<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/NCT02971644</url>
  </required_header>
  <id_info>
    <org_study_id>HebeiU_001</org_study_id>
    <nct_id>NCT02971644</nct_id>
  </id_info>
  <brief_title>Cobalt Alloy Pedicle Screw Implantation for Severe Kyphosis Deformity in Spinal Tuberculosis</brief_title>
  <official_title>Cobalt Alloy Pedicle Screw Implantation for Severe Kyphosis Deformity in Spinal Tuberculosis: a Selfcontrolled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Affiliated Hospital of Hebei University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Affiliated Hospital of Hebei University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To investigate whether implantation of cobalt alloy pedicle screws is effective in treating&#xD;
      severe kyphosis deformity in spinal tuberculosis, and to determine the factors that are&#xD;
      likely to have influenced the curative effects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      History and current related studies The incidence of spinal tuberculosis has continually&#xD;
      increased in recent years; this disease commonly occurs in the lumbar spine, lumbar&#xD;
      vertebrae, thoracic vertebrae, and cervical vertebrae. The majority of spinal tuberculosis&#xD;
      patients present with kyphosis deformity in corresponding segments. In spinal tuberculosis&#xD;
      patients with severe kyphotic deformity, the key to successful treatment is the individual&#xD;
      patient's response to tuberculosis drugs and the implementation of rational fixation&#xD;
      approaches at an appropriate time; good curative effects have been shown using anterior or&#xD;
      posterior fixation, followed by posterior debridement and bone graft fusion.&#xD;
&#xD;
      Surgery via the posterior or anterior approach will be respectively performed in 16 of 32&#xD;
      patients with tuberculosis of the lumbar spine. The spinal cord function of these 32 patients&#xD;
      has been assessed as Frankel grade C (n = 7), D (n = 14) and E (n = 11). The primary outcome&#xD;
      measure of this study will be the Cobb angle at the thoracic spine segments preoperatively&#xD;
      versus 2 years postoperatively, which will be used to evaluate the postoperative change in&#xD;
      the thoracic spine curvature. The primary causes of poor healing or recurrence of spinal&#xD;
      tuberculosis at the thoracic and lumbar segments are reportedly improper surgical timing,&#xD;
      poor debridement, improper selection of internal fixation methods, poor selection of bone&#xD;
      graft material or grafting position, irregular anti-tuberculosis bacilli chemotherapy, drug&#xD;
      tolerance, poor braking, and not using a brace after surgery. However, the factors that&#xD;
      influence curative effects require further investigation.&#xD;
&#xD;
      Pedicle screws are commonly used to repair spine fracture, and therefore they should have&#xD;
      good biocompatibility. Cobalt alloy reportedly exhibits good anti-bending and&#xD;
      anti-compressive strength, strong impact toughness, good elastic modulus, small thermal&#xD;
      expansion coefficient, and good compatibility with the human body. However, few studies have&#xD;
      investigated the use of cobalt alloy pedicle screws for treatment of severe kyphosis&#xD;
      deformity in spinal tuberculosis.&#xD;
&#xD;
      Adverse events The investigators will record adverse events, including vertebral body&#xD;
      displacement, thoracic and lumbar back muscle injury, nonspecific low back pain, and screw&#xD;
      pull out or loosening. If severe adverse events occur, investigators will report details,&#xD;
      including the data of occurrence and measures taken to treat the adverse events, to the&#xD;
      principle investigator and the institutional review board within 24 hours.&#xD;
&#xD;
      Data collection, management, analysis and open-access Data collection: Case report forms with&#xD;
      demographic data, disease diagnosis, accompanying diseases, drug allergy history, and adverse&#xD;
      events will be collected, processed using Epidata software (Epidata Association, Odense,&#xD;
      Denmark), collated, and then recorded electronically by data managers using a double-data&#xD;
      entry strategy.&#xD;
&#xD;
      Data management: The locked electronic database will be accessible and locked only by the&#xD;
      project manager, and will not be altered. All data regarding this trial will be preserved by&#xD;
      the Affiliated Hospital of Hebei University, China.&#xD;
&#xD;
      Data analysis: The electronic database will be statistically analyzed by a professional&#xD;
      statistician who will create an outcome analysis report that will be submitted to the lead&#xD;
      researchers. An independent data monitoring committee will supervise the mange the trial&#xD;
      data, ensuring a scientific and stringent trial to yield accurate and complete data.&#xD;
&#xD;
      Data open access: Anonymized trial data will be published at www.figshare.com.&#xD;
&#xD;
      Statistical analysis Statistical analysis will be performed using SPSS 19.0 software, and&#xD;
      will follow the intention-to-treat principle. Normally distributed measurement data will be&#xD;
      expressed as mean ± standard deviation, and minimums and maximums. Non-normally distributed&#xD;
      measurement data will be expressed as lower quartile (q1), and median and upper quartile&#xD;
      (q3). The Wilcoxon matched pairs test will be performed for comparison of the Cobb angle&#xD;
      preoperatively versus 2 years postoperatively. The Wilcoxon signed-rank test will be&#xD;
      performed for comparison of pre- and post-operative Frankel grade, and McNemar's chi-squared&#xD;
      test will be used to analyze the incidence of adverse reactions. Multiple logistic regression&#xD;
      analysis will be performed to analyze the factors that influence curative effects, with&#xD;
      calculation of regression coefficients, odd ratios and 95% confidence interval. The&#xD;
      significance level will be α = 0.05.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>December 2014</start_date>
  <completion_date type="Anticipated">December 2016</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>Cobb angle</measure>
    <time_frame>2 years postoperatively</time_frame>
    <description>A greater Cobb angle indicates more severe kyphosis deformity.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>X-ray image</measure>
    <time_frame>baseline and 2 years postoperatively</time_frame>
    <description>Anterior-posterior X-ray images of the scoliotic spine will be taken using a digital X-ray scanner.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frankel Grade</measure>
    <time_frame>baseline and 2 years postoperatively</time_frame>
    <description>To evaluate the recovery of spinal cord function. The Frankel Grade classification is used to assess the severity of spinal cord injury.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">84</enrollment>
  <condition>Spinal Tuberculosis</condition>
  <arm_group>
    <arm_group_label>cobalt alloy pedicle screw implantation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The spinal tuberculosis patients with severe kyphosis deformity who will undergo cobalt alloy pedicle screw implantation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>cobalt alloy pedicle screw implantation</intervention_name>
    <description>The patients with severe kyphosis deformity undergo cobalt alloy pedicle screw implantation.</description>
    <arm_group_label>cobalt alloy pedicle screw implantation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Meeting the diagnostic criteria of spinal tuberculosis&#xD;
&#xD;
          -  Diagnosed with spinal tuberculosis via X-ray or MRI&#xD;
&#xD;
          -  Spinal tuberculosis patients with severe kyphosis deformity at the thoracic and lumbar&#xD;
             segments and a spinal Cobb angle ≥ 90° complicated by spinal cord compression or&#xD;
             neurological dysfunction, spinal stability destruction and paravertebral abscess&#xD;
&#xD;
          -  Frankel grade C, D, or E&#xD;
&#xD;
          -  Age 24-67 years&#xD;
&#xD;
          -  Provision of complete medical data&#xD;
&#xD;
          -  Receiving anti-tuberculosis medication for 3 weeks&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to tolerate surgery&#xD;
&#xD;
          -  Other concomitant spine diseases&#xD;
&#xD;
          -  Unable or unwilling to participate in this clinical trial&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>24 Years</minimum_age>
    <maximum_age>67 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yu Hou, Master</last_name>
    <role>Principal Investigator</role>
    <affiliation>Affiliated Hospital of Hebei University</affiliation>
  </overall_official>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 14, 2016</study_first_submitted>
  <study_first_submitted_qc>November 20, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 23, 2016</study_first_posted>
  <last_update_submitted>November 20, 2016</last_update_submitted>
  <last_update_submitted_qc>November 20, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 23, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Affiliated Hospital of Hebei University</investigator_affiliation>
    <investigator_full_name>Yu Hou</investigator_full_name>
    <investigator_title>Associate Chief Physician</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tuberculosis</mesh_term>
    <mesh_term>Tuberculosis, Spinal</mesh_term>
    <mesh_term>Kyphosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cobalt</mesh_term>
  </intervention_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/NCT02971644
org study id: HebeiU_001
nct id: NCT02971644
lead sponsor: 
has dmc: Yes
To investigate whether implantation of cobalt alloy pedicle screws is effective in treating
      severe kyphosis deformity in spinal tuberculosis, and to determine the factors that are
      likely to have influenced the curative effects.
History and current related studies The incidence of spinal tuberculosis has continually
      increased in recent years; this disease commonly occurs in the lumbar spine, lumbar
      vertebrae, thoracic vertebrae, and cervical vertebrae. The majority of spinal tuberculosis
      patients present with kyphosis deformity in corresponding segments. In spinal tuberculosis
      patients with severe kyphotic deformity, the key to successful treatment is the individual
      patient's response to tuberculosis drugs and the implementation of rational fixation
      approaches at an appropriate time; good curative effects have been shown using anterior or
      posterior fixation, followed by posterior debridement and bone graft fusion.

      Surgery via the posterior or anterior approach will be respectively performed in 16 of 32
      patients with tuberculosis of the lumbar spine. The spinal cord function of these 32 patients
      has been assessed as Frankel grade C (n = 7), D (n = 14) and E (n = 11). The primary outcome
      measure of this study will be the Cobb angle at the thoracic spine segments preoperatively
      versus 2 years postoperatively, which will be used to evaluate the postoperative change in
      the thoracic spine curvature. The primary causes of poor healing or recurrence of spinal
      tuberculosis at the thoracic and lumbar segments are reportedly improper surgical timing,
      poor debridement, improper selection of internal fixation methods, poor selection of bone
      graft material or grafting position, irregular anti-tuberculosis bacilli chemotherapy, drug
      tolerance, poor braking, and not using a brace after surgery. However, the factors that
      influence curative effects require further investigation.

      Pedicle screws are commonly used to repair spine fracture, and therefore they should have
      good biocompatibility. Cobalt alloy reportedly exhibits good anti-bending and
      anti-compressive strength, strong impact toughness, good elastic modulus, small thermal
      expansion coefficient, and good compatibility with the human body. However, few studies have
      investigated the use of cobalt alloy pedicle screws for treatment of severe kyphosis
      deformity in spinal tuberculosis.

      Adverse events The investigators will record adverse events, including vertebral body
      displacement, thoracic and lumbar back muscle injury, nonspecific low back pain, and screw
      pull out or loosening. If severe adverse events occur, investigators will report details,
      including the data of occurrence and measures taken to treat the adverse events, to the
      principle investigator and the institutional review board within 24 hours.

      Data collection, management, analysis and open-access Data collection: Case report forms with
      demographic data, disease diagnosis, accompanying diseases, drug allergy history, and adverse
      events will be collected, processed using Epidata software (Epidata Association, Odense,
      Denmark), collated, and then recorded electronically by data managers using a double-data
      entry strategy.

      Data management: The locked electronic database will be accessible and locked only by the
      project manager, and will not be altered. All data regarding this trial will be preserved by
      the Affiliated Hospital of Hebei University, China.

      Data analysis: The electronic database will be statistically analyzed by a professional
      statistician who will create an outcome analysis report that will be submitted to the lead
      researchers. An independent data monitoring committee will supervise the mange the trial
      data, ensuring a scientific and stringent trial to yield accurate and complete data.

      Data open access: Anonymized trial data will be published at www.figshare.com.

      Statistical analysis Statistical analysis will be performed using SPSS 19.0 software, and
      will follow the intention-to-treat principle. Normally distributed measurement data will be
      expressed as mean ± standard deviation, and minimums and maximums. Non-normally distributed
      measurement data will be expressed as lower quartile (q1), and median and upper quartile
      (q3). The Wilcoxon matched pairs test will be performed for comparison of the Cobb angle
      preoperatively versus 2 years postoperatively. The Wilcoxon signed-rank test will be
      performed for comparison of pre- and post-operative Frankel grade, and McNemar's chi-squared
      test will be used to analyze the incidence of adverse reactions. Multiple logistic regression
      analysis will be performed to analyze the factors that influence curative effects, with
      calculation of regression coefficients, odd ratios and 95% confidence interval. The
      significance level will be α = 0.05.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Cobb angle
time frame: 2 years postoperatively
description: A greater Cobb angle indicates more severe kyphosis deformity.
measure: X-ray image
time frame: baseline and 2 years postoperatively
description: Anterior-posterior X-ray images of the scoliotic spine will be taken using a digital X-ray scanner.
measure: Frankel Grade
time frame: baseline and 2 years postoperatively
description: To evaluate the recovery of spinal cord function. The Frankel Grade classification is used to assess the severity of spinal cord injury.
arm group label: cobalt alloy pedicle screw implantation
arm group type: Experimental
description: The spinal tuberculosis patients with severe kyphosis deformity who will undergo cobalt alloy pedicle screw implantation.
intervention type: Device
intervention name: cobalt alloy pedicle screw implantation
description: The patients with severe kyphosis deformity undergo cobalt alloy pedicle screw implantation.
arm group label: cobalt alloy pedicle screw implantation
criteria: 
gender: All
minimum age: 24 Years
maximum age: 67 Years
healthy volunteers: No
last name: Yu Hou, Master
role: Principal Investigator
affiliation: Affiliated Hospital of Hebei University
responsible party type: Principal Investigator
investigator affiliation: Affiliated Hospital of Hebei University
investigator full name: Yu Hou
investigator title: Associate Chief Physician
mesh term: Tuberculosis
mesh term: Tuberculosis, Spinal
mesh term: Kyphosis
mesh term: Cobalt
sharing ipd: Undecided