<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/NCT02252185</url>
  </required_header>
  <id_info>
    <org_study_id>DPS-201303</org_study_id>
    <nct_id>NCT02252185</nct_id>
  </id_info>
  <brief_title>A Clinical Study of a Spine Fusion System in Vertebral Body Fusion Surgery</brief_title>
  <official_title>A Prospective, Multicenter, Randomized, Open-label, Controlled Study to Evaluate the Safety and Efficacy of a Spine Fusion System in Vertebral Body Fusion Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johnson &amp; Johnson Medical (Suzhou) Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Johnson &amp; Johnson Medical (Suzhou) Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of this study is to demonstrate that the efficacy and safety of Spine&#xD;
      fusion system manufactured in China is no inferior than imported product.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a prospective, multicenter, randomized, comparative, non-inferiority study&#xD;
      comparing the change of Japanese Orthopaedic Association Score from baseline at postoperative&#xD;
      24 weeks for patients implanted with local made Spine Fusion System versus imported products.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">September 2015</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>Change of Japanese Orthopaedic Association score</measure>
    <time_frame>Preoperation and 24week post operation</time_frame>
    <description>Questionnaire</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Improvement rate of Japanese Orthopaedic Association score</measure>
    <time_frame>7day, 12week, and 24week post operation</time_frame>
    <description>Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fixation stability</measure>
    <time_frame>12week, and 24week post operation</time_frame>
    <description>Fixation stability should be measured based on translational motion and angular motion which is demonstrated on X-Ray examination (A/P lateral, Flexion and extension).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visual Analogue Score of low back and leg pain</measure>
    <time_frame>7day, 12week, and 24week post operation</time_frame>
    <description>Visual Analogue Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Wound healing</measure>
    <time_frame>7day, 12week, and 24week post operation</time_frame>
    <description>would healing are classified as 3 classes. (Class I, Class II, Class III)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Adverse Events</measure>
    <time_frame>up to 24week post operation</time_frame>
    <description>Number of events</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">106</enrollment>
  <condition>Disc Degenerative Disease</condition>
  <condition>Spondylolisthesis</condition>
  <condition>Spinal Fracture</condition>
  <condition>Spinal Deformity</condition>
  <condition>Spinal Stenosis</condition>
  <condition>Spinal Tumor</condition>
  <arm_group>
    <arm_group_label>China made spine fusion system</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patents in this arm will be implanted with Johnson&amp;Johnson Medical Suzhou made Spine Fusion System.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Imported spine fusion system</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>patents in this arm will be implanted with Imported EXPEDIUM screws and OPAL cage .</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Johnson&amp;Johnson Medical Suzhou made Spine Fusion System</intervention_name>
    <description>interventional device is Spine Fusion System that is manufactured by Johnson &amp; Johnson Medical Suzhou Ltd.</description>
    <arm_group_label>China made spine fusion system</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Imported EXPEDIUM screws and OPAL cage</intervention_name>
    <description>Comparator in this study is active comparator.</description>
    <arm_group_label>Imported spine fusion system</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  20-70 years old, male or female;&#xD;
&#xD;
          -  Subject being diagnosed as having disc degeneration disease, spondylolisthesis, spinal&#xD;
             fracture, deformity(degenerative deformity), spinal stenosis, or spinal tumor, has&#xD;
             been treated with conservative treatment without relief or getting worse, who is&#xD;
             suitable for surgery according to clinic practice.&#xD;
&#xD;
          -  Subject is a suitable candidate for implanting investigational products described in&#xD;
             study protocols according to investigator's assessment;&#xD;
&#xD;
          -  Patient, in the opinion of the Clinical Investigator, is able to understand this&#xD;
             clinical investigation and willing to be available for each required study procedure&#xD;
             over the study duration.&#xD;
&#xD;
          -  Subject has been given voluntary, written informed consent to participate in this&#xD;
             clinical investigation and has authorized the transfer of his/her information to study&#xD;
             Sponsor.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient has a local or systemic infection.&#xD;
&#xD;
          -  Patient has had one or more previous non-fusion spinal surgery at the involved&#xD;
             level(s).&#xD;
&#xD;
          -  Patient without spinal deformity and requires fusion at 3 or more levels.&#xD;
&#xD;
          -  Has been previously diagnosed with osteopenia, osteoporosis, or osteomalacia to a&#xD;
             degree that spinal instrumentation would be contraindicated&#xD;
&#xD;
          -  Has presence of active malignancy&#xD;
&#xD;
          -  Has a medical condition with less than 1 year of life expectancy.&#xD;
&#xD;
          -  Pregnancy or women in lactation period.&#xD;
&#xD;
          -  Is grossly obese, i.e. Body Mass Index≥40.&#xD;
&#xD;
          -  Has a diagnosis, which requires postoperative medication or treatment that interferes&#xD;
             with fusion, such as steroids, chemotherapy, radiotherapy, growth factor (for more&#xD;
             than 3 months), Nonsteroidal Antiinflammatory Drugs(for more than 3 months), and etc.&#xD;
&#xD;
          -  Has history of endocrine or metabolic disorder known to affect osteogenesis (e.g.&#xD;
             uncontrolled Diabetes with medication, renal osteodystrophy, or osteogenesis&#xD;
             imperfect)&#xD;
&#xD;
          -  Alcoholic (taking more than 40g/day, equals to 100ml 50°Chinese liquor), smoking more&#xD;
             than 40 cigarettes/day, or Drug abuser;&#xD;
&#xD;
          -  Is currently participating in another investigational drug or device study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wei Tian</last_name>
    <role>Principal Investigator</role>
    <affiliation>Beijing Jishuitan Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Anhui Province Hospital</name>
      <address>
        <city>Hefei</city>
        <state>Anhui</state>
        <zip>230088</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beijing Jishuitan Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100035</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Henan Provincial People's Hospital</name>
      <address>
        <city>Zhengzhou</city>
        <state>Henan</state>
        <zip>450003</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jiangxi Provincial People's Hospital</name>
      <address>
        <city>Nanchang</city>
        <state>Jiangxi</state>
        <zip>330006</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shanghai Ruijin Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200025</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Xijing Hospital</name>
      <address>
        <city>Xi'an</city>
        <state>Shanxi</state>
        <zip>710032</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Xi'an Jiaotong University Medical College</name>
      <address>
        <city>Xi'an</city>
        <state>Shanxi</state>
        <zip>710061</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Kunming Medical College</name>
      <address>
        <city>Kunming</city>
        <state>Yunnan</state>
        <zip>650032</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>March 2015</verification_date>
  <study_first_submitted>September 24, 2014</study_first_submitted>
  <study_first_submitted_qc>September 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 30, 2014</study_first_posted>
  <last_update_submitted>December 2, 2015</last_update_submitted>
  <last_update_submitted_qc>December 2, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 3, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spinal Cord Neoplasms</mesh_term>
    <mesh_term>Spinal Neoplasms</mesh_term>
    <mesh_term>Spinal Stenosis</mesh_term>
    <mesh_term>Spondylolisthesis</mesh_term>
    <mesh_term>Intervertebral Disc Degeneration</mesh_term>
    <mesh_term>Spinal Fractures</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/NCT02252185
org study id: DPS-201303
nct id: NCT02252185
lead sponsor: 
has dmc: No
The primary objective of this study is to demonstrate that the efficacy and safety of Spine
      fusion system manufactured in China is no inferior than imported product.
This study is a prospective, multicenter, randomized, comparative, non-inferiority study
      comparing the change of Japanese Orthopaedic Association Score from baseline at postoperative
      24 weeks for patients implanted with local made Spine Fusion System versus imported products.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change of Japanese Orthopaedic Association score
time frame: Preoperation and 24week post operation
description: Questionnaire
measure: Improvement rate of Japanese Orthopaedic Association score
time frame: 7day, 12week, and 24week post operation
description: Questionnaire
measure: Fixation stability
time frame: 12week, and 24week post operation
description: Fixation stability should be measured based on translational motion and angular motion which is demonstrated on X-Ray examination (A/P lateral, Flexion and extension).
measure: Visual Analogue Score of low back and leg pain
time frame: 7day, 12week, and 24week post operation
description: Visual Analogue Scale
measure: Wound healing
time frame: 7day, 12week, and 24week post operation
description: would healing are classified as 3 classes. (Class I, Class II, Class III)
measure: Adverse Events
time frame: up to 24week post operation
description: Number of events
arm group label: China made spine fusion system
arm group type: Experimental
description: patents in this arm will be implanted with Johnson&Johnson Medical Suzhou made Spine Fusion System.
arm group label: Imported spine fusion system
arm group type: Active Comparator
description: patents in this arm will be implanted with Imported EXPEDIUM screws and OPAL cage .
intervention type: Device
intervention name: Johnson&Johnson Medical Suzhou made Spine Fusion System
description: interventional device is Spine Fusion System that is manufactured by Johnson & Johnson Medical Suzhou Ltd.
arm group label: China made spine fusion system
intervention type: Device
intervention name: Imported EXPEDIUM screws and OPAL cage
description: Comparator in this study is active comparator.
arm group label: Imported spine fusion system
criteria: 
gender: All
minimum age: 20 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Wei Tian
role: Principal Investigator
affiliation: Beijing Jishuitan Hospital
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: China
responsible party type: Sponsor
mesh term: Spinal Cord Neoplasms
mesh term: Spinal Neoplasms
mesh term: Spinal Stenosis
mesh term: Spondylolisthesis
mesh term: Intervertebral Disc Degeneration
mesh term: Spinal Fractures