<?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>IRCT20230222057496N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-12-06</date_registration>
      <primary_sponsor>Hamedan University of Medical Sciences</primary_sponsor>
      <public_title>Comparison study of surgical methods of laminectomy with and without unilateral and bilateral lumbar pedicle screw fixation</public_title>
      <acronym></acronym>
      <scientific_title>Comparison study of surgical methods of laminectomy with and without unilateral and bilateral lumbar pedicle screw fixation in young patients with spinal canal stenosis: a randomized clinical trial.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-12-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>81</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/74019</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be included in the study as available sampling and will be randomly divided into three groups A, B, C based on permutation block design (rows of 6). Allocation concealment is done using a sealed envelope (the envelope contains letters) which will be opened in the operating room after the induction of the patient. The amount of electrocautery current voltage will be set the same in all patients.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Lumbar spine degenerative disease.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Laminectomy with unilateral fixation. Intervention 2: Intervention group: Laminectomy with bilateral fixation.</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:
The information of all participants without individual information will be published in the majority of tables as a general conclusion.

When:
After the end of the patient admission and the final analysis of the data

To whom:
The general public

Conditions:
In order to increase people's awareness in the field of laminar ectone surgery with and without prosthesis, to improve the clinical skills of patients in the field of choosing a more effective surgical method according to the lifestyle and clinical condition of patients.

Where to obtain:
Valid databases for publishing articles

How to obtain:
Refer to the desired database and use keywords to access the article

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Parisa hajilo</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 31, 61 Nevut Tawheed Square</address>
        <city>Qom</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3717195170</zip>
        <telephone>+98 25 3861 9252</telephone>
        <email>Parisahajilo73@gmail.com</email>
        <affiliation>Hamedan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>dr.ali mehrafshan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tawheed square, alley 9</address>
        <city>Qom</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3717195170</zip>
        <telephone>+98 25 3881 5722</telephone>
        <email>Alimehrafshan2@yahoo.com</email>
        <affiliation>Ghoum University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age range less than 40 years
observation of lumbar spinal stenosis in the L3-L5 range in magnetic imaging (a discopathy level at the level of L3-L4 or L4-L5 vertebrae)
use of conservative treatments for at least 6 weeks
BMI between 20-30
visual analog scale above 7 before surgery</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>40 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>The presence of any previous surgery in the lumbar region
Rheumatoid arthritis, osteoporosis, high blood pressure and uncontrolled diabetes, or the presence of any active infection in the body
Taking anti-coagulant drugs or any type of drug effective on wound healing, long-term use of opioids, smoking and other narcotic drugs before surgery to reduce pain
The presence of any pathological or discopathy material in other vertebrae</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G30-G32</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other degenerative diseases of the nervous system</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: Laminectomy with unilateral fixation</i_keyword>
      <i_keyword>Intervention group: Laminectomy with bilateral fixation</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Bleeding. Timepoint: during surgery. Method of measurement: Accumulated blood in the suction bottle and blood gases.</prim_outcome>
      <prim_outcome>Time of surgery. Timepoint: during surgery. Method of measurement: stopwatch.</prim_outcome>
      <prim_outcome>Pain. Timepoint: During surgery and 6 months after surgery. Method of measurement: Visual Analogue Scale.</prim_outcome>
      <prim_outcome>Rehabilitation. Timepoint: Before surgery. Method of measurement: Oswestry Disability Index.</prim_outcome>
      <prim_outcome>Quality of Life. Timepoint: Before surgery. Method of measurement: Varusherbon 36-item quality of life questionnaire.</prim_outcome>
      <prim_outcome>Wound Healing. Timepoint: Up to one month after surgery. Method of measurement: Southampton Wound Healing Assessment Scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Rehabilitation. Timepoint: 6 months after surgery. Method of measurement: Oswestry Disability Index.</sec_outcome>
      <sec_outcome>Quality of Life. Timepoint: 6 months after surgery. Method of measurement: Varusherbon 36-item quality of life questionnaire.</sec_outcome>
      <sec_outcome>Pain. Timepoint: 3 and 6 months after surgery. Method of measurement: مقیاس آنالوگ بینایی.</sec_outcome>
      <sec_outcome>Fution. Timepoint: 6 months after surgery. Method of measurement: Brantigan Steffee-Fraser scale.</sec_outcome>
      <sec_outcome>Adjacent segment disease. Timepoint: 6 months after surgery. Method of measurement: Prrmann grading system.</sec_outcome>
      <sec_outcome>Spondylolisthesis. Timepoint: 6 months after surgery. Method of measurement: meyerding classification.</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>Hamedan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-11-29</approval_date>
        <contact_name>Ethics Committee of Hamadan University of Medical Sciences</contact_name>
        <contact_address>5th floor, Central Headquarters of University of Medical Sciences, Shahid Fahmideh Blvd., Hamadan, Hamedan Hamadan Hamadan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
