<?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>IRCT20110809007274N17</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-02-10</date_registration>
      <primary_sponsor>Rasht University of Medical Sciences</primary_sponsor>
      <public_title>full weight bearing immediately after surgery and Partial weight bearing in the first month in anterior cruciate ligament rupture</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of full weight bearing results immediately after surgery compared with Partial weight bearing in the first month after surgery in patients with anterior cruciate ligament rupture: A randomized clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-01-25</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>84</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/61303</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study estimated sample size is 84 patients and randomization will be applied using random block design (block size: 4, via online Random allocation software). So, 21 quadruple blocks will be obtained and 42 patients will be in group A and 42 patients in group B. List of patients is kept in orthopedic research center in a sealed envelope and will be read daily after the study begins, Blinding description: In current Double-Blind randomized clinical trial, patients are unaware about when and how to weight bearing. Also, evaluating researcher will be different from the person doing the study intervention. Two orthopedic assistants will be used for this purpose.</study_design>
      <phase>3</phase>
      <hc_freetext>Anterior Cruciate Ligament (ACL) rupture.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Full weight bearing immediately after surgery. Intervention 2: Control group: Partial weight bearing in the first month after surgery in patients with anterior cruciate ligament rupture.</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 Due to the uncertainty of providing the necessary conditions (such as patient cooperation)</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>dr. Mohsen Mardani-kivi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Poursina Hospital, Poursina Crossroads, Rasht, Guilan, Iran</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>41937-13194</zip>
        <telephone>+98 13 3332 5783</telephone>
        <email>mardani.kivi@gmail.com</email>
        <affiliation>Rasht University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>dr. Mohsen Mardani-kivi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Poursina Hospital, Poursina Crossroads, Rasht, Guilan, Iran</address>
        <city>rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>41937-13194</zip>
        <telephone>+98 13 3332 5783</telephone>
        <email>mardani.kivi@gmail.com</email>
        <affiliation>Rasht University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Anterior Cruciate Ligament (ACL) rupture defined as +3 Lachman test in physical examination confirmed by Knee Magnetic resonance imaging (MRI) as complete rupture
Individuals aged from 18 to 50
Individual consent for participation in the study</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Any history of knee surgery
History of Anterior Cruciate Ligament (ACL) rupture in opposite knee
Any injuries in knee ligaments
Abnormal radiography of the knee (including Varus above 15 degrees)
Any sign or symptom in hip or ankle</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>S83.51</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Sprain and strain of knee: Distortion of anterior cruciate ligament</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Full weight bearing immediately after surgery</i_keyword>
      <i_keyword>Control group: Partial weight bearing in the first month after surgery in patients with anterior cruciate ligament rupture</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Time to return to exercise. Timepoint: 1, 3 and 6 months after surgery. Method of measurement: Ask the patient.</prim_outcome>
      <prim_outcome>Quality of return to exercise. Timepoint: 1, 3 and 6 months after surgery. Method of measurement: Ask the patient.</prim_outcome>
      <prim_outcome>Range of motion. Timepoint: Before and 3 and 6 months after surgery. Method of measurement: According to the surgeon's report.</prim_outcome>
      <prim_outcome>International Knee Documentation Committee (IKDC). Timepoint: Before and 3 and 6 months after surgery. Method of measurement: Based on IKDS questionnaire.</prim_outcome>
      <prim_outcome>Knee Injury and Osteoarthritis Outcome Score (KOOS). Timepoint: Before and 3 and 6 months after surgery. Method of measurement: Based on KOOS questionnaire.</prim_outcome>
      <prim_outcome>Lachman test. Timepoint: Before and 3 and 6 months after surgery. Method of measurement: According to the surgeon's report.</prim_outcome>
      <prim_outcome>Lysholm Score. Timepoint: Before and 3 and 6 months after surgery. Method of measurement: Based on Lysholm questionnaire.</prim_outcome>
      <prim_outcome>Anterior knee pain. Timepoint: Before and 3 and 6 months after surgery. Method of measurement: Ask the patient.</prim_outcome>
      <prim_outcome>Pain during kneeling. Timepoint: Before and 3 and 6 months after surgery. Method of measurement: Ask the patient.</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>Rasht University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-01-12</approval_date>
        <contact_name>Research Ethics Committees of Guilan university of medical sciences</contact_name>
        <contact_address>Poursina Hospital, Poursina Crossroads, Rasht, Guilan, Iran Rasht Guilan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
