<?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>IRCT20241220064110N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-01-16</date_registration>
      <primary_sponsor>Neurosurgery Department, Pir Abdul Qadir Shah Jeelani Institute of Medical Sciences Gambat,</primary_sponsor>
      <public_title>Efficacy of Non-instrumented Versus Instrumented Fusion in Anterior Cervical Discectomy</public_title>
      <acronym>ACDF-NI</acronym>
      <scientific_title>Comparing the Efficacy of Non-instrumented Versus Instrumented Fusion in Anterior Cervical Discectomy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-05-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>48</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/81024</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: simple randomization based on individual unit was done using a lottery method in a concealed envelop, mentioning the name of intervention group, Blinding description: in this study, the only participants of study i.e patients were blinded only regarding which type of intervention they will receives. The investigators and care takers were fully aware about the intervention groups and provided upto the mark care.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Degenerative cervical disease.</hc_freetext>
      <i_freetext>Intervention 1: Anterior Cervical Dissectomy and fusion will serve as the Intervention group. After induction under general anesthesia, in a supine postion, a layer-by-layer blunt dissection will be performed. Discectomy was performed with loupe magnification to achieve precise surgical intervention. During surgery in cases of hypertrophy and OPLL posterior longitudinal ligament and dura matter were severed, foramina patency was assessed and stenosis was relieved with foraminotomy. Bone graft was placed with graft cage and anterior interlocking was done at specific positions. Plate positioning and sagittal alignment were confirmed intraoperatively using fluoroscopy. Intervention 2: Anterior Cervical Dissectomy will serve as the Control group:  After induction under general anesthesia, in a supine postion, a layer-by-layer blunt dissection will be performed. Only Discectomy will be performed with loupe magnification to achieve precise surgical intervention.</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:
Comparing the efficacy of non-instrumented versus instrumented fusion in anterior cervical discectomy; as soon as the study is completed, there is plan to a share the document as well as data

When:
Data will be available publicly forever

To whom:
To all the medical fraternity

Conditions:
document can be used for similar studies, esp carrying out meta-analysis

Where to obtain:
Data will be shared on demand via email, as well as from the publishers site

How to obtain:
Just a simple email will be required.

Comments:
Comparing the efficacy of non-instrumented versus instrumented fusion in anterior cervical discectomy, this work has been done with great responsibility, dedication, and honesty. It will be a rich source of decision-making for neurosurgeons.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Tahir Shahab</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Pir Abdul Qadir Shah Jeelani Institute of Medical Sciences, Gambat Station Road, Pakistan</address>
        <city>Gambat</city>
        <country1>Pakistan</country1>
        <zip>66080</zip>
        <telephone>+92 332 2358385</telephone>
        <email>dr.tahirshahab@gmail.com</email>
        <affiliation>Neurosurgery Department, Pir Abdul Qadir Shah Jeelani Institute of Medical Sciences Gambat,</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Tahir Shahab</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Pir Abdul Qadir Shah Jeelani Institute of Medical Sciences, Gambat Station Road, Pakistan</address>
        <city>Gambat</city>
        <country1>Pakistan</country1>
        <zip>66080</zip>
        <telephone>+92 332 2358385</telephone>
        <email>dr.tahirshahab@gmail.com</email>
        <affiliation>Neurosurgery Department, Pir Abdul Qadir Shah Jeelani Institute of Medical Sciences Gambat,</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients aged 18-65 years
of both genders
Patients of degenerative cervical disease
Patients with failed conservative management plan
Patients who developed neurological deficits</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with a history of any cardiac disease
Cervical radiculopathy from below 12 weeks
Patients with two-level disease
Patients who developed neurological deficits of advanced stage
Diabetic patients with neuropathy,
Patients unfit for general anesthesia</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M50.30</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other cervical disc degeneration, unspecified cervical region</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Surgery</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Anterior Cervical Dissectomy and fusion will serve as the Intervention group. After induction under general anesthesia, in a supine postion, a layer-by-layer blunt dissection will be performed. Discectomy was performed with loupe magnification to achieve precise surgical intervention. During surgery in cases of hypertrophy and OPLL posterior longitudinal ligament and dura matter were severed, foramina patency was assessed and stenosis was relieved with foraminotomy. Bone graft was placed with graft cage and anterior interlocking was done at specific positions. Plate positioning and sagittal alignment were confirmed intraoperatively using fluoroscopy.</i_keyword>
      <i_keyword>Anterior Cervical Dissectomy will serve as the Control group:  After induction under general anesthesia, in a supine postion, a layer-by-layer blunt dissection will be performed. Only Discectomy will be performed with loupe magnification to achieve precise surgical intervention</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain Reduction. Timepoint: 12 weeks after the intervention. Method of measurement: VAS score for pain.</prim_outcome>
      <prim_outcome>Recovery Rate. Timepoint: 12 weeks after the intervention. Method of measurement: Time of recovery.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Length of hospital stay. Timepoint: hospital stay. Method of measurement: days of hospital stay.</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>Neurosurgery Department, Pir Abdul Qadir Shah Jeelani Institute of Medical Sciences Gambat,</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-04-01</approval_date>
        <contact_name>Institutional Ethical Review Board, Gambat</contact_name>
        <contact_address>Pir Abdul Qadir Shah Jeelani Institute of Medical Sciences, Gambat Station Road, Pakistan Gambat Sindh Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
