ultrasonography and clinical outcomes are measured using the American&#xD;
        Shoulder and Elbow Surgeons (ASES) Score, The Disabilities of the Arm, Shoulder and Hand&#xD;
        (DASH) questionnaire and The Constant-Murley score (CMS).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        High numbers of re-tear after rotator cuff surgery have been shown, though not always&#xD;
        influencing patient satisfaction. If there is an atraumatic tendon tear, the risk of having a&#xD;
        contralateral rotator cuff tendon tear is high.&#xD;
  &#xD;
        The aim is to study surgically treated rotator cuff injury patients 5 years after repair to&#xD;
        evaluate tendon integrity on ultrasonography and answer the question do the findings&#xD;
        correlate with functionality and patient satisfaction. It has been shown that people over the&#xD;
        age of 66 who have been diagnosed with rotator cuff tendon tear, have up to 50 % chance of&#xD;
        having a rotator cuff tendon tear in contralateral shoulder (Yamaguchi, et al. 2006).&#xD;
        Therefore the study will evaluate the function and the integrity of the rotator cuff in both&#xD;
        shoulders.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">September 2025</completion_date>
    <primary_completion_date type="Anticipated">September 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Screening</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Ultrasonography</measure>
      <time_frame>5 years after primary repair</time_frame>
      <description>Integrity of the rotator cuff tendons</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>American Shoulder and Elbow Surgeons (ASES) score</measure>
      <time_frame>5 years after primary repair</time_frame>
      <description>The higher the score, the better the outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Constant-Murley score (CMS)</measure>
      <time_frame>5 years after primary repair</time_frame>
      <description>The higher the score, the higher the quality of the function.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The Disabilities of the Arm, Shoulder and Hand (DASH)</measure>
      <time_frame>5 years after primary repair</time_frame>
      <description>The higher the score, more severe disability.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">150</enrollment>
    <condition>Rotator Cuff Tears</condition>
    <condition>Rotator Cuff Injuries</condition>
    <condition>Rotator Cuff Tear or Rupture, Not Specified as Traumatic</condition>
    <arm_group>
      <arm_group_label>Atraumatic rotator cuff tendon repair</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Ultrasonography imaging of the operated shoulder</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Contralateral shoulder</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Ultrasonography imaging of the contralateral shoulder</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Ultrasonography imaging</intervention_name>
      <description>Ultrasonography: rotator cuff tendons (supraspinatus, infraspinatus, subscapularis and teres minor) integrity, long head of the biceps tendon integrity and location, SASD (subacromial-subdeltoid) bursitis, synovitis and muscle atrophy.</description>
      <arm_group_label>Atraumatic rotator cuff tendon repair</arm_group_label>
      <arm_group_label>Contralateral shoulder</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>American Shoulder and Elbow Surgeons (ASES) Score</intervention_name>
      <description>The patient self-assessment (pASES) includes 6 pain items and 10 functional items that are shoulder specific (Angst, 2008).&#xD;
  The pASES form has 3 sections: pain, instability, ADLs (Goldhahn, 2008).&#xD;
  Pain section: 4 questions with yes/no responses, 1 question covering number of pain tablets per day, and a VAS (visual analogue scale) from 0 (no pain) to 10 (worst pain).&#xD;
  Instability section: 2 questions (1. Response yes/no about feelings of instability, 2. Quantify instability from 0 (stable) to 10 (very unstable)).&#xD;
  Activities of daily living (ADLs): Each shoulder is included (affected/non affected), 10 items, with a 4 point ordinal scale, range: 0 (unable to perform activity) to 3 (no difficulty in doing activity) (Goldhahn 2008).</description>
      <arm_group_label>Atraumatic rotator cuff tendon repair</arm_group_label>
      <arm_group_label>Contralateral shoulder</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>The Constant-Murley score (CMS)</intervention_name>
      <description>The test is divided into four subscales: pain (15 points), activities of daily living (ADL) (20 points), strength (25 points) and range of motion: forward elevation, external rotation, abduction and internal rotation of the shoulder (40 points).</description>
      <arm_group_label>Atraumatic rotator cuff tendon repair</arm_group_label>
      <arm_group_label>Contralateral shoulder</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>The Disabilities of the Arm, Shoulder and Hand (DASH)</intervention_name>
      <description>30-item self-report questionnaire designed to assess symptoms and function of the entire upper extremity.&#xD;
  Total scores range from 0 (minimum) to (100) maximum.</description>
      <arm_group_label>Atraumatic rotator cuff tendon repair</arm_group_label>
      <arm_group_label>Contralateral shoulder</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients underwent rotator cuff repair by three orthopaedic surgeons at the Tartu&#xD;
               University Hospital Sports Traumatology Centre between 2013 and 2019.&#xD;
  &#xD;
            -  Subject gives an informed consent and is willing to come for one outpatient visit.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients who underwent rotator cuff repair for traumatic tears are excluded from&#xD;
               clinical assessment (stage II).&#xD;
  &#xD;
            -  Patients who underwent revision surgery are excluded from clinical assessment (stage&#xD;
               II).&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Tiina Tikk, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Tartu University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Tiina Tikk, MD</last_name>
      <phone>55929399</phone>
      <phone_ext>+372</phone_ext>
      <email>tiinatikk@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Madis Rahu, PhD/MD</last_name>
      <email>madis.rahu@regionaalhaigla.ee</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Tartu University Hospital</name>
        <address>
          <city>Tartu</city>
          <state>Tartumaa</state>
          <zip>50410</zip>
          <country>Estonia</country>
        </address>
      </facility>
      <contact>
        <last_name>Tiina Tikk, MD</last_name>
        <phone>55929399</phone>
        <phone_ext>+372</phone_ext>
        <email>tiinatikk@gmail.com</email>
      </contact>
      <contact_backup>
        <last_name>Madis Rahu, PhD/MD</last_name>
        <email>madis.rahu@regionaalhaigla.ee</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Estonia</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 4, 2023</study_first_submitted>
    <study_first_submitted_qc>August 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>rotator cuff injury</keyword>
    <keyword>rotator cuff tears</keyword>
    <keyword>sonography</keyword>
    <keyword>shoulder injuries</keyword>
    <keyword>atraumatic tears</keyword>
    <keyword>shoulder pathology</keyword>
    <keyword>shoulder ultrasound</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Wounds and Injuries</mesh_term>
      <mesh_term>Rupture</mesh_term>
      <mesh_term>Rotator Cuff Injuries</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05988541
  org study id: Tikk2023
  nct id: NCT05988541
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The study gives an overview of surgically treated rotator cuff injury patients in Tartu
        University Hospital Sports Traumatology Centre during 2013-2019 and evaluates the integrity
        of rotator cuff at minimum 5 years after atraumatic rotator cuff tendon repair.
  
        First stage of the study describes the study population, etiology of the injury
        (traumatic/atraumatic) and aims to answer the question whether the arthroscopic findings are
        in line with the preoperative imaging studies or not.
  
        Second stage of the study focuses on atraumatic tendon tears assessing structural integrity
        of the tendons 5 years after repair using ultrasound imaging. The main question is - does the
        findings correlate with clinical outcomes and patient satisfaction.
  
        Participants of the second phase of the study will be asked for an appointment to have their
        shoulders examined with ultrasonography and clinical outcomes are measured using the American
        Shoulder and Elbow Surgeons (ASES) Score, The Disabilities of the Arm, Shoulder and Hand
        (DASH) questionnaire and The Constant-Murley score (CMS).
  High numbers of re-tear after rotator cuff surgery have been shown, though not always
        influencing patient satisfaction. If there is an atraumatic tendon tear, the risk of having a
        contralateral rotator cuff tendon tear is high.
  
        The aim is to study surgically treated rotator cuff injury patients 5 years after repair to
        evaluate tendon integrity on ultrasonography and answer the question do the findings
        correlate with functionality and patient satisfaction. It has been shown that people over the
        age of 66 who have been diagnosed with rotator cuff tendon tear, have up to 50 % chance of
        having a rotator cuff tendon tear in contralateral shoulder (Yamaguchi, et al. 2006).
        Therefore the study will evaluate the function and the integrity of the rotator cuff in both
        shoulders.
  allocation: Non-Randomized
  intervention model: Single Group Assignment
  primary purpose: Screening
  masking: None (Open Label)
  measure: Ultrasonography
  time frame: 5 years after primary repair
  description: Integrity of the rotator cuff tendons
  measure: American Shoulder and Elbow Surgeons (ASES) score
  time frame: 5 years after primary repair
  description: The higher the score, the better the outcome.
  measure: Constant-Murley score (CMS)
  time frame: 5 years after primary repair
  description: The higher the score, the higher the quality of the function.
  measure: The Disabilities of the Arm, Shoulder and Hand (DASH)
  time frame: 5 years after primary repair
  description: The higher the score, more severe disability.
  arm group label: Atraumatic rotator cuff tendon repair
  arm group type: Other
  description: Ultrasonography imaging of the operated shoulder
  arm group label: Contralateral shoulder
  arm group type: Other
  description: Ultrasonography imaging of the contralateral shoulder
  intervention type: Diagnostic Test
  intervention name: Ultrasonography imaging
  description: Ultrasonography: rotator cuff tendons (supraspinatus, infraspinatus, subscapularis and teres minor) integrity, long head of the biceps tendon integrity and location, SASD (subacromial-subdeltoid) bursitis, synovitis and muscle atrophy.
  arm group label: Atraumatic rotator cuff tendon repair
  arm group label: Contralateral shoulder
  intervention type: Diagnostic Test
  intervention name: American Shoulder and Elbow Surgeons (ASES) Score
  description: The patient self-assessment (pASES) includes 6 pain items and 10 functional items that are shoulder specific (Angst, 2008).
  The pASES form has 3 sections: pain, instability, ADLs (Goldhahn, 2008).
  Pain section: 4 questions with yes/no responses, 1 question covering number of pain tablets per day, and a VAS (visual analogue scale) from 0 (no pain) to 10 (worst pain).
  Instability section: 2 questions (1. Response yes/no about feelings of instability, 2. Quantify instability from 0 (stable) to 10 (very unstable)).
  Activities of daily living (ADLs): Each shoulder is included (affected/non affected), 10 items, with a 4 point ordinal scale, range: 0 (unable to perform activity) to 3 (no difficulty in doing activity) (Goldhahn 2008).
  arm group label: Atraumatic rotator cuff tendon repair
  arm group label: Contralateral shoulder
  intervention type: Diagnostic Test
  intervention name: The Constant-Murley score (CMS)
  description: The test is divided into four subscales: pain (15 points), activities of daily living (ADL) (20 points), strength (25 points) and range of motion: forward elevation, external rotation, abduction and internal rotation of the shoulder (40 points).
  arm group label: Atraumatic rotator cuff tendon repair
  arm group label: Contralateral shoulder
  intervention type: Diagnostic Test
  intervention name: The Disabilities of the Arm, Shoulder and Hand (DASH)
  description: 30-item self-report questionnaire designed to assess symptoms and function of the entire upper extremity.
  Total scores range from 0 (minimum) to (100) maximum.
  arm group label: Atraumatic rotator cuff tendon repair
  arm group label: Contralateral shoulder
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  last name: Tiina Tikk, MD
  role: Principal Investigator
  affiliation: Tartu University
  last name: Tiina Tikk, MD
  phone: 55929399
  phone ext: +372
  email: tiinatikk@gmail.com
  last name: Madis Rahu, PhD/MD
  email: madis.rahu@regionaalhaigla.ee
  facility: 
  contact: 
  contact backup: 
  country: Estonia
  responsible party type: Sponsor
  mesh term: Wounds and Injuries
  mesh term: Rupture
  mesh term: Rotator Cuff Injuries
  sharing ipd: No