<?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>IRCT20190127042514N6</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-06-17</date_registration>
      <primary_sponsor>Kerman University of Medical Sciences</primary_sponsor>
      <public_title>Comparison  of Clinical outcomes and complications of bilateral knee joint replacement simultaneously and after 48 hours</public_title>
      <acronym></acronym>
      <scientific_title>Comparison  of Clinical outcomes and complications of bilateral knee joint replacement simultaneously and after 48 hours</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-08-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/48261</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>knee joint.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:first group includes patients who will have bilateral knee joints replacement Simultaneously  : All patients will undergo the same  anesthesia. Surgical method  will be the same in all patients (classic knee replacement surgery) . antibiotics (48 hours of injectable cephalexin and then thirty cephalexin 500 mg every 6 hours) and painkillers (injection of one gram of apotel every eight hours). For 48 hours and then taking codeine acetaminophen every eight hours until five days after discharge) and anticoagulants (taking subcutaneous clexan for 14 days after discharge and all the time hospitalized once a day)  will be the same after surgery too. Intervention 2: Intervention group:The second group includes patients who will have bilateral knee joints replacements 48 hours apart : All patients will undergo the same  anesthesia. Surgical method will be the same in all patients (classic knee replacement surgery) . antibiotics (48 hours of injectable cephalexin and then thirty cephalexin 500 mg every 6 hours) and painkillers (injection of one gram of apotel every eight hours). For 48 hours and then taking codeine acetaminophen every eight hours until five days after discharge) and anticoagulants (taking subcutaneous clexan for 14 days after discharge and all the time hospitalized once a day)  will be the same after surgery too.</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 No subscription required</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Amirreza Mirzaei Sosafidi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Qarani Avenue</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7613747181</zip>
        <telephone>+98 34 3223 5011</telephone>
        <email>amirreza.mirzaei@live.com</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Amirreza Mirzaei Sosafidi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Qarani Avenue</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7613747181</zip>
        <telephone>+98 34 3223 5011</telephone>
        <email>amirreza.mirzaei@live.com</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients are candidates for joint replacement of both knees
all patient were from ASAI,II class</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Previous major knee surgery
History of joint infection
Chronic diseases such as diabetes
Immunodeficiency
Infection of other parts of the body or recent active infection</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></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:first group includes patients who will have bilateral knee joints replacement Simultaneously  : All patients will undergo the same  anesthesia. Surgical method  will be the same in all patients (classic knee replacement surgery) . antibiotics (48 hours of injectable cephalexin and then thirty cephalexin 500 mg every 6 hours) and painkillers (injection of one gram of apotel every eight hours). For 48 hours and then taking codeine acetaminophen every eight hours until five days after discharge) and anticoagulants (taking subcutaneous clexan for 14 days after discharge and all the time hospitalized once a day)  will be the same after surgery too</i_keyword>
      <i_keyword>Intervention group:The second group includes patients who will have bilateral knee joints replacements 48 hours apart : All patients will undergo the same  anesthesia. Surgical method will be the same in all patients (classic knee replacement surgery) . antibiotics (48 hours of injectable cephalexin and then thirty cephalexin 500 mg every 6 hours) and painkillers (injection of one gram of apotel every eight hours). For 48 hours and then taking codeine acetaminophen every eight hours until five days after discharge) and anticoagulants (taking subcutaneous clexan for 14 days after discharge and all the time hospitalized once a day)  will be the same after surgery too</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Infection (Purulent discharge from the surgical site and redness and warmth and tenderness of the surgical site). Timepoint: 2 week -1 months - 3 months After surgery. Method of measurement: Physical examination.</prim_outcome>
      <prim_outcome>Deep vein thrombosis. Timepoint: 2 week -1 months - 3 months After surgery. Method of measurement: Physical examination - sonography.</prim_outcome>
      <prim_outcome>Duration of hospitalization. Timepoint: After surgery. Method of measurement: Physical examination.</prim_outcome>
      <prim_outcome>Stair climbing. Timepoint: 2 week -1 months - 3 months After surgery. Method of measurement: Lysholm questionnaire.</prim_outcome>
      <prim_outcome>Joint Locking. Timepoint: 2 week -1 months - 3 months After surgery. Method of measurement: Lysholm questionnaire.</prim_outcome>
      <prim_outcome>Joint Instability. Timepoint: 2 week -1 months - 3 months After surgery. Method of measurement: Lysholm questionnaire.</prim_outcome>
      <prim_outcome>Swelling. Timepoint: 2 week -1 months - 3 months After surgery. Method of measurement: Lysholm questionnaire.</prim_outcome>
      <prim_outcome>Pain. Timepoint: 2 week -1 months - 3 months After surgery. Method of measurement: Lysholm questionnaire.</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>Kerman University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-07-29</approval_date>
        <contact_name>Ethics committee of Kerman University of Medical Sciences</contact_name>
        <contact_address>Ibn Sina avenue; Jahad Blvd kerman Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
