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/NCT05981833</url>
    </required_header>
    <id_info>
      <org_study_id>AIRR-0094</org_study_id>
      <nct_id>NCT05981833</nct_id>
    </id_info>
    <brief_title>Dermal Allograft Augmentation of Large and Massive Rotator Cuff Tears</brief_title>
    <official_title>A Randomized, Post-market Study Evaluating Dermal Allograft Augmentation of Large and Massive Rotator Cuff Tears</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Arthrex, Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Arthrex, Inc.</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <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>
        The purpose of this study is to compare postoperative healing of large and massive rotator&#xD;
        cuff tears with preoperative MRI confirmed fatty infiltration stage II and higher repaired&#xD;
        with or without dermal allograft augmentation (DAA).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The primary objective is to evaluate postoperative healing of rotator cuff repair with and&#xD;
        without DAA.&#xD;
  &#xD;
        Primary: The primary outcome measure is healing evaluation in MRI . MRI Post-Operative&#xD;
        Assessment (Goutallier Stage and Sugaya Classification)&#xD;
  &#xD;
        Secondary: The secondary outcome measures are patient-reported outcome measures from&#xD;
        validated outcome scoring systems, including:&#xD;
  &#xD;
        American Shoulder and Elbow Surgeons Score (ASES)&#xD;
  &#xD;
        Single Assessment Numeric Evaluation score (SANE)&#xD;
  &#xD;
        Visual Analog Scale (VAS) for pain&#xD;
  &#xD;
        Veterans RAND Health Survey (VR-12)&#xD;
  &#xD;
        Population: Males and females between the ages of 30 and 75 years that require surgery for&#xD;
        large and massive rotator cuff tears&#xD;
  &#xD;
        Description of Treatment: Rotator cuff repair with or without augmentation using&#xD;
        decellularized human dermal allograft.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 15, 2023</start_date>
    <completion_date type="Anticipated">September 15, 2026</completion_date>
    <primary_completion_date type="Anticipated">September 15, 2025</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>The primary outcome measure is healing evaluation in MRI</measure>
      <time_frame>26 Weeks</time_frame>
      <description>MRI Post-Operative Assessment (Goutallier Stage and Sugaya Classification)&#xD;
  MRI Post-Operative Assessment (Goutallier Stage and Sugaya Classification)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>The secondary outcome measures are patient-reported outcome measures from validated outcome scoring systems</measure>
      <time_frame>Preop, 26 Weeks, 1 Year, 2 Year</time_frame>
      <description>1. American Shoulder and Elbow Surgeons Score (ASES) A combination of objective measures and patient-reported outcomes, it measures pain and functional limitations in the shoulder. The objective questionnaire allows documentation of range of motion in the patient.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Single Assessment Numeric Evaluation score (SANE)</measure>
      <time_frame>Preop, 26 Weeks, 1 Year, 2 Year</time_frame>
      <description>Asks patients to rate shoulder pain as a percentage of normal.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Visual Analog Scale (VAS) for pain</measure>
      <time_frame>Preop, two-week, six week, 26 Weeks, 1 Year, 2 Year</time_frame>
      <description>The standard measure for pain on a 0-10 scale, 10 being the worst.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Veterans RAND Health Survey (VR-12)</measure>
      <time_frame>Preop, 26 Weeks, 1 Year, 2 Year</time_frame>
      <description>A self-administered health measure. Answers are summarized into two scores, a Physical Component Score and a Mental Component Score, which provides an important contrast between the respondents' physical and psychological health status.</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">120</enrollment>
    <condition>Full-thickness Rotator Cuff Tear</condition>
    <arm_group>
      <arm_group_label>Repair without DAA</arm_group_label>
      <description>repaired without dermal allograft augmentation (DAA).</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Repair with DAA (dermal allograft augmentation)</intervention_name>
      <description>Patients undergo rotator cuff repair with dermal allograft augmentation.</description>
      <arm_group_label>Repair without DAA</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Males and females between the ages of 30 and 75 years that require surgery for large and&#xD;
          massive rotator cuff tears&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  The subject is between the ages of 30 and 75 years.&#xD;
  &#xD;
            -  Subject is planning to undergo arthroscopic surgery for full-thickness rotator cuff&#xD;
               tear (RCT)&#xD;
  &#xD;
            -  Two complete RCTs or tear size equal to or greater than 3 cm in either the&#xD;
               anterior-posterior or medial-lateral dimension&#xD;
  &#xD;
            -  Primary rotator cuff repair&#xD;
  &#xD;
            -  Stage II fatty infiltration or higher of the supraspinatus or infraspinatus muscle&#xD;
               based on preoperative MRI6. Subject has a dual x-ray absorptiometry (DXA) or anterior&#xD;
               posterior x-ray view of the target shoulder&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  The Subject is unable or unwilling to sign the patient informed consent, approved by&#xD;
               the Institutional Review Board.&#xD;
  &#xD;
            -  The subject objects to the use of allograft&#xD;
  &#xD;
            -  Stage I or lower fatty infiltration of the supraspinatus AND infraspinatus muscle&#xD;
  &#xD;
            -  Complete full-thickness subscapularis tears of greater than the superior one third of&#xD;
               the tendon (Lafosse grade 3 and above)&#xD;
  &#xD;
            -  Less than 2 mm joint space of the glenohumeral joint on either an anteroposterior or&#xD;
               axillary radiograph&#xD;
  &#xD;
            -  Recurrent shoulder instability&#xD;
  &#xD;
            -  Corticosteroid injection in the operative shoulder within one month of surgery&#xD;
  &#xD;
            -  Revision rotator cuff repair&#xD;
  &#xD;
            -  Subject preoperative MRI obtained more than 12 months prior to surgery&#xD;
  &#xD;
            -  Pregnant or planning to become pregnant during the study period&#xD;
  &#xD;
            -  Workman's compensation case&#xD;
  &#xD;
            -  Subject has conditions or circumstances that would interfere with study requirements.&#xD;
  &#xD;
          Intraoperative exclusion criteria:&#xD;
  &#xD;
          Partial rotator cuff repairs&#xD;
  &#xD;
          Lafosse grade 3 or higher subscapularis tears&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>30 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Alicia Ruiz, MS</last_name>
      <role>Study Director</role>
      <affiliation>Arthrex, Inc.</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Caroline Caraci, BA</last_name>
      <phone>18009337001</phone>
      <email>caroline.caraci@arthrex.com</email>
    </overall_contact>
    <reference>
      <citation>Kwon J, Kim SH, Lee YH, Kim TI, Oh JH. The Rotator Cuff Healing Index: A New Scoring System to Predict Rotator Cuff Healing After Surgical Repair. Am J Sports Med. 2019 Jan;47(1):173-180. doi: 10.1177/0363546518810763. Epub 2018 Nov 28.</citation>
      <PMID>30485753</PMID>
    </reference>
    <reference>
      <citation>Duong JKH, Lam PH, Murrell GAC. Anteroposterior tear size, age, hospital, and case number are important predictors of repair integrity: an analysis of 1962 consecutive arthroscopic single-row rotator cuff repairs. J Shoulder Elbow Surg. 2021 Aug;30(8):1907-1914. doi: 10.1016/j.jse.2020.09.038. Epub 2020 Nov 4.</citation>
      <PMID>33160028</PMID>
    </reference>
    <reference>
      <citation>Pashuck TD, Hirahara AM, Cook JL, Cook CR, Andersen WJ, Smith MJ. Superior Capsular Reconstruction Using Dermal Allograft Is a Safe and Effective Treatment for Massive Irreparable Rotator Cuff Tears: 2-Year Clinical Outcomes. Arthroscopy. 2021 Feb;37(2):489-496.e1. doi: 10.1016/j.arthro.2020.10.014. Epub 2020 Oct 17.</citation>
      <PMID>33080333</PMID>
    </reference>
    <reference>
      <citation>Jackson GR, Bedi A, Denard PJ. Graft Augmentation of Repairable Rotator Cuff Tears: An Algorithmic Approach Based on Healing Rates. Arthroscopy. 2022 Jul;38(7):2342-2347. doi: 10.1016/j.arthro.2021.10.032. Epub 2021 Nov 10.</citation>
      <PMID>34767956</PMID>
    </reference>
    <reference>
      <citation>Omae H, Steinmann SP, Zhao C, Zobitz ME, Wongtriratanachai P, Sperling JW, An KN. Biomechanical effect of rotator cuff augmentation with an acellular dermal matrix graft: a cadaver study. Clin Biomech (Bristol, Avon). 2012 Oct;27(8):789-92. doi: 10.1016/j.clinbiomech.2012.05.001. Epub 2012 May 17.</citation>
      <PMID>22607908</PMID>
    </reference>
    <reference>
      <citation>Snyder SJ, Arnoczky SP, Bond JL, Dopirak R. Histologic evaluation of a biopsy specimen obtained 3 months after rotator cuff augmentation with GraftJacket Matrix. Arthroscopy. 2009 Mar;25(3):329-33. doi: 10.1016/j.arthro.2008.05.023. Epub 2008 Jul 24.</citation>
      <PMID>19245998</PMID>
    </reference>
    <reference>
      <citation>Barber FA, Burns JP, Deutsch A, Labbe MR, Litchfield RB. A prospective, randomized evaluation of acellular human dermal matrix augmentation for arthroscopic rotator cuff repair. Arthroscopy. 2012 Jan;28(1):8-15. doi: 10.1016/j.arthro.2011.06.038. Epub 2011 Oct 5.</citation>
      <PMID>21978432</PMID>
    </reference>
    <reference>
      <citation>Cummins CA, Murrell GA. Mode of failure for rotator cuff repair with suture anchors identified at revision surgery. J Shoulder Elbow Surg. 2003 Mar-Apr;12(2):128-33. doi: 10.1067/mse.2003.21.</citation>
      <PMID>12700563</PMID>
    </reference>
    <reference>
      <citation>Haque A, Pal Singh H. Does structural integrity following rotator cuff repair affect functional outcomes and pain scores? A meta-analysis. Shoulder Elbow. 2018 Jul;10(3):163-169. doi: 10.1177/1758573217731548. Epub 2017 Sep 25.</citation>
      <PMID>29796103</PMID>
    </reference>
    <reference>
      <citation>Sugaya H, Maeda K, Matsuki K, Moriishi J. Repair integrity and functional outcome after arthroscopic double-row rotator cuff repair. A prospective outcome study. J Bone Joint Surg Am. 2007 May;89(5):953-60. doi: 10.2106/JBJS.F.00512.</citation>
      <PMID>17473131</PMID>
    </reference>
    <reference>
      <citation>Mather J, MacDermid JC, Faber KJ, Athwal GS. Proximal humerus cortical bone thickness correlates with bone mineral density and can clinically rule out osteoporosis. J Shoulder Elbow Surg. 2013 Jun;22(6):732-8. doi: 10.1016/j.jse.2012.08.018. Epub 2012 Nov 22.</citation>
      <PMID>23183030</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 1, 2023</study_first_submitted>
    <study_first_submitted_qc>August 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>September 15, 2023</last_update_submitted>
    <last_update_submitted_qc>September 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</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>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/NCT05981833
  org study id: AIRR-0094
  nct id: NCT05981833
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: No
  The purpose of this study is to compare postoperative healing of large and massive rotator
        cuff tears with preoperative MRI confirmed fatty infiltration stage II and higher repaired
        with or without dermal allograft augmentation (DAA).
  The primary objective is to evaluate postoperative healing of rotator cuff repair with and
        without DAA.
  
        Primary: The primary outcome measure is healing evaluation in MRI . MRI Post-Operative
        Assessment (Goutallier Stage and Sugaya Classification)
  
        Secondary: The secondary outcome measures are patient-reported outcome measures from
        validated outcome scoring systems, including:
  
        American Shoulder and Elbow Surgeons Score (ASES)
  
        Single Assessment Numeric Evaluation score (SANE)
  
        Visual Analog Scale (VAS) for pain
  
        Veterans RAND Health Survey (VR-12)
  
        Population: Males and females between the ages of 30 and 75 years that require surgery for
        large and massive rotator cuff tears
  
        Description of Treatment: Rotator cuff repair with or without augmentation using
        decellularized human dermal allograft.
  observational model: Case-Control
  time perspective: Prospective
  measure: The primary outcome measure is healing evaluation in MRI
  time frame: 26 Weeks
  description: MRI Post-Operative Assessment (Goutallier Stage and Sugaya Classification)
  MRI Post-Operative Assessment (Goutallier Stage and Sugaya Classification)
  measure: The secondary outcome measures are patient-reported outcome measures from validated outcome scoring systems
  time frame: Preop, 26 Weeks, 1 Year, 2 Year
  description: 1. American Shoulder and Elbow Surgeons Score (ASES) A combination of objective measures and patient-reported outcomes, it measures pain and functional limitations in the shoulder. The objective questionnaire allows documentation of range of motion in the patient.
  measure: Single Assessment Numeric Evaluation score (SANE)
  time frame: Preop, 26 Weeks, 1 Year, 2 Year
  description: Asks patients to rate shoulder pain as a percentage of normal.
  measure: Visual Analog Scale (VAS) for pain
  time frame: Preop, two-week, six week, 26 Weeks, 1 Year, 2 Year
  description: The standard measure for pain on a 0-10 scale, 10 being the worst.
  measure: Veterans RAND Health Survey (VR-12)
  time frame: Preop, 26 Weeks, 1 Year, 2 Year
  description: A self-administered health measure. Answers are summarized into two scores, a Physical Component Score and a Mental Component Score, which provides an important contrast between the respondents' physical and psychological health status.
  arm group label: Repair without DAA
  description: repaired without dermal allograft augmentation (DAA).
  intervention type: Device
  intervention name: Repair with DAA (dermal allograft augmentation)
  description: Patients undergo rotator cuff repair with dermal allograft augmentation.
  arm group label: Repair without DAA
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 30 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Alicia Ruiz, MS
  role: Study Director
  affiliation: Arthrex, Inc.
  last name: Caroline Caraci, BA
  phone: 18009337001
  email: caroline.caraci@arthrex.com
  citation: Kwon J, Kim SH, Lee YH, Kim TI, Oh JH. The Rotator Cuff Healing Index: A New Scoring System to Predict Rotator Cuff Healing After Surgical Repair. Am J Sports Med. 2019 Jan;47(1):173-180. doi: 10.1177/0363546518810763. Epub 2018 Nov 28.
  PMID: 30485753
  citation: Duong JKH, Lam PH, Murrell GAC. Anteroposterior tear size, age, hospital, and case number are important predictors of repair integrity: an analysis of 1962 consecutive arthroscopic single-row rotator cuff repairs. J Shoulder Elbow Surg. 2021 Aug;30(8):1907-1914. doi: 10.1016/j.jse.2020.09.038. Epub 2020 Nov 4.
  PMID: 33160028
  citation: Pashuck TD, Hirahara AM, Cook JL, Cook CR, Andersen WJ, Smith MJ. Superior Capsular Reconstruction Using Dermal Allograft Is a Safe and Effective Treatment for Massive Irreparable Rotator Cuff Tears: 2-Year Clinical Outcomes. Arthroscopy. 2021 Feb;37(2):489-496.e1. doi: 10.1016/j.arthro.2020.10.014. Epub 2020 Oct 17.
  PMID: 33080333
  citation: Jackson GR, Bedi A, Denard PJ. Graft Augmentation of Repairable Rotator Cuff Tears: An Algorithmic Approach Based on Healing Rates. Arthroscopy. 2022 Jul;38(7):2342-2347. doi: 10.1016/j.arthro.2021.10.032. Epub 2021 Nov 10.
  PMID: 34767956
  citation: Omae H, Steinmann SP, Zhao C, Zobitz ME, Wongtriratanachai P, Sperling JW, An KN. Biomechanical effect of rotator cuff augmentation with an acellular dermal matrix graft: a cadaver study. Clin Biomech (Bristol, Avon). 2012 Oct;27(8):789-92. doi: 10.1016/j.clinbiomech.2012.05.001. Epub 2012 May 17.
  PMID: 22607908
  citation: Snyder SJ, Arnoczky SP, Bond JL, Dopirak R. Histologic evaluation of a biopsy specimen obtained 3 months after rotator cuff augmentation with GraftJacket Matrix. Arthroscopy. 2009 Mar;25(3):329-33. doi: 10.1016/j.arthro.2008.05.023. Epub 2008 Jul 24.
  PMID: 19245998
  citation: Barber FA, Burns JP, Deutsch A, Labbe MR, Litchfield RB. A prospective, randomized evaluation of acellular human dermal matrix augmentation for arthroscopic rotator cuff repair. Arthroscopy. 2012 Jan;28(1):8-15. doi: 10.1016/j.arthro.2011.06.038. Epub 2011 Oct 5.
  PMID: 21978432
  citation: Cummins CA, Murrell GA. Mode of failure for rotator cuff repair with suture anchors identified at revision surgery. J Shoulder Elbow Surg. 2003 Mar-Apr;12(2):128-33. doi: 10.1067/mse.2003.21.
  PMID: 12700563
  citation: Haque A, Pal Singh H. Does structural integrity following rotator cuff repair affect functional outcomes and pain scores? A meta-analysis. Shoulder Elbow. 2018 Jul;10(3):163-169. doi: 10.1177/1758573217731548. Epub 2017 Sep 25.
  PMID: 29796103
  citation: Sugaya H, Maeda K, Matsuki K, Moriishi J. Repair integrity and functional outcome after arthroscopic double-row rotator cuff repair. A prospective outcome study. J Bone Joint Surg Am. 2007 May;89(5):953-60. doi: 10.2106/JBJS.F.00512.
  PMID: 17473131
  citation: Mather J, MacDermid JC, Faber KJ, Athwal GS. Proximal humerus cortical bone thickness correlates with bone mineral density and can clinically rule out osteoporosis. J Shoulder Elbow Surg. 2013 Jun;22(6):732-8. doi: 10.1016/j.jse.2012.08.018. Epub 2012 Nov 22.
  PMID: 23183030
  responsible party type: Sponsor
  mesh term: Rotator Cuff Injuries
  sharing ipd: No