<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20250307064959N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-04-08</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>A study of three surgical methods for anterior cruciate ligament rupture.</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the clinical outcomes of anterior cruciate ligament reconstruction alone compared to anterior cruciate ligament reconstruction combined with iliotibial band tendon grafting using the Arnold and Coker method and modified iliotibial band tendinosis using the Lemaire method in patients with anterior cruciate ligament rupture.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-03-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>48</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/82355</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Cruciate ligament rupture.</hc_freetext>
      <i_freetext>Intervention 1: Patients undergo only anterior cruciate ligament (ACL) reconstruction. The surgery is performed arthroscopically under general anesthesia. A tendon graft is used to replace the ACL and is attached to the femur and tibia with screws or standard fixation devices. No intervention is performed on the anterolateral ligament or iliotibial band in this group. Intervention 2: Patients undergo ACL reconstruction with anterolateral ligament repair using the Arnold and Coker technique. In this procedure, a portion of the iliotibial band is removed from the outer thigh and used as a graft. The surgery is performed arthroscopically and minimally invasively. The iliotibial band is guided in the appropriate direction and attached to the femur and tibia with surgical sutures and fixation devices to increase lateral knee stability in addition to ACL reconstruction. Intervention 3: Patients undergo ACL reconstruction with modified iliotibial band tendinosis using the Lemierre technique. In this technique, a portion of the iliotibial band is released from its natural location and placed in the anterolateral aspect of the knee. The surgery is performed arthroscopically under general anesthesia, and the graft is secured to the femur and tibia using sutures and fixation screws. This technique is used to enhance lateral stability and reduce knee instability in conjunction with ACL reconstruction.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is Maintaining patient privacy and confidentiality</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Soroush Hoseini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Valiasr street, Tajrish square</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1989934148</zip>
        <telephone>+98 21 25719</telephone>
        <email>soroush.hosseinik93@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mehrdad Sedighi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Vliast street, Tajrish square</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1989934148</zip>
        <telephone>+98 21 25719</telephone>
        <email>mehrdad_1330@yahoo.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with anterior cruciate ligament rupture  who have a positive Pivot Shift test and a Pivot Shift score of 3</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>30 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>knee joint osteoarthritis
simultaneous multiple ligament injury</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>S83.5</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Sprain of cruciate ligament of knee</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Surgery</i_code>
      <i_code>Treatment - Surgery</i_code>
      <i_code>Treatment - Surgery</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Patients undergo only anterior cruciate ligament (ACL) reconstruction. The surgery is performed arthroscopically under general anesthesia. A tendon graft is used to replace the ACL and is attached to the femur and tibia with screws or standard fixation devices. No intervention is performed on the anterolateral ligament or iliotibial band in this group.</i_keyword>
      <i_keyword>Patients undergo ACL reconstruction with anterolateral ligament repair using the Arnold and Coker technique. In this procedure, a portion of the iliotibial band is removed from the outer thigh and used as a graft. The surgery is performed arthroscopically and minimally invasively. The iliotibial band is guided in the appropriate direction and attached to the femur and tibia with surgical sutures and fixation devices to increase lateral knee stability in addition to ACL reconstruction.</i_keyword>
      <i_keyword>Patients undergo ACL reconstruction with modified iliotibial band tendinosis using the Lemierre technique. In this technique, a portion of the iliotibial band is released from its natural location and placed in the anterolateral aspect of the knee. The surgery is performed arthroscopically under general anesthesia, and the graft is secured to the femur and tibia using sutures and fixation screws. This technique is used to enhance lateral stability and reduce knee instability in conjunction with ACL reconstruction.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Knee score. Timepoint: Before the intervention and one year after ending the intervention. Method of measurement: International Knee Documentation Committee scale, Lysholm Knee Score and Knee injury and Osteoarthritis Outcome Score.</prim_outcome>
      <prim_outcome>Knee function. Timepoint: Before the intervention and one year after ending the intervention. Method of measurement: International Knee Documentation Committee scale, Lysholm Knee Score and Knee injury and Osteoarthritis Outcome Score.</prim_outcome>
      <prim_outcome>Quality of life. Timepoint: Before the intervention and one year after ending the intervention. Method of measurement: International Knee Documentation Committee scale, Lysholm Knee Score and Knee injury and Osteoarthritis Outcome Score.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-02-04</approval_date>
        <contact_name>Ethics Committee of the Faculty of Medicine, Shahid Beheshti University of Medical Sciences</contact_name>
        <contact_address>Arabi street, Velenjak Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
