<?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>IRCT20201124049484N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-01-06</date_registration>
      <primary_sponsor>Kashan University of Medical Sciences</primary_sponsor>
      <public_title>The effects of early weight-bearing and mobilization after internal fixation of unstable ankle fractures</public_title>
      <acronym></acronym>
      <scientific_title>The effects of early weight-bearing and mobilization on the outcomes of patients with unstable ankle fractures after internal fixation surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-01-09</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/52563</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: First, the intervention group (early weight-bearing) was coded with the letter A and the control group with the letter B, and then using the website www. sealedenvelope.com/simple-randomiser/v1/lists, randomization list was prepared by selecting a sample size of 52 (two groups of 26) and permuted block randomization method (block size=4) (13 blocks of 4). Then, through the obtained randomization list, the subjects included in the study will be assigned to one of the two groups A or B (Based on the entry order). For example, suppose that in the first four blocks, the permutation method is ABBA, so the first and fourth samples will be assigned to group A and the second and third samples to group B and the same will continue until the last sample (52th person).</study_design>
      <phase>N/A</phase>
      <hc_freetext>Unstable ankle fracture.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In this group, weight-bearing and mobilization will begin 2 weeks after internal fixation surgery of the ankle fracture (early weight-bearing and mobilization) (n = 25). Intervention 2: Control group: In this group, 6 weeks after internal fixation surgery of the ankle fracture, weight-bearing and mobilization will begin (n = 25).</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 There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Davood Dehghani Ashkezari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Beheshti Hospital, Ghotbe Ravandi Boulevard, Kashan</address>
        <city>Kashan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8115187159</zip>
        <telephone>+98 31 5554 0026</telephone>
        <email>Davooddehghani@kaums.ac.ir</email>
        <affiliation>Kashan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Davood Dehghani Ashkezari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Beheshti Hospital, Ghotbe Ravandi Boulevard, Kashan</address>
        <city>Kashan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8115187159</zip>
        <telephone>+98 31 5554 0026</telephone>
        <email>Davooddehghani@kaums.ac.ir</email>
        <affiliation>Kashan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients who aged 18 to 65 Years
Unstable fractures of lateral malleolus with or without talar shift
Unstable fractures of the medial malleolus or vertical fractures of the medial malleolus
Bimalleolar fractures
Trimalleolar fractures (fractures involved less than 25% of posterior malleolus and do not require posterior malleolus surgery)
Closed fractures and open fractures of grade 1 and grade 2</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Immature skeleton
Previous ankle surgery
The need for medical care preventing other practical interventions
Impossibility to follow the protocol after the operation
Surgery after more than 14 days from the time of injury
Concurrent posterior malleolus fracture with involvement of more than 25%
Open grade 3 fractures
Concurrent Syndesmosis Injury</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>S82</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Fracture of lower leg, including ankle</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In this group, weight-bearing and mobilization will begin 2 weeks after internal fixation surgery of the ankle fracture (early weight-bearing and mobilization) (n = 25)</i_keyword>
      <i_keyword>Control group: In this group, 6 weeks after internal fixation surgery of the ankle fracture, weight-bearing and mobilization will begin (n = 25)</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Time required to return to work. Timepoint: 2 weeks, 6 weeks, 3 months, 6 months and 1 year after surgery. Method of measurement: Checklist.</prim_outcome>
      <prim_outcome>The time required to bear the full body weight. Timepoint: 2 weeks, 6 weeks, 3 months, 6 months and 1 year after surgery. Method of measurement: Checklist.</prim_outcome>
      <prim_outcome>Olerud-Molander Ankle Score. Timepoint: 2 weeks, 6 weeks, 3 months, 6 months and 1 year after surgery. Method of measurement: Olerud-Molander Ankle Score Checklist.</prim_outcome>
      <prim_outcome>Time required for physiotherapy. Timepoint: 2 weeks, 6 weeks, 3 months, 6 months and 1 year after surgery. Method of measurement: By asking patients.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Wound complications (Delay in healing, infection and etc). Timepoint: 2 weeks, 6 weeks, 3 months, 6 months and 1 year after surgery. Method of measurement: Physical examination.</sec_outcome>
      <sec_outcome>Need for reoperation. Timepoint: 2 weeks, 6 weeks, 3 months, 6 months and 1 year after surgery. Method of measurement: Checklist.</sec_outcome>
      <sec_outcome>Incidence of nonunion. Timepoint: 2 weeks, 6 weeks, 3 months, 6 months and 1 year after surgery. Method of measurement: Plain radiography (X-ray).</sec_outcome>
      <sec_outcome>Incidence of malunion. Timepoint: 2 weeks, 6 weeks, 3 months, 6 months and 1 year after surgery. Method of measurement: Plain radiography (X-ray).</sec_outcome>
      <sec_outcome>Range of motion in ankle joint. Timepoint: 2 weeks, 6 weeks, 3 months, 6 months and 1 year after surgery. Method of measurement: Physical examination.</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>Vice chancellor for research, Kashan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-11-11</approval_date>
        <contact_name>Ethics committee of Kashan University of Medical Sciences</contact_name>
        <contact_address>Kashan University of Medical Sciences, Pezeshk Boulevard, Ghotbe Ravandi Boulevard, Kashan Kashan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
