<?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>IRCT20210918052512N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-05-17</date_registration>
      <primary_sponsor>Kerman University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of pinning treatment approach to casting in lateral condylar fractures of type 1 Homer on the range of motion of the elbow joint in children 3-10 years.</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of pinning treatment approach to casting in lateral condylar fractures of type 1 Homer on the range of motion of the elbow joint in children 3-10 years.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-06-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>22</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/62946</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, patients are divided into two groups of 22 cases and control through simple randomization. The random feature of Excel software was used for randomization, Blinding description: In this study, since blinding is not possible for physicians and patients, blinding is performed only for the analyst, so that the data of the two treatment approaches are identified with codes A and B so that it is possible to diagnose treatments for There is no analyst.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Lateral condyle fracture.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: After Closed Reduction under C_Arm and pinning, smooth pins with a diameter of 1.5 to 2 mm will be used according to the patient's weight and age. Intervention 2: Control group: Non-surgical treatment in one group will be performed using a long cast on 90 degrees of elbow flexion in the pronation position.</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:
Individual data of study participants can be shared after identifying individuals. This data includes:
Therapeutic approach
Range of motion of the elbow joint
Elbow joint stiffness
Wound infection at the site of the pins
Bone necrosis
Cubitus varus
Bone burn
Age
Gender

When:
The data access period starts 6 months after the results are published.

To whom:
The text of the dissertation will be available to the public.
Access to specialized data will be available for researchers working in academic and scientific institutions.

Conditions:
The analysis of the data of this study will be possible for the people who have access to it for scientific research in university centers.
Public address for dissertation text
For scientific researchers in academic and research centers

Where to obtain:
The full text of the dissertation on the digital resources website of Kerman University of Medical Sciences at https://centlib.uk.ac.ir/%D9%85%D9%86%D8%A7%D8%A8%D8%B9-%D8% AF% DB% 8C% D8% AC% DB% 8C% D8% AA% D8% A7% D9% 84 and is available on the Ganj website at https://ganj.irandoc.ac.ir.
To receive study data, correspondence with the Research Committee of Kerman University of Medical Sciences should be done at https://ksrc.kmu.ac.ir/fa.

How to obtain:
After correspondence with the research committee of Kerman University of Medical Sciences and accepting the request and confirming the data, the data will be sent to the individuals.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohammad Nikukar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Bahonar Hospital, Qarani Street</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7613744579</zip>
        <telephone>+98 34 3223 5011</telephone>
        <email>mohammad.nikukar@gmail.com</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Nikukar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Bahonar Hospital, QaraniStreet.</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7613744579</zip>
        <telephone>+98 34 3223 5011</telephone>
        <email>mohammad.nikukar@gmail.com</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Girls and boys in the age range of 3 to 10 years
Lateral condylar fractures type one</inclusion_criteria>
      <agemin>3 years</agemin>
      <agemax>10 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Open fractures
Fractures with a higher degree
Old fractures
History of underlying disease
Dislocations and other fractures associated with type 1 fractures
Children outside the age range studied
Parents' dissatisfaction with the child's participation in the study
And not referring for follow-up after treatment</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>S42.45</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Fracture of lateral condyle of humerus</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: After Closed Reduction under C_Arm and pinning, smooth pins with a diameter of 1.5 to 2 mm will be used according to the patient's weight and age.</i_keyword>
      <i_keyword>Control group: Non-surgical treatment in one group will be performed using a long cast on 90 degrees of elbow flexion in the pronation position.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Range of motion of the elbow joint. Timepoint: two weeks. Method of measurement: Goniometer.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Bone union. Timepoint: monthly. Method of measurement: Radiography.</sec_outcome>
      <sec_outcome>Elbow joint stiffness. Timepoint: Monthly. Method of measurement: Physical examination.</sec_outcome>
      <sec_outcome>Wound infection at the site of the pins. Timepoint: two weeks. Method of measurement: Physical examination.</sec_outcome>
      <sec_outcome>Bone necrosis. Timepoint: Monthly. Method of measurement: Radiography.</sec_outcome>
      <sec_outcome>Cubitus varus. Timepoint: Monthly. Method of measurement: 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>Kerman University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-04-10</approval_date>
        <contact_name>Ethics Committee of Kerman University of Medical Sciences</contact_name>
        <contact_address>West First, Sixth Alley, Vahshi Bafghi Street Kerman Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
