xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05971472</url>
    </required_header>
    <id_info>
      <org_study_id>FMASU MD 169/2021</org_study_id>
      <nct_id>NCT05971472</nct_id>
    </id_info>
    <brief_title>Arthroscopic Repair Versus High Tibial Osteotomy for Medial Meniscus Posterior Root Tears</brief_title>
    <acronym>Root Tears</acronym>
    <official_title>Arthroscopic Repair Versus Opening Wedge High Tibial Osteotomy for Medial Meniscus Posterior Root Tears</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ain Shams University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Ain Shams University</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 goal of the trial is to compare Arthroscopic repair against Opening wedge high tibial&#xD;
        osteotomy for Medial Meniscus posterior root tears&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        All Patients included in this clinical trial will be informed by written consent will undergo&#xD;
        a one week screening to determine the eligibility for study entry.&#xD;
  &#xD;
        Patients who meet the eligibility requirements will be randomized in a single blinded manner&#xD;
        (patients).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">September 12, 2021</start_date>
    <completion_date type="Anticipated">December 2024</completion_date>
    <primary_completion_date type="Anticipated">September 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Participant)</masking>
      <masking_description>single (participant)</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Lysholm Score</measure>
      <time_frame>3 month and 6 month</time_frame>
      <description>Validated Arabic form of Lyshlom score</description>
    </primary_outcome>
    <primary_outcome>
      <measure>IKDC Score</measure>
      <time_frame>3 month and 6 month</time_frame>
      <description>Validated Arabic form of IKDC score</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>infection</measure>
      <time_frame>3 month and 6 month</time_frame>
      <description>Occurrence of infection</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Non union</measure>
      <time_frame>3 month and 6 month</time_frame>
      <description>Occurrence of delayed or non union</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Arthrofibrosis</measure>
      <time_frame>3 month and 6 month</time_frame>
      <description>Loss of knee ROM or occurrence of Arthrofibrosis</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Medial Mensical Tear</condition>
    <arm_group>
      <arm_group_label>Arthroscopic Repair</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Arthroscopic Repair for medial meniscus posterior root tears</description>
    </arm_group>
    <arm_group>
      <arm_group_label>High tibial osteotomy</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Open wedge High tibial osteotomy for medial meniscus posterior root tears</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Arthroscopic Repair</intervention_name>
      <description>Arthroscopic Repair for medial meniscus posterior Root tears</description>
      <arm_group_label>Arthroscopic Repair</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>High tibial osteotomy</intervention_name>
      <description>Open Wedge High tibial osteotomy for medial meniscus posterior Root tears</description>
      <arm_group_label>High tibial osteotomy</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Sex: both sexes.&#xD;
  &#xD;
            -  Age: Above 40&#xD;
  &#xD;
            -  Degree of Varus: Neutral to 10 degrees of Varus&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  History of high energy trauma.&#xD;
  &#xD;
            -  Multiligamentous knee Injury.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>40 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Wael S. Abdel Megid, Professor</last_name>
      <role>Study Director</role>
      <affiliation>Ain Shams University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Zeiad M. Zakaria, Assistant Professor</last_name>
      <role>Study Director</role>
      <affiliation>Ain Shams University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Radwan G. Abdel Hamid, Assistant Professor</last_name>
      <role>Study Director</role>
      <affiliation>Ain Shams University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Mohamed E. Awad, Assistant Professor</last_name>
      <role>Study Director</role>
      <affiliation>Ain Shams University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Amr S. Ahmed, Master</last_name>
      <phone>+201113742474</phone>
      <email>AmrElhady@med.asu.edu.eg</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Amr S. Ahmed, Master</last_name>
      <phone>+201008026969</phone>
      <email>amrsamyelhady@gmail.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Demerdash Hospital</name>
        <address>
          <city>Cairo</city>
          <country>Egypt</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <reference>
      <citation>Kim KI, Bae JK, Jeon SW, Kim GB. Medial Meniscus Posterior Root Tear Does Not Affect the Outcome of Medial Open-Wedge High Tibial Osteotomy. J Arthroplasty. 2021 Feb;36(2):423-428. doi: 10.1016/j.arth.2020.08.067. Epub 2020 Sep 7.</citation>
      <PMID>32978022</PMID>
    </reference>
    <reference>
      <citation>Nha KW, Lee YS, Hwang DH, Kwon JH, Chae DJ, Park YJ, Kim JI. Second-look arthroscopic findings after open-wedge high tibia osteotomy focusing on the posterior root tears of the medial meniscus. Arthroscopy. 2013 Feb;29(2):226-31. doi: 10.1016/j.arthro.2012.08.027. Erratum In: Arthroscopy. 2019 Feb;35(2):691. Arthroscopy. 2020 Mar;36(3):923.</citation>
      <PMID>23369476</PMID>
    </reference>
    <reference>
      <citation>Marzo JM, Gurske-DePerio J. Effects of medial meniscus posterior horn avulsion and repair on tibiofemoral contact area and peak contact pressure with clinical implications. Am J Sports Med. 2009 Jan;37(1):124-9. doi: 10.1177/0363546508323254. Epub 2008 Sep 24.</citation>
      <PMID>18815238</PMID>
    </reference>
    <reference>
      <citation>Feucht MJ, Kuhle J, Bode G, Mehl J, Schmal H, Sudkamp NP, Niemeyer P. Arthroscopic Transtibial Pullout Repair for Posterior Medial Meniscus Root Tears: A Systematic Review of Clinical, Radiographic, and Second-Look Arthroscopic Results. Arthroscopy. 2015 Sep;31(9):1808-16. doi: 10.1016/j.arthro.2015.03.022. Epub 2015 May 13.</citation>
      <PMID>25979687</PMID>
    </reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 25, 2023</study_first_submitted>
    <study_first_submitted_qc>July 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>July 25, 2023</last_update_submitted>
    <last_update_submitted_qc>July 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 2, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Medial</keyword>
    <keyword>Meniscus</keyword>
    <keyword>Posterior</keyword>
    <keyword>Root</keyword>
    <keyword>Tear</keyword>
    <keyword>High Tibial Osteotomy</keyword>
    <keyword>Arthroscopic Root Repair</keyword>
    <keyword>Transtibial Pullout</keyword>
    <keyword>Arthroscopic Repair</keyword>
    <keyword>Open Wedge</keyword>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05971472
  org study id: FMASU MD 169/2021
  nct id: NCT05971472
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of the trial is to compare Arthroscopic repair against Opening wedge high tibial
        osteotomy for Medial Meniscus posterior root tears
  All Patients included in this clinical trial will be informed by written consent will undergo
        a one week screening to determine the eligibility for study entry.
  
        Patients who meet the eligibility requirements will be randomized in a single blinded manner
        (patients).
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Participant)
  masking description: single (participant)
  measure: Lysholm Score
  time frame: 3 month and 6 month
  description: Validated Arabic form of Lyshlom score
  measure: IKDC Score
  time frame: 3 month and 6 month
  description: Validated Arabic form of IKDC score
  measure: infection
  time frame: 3 month and 6 month
  description: Occurrence of infection
  measure: Non union
  time frame: 3 month and 6 month
  description: Occurrence of delayed or non union
  measure: Arthrofibrosis
  time frame: 3 month and 6 month
  description: Loss of knee ROM or occurrence of Arthrofibrosis
  arm group label: Arthroscopic Repair
  arm group type: Active Comparator
  description: Arthroscopic Repair for medial meniscus posterior root tears
  arm group label: High tibial osteotomy
  arm group type: Active Comparator
  description: Open wedge High tibial osteotomy for medial meniscus posterior root tears
  intervention type: Procedure
  intervention name: Arthroscopic Repair
  description: Arthroscopic Repair for medial meniscus posterior Root tears
  arm group label: Arthroscopic Repair
  intervention type: Procedure
  intervention name: High tibial osteotomy
  description: Open Wedge High tibial osteotomy for medial meniscus posterior Root tears
  arm group label: High tibial osteotomy
  criteria: 
  gender: All
  minimum age: 40 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Wael S. Abdel Megid, Professor
  role: Study Director
  affiliation: Ain Shams University
  last name: Zeiad M. Zakaria, Assistant Professor
  role: Study Director
  affiliation: Ain Shams University
  last name: Radwan G. Abdel Hamid, Assistant Professor
  role: Study Director
  affiliation: Ain Shams University
  last name: Mohamed E. Awad, Assistant Professor
  role: Study Director
  affiliation: Ain Shams University
  last name: Amr S. Ahmed, Master
  phone: +201113742474
  email: AmrElhady@med.asu.edu.eg
  last name: Amr S. Ahmed, Master
  phone: +201008026969
  email: amrsamyelhady@gmail.com
  facility: 
  status: Recruiting
  country: Egypt
  citation: Kim KI, Bae JK, Jeon SW, Kim GB. Medial Meniscus Posterior Root Tear Does Not Affect the Outcome of Medial Open-Wedge High Tibial Osteotomy. J Arthroplasty. 2021 Feb;36(2):423-428. doi: 10.1016/j.arth.2020.08.067. Epub 2020 Sep 7.
  PMID: 32978022
  citation: Nha KW, Lee YS, Hwang DH, Kwon JH, Chae DJ, Park YJ, Kim JI. Second-look arthroscopic findings after open-wedge high tibia osteotomy focusing on the posterior root tears of the medial meniscus. Arthroscopy. 2013 Feb;29(2):226-31. doi: 10.1016/j.arthro.2012.08.027. Erratum In: Arthroscopy. 2019 Feb;35(2):691. Arthroscopy. 2020 Mar;36(3):923.
  PMID: 23369476
  citation: Marzo JM, Gurske-DePerio J. Effects of medial meniscus posterior horn avulsion and repair on tibiofemoral contact area and peak contact pressure with clinical implications. Am J Sports Med. 2009 Jan;37(1):124-9. doi: 10.1177/0363546508323254. Epub 2008 Sep 24.
  PMID: 18815238
  citation: Feucht MJ, Kuhle J, Bode G, Mehl J, Schmal H, Sudkamp NP, Niemeyer P. Arthroscopic Transtibial Pullout Repair for Posterior Medial Meniscus Root Tears: A Systematic Review of Clinical, Radiographic, and Second-Look Arthroscopic Results. Arthroscopy. 2015 Sep;31(9):1808-16. doi: 10.1016/j.arthro.2015.03.022. Epub 2015 May 13.
  PMID: 25979687
  responsible party type: Sponsor