<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/NCT03037242</url>
  </required_header>
  <id_info>
    <org_study_id>16-005841</org_study_id>
    <nct_id>NCT03037242</nct_id>
  </id_info>
  <brief_title>Outcomes of Meniscus Root Repair Using a Transtibial Pullout Technique</brief_title>
  <official_title>Multi-Center Prospective Clinical and Radiographic Outcomes of Meniscus Root Repair Using a Transtibial Pullout Technique</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mayo Clinic</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The results of this study will optimize the care for patients with a meniscus root tear.&#xD;
      Surgeons will be able to determine if MRR (meniscus root repair) with transtibial pullout&#xD;
      technique is an effective treatment and will identify potential risk factors for poor&#xD;
      clinical outcomes. In addition, investigators will determine if MRR is successful in delaying&#xD;
      the radiographic progression of arthritis in the involved compartment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The loss of attachment at the root of the meniscus impairs the ability to maintain hoop&#xD;
      strain when the tibiofemoral joint is loaded. This loss of hoop strain is responsible for the&#xD;
      increased pressure on the articular cartilage.&#xD;
&#xD;
      This new awareness has prompted surgeons to consider surgical repair for treatment of&#xD;
      meniscal root avulsions. Despite this recent focus on results of surgical repair, prospective&#xD;
      studies are lacking, and the optimal surgical indications and technique have not been&#xD;
      optimized.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date type="Actual">May 1, 2017</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2023</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>Change in Tegner activity score</measure>
    <time_frame>baseline, 2 years</time_frame>
    <description>Tegner activity level scale is a graduated list of activities of daily living, recreation, and competitive sports. The patient is asked to select the level of participation that best describes their current level of activity and that before injury. The score varies from 0-10.&#xD;
A score of 0 represents sick leave or disability pension because of knee problems, whereas a score of 10 corresponds to participation in national and international elite competitive sports &gt;6 score can only be achieved if the person participates in recreational or competitive sport.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">55</enrollment>
  <condition>Meniscus Tear</condition>
  <arm_group>
    <arm_group_label>Transtibial pullout technique</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Evaluation of the clinical and radiographic outcomes for patients undergoing a meniscus root repair (MRR) using a transtibial pullout technique.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Transtibial pullout technique</intervention_name>
    <description>Evaluating radographs</description>
    <arm_group_label>Transtibial pullout technique</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Meniscus root avulsion tear (defined as meniscus posterior horn root avulsion or full&#xD;
             thickness tear within 9 mm of the root attachment)&#xD;
&#xD;
          2. Age 18-65&#xD;
&#xD;
          3. Ligament injury with concomitant reconstruction is acceptable&#xD;
&#xD;
          4. Malalignment with corrective osteotomy is acceptable&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subchondral collapse on pre-op MRI&#xD;
&#xD;
          2. Extrusion greater than 3 mm&#xD;
&#xD;
          3. Intra-op Outerbridge grade 3 or greater chondromalacia&#xD;
&#xD;
          4. Intra-op poor quality meniscus tissue&#xD;
&#xD;
          5. Mal-alignment greater than 5 degrees without corrective osteotomy&#xD;
&#xD;
          6. Obesity with BMI over 40&#xD;
&#xD;
          7. Kellgren Lawrence &gt; grade 2&#xD;
&#xD;
          8. Worker's compensation status&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Daniel Saris, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <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>Columbia Orthopaedic Group</name>
      <address>
        <city>Columbia</city>
        <state>Missouri</state>
        <zip>65201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.mayo.edu/research/clinical-trials</url>
    <description>Mayo Clinic Clinical Trials</description>
  </link>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>January 26, 2017</study_first_submitted>
  <study_first_submitted_qc>January 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 31, 2017</study_first_posted>
  <last_update_submitted>January 11, 2023</last_update_submitted>
  <last_update_submitted_qc>January 11, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Daniel B. F. Saris</investigator_full_name>
    <investigator_title>Professor of Orthopedics</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03037242
org study id: 16-005841
nct id: NCT03037242
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The results of this study will optimize the care for patients with a meniscus root tear.
      Surgeons will be able to determine if MRR (meniscus root repair) with transtibial pullout
      technique is an effective treatment and will identify potential risk factors for poor
      clinical outcomes. In addition, investigators will determine if MRR is successful in delaying
      the radiographic progression of arthritis in the involved compartment.
The loss of attachment at the root of the meniscus impairs the ability to maintain hoop
      strain when the tibiofemoral joint is loaded. This loss of hoop strain is responsible for the
      increased pressure on the articular cartilage.

      This new awareness has prompted surgeons to consider surgical repair for treatment of
      meniscal root avulsions. Despite this recent focus on results of surgical repair, prospective
      studies are lacking, and the optimal surgical indications and technique have not been
      optimized.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in Tegner activity score
time frame: baseline, 2 years
description: Tegner activity level scale is a graduated list of activities of daily living, recreation, and competitive sports. The patient is asked to select the level of participation that best describes their current level of activity and that before injury. The score varies from 0-10.
A score of 0 represents sick leave or disability pension because of knee problems, whereas a score of 10 corresponds to participation in national and international elite competitive sports >6 score can only be achieved if the person participates in recreational or competitive sport.
arm group label: Transtibial pullout technique
arm group type: Other
description: Evaluation of the clinical and radiographic outcomes for patients undergoing a meniscus root repair (MRR) using a transtibial pullout technique.
intervention type: Procedure
intervention name: Transtibial pullout technique
description: Evaluating radographs
arm group label: Transtibial pullout technique
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Daniel Saris, MD
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
facility: 
country: United States
url: https://www.mayo.edu/research/clinical-trials
description: Mayo Clinic Clinical Trials
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Daniel B. F. Saris
investigator title: Professor of Orthopedics
sharing ipd: No