<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/NCT02237001</url>
  </required_header>
  <id_info>
    <org_study_id>CTX-CP001</org_study_id>
    <nct_id>NCT02237001</nct_id>
  </id_info>
  <brief_title>Study of Suture Repair of Torn Meniscus in the Knee</brief_title>
  <acronym>STITCH</acronym>
  <official_title>A Prospective, Non-randomized, Multi-Center Investigation of All-suture-based Repair of Horizontal Meniscal Tears (STITCH Study)</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Horizontal meniscus tears meeting specified criteria will be repaired by any commonly used&#xD;
      suture technique. Subjects will be followed for 2 years to evaluate the effectiveness of the&#xD;
      repair, by assessing the re-operation rate, and by assessing improvements in knee pain and&#xD;
      knee function.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Potential subjects will undergo Screening for eligibility based on Inclusion/Exclusion&#xD;
      criteria. Screening will include an x-ray of the injured knee and evaluation of an MRI of the&#xD;
      injured knee within 6 months prior to the scheduled procedure. During the procedure, the&#xD;
      meniscal tear will be evaluated by arthroscopy to determine if the tear meets study&#xD;
      requirements. If the meniscal tear is determined to meet inclusion/exclusion criteria, the&#xD;
      subject will be considered enrolled. If any inclusion/exclusion criteria is not met, the&#xD;
      subject will be considered a screen failure and will not be enrolled. For enrolled subjects,&#xD;
      specific information regarding the repair and repair technique will be collected during the&#xD;
      procedure, including still and video images.&#xD;
&#xD;
      Subjects will be contacted 7-15 days post-procedure for safety follow-up. Subjects will&#xD;
      return for follow-up visits at approximately post-procedure Days 90, 185, 365 and 730.&#xD;
      Identical questionnaires will be completed at each visit to assess knee pain and knee&#xD;
      function. Safety information will be collected at each post-procedure visit. Additionally, an&#xD;
      in-office arthroscopy of the treated knee will be performed at participating sites at Day&#xD;
      185, an MRI of the treated knee will be performed at Day 365 and an X-ray of the treated knee&#xD;
      will be performed at Day 730. The patient will exit the study at the Day 730 visit.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 19, 2014</start_date>
  <completion_date type="Actual">November 18, 2019</completion_date>
  <primary_completion_date type="Actual">November 18, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Freedom From Re-operation of the Index Meniscus Repair Site (Incidence of Subjects Requiring Re-operation)</measure>
    <time_frame>6 months, 1 year, and 2 years</time_frame>
    <description>Occurrence of any re-operation of study knee to treat previously repaired meniscal tear during the 2 years following the study procedure.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Knee Pain and Function by Completion of International Knee Documentation Committee Subjective Knee Evaluation Form (IKDC Knee Evaluation) at 3 Months, 6 Months, 1 Year, and 2 Years</measure>
    <time_frame>Baseline, 3 months, 6 months, 1 year, and 2 years</time_frame>
    <description>Change in knee pain and function will be measured by completion of The International Knee Documentation Committee (IKDC) Subjective score. The IKDC Score was developed to detect improvement or deterioration in symptoms, function, and sports activities due to knee impairment, including patients with meniscal injuries.&#xD;
There are three domains: 1) symptoms, including pain, stiffness, swelling, locking/catching, and giving way (7 items), 2) sports and daily activities (10 items), and 3) current knee function and knee function prior to knee injury (1 item, not included in the score). Responses vary for each item. The possible score ranges from 0-100, where 100 = no limitation with daily or sporting activities and the absence of symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Knee Pain and Function by the Knee Injury and Osteoarthritis Outcome Score (KOOS): Pain Score at 3 Months, 6 Months, 1 Year, and 2 Years</measure>
    <time_frame>Baseline, 3 months, 6 months, 1 year, 2 years</time_frame>
    <description>Change in knee pain and function will be measured by completion the Knee Injury and Osteoarthritis Outcome Score (KOOS). There are five patient-relevant subscales of the KOOS, and each are scored separately: Pain (9 items), ADL function (17 items), Sport and Recreation Function (5 items), Symptoms (7 items), and Quality of Life (4 items).&#xD;
A Likert scale is used and all items have five possible answer options scored from 0 (no problems) to 4 (extreme problems). Each of the 5 scores is calculated as the sum of the items included and then each score is transformed to a 0-100 scale, with 0 representing extreme knee problems and 100 representing no knee problems as common in orthopedic assessment scales and generic measures. An aggregate score is not calculated so that each of the 5 dimensions can be assess separately.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Daily Living (ADL) Score at 3 Months, 6 Months, 1 Year, and 2 Years</measure>
    <time_frame>Baseline, 3 months, 6 months, 1 year, 2 years</time_frame>
    <description>Change in knee pain and function will be measured by completion the Knee Injury and Osteoarthritis Outcome Score (KOOS). There are five patient-relevant subscales of the KOOS, and each are scored separately: Pain (9 items), ADL function (17 items), Sport and Recreation Function (5 items), Symptoms (7 items), and Quality of Life (4 items).&#xD;
A Likert scale is used and all items have five possible answer options scored from 0 (no problems) to 4 (extreme problems). Each of the 5 scores is calculated as the sum of the items included and then each score is transformed to a 0-100 scale, with 0 representing extreme knee problems and 100 representing no knee problems as common in orthopedic assessment scales and generic measures. An aggregate score is not calculated so that each of the 5 dimensions can be assess separately.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Knee Pain and Function by the Knee Injury and Osteoarthritis Outcome Score (KOOS): Sport and Recreation Function (Sport) Score at 3 Months, 6 Months, 1 Year, and 2 Years</measure>
    <time_frame>Baseline, 3 months, 6 months, 1 year, 2 years</time_frame>
    <description>Change in knee pain and function will be measured by completion the Knee Injury and Osteoarthritis Outcome Score (KOOS). There are five patient-relevant subscales of the KOOS, and each are scored separately: Pain (9 items), ADL function (17 items), Sport and Recreation Function (5 items), Symptoms (7 items), and Quality of Life (4 items).&#xD;
A Likert scale is used and all items have five possible answer options scored from 0 (no problems) to 4 (extreme problems). Each of the 5 scores is calculated as the sum of the items included and then each score is transformed to a 0-100 scale, with 0 representing extreme knee problems and 100 representing no knee problems as common in orthopedic assessment scales and generic measures. An aggregate score is not calculated so that each of the 5 dimensions can be assess separately.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Knee Pain and Function by the Knee Injury and Osteoarthritis Outcome Score (KOOS): Symptom Score at 3 Months, 6 Months, 1 Year, and 2 Years</measure>
    <time_frame>Baseline, 3 months, 6 months, 1 year, 2 years</time_frame>
    <description>Change in knee pain and function will be measured by completion the Knee Injury and Osteoarthritis Outcome Score (KOOS). There are five patient-relevant subscales of the KOOS, and each are scored separately: Pain (9 items), ADL function (17 items), Sport and Recreation Function (5 items), Symptoms (7 items), and Quality of Life (4 items).&#xD;
A Likert scale is used and all items have five possible answer options scored from 0 (no problems) to 4 (extreme problems). Each of the 5 scores is calculated as the sum of the items included and then each score is transformed to a 0-100 scale, with 0 representing extreme knee problems and 100 representing no knee problems as common in orthopedic assessment scales and generic measures. An aggregate score is not calculated so that each of the 5 dimensions can be assess separately.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Knee Pain and Function by the Knee Injury and Osteoarthritis Outcome Score (KOOS): Quality of Life (QOL) Score at 3 Months, 6 Months, 1 Year, and 2 Years</measure>
    <time_frame>Baseline, 3 months, 6 months, 1 year, 2 years</time_frame>
    <description>Change in knee pain and function will be measured by completion the Knee Injury and Osteoarthritis Outcome Score (KOOS). There are five patient-relevant subscales of the KOOS, and each are scored separately: Pain (9 items), ADL function (17 items), Sport and Recreation Function (5 items), Symptoms (7 items), and Quality of Life (4 items).&#xD;
A Likert scale is used and all items have five possible answer options scored from 0 (no problems) to 4 (extreme problems). Each of the 5 scores is calculated as the sum of the items included and then each score is transformed to a 0-100 scale, with 0 representing extreme knee problems and 100 representing no knee problems as common in orthopedic assessment scales and generic measures. An aggregate score is not calculated so that each of the 5 dimensions can be assess separately.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Knee Pain and Function by Lysholm Knee Questionnaire at 3 Months, 6 Months, 1 Year, and 2 Years</measure>
    <time_frame>Baseline, 3 months, 6 months, 1 year, and 2 years</time_frame>
    <description>Change in knee pain and function will be measured by completion of the Lysholm Knee Questionnaire. This tool measures the domains of symptoms and complaints and functioning of daily activities. The scale consists of 8 item and is scaled from 0 to 100, with a higher score indicating fewer symptoms and higher level of functioning.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Knee Pain and Function by Tegner Activity Scale at 3 Months, 6 Months, 1 Year, and 2 Years</measure>
    <time_frame>Baseline, 3 months, 6 months, 1 year, and 2 years</time_frame>
    <description>Change in knee pain and function will be measured by completion of the Tegner activity scale. The Tegner activity scale was designed as a score of activity level to complement other functional scores for patients with ligamentous injuries. The Tegner activity scale is a numerical scale ranging from 0 to 10. Each value indicates the ability to perform specific activities. An activity level of 10 corresponds to participation in competitive sports, including soccer, football, and rugby at the elite level; an activity level of 6 points corresponds to participation in recreational sports; and an activity level of 0 is assigned if a person is on sick leave or receiving a disability pension because of knee problems. An activity level of 5 to 10 is recorded only if the patient participates in recreational or competitive sports.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Meniscal Tear</condition>
  <condition>Meniscus Tear</condition>
  <arm_group>
    <arm_group_label>Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Suture-based meniscal repair</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Suture-based meniscal repair</intervention_name>
    <description>Suture-based meniscal repair</description>
    <arm_group_label>Treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Screening Inclusion Criteria:&#xD;
&#xD;
        Subjects of either gender may be eligible for inclusion in the study only if they meet all&#xD;
        of the following criteria:&#xD;
&#xD;
          -  Able and willing to give informed consent by voluntarily providing written informed&#xD;
             consent in accordance with governing Institutional Review Board&#xD;
&#xD;
          -  18 to 60 years of age, inclusive at the time of screening;&#xD;
&#xD;
          -  History indicative of meniscal pathology (e.g., pain, mechanical symptoms described as&#xD;
             locking, clicking or giving way);&#xD;
&#xD;
          -  Physical exam consistent with meniscus tear (e.g., locked joint, joint line tenderness&#xD;
             and/or pain on meniscal compression);&#xD;
&#xD;
          -  If prior ligament reconstruction, the study knee is clinically stable;&#xD;
&#xD;
          -  Preoperative MRI evidence within 6 months consistent with a horizontal/radial/oblique&#xD;
             meniscus tear in the symptomatic compartment&#xD;
&#xD;
        Arthroscopy Inclusion Criteria:&#xD;
&#xD;
        Consented subjects may be included in the study only if, upon arthroscopic inspection,&#xD;
        their meniscal study lesion meets all of the following criteria established by the&#xD;
        International Society of Arthroscopy, Knee Surgery and Orthopaedic Sports Medicine (ISAKOS)&#xD;
        (see Appendix 1):&#xD;
&#xD;
          -  Zone location: circumferential location of tear includes locations within 10mm of the&#xD;
             peripheral rim of the meniscus;&#xD;
&#xD;
          -  Radial location: any location from anterior to posterior;&#xD;
&#xD;
          -  Tear pattern: primarily horizontal or oblique in orientation (not to exceed 45 degrees&#xD;
             from horizontal);&#xD;
&#xD;
          -  Compartment: either lateral or medial, but not both;&#xD;
&#xD;
          -  Opposite compartment meniscal tear (if present) limited to the central portion (i.e.,&#xD;
             Zone 3/&quot;white zone&quot;);&#xD;
&#xD;
          -  Tear amenable to repair with all suture-based techniques.&#xD;
&#xD;
        Screening Exclusion Criteria:&#xD;
&#xD;
        Subjects will be excluded from the study for any of the following reasons:&#xD;
&#xD;
          -  Arthritis in the study knee (Kellgren-Lawrence Grade 3 or higher [See Appendix 4]);&#xD;
&#xD;
          -  Body Mass Index (BMI) ≥35 kg/m2;&#xD;
&#xD;
          -  Previous meniscal repair or meniscectomy of the study meniscus;&#xD;
&#xD;
          -  Unstable knee;&#xD;
&#xD;
          -  Malalignment (&gt; 5 degrees) of the study knee, based on X-ray within 6 months requiring&#xD;
             osteotomy and/or requiring correction;&#xD;
&#xD;
          -  History of constitutional/systemic inflammatory/arthritic problem or pain condition,&#xD;
             history of knee infection, vascular condition of legs, benign neoplasms of knee,&#xD;
             hepatitis, HIV, drug/alcohol abuse, tobacco use, cancer;&#xD;
&#xD;
          -  Expected to undergo any other primary treatment of the knee;&#xD;
&#xD;
          -  Any concomitant painful or disabling disease, condition or post-procedure status of&#xD;
             either lower extremity that would interfere with evaluation or rehabilitation of the&#xD;
             study knee.&#xD;
&#xD;
          -  Pregnant or planning to become pregnant in the next 2 years.&#xD;
&#xD;
        Arthroscopy Exclusion Criteria:&#xD;
&#xD;
        Subjects will be excluded from the study if their study meniscus lesion meets any of the&#xD;
        following criteria at arthroscopy:&#xD;
&#xD;
          -  Tear pattern: primarily vertical longitudinal in orientation;&#xD;
&#xD;
          -  Partial meniscectomy of any portion of the study meniscus extends beyond the central&#xD;
             portion (i.e., Zone 3/&quot;white zone&quot;);&#xD;
&#xD;
          -  Intact or partially intact meniscus tear that, in the opinion of the Investigator,&#xD;
             does not require repair;&#xD;
&#xD;
          -  Poor meniscal tissue quality such that it will not hold a suture;&#xD;
&#xD;
          -  Any portion of the meniscus repair that, in the opinion of the Investigator, is best&#xD;
             treated using an implant other than suture;&#xD;
&#xD;
          -  Bicompartmental Zone 1/&quot;red zone&quot; and/or Zone 2/&quot;red-white zone&quot; meniscal tears;&#xD;
&#xD;
          -  Performance of a significant concomitant procedure intended as a therapeutic&#xD;
             intervention on the study knee;&#xD;
&#xD;
          -  Arthritis in the surgical knee (International Cartilage Research Society [ICRS] Grade&#xD;
             3b or higher or Modified Outerbridge Grade III or higher)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Peter R Kurzweil, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Memorial Orthopedic Surgical Group Long Beach</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Darvin Griffin</last_name>
    <role>Study Chair</role>
    <affiliation>Smith &amp; Nephew, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CORE Orthopaedic Medical Center</name>
      <address>
        <city>Encinitas</city>
        <state>California</state>
        <zip>92024</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Orthopedic Surgical Group Long Beach</name>
      <address>
        <city>Long Beach</city>
        <state>California</state>
        <zip>90806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Andrews Research and Education Foundation, INC</name>
      <address>
        <city>Gulf Breeze</city>
        <state>Florida</state>
        <zip>32561</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>OrthoIndy South</name>
      <address>
        <city>Greenwood</city>
        <state>Indiana</state>
        <zip>46143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Ohio State University</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43221</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Virginia</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22908</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Winchester Medical Center</name>
      <address>
        <city>Winchester</city>
        <state>Virginia</state>
        <zip>22601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Kurzweil PR, Lynch NM, Coleman S, Kearney B. Repair of horizontal meniscus tears: a systematic review. Arthroscopy. 2014 Nov;30(11):1513-9. doi: 10.1016/j.arthro.2014.05.038. Epub 2014 Aug 6.</citation>
    <PMID>25108905</PMID>
  </reference>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>September 6, 2014</study_first_submitted>
  <study_first_submitted_qc>September 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 11, 2014</study_first_posted>
  <results_first_submitted>August 20, 2020</results_first_submitted>
  <results_first_submitted_qc>October 2, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">October 27, 2020</results_first_posted>
  <last_update_submitted>November 19, 2020</last_update_submitted>
  <last_update_submitted_qc>November 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>meniscal</keyword>
  <keyword>meniscus</keyword>
  <keyword>repair</keyword>
  <keyword>knee</keyword>
  <keyword>arthroscopy knee</keyword>
  <keyword>horizontal</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lacerations</mesh_term>
    <mesh_term>Rupture</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>December 16, 2014</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/01/NCT02237001/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 5, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/01/NCT02237001/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Subjects enrolled at clinics from 19NOV2014 until 08NOV2017; last subject visit was 18NOV2019</recruitment_details>
      <pre_assignment_details>The planned sample size of 30 subjects was accrued for the Safety Population (SAF); however, a total of 4 subjects were excluded to comprise the Analysis Population (AS) due to late screen failure (eligibility criteria) or withdrawal by the subject.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Treatment</title>
          <description>Suture-based meniscal repair&#xD;
Suture-based meniscal repair: Suture-based meniscal repair</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>6 Month Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="27"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>12 Month Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>24 Month Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Eligibility criteria/Late Screen Failure</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Re-operation</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Incarceration</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Treatment</title>
          <description>Suture-based meniscal repair&#xD;
Suture-based meniscal repair: Suture-based meniscal repair</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="30"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="38.2" spread="11.08"/>
                  </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>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                  </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>
              <category_list>
                <category>
                  <title>Caucasian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Hispanic</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </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>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Height</title>
          <units>inches</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="69.25" spread="3.897"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight</title>
          <units>pounds (lb)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="176.68" spread="33.356"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25.68" spread="3.502"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index (BMI) Group</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;30</title>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=30</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Freedom From Re-operation of the Index Meniscus Repair Site (Incidence of Subjects Requiring Re-operation)</title>
        <description>Occurrence of any re-operation of study knee to treat previously repaired meniscal tear during the 2 years following the study procedure.</description>
        <time_frame>6 months, 1 year, and 2 years</time_frame>
        <population>Overall number of participants analyzed indicates total number of participants enrolled in the Safety Population (SAF) at 6 months that provided data. Number analyzed for each time frame indicates all data available starting at 6 months.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment</title>
            <description>Suture-based meniscal repair&#xD;
Suture-based meniscal repair: Suture-based meniscal repair</description>
          </group>
        </group_list>
        <measure>
          <title>Freedom From Re-operation of the Index Meniscus Repair Site (Incidence of Subjects Requiring Re-operation)</title>
          <description>Occurrence of any re-operation of study knee to treat previously repaired meniscal tear during the 2 years following the study procedure.</description>
          <population>Overall number of participants analyzed indicates total number of participants enrolled in the Safety Population (SAF) at 6 months that provided data. Number analyzed for each time frame indicates all data available starting at 6 months.</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="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Freedom from re-operation at 6 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Participants Free From Re-operation</title>
                  <measurement_list>
                    <measurement group_id="O1" value="26"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Participants Requiring Re-operation</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Freedom from re-operation at 1 year</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Participants Free From Re-operation</title>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Participants Requiring Re-operation</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Freedom from re-operation at 2 years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Participants Free From Re-operation</title>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Participants Requiring Re-operation</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Knee Pain and Function by Completion of International Knee Documentation Committee Subjective Knee Evaluation Form (IKDC Knee Evaluation) at 3 Months, 6 Months, 1 Year, and 2 Years</title>
        <description>Change in knee pain and function will be measured by completion of The International Knee Documentation Committee (IKDC) Subjective score. The IKDC Score was developed to detect improvement or deterioration in symptoms, function, and sports activities due to knee impairment, including patients with meniscal injuries.&#xD;
There are three domains: 1) symptoms, including pain, stiffness, swelling, locking/catching, and giving way (7 items), 2) sports and daily activities (10 items), and 3) current knee function and knee function prior to knee injury (1 item, not included in the score). Responses vary for each item. The possible score ranges from 0-100, where 100 = no limitation with daily or sporting activities and the absence of symptoms.</description>
        <time_frame>Baseline, 3 months, 6 months, 1 year, and 2 years</time_frame>
        <population>30 participants in Safety Population (SAF) and 26 participants in Analysis Population (AS). Planned sample size of 30 participants was accrued for SAF; however, a total of 4 participants were excluded to comprise AS due to late screen failure or withdrawal by participant. Each row represents all enrolled participants at the referenced time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment</title>
            <description>Suture-based meniscal repair&#xD;
Suture-based meniscal repair: Suture-based meniscal repair</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Knee Pain and Function by Completion of International Knee Documentation Committee Subjective Knee Evaluation Form (IKDC Knee Evaluation) at 3 Months, 6 Months, 1 Year, and 2 Years</title>
          <description>Change in knee pain and function will be measured by completion of The International Knee Documentation Committee (IKDC) Subjective score. The IKDC Score was developed to detect improvement or deterioration in symptoms, function, and sports activities due to knee impairment, including patients with meniscal injuries.&#xD;
There are three domains: 1) symptoms, including pain, stiffness, swelling, locking/catching, and giving way (7 items), 2) sports and daily activities (10 items), and 3) current knee function and knee function prior to knee injury (1 item, not included in the score). Responses vary for each item. The possible score ranges from 0-100, where 100 = no limitation with daily or sporting activities and the absence of symptoms.</description>
          <population>30 participants in Safety Population (SAF) and 26 participants in Analysis Population (AS). Planned sample size of 30 participants was accrued for SAF; however, a total of 4 participants were excluded to comprise AS due to late screen failure or withdrawal by participant. Each row represents all enrolled participants at the referenced time point.</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="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>IKDC Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.7" spread="16.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IKDC Change from Baseline at 3 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.9" spread="24.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IKDC Change from Baseline at 6 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.3" spread="25.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IKDC Change from Baseline at 1 year</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.8" spread="21.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IKDC Change from Baseline at 2 years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41.8" spread="21.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Knee Pain and Function by the Knee Injury and Osteoarthritis Outcome Score (KOOS): Pain Score at 3 Months, 6 Months, 1 Year, and 2 Years</title>
        <description>Change in knee pain and function will be measured by completion the Knee Injury and Osteoarthritis Outcome Score (KOOS). There are five patient-relevant subscales of the KOOS, and each are scored separately: Pain (9 items), ADL function (17 items), Sport and Recreation Function (5 items), Symptoms (7 items), and Quality of Life (4 items).&#xD;
A Likert scale is used and all items have five possible answer options scored from 0 (no problems) to 4 (extreme problems). Each of the 5 scores is calculated as the sum of the items included and then each score is transformed to a 0-100 scale, with 0 representing extreme knee problems and 100 representing no knee problems as common in orthopedic assessment scales and generic measures. An aggregate score is not calculated so that each of the 5 dimensions can be assess separately.</description>
        <time_frame>Baseline, 3 months, 6 months, 1 year, 2 years</time_frame>
        <population>30 participants in Safety Population (SAF) and 26 participants in Analysis Population (AS). Planned sample size of 30 participants was accrued for SAF; however, a total of 4 participants were excluded to comprise AS due to late screen failure or withdrawal by participant. Each row represents all enrolled participants at the referenced time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment</title>
            <description>Suture-based meniscal repair&#xD;
Suture-based meniscal repair: Suture-based meniscal repair</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Knee Pain and Function by the Knee Injury and Osteoarthritis Outcome Score (KOOS): Pain Score at 3 Months, 6 Months, 1 Year, and 2 Years</title>
          <description>Change in knee pain and function will be measured by completion the Knee Injury and Osteoarthritis Outcome Score (KOOS). There are five patient-relevant subscales of the KOOS, and each are scored separately: Pain (9 items), ADL function (17 items), Sport and Recreation Function (5 items), Symptoms (7 items), and Quality of Life (4 items).&#xD;
A Likert scale is used and all items have five possible answer options scored from 0 (no problems) to 4 (extreme problems). Each of the 5 scores is calculated as the sum of the items included and then each score is transformed to a 0-100 scale, with 0 representing extreme knee problems and 100 representing no knee problems as common in orthopedic assessment scales and generic measures. An aggregate score is not calculated so that each of the 5 dimensions can be assess separately.</description>
          <population>30 participants in Safety Population (SAF) and 26 participants in Analysis Population (AS). Planned sample size of 30 participants was accrued for SAF; however, a total of 4 participants were excluded to comprise AS due to late screen failure or withdrawal by participant. Each row represents all enrolled participants at the referenced time point.</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="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pain Score Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52.2" spread="19.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain Score Change from Baseline at 3 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.9" spread="26.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain Score Change from Baseline at 6 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.8" spread="23.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain Score Change from Baseline at 1 year</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.9" spread="20.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain Score Change from Baseline at 2 years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.4" spread="22.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Daily Living (ADL) Score at 3 Months, 6 Months, 1 Year, and 2 Years</title>
        <description>Change in knee pain and function will be measured by completion the Knee Injury and Osteoarthritis Outcome Score (KOOS). There are five patient-relevant subscales of the KOOS, and each are scored separately: Pain (9 items), ADL function (17 items), Sport and Recreation Function (5 items), Symptoms (7 items), and Quality of Life (4 items).&#xD;
A Likert scale is used and all items have five possible answer options scored from 0 (no problems) to 4 (extreme problems). Each of the 5 scores is calculated as the sum of the items included and then each score is transformed to a 0-100 scale, with 0 representing extreme knee problems and 100 representing no knee problems as common in orthopedic assessment scales and generic measures. An aggregate score is not calculated so that each of the 5 dimensions can be assess separately.</description>
        <time_frame>Baseline, 3 months, 6 months, 1 year, 2 years</time_frame>
        <population>30 participants in Safety Population (SAF) and 26 participants in Analysis Population (AS). Planned sample size of 30 participants was accrued for SAF; however, a total of 4 participants were excluded to comprise AS due to late screen failure or withdrawal by participant. Each row represents all enrolled participants at the referenced time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment</title>
            <description>Suture-based meniscal repair&#xD;
Suture-based meniscal repair: Suture-based meniscal repair</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Daily Living (ADL) Score at 3 Months, 6 Months, 1 Year, and 2 Years</title>
          <description>Change in knee pain and function will be measured by completion the Knee Injury and Osteoarthritis Outcome Score (KOOS). There are five patient-relevant subscales of the KOOS, and each are scored separately: Pain (9 items), ADL function (17 items), Sport and Recreation Function (5 items), Symptoms (7 items), and Quality of Life (4 items).&#xD;
A Likert scale is used and all items have five possible answer options scored from 0 (no problems) to 4 (extreme problems). Each of the 5 scores is calculated as the sum of the items included and then each score is transformed to a 0-100 scale, with 0 representing extreme knee problems and 100 representing no knee problems as common in orthopedic assessment scales and generic measures. An aggregate score is not calculated so that each of the 5 dimensions can be assess separately.</description>
          <population>30 participants in Safety Population (SAF) and 26 participants in Analysis Population (AS). Planned sample size of 30 participants was accrued for SAF; however, a total of 4 participants were excluded to comprise AS due to late screen failure or withdrawal by participant. Each row represents all enrolled participants at the referenced time point.</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="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>ADL Score Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="58.4" spread="21.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ADL Score Change from Baseline at 3 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.4" spread="24.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ADL Score Change from Baseline at 6 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.1" spread="20.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ADL Score Change from Baseline at 1 year</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.7" spread="18.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ADL Score Change from Baseline at 2 years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.9" spread="20.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Knee Pain and Function by the Knee Injury and Osteoarthritis Outcome Score (KOOS): Sport and Recreation Function (Sport) Score at 3 Months, 6 Months, 1 Year, and 2 Years</title>
        <description>Change in knee pain and function will be measured by completion the Knee Injury and Osteoarthritis Outcome Score (KOOS). There are five patient-relevant subscales of the KOOS, and each are scored separately: Pain (9 items), ADL function (17 items), Sport and Recreation Function (5 items), Symptoms (7 items), and Quality of Life (4 items).&#xD;
A Likert scale is used and all items have five possible answer options scored from 0 (no problems) to 4 (extreme problems). Each of the 5 scores is calculated as the sum of the items included and then each score is transformed to a 0-100 scale, with 0 representing extreme knee problems and 100 representing no knee problems as common in orthopedic assessment scales and generic measures. An aggregate score is not calculated so that each of the 5 dimensions can be assess separately.</description>
        <time_frame>Baseline, 3 months, 6 months, 1 year, 2 years</time_frame>
        <population>30 participants in Safety Population (SAF) and 26 participants in Analysis Population (AS). Planned sample size of 30 participants was accrued for SAF; however, a total of 4 participants were excluded to comprise AS due to late screen failure or withdrawal by participant. Each row represents all enrolled participants at the referenced time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment</title>
            <description>Suture-based meniscal repair&#xD;
Suture-based meniscal repair: Suture-based meniscal repair</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Knee Pain and Function by the Knee Injury and Osteoarthritis Outcome Score (KOOS): Sport and Recreation Function (Sport) Score at 3 Months, 6 Months, 1 Year, and 2 Years</title>
          <description>Change in knee pain and function will be measured by completion the Knee Injury and Osteoarthritis Outcome Score (KOOS). There are five patient-relevant subscales of the KOOS, and each are scored separately: Pain (9 items), ADL function (17 items), Sport and Recreation Function (5 items), Symptoms (7 items), and Quality of Life (4 items).&#xD;
A Likert scale is used and all items have five possible answer options scored from 0 (no problems) to 4 (extreme problems). Each of the 5 scores is calculated as the sum of the items included and then each score is transformed to a 0-100 scale, with 0 representing extreme knee problems and 100 representing no knee problems as common in orthopedic assessment scales and generic measures. An aggregate score is not calculated so that each of the 5 dimensions can be assess separately.</description>
          <population>30 participants in Safety Population (SAF) and 26 participants in Analysis Population (AS). Planned sample size of 30 participants was accrued for SAF; however, a total of 4 participants were excluded to comprise AS due to late screen failure or withdrawal by participant. Each row represents all enrolled participants at the referenced time point.</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="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Sport Score Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.6" spread="21.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sport Score Change from Baseline at 3 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.9" spread="34.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sport Score Change from Baseline at 6 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.0" spread="36.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sport Score Change from Baseline at 1 year</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46.8" spread="31.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sport Score Change from Baseline at 2 years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48.7" spread="31.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Knee Pain and Function by the Knee Injury and Osteoarthritis Outcome Score (KOOS): Symptom Score at 3 Months, 6 Months, 1 Year, and 2 Years</title>
        <description>Change in knee pain and function will be measured by completion the Knee Injury and Osteoarthritis Outcome Score (KOOS). There are five patient-relevant subscales of the KOOS, and each are scored separately: Pain (9 items), ADL function (17 items), Sport and Recreation Function (5 items), Symptoms (7 items), and Quality of Life (4 items).&#xD;
A Likert scale is used and all items have five possible answer options scored from 0 (no problems) to 4 (extreme problems). Each of the 5 scores is calculated as the sum of the items included and then each score is transformed to a 0-100 scale, with 0 representing extreme knee problems and 100 representing no knee problems as common in orthopedic assessment scales and generic measures. An aggregate score is not calculated so that each of the 5 dimensions can be assess separately.</description>
        <time_frame>Baseline, 3 months, 6 months, 1 year, 2 years</time_frame>
        <population>30 participants in Safety Population (SAF) and 26 participants in Analysis Population (AS). Planned sample size of 30 participants was accrued for SAF; however, a total of 4 participants were excluded to comprise AS due to late screen failure or withdrawal by participant. Each row represents all enrolled participants at the referenced time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment</title>
            <description>Suture-based meniscal repair&#xD;
Suture-based meniscal repair: Suture-based meniscal repair</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Knee Pain and Function by the Knee Injury and Osteoarthritis Outcome Score (KOOS): Symptom Score at 3 Months, 6 Months, 1 Year, and 2 Years</title>
          <description>Change in knee pain and function will be measured by completion the Knee Injury and Osteoarthritis Outcome Score (KOOS). There are five patient-relevant subscales of the KOOS, and each are scored separately: Pain (9 items), ADL function (17 items), Sport and Recreation Function (5 items), Symptoms (7 items), and Quality of Life (4 items).&#xD;
A Likert scale is used and all items have five possible answer options scored from 0 (no problems) to 4 (extreme problems). Each of the 5 scores is calculated as the sum of the items included and then each score is transformed to a 0-100 scale, with 0 representing extreme knee problems and 100 representing no knee problems as common in orthopedic assessment scales and generic measures. An aggregate score is not calculated so that each of the 5 dimensions can be assess separately.</description>
          <population>30 participants in Safety Population (SAF) and 26 participants in Analysis Population (AS). Planned sample size of 30 participants was accrued for SAF; however, a total of 4 participants were excluded to comprise AS due to late screen failure or withdrawal by participant. Each row represents all enrolled participants at the referenced time point.</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="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Symptom Score Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="56.3" spread="19.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Symptom Score Change from Baseline at 3 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.6" spread="30.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Symptom Score Change from Baseline at 6 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.0" spread="23.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Symptom Score Change from Baseline at 1 year</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.4" spread="20.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Symptom Score Change from Baseline at 2 years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.4" spread="23.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Knee Pain and Function by the Knee Injury and Osteoarthritis Outcome Score (KOOS): Quality of Life (QOL) Score at 3 Months, 6 Months, 1 Year, and 2 Years</title>
        <description>Change in knee pain and function will be measured by completion the Knee Injury and Osteoarthritis Outcome Score (KOOS). There are five patient-relevant subscales of the KOOS, and each are scored separately: Pain (9 items), ADL function (17 items), Sport and Recreation Function (5 items), Symptoms (7 items), and Quality of Life (4 items).&#xD;
A Likert scale is used and all items have five possible answer options scored from 0 (no problems) to 4 (extreme problems). Each of the 5 scores is calculated as the sum of the items included and then each score is transformed to a 0-100 scale, with 0 representing extreme knee problems and 100 representing no knee problems as common in orthopedic assessment scales and generic measures. An aggregate score is not calculated so that each of the 5 dimensions can be assess separately.</description>
        <time_frame>Baseline, 3 months, 6 months, 1 year, 2 years</time_frame>
        <population>30 participants in Safety Population (SAF) and 26 participants in Analysis Population (AS). Planned sample size of 30 participants was accrued for SAF; however, a total of 4 participants were excluded to comprise AS due to late screen failure or withdrawal by participant. Each row represents all enrolled participants at the referenced time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment</title>
            <description>Suture-based meniscal repair&#xD;
Suture-based meniscal repair: Suture-based meniscal repair</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Knee Pain and Function by the Knee Injury and Osteoarthritis Outcome Score (KOOS): Quality of Life (QOL) Score at 3 Months, 6 Months, 1 Year, and 2 Years</title>
          <description>Change in knee pain and function will be measured by completion the Knee Injury and Osteoarthritis Outcome Score (KOOS). There are five patient-relevant subscales of the KOOS, and each are scored separately: Pain (9 items), ADL function (17 items), Sport and Recreation Function (5 items), Symptoms (7 items), and Quality of Life (4 items).&#xD;
A Likert scale is used and all items have five possible answer options scored from 0 (no problems) to 4 (extreme problems). Each of the 5 scores is calculated as the sum of the items included and then each score is transformed to a 0-100 scale, with 0 representing extreme knee problems and 100 representing no knee problems as common in orthopedic assessment scales and generic measures. An aggregate score is not calculated so that each of the 5 dimensions can be assess separately.</description>
          <population>30 participants in Safety Population (SAF) and 26 participants in Analysis Population (AS). Planned sample size of 30 participants was accrued for SAF; however, a total of 4 participants were excluded to comprise AS due to late screen failure or withdrawal by participant. Each row represents all enrolled participants at the referenced time point.</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="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>QOL Score Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.1" spread="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QOL Score Change from Baseline at 3 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.6" spread="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QOL Score Change from Baseline at 6 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.8" spread="28.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QOL Score Change from Baseline at 1 year</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.0" spread="26.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QOL Score Change from Baseline at 2 years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43.8" spread="27.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Knee Pain and Function by Lysholm Knee Questionnaire at 3 Months, 6 Months, 1 Year, and 2 Years</title>
        <description>Change in knee pain and function will be measured by completion of the Lysholm Knee Questionnaire. This tool measures the domains of symptoms and complaints and functioning of daily activities. The scale consists of 8 item and is scaled from 0 to 100, with a higher score indicating fewer symptoms and higher level of functioning.</description>
        <time_frame>Baseline, 3 months, 6 months, 1 year, and 2 years</time_frame>
        <population>30 participants in Safety Population (SAF) and 26 participants in Analysis Population (AS). Planned sample size of 30 participants was accrued for SAF; however, a total of 4 participants were excluded to comprise AS due to late screen failure or withdrawal by participant. Each row represents all enrolled participants at the referenced time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment</title>
            <description>Suture-based meniscal repair&#xD;
Suture-based meniscal repair: Suture-based meniscal repair</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Knee Pain and Function by Lysholm Knee Questionnaire at 3 Months, 6 Months, 1 Year, and 2 Years</title>
          <description>Change in knee pain and function will be measured by completion of the Lysholm Knee Questionnaire. This tool measures the domains of symptoms and complaints and functioning of daily activities. The scale consists of 8 item and is scaled from 0 to 100, with a higher score indicating fewer symptoms and higher level of functioning.</description>
          <population>30 participants in Safety Population (SAF) and 26 participants in Analysis Population (AS). Planned sample size of 30 participants was accrued for SAF; however, a total of 4 participants were excluded to comprise AS due to late screen failure or withdrawal by participant. Each row represents all enrolled participants at the referenced time point.</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="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Lysholm Score Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.2" spread="17.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lysholm Score Change from Baseline at 3 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.3" spread="27.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lysholm Score Change from Baseline at 6 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.4" spread="23.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lysholm Score Change from Baseline at 1 year</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.9" spread="24.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lysholm Score Change from Baseline at 2 years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.5" spread="22.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Knee Pain and Function by Tegner Activity Scale at 3 Months, 6 Months, 1 Year, and 2 Years</title>
        <description>Change in knee pain and function will be measured by completion of the Tegner activity scale. The Tegner activity scale was designed as a score of activity level to complement other functional scores for patients with ligamentous injuries. The Tegner activity scale is a numerical scale ranging from 0 to 10. Each value indicates the ability to perform specific activities. An activity level of 10 corresponds to participation in competitive sports, including soccer, football, and rugby at the elite level; an activity level of 6 points corresponds to participation in recreational sports; and an activity level of 0 is assigned if a person is on sick leave or receiving a disability pension because of knee problems. An activity level of 5 to 10 is recorded only if the patient participates in recreational or competitive sports.</description>
        <time_frame>Baseline, 3 months, 6 months, 1 year, and 2 years</time_frame>
        <population>30 participants in Safety Population (SAF) and 26 participants in Analysis Population (AS). Planned sample size of 30 participants was accrued for SAF; however, a total of 4 participants were excluded to comprise AS due to late screen failure or withdrawal by participant. Each row represents all enrolled participants at the referenced time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment</title>
            <description>Suture-based meniscal repair&#xD;
Suture-based meniscal repair: Suture-based meniscal repair</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Knee Pain and Function by Tegner Activity Scale at 3 Months, 6 Months, 1 Year, and 2 Years</title>
          <description>Change in knee pain and function will be measured by completion of the Tegner activity scale. The Tegner activity scale was designed as a score of activity level to complement other functional scores for patients with ligamentous injuries. The Tegner activity scale is a numerical scale ranging from 0 to 10. Each value indicates the ability to perform specific activities. An activity level of 10 corresponds to participation in competitive sports, including soccer, football, and rugby at the elite level; an activity level of 6 points corresponds to participation in recreational sports; and an activity level of 0 is assigned if a person is on sick leave or receiving a disability pension because of knee problems. An activity level of 5 to 10 is recorded only if the patient participates in recreational or competitive sports.</description>
          <population>30 participants in Safety Population (SAF) and 26 participants in Analysis Population (AS). Planned sample size of 30 participants was accrued for SAF; however, a total of 4 participants were excluded to comprise AS due to late screen failure or withdrawal by participant. Each row represents all enrolled participants at the referenced time point.</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="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Tegner Score Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.3" spread="2.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Tegner Score Change from Baseline at 3 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2" spread="2.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Tegner Score Change from Baseline at 6 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.3" spread="3.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Tegner Score Change from Baseline at 1 year</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.8" spread="2.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Tegner Score Change from Baseline at 2 years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.7" spread="2.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Enrollment through end of study (2 years)</time_frame>
      <desc>Adverse events were collected &amp; reported as complications per the protocol. A complication was any untoward medical occurrence, unfavorable and unintended sign (including clinically significant abnormal laboratory finding), symptom, or condition experienced by the subject and temporally associated with the procedure whether or not considered related to the procedure. The Sponsor then reviewed all AEs and classified per ISO, using the higher level of classification, whether it be Site or Sponsor.</desc>
      <group_list>
        <group group_id="E1">
          <title>Treatment</title>
          <description>Suture-based meniscal repair&#xD;
Suture-based meniscal repair: Suture-based meniscal repair</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="30"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Knee pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Further non-repairable tear meniscus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Swelling in knee</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Knee repair did not heal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </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="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Knee pain</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Swelling of knee</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Neuropathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </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>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>No limitations reported.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Kirsten Wall</name_or_title>
      <organization>Smith+Nephew, Inc.</organization>
      <phone>720-338-9460</phone>
      <email>Kirsten.wall@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/NCT02237001
org study id: CTX-CP001
nct id: NCT02237001
lead sponsor: 
has dmc: No
Horizontal meniscus tears meeting specified criteria will be repaired by any commonly used
      suture technique. Subjects will be followed for 2 years to evaluate the effectiveness of the
      repair, by assessing the re-operation rate, and by assessing improvements in knee pain and
      knee function.
Potential subjects will undergo Screening for eligibility based on Inclusion/Exclusion
      criteria. Screening will include an x-ray of the injured knee and evaluation of an MRI of the
      injured knee within 6 months prior to the scheduled procedure. During the procedure, the
      meniscal tear will be evaluated by arthroscopy to determine if the tear meets study
      requirements. If the meniscal tear is determined to meet inclusion/exclusion criteria, the
      subject will be considered enrolled. If any inclusion/exclusion criteria is not met, the
      subject will be considered a screen failure and will not be enrolled. For enrolled subjects,
      specific information regarding the repair and repair technique will be collected during the
      procedure, including still and video images.

      Subjects will be contacted 7-15 days post-procedure for safety follow-up. Subjects will
      return for follow-up visits at approximately post-procedure Days 90, 185, 365 and 730.
      Identical questionnaires will be completed at each visit to assess knee pain and knee
      function. Safety information will be collected at each post-procedure visit. Additionally, an
      in-office arthroscopy of the treated knee will be performed at participating sites at Day
      185, an MRI of the treated knee will be performed at Day 365 and an X-ray of the treated knee
      will be performed at Day 730. The patient will exit the study at the Day 730 visit.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Freedom From Re-operation of the Index Meniscus Repair Site (Incidence of Subjects Requiring Re-operation)
time frame: 6 months, 1 year, and 2 years
description: Occurrence of any re-operation of study knee to treat previously repaired meniscal tear during the 2 years following the study procedure.
measure: Change in Knee Pain and Function by Completion of International Knee Documentation Committee Subjective Knee Evaluation Form (IKDC Knee Evaluation) at 3 Months, 6 Months, 1 Year, and 2 Years
time frame: Baseline, 3 months, 6 months, 1 year, and 2 years
description: Change in knee pain and function will be measured by completion of The International Knee Documentation Committee (IKDC) Subjective score. The IKDC Score was developed to detect improvement or deterioration in symptoms, function, and sports activities due to knee impairment, including patients with meniscal injuries.
There are three domains: 1) symptoms, including pain, stiffness, swelling, locking/catching, and giving way (7 items), 2) sports and daily activities (10 items), and 3) current knee function and knee function prior to knee injury (1 item, not included in the score). Responses vary for each item. The possible score ranges from 0-100, where 100 = no limitation with daily or sporting activities and the absence of symptoms.
measure: Change in Knee Pain and Function by the Knee Injury and Osteoarthritis Outcome Score (KOOS): Pain Score at 3 Months, 6 Months, 1 Year, and 2 Years
time frame: Baseline, 3 months, 6 months, 1 year, 2 years
description: Change in knee pain and function will be measured by completion the Knee Injury and Osteoarthritis Outcome Score (KOOS). There are five patient-relevant subscales of the KOOS, and each are scored separately: Pain (9 items), ADL function (17 items), Sport and Recreation Function (5 items), Symptoms (7 items), and Quality of Life (4 items).
A Likert scale is used and all items have five possible answer options scored from 0 (no problems) to 4 (extreme problems). Each of the 5 scores is calculated as the sum of the items included and then each score is transformed to a 0-100 scale, with 0 representing extreme knee problems and 100 representing no knee problems as common in orthopedic assessment scales and generic measures. An aggregate score is not calculated so that each of the 5 dimensions can be assess separately.
measure: Change in Daily Living (ADL) Score at 3 Months, 6 Months, 1 Year, and 2 Years
time frame: Baseline, 3 months, 6 months, 1 year, 2 years
description: Change in knee pain and function will be measured by completion the Knee Injury and Osteoarthritis Outcome Score (KOOS). There are five patient-relevant subscales of the KOOS, and each are scored separately: Pain (9 items), ADL function (17 items), Sport and Recreation Function (5 items), Symptoms (7 items), and Quality of Life (4 items).
A Likert scale is used and all items have five possible answer options scored from 0 (no problems) to 4 (extreme problems). Each of the 5 scores is calculated as the sum of the items included and then each score is transformed to a 0-100 scale, with 0 representing extreme knee problems and 100 representing no knee problems as common in orthopedic assessment scales and generic measures. An aggregate score is not calculated so that each of the 5 dimensions can be assess separately.
measure: Change in Knee Pain and Function by the Knee Injury and Osteoarthritis Outcome Score (KOOS): Sport and Recreation Function (Sport) Score at 3 Months, 6 Months, 1 Year, and 2 Years
time frame: Baseline, 3 months, 6 months, 1 year, 2 years
description: Change in knee pain and function will be measured by completion the Knee Injury and Osteoarthritis Outcome Score (KOOS). There are five patient-relevant subscales of the KOOS, and each are scored separately: Pain (9 items), ADL function (17 items), Sport and Recreation Function (5 items), Symptoms (7 items), and Quality of Life (4 items).
A Likert scale is used and all items have five possible answer options scored from 0 (no problems) to 4 (extreme problems). Each of the 5 scores is calculated as the sum of the items included and then each score is transformed to a 0-100 scale, with 0 representing extreme knee problems and 100 representing no knee problems as common in orthopedic assessment scales and generic measures. An aggregate score is not calculated so that each of the 5 dimensions can be assess separately.
measure: Change in Knee Pain and Function by the Knee Injury and Osteoarthritis Outcome Score (KOOS): Symptom Score at 3 Months, 6 Months, 1 Year, and 2 Years
time frame: Baseline, 3 months, 6 months, 1 year, 2 years
description: Change in knee pain and function will be measured by completion the Knee Injury and Osteoarthritis Outcome Score (KOOS). There are five patient-relevant subscales of the KOOS, and each are scored separately: Pain (9 items), ADL function (17 items), Sport and Recreation Function (5 items), Symptoms (7 items), and Quality of Life (4 items).
A Likert scale is used and all items have five possible answer options scored from 0 (no problems) to 4 (extreme problems). Each of the 5 scores is calculated as the sum of the items included and then each score is transformed to a 0-100 scale, with 0 representing extreme knee problems and 100 representing no knee problems as common in orthopedic assessment scales and generic measures. An aggregate score is not calculated so that each of the 5 dimensions can be assess separately.
measure: Change in Knee Pain and Function by the Knee Injury and Osteoarthritis Outcome Score (KOOS): Quality of Life (QOL) Score at 3 Months, 6 Months, 1 Year, and 2 Years
time frame: Baseline, 3 months, 6 months, 1 year, 2 years
description: Change in knee pain and function will be measured by completion the Knee Injury and Osteoarthritis Outcome Score (KOOS). There are five patient-relevant subscales of the KOOS, and each are scored separately: Pain (9 items), ADL function (17 items), Sport and Recreation Function (5 items), Symptoms (7 items), and Quality of Life (4 items).
A Likert scale is used and all items have five possible answer options scored from 0 (no problems) to 4 (extreme problems). Each of the 5 scores is calculated as the sum of the items included and then each score is transformed to a 0-100 scale, with 0 representing extreme knee problems and 100 representing no knee problems as common in orthopedic assessment scales and generic measures. An aggregate score is not calculated so that each of the 5 dimensions can be assess separately.
measure: Change in Knee Pain and Function by Lysholm Knee Questionnaire at 3 Months, 6 Months, 1 Year, and 2 Years
time frame: Baseline, 3 months, 6 months, 1 year, and 2 years
description: Change in knee pain and function will be measured by completion of the Lysholm Knee Questionnaire. This tool measures the domains of symptoms and complaints and functioning of daily activities. The scale consists of 8 item and is scaled from 0 to 100, with a higher score indicating fewer symptoms and higher level of functioning.
measure: Change in Knee Pain and Function by Tegner Activity Scale at 3 Months, 6 Months, 1 Year, and 2 Years
time frame: Baseline, 3 months, 6 months, 1 year, and 2 years
description: Change in knee pain and function will be measured by completion of the Tegner activity scale. The Tegner activity scale was designed as a score of activity level to complement other functional scores for patients with ligamentous injuries. The Tegner activity scale is a numerical scale ranging from 0 to 10. Each value indicates the ability to perform specific activities. An activity level of 10 corresponds to participation in competitive sports, including soccer, football, and rugby at the elite level; an activity level of 6 points corresponds to participation in recreational sports; and an activity level of 0 is assigned if a person is on sick leave or receiving a disability pension because of knee problems. An activity level of 5 to 10 is recorded only if the patient participates in recreational or competitive sports.
arm group label: Treatment
arm group type: Experimental
description: Suture-based meniscal repair
intervention type: Device
intervention name: Suture-based meniscal repair
description: Suture-based meniscal repair
arm group label: Treatment
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Peter R Kurzweil, MD
role: Principal Investigator
affiliation: Memorial Orthopedic Surgical Group Long Beach
last name: Darvin Griffin
role: Study Chair
affiliation: Smith & Nephew, Inc.
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
citation: Kurzweil PR, Lynch NM, Coleman S, Kearney B. Repair of horizontal meniscus tears: a systematic review. Arthroscopy. 2014 Nov;30(11):1513-9. doi: 10.1016/j.arthro.2014.05.038. Epub 2014 Aug 6.
PMID: 25108905
responsible party type: Sponsor
mesh term: Lacerations
mesh term: Rupture
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: No limitations reported.
point of contact: 