<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03271060</url>
  </required_header>
  <id_info>
    <org_study_id>Lumbar spondylolisthesis</org_study_id>
    <nct_id>NCT03271060</nct_id>
  </id_info>
  <brief_title>Comparative Study Between Posterior Lumbar Interbody Fusion(PLIF) and Intertransverse Process Fusion in Treatment of Spodylolithesis</brief_title>
  <official_title>Comparative Study Between Posterior Lumbar Interbody Fusion(PLF) and Intertransverse Process Fusion in Treatment of Spodylolithesis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The first technique described for interbody fusion was the anterior lumbar interbody fusion&#xD;
      (ALIF).(20) For this technique, the intervertebral disc is accessed through a retroperitoneal&#xD;
      or transperitoneal approach.&#xD;
&#xD;
      While the posterior approach was first described by Russell Hibbs in 1911, in the 1950's,&#xD;
      Cloward (7)popularized the posterior approach for a posterior lumbar interbody fusion (PLIF).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this study we will try to identify the benefits and outcome of posterior lumbar interbody&#xD;
      fusion and inter transverse process bone graft fusion.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 1, 2017</start_date>
  <completion_date type="Anticipated">September 1, 2019</completion_date>
  <primary_completion_date type="Anticipated">August 30, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Posterior inter body fusion and inter transverse process bone graft</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Back pain</measure>
    <time_frame>1year postoperative</time_frame>
    <description>Back pain severity grading mild, moderate, severe</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Lumbar Spondylolisthesis</condition>
  <arm_group>
    <arm_group_label>Lumbar spondylolisthesis1</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Lumbar spondylolisthesis 2</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Posterior lumbar interbody fusion</intervention_name>
    <description>Lumbar fusion by screws and inter vertebral cage</description>
    <arm_group_label>Lumbar spondylolisthesis 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Inter transverse bone grafting</intervention_name>
    <description>Inter transverse process bone grafting by bone graft from illiac crest or other sites</description>
    <arm_group_label>Lumbar spondylolisthesis1</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  lumbar spondylolisthesis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  infection of lumbar spine&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Mahmoud Garamoun, Resident</last_name>
    <phone>201091123869</phone>
    <email>Garamoun.mahmoud@yahoo.com</email>
  </overall_contact>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 31, 2017</study_first_submitted>
  <study_first_submitted_qc>August 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 1, 2017</study_first_posted>
  <last_update_submitted>August 31, 2017</last_update_submitted>
  <last_update_submitted_qc>August 31, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 1, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Mahmoud Garamoun Abd El Zaher</investigator_full_name>
    <investigator_title>Doctor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spondylolisthesis</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03271060
org study id: Lumbar spondylolisthesis
nct id: NCT03271060
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The first technique described for interbody fusion was the anterior lumbar interbody fusion
      (ALIF).(20) For this technique, the intervertebral disc is accessed through a retroperitoneal
      or transperitoneal approach.

      While the posterior approach was first described by Russell Hibbs in 1911, in the 1950's,
      Cloward (7)popularized the posterior approach for a posterior lumbar interbody fusion (PLIF).
In this study we will try to identify the benefits and outcome of posterior lumbar interbody
      fusion and inter transverse process bone graft fusion.
allocation: Randomized
intervention model: Single Group Assignment
intervention model description: Posterior inter body fusion and inter transverse process bone graft
primary purpose: Treatment
masking: None (Open Label)
measure: Back pain
time frame: 1year postoperative
description: Back pain severity grading mild, moderate, severe
arm group label: Lumbar spondylolisthesis1
arm group type: Active Comparator
arm group label: Lumbar spondylolisthesis 2
arm group type: Active Comparator
intervention type: Procedure
intervention name: Posterior lumbar interbody fusion
description: Lumbar fusion by screws and inter vertebral cage
arm group label: Lumbar spondylolisthesis 2
intervention type: Procedure
intervention name: Inter transverse bone grafting
description: Inter transverse process bone grafting by bone graft from illiac crest or other sites
arm group label: Lumbar spondylolisthesis1
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Mahmoud Garamoun, Resident
phone: 201091123869
email: Garamoun.mahmoud@yahoo.com
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Mahmoud Garamoun Abd El Zaher
investigator title: Doctor
mesh term: Spondylolisthesis