<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/NCT03768167</url>
  </required_header>
  <id_info>
    <org_study_id>Sohag2</org_study_id>
    <nct_id>NCT03768167</nct_id>
  </id_info>
  <brief_title>Corpectomy With Pyramesh Titanium Cage Reconstruction in Dorsolumber Metastatic Lesions</brief_title>
  <official_title>Posterolateral Corpectomy With Pyramesh Titanium Cage Reconstruction in Dorsolumber Metastatic Lesions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sohag University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sohag 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 vertebral column represents the most common bony site for metastasis with an incidence&#xD;
      ranged from 30% to 70% in patients with metastatic neoplasms. The dorsal spine carries the&#xD;
      highest frequent site for metastasis all over the vertebral column followed by the lumber&#xD;
      spine. These metastatic lesions are clinical entities that often necessitate a complex spinal&#xD;
      decompression and anterior reconstruction. Posterolateral approaches alone allow for&#xD;
      excellent decompression with transpedicular fixation and safe visualization of the neural&#xD;
      elements for corpectomy and reconstruction so the investigators can avoid the complications&#xD;
      that can be happened with the staged surgery.&#xD;
&#xD;
      Purpose: investigators' aim in the study is to report cases and evaluate investigators'&#xD;
      approach for fixation and assess the postoperative period regarding pain improvement and&#xD;
      neurological deficit.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      At neurosurgery department in Sohag faculty of medicine, Between August 2014 and August 2017,&#xD;
      26 patients with single dorsolumbar metastatic spinal lesions with vertebral body collapse&#xD;
      underwent a single-stage, circumferential corpectomy and anterior spinal reconstruction with&#xD;
      a pyramesh titanium cage via a midline, posterior and lateral approach. Investigators&#xD;
      included in the study patients with retropulsed fragment inside the canal that causes spinal&#xD;
      cord compression with neurological manifestation. Metastatic work up was done for cases.&#xD;
      Exclusion criteria include patients with more than one spinal metastases or extra-spinal&#xD;
      metastasis, patients with other comorbidities as cardiac ill patients, patients with chronic&#xD;
      renal failure and patients who received radiotherapy or chemotherapy within one year before&#xD;
      surgery. A preoperative neurological assessment, full laboratory investigations were done.&#xD;
      Investigators used the Quebec scale to assess the patients' improvement regarding pain, and&#xD;
      muscle power scale to evaluate the motor.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2014</start_date>
  <completion_date type="Actual">August 1, 2017</completion_date>
  <primary_completion_date type="Actual">August 1, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>(Quebec scale) to assess back pain in three years</measure>
    <time_frame>3 years</time_frame>
    <description>(Quebec Scale) the lower scale the better is the pain</description>
  </primary_outcome>
  <primary_outcome>
    <measure>(muscle power grading scale) to evaluate motor power using in three years</measure>
    <time_frame>3 years</time_frame>
    <description>(Muscle power grading) the higher the grade the better is the motor power</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">26</enrollment>
  <condition>Spinal Metastases</condition>
  <arm_group>
    <arm_group_label>patients with metastatic spinal lesions</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>corpectomy</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Posterolateral corpectomy</intervention_name>
    <description>Investigators' goal in this study is to report clinical series of 26 patients in Sohag university hospital with dorsolumbar metastatic lesions from different primaries treated by single-stage posterolateral circumferential corpectomy with reconstruction by a pyramesh titanium cage and account the degree of improvement regarding the pain.</description>
    <arm_group_label>patients with metastatic spinal lesions</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with retropulsed fragment inside the canal that causes spinal cord&#xD;
             compression with neurological manifestation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients with more than one spinal metastases or extra-spinal metastasis.&#xD;
&#xD;
          -  patients with other comorbidities as cardiac ill patients, patients with chronic renal&#xD;
             failure.&#xD;
&#xD;
          -  patients who received radiotherapy or chemotherapy within one year before surgery.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>33 Years</minimum_age>
    <maximum_age>67 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Roshdy A Elkhayat, Professor of neurosurgery</last_name>
    <role>Study Chair</role>
    <affiliation>Assuit faculty of medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ahmed Salaheldin Mohammed Saro</name>
      <address>
        <city>Sohag</city>
        <zip>82511</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 5, 2018</study_first_submitted>
  <study_first_submitted_qc>December 5, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 7, 2018</study_first_posted>
  <last_update_submitted>December 6, 2018</last_update_submitted>
  <last_update_submitted_qc>December 6, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 10, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sohag University</investigator_affiliation>
    <investigator_full_name>ahmed salaheldin mohammed saro</investigator_full_name>
    <investigator_title>Assistant professor of neurosurgery</investigator_title>
  </responsible_party>
  <keyword>Corpectomy</keyword>
  <keyword>Pyramesh</keyword>
  <keyword>Posterolateral</keyword>
  <keyword>Pediculectomy</keyword>
  <keyword>Facetectomies</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasm Metastasis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03768167
org study id: Sohag2
nct id: NCT03768167
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The vertebral column represents the most common bony site for metastasis with an incidence
      ranged from 30% to 70% in patients with metastatic neoplasms. The dorsal spine carries the
      highest frequent site for metastasis all over the vertebral column followed by the lumber
      spine. These metastatic lesions are clinical entities that often necessitate a complex spinal
      decompression and anterior reconstruction. Posterolateral approaches alone allow for
      excellent decompression with transpedicular fixation and safe visualization of the neural
      elements for corpectomy and reconstruction so the investigators can avoid the complications
      that can be happened with the staged surgery.

      Purpose: investigators' aim in the study is to report cases and evaluate investigators'
      approach for fixation and assess the postoperative period regarding pain improvement and
      neurological deficit.
At neurosurgery department in Sohag faculty of medicine, Between August 2014 and August 2017,
      26 patients with single dorsolumbar metastatic spinal lesions with vertebral body collapse
      underwent a single-stage, circumferential corpectomy and anterior spinal reconstruction with
      a pyramesh titanium cage via a midline, posterior and lateral approach. Investigators
      included in the study patients with retropulsed fragment inside the canal that causes spinal
      cord compression with neurological manifestation. Metastatic work up was done for cases.
      Exclusion criteria include patients with more than one spinal metastases or extra-spinal
      metastasis, patients with other comorbidities as cardiac ill patients, patients with chronic
      renal failure and patients who received radiotherapy or chemotherapy within one year before
      surgery. A preoperative neurological assessment, full laboratory investigations were done.
      Investigators used the Quebec scale to assess the patients' improvement regarding pain, and
      muscle power scale to evaluate the motor.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: (Quebec scale) to assess back pain in three years
time frame: 3 years
description: (Quebec Scale) the lower scale the better is the pain
measure: (muscle power grading scale) to evaluate motor power using in three years
time frame: 3 years
description: (Muscle power grading) the higher the grade the better is the motor power
arm group label: patients with metastatic spinal lesions
arm group type: Other
description: corpectomy
intervention type: Procedure
intervention name: Posterolateral corpectomy
description: Investigators' goal in this study is to report clinical series of 26 patients in Sohag university hospital with dorsolumbar metastatic lesions from different primaries treated by single-stage posterolateral circumferential corpectomy with reconstruction by a pyramesh titanium cage and account the degree of improvement regarding the pain.
arm group label: patients with metastatic spinal lesions
criteria: 
gender: All
minimum age: 33 Years
maximum age: 67 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Roshdy A Elkhayat, Professor of neurosurgery
role: Study Chair
affiliation: Assuit faculty of medicine
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Sohag University
investigator full name: ahmed salaheldin mohammed saro
investigator title: Assistant professor of neurosurgery
mesh term: Neoplasm Metastasis
sharing ipd: No