<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/NCT02972190</url>
  </required_header>
  <id_info>
    <org_study_id>SNPHO-161107</org_study_id>
    <nct_id>NCT02972190</nct_id>
  </id_info>
  <brief_title>Clinical Study of Bilateral Decompression With Interbody Fusion for Spondylolisthesis</brief_title>
  <official_title>Clinical Study of Bilateral Decompression With Interbody Fusion for Spondylolisthesis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University</source>
  <brief_summary>
    <textblock>
      Laminectomy with PLIF has been shown to achieve satisfactory clinical outcomes, but it leads&#xD;
      to potential adverse consequences associated with extensive disruption of posterior bony and&#xD;
      soft-tissue structures. The investigators plan to compare the clinical and radiographic&#xD;
      outcomes of bilateral decompression with transforaminal lumbar interbody fusion and&#xD;
      laminectomy with posterior lumbar interbody fusion in the treatment of degenerative&#xD;
      spondylolisthesis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>November 2016</start_date>
  <completion_date type="Anticipated">October 2020</completion_date>
  <primary_completion_date type="Anticipated">October 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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>visual analog scale for low back pain and leg pain</measure>
    <time_frame>2 years postoperatively</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Oswestry disability index</measure>
    <time_frame>2 years postoperatively</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Zurich claudication questionnaire</measure>
    <time_frame>2 years postoperatively</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>SF-36 score</measure>
    <time_frame>2 years postoperatively</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Fusion rate</measure>
    <time_frame>2 years postoperatively</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Surgery procedure duration</measure>
    <time_frame>Intraoperation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Estimated blood loss</measure>
    <time_frame>Intraoperation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of postoperative hospital stay</measure>
    <time_frame>1 week after hospital discharge</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complication</measure>
    <time_frame>2 years postoperatively</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Degree of spondylolisthesis measured by X ray</measure>
    <time_frame>2 years postoperatively</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disc space height measured by X ray</measure>
    <time_frame>2 years postoperatively</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lumbar lordosis measured by X ray</measure>
    <time_frame>2 years postoperatively</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">90</enrollment>
  <condition>Lumbar Spondylolisthesis</condition>
  <arm_group>
    <arm_group_label>Bilateral decompression with TLIF</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients undergoing bilateral decompression with TLIF</description>
  </arm_group>
  <arm_group>
    <arm_group_label>laminectomy with PLIF</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients undergoing laminectomy with PLIF</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Bilateral decompression with TLIF</intervention_name>
    <description>Bilateral decompression of neural elements combined with TLIF</description>
    <arm_group_label>Bilateral decompression with TLIF</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>laminectomy with PLIF</intervention_name>
    <description>Decompression of neural elements using laminectomy combined with PLIF</description>
    <arm_group_label>laminectomy with PLIF</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Pedicle screw and interbody cage</intervention_name>
    <description>Pedicle screw and interbody cage</description>
    <arm_group_label>Bilateral decompression with TLIF</arm_group_label>
    <arm_group_label>laminectomy with PLIF</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. lumbar spondylolisthesis&#xD;
&#xD;
          2. symptoms of low back pain and/or neurogenic claudication with or without radiculopathy&#xD;
             referable to the lumbar spine,&#xD;
&#xD;
          3. at least 3 months of failed conservative therapies&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. multilevel lumbar degenerative diseases&#xD;
&#xD;
          2. history of previous lumbar surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Xiaofei Cheng, MD</last_name>
    <phone>8613917556604</phone>
    <email>chengxf2015@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Department of Orthopedic Surgery, Shanghai Ninth People's Hospital</name>
      <address>
        <city>Shanghai</city>
        <zip>200011</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xiaofei Cheng, MD</last_name>
      <phone>8613917556604</phone>
      <email>chengxf2015@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 7, 2016</study_first_submitted>
  <study_first_submitted_qc>November 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 23, 2016</study_first_posted>
  <last_update_submitted>November 24, 2016</last_update_submitted>
  <last_update_submitted_qc>November 24, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 28, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University</investigator_affiliation>
    <investigator_full_name>Xiaofei Cheng</investigator_full_name>
    <investigator_title>M.D.</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/NCT02972190
org study id: SNPHO-161107
nct id: NCT02972190
lead sponsor: 
Laminectomy with PLIF has been shown to achieve satisfactory clinical outcomes, but it leads
      to potential adverse consequences associated with extensive disruption of posterior bony and
      soft-tissue structures. The investigators plan to compare the clinical and radiographic
      outcomes of bilateral decompression with transforaminal lumbar interbody fusion and
      laminectomy with posterior lumbar interbody fusion in the treatment of degenerative
      spondylolisthesis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: visual analog scale for low back pain and leg pain
time frame: 2 years postoperatively
measure: Oswestry disability index
time frame: 2 years postoperatively
measure: Zurich claudication questionnaire
time frame: 2 years postoperatively
measure: SF-36 score
time frame: 2 years postoperatively
measure: Fusion rate
time frame: 2 years postoperatively
measure: Surgery procedure duration
time frame: Intraoperation
measure: Estimated blood loss
time frame: Intraoperation
measure: Length of postoperative hospital stay
time frame: 1 week after hospital discharge
measure: Complication
time frame: 2 years postoperatively
measure: Degree of spondylolisthesis measured by X ray
time frame: 2 years postoperatively
measure: Disc space height measured by X ray
time frame: 2 years postoperatively
measure: Lumbar lordosis measured by X ray
time frame: 2 years postoperatively
arm group label: Bilateral decompression with TLIF
arm group type: Experimental
description: Patients undergoing bilateral decompression with TLIF
arm group label: laminectomy with PLIF
arm group type: Active Comparator
description: Patients undergoing laminectomy with PLIF
intervention type: Procedure
intervention name: Bilateral decompression with TLIF
description: Bilateral decompression of neural elements combined with TLIF
arm group label: Bilateral decompression with TLIF
intervention type: Procedure
intervention name: laminectomy with PLIF
description: Decompression of neural elements using laminectomy combined with PLIF
arm group label: laminectomy with PLIF
intervention type: Device
intervention name: Pedicle screw and interbody cage
description: Pedicle screw and interbody cage
arm group label: Bilateral decompression with TLIF
arm group label: laminectomy with PLIF
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Xiaofei Cheng, MD
phone: 8613917556604
email: chengxf2015@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
investigator full name: Xiaofei Cheng
investigator title: M.D.
mesh term: Spondylolisthesis