<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/NCT04492748</url>
  </required_header>
  <id_info>
    <org_study_id>SMC2020001</org_study_id>
    <nct_id>NCT04492748</nct_id>
  </id_info>
  <brief_title>Rotator Cuff Tendinopathy Conservative Treatment With Collagen, PRP or Both</brief_title>
  <acronym>RCCT</acronym>
  <official_title>Collagen and PRP in Partial Thickness Rotator Cuff Injuries: Friends or Only Indifferent Neighbors: Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sutherland Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sutherland Medical Center</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 aim of the trial is comparison of the effectiveness of three methods of conservative&#xD;
      treatment in partial thickness rotator cuff injury (PTRCI): collagen with PRP injections, PRP&#xD;
      injections alone and collagen injections alone.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      BACKGROUND: Rotator cuff injury (RCI) occupy third place in the population among the&#xD;
      musculoskeletal system pathologies (16%) after low back pain (25%) and knee pain (19%).&#xD;
      Partial thickness RCI (PTRCI) is the sum of degenerative, overload and microtrauma processes&#xD;
      and their incidence increases significantly with age (up to 30% over 60). One of the factors&#xD;
      contributing to the injury is a negative collagen balance and slowed tendon metabolism in&#xD;
      proportion to its blood supply disorders. Conservative treatment of PTRCI of degenerative&#xD;
      origin is the first choice management, but there are no clear guidelines. External supply of&#xD;
      collagen and PRP could potentially counteract these processes.&#xD;
&#xD;
      AIM: Comparison of the effectiveness of three treatment concepts: collagen with PRP, PRP&#xD;
      alone, collagen alone in the treatment of PTRCI.&#xD;
&#xD;
      DESIGN: Randomized prospective trial without blinding SETTING: Open study for outpatients,&#xD;
      single center study POPULATION: local population METHODS: Three groups of patients (each&#xD;
      group 30 patients) with PTRCI confirmed by ultrasound (N=90). The assessment of the&#xD;
      supraspinatus tendon (SSP) in standard position of internal rotation of the upper limb for&#xD;
      ultrasound examination, assessment of the thickness of the RC in cross-section (mm). Each&#xD;
      group treated by three ultrasound guided injections into the shoulder bursa every consecutive&#xD;
      week: Group A - collagen (3 amp Collagen MD Shoulder) together with PRP (2ml); Group B -&#xD;
      collagen alone (3 amp Collagen MD Shoulder); Group C - PRP alone. All patients were allowed&#xD;
      to continue rehabilitation protocol. Primary control tools: NRS, QuickDash, EQ-5D-5L in&#xD;
      control points: IA (initial assessment), 6, 12 and 24 weeks after last injection. Secondary&#xD;
      control tools: percentage of patients where the RC continuity were preserved and percentage&#xD;
      of patients who had ultrasonographic signs of RC regeneration (crossection width increase,&#xD;
      improvement of echogenicity) during the observation period between W0 and 24 weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">July 1, 2020</start_date>
  <completion_date type="Anticipated">September 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">September 30, 2021</primary_completion_date>
  <phase>Phase 4</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 EQ-5D-5L index from baseline to 24 week</measure>
    <time_frame>Change from baseline to 24 weeks</time_frame>
    <description>EQ-5D-5L index estimated from EQ-5D-5L desrcriptive system based on Polish directly measured value set. Mininmum: -0.590; Maximum: 1.0; More points means better outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>QuickDASH (Disabilities of Arm, Shoulder and Hand) questionnaire summary score change from baseline to 24 weeks</measure>
    <time_frame>Change from baseline to 24 weeks</time_frame>
    <description>Range: 0 (the best outcome) - 100 (the worst outcome).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain according to Numeric Rating Scale (NRS)</measure>
    <time_frame>Change from baseline to 6 weeks</time_frame>
    <description>0 (no pain) - 10 points (the worst possible pain)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain according to Numeric Rating Scale (NRS)</measure>
    <time_frame>Change from baseline to 12 weeks</time_frame>
    <description>0 (no pain) - 10 points (the worst possible pain)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain according to Numeric Rating Scale (NRS)</measure>
    <time_frame>Change from baseline to 24 weeks</time_frame>
    <description>0 (no pain) - 10 points (the worst possible pain)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Width of rotator cuff in ultrasound imaging</measure>
    <time_frame>Change from baseline to 24 weeks</time_frame>
    <description>Dimensions of cross-section rotator cuff measure in milimeters.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Preservation of rotator cuff continuity in ultrasound imaging</measure>
    <time_frame>Change from baseline to 24 weeks</time_frame>
    <description>Presence / Absence</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Regenaration of rotator cuff in ultrasound imaging</measure>
    <time_frame>24 weeks</time_frame>
    <description>Presence / Absence</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in EQ-5D-5L index from baseline to 6 week</measure>
    <time_frame>Change from baseline to 6 weeks</time_frame>
    <description>EQ-5D-5L index estimated from EQ-5D-5L desrcriptive system based on Polish directly measured value set. Mininmum: -0.590; Maximum: 1.0; More points means better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in EQ-5D-5L index from baseline to 12 week</measure>
    <time_frame>Change from baseline to 12 weeks</time_frame>
    <description>EQ-5D-5L index estimated from EQ-5D-5L desrcriptive system based on Polish directly measured value set. Mininmum: -0.590; Maximum: 1.0; More points means better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>QuickDASH (Disabilities of Arm, Shoulder and Hand) questionnaire summary score change from baseline to 6 weeks</measure>
    <time_frame>Change from baseline to 6 weeks</time_frame>
    <description>Range: 0 (the best outcome) - 100 (the worst outcome).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>QuickDASH (Disabilities of Arm, Shoulder and Hand) questionnaire summary score change from baseline to 12 weeks</measure>
    <time_frame>Change from baseline to 12 weeks</time_frame>
    <description>Range: 0 (the best outcome) - 100 (the worst outcome).</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">90</enrollment>
  <condition>Rotator Cuff Tendinosis</condition>
  <condition>Rotator Cuff Tears</condition>
  <arm_group>
    <arm_group_label>Collagen and PRP injections</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ultrasound guided injections</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Collagen injections</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Ultrasound guided injections</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PRP injections</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Ultrasound guided injections</description>
  </arm_group>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>Collagen and platelet rich plasma (PRP)</intervention_name>
    <description>Ultrasound guided injections</description>
    <arm_group_label>Collagen and PRP injections</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>Collagen</intervention_name>
    <description>Ultrasound guided injections</description>
    <arm_group_label>Collagen injections</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>Platelet rich plasma (PRP)</intervention_name>
    <description>Ultrasound guided injections</description>
    <arm_group_label>PRP injections</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  clinical signs and symptoms of rotator cuff pathology&#xD;
&#xD;
          -  an adult person consenting to injections&#xD;
&#xD;
          -  partial thickness rotator cuff injury confirmed by ultrasound examination without&#xD;
             coexisting severe pathologies (systemic inflammatory disease, malignancy, severe stage&#xD;
             OA)&#xD;
&#xD;
          -  no traumatic event&#xD;
&#xD;
          -  no injections or any other local treatment in previous 1 month&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  full thickness rotator cuff injury&#xD;
&#xD;
          -  acute, traumatic injuries requiring surgical treatment&#xD;
&#xD;
          -  coexisting injuries of the shoulder joint requiring other intervention&#xD;
&#xD;
          -  severe pathologies of the shoulder of another origin (systemic inflammatory disease,&#xD;
             malignancy, severe stage OA)&#xD;
&#xD;
          -  no consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Piotr Godek, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sutherland Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sutherland Medical Center</name>
      <address>
        <city>Warsaw</city>
        <state>Mazowieckie</state>
        <zip>04-036</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>July 20, 2020</study_first_submitted>
  <study_first_submitted_qc>July 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 30, 2020</study_first_posted>
  <last_update_submitted>March 10, 2021</last_update_submitted>
  <last_update_submitted_qc>March 10, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 11, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sutherland Medical Center</investigator_affiliation>
    <investigator_full_name>Piotr Godek</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tendinopathy</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>


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/NCT04492748
org study id: SMC2020001
nct id: NCT04492748
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of the trial is comparison of the effectiveness of three methods of conservative
      treatment in partial thickness rotator cuff injury (PTRCI): collagen with PRP injections, PRP
      injections alone and collagen injections alone.
BACKGROUND: Rotator cuff injury (RCI) occupy third place in the population among the
      musculoskeletal system pathologies (16%) after low back pain (25%) and knee pain (19%).
      Partial thickness RCI (PTRCI) is the sum of degenerative, overload and microtrauma processes
      and their incidence increases significantly with age (up to 30% over 60). One of the factors
      contributing to the injury is a negative collagen balance and slowed tendon metabolism in
      proportion to its blood supply disorders. Conservative treatment of PTRCI of degenerative
      origin is the first choice management, but there are no clear guidelines. External supply of
      collagen and PRP could potentially counteract these processes.

      AIM: Comparison of the effectiveness of three treatment concepts: collagen with PRP, PRP
      alone, collagen alone in the treatment of PTRCI.

      DESIGN: Randomized prospective trial without blinding SETTING: Open study for outpatients,
      single center study POPULATION: local population METHODS: Three groups of patients (each
      group 30 patients) with PTRCI confirmed by ultrasound (N=90). The assessment of the
      supraspinatus tendon (SSP) in standard position of internal rotation of the upper limb for
      ultrasound examination, assessment of the thickness of the RC in cross-section (mm). Each
      group treated by three ultrasound guided injections into the shoulder bursa every consecutive
      week: Group A - collagen (3 amp Collagen MD Shoulder) together with PRP (2ml); Group B -
      collagen alone (3 amp Collagen MD Shoulder); Group C - PRP alone. All patients were allowed
      to continue rehabilitation protocol. Primary control tools: NRS, QuickDash, EQ-5D-5L in
      control points: IA (initial assessment), 6, 12 and 24 weeks after last injection. Secondary
      control tools: percentage of patients where the RC continuity were preserved and percentage
      of patients who had ultrasonographic signs of RC regeneration (crossection width increase,
      improvement of echogenicity) during the observation period between W0 and 24 weeks.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in EQ-5D-5L index from baseline to 24 week
time frame: Change from baseline to 24 weeks
description: EQ-5D-5L index estimated from EQ-5D-5L desrcriptive system based on Polish directly measured value set. Mininmum: -0.590; Maximum: 1.0; More points means better outcome.
measure: QuickDASH (Disabilities of Arm, Shoulder and Hand) questionnaire summary score change from baseline to 24 weeks
time frame: Change from baseline to 24 weeks
description: Range: 0 (the best outcome) - 100 (the worst outcome).
measure: Pain according to Numeric Rating Scale (NRS)
time frame: Change from baseline to 6 weeks
description: 0 (no pain) - 10 points (the worst possible pain)
measure: Pain according to Numeric Rating Scale (NRS)
time frame: Change from baseline to 12 weeks
description: 0 (no pain) - 10 points (the worst possible pain)
measure: Pain according to Numeric Rating Scale (NRS)
time frame: Change from baseline to 24 weeks
description: 0 (no pain) - 10 points (the worst possible pain)
measure: Width of rotator cuff in ultrasound imaging
time frame: Change from baseline to 24 weeks
description: Dimensions of cross-section rotator cuff measure in milimeters.
measure: Preservation of rotator cuff continuity in ultrasound imaging
time frame: Change from baseline to 24 weeks
description: Presence / Absence
measure: Regenaration of rotator cuff in ultrasound imaging
time frame: 24 weeks
description: Presence / Absence
measure: Change in EQ-5D-5L index from baseline to 6 week
time frame: Change from baseline to 6 weeks
description: EQ-5D-5L index estimated from EQ-5D-5L desrcriptive system based on Polish directly measured value set. Mininmum: -0.590; Maximum: 1.0; More points means better outcome.
measure: Change in EQ-5D-5L index from baseline to 12 week
time frame: Change from baseline to 12 weeks
description: EQ-5D-5L index estimated from EQ-5D-5L desrcriptive system based on Polish directly measured value set. Mininmum: -0.590; Maximum: 1.0; More points means better outcome.
measure: QuickDASH (Disabilities of Arm, Shoulder and Hand) questionnaire summary score change from baseline to 6 weeks
time frame: Change from baseline to 6 weeks
description: Range: 0 (the best outcome) - 100 (the worst outcome).
measure: QuickDASH (Disabilities of Arm, Shoulder and Hand) questionnaire summary score change from baseline to 12 weeks
time frame: Change from baseline to 12 weeks
description: Range: 0 (the best outcome) - 100 (the worst outcome).
arm group label: Collagen and PRP injections
arm group type: Experimental
description: Ultrasound guided injections
arm group label: Collagen injections
arm group type: Active Comparator
description: Ultrasound guided injections
arm group label: PRP injections
arm group type: Active Comparator
description: Ultrasound guided injections
intervention type: Combination Product
intervention name: Collagen and platelet rich plasma (PRP)
description: Ultrasound guided injections
arm group label: Collagen and PRP injections
intervention type: Combination Product
intervention name: Collagen
description: Ultrasound guided injections
arm group label: Collagen injections
intervention type: Combination Product
intervention name: Platelet rich plasma (PRP)
description: Ultrasound guided injections
arm group label: PRP injections
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Piotr Godek, PhD
role: Principal Investigator
affiliation: Sutherland Medical Center
facility: 
country: Poland
responsible party type: Principal Investigator
investigator affiliation: Sutherland Medical Center
investigator full name: Piotr Godek
investigator title: Principal Investigator
mesh term: Tendinopathy
mesh term: Rotator Cuff Injuries
sharing ipd: No