<?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>IRCT20180729040636N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-05-01</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of kinematics and kinetic gait, after knee surgery with ACL and Anterolateral Ligament Reconstruction technique, and Lemire - tenodesis technique</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of kinematics and kinetic gait, after knee surgery with ACL and Anterolateral Ligament Reconstruction technique, and Lemire - tenodesis technique</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-04-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>20</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/55687</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The patients were allocated into intervention or control group using block randomization method to keep an even randomization ratio of (1:1). If the patient had inclusion criteria and did not excluded from the study according to above mentioned protocol, the random number generating software was used to determine their designated group. Numbers were between 0-9. If the number was even, the letter "A" was wrote at the top of their checklist by the examining physician, and if the number was odd, the letter "B" was used. Then, the next patient had to be assigned to the opposite group. This process repeated for the upcoming patients and continued until we reached our estimated sample size. After completing the study and before starting the data analysis process, the encrypted letters were revealed by the pharmaceutical company. The letter "A" was assigned to the intervention group and the letter "B" was assigned to the control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Anterolateral Ligament Reconstruction.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Reconstruction of the anterior cruciate ligament with a hamstring autograft. Intervention 2: Intervention group: Reconstruction of anterior cruciate ligament using hamstring autograft and anterolateral ligament by Lemir method.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Part of the data related to the results of data analysis and review can be shared

When:
3 months after the results are published in an international journal

To whom:
For researchers only

Conditions:
Individuals are allowed to use the data for research purposes.

Where to obtain:
corresponding author 
akbariaghdam@mui.ac.ir

How to obtain:
After requesting and confirming it, it will take about two weeks to send the data.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hossein Akbari aghdam</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nikan appartment , east allame amini ave ,ghadir park,isfahan</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673441</zip>
        <telephone>+98 31 3620 2085</telephone>
        <email>akbariaghdam@med.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hossein Akbari aghdam</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nikan appartment , east allame amini ave ,ghadir park,isfahan</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673441</zip>
        <telephone>+98 31 3620 2085</telephone>
        <email>akbariaghdam@med.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Candidates for knee surgery with ACL and Anterolateral Ligament Reconstruction admitted in the Kashani hospital. -Signing the consent form.</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>40 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>knee arthroplasty
Knee surgery in the last 12 months
Lower limb fractures in the last 6 months
Bilateral anterior cruciate ligament injury of the knee
Bucket-handle meniscal tear
injection of intra-articular in the last 6 months
Metabolic bone diseases
osteomalacia
Individuals with an underlying disease
People with osteoporosis</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>S83.51</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Sprain of anterior 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>Intervention group: Reconstruction of the anterior cruciate ligament with a hamstring autograft</i_keyword>
      <i_keyword>Intervention group: Reconstruction of anterior cruciate ligament using hamstring autograft and anterolateral ligament by Lemir method</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Internal forces of knee compartments. Timepoint: Before the intervention and 6 months after. Method of measurement: motion capture system.</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>Esfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-04-14</approval_date>
        <contact_name>Ethics committee of  Isfahan University of Medical Sciences</contact_name>
        <contact_address>Hezar Jerib street, Isfahan, Iran isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
