<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/NCT02985138</url>
  </required_header>
  <id_info>
    <org_study_id>SNPHO-161116</org_study_id>
    <nct_id>NCT02985138</nct_id>
  </id_info>
  <brief_title>Comparison of Unilateral or Bilateral Fixation in the Treatment of LFS</brief_title>
  <official_title>Comparison of Unilateral or Bilateral Fixation Using Pedicle Screws and TLIF in the Treatment of Lumbar Foraminal Stenosis</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>
      TLIF is a popular lumbar fusion technique to perform interbody fusion. Pedicle screws&#xD;
      providing initial stability have been developed to correct deformity, improve the rate of&#xD;
      fusion and speed patient's postoperative recovery. Conventionally, bilateral pedicle screw&#xD;
      fixation is a standard approach. Recently, studies have revealed that unilateral pedicle&#xD;
      screw fixation provides equivalent clinical outcomes and fusion rates as compared with&#xD;
      bilateral pedicle screw fixation in lumbar fusion. Meanwhile, the unilateral approach can&#xD;
      reduce intraoperative blood loss and operating time. To our knowledge, few randomized&#xD;
      controlled studies comparing unilateral versus bilateral instrumented TLIF in lumbar&#xD;
      degenerative diseases have been reported. The purpose of this study is to compare clinical&#xD;
      and radiographic outcomes in a series of patients with lumbar foraminal stenosis using&#xD;
      instrumented TLIF with unilateral or bilateral pedicle screw fixation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2016</start_date>
  <completion_date type="Actual">September 2021</completion_date>
  <primary_completion_date type="Actual">September 2021</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Visual Analogue Scale (VAS) scores</measure>
    <time_frame>2 years postoperatively</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adverse events related to procedure</measure>
    <time_frame>2 years postoperatively</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Operative duration</measure>
    <time_frame>1 week postoperatively</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Estimated blood loss</measure>
    <time_frame>1 week postoperatively</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of hospital stay</measure>
    <time_frame>1 week after discharge</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Spinal angles</measure>
    <time_frame>2 years postoperatively</time_frame>
    <description>Radiographic parameters</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intervertebral space height</measure>
    <time_frame>2 years postoperatively</time_frame>
    <description>Radiographic parameters</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Foraminal height</measure>
    <time_frame>2 years postoperatively</time_frame>
    <description>Radiographic parameters</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost of treatment</measure>
    <time_frame>2 years postoperatively</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fusion rate</measure>
    <time_frame>2 years postoperatively</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oswestry Disability Index (ODI)</measure>
    <time_frame>2 years postoperatively</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">53</enrollment>
  <condition>Lumbar Foraminal Stenosis</condition>
  <arm_group>
    <arm_group_label>Unilateral fixation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients undergoing TLIF and unilateral pedicle screw fixation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Bilateral fixation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients undergoing TLIF and bilateral pedicle screw fixation</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>TLIF and unilateral pedicle screw fixation</intervention_name>
    <description>TLIF combined with posterior unilateral pedicle screw fixation</description>
    <arm_group_label>Unilateral fixation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>TLIF and bilateral pedicle screw fixation</intervention_name>
    <description>TLIF combined with posterior bilateral pedicle screw fixation</description>
    <arm_group_label>Bilateral fixation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Pedicle screw and cage</intervention_name>
    <description>Pedicle screw and cage</description>
    <arm_group_label>Bilateral fixation</arm_group_label>
    <arm_group_label>Unilateral fixation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Signed informed consent.&#xD;
&#xD;
          -  Patient is willing to be available for each examination scheduled over the study&#xD;
             duration.&#xD;
&#xD;
          -  Lumbar foraminal stenosis diagnosed by patient history, physical examination and image&#xD;
             confirmation.&#xD;
&#xD;
          -  Patient has symptoms referable to the stenosis level (low back pain, leg pain,&#xD;
             tingling, numbness or weakness), which are relieved after a selective nerve root&#xD;
             block.&#xD;
&#xD;
          -  Has not responded to conservative treatment for a period of 3 months (e.g. bed rest,&#xD;
             physical therapy, medication, manipulations, other).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Has systemic infection, highly communicable diseases, inflammatory or autoimmune&#xD;
             disease (e.g. osteomyelitis, crohn's, rheumatoid arthritis, systemic lupus, gout,&#xD;
             HIV/AIDS, active tuberculosis, venereal disease, active hepatitis).&#xD;
&#xD;
          -  Has presence of active malignancy&#xD;
&#xD;
          -  Has a history of severe allergy&#xD;
&#xD;
          -  Has a significant medical history that, in the investigator's opinion, would not make&#xD;
             them a good study candidate.&#xD;
&#xD;
          -  Pregnant, or may become pregnant within follow-up period of study&#xD;
&#xD;
          -  Has other spinal conditions that will interfere with clinical outcomes (e.g. spinal&#xD;
             structural deformities, spinal fractures, ankylosing spondylitis, spinal tuberculosis,&#xD;
             spinal infection, spinal tumors, symptomatic cervical spinal disease)&#xD;
&#xD;
          -  Spondylolisthesis at the target level&#xD;
&#xD;
          -  Has undergone previous lumbar surgery&#xD;
&#xD;
          -  Has severe osteoporosis (T-score ≤ -3.5)&#xD;
&#xD;
          -  BMI &gt; 35kg/m2&#xD;
&#xD;
          -  Has a diagnosis, which requires postoperative medication that interferes with fusion,&#xD;
             such as steroids.&#xD;
&#xD;
          -  Has history of endocrine or metabolic disorder known to affect osteogenesis (e.g.&#xD;
             Paget's disease, renal osteodystrophy, Ehlers-Danios syndrome or osteogenesis&#xD;
             imperfecta)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <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>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>November 23, 2016</study_first_submitted>
  <study_first_submitted_qc>December 4, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 7, 2016</study_first_posted>
  <last_update_submitted>January 8, 2022</last_update_submitted>
  <last_update_submitted_qc>January 8, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 25, 2022</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>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Constriction, Pathologic</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/NCT02985138
org study id: SNPHO-161116
nct id: NCT02985138
lead sponsor: 
TLIF is a popular lumbar fusion technique to perform interbody fusion. Pedicle screws
      providing initial stability have been developed to correct deformity, improve the rate of
      fusion and speed patient's postoperative recovery. Conventionally, bilateral pedicle screw
      fixation is a standard approach. Recently, studies have revealed that unilateral pedicle
      screw fixation provides equivalent clinical outcomes and fusion rates as compared with
      bilateral pedicle screw fixation in lumbar fusion. Meanwhile, the unilateral approach can
      reduce intraoperative blood loss and operating time. To our knowledge, few randomized
      controlled studies comparing unilateral versus bilateral instrumented TLIF in lumbar
      degenerative diseases have been reported. The purpose of this study is to compare clinical
      and radiographic outcomes in a series of patients with lumbar foraminal stenosis using
      instrumented TLIF with unilateral or bilateral pedicle screw fixation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Visual Analogue Scale (VAS) scores
time frame: 2 years postoperatively
measure: Adverse events related to procedure
time frame: 2 years postoperatively
measure: Operative duration
time frame: 1 week postoperatively
measure: Estimated blood loss
time frame: 1 week postoperatively
measure: Length of hospital stay
time frame: 1 week after discharge
measure: Spinal angles
time frame: 2 years postoperatively
description: Radiographic parameters
measure: Intervertebral space height
time frame: 2 years postoperatively
description: Radiographic parameters
measure: Foraminal height
time frame: 2 years postoperatively
description: Radiographic parameters
measure: Cost of treatment
time frame: 2 years postoperatively
measure: Fusion rate
time frame: 2 years postoperatively
measure: Oswestry Disability Index (ODI)
time frame: 2 years postoperatively
arm group label: Unilateral fixation
arm group type: Experimental
description: Patients undergoing TLIF and unilateral pedicle screw fixation
arm group label: Bilateral fixation
arm group type: Active Comparator
description: Patients undergoing TLIF and bilateral pedicle screw fixation
intervention type: Procedure
intervention name: TLIF and unilateral pedicle screw fixation
description: TLIF combined with posterior unilateral pedicle screw fixation
arm group label: Unilateral fixation
intervention type: Procedure
intervention name: TLIF and bilateral pedicle screw fixation
description: TLIF combined with posterior bilateral pedicle screw fixation
arm group label: Bilateral fixation
intervention type: Device
intervention name: Pedicle screw and cage
description: Pedicle screw and cage
arm group label: Bilateral fixation
arm group label: Unilateral fixation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
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: Principal Investigator
mesh term: Constriction, Pathologic