<?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>IRCT20170912036152N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-12-12</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>pain management in total knee arthroplasty (TKA)</public_title>
      <acronym></acronym>
      <scientific_title>The effects of epiphysiodesis on angular deformity using staple, screw or plate and screw in children</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-01-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/27109</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: All patients were provided self-specific number using random allocation software and then were divided in three groups based on their numbers of 3k, 3k+1 and 3k+2.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Angular deformity.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Staple group: After patients' positioning in supine position, following provisional pin embedding and detection of physis proximal and distal part, the skin would be incised and staple will be placed in the position of pins(Osveh; Iran). Intervention 2: Intervention group: Screw group: After patients' positioning in supine position, following embedding provisional pins using C-arm, the physis position will be detected and epiphysiodesis will be performed using canulated screws(Osveh; Iran). Intervention 3: Intervention group: Screw and plaque group:After patients' positioning in supine position, following provisional pin embedding, distal and proximal part of involved limb will be detected using C-arm and then the skin will be incised and plaque will be embedded around the physis bilaterally and screws will be embedded in provisional pins situation bilaterally(Osveh; Iran).</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:
Data are type of surgical procedure, deformity correction rate and required duration for deformity correction

When:
Since project cessation and its submission, the end of 2019

To whom:
Researchers who want to compare their projects about angular deformity correction with our findings

Conditions:
For comparison of different surgical procedures with findings of our study

Where to obtain:
Corresponding of this stud, Dr. Sharifi and Dr. Tahririan should be referred.

How to obtain:
The correspondent professor, Dr. Tahririan should be contacted. Then he can provide an SPSS file. This request should be done thorough an Email and proposal and/or an official request from the university.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ghasem Mohammadsharifi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kashani Hospital, Kashani Street, Isfahan, Iran</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8196736573</zip>
        <telephone>+98 31342201143</telephone>
        <email>iman.m.sharifi@gmail.com</email>
        <affiliation>Isfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Mohammad Ali Tahririan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kashani Hospital, Kashani Street, Isfahan, Iran</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>81967367573</zip>
        <telephone>+98 31 3620 2085</telephone>
        <email>tahririan@med.mui.ac.ir</email>
        <affiliation>Isfahan University of Medical Sceinces</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The presence of non-physiological genovugum or genovalogom with its numerical value
Having a kind of angular deformity detected by an orthopedic specialist.
Intermediate distance (IMD) above 10 cm, or Intercondillier spacing (ICD) greater than 6 centimeters
Parental consent to participate in this study
If the mechanical axis of the lower limb is not placed on the knee (outside or inside the knee)</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Uncontrolled metabolic disease
There is less than 12 months to stop the growth of the bone</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Q74.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Congenital malformation 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>Intervention group: Staple group: After patients' positioning in supine position, following provisional pin embedding and detection of physis proximal and distal part, the skin would be incised and staple will be placed in the position of pins(Osveh; Iran).</i_keyword>
      <i_keyword>Intervention group: Screw group: After patients' positioning in supine position, following embedding provisional pins using C-arm, the physis position will be detected and epiphysiodesis will be performed using canulated screws(Osveh; Iran).</i_keyword>
      <i_keyword>Intervention group: Screw and plaque group:After patients' positioning in supine position, following provisional pin embedding, distal and proximal part of involved limb will be detected using C-arm and then the skin will be incised and plaque will be embedded around the physis bilaterally and screws will be embedded in provisional pins situation bilaterally(Osveh; Iran).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Average deviation of mechanical deformity. Timepoint: Prior to the surgery, immediately after surgery and then every three months until a year. Method of measurement: Using Anterior-Posterior radiography.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Deformity correction velocity. Timepoint: Every three months until a year. Method of measurement: Measurement and comparison of deformity angle using anterior-posterior radiography.</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>2017-05-31</approval_date>
        <contact_name>Isfahan Medical School Ethic Committee</contact_name>
        <contact_address>Hezar Jarib Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
