<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/NCT04455516</url>
  </required_header>
  <id_info>
    <org_study_id>M2020024</org_study_id>
    <nct_id>NCT04455516</nct_id>
  </id_info>
  <brief_title>Meniscus Repair With Simultaneous ACL Reconstruction: Clinical Outcomes，Failure Rates And Subsequent Processing</brief_title>
  <official_title>Meniscus Repair With Simultaneous ACL Reconstruction: Clinical Outcomes，Failure Rates And Subsequent Processing</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking University Third Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking University Third Hospital</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>
      Our study has explored the causes of failure of meniscus repair and investigated the clinical&#xD;
      effects of partial meniscectomy when meniscus repair failed.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: Meniscus repair performed during ACL reconstruction may fail and the subsequent&#xD;
      treatment includes revision meniscal repair or partial meniscectomy.&#xD;
&#xD;
      Purpose: To retrospectively analyze the clinical outcomes of meniscus repair with&#xD;
      simultaneous anterior cruciate ligament (ACL) reconstruction and explore the causes of&#xD;
      failure of meniscus repair.&#xD;
&#xD;
      Methods: From May 2013 to July 2018, the clinical data of 165 patients who were treated with&#xD;
      meniscus surgery and simultaneous ACL reconstruction by the same doctor, including 69 cases&#xD;
      of meniscus repair (repair group) and 96 cases of partial meniscectomy (partial meniscectomy&#xD;
      group), were retrospectively analyzed. The 69 patients of the repair group were divided into&#xD;
      the nonfailure group (62 cases) and the failure group (7 cases) depending on the repair&#xD;
      effect. The average follow-up period was 38 (±10.5) months. Postoperative outcomes of the&#xD;
      repair group and the partial meniscectomy group were compared. General conditions and&#xD;
      postoperative outcomes of the failure group and the nonfailure group were compared. Seven&#xD;
      patients in the failure group who underwent second arthroscopy were followed up for 30&#xD;
      (±17.4) months, and their postoperative outcomes were summarized.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 16, 2020</start_date>
  <completion_date type="Actual">May 16, 2020</completion_date>
  <primary_completion_date type="Actual">April 16, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The result of partial meniscus resection</measure>
    <time_frame>Two years after the surgery</time_frame>
    <description>Clinical signs were assessed after the surgery, including swelling of the joint, tenderness at the joint line, locked-in syndrome, and positive McMurray's sign.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>International Knee Documentation Committee（IKDC）scores</measure>
    <time_frame>Two years after the surgery</time_frame>
    <description>The minimum is 0, the maximum is 100, and the higher the score, the better the result</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Visual analog scale (VAS) scores</measure>
    <time_frame>Two years after the surgery</time_frame>
    <description>The minimum is 0, the maximum is 10, and the higher the score, the worse the result</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Lysholm scores</measure>
    <time_frame>Two years after the surgery</time_frame>
    <description>The minimum is 0, the maximum is 100, and the higher the score, the better the result</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">165</enrollment>
  <condition>The ACL Rupture</condition>
  <condition>Meniscus Injury</condition>
  <arm_group>
    <arm_group_label>repair group</arm_group_label>
    <description>The first operation in these patients was meniscus repair</description>
  </arm_group>
  <arm_group>
    <arm_group_label>nonfailure group</arm_group_label>
    <description>These patients had a successful first operation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>failure group</arm_group_label>
    <description>In these patients, the first meniscus repair operation failed</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Meniscus repair; partial meniscectomy</intervention_name>
    <description>69 cases of meniscus repair (repair group) and 96 cases of partial meniscectomy (partial meniscectomy group), were retrospectively analyzed. The 69 patients of the repair group were divided into the nonfailure group (62 cases) and the failure group (7 cases) depending on the repair effect.</description>
    <arm_group_label>failure group</arm_group_label>
    <arm_group_label>nonfailure group</arm_group_label>
    <arm_group_label>repair group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        This retrospective case series was conducted to evaluate the clinical outcomes and failure&#xD;
        rates of primary meniscus repair with simultaneous ACL reconstruction in patients who were&#xD;
        operated by the same physician at our institution.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. patients with intraoperatively confirmed ACL rupture combined with medial, lateral, or&#xD;
             medial and lateral meniscal injury;&#xD;
&#xD;
          2. age &lt;60 years&#xD;
&#xD;
          3. no history of previous ipsilateral knee meniscal injury.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. ACL rupture associated with fracture, collateral ligament injury, or complex ligament&#xD;
             injury;&#xD;
&#xD;
          2. a history of knee surgery;&#xD;
&#xD;
          3. a significant degree of osteoarthritis.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>13 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Peking University Third Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100191</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 25, 2020</study_first_submitted>
  <study_first_submitted_qc>July 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 2, 2020</study_first_posted>
  <last_update_submitted>July 1, 2020</last_update_submitted>
  <last_update_submitted_qc>July 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>meniscus</keyword>
  <keyword>failure of repair</keyword>
  <keyword>anterior cruciate ligament reconstruction</keyword>
  <keyword>arthroscopy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rupture</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04455516
org study id: M2020024
nct id: NCT04455516
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Our study has explored the causes of failure of meniscus repair and investigated the clinical
      effects of partial meniscectomy when meniscus repair failed.
Background: Meniscus repair performed during ACL reconstruction may fail and the subsequent
      treatment includes revision meniscal repair or partial meniscectomy.

      Purpose: To retrospectively analyze the clinical outcomes of meniscus repair with
      simultaneous anterior cruciate ligament (ACL) reconstruction and explore the causes of
      failure of meniscus repair.

      Methods: From May 2013 to July 2018, the clinical data of 165 patients who were treated with
      meniscus surgery and simultaneous ACL reconstruction by the same doctor, including 69 cases
      of meniscus repair (repair group) and 96 cases of partial meniscectomy (partial meniscectomy
      group), were retrospectively analyzed. The 69 patients of the repair group were divided into
      the nonfailure group (62 cases) and the failure group (7 cases) depending on the repair
      effect. The average follow-up period was 38 (±10.5) months. Postoperative outcomes of the
      repair group and the partial meniscectomy group were compared. General conditions and
      postoperative outcomes of the failure group and the nonfailure group were compared. Seven
      patients in the failure group who underwent second arthroscopy were followed up for 30
      (±17.4) months, and their postoperative outcomes were summarized.
observational model: Case-Control
time perspective: Retrospective
measure: The result of partial meniscus resection
time frame: Two years after the surgery
description: Clinical signs were assessed after the surgery, including swelling of the joint, tenderness at the joint line, locked-in syndrome, and positive McMurray's sign.
measure: International Knee Documentation Committee（IKDC）scores
time frame: Two years after the surgery
description: The minimum is 0, the maximum is 100, and the higher the score, the better the result
measure: Visual analog scale (VAS) scores
time frame: Two years after the surgery
description: The minimum is 0, the maximum is 10, and the higher the score, the worse the result
measure: Lysholm scores
time frame: Two years after the surgery
description: The minimum is 0, the maximum is 100, and the higher the score, the better the result
arm group label: repair group
description: The first operation in these patients was meniscus repair
arm group label: nonfailure group
description: These patients had a successful first operation
arm group label: failure group
description: In these patients, the first meniscus repair operation failed
intervention type: Procedure
intervention name: Meniscus repair; partial meniscectomy
description: 69 cases of meniscus repair (repair group) and 96 cases of partial meniscectomy (partial meniscectomy group), were retrospectively analyzed. The 69 patients of the repair group were divided into the nonfailure group (62 cases) and the failure group (7 cases) depending on the repair effect.
arm group label: failure group
arm group label: nonfailure group
arm group label: repair group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 13 Years
maximum age: 60 Years
healthy volunteers: No
facility: 
country: China
responsible party type: Sponsor
mesh term: Rupture
sharing ipd: No