<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/NCT02200939</url>
  </required_header>
  <id_info>
    <org_study_id>2014.05.12</org_study_id>
    <nct_id>NCT02200939</nct_id>
  </id_info>
  <brief_title>Post-Market Evaluation of the Rotation Medical Rotator Cuff System</brief_title>
  <official_title>Post-Market Evaluation of the Rotation Medical Rotator Cuff System</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Smith &amp; Nephew, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Smith &amp; Nephew, 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 evaluate bioinduction of new tissue and tendon healing after&#xD;
      implantation of the Rotation Medical Bioinductive Implant used as either a standalone device&#xD;
      or adjunct to surgical repair in the treatment of supraspinatus tendon tears.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 20, 2014</start_date>
  <completion_date type="Actual">November 24, 2020</completion_date>
  <primary_completion_date type="Actual">November 24, 2020</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Tendon Thickness</measure>
    <time_frame>Pre-operatively (baseline) to 3 month, 1 year, and 2 year</time_frame>
    <description>The total thickness of the tendon and any newly induced tissue at the implant site were measured at 3 months, 1 year, and 2 years using magnetic resonance imaging (MRI). Measurements were compared to pre-operative (baseline) supraspinatus tendon thickness to calculate the mean (± SD) change in post-operative supraspinatus tendon thickness by partial-thickness tear size (Intermediate or High) or full thickness tear size (Medium or Large).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Integration of Induced Tissue With Underlying Tendon</measure>
    <time_frame>3 months, 1 year, and 2 years</time_frame>
    <description>Partial-thickness tears were classified as Intermediate (3-6 mm) or High (&gt; 6 mm) grade tears. Full thickness tears were categorized using Cofield classification as Medium (1-3 cm) or Large (3-5 cm). Integration and maturation of the newly induced tissue was assessed by MRI at each post-operative follow-up and determined by answering Yes, No, or Unable to determine to the following questions:&#xD;
Is there a visible boundary between the collagen scaffold/new tissue and the supraspinatus tendon?&#xD;
Is there visible evidence of a good margin between the collagen scaffold/new tissue and the deltoid?&#xD;
Was there evidence of bursitis in the shoulder?&#xD;
Does the new tissue resemble normal tendon tissue?&#xD;
Does the underlying tendon resemble normal tendon tissue?&#xD;
Is there any new defect (i.e., loss in supraspinatus tendon continuity; re-tear)?</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fill-In of Partial Thickness Tears and Underlying Tendon Quality</measure>
    <time_frame>3 months, 1 year, and 2 years</time_frame>
    <description>For tendon defects treated by standalone use of the device (i.e., implantation without surgical repair using sutures/suture anchors), post-operative follow-up MRIs will be used to estimate the amount of defect fill-in with newly induced tissue and the quality of the filled-in tissue. In the absence of fill-in with newly induced tissue, defect progression (i.e., change in size relative to previous MRIs) will be assessed. The amount of fill-in relative to the pre-operative, baseline MRI classified as:&#xD;
0 to &lt;25%&#xD;
25% to &lt;50%&#xD;
50% to &lt; 75%&#xD;
75% to &lt; 100%&#xD;
100%</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With a Re-Tear</measure>
    <time_frame>3 months, 1 year, and 2 years</time_frame>
    <description>Re-tear rate following rotator cuff repair assessed by MRI. Any new observable defect (i.e. loss in supraspinatus tendon continuity) will be classified as a re-tear.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Procedure Parameters: Device Implant Time</measure>
    <time_frame>Intraoperative</time_frame>
    <description>Mean (± SD) device implant time in minutes was assessed starting at time from introduction of the guide wire instrument into the subacromial space through completion of the last staple.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Procedure Parameters: Procedure Technical Success</measure>
    <time_frame>Intraoperative</time_frame>
    <description>Procedure technical success was measured by the count of participants where the device was successfully delivered and affixed to the target tendon location (i.e., implant of device was attempted and successful).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>American Shoulder and Elbow Society (ASES) Score</measure>
    <time_frame>Baseline, 3 month, 1 year, and 2 years</time_frame>
    <description>The ASES consisted of subcomponent scores including pain, shoulder function, and shoulder scores as follows:&#xD;
ASES Pain Score ranges from 0 to 10, with 0 being no pain and 10 being the worst pain (lower score better).&#xD;
ASES Shoulder Function Score ranges from 0 to 30, with 0 being no function and 30 being full function (higher score better).&#xD;
ASES Shoulder Score ranges from 10 to 100, with 0 being no function and 100 being normal function (higher score better).&#xD;
Scores were collected at baseline and each successive follow-up visits (3 months, 1 year, and 2 years).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Constant-Murley Shoulder (CMS) Score</measure>
    <time_frame>Baseline, 3 months, 1 year, and 2 years</time_frame>
    <description>The overall CMS shoulder score ranges from 0 to 100, with 0 being severe restrictions and 100 being no restrictions (i.e., higher score is better). Scores were collected a baseline and each subsequent follow-up (3 months, 1 year, and 2 years).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Recovery: Sling Time</measure>
    <time_frame>Post-operatively to study completion, approximately 2 years</time_frame>
    <description>Cumulative number of days index shoulder was in a sling.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Recovery: Rehabilitation Time</measure>
    <time_frame>Post-operatively to study completion, approximately 2 years</time_frame>
    <description>Cumulative number of completed rehabilitation or physical therapy (PT) visits in days to treat index shoulder.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Recovery: Return to Work</measure>
    <time_frame>Post-operatively to study completion, approximately 2 years</time_frame>
    <description>Cumulative number of days between discharge and return to work (employed subjects only).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Recovery: Return to Normal Daily Activities</measure>
    <time_frame>Post-operatively to study completion, approximately 2 years</time_frame>
    <description>Return to normal daily activities (i.e. full, unrestricted activity) determined by the cumulative number of days between discharge and return to normal daily activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participant Satisfaction</measure>
    <time_frame>3 months, 1 year, and 2 years</time_frame>
    <description>Self-reported measure of the level of satisfaction with the surgical outcome of the index surgery on 5-point Likert scale where participants were asked to indicated the best response to being satisfied with the outcome of the study procedure from one of the following:&#xD;
Strongly Disagree&#xD;
Disagree&#xD;
Neither Agree or Disagree&#xD;
Agree&#xD;
Strongly Agree&#xD;
&quot;Strongly Disagree&quot; indicated the lowest level of satisfaction and &quot;Strongly Agree&quot; indicated the greatest level of satisfaction.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">148</enrollment>
  <condition>Partial Thickness Supraspinatus Tendon Tear</condition>
  <condition>Full Thickness Supraspinatus Tendon Tear</condition>
  <arm_group>
    <arm_group_label>Partial-Thickness Tear</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intermediate or High partial-thickness tear (PTT) or very small full-thickness tear of the supraspinatus tendon surgically treated by implantation of the bioinductive implant.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Full Thickness Tear</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Medium or large full thickness tear (FTT) of the supraspinatus tendon surgically treated with the bioinductive implant adjunctive to surgical repair.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Bioinductive implant</intervention_name>
    <arm_group_label>Full Thickness Tear</arm_group_label>
    <arm_group_label>Partial-Thickness Tear</arm_group_label>
    <other_name>Rotation Medical Rotator Cuff System™</other_name>
    <other_name>REGENETEN™ Bioinductive Implant System.</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Surgical repair</intervention_name>
    <description>Surgical repair with commercially-available sutures/suture anchors.</description>
    <arm_group_label>Full Thickness Tear</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        INCLUSION CRITERIA&#xD;
&#xD;
        Subjects enrolled in the study MUST meet all of the following criteria:&#xD;
&#xD;
          1. At least 21 years of age&#xD;
&#xD;
          2. Rotator cuff tear requiring surgery that meets either criterion A or B:&#xD;
&#xD;
             A. Medium or large partial-thickness tear or very small full-thickness tear of the&#xD;
             supraspinatus tendon planned for standalone treatment (no surgical repair with&#xD;
             sutures/suture anchors) with the bioinductive implant B. Medium or large&#xD;
             full-thickness tear primarily of the supraspinatus tendon planned for treatment with&#xD;
             the bioinductive implant adjunctive to surgical repair&#xD;
&#xD;
          3. Chronic shoulder pain lasting longer than 3 months unresponsive to conservative&#xD;
             therapy including, but not limited to, pain medication, physical therapy and&#xD;
             injections&#xD;
&#xD;
          4. MRI of the shoulder within 60 days prior to the study procedure&#xD;
&#xD;
          5. Willing to comply with the prescribed post-operative rehabilitation program&#xD;
&#xD;
          6. Willing to be available for each protocol-required follow-up examination&#xD;
&#xD;
          7. Able to understand the informed consent process, including regulatory requirements&#xD;
             such as HIPAA authorization, and document informed consent prior to completion of any&#xD;
             study-related procedures&#xD;
&#xD;
          8. Ability to read, understand, and complete subject-reported outcomes in English&#xD;
&#xD;
        EXCLUSION CRITERIA&#xD;
&#xD;
        Subjects enrolled in the study MUST NOT meet any of the following criteria:&#xD;
&#xD;
          1. Massive rotator cuff tears (≥ 5 cm)&#xD;
&#xD;
          2. Acute rotator cuff tears less than 12 months from injury&#xD;
&#xD;
          3. Previous rotator cuff surgery on the index shoulder&#xD;
&#xD;
          4. Instability of the index shoulder&#xD;
&#xD;
          5. Chondromalacia of index shoulder ≥ Grade 3&#xD;
&#xD;
          6. Fatty infiltration of the index shoulder rotator cuff muscle ≥ Grade 2&#xD;
&#xD;
          7. Calcification of the index shoulder rotator cuff&#xD;
&#xD;
          8. Genetic collagen disease&#xD;
&#xD;
          9. History of insulin dependent diabetes&#xD;
&#xD;
         10. History of auto-immune or immunodeficiency disorders&#xD;
&#xD;
         11. History of chronic inflammatory disorders&#xD;
&#xD;
         12. Oral steroid use in last 2 months or injectable steroid use in last 4 weeks&#xD;
&#xD;
         13. History of heavy smoking (&gt; 1 pack per day) within last 6 months&#xD;
&#xD;
         14. Hypersensitivity to bovine-derived materials&#xD;
&#xD;
         15. Females of child-bearing potential who are pregnant or plan to become pregnant during&#xD;
             the course of the study&#xD;
&#xD;
         16. Currently involved in any injury litigation or worker's compensation claims relating&#xD;
             to the index shoulder&#xD;
&#xD;
         17. Enrolled, or plans to enroll, in another clinical trial during this study that would&#xD;
             affect the outcomes of this study&#xD;
&#xD;
         18. History of non-compliance with medical treatment, physical therapy/rehabilitation, or&#xD;
             clinical study participation&#xD;
&#xD;
         19. History of cognitive or mental health status that interferes with study participation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Laura England</last_name>
    <role>Study Chair</role>
    <affiliation>Smith &amp; Nephew, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Southern California Orthopedic Institute</name>
      <address>
        <city>Van Nuys</city>
        <state>California</state>
        <zip>91405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Steadman Hawkins Clinic-Denver</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Holy Cross Hospital Orthopedic Research Institute</name>
      <address>
        <city>Fort Lauderdale</city>
        <state>Florida</state>
        <zip>33334</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Harbin Clinic Orthopaedics &amp; Sports Medicine Rome</name>
      <address>
        <city>Rome</city>
        <state>Georgia</state>
        <zip>30165</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>OrthoIllinois, LTD</name>
      <address>
        <city>Rockford</city>
        <state>Illinois</state>
        <zip>61107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Iowa Sports Medicine</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Towson Orthopaedic Associates / University of Maryland St Joseph Med Ctr</name>
      <address>
        <city>Towson</city>
        <state>Maryland</state>
        <zip>21204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Great Lakes Orthopaedic Center</name>
      <address>
        <city>Traverse City</city>
        <state>Michigan</state>
        <zip>49684</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Twin Cities Orthopedics</name>
      <address>
        <city>Edina</city>
        <state>Minnesota</state>
        <zip>55435</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Princeton Orthopaedic Associates, P.A.</name>
      <address>
        <city>Princeton</city>
        <state>New Jersey</state>
        <zip>08540</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>OrthoCarolina Research Institute</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44125</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Orthopedic Specialists, P.L.L.C.</name>
      <address>
        <city>Bedford</city>
        <state>Texas</state>
        <zip>76021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bone &amp; Joint Clinic of Houston</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ProOrtho Orthopedic Clinic</name>
      <address>
        <city>Kirkland</city>
        <state>Washington</state>
        <zip>98034</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>July 23, 2014</study_first_submitted>
  <study_first_submitted_qc>July 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 25, 2014</study_first_posted>
  <results_first_submitted>November 18, 2021</results_first_submitted>
  <results_first_submitted_qc>February 28, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">March 2, 2022</results_first_posted>
  <last_update_submitted>February 28, 2022</last_update_submitted>
  <last_update_submitted_qc>February 28, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 2, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>January 1, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/39/NCT02200939/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Recruitment started on 20 August 2014 and the study concluded on 24 November 2020 across 15 participating medical clinics in the United States.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Partial-Thickness Tear</title>
          <description>Intermediate or High partial-thickness tear (PTT) or very small full-thickness tear (FTT) of the supraspinatus tendon surgically treated by implantation of the bioinductive implant.</description>
        </group>
        <group group_id="P2">
          <title>Full Thickness Tear</title>
          <description>Medium or large full thickness tear (FTT) of the supraspinatus tendon surgically treated with the bioinductive implant adjunctive to surgical repair.&#xD;
Surgical repair: Surgical repair with commercially-available sutures/suture anchors.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="33"/>
                <participants group_id="P2" count="115"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="31"/>
                <participants group_id="P2" count="104"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="11"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Participant withdrew consent</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="9"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Subject moved out of town and unable to make it back to study</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Number of participants after implantation of the REGENETEN Bioinductive Implant for partial-thickness tear (PTT) or full-thickness tear (FTT) that provided data.</population>
      <group_list>
        <group group_id="B1">
          <title>Partial-Thickness Tear</title>
          <description>Intermediate or High partial-thickness tear (PTT) or very small full-thickness tear (FTT) of the supraspinatus tendon surgically treated by implantation of the bioinductive implant.</description>
        </group>
        <group group_id="B2">
          <title>Full Thickness Tear</title>
          <description>Medium or large full thickness tear (FTT) of the supraspinatus tendon surgically treated with the bioinductive implant adjunctive to surgical repair.&#xD;
Surgical repair: Surgical repair with commercially-available sutures/suture anchors.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="33"/>
            <count group_id="B2" value="115"/>
            <count group_id="B3" value="148"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="33"/>
                    <count group_id="B2" value="115"/>
                    <count group_id="B3" value="148"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="54.60" spread="10.13"/>
                    <measurement group_id="B2" value="60.40" spread="8.01"/>
                    <measurement group_id="B3" value="59.10" spread="8.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="33"/>
                    <count group_id="B2" value="115"/>
                    <count group_id="B3" value="148"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="39"/>
                    <measurement group_id="B3" value="53"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="76"/>
                    <measurement group_id="B3" value="95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Ethnicity</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="33"/>
                    <count group_id="B2" value="115"/>
                    <count group_id="B3" value="148"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Caucasian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                    <measurement group_id="B2" value="100"/>
                    <measurement group_id="B3" value="133"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Hispanic</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="33"/>
                    <count group_id="B2" value="115"/>
                    <count group_id="B3" value="148"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                    <measurement group_id="B2" value="115"/>
                    <measurement group_id="B3" value="148"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Hand Dominance</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="33"/>
                    <count group_id="B2" value="115"/>
                    <count group_id="B3" value="148"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Right</title>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                    <measurement group_id="B2" value="103"/>
                    <measurement group_id="B3" value="132"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Left</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Affected Shoulder</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="33"/>
                    <count group_id="B2" value="115"/>
                    <count group_id="B3" value="148"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Right</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="78"/>
                    <measurement group_id="B3" value="95"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Left</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="37"/>
                    <measurement group_id="B3" value="53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Smoking Habit</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="33"/>
                    <count group_id="B2" value="115"/>
                    <count group_id="B3" value="148"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Never Smoked</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="81"/>
                    <measurement group_id="B3" value="101"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Former Smoker</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="31"/>
                    <measurement group_id="B3" value="43"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Current Smoker</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Employment Status</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="33"/>
                    <count group_id="B2" value="115"/>
                    <count group_id="B3" value="148"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Currently employed (working for pay)</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="83"/>
                    <measurement group_id="B3" value="105"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Currently unemployed (not working for pay)</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="32"/>
                    <measurement group_id="B3" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Tear Size: Partial-Thickness ONLY</title>
          <description>Partial-Thickness Tear Size classified using Ellman grading as:&#xD;
Grade 1: Low (less than 3 millimeters deep)&#xD;
Grade 2: Intermediate (3-6 millimeters deep)&#xD;
Grade 3: High (greater than 6 millimeters deep).&#xD;
Tear Size for Partial-Thickness Tears assessed by magnetic resonance imaging (MRI).</description>
          <population>Full Thickness Tear not measured using this classification (i.e. measure applies to Partial-Thickness Tears only).</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Grade 1: Low (&lt; 3 mm)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="33"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="33"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 2: Intermediate (3-6 mm)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="33"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="33"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3: High (&gt; 6 mm)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="33"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="33"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Tear Size: Full Thickness ONLY</title>
          <description>Full Thickness Tear Size categorized according to Cofield classification:&#xD;
Small (less than 1 centimeter)&#xD;
Medium (1-3 centimeters)&#xD;
Large (3-5 centimeters)&#xD;
Massive (greater than 5 centimeters).&#xD;
Full Thickness Tear size assessed by magnetic resonance imaging (MRI).</description>
          <population>Partial-Thickness Tear not classified using this measurement (i.e. measure applies to Full Thickness Tears only).</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Small (&lt; 1 cm)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="115"/>
                    <count group_id="B3" value="115"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Medium (1-3 cm)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="115"/>
                    <count group_id="B3" value="115"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="66"/>
                    <measurement group_id="B3" value="66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Large (3-5 cm)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="115"/>
                    <count group_id="B3" value="115"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="49"/>
                    <measurement group_id="B3" value="49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Massive (&gt; 5 cm)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="115"/>
                    <count group_id="B3" value="115"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Tendon Thickness</title>
        <description>The total thickness of the tendon and any newly induced tissue at the implant site were measured at 3 months, 1 year, and 2 years using magnetic resonance imaging (MRI). Measurements were compared to pre-operative (baseline) supraspinatus tendon thickness to calculate the mean (± SD) change in post-operative supraspinatus tendon thickness by partial-thickness tear size (Intermediate or High) or full thickness tear size (Medium or Large).</description>
        <time_frame>Pre-operatively (baseline) to 3 month, 1 year, and 2 year</time_frame>
        <population>Participants with partial-thickness or full thickness tears that provided data at the specified time frames.</population>
        <group_list>
          <group group_id="O1">
            <title>Intermediate Partial-Thickness Tear</title>
            <description>Intermediate partial-thickness tear (3-6 mm) of the supraspinatus tendon surgically treated by implantation of the bioinductive implant.</description>
          </group>
          <group group_id="O2">
            <title>High Partial-Thickness Tear</title>
            <description>High partial-thickness tear (&gt; 6 mm) of the supraspinatus tendon surgically treated by implantation of the bioinductive implant.</description>
          </group>
          <group group_id="O3">
            <title>Medium Full Thickness Tear</title>
            <description>Medium full thickness tear (1-3 cm) of the supraspinatus tendon surgically treated by implantation of the bioinductive implant.</description>
          </group>
          <group group_id="O4">
            <title>Large Full Thickness Tear</title>
            <description>Large full thickness tear (3-5 cm) of the supraspinatus tendon surgically treated by implantation of the bioinductive implant.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Tendon Thickness</title>
          <description>The total thickness of the tendon and any newly induced tissue at the implant site were measured at 3 months, 1 year, and 2 years using magnetic resonance imaging (MRI). Measurements were compared to pre-operative (baseline) supraspinatus tendon thickness to calculate the mean (± SD) change in post-operative supraspinatus tendon thickness by partial-thickness tear size (Intermediate or High) or full thickness tear size (Medium or Large).</description>
          <population>Participants with partial-thickness or full thickness tears that provided data at the specified time frames.</population>
          <units>millimeters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="21"/>
                <count group_id="O3" value="58"/>
                <count group_id="O4" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change from Baseline to 3 Month</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="21"/>
                    <count group_id="O3" value="53"/>
                    <count group_id="O4" value="37"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.7" spread="1.5"/>
                    <measurement group_id="O2" value="2.6" spread="19"/>
                    <measurement group_id="O3" value="1.2" spread="1.7"/>
                    <measurement group_id="O4" value="1.2" spread="2.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline to 1 Year</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="19"/>
                    <count group_id="O3" value="50"/>
                    <count group_id="O4" value="38"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.4" spread="1.3"/>
                    <measurement group_id="O2" value="2.3" spread="1.8"/>
                    <measurement group_id="O3" value="0.6" spread="1.9"/>
                    <measurement group_id="O4" value="0.7" spread="2.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline to 2 Year</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="18"/>
                    <count group_id="O3" value="48"/>
                    <count group_id="O4" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.2" spread="1.3"/>
                    <measurement group_id="O2" value="1.8" spread="2.2"/>
                    <measurement group_id="O3" value="0.7" spread="2.0"/>
                    <measurement group_id="O4" value="0.7" spread="2.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from 3 Months to 1 Year</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="20"/>
                    <count group_id="O3" value="58"/>
                    <count group_id="O4" value="36"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.3" spread="0.4"/>
                    <measurement group_id="O2" value="-0.4" spread="0.6"/>
                    <measurement group_id="O3" value="-0.5" spread="1.3"/>
                    <measurement group_id="O4" value="-0.4" spread="1.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from 3 Months to 2 Year</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="19"/>
                    <count group_id="O3" value="55"/>
                    <count group_id="O4" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.3" spread="0.4"/>
                    <measurement group_id="O2" value="-0.8" spread="1.2"/>
                    <measurement group_id="O3" value="-0.6" spread="1.6"/>
                    <measurement group_id="O4" value="-0.6" spread="1.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from 1 Year to 2 Year</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="19"/>
                    <count group_id="O3" value="55"/>
                    <count group_id="O4" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.1" spread="0.3"/>
                    <measurement group_id="O2" value="-0.4" spread="0.9"/>
                    <measurement group_id="O3" value="-0.2" spread="0.9"/>
                    <measurement group_id="O4" value="-0.1" spread="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Integration of Induced Tissue With Underlying Tendon</title>
        <description>Partial-thickness tears were classified as Intermediate (3-6 mm) or High (&gt; 6 mm) grade tears. Full thickness tears were categorized using Cofield classification as Medium (1-3 cm) or Large (3-5 cm). Integration and maturation of the newly induced tissue was assessed by MRI at each post-operative follow-up and determined by answering Yes, No, or Unable to determine to the following questions:&#xD;
Is there a visible boundary between the collagen scaffold/new tissue and the supraspinatus tendon?&#xD;
Is there visible evidence of a good margin between the collagen scaffold/new tissue and the deltoid?&#xD;
Was there evidence of bursitis in the shoulder?&#xD;
Does the new tissue resemble normal tendon tissue?&#xD;
Does the underlying tendon resemble normal tendon tissue?&#xD;
Is there any new defect (i.e., loss in supraspinatus tendon continuity; re-tear)?</description>
        <time_frame>3 months, 1 year, and 2 years</time_frame>
        <population>Participants with partial-thickness tear or full thickness tear that provided data for the specified time frames.</population>
        <group_list>
          <group group_id="O1">
            <title>Intermediate Partial-Thickness Tear</title>
            <description>Intermediate partial-thickness tear (3-6 mm) of the supraspinatus tendon surgically treated by implantation of the bioinductive implant.</description>
          </group>
          <group group_id="O2">
            <title>High Partial-Thickness Tear</title>
            <description>High partial-thickness tear (&gt; 6 mm) of the supraspinatus tendon surgically treated by implantation of the bioinductive implant.</description>
          </group>
          <group group_id="O3">
            <title>Medium Full Thickness Tear</title>
            <description>Medium full thickness tear (1-3 cm) of the supraspinatus tendon surgically treated by implantation of the bioinductive implant.</description>
          </group>
          <group group_id="O4">
            <title>Large Full Thickness Tear</title>
            <description>Large full thickness tear (3-5 cm) of the supraspinatus tendon surgically treated by implantation of the bioinductive implant.</description>
          </group>
        </group_list>
        <measure>
          <title>Integration of Induced Tissue With Underlying Tendon</title>
          <description>Partial-thickness tears were classified as Intermediate (3-6 mm) or High (&gt; 6 mm) grade tears. Full thickness tears were categorized using Cofield classification as Medium (1-3 cm) or Large (3-5 cm). Integration and maturation of the newly induced tissue was assessed by MRI at each post-operative follow-up and determined by answering Yes, No, or Unable to determine to the following questions:&#xD;
Is there a visible boundary between the collagen scaffold/new tissue and the supraspinatus tendon?&#xD;
Is there visible evidence of a good margin between the collagen scaffold/new tissue and the deltoid?&#xD;
Was there evidence of bursitis in the shoulder?&#xD;
Does the new tissue resemble normal tendon tissue?&#xD;
Does the underlying tendon resemble normal tendon tissue?&#xD;
Is there any new defect (i.e., loss in supraspinatus tendon continuity; re-tear)?</description>
          <population>Participants with partial-thickness tear or full thickness tear that provided data for the specified time frames.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="21"/>
                <count group_id="O3" value="66"/>
                <count group_id="O4" value="48"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>3 Month: Visible boundary between the collagen scaffold/new tissue and the supraspinatus tendon?</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="21"/>
                    <count group_id="O3" value="65"/>
                    <count group_id="O4" value="47"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="8"/>
                    <measurement group_id="O4" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="18"/>
                    <measurement group_id="O3" value="14"/>
                    <measurement group_id="O4" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unable to determine</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="43"/>
                    <measurement group_id="O4" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 Year: Visible boundary between the collagen scaffold/new tissue and the supraspinatus tendon?</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="20"/>
                    <count group_id="O3" value="65"/>
                    <count group_id="O4" value="48"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="11"/>
                    <measurement group_id="O3" value="5"/>
                    <measurement group_id="O4" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unable to determine</title>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="60"/>
                    <measurement group_id="O4" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 Years: Visible boundary between the collagen scaffold/new tissue and the supraspinatus tendon?</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="20"/>
                    <count group_id="O3" value="62"/>
                    <count group_id="O4" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unable to determine</title>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="13"/>
                    <measurement group_id="O3" value="60"/>
                    <measurement group_id="O4" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 Month: Visible evidence of a good margin between the collagen scaffold/new tissue and the deltoid?</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="21"/>
                    <count group_id="O3" value="65"/>
                    <count group_id="O4" value="47"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="12"/>
                    <measurement group_id="O3" value="39"/>
                    <measurement group_id="O4" value="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unable to determine</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="26"/>
                    <measurement group_id="O4" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 Year: Visible evidence of a good margin between the collagen scaffold/new tissue and the deltoid?</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="21"/>
                    <count group_id="O3" value="65"/>
                    <count group_id="O4" value="48"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="8"/>
                    <measurement group_id="O4" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unable to determine</title>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="15"/>
                    <measurement group_id="O3" value="57"/>
                    <measurement group_id="O4" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 Years: Visible evidence of a good margin between the collagen scaffold/new tissue and the deltoid?</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="20"/>
                    <count group_id="O3" value="62"/>
                    <count group_id="O4" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="11"/>
                    <measurement group_id="O4" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unable to determine</title>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="16"/>
                    <measurement group_id="O3" value="51"/>
                    <measurement group_id="O4" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 Month: Was there evidence of bursitis in the shoulder?</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="21"/>
                    <count group_id="O3" value="65"/>
                    <count group_id="O4" value="48"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="21"/>
                    <measurement group_id="O3" value="65"/>
                    <measurement group_id="O4" value="48"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unable to determine</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 Year: Was there evidence of bursitis in the shoulder?</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="21"/>
                    <count group_id="O3" value="66"/>
                    <count group_id="O4" value="48"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="21"/>
                    <measurement group_id="O3" value="66"/>
                    <measurement group_id="O4" value="48"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unable to determine</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 Years: Was there evidence of bursitis in the shoulder?</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="20"/>
                    <count group_id="O3" value="62"/>
                    <count group_id="O4" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="18"/>
                    <measurement group_id="O3" value="57"/>
                    <measurement group_id="O4" value="40"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="5"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unable to determine</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 Month: Does the new tissue resemble normal tendon tissue?</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="21"/>
                    <count group_id="O3" value="66"/>
                    <count group_id="O4" value="47"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="21"/>
                    <measurement group_id="O3" value="65"/>
                    <measurement group_id="O4" value="45"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unable to determine</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 Year: Does the new tissue resemble normal tendon tissue?</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="21"/>
                    <count group_id="O3" value="65"/>
                    <count group_id="O4" value="48"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="21"/>
                    <measurement group_id="O3" value="65"/>
                    <measurement group_id="O4" value="43"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unable to determine</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 Years: Does the new tissue resemble normal tendon tissue?</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="20"/>
                    <count group_id="O3" value="62"/>
                    <count group_id="O4" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="20"/>
                    <measurement group_id="O3" value="60"/>
                    <measurement group_id="O4" value="37"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unable to determine</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 Month: Does the underlying tendon resemble normal tendon tissue?</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="21"/>
                    <count group_id="O3" value="66"/>
                    <count group_id="O4" value="48"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="21"/>
                    <measurement group_id="O3" value="66"/>
                    <measurement group_id="O4" value="48"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unable to determine</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 Year: Does the underlying tendon resemble normal tendon tissue?</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="21"/>
                    <count group_id="O3" value="66"/>
                    <count group_id="O4" value="48"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="21"/>
                    <measurement group_id="O3" value="66"/>
                    <measurement group_id="O4" value="48"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unable to determine</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 Years: 3 Month: Does the underlying tendon resemble normal tendon tissue?</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="20"/>
                    <count group_id="O3" value="62"/>
                    <count group_id="O4" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="20"/>
                    <measurement group_id="O3" value="60"/>
                    <measurement group_id="O4" value="40"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unable to determine</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 Month: Is there any new defect (i.e., loss in supraspinatus tendon continuity; re-tear)?</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="21"/>
                    <count group_id="O3" value="66"/>
                    <count group_id="O4" value="48"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="13"/>
                    <measurement group_id="O4" value="21"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="19"/>
                    <measurement group_id="O3" value="52"/>
                    <measurement group_id="O4" value="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unable to determine</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 Year: Is there any new defect (i.e., loss in supraspinatus tendon continuity; re-tear)?</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="21"/>
                    <count group_id="O3" value="66"/>
                    <count group_id="O4" value="48"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="43"/>
                    <measurement group_id="O4" value="29"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="20"/>
                    <measurement group_id="O4" value="19"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unable to determine</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 Years: Is there any new defect (i.e., loss in supraspinatus tendon continuity; re-tear)?</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="20"/>
                    <count group_id="O3" value="62"/>
                    <count group_id="O4" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="10"/>
                    <measurement group_id="O3" value="49"/>
                    <measurement group_id="O4" value="22"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="8"/>
                    <measurement group_id="O3" value="13"/>
                    <measurement group_id="O4" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unable to determine</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Fill-In of Partial Thickness Tears and Underlying Tendon Quality</title>
        <description>For tendon defects treated by standalone use of the device (i.e., implantation without surgical repair using sutures/suture anchors), post-operative follow-up MRIs will be used to estimate the amount of defect fill-in with newly induced tissue and the quality of the filled-in tissue. In the absence of fill-in with newly induced tissue, defect progression (i.e., change in size relative to previous MRIs) will be assessed. The amount of fill-in relative to the pre-operative, baseline MRI classified as:&#xD;
0 to &lt;25%&#xD;
25% to &lt;50%&#xD;
50% to &lt; 75%&#xD;
75% to &lt; 100%&#xD;
100%</description>
        <time_frame>3 months, 1 year, and 2 years</time_frame>
        <population>Only participants with partial-thickness tears that provided data for the specified time frame. Participants with Full Thickness Tears were not assessed as data for this outcome measure can only be obtained from participants with a Partial-Thickness Tear (i.e., participants with full thickness tears cannot provide fill-in partial thickness tear information needed for this outcome).</population>
        <group_list>
          <group group_id="O1">
            <title>Intermediate Partial-Thickness Tear</title>
            <description>Intermediate partial-thickness tear (3-6 mm) of the supraspinatus tendon surgically treated by implantation of the bioinductive implant.</description>
          </group>
          <group group_id="O2">
            <title>High Partial-Thickness Tear</title>
            <description>High partial-thickness tear (&gt; 6 mm) of the supraspinatus tendon surgically treated by implantation of the bioinductive implant.</description>
          </group>
        </group_list>
        <measure>
          <title>Fill-In of Partial Thickness Tears and Underlying Tendon Quality</title>
          <description>For tendon defects treated by standalone use of the device (i.e., implantation without surgical repair using sutures/suture anchors), post-operative follow-up MRIs will be used to estimate the amount of defect fill-in with newly induced tissue and the quality of the filled-in tissue. In the absence of fill-in with newly induced tissue, defect progression (i.e., change in size relative to previous MRIs) will be assessed. The amount of fill-in relative to the pre-operative, baseline MRI classified as:&#xD;
0 to &lt;25%&#xD;
25% to &lt;50%&#xD;
50% to &lt; 75%&#xD;
75% to &lt; 100%&#xD;
100%</description>
          <population>Only participants with partial-thickness tears that provided data for the specified time frame. Participants with Full Thickness Tears were not assessed as data for this outcome measure can only be obtained from participants with a Partial-Thickness Tear (i.e., participants with full thickness tears cannot provide fill-in partial thickness tear information needed for this outcome).</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>3 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>0 to &lt; 25%</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>25% to &lt; 50%</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>50% to &lt; 75%</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>75% to &lt; 100%</title>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>100%</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 Year</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>0 to &lt; 25%</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>25% to &lt; 50%</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>50% to &lt; 75%</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>75% to &lt; 100%</title>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>100%</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 Years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>0 to &lt; 25%</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>25% to &lt; 50%</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>50% to &lt; 75%</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>75% to &lt; 100%</title>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>100%</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With a Re-Tear</title>
        <description>Re-tear rate following rotator cuff repair assessed by MRI. Any new observable defect (i.e. loss in supraspinatus tendon continuity) will be classified as a re-tear.</description>
        <time_frame>3 months, 1 year, and 2 years</time_frame>
        <population>Participants with partial-thickness tear or full thickness tear that provided data for the specified time frames.</population>
        <group_list>
          <group group_id="O1">
            <title>Intermediate Partial-Thickness Tear</title>
            <description>Intermediate partial-thickness tear (3-6 mm) of the supraspinatus tendon surgically treated by implantation of the bioinductive implant.</description>
          </group>
          <group group_id="O2">
            <title>High Partial-Thickness Tear</title>
            <description>High partial-thickness tear (&gt; 6 mm) of the supraspinatus tendon surgically treated by implantation of the bioinductive implant.</description>
          </group>
          <group group_id="O3">
            <title>Medium Full Thickness Tear</title>
            <description>Medium full thickness tear (1-3 cm) of the supraspinatus tendon surgically treated by implantation of the bioinductive implant.</description>
          </group>
          <group group_id="O4">
            <title>Large Full Thickness Tear</title>
            <description>Large full thickness tear (3-5 cm) of the supraspinatus tendon surgically treated by implantation of the bioinductive implant.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With a Re-Tear</title>
          <description>Re-tear rate following rotator cuff repair assessed by MRI. Any new observable defect (i.e. loss in supraspinatus tendon continuity) will be classified as a re-tear.</description>
          <population>Participants with partial-thickness tear or full thickness tear that provided data for the specified time frames.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="21"/>
                <count group_id="O3" value="66"/>
                <count group_id="O4" value="49"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>3 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="21"/>
                    <count group_id="O3" value="66"/>
                    <count group_id="O4" value="49"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 Year</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="21"/>
                    <count group_id="O3" value="66"/>
                    <count group_id="O4" value="49"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="7"/>
                    <measurement group_id="O4" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 Years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="20"/>
                    <count group_id="O3" value="61"/>
                    <count group_id="O4" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="7"/>
                    <measurement group_id="O4" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Procedure Parameters: Device Implant Time</title>
        <description>Mean (± SD) device implant time in minutes was assessed starting at time from introduction of the guide wire instrument into the subacromial space through completion of the last staple.</description>
        <time_frame>Intraoperative</time_frame>
        <population>Participants with partial-thickness tear or full thickness tear that provided data for the specified time frames.</population>
        <group_list>
          <group group_id="O1">
            <title>Partial-Thickness Tear</title>
            <description>Intermediate or High partial-thickness tear (PTT) or very small full-thickness tear (FTT) of the supraspinatus tendon surgically treated by implantation of the bioinductive implant.</description>
          </group>
          <group group_id="O2">
            <title>Full Thickness Tear</title>
            <description>Medium or large full-thickness tear (FTT) of the supraspinatus tendon surgically treated with the bioinductive implant adjunctive to surgical repair.&#xD;
Surgical repair: Surgical repair with commercially-available sutures/suture anchors.</description>
          </group>
        </group_list>
        <measure>
          <title>Procedure Parameters: Device Implant Time</title>
          <description>Mean (± SD) device implant time in minutes was assessed starting at time from introduction of the guide wire instrument into the subacromial space through completion of the last staple.</description>
          <population>Participants with partial-thickness tear or full thickness tear that provided data for the specified time frames.</population>
          <units>minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="33"/>
                <count group_id="O2" value="115"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.00" spread="16.65"/>
                    <measurement group_id="O2" value="10.50" spread="12.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Procedure Parameters: Procedure Technical Success</title>
        <description>Procedure technical success was measured by the count of participants where the device was successfully delivered and affixed to the target tendon location (i.e., implant of device was attempted and successful).</description>
        <time_frame>Intraoperative</time_frame>
        <population>Participants with partial-thickness tear or full thickness tear that provided data for the specified time frames.</population>
        <group_list>
          <group group_id="O1">
            <title>Partial-Thickness Tear</title>
            <description>Intermediate or High partial-thickness tear (PTT) or very small full-thickness tear (FTT) of the supraspinatus tendon surgically treated by implantation of the bioinductive implant.</description>
          </group>
          <group group_id="O2">
            <title>Full Thickness Tear</title>
            <description>Medium or large full-thickness tear (FTT) of the supraspinatus tendon surgically treated with the bioinductive implant adjunctive to surgical repair.&#xD;
Surgical repair: Surgical repair with commercially-available sutures/suture anchors.</description>
          </group>
        </group_list>
        <measure>
          <title>Procedure Parameters: Procedure Technical Success</title>
          <description>Procedure technical success was measured by the count of participants where the device was successfully delivered and affixed to the target tendon location (i.e., implant of device was attempted and successful).</description>
          <population>Participants with partial-thickness tear or full thickness tear that provided data for the specified time frames.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="33"/>
                <count group_id="O2" value="115"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Device Implant Successful</title>
                  <measurement_list>
                    <measurement group_id="O1" value="33"/>
                    <measurement group_id="O2" value="115"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Device Implant NOT Successful</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>American Shoulder and Elbow Society (ASES) Score</title>
        <description>The ASES consisted of subcomponent scores including pain, shoulder function, and shoulder scores as follows:&#xD;
ASES Pain Score ranges from 0 to 10, with 0 being no pain and 10 being the worst pain (lower score better).&#xD;
ASES Shoulder Function Score ranges from 0 to 30, with 0 being no function and 30 being full function (higher score better).&#xD;
ASES Shoulder Score ranges from 10 to 100, with 0 being no function and 100 being normal function (higher score better).&#xD;
Scores were collected at baseline and each successive follow-up visits (3 months, 1 year, and 2 years).</description>
        <time_frame>Baseline, 3 month, 1 year, and 2 years</time_frame>
        <population>Participants with partial-thickness tear or full thickness tear that provided data for the specified time frames.</population>
        <group_list>
          <group group_id="O1">
            <title>Intermediate Partial-Thickness Tear</title>
            <description>Intermediate partial-thickness tear (3-6 mm) of the supraspinatus tendon surgically treated by implantation of the bioinductive implant.</description>
          </group>
          <group group_id="O2">
            <title>High Partial-Thickness Tear</title>
            <description>High partial-thickness tear (&gt; 6 mm) of the supraspinatus tendon surgically treated by implantation of the bioinductive implant.</description>
          </group>
          <group group_id="O3">
            <title>Medium Full Thickness Tear</title>
            <description>Medium full thickness tear (1-3 cm) of the supraspinatus tendon surgically treated by implantation of the bioinductive implant.</description>
          </group>
          <group group_id="O4">
            <title>Large Full Thickness Tear</title>
            <description>Large full thickness tear (3-5 cm) of the supraspinatus tendon surgically treated by implantation of the bioinductive implant.</description>
          </group>
        </group_list>
        <measure>
          <title>American Shoulder and Elbow Society (ASES) Score</title>
          <description>The ASES consisted of subcomponent scores including pain, shoulder function, and shoulder scores as follows:&#xD;
ASES Pain Score ranges from 0 to 10, with 0 being no pain and 10 being the worst pain (lower score better).&#xD;
ASES Shoulder Function Score ranges from 0 to 30, with 0 being no function and 30 being full function (higher score better).&#xD;
ASES Shoulder Score ranges from 10 to 100, with 0 being no function and 100 being normal function (higher score better).&#xD;
Scores were collected at baseline and each successive follow-up visits (3 months, 1 year, and 2 years).</description>
          <population>Participants with partial-thickness tear or full thickness tear that provided data for the specified time frames.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="21"/>
                <count group_id="O3" value="66"/>
                <count group_id="O4" value="49"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline: ASES Pain Score</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="21"/>
                    <count group_id="O3" value="66"/>
                    <count group_id="O4" value="49"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.6" spread="1.9"/>
                    <measurement group_id="O2" value="4" spread="2.7"/>
                    <measurement group_id="O3" value="4.8" spread="2.3"/>
                    <measurement group_id="O4" value="5.2" spread="2.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 Month: ASES Pain Score</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="21"/>
                    <count group_id="O3" value="66"/>
                    <count group_id="O4" value="49"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.8" spread="1.9"/>
                    <measurement group_id="O2" value="1.3" spread="1.6"/>
                    <measurement group_id="O3" value="1.8" spread="2.2"/>
                    <measurement group_id="O4" value="1.7" spread="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 Year: ASES Pain Score</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="21"/>
                    <count group_id="O3" value="66"/>
                    <count group_id="O4" value="48"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.2" spread="1.6"/>
                    <measurement group_id="O2" value="0.2" spread="0.5"/>
                    <measurement group_id="O3" value="0.5" spread="1.2"/>
                    <measurement group_id="O4" value="0.5" spread="1.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 Years: ASES Pain Score</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="20"/>
                    <count group_id="O3" value="63"/>
                    <count group_id="O4" value="41"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2" spread="0.4"/>
                    <measurement group_id="O2" value="0.3" spread="0.7"/>
                    <measurement group_id="O3" value="0.2" spread="0.8"/>
                    <measurement group_id="O4" value="0.5" spread="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline: Shoulder Function Score</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="20"/>
                    <count group_id="O3" value="66"/>
                    <count group_id="O4" value="46"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.3" spread="5.4"/>
                    <measurement group_id="O2" value="18" spread="8.5"/>
                    <measurement group_id="O3" value="15.9" spread="5.7"/>
                    <measurement group_id="O4" value="14.2" spread="6.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 Month: Shoulder Function Score</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="17"/>
                    <count group_id="O3" value="66"/>
                    <count group_id="O4" value="45"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17" spread="7"/>
                    <measurement group_id="O2" value="21.1" spread="8"/>
                    <measurement group_id="O3" value="14.6" spread="6.7"/>
                    <measurement group_id="O4" value="15.6" spread="7.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 Year: Shoulder Function Score</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="17"/>
                    <count group_id="O3" value="64"/>
                    <count group_id="O4" value="47"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27" spread="4"/>
                    <measurement group_id="O2" value="26.8" spread="6.8"/>
                    <measurement group_id="O3" value="27.8" spread="4.2"/>
                    <measurement group_id="O4" value="27.4" spread="5.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 Years: Shoulder Function Score</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="20"/>
                    <count group_id="O3" value="63"/>
                    <count group_id="O4" value="41"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.7" spread="3.4"/>
                    <measurement group_id="O2" value="26.6" spread="9.1"/>
                    <measurement group_id="O3" value="27.9" spread="6.6"/>
                    <measurement group_id="O4" value="29.2" spread="1.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline: Shoulder Score</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="20"/>
                    <count group_id="O3" value="66"/>
                    <count group_id="O4" value="46"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52.5" spread="13.6"/>
                    <measurement group_id="O2" value="60.9" spread="19.9"/>
                    <measurement group_id="O3" value="52.4" spread="18.3"/>
                    <measurement group_id="O4" value="48" spread="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 Month: Shoulder Score</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="17"/>
                    <count group_id="O3" value="66"/>
                    <count group_id="O4" value="45"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70.2" spread="18.6"/>
                    <measurement group_id="O2" value="78.9" spread="18.4"/>
                    <measurement group_id="O3" value="65.2" spread="19.6"/>
                    <measurement group_id="O4" value="67.9" spread="16.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 Year: Shoulder Score</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="17"/>
                    <count group_id="O3" value="64"/>
                    <count group_id="O4" value="47"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89.2" spread="14.4"/>
                    <measurement group_id="O2" value="93.7" spread="11.7"/>
                    <measurement group_id="O3" value="94.3" spread="11.6"/>
                    <measurement group_id="O4" value="93.1" spread="13.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 Years: Shoulder Score</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="20"/>
                    <count group_id="O3" value="63"/>
                    <count group_id="O4" value="41"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="95.3" spread="5.8"/>
                    <measurement group_id="O2" value="92.8" spread="15.3"/>
                    <measurement group_id="O3" value="95.6" spread="13.2"/>
                    <measurement group_id="O4" value="96.3" spread="8.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Constant-Murley Shoulder (CMS) Score</title>
        <description>The overall CMS shoulder score ranges from 0 to 100, with 0 being severe restrictions and 100 being no restrictions (i.e., higher score is better). Scores were collected a baseline and each subsequent follow-up (3 months, 1 year, and 2 years).</description>
        <time_frame>Baseline, 3 months, 1 year, and 2 years</time_frame>
        <population>Participants with partial-thickness tear or full thickness tear that provided data for the specified time frames.</population>
        <group_list>
          <group group_id="O1">
            <title>Intermediate Partial-Thickness Tear</title>
            <description>Intermediate partial-thickness tear (3-6 mm) of the supraspinatus tendon surgically treated by implantation of the bioinductive implant.</description>
          </group>
          <group group_id="O2">
            <title>High Partial-Thickness Tear</title>
            <description>High partial-thickness tear (&gt; 6 mm) of the supraspinatus tendon surgically treated by implantation of the bioinductive implant.</description>
          </group>
          <group group_id="O3">
            <title>Medium Full Thickness Tear</title>
            <description>Medium full thickness tear (1-3 cm) of the supraspinatus tendon surgically treated by implantation of the bioinductive implant.</description>
          </group>
          <group group_id="O4">
            <title>Large Full Thickness Tear</title>
            <description>Large full thickness tear (3-5 cm) of the supraspinatus tendon surgically treated by implantation of the bioinductive implant.</description>
          </group>
        </group_list>
        <measure>
          <title>Constant-Murley Shoulder (CMS) Score</title>
          <description>The overall CMS shoulder score ranges from 0 to 100, with 0 being severe restrictions and 100 being no restrictions (i.e., higher score is better). Scores were collected a baseline and each subsequent follow-up (3 months, 1 year, and 2 years).</description>
          <population>Participants with partial-thickness tear or full thickness tear that provided data for the specified time frames.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="20"/>
                <count group_id="O3" value="64"/>
                <count group_id="O4" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="20"/>
                    <count group_id="O3" value="64"/>
                    <count group_id="O4" value="46"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51.6" spread="5.6"/>
                    <measurement group_id="O2" value="58.9" spread="19.6"/>
                    <measurement group_id="O3" value="51.2" spread="16.8"/>
                    <measurement group_id="O4" value="48.5" spread="18.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="21"/>
                    <count group_id="O4" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51.5" spread="13.8"/>
                    <measurement group_id="O2" value="73.7" spread="15.2"/>
                    <measurement group_id="O3" value="63.2" spread="16.8"/>
                    <measurement group_id="O4" value="65.2" spread="14.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 Year</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="18"/>
                    <count group_id="O3" value="61"/>
                    <count group_id="O4" value="46"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="82.2" spread="10.4"/>
                    <measurement group_id="O2" value="85.6" spread="11.3"/>
                    <measurement group_id="O3" value="79.1" spread="11.8"/>
                    <measurement group_id="O4" value="85.3" spread="9.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 Years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="18"/>
                    <count group_id="O3" value="58"/>
                    <count group_id="O4" value="37"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="83.3" spread="9.9"/>
                    <measurement group_id="O2" value="93.8" spread="6"/>
                    <measurement group_id="O3" value="83.7" spread="9.5"/>
                    <measurement group_id="O4" value="84.4" spread="9.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Recovery: Sling Time</title>
        <description>Cumulative number of days index shoulder was in a sling.</description>
        <time_frame>Post-operatively to study completion, approximately 2 years</time_frame>
        <population>Participants with partial-thickness tear or full thickness tear that provided data for the specified time frame.</population>
        <group_list>
          <group group_id="O1">
            <title>Intermediate Partial-Thickness Tear</title>
            <description>Intermediate partial-thickness tear (3-6 mm) of the supraspinatus tendon surgically treated by implantation of the bioinductive implant.</description>
          </group>
          <group group_id="O2">
            <title>High Partial-Thickness Tear</title>
            <description>High partial-thickness tear (&gt; 6 mm) of the supraspinatus tendon surgically treated by implantation of the bioinductive implant.</description>
          </group>
          <group group_id="O3">
            <title>Medium Full Thickness Tear</title>
            <description>Medium full thickness tear (1-3 cm) of the supraspinatus tendon surgically treated by implantation of the bioinductive implant.</description>
          </group>
          <group group_id="O4">
            <title>Large Full Thickness Tear</title>
            <description>Large full thickness tear (3-5 cm) of the supraspinatus tendon surgically treated by implantation of the bioinductive implant.</description>
          </group>
        </group_list>
        <measure>
          <title>Recovery: Sling Time</title>
          <description>Cumulative number of days index shoulder was in a sling.</description>
          <population>Participants with partial-thickness tear or full thickness tear that provided data for the specified time frame.</population>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="21"/>
                <count group_id="O3" value="64"/>
                <count group_id="O4" value="49"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.90" spread="9.39"/>
                    <measurement group_id="O2" value="26.60" spread="15.94"/>
                    <measurement group_id="O3" value="44.60" spread="43.23"/>
                    <measurement group_id="O4" value="39.20" spread="20.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Recovery: Rehabilitation Time</title>
        <description>Cumulative number of completed rehabilitation or physical therapy (PT) visits in days to treat index shoulder.</description>
        <time_frame>Post-operatively to study completion, approximately 2 years</time_frame>
        <population>Participants with partial-thickness tear or full thickness tear that provided data for the specified time frame.</population>
        <group_list>
          <group group_id="O1">
            <title>Intermediate Partial-Thickness Tear</title>
            <description>Intermediate partial-thickness tear (3-6 mm) of the supraspinatus tendon surgically treated by implantation of the bioinductive implant.</description>
          </group>
          <group group_id="O2">
            <title>High Partial-Thickness Tear</title>
            <description>High partial-thickness tear (&gt; 6 mm) of the supraspinatus tendon surgically treated by implantation of the bioinductive implant.</description>
          </group>
          <group group_id="O3">
            <title>Medium Full Thickness Tear</title>
            <description>Medium full thickness tear (1-3 cm) of the supraspinatus tendon surgically treated by implantation of the bioinductive implant.</description>
          </group>
          <group group_id="O4">
            <title>Large Full Thickness Tear</title>
            <description>Large full thickness tear (3-5 cm) of the supraspinatus tendon surgically treated by implantation of the bioinductive implant.</description>
          </group>
        </group_list>
        <measure>
          <title>Recovery: Rehabilitation Time</title>
          <description>Cumulative number of completed rehabilitation or physical therapy (PT) visits in days to treat index shoulder.</description>
          <population>Participants with partial-thickness tear or full thickness tear that provided data for the specified time frame.</population>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="60"/>
                <count group_id="O4" value="47"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.30" spread="7.19"/>
                    <measurement group_id="O2" value="21.20" spread="11.08"/>
                    <measurement group_id="O3" value="22.50" spread="11.01"/>
                    <measurement group_id="O4" value="21.80" spread="14.44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Recovery: Return to Work</title>
        <description>Cumulative number of days between discharge and return to work (employed subjects only).</description>
        <time_frame>Post-operatively to study completion, approximately 2 years</time_frame>
        <population>Participants with partial-thickness tear or full thickness tear that provided data for the specified time frame.</population>
        <group_list>
          <group group_id="O1">
            <title>Intermediate Partial-Thickness Tear</title>
            <description>Intermediate partial-thickness tear (3-6 mm) of the supraspinatus tendon surgically treated by implantation of the bioinductive implant.</description>
          </group>
          <group group_id="O2">
            <title>High Partial-Thickness Tear</title>
            <description>High partial-thickness tear (&gt; 6 mm) of the supraspinatus tendon surgically treated by implantation of the bioinductive implant.</description>
          </group>
          <group group_id="O3">
            <title>Medium Full Thickness Tear</title>
            <description>Medium full thickness tear (1-3 cm) of the supraspinatus tendon surgically treated by implantation of the bioinductive implant.</description>
          </group>
          <group group_id="O4">
            <title>Large Full Thickness Tear</title>
            <description>Large full thickness tear (3-5 cm) of the supraspinatus tendon surgically treated by implantation of the bioinductive implant.</description>
          </group>
        </group_list>
        <measure>
          <title>Recovery: Return to Work</title>
          <description>Cumulative number of days between discharge and return to work (employed subjects only).</description>
          <population>Participants with partial-thickness tear or full thickness tear that provided data for the specified time frame.</population>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="21"/>
                <count group_id="O3" value="44"/>
                <count group_id="O4" value="36"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46.00" spread="62.99"/>
                    <measurement group_id="O2" value="58.80" spread="108.70"/>
                    <measurement group_id="O3" value="50.00" spread="72.93"/>
                    <measurement group_id="O4" value="66.50" spread="83.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Recovery: Return to Normal Daily Activities</title>
        <description>Return to normal daily activities (i.e. full, unrestricted activity) determined by the cumulative number of days between discharge and return to normal daily activity.</description>
        <time_frame>Post-operatively to study completion, approximately 2 years</time_frame>
        <population>Participants with partial-thickness tear or full thickness tear that provided data for the specified time frame.</population>
        <group_list>
          <group group_id="O1">
            <title>Intermediate Partial-Thickness Tear</title>
            <description>Intermediate partial-thickness tear (3-6 mm) of the supraspinatus tendon surgically treated by implantation of the bioinductive implant.</description>
          </group>
          <group group_id="O2">
            <title>High Partial-Thickness Tear</title>
            <description>High partial-thickness tear (&gt; 6 mm) of the supraspinatus tendon surgically treated by implantation of the bioinductive implant.</description>
          </group>
          <group group_id="O3">
            <title>Medium Full Thickness Tear</title>
            <description>Medium full thickness tear (1-3 cm) of the supraspinatus tendon surgically treated by implantation of the bioinductive implant.</description>
          </group>
          <group group_id="O4">
            <title>Large Full Thickness Tear</title>
            <description>Large full thickness tear (3-5 cm) of the supraspinatus tendon surgically treated by implantation of the bioinductive implant.</description>
          </group>
        </group_list>
        <measure>
          <title>Recovery: Return to Normal Daily Activities</title>
          <description>Return to normal daily activities (i.e. full, unrestricted activity) determined by the cumulative number of days between discharge and return to normal daily activity.</description>
          <population>Participants with partial-thickness tear or full thickness tear that provided data for the specified time frame.</population>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="21"/>
                <count group_id="O3" value="62"/>
                <count group_id="O4" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="102.40" spread="99.95"/>
                    <measurement group_id="O2" value="147.30" spread="125.30"/>
                    <measurement group_id="O3" value="130.50" spread="64.45"/>
                    <measurement group_id="O4" value="130.90" spread="84.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Participant Satisfaction</title>
        <description>Self-reported measure of the level of satisfaction with the surgical outcome of the index surgery on 5-point Likert scale where participants were asked to indicated the best response to being satisfied with the outcome of the study procedure from one of the following:&#xD;
Strongly Disagree&#xD;
Disagree&#xD;
Neither Agree or Disagree&#xD;
Agree&#xD;
Strongly Agree&#xD;
&quot;Strongly Disagree&quot; indicated the lowest level of satisfaction and &quot;Strongly Agree&quot; indicated the greatest level of satisfaction.</description>
        <time_frame>3 months, 1 year, and 2 years</time_frame>
        <population>Participants with partial-thickness tear or full thickness tear that provided data for the specified time frames.</population>
        <group_list>
          <group group_id="O1">
            <title>Intermediate Partial-Thickness Tear</title>
            <description>Intermediate partial-thickness tear (3-6 mm) of the supraspinatus tendon surgically treated by implantation of the bioinductive implant.</description>
          </group>
          <group group_id="O2">
            <title>High Partial-Thickness Tear</title>
            <description>High partial-thickness tear (&gt; 6 mm) of the supraspinatus tendon surgically treated by implantation of the bioinductive implant.</description>
          </group>
          <group group_id="O3">
            <title>Medium Full Thickness Tear</title>
            <description>Medium full thickness tear (1-3 cm) of the supraspinatus tendon surgically treated by implantation of the bioinductive implant.</description>
          </group>
          <group group_id="O4">
            <title>Large Full Thickness Tear</title>
            <description>Large full thickness tear (3-5 cm) of the supraspinatus tendon surgically treated by implantation of the bioinductive implant.</description>
          </group>
        </group_list>
        <measure>
          <title>Participant Satisfaction</title>
          <description>Self-reported measure of the level of satisfaction with the surgical outcome of the index surgery on 5-point Likert scale where participants were asked to indicated the best response to being satisfied with the outcome of the study procedure from one of the following:&#xD;
Strongly Disagree&#xD;
Disagree&#xD;
Neither Agree or Disagree&#xD;
Agree&#xD;
Strongly Agree&#xD;
&quot;Strongly Disagree&quot; indicated the lowest level of satisfaction and &quot;Strongly Agree&quot; indicated the greatest level of satisfaction.</description>
          <population>Participants with partial-thickness tear or full thickness tear that provided data for the specified time frames.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="20"/>
                <count group_id="O3" value="66"/>
                <count group_id="O4" value="49"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>3 Month</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="20"/>
                    <count group_id="O3" value="66"/>
                    <count group_id="O4" value="49"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Strongly Disagree</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Disagree</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Neither Agree or Disagree</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Agree</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="13"/>
                    <measurement group_id="O4" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Strongly Agree</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="10"/>
                    <measurement group_id="O3" value="49"/>
                    <measurement group_id="O4" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 Year</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="20"/>
                    <count group_id="O3" value="66"/>
                    <count group_id="O4" value="48"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Strongly Disagree</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Disagree</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Neither Agree or Disagree</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Agree</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="7"/>
                    <measurement group_id="O4" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Strongly Agree</title>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="16"/>
                    <measurement group_id="O3" value="57"/>
                    <measurement group_id="O4" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 Year</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="20"/>
                    <count group_id="O3" value="63"/>
                    <count group_id="O4" value="41"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Strongly Disagree</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Disagree</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Neither Agree or Disagree</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Agree</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Strongly Agree</title>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="16"/>
                    <measurement group_id="O3" value="59"/>
                    <measurement group_id="O4" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Time of enrollment (i.e. intra-operative confirmation of eligibility) through end of the study (2 year follow-up visit).</time_frame>
      <desc>Only non-serious Adverse Events (AEs) classified by the Investigator as either device-related or procedure-related were to be reported, all Serious Adverse Events (SAEs) regardless of relationship to the device, and all Unanticipated Serious Adverse Device Effects (USADEs) were to be reported per protocol. However, all Serious &amp; Other AEs regardless of device/procedure relationship have been reported as provided. AEs were collected by investigator assessment, MRIs, and patient self-reporting.</desc>
      <group_list>
        <group group_id="E1">
          <title>Partial-Thickness Tear</title>
          <description>Intermediate or High partial-thickness tear (PTT) or very small full-thickness tear (FTT) of the supraspinatus tendon surgically treated by implantation of the bioinductive implant.</description>
        </group>
        <group group_id="E2">
          <title>Full Thickness Tear</title>
          <description>Medium or large full thickness tear (FTT) of the supraspinatus tendon surgically treated with the bioinductive implant adjunctive to surgical repair.&#xD;
Surgical repair: Surgical repair with commercially-available sutures/suture anchors.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="115"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Cardiac Ablation</sub_title>
                <description>Unrelated to device and procedure</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="115"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Foot Pain</sub_title>
                <description>Unrelated to device and procedure</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="115"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Index shoulder new rotator cuff tear and lack of healing</sub_title>
                <description>Unrelated to device and procedure</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Contralateral shoulder distal clavical excision, RCT debridement of degenerative labrum &amp; bursectomy</sub_title>
                <description>Unrelated to device and procedure</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Index shoulder recurrent rotator cuff tear</sub_title>
                <description>Unrelated to device and procedure</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Index shoulder recurrent full thickness rotator cuff tear</sub_title>
                <description>Unrelated to device and procedure</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Contralateral Rotator Cuff Tear</sub_title>
                <description>Unrelated to device and procedure</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="115"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Product Issues</title>
            <event_list>
              <event>
                <sub_title>Index shoulder swelling and drainage</sub_title>
                <description>Possibly related to device and procedure</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Index shoulder pain, inflammatory changes, and osteopenia in the region of the greater tuberosity</sub_title>
                <description>Possibly related to device and procedure</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="115"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="115"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Midthoracic pain; slow heartbeat; R clavicle nondisplaced fracture w/fibrous union &amp; bone formation</sub_title>
                <description>Unrelated to device and procedure</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="115"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Leg trauma</sub_title>
                <description>Unrelated to device and procedure</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Index shoulder bicep tendonitis</sub_title>
                <description>Unrelated to device and possibly related to procedure</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Index shoulder rash</sub_title>
                <description>Unrelated to device and definitely related to procedure</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Index shoulder superficial stitch abscess with continued wound drainage</sub_title>
                <description>Unrelated to device and definitely related to procedure</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Index shoulder asymptomatic recurrent rotator cuff tear</sub_title>
                <description>Unrelated to device and possibly related to procedure</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Index shoulder pain</sub_title>
                <description>Unrelated to device and definitely related to procedure</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Index shoulder proximal long-head biceps rupture</sub_title>
                <description>Unrelated to device and possibly related to procedure</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Index shoulder recurrent rotator cuff tear</sub_title>
                <description>Unrelated to device and possibly related to procedure</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="115"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Index shoulder pain</sub_title>
                <description>Unrelated to device and procedure</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Index shoulder pain and stiffness</sub_title>
                <description>Unrelated to device and procedure</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Contralateral shoulder ache</sub_title>
                <description>Unrelated to device and procedure</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Contralateral shoulder pain</sub_title>
                <description>Unrelated to device and procedure</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="115"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Product Issues</title>
            <event_list>
              <event>
                <sub_title>Index shoulder subacromial fluid collection/inflammation</sub_title>
                <description>Possibly related to device and procedure</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Index shoulder pain and stiffness</sub_title>
                <description>Possibly related to device and procedure</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Index shoulder pain</sub_title>
                <description>Possibly related to device and definitely related to procedure</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="115"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>For multicenter studies the study data and results will be pooled and analyzed. If a multicenter publication is not submitted within 24 months after conclusion of study, site/investigator may publish individual results. Proposed publication must be submitted to sponsor no later than 90 prior to submission. Sponsor has right within 60 days to modify proposed publication if it will disclose patentable items.</restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Limitations of the study include minimal source data verification, limited safety event collection due to protocol definition, the independent Sponsor safety review occurred after data was locked and extracted from the database due to acquisition integration process.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Laura England, Sr. Director Global Clinical Strategy</name_or_title>
      <organization>Smith+Nephew, Inc.</organization>
      <phone>+1 650 223 6941</phone>
      <email>Laura.England@smith-nephew.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02200939
org study id: 2014.05.12
nct id: NCT02200939
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 evaluate bioinduction of new tissue and tendon healing after
      implantation of the Rotation Medical Bioinductive Implant used as either a standalone device
      or adjunct to surgical repair in the treatment of supraspinatus tendon tears.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in Tendon Thickness
time frame: Pre-operatively (baseline) to 3 month, 1 year, and 2 year
description: The total thickness of the tendon and any newly induced tissue at the implant site were measured at 3 months, 1 year, and 2 years using magnetic resonance imaging (MRI). Measurements were compared to pre-operative (baseline) supraspinatus tendon thickness to calculate the mean (± SD) change in post-operative supraspinatus tendon thickness by partial-thickness tear size (Intermediate or High) or full thickness tear size (Medium or Large).
measure: Integration of Induced Tissue With Underlying Tendon
time frame: 3 months, 1 year, and 2 years
description: Partial-thickness tears were classified as Intermediate (3-6 mm) or High (> 6 mm) grade tears. Full thickness tears were categorized using Cofield classification as Medium (1-3 cm) or Large (3-5 cm). Integration and maturation of the newly induced tissue was assessed by MRI at each post-operative follow-up and determined by answering Yes, No, or Unable to determine to the following questions:
Is there a visible boundary between the collagen scaffold/new tissue and the supraspinatus tendon?
Is there visible evidence of a good margin between the collagen scaffold/new tissue and the deltoid?
Was there evidence of bursitis in the shoulder?
Does the new tissue resemble normal tendon tissue?
Does the underlying tendon resemble normal tendon tissue?
Is there any new defect (i.e., loss in supraspinatus tendon continuity; re-tear)?
measure: Fill-In of Partial Thickness Tears and Underlying Tendon Quality
time frame: 3 months, 1 year, and 2 years
description: For tendon defects treated by standalone use of the device (i.e., implantation without surgical repair using sutures/suture anchors), post-operative follow-up MRIs will be used to estimate the amount of defect fill-in with newly induced tissue and the quality of the filled-in tissue. In the absence of fill-in with newly induced tissue, defect progression (i.e., change in size relative to previous MRIs) will be assessed. The amount of fill-in relative to the pre-operative, baseline MRI classified as:
0 to <25%
25% to <50%
50% to < 75%
75% to < 100%
100%
measure: Number of Participants With a Re-Tear
time frame: 3 months, 1 year, and 2 years
description: Re-tear rate following rotator cuff repair assessed by MRI. Any new observable defect (i.e. loss in supraspinatus tendon continuity) will be classified as a re-tear.
measure: Procedure Parameters: Device Implant Time
time frame: Intraoperative
description: Mean (± SD) device implant time in minutes was assessed starting at time from introduction of the guide wire instrument into the subacromial space through completion of the last staple.
measure: Procedure Parameters: Procedure Technical Success
time frame: Intraoperative
description: Procedure technical success was measured by the count of participants where the device was successfully delivered and affixed to the target tendon location (i.e., implant of device was attempted and successful).
measure: American Shoulder and Elbow Society (ASES) Score
time frame: Baseline, 3 month, 1 year, and 2 years
description: The ASES consisted of subcomponent scores including pain, shoulder function, and shoulder scores as follows:
ASES Pain Score ranges from 0 to 10, with 0 being no pain and 10 being the worst pain (lower score better).
ASES Shoulder Function Score ranges from 0 to 30, with 0 being no function and 30 being full function (higher score better).
ASES Shoulder Score ranges from 10 to 100, with 0 being no function and 100 being normal function (higher score better).
Scores were collected at baseline and each successive follow-up visits (3 months, 1 year, and 2 years).
measure: Constant-Murley Shoulder (CMS) Score
time frame: Baseline, 3 months, 1 year, and 2 years
description: The overall CMS shoulder score ranges from 0 to 100, with 0 being severe restrictions and 100 being no restrictions (i.e., higher score is better). Scores were collected a baseline and each subsequent follow-up (3 months, 1 year, and 2 years).
measure: Recovery: Sling Time
time frame: Post-operatively to study completion, approximately 2 years
description: Cumulative number of days index shoulder was in a sling.
measure: Recovery: Rehabilitation Time
time frame: Post-operatively to study completion, approximately 2 years
description: Cumulative number of completed rehabilitation or physical therapy (PT) visits in days to treat index shoulder.
measure: Recovery: Return to Work
time frame: Post-operatively to study completion, approximately 2 years
description: Cumulative number of days between discharge and return to work (employed subjects only).
measure: Recovery: Return to Normal Daily Activities
time frame: Post-operatively to study completion, approximately 2 years
description: Return to normal daily activities (i.e. full, unrestricted activity) determined by the cumulative number of days between discharge and return to normal daily activity.
measure: Participant Satisfaction
time frame: 3 months, 1 year, and 2 years
description: Self-reported measure of the level of satisfaction with the surgical outcome of the index surgery on 5-point Likert scale where participants were asked to indicated the best response to being satisfied with the outcome of the study procedure from one of the following:
Strongly Disagree
Disagree
Neither Agree or Disagree
Agree
Strongly Agree
"Strongly Disagree" indicated the lowest level of satisfaction and "Strongly Agree" indicated the greatest level of satisfaction.
arm group label: Partial-Thickness Tear
arm group type: Experimental
description: Intermediate or High partial-thickness tear (PTT) or very small full-thickness tear of the supraspinatus tendon surgically treated by implantation of the bioinductive implant.
arm group label: Full Thickness Tear
arm group type: Experimental
description: Medium or large full thickness tear (FTT) of the supraspinatus tendon surgically treated with the bioinductive implant adjunctive to surgical repair.
intervention type: Device
intervention name: Bioinductive implant
arm group label: Full Thickness Tear
arm group label: Partial-Thickness Tear
other name: Rotation Medical Rotator Cuff System™
other name: REGENETEN™ Bioinductive Implant System.
intervention type: Device
intervention name: Surgical repair
description: Surgical repair with commercially-available sutures/suture anchors.
arm group label: Full Thickness Tear
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: Laura England
role: Study Chair
affiliation: Smith & Nephew, Inc.
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country: United States
responsible party type: Sponsor
provided document: 
participant flow: 
baseline: 
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reported events: 
certain agreements: 
limitations and caveats: Limitations of the study include minimal source data verification, limited safety event collection due to protocol definition, the independent Sponsor safety review occurred after data was locked and extracted from the database due to acquisition integration process.
point of contact: 