<?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>IRCT20191210045682N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-04-09</date_registration>
      <primary_sponsor>akhtar bone and joint research center</primary_sponsor>
      <public_title>a less invasive surgery for pelvic fracture</public_title>
      <acronym>MIAPF</acronym>
      <scientific_title>A Novel Minimally Invasive Approach for Anterior Pelvic Ring fracture Fixation in patients with pelvic fracture</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-03-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>18</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/44209</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: low blood loss - minor incision- better recovery- low pain after surgery.</study_design>
      <phase>2</phase>
      <hc_freetext>anterior pelvic ring fracture.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:  patients who were refered to akhtar hospital with ant.pelvic ring fx.                                                             in our study:Under general or local anesthesia, patients were positioned on a radio-transparent operation table in the supine position. Preparation and drape of the skin was from above the umbilicus to the upper third of the lower extremities. The MIAPF started with a transversely 1-inch-long incision over the pubic symphysis. With the intact abdominal rectus muscle, the position and path of screw was defined and optimized with a 2.7 mm drill bit with the help of C-ARM ﬂuoroscopic 2D images.A 3-hole reconstruction plate was fixed in the pubis body of the intact side with two 3.5 mm cortical screws. Then a long cortical screw (Synthes, Switzerland) was placed in the fracture site according to the previously-planed path with drill bit. The length of the screws varied from 80 to 120 mm, depending on the anatomy of the patient’s pelvis. If bilateral anterior pelvic fracture was present, then two long cortical screws (Synthes, Switzerland)  were placed in bilateral fracture sites through three hole reconstruction plate. Intervention 2: Control group: control group was the patients who dosent accept this technique  and treated with previouse  procedures.the fan incision&amp; fixation with bigger plate and screw.</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:
bleeding. time of surgery. complication of surgery

When:
any time

To whom:
orthopaedic student. orthopaedic surgion

Conditions:
to compare with other method of surgery of pelvic ring fx

Where to obtain:
by  Email  from ali asghar alamian or seyyed mohammad qoerishy

How to obtain:
email or phone call

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>seyyed mohammad qureishy</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>sharifimanesh blv. azar street</address>
        <city>tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>199545658474</zip>
        <telephone>+98 21 2664 0307</telephone>
        <email>shahramalamian@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>ali asghar alamian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>qavampor ave.</address>
        <city>tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1995758464</zip>
        <telephone>+98 21 8803 1255</telephone>
        <email>shahramalamian@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>pelvic fracture which is nearby the symphisis
fractures that include classification nakatani type 1</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>fractures which are  nakatani type 2 or 3
patient dosent  accept this surgery
fractures with comminution of  ramus that cant be fixed with this procedure</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M00-M99</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Biomechanical lesions, not elsewhere classified, Pyogenic arthritis</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:  patients who were refered to akhtar hospital with ant.pelvic ring fx.                                                             in our study:Under general or local anesthesia, patients were positioned on a radio-transparent operation table in the supine position. Preparation and drape of the skin was from above the umbilicus to the upper third of the lower extremities. The MIAPF started with a transversely 1-inch-long incision over the pubic symphysis. With the intact abdominal rectus muscle, the position and path of screw was defined and optimized with a 2.7 mm drill bit with the help of C-ARM ﬂuoroscopic 2D images.A 3-hole reconstruction plate was fixed in the pubis body of the intact side with two 3.5 mm cortical screws. Then a long cortical screw (Synthes, Switzerland) was placed in the fracture site according to the previously-planed path with drill bit. The length of the screws varied from 80 to 120 mm, depending on the anatomy of the patient’s pelvis. If bilateral anterior pelvic fracture was present, then two long cortical screws (Synthes, Switzerland)  were placed in bilateral fracture sites through three hole reconstruction plate.</i_keyword>
      <i_keyword>Control group: control group was the patients who dosent accept this technique  and treated with previouse  procedures.the fan incision&amp; fixation with bigger plate and screw</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Bleeding  amount in this method. Timepoint: during surgery. Method of measurement: volume of suction&amp; number of strile gauze.</prim_outcome>
      <prim_outcome>Infection rate after surgery. Timepoint: after 1and 2 week.3month. 1year. Method of measurement: physical exame.</prim_outcome>
      <prim_outcome>Duration time of surgery. Timepoint: during surgery. Method of measurement: record by surgery nurse.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>A smaller incision. Timepoint: during  surgery. Method of measurement: ruller.</sec_outcome>
      <sec_outcome>Lower pain. Timepoint: just after surgery 1.2 weeks after that. Method of measurement: patients scoring 1to 10.</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>akhtar hospital</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-03-12</approval_date>
        <contact_name>ethics committee of shahid beheshti university of medical science</contact_name>
        <contact_address>sheykh bahaie. ghavam pour. tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
