<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/NCT02970578</url>
  </required_header>
  <id_info>
    <org_study_id>PutianU_001</org_study_id>
    <nct_id>NCT02970578</nct_id>
  </id_info>
  <brief_title>3D-printed Module-assisted Minimally Invasive Lumbar Pedicle Screw Placement</brief_title>
  <official_title>3D-printed Module-assisted Minimally Invasive Lumbar Pedicle Screw Placement: a Retrospective, Self-controlled, Open-label Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Affiliated Hospital of Putian University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Affiliated Hospital of Putian University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To explore the accuracy of 3D printed module assisted minimally invasive lumbar pedicle screw&#xD;
      placement using Quandrant system, and verify its feasibility of reducing error rate of screw&#xD;
      placement and postoperative complications.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      History and current related studies Pedicle screw fixation has been widely used in spinal&#xD;
      surgery, such as spinal fractures, lumbar spondylolisthesis, scoliosis, lumbar spinal&#xD;
      stenosis. However, difficulties in pedicle screw placement are unavoidable because of&#xD;
      anatomical variations in the spinal structure and spinal degeneration. Consequently, the&#xD;
      precise localization for screw placement is essential. If not, errors in screw placement will&#xD;
      result in reduced strength or even failure of the internal fixation, which may lead to a&#xD;
      series of injuries, including nerve root injury, dural sac tear, vascular injury and even&#xD;
      spinal cord injury. To conclude, it is urgent to improve the accuracy of screw placement and&#xD;
      reduce complications of screw placement in the pedicle screw fixation.&#xD;
&#xD;
      With the rapid adoption of digital medicine and 3D printing technology in orthopedic&#xD;
      practice, 3D techniques, based on preoperative high-resolution CT scan data, can&#xD;
      theoretically restore the three-dimensional structure of the bone. That is to say, the&#xD;
      investigators can present a detailed description of the complex anatomical structure of the&#xD;
      bone, to accurately make a preoperative plan and an intraoperative simulation. Numerous&#xD;
      evidences have been achieved with digital three-dimensional reconstruction and 3D techniques&#xD;
      to assist the posterior pedicle screw fixation in the treatment of spine lesions.&#xD;
&#xD;
      Adverse events Postoperative adverse events were recorded and reported to the Affiliated&#xD;
      Hospital of Putian Hospital within 24 hours.&#xD;
&#xD;
      Proper therapeutic measures could be performed if the following adverse events occurred,&#xD;
      including incision infection, back muscle pain, dural sac tear, vascular injury, nerve root&#xD;
      injury, spinal cord injury, screw falling off and loosening.&#xD;
&#xD;
      Data collection, management, analysis, and open access Baseline data were collected at the&#xD;
      day when the participants were enrolled in the study. Other data were collected&#xD;
      preoperatively, intraoperatively, postoperatively and during the follow-up. All data were&#xD;
      input using Epidata and saved electronically.&#xD;
&#xD;
      All data regarding this clinical study were preserved by the Affiliated Hospital of Putian&#xD;
      University, China.&#xD;
&#xD;
      All data were statistically analyzed by professional statisticians who were responsible for&#xD;
      completing an outcome analysis report that was submitted to the project manager who was&#xD;
      responsible for completing a research report. An independent data monitoring committee was&#xD;
      responsible for data monitoring and management throughout the entire trial.&#xD;
&#xD;
      Statistical analysis All data were statistically analyzed by statisticians using SPSS 19.0&#xD;
      software (IBM Corporation, Armonk, NY, USA) in accordance with the intention-to-treat&#xD;
      principle.&#xD;
&#xD;
      Normally distributed measurement data were expressed as means, standard deviations, minimums,&#xD;
      and maximums; non-normally distributed data were expressed as lower quartiles, medians, and&#xD;
      upper quartiles.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">November 2015</completion_date>
  <primary_completion_date type="Actual">June 2015</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>Accurate rate of screw placement</measure>
    <time_frame>during the operation</time_frame>
    <description>To assess whether the screw placement by 3D printed module navigation achieves the desired results. The higher value indicates the higher accuracy.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Lumbar CT imaging</measure>
    <time_frame>Baseline and month 6, month 24 after surgery</time_frame>
    <description>To observe the conditions of lumbar fixation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time of operation</measure>
    <time_frame>during the operation</time_frame>
    <description>To evaluate the speed of surgery. The shorter operation time indicates that this method is easier to operate.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Amount of intraoperative bleeding</measure>
    <time_frame>during the operation</time_frame>
    <description>To evaluate the conditions of intraoperative blood loss. Less blood loss indicates the higher improvement in the surgical quality by this method being studied.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Thoracolumbar; Spina Bifida</condition>
  <arm_group>
    <arm_group_label>3D printed module</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The patients underwent 3D printed module-assisted lumbar pedicle screw placement using the Quandrant system, aiming to restore the stability of the spine.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>3D printed module</intervention_name>
    <description>The patients underwent 3D printed module-assisted lumbar pedicle screw placement using the Quandrant system, aiming to restore the stability of the spine.</description>
    <arm_group_label>3D printed module</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Lumbar degenerative diseases as diagnosed by the criteria for diagnosis of lumbar&#xD;
             degenerative diseases&#xD;
&#xD;
          -  Indications for internal fixation in the degenerative lumbar spine&#xD;
&#xD;
          -  Lumbar single segment or multi-segment lesions&#xD;
&#xD;
          -  Average age 63 years&#xD;
&#xD;
          -  Provision of the informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Lumbar spine tumors, lumbar tuberculosis, trauma fractures or joint disorders&#xD;
&#xD;
          -  Lumbar infection or acute inflammation in the other parts of the body&#xD;
&#xD;
          -  Unable to undergo lumbar surgery due to surgical contraindications (coagulation&#xD;
             disorders) and poor cardiopulmonary function&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Haibin Lin, bachelor</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Affiliated Hospital of Putian University</affiliation>
  </overall_official>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 16, 2016</study_first_submitted>
  <study_first_submitted_qc>November 18, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 22, 2016</study_first_posted>
  <last_update_submitted>November 18, 2016</last_update_submitted>
  <last_update_submitted_qc>November 18, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 22, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Affiliated Hospital of Putian University</investigator_affiliation>
    <investigator_full_name>Haibin Lin</investigator_full_name>
    <investigator_title>Chief Physician</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spinal Dysraphism</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT02970578
org study id: PutianU_001
nct id: NCT02970578
lead sponsor: 
has dmc: Yes
To explore the accuracy of 3D printed module assisted minimally invasive lumbar pedicle screw
      placement using Quandrant system, and verify its feasibility of reducing error rate of screw
      placement and postoperative complications.
History and current related studies Pedicle screw fixation has been widely used in spinal
      surgery, such as spinal fractures, lumbar spondylolisthesis, scoliosis, lumbar spinal
      stenosis. However, difficulties in pedicle screw placement are unavoidable because of
      anatomical variations in the spinal structure and spinal degeneration. Consequently, the
      precise localization for screw placement is essential. If not, errors in screw placement will
      result in reduced strength or even failure of the internal fixation, which may lead to a
      series of injuries, including nerve root injury, dural sac tear, vascular injury and even
      spinal cord injury. To conclude, it is urgent to improve the accuracy of screw placement and
      reduce complications of screw placement in the pedicle screw fixation.

      With the rapid adoption of digital medicine and 3D printing technology in orthopedic
      practice, 3D techniques, based on preoperative high-resolution CT scan data, can
      theoretically restore the three-dimensional structure of the bone. That is to say, the
      investigators can present a detailed description of the complex anatomical structure of the
      bone, to accurately make a preoperative plan and an intraoperative simulation. Numerous
      evidences have been achieved with digital three-dimensional reconstruction and 3D techniques
      to assist the posterior pedicle screw fixation in the treatment of spine lesions.

      Adverse events Postoperative adverse events were recorded and reported to the Affiliated
      Hospital of Putian Hospital within 24 hours.

      Proper therapeutic measures could be performed if the following adverse events occurred,
      including incision infection, back muscle pain, dural sac tear, vascular injury, nerve root
      injury, spinal cord injury, screw falling off and loosening.

      Data collection, management, analysis, and open access Baseline data were collected at the
      day when the participants were enrolled in the study. Other data were collected
      preoperatively, intraoperatively, postoperatively and during the follow-up. All data were
      input using Epidata and saved electronically.

      All data regarding this clinical study were preserved by the Affiliated Hospital of Putian
      University, China.

      All data were statistically analyzed by professional statisticians who were responsible for
      completing an outcome analysis report that was submitted to the project manager who was
      responsible for completing a research report. An independent data monitoring committee was
      responsible for data monitoring and management throughout the entire trial.

      Statistical analysis All data were statistically analyzed by statisticians using SPSS 19.0
      software (IBM Corporation, Armonk, NY, USA) in accordance with the intention-to-treat
      principle.

      Normally distributed measurement data were expressed as means, standard deviations, minimums,
      and maximums; non-normally distributed data were expressed as lower quartiles, medians, and
      upper quartiles.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Accurate rate of screw placement
time frame: during the operation
description: To assess whether the screw placement by 3D printed module navigation achieves the desired results. The higher value indicates the higher accuracy.
measure: Lumbar CT imaging
time frame: Baseline and month 6, month 24 after surgery
description: To observe the conditions of lumbar fixation.
measure: Time of operation
time frame: during the operation
description: To evaluate the speed of surgery. The shorter operation time indicates that this method is easier to operate.
measure: Amount of intraoperative bleeding
time frame: during the operation
description: To evaluate the conditions of intraoperative blood loss. Less blood loss indicates the higher improvement in the surgical quality by this method being studied.
arm group label: 3D printed module
arm group type: Experimental
description: The patients underwent 3D printed module-assisted lumbar pedicle screw placement using the Quandrant system, aiming to restore the stability of the spine.
intervention type: Procedure
intervention name: 3D printed module
description: The patients underwent 3D printed module-assisted lumbar pedicle screw placement using the Quandrant system, aiming to restore the stability of the spine.
arm group label: 3D printed module
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Haibin Lin, bachelor
role: Principal Investigator
affiliation: The Affiliated Hospital of Putian University
responsible party type: Principal Investigator
investigator affiliation: The Affiliated Hospital of Putian University
investigator full name: Haibin Lin
investigator title: Chief Physician
mesh term: Spinal Dysraphism
sharing ipd: Undecided