<?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>IRCT20210520051351N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-06-16</date_registration>
      <primary_sponsor>Vice Chancellor for Research, Iran University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of anterior cruciate ligament blood flow after reconstruction</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of anterior cruciate ligament perfusion after reconstruction with hamstring autograft in two methods of preservation or isolation of tibial junction based on dynamic contrast enhanced MRI findings of a randomized clinical trial study</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-06-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/56440</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization method in the present study: Simple randomization is such that the form is divided among the control and intervention groups once.
Randomization unit: will be personal.
Visualization layers: Using randomization layers (stratified randomization) Using random options is placed in different groups and image blocks are used for balance in groups
The samples are classified according to the center of the class and then in each class with the help of software to generate a random sequence
Visualization tool: Random number table
How to construct a random sequence is selected one by one
Explanation of Concealment of Concealment Allocation: The surgical material and the person performing the analysis are not aware of the type of intervention, Blinding description: At the time of obtaining informed consent, patients are explained in an understandable language that they will undergo method 1 or 2 in one of these two hospitals. Random patients are operated on in one of two ways. There is no difference between the two methods in terms of preoperative and postoperative programs. There is no difference between the two methods in terms of pre- and postoperative interventions and complications. There is no difference between patients in terms of the appearance of extremity after surgery. There is no difference in preoperative and postoperative rehabilitation between the two groups. The surgeon is aware of the type of surgery, but visit the patient in the same way in both groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Anterior cruciate ligament tear.</hc_freetext>
      <i_freetext>Intervention 1: Control group: Patients with ACL tear who undergo normal ACL reconstruction surgery with complete separation of the hamstring tendons from the distal and proximal attachment. The distal and proximal hamstring tendons are detached from the lower extremity on the same side and harvested and reconstructed arthroscopically. Intervention 2: Intervention group: Patients with ACL tear who undergo ACL reconstruction surgery in a new way with complete preservation of the hamstring tendons from the distal and separation from the proximal. The hamstring tendons are preserved distally and detached from the proximal to the lower extremity on the same side, and are harvest while the distal attachment of the tendons is attached. It is then reconstructed arthroscopically.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is After collecting the data, they are analyzed and written an article. If the journal wants the data, we will provide it to the journal with the patients' consent.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Alireza Askari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mojahedin-e-Islam Street</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1157637131</zip>
        <telephone>+98 21 3354 2041</telephone>
        <email>aaskari60@yahoo.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mehdi Mohammadpour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mojahedin-e-Islam Street</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1157637131</zip>
        <telephone>+98 21 3354 2041</telephone>
        <email>mehdi.668491@gmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients aged 18-40 years with ACL tear following trauma</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>40 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Knee or leg fracture
Simultaneous ligament injury
Meniscus damage that needs to be repaired and affects postoperative rehabilitation.
Previous trauma to the knee or leg
Obvious deformity in the knee or leg
History of previous knee or leg surgery</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>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: Patients with ACL tear who undergo normal ACL reconstruction surgery with complete separation of the hamstring tendons from the distal and proximal attachment. The distal and proximal hamstring tendons are detached from the lower extremity on the same side and harvested and reconstructed arthroscopically.</i_keyword>
      <i_keyword>Intervention group: Patients with ACL tear who undergo ACL reconstruction surgery in a new way with complete preservation of the hamstring tendons from the distal and separation from the proximal. The hamstring tendons are preserved distally and detached from the proximal to the lower extremity on the same side, and are harvest while the distal attachment of the tendons is attached. It is then reconstructed arthroscopically.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Anterior cruciate ligament vascularization rate reconstructed by preserving distal attachment. Timepoint: Measurements of vascularization were taken at 6 and 12 weeks after reconstruction. Method of measurement: With Gadolinium enhanced MRI.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Womac and Tegner-lysholm form score. Timepoint: 6 and 12 weeks after reconstruction. Method of measurement: Womac , Tegner-lysholm form.</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>Vice Chancellor for Research, Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-03-09</approval_date>
        <contact_name>Ethics committee of Iran University of Medical Sciences</contact_name>
        <contact_address>Mojahedin Islam St. Shafa Yahyaian Hospital تهران Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
