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/NCT06016439</url>
    </required_header>
    <id_info>
      <org_study_id>Tikk23</org_study_id>
      <nct_id>NCT06016439</nct_id>
    </id_info>
    <brief_title>Outcomes of Massive Rotator Cuff Tendon Tear Treatment.</brief_title>
    <official_title>Outcomes of Different Treatment Modalities for Massive Rotator Cuff Tendon Tear.</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>
        Rotator cuff tear is the leading cause of shoulder pain in the elderly. There isn't enough&#xD;
        evidence nor clinical guidelines to guide the treatment of massive rotator cuff tears,&#xD;
        specially irreparable tears. Arthroscopic partial repair has been widely used and superior&#xD;
        capsular reconstruction (SCR), either with allograft, autograft or augmentation with long&#xD;
        head biceps brachii tendon (LHBBT), has been recently added. It is showing promising results,&#xD;
        but lacking high quality evidence.&#xD;
  &#xD;
        This is a prospective clinical study to compare the outcomes of different surgical methods&#xD;
        for massive rotator cuff tendon tears. Minimal follow-up time will be two years. In this&#xD;
        trial, massive rotator cuff tears will be anatomically repaired if possible. For irreparable&#xD;
        tears a method will be randomly assigned intra-operatively once a tear is determined to be&#xD;
        irreparable - either partial repair or partial repair with superior capsular reconstruction&#xD;
        using the long head biceps brachii (LHBB) tendon. Patients who are eligible for the study but&#xD;
        refuse operative treatment, will serve as conservative study group.&#xD;
  &#xD;
        The hypothesis is that massive rotator cuff tears that are reparable will have the best&#xD;
        functional outcomes. For irreparable tears, augmentation with LHBBT will give superior&#xD;
        results over partial repair.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Patients with massive rotator cuff tendon tears aged between 50 to 80 years will be included&#xD;
        in the study following the eligibility criteria. Massive tear is defined as grade III tear&#xD;
        according to Davidson and Burkhart classification (2010), supraspinatus (SSP) tendon&#xD;
        retraction described by Patte (1990) classification.&#xD;
  &#xD;
        The study is conducted in Tartu University Hospital Sports Traumatology Centre and rotator&#xD;
        cuff repair procedures will be done by three orthopaedic surgeons with long experience in&#xD;
        arthroscopic shoulder surgery.&#xD;
  &#xD;
        It is determined intra-operatively whether the tear is reparable or not. If possible, the&#xD;
        tendon(s) will be anatomically repaired. For irreparable tears intra-operative urn&#xD;
        randomization takes place - either partial repair or partial repair with SCR using the LHBB&#xD;
        tendon. Surgical techniques will be standardized. Patients who refuse operative treatment,&#xD;
        will be followed as conservative treatment group.&#xD;
  &#xD;
        The primary objective of the study is the functional status of the included subjects in&#xD;
        different treatment groups. The secondary objective of the study is to confirm whether the&#xD;
        tendons are intact on follow-up magnetic resonance imaging (MRI) 6 months, 12 months and 24&#xD;
        months after operation using Sugaya classification (2007).&#xD;
  &#xD;
        The post-operative therapy regimen will be the same for each study group. Subjects will come&#xD;
        for scheduled visits at 6-month, 12-month, and 24-month timepoints. Assessment tools consist&#xD;
        of range of motion (ROM), strength measurements, preoperative radiography measuring&#xD;
        acromio-humeral index (AHI), critical shoulder angle (CSA), acromion type and shoulder&#xD;
        arthrosis (Hamada), functional scores: The Disabilities of the Arm, Shoulder and Hand (DASH),&#xD;
        The Constant-Murley score (CMS), The American Shoulder and Elbow Surgeons (ASES) and visual&#xD;
        analogue scale (VAS), also including Tampa kinesiophobia score and emotional well-being (EEK)&#xD;
        score. Goutallier classification (1994) will be used pre- and postoperatively to measure&#xD;
        muscle fatty infiltration.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">December 2033</completion_date>
    <primary_completion_date type="Anticipated">December 2033</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>Change in shoulder strength</measure>
      <time_frame>Pre-operative baseline, 6-months, 12-months and 24-months follow-up visit</time_frame>
      <description>Measured by the change in rotator cuff strength isokinetic testing (abduction, internal and external rotation).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in shoulder range of motion.</measure>
      <time_frame>Pre-operative baseline, 6-months, 12-months and 24-months follow-up visit</time_frame>
      <description>Measured by the change in shoulder range of motion (abduction, internal and external rotation).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Functional outcome according to the American Shoulder and Elbow Surgeons (ASES) score.</measure>
      <time_frame>Pre-operative baseline, 6-months, 12-months and 24-months follow-up visit</time_frame>
      <description>Measured by the change in joint functional score.&#xD;
  The higher the score, the better the outcome.&#xD;
  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, activities of daily living (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>
    </primary_outcome>
    <primary_outcome>
      <measure>Functional outcome according to the Constant-Murley score (CMS).</measure>
      <time_frame>Pre-operative baseline, 6-months, 12-months and 24-months follow-up visit</time_frame>
      <description>Measured by the change in joint functional score.&#xD;
  The higher the score, the higher the quality of the function.&#xD;
  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>
    </primary_outcome>
    <primary_outcome>
      <measure>Functional outcome according to the Disabilities of the Arm, Shoulder and Hand (DASH).</measure>
      <time_frame>Pre-operative baseline, 6-months, 12-months and 24-months follow-up visit</time_frame>
      <description>Measured by the change in joint functional score.&#xD;
  The higher the score, the more severe disability.&#xD;
  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>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in pain score</measure>
      <time_frame>Pre-operative baseline, 6-months, 12-months and 24-months follow-up visit</time_frame>
      <description>Measured by the change in pain score according to the visual analogue scale (VAS) from 0 (no pain) to 10 (worst pain).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Integrity of surgically repaired rotator cuff tendons on MRI studies using Sugaya classification (2005).</measure>
      <time_frame>postoperatively 6 months, 12 months and 24 months</time_frame>
      <description>Integrity of surgically repaired rotator cuff tendons on post-operative MRI studies.&#xD;
  Classified into five categories (from intact tendon to full tear):&#xD;
  Type I: sufficient thickness with homogeneously low intensity; Type II: sufficient thickness with partial high intensity; Type III: insufficient thickness without discontinuity; Type IV: the presence of a minor discontinuity; Type V: the presence of a major discontinuity.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in quality of life</measure>
      <time_frame>Pre-operative baseline, 6-months, 12-months and 24-months follow-up visit</time_frame>
      <description>Measured by the change in score according to EEK-2 (emotsionaalse enesetunde küsimustik, Emotional State Questionnaire) score.&#xD;
  The higher the score, the higher the risk of having emotional state disabilities.&#xD;
  The overall score ranges from 0-112, but it is divided into six categories that are assessed separately.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in kinesiophobia score</measure>
      <time_frame>Pre-operative baseline, 6-months, 12-months and 24-months follow-up visit</time_frame>
      <description>Change in kinesiophobia score according to Tampa Scale for Kinesiophobia.&#xD;
  The higher the score, the higher the degree of kinesiophobia.&#xD;
  Results consist of a total raw score (range between 17 and 68) and two subscale scores (activity avoidance and somatic focus).</description>
    </secondary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">80</enrollment>
    <condition>Rotator Cuff Tears</condition>
    <condition>Rotator Cuff Syndrome</condition>
    <arm_group>
      <arm_group_label>Arthroscopic rotator cuff partial repair with superior capsule augmentation with LHBBT</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>If a tear is intra-operatively determined irreparable, randomization takes place.&#xD;
  Irreparable tears that are randomly selected to receive arthroscopic rotator cuff partial repair including superior capsular augmentation with proximal part of the long head of the biceps tendon. The long head of the biceps tendon will be released from bicipital groove and proximal part of the tendon will be used to cover the rotator cuff gap and anchored to the greater tuberosity.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Arthroscopic partial rotator cuff repair</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>If a tear is intra-operatively determined irreparable, randomization takes place.&#xD;
  Irreparable tears that are randomly selected to receive arthroscopic partial repair.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Arthroscopic rotator cuff repair</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Arthroscopic complete repair.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Rotator cuff tear conservative treatment</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Conservative treatment following physiotherapy protocol.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Arthroscopic rotator cuff partial repair with superior capsular augmentation with LHBBT</intervention_name>
      <description>Residual rotator cuff defect will be reconstructed using LHBBT.</description>
      <arm_group_label>Arthroscopic rotator cuff partial repair with superior capsule augmentation with LHBBT</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Arthroscopic rotator cuff partial repair</intervention_name>
      <description>Rotator cuff will be repaired with remaining residual defect.</description>
      <arm_group_label>Arthroscopic partial rotator cuff repair</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Arthroscopic complete rotator cuff repair</intervention_name>
      <description>Arthroscopic complete repair as a standard procedure.</description>
      <arm_group_label>Arthroscopic rotator cuff repair</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Suture anchor(s)</intervention_name>
      <description>Arthroscopic rotator cuff tendon(s) repair using suture anchor(s).</description>
      <arm_group_label>Arthroscopic partial rotator cuff repair</arm_group_label>
      <arm_group_label>Arthroscopic rotator cuff partial repair with superior capsule augmentation with LHBBT</arm_group_label>
      <arm_group_label>Arthroscopic rotator cuff repair</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Massive rotator cuff tendon tear: grade III according to Davidson and Burkhart 2010&#xD;
               classification, diagnosed on MRI, and LHBB tendon is intact.&#xD;
  &#xD;
            -  Primary rotator cuff pathology AND&#xD;
  &#xD;
            -  Symptoms have not lasted more than 6 months.&#xD;
  &#xD;
            -  In case of trauma, traumatic event no more than 6 months ago.&#xD;
  &#xD;
            -  Aged between 50 and 80 at the time of enrollment.&#xD;
  &#xD;
            -  Subject is able and willing to give informed consent AND&#xD;
  &#xD;
            -  Subject is physically and mentally willing and able to comply with the post-operative&#xD;
               rehabilitation protocol, questionnaires, and scheduled clinical and radiographic&#xD;
               visits.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Previous rotator cuff surgery of the index shoulder.&#xD;
  &#xD;
            -  Acute or chronic osteomyelitis.&#xD;
  &#xD;
            -  Inflammatory joint disease (rheumatoid arthritis/ (pseudo)gout arthritis).&#xD;
  &#xD;
            -  Uncontrolled diabetes.&#xD;
  &#xD;
            -  Active oncological disease.&#xD;
  &#xD;
            -  Radiologically stage IV shoulder joint arthrosis (rotator cuff arthropathy).&#xD;
  &#xD;
            -  Systemic or intra-articular corticosteroid therapy less than 60 days prior to planned&#xD;
               operation date.&#xD;
  &#xD;
            -  Intramuscular or peroral corticosteroid treatment less than 30 days prior to planned&#xD;
               operation date.&#xD;
  &#xD;
            -  Acute or chronic conditions that are contraindications for functional testing.&#xD;
  &#xD;
            -  MRI contraindicated.&#xD;
  &#xD;
            -  Substance or alcohol abuse.&#xD;
  &#xD;
            -  Refusal or withdrawal of consent.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>50 Years</minimum_age>
      <maximum_age>80 Years</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>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 7, 2023</study_first_submitted>
    <study_first_submitted_qc>August 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 29, 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 29, 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>massive</keyword>
    <keyword>shoulder</keyword>
    <keyword>shoulder injuries</keyword>
    <keyword>superior capsular reconstruction</keyword>
    <keyword>long head of biceps tendon</keyword>
    <keyword>irreparable</keyword>
    <keyword>tear</keyword>
    <keyword>rupture</keyword>
    <keyword>partial repair</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <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/NCT06016439
  org study id: Tikk23
  nct id: NCT06016439
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Rotator cuff tear is the leading cause of shoulder pain in the elderly. There isn't enough
        evidence nor clinical guidelines to guide the treatment of massive rotator cuff tears,
        specially irreparable tears. Arthroscopic partial repair has been widely used and superior
        capsular reconstruction (SCR), either with allograft, autograft or augmentation with long
        head biceps brachii tendon (LHBBT), has been recently added. It is showing promising results,
        but lacking high quality evidence.
  
        This is a prospective clinical study to compare the outcomes of different surgical methods
        for massive rotator cuff tendon tears. Minimal follow-up time will be two years. In this
        trial, massive rotator cuff tears will be anatomically repaired if possible. For irreparable
        tears a method will be randomly assigned intra-operatively once a tear is determined to be
        irreparable - either partial repair or partial repair with superior capsular reconstruction
        using the long head biceps brachii (LHBB) tendon. Patients who are eligible for the study but
        refuse operative treatment, will serve as conservative study group.
  
        The hypothesis is that massive rotator cuff tears that are reparable will have the best
        functional outcomes. For irreparable tears, augmentation with LHBBT will give superior
        results over partial repair.
  Patients with massive rotator cuff tendon tears aged between 50 to 80 years will be included
        in the study following the eligibility criteria. Massive tear is defined as grade III tear
        according to Davidson and Burkhart classification (2010), supraspinatus (SSP) tendon
        retraction described by Patte (1990) classification.
  
        The study is conducted in Tartu University Hospital Sports Traumatology Centre and rotator
        cuff repair procedures will be done by three orthopaedic surgeons with long experience in
        arthroscopic shoulder surgery.
  
        It is determined intra-operatively whether the tear is reparable or not. If possible, the
        tendon(s) will be anatomically repaired. For irreparable tears intra-operative urn
        randomization takes place - either partial repair or partial repair with SCR using the LHBB
        tendon. Surgical techniques will be standardized. Patients who refuse operative treatment,
        will be followed as conservative treatment group.
  
        The primary objective of the study is the functional status of the included subjects in
        different treatment groups. The secondary objective of the study is to confirm whether the
        tendons are intact on follow-up magnetic resonance imaging (MRI) 6 months, 12 months and 24
        months after operation using Sugaya classification (2007).
  
        The post-operative therapy regimen will be the same for each study group. Subjects will come
        for scheduled visits at 6-month, 12-month, and 24-month timepoints. Assessment tools consist
        of range of motion (ROM), strength measurements, preoperative radiography measuring
        acromio-humeral index (AHI), critical shoulder angle (CSA), acromion type and shoulder
        arthrosis (Hamada), functional scores: The Disabilities of the Arm, Shoulder and Hand (DASH),
        The Constant-Murley score (CMS), The American Shoulder and Elbow Surgeons (ASES) and visual
        analogue scale (VAS), also including Tampa kinesiophobia score and emotional well-being (EEK)
        score. Goutallier classification (1994) will be used pre- and postoperatively to measure
        muscle fatty infiltration.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Change in shoulder strength
  time frame: Pre-operative baseline, 6-months, 12-months and 24-months follow-up visit
  description: Measured by the change in rotator cuff strength isokinetic testing (abduction, internal and external rotation).
  measure: Change in shoulder range of motion.
  time frame: Pre-operative baseline, 6-months, 12-months and 24-months follow-up visit
  description: Measured by the change in shoulder range of motion (abduction, internal and external rotation).
  measure: Functional outcome according to the American Shoulder and Elbow Surgeons (ASES) score.
  time frame: Pre-operative baseline, 6-months, 12-months and 24-months follow-up visit
  description: Measured by the change in joint functional score.
  The higher the score, the better the outcome.
  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, activities of daily living (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).
  measure: Functional outcome according to the Constant-Murley score (CMS).
  time frame: Pre-operative baseline, 6-months, 12-months and 24-months follow-up visit
  description: Measured by the change in joint functional score.
  The higher the score, the higher the quality of the function.
  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).
  measure: Functional outcome according to the Disabilities of the Arm, Shoulder and Hand (DASH).
  time frame: Pre-operative baseline, 6-months, 12-months and 24-months follow-up visit
  description: Measured by the change in joint functional score.
  The higher the score, the more severe disability.
  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.
  measure: Change in pain score
  time frame: Pre-operative baseline, 6-months, 12-months and 24-months follow-up visit
  description: Measured by the change in pain score according to the visual analogue scale (VAS) from 0 (no pain) to 10 (worst pain).
  measure: Integrity of surgically repaired rotator cuff tendons on MRI studies using Sugaya classification (2005).
  time frame: postoperatively 6 months, 12 months and 24 months
  description: Integrity of surgically repaired rotator cuff tendons on post-operative MRI studies.
  Classified into five categories (from intact tendon to full tear):
  Type I: sufficient thickness with homogeneously low intensity; Type II: sufficient thickness with partial high intensity; Type III: insufficient thickness without discontinuity; Type IV: the presence of a minor discontinuity; Type V: the presence of a major discontinuity.
  measure: Change in quality of life
  time frame: Pre-operative baseline, 6-months, 12-months and 24-months follow-up visit
  description: Measured by the change in score according to EEK-2 (emotsionaalse enesetunde küsimustik, Emotional State Questionnaire) score.
  The higher the score, the higher the risk of having emotional state disabilities.
  The overall score ranges from 0-112, but it is divided into six categories that are assessed separately.
  measure: Change in kinesiophobia score
  time frame: Pre-operative baseline, 6-months, 12-months and 24-months follow-up visit
  description: Change in kinesiophobia score according to Tampa Scale for Kinesiophobia.
  The higher the score, the higher the degree of kinesiophobia.
  Results consist of a total raw score (range between 17 and 68) and two subscale scores (activity avoidance and somatic focus).
  arm group label: Arthroscopic rotator cuff partial repair with superior capsule augmentation with LHBBT
  arm group type: Experimental
  description: If a tear is intra-operatively determined irreparable, randomization takes place.
  Irreparable tears that are randomly selected to receive arthroscopic rotator cuff partial repair including superior capsular augmentation with proximal part of the long head of the biceps tendon. The long head of the biceps tendon will be released from bicipital groove and proximal part of the tendon will be used to cover the rotator cuff gap and anchored to the greater tuberosity.
  arm group label: Arthroscopic partial rotator cuff repair
  arm group type: Active Comparator
  description: If a tear is intra-operatively determined irreparable, randomization takes place.
  Irreparable tears that are randomly selected to receive arthroscopic partial repair.
  arm group label: Arthroscopic rotator cuff repair
  arm group type: Other
  description: Arthroscopic complete repair.
  arm group label: Rotator cuff tear conservative treatment
  arm group type: No Intervention
  description: Conservative treatment following physiotherapy protocol.
  intervention type: Procedure
  intervention name: Arthroscopic rotator cuff partial repair with superior capsular augmentation with LHBBT
  description: Residual rotator cuff defect will be reconstructed using LHBBT.
  arm group label: Arthroscopic rotator cuff partial repair with superior capsule augmentation with LHBBT
  intervention type: Procedure
  intervention name: Arthroscopic rotator cuff partial repair
  description: Rotator cuff will be repaired with remaining residual defect.
  arm group label: Arthroscopic partial rotator cuff repair
  intervention type: Procedure
  intervention name: Arthroscopic complete rotator cuff repair
  description: Arthroscopic complete repair as a standard procedure.
  arm group label: Arthroscopic rotator cuff repair
  intervention type: Device
  intervention name: Suture anchor(s)
  description: Arthroscopic rotator cuff tendon(s) repair using suture anchor(s).
  arm group label: Arthroscopic partial rotator cuff repair
  arm group label: Arthroscopic rotator cuff partial repair with superior capsule augmentation with LHBBT
  arm group label: Arthroscopic rotator cuff repair
  criteria: 
  gender: All
  minimum age: 50 Years
  maximum age: 80 Years
  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
  responsible party type: Sponsor
  mesh term: Rotator Cuff Injuries
  sharing ipd: No