xml: <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/NCT06029764</url>
    </required_header>
    <id_info>
      <org_study_id>XuanwuASD</org_study_id>
      <nct_id>NCT06029764</nct_id>
    </id_info>
    <brief_title>Extended One-level Interbody Fusion for Adjacent Vacuum Phenomenon in Lumbar Degenerative Disc Disease</brief_title>
    <official_title>Extended One-level Interbody Fusion for Adjacent Vacuum Phenomenon in Lumbar Degenerative Disc Disease</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Xuanwu Hospital, Beijing</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Xuanwu Hospital, Beijing</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The main objective of this study was to validate the clinical effectiveness of interbody&#xD;
        fusion with a one-segment extension for the treatment of adjacent segmental space discs in&#xD;
        the surgical treatment of lumbar degeneration.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The study will include patients with lumbar degeneration who underwent 1-2 segment interbody&#xD;
        fusion, and for patients with vacuum signs but no symptoms and no instability of the discs in&#xD;
        the adjacent segments of the operated segments, lumbar interbody fusion will be extended by&#xD;
        one segment, and the patients will be followed up annually in the immediate postoperative&#xD;
        period, in March, June, and in the period of 1-5 years, and lumbar MR will be taken at the&#xD;
        time of follow-up to determine the degree of progression of the degeneration in the&#xD;
        neighboring segments, and whether or not revision surgery is needed. The lumbar spine was&#xD;
        photographed in the frontal and lateral + anterior flexion and posterior extension X-rays and&#xD;
        CT-3D reconstruction to determine the bony fusion of the interbody fusion. In addition, the&#xD;
        lumbar spine ODI score was applied for evaluation at the follow-up visit, and the total&#xD;
        lumbar spine-related expenses of the patients up to the follow-up visit were recorded.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">February 1, 2023</start_date>
    <completion_date type="Anticipated">January 1, 2029</completion_date>
    <primary_completion_date type="Anticipated">January 1, 2028</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>
      <intervention_model_description>This study will use a simple randomization method to group patients who meet the inclusion criteria using a computer-generated randomization scheme.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Surgical revision rate</measure>
      <time_frame>Postoperative month 3 (±15 days), month 6 (±15 days), yearly for 5 years (±30 days)</time_frame>
      <description>MR of the lumbar spine was taken at follow-up to determine the degree of progression of degeneration in the neighboring segments and the need for revision surgery.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">126</enrollment>
    <condition>Adjacent Segment Degeneration</condition>
    <arm_group>
      <arm_group_label>experimental group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The study will enroll patients with lumbar degeneration undergoing 1-2 level intervertebral fusion, and for patients with asymptomatic and non-instability intervertebral discs adjacent to the operative level with vacuum signs, extended one-level interbody fusion will be performed.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>control group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>The control group underwent intervertebral fusion only at the responsible segment.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>extended one-level interbody fusion</intervention_name>
      <description>For patients who have vacuum signs in the intervertebral disc adjacent to the surgical segment but are asymptomatic and not unstable, the intervertebral fusion surgery is extended to one segment and followed up immediately after surgery, 3 months, 6 months, and annually within 1 to 5 years. Take lumbar spine MR to determine the degree of degeneration progression of adjacent segments and whether revision surgery is needed. Take X-rays of the lumbar spine in frontal and lateral + flexion and extension positions, and CT-three-dimensional reconstruction to judge the bony fusion of the intervertebral fusion.</description>
      <arm_group_label>experimental group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  The age was between 18-60 years old; patients with lumbar degeneration required 1-2&#xD;
               segment interbody fusion, and there were vacuum signs but no symptoms and no&#xD;
               instability of the discs in the adjacent segments (power position slip ≤3mm and&#xD;
               segmental angle change ≤10°); they agreed with the surgical plan and were willing to&#xD;
               undergo long-term clinical follow-up, and signed an informed consent form.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Drug or alcohol abusers; those with abnormal liver or kidney function unsuitable for&#xD;
               surgery; those with cardiac insufficiency unsuitable for surgery; those with severe&#xD;
               metabolic and endocrine diseases unsuitable for surgery; those with severe lung&#xD;
               disorders such as asthma and abnormal lung function unsuitable for surgery; pregnant&#xD;
               and breastfeeding women as well as those who are planning to become pregnant in the&#xD;
               near future; those who have participated in other clinical trials within 3 months; and&#xD;
               those who are not suitable for participation in the experiment in the opinion of the&#xD;
               investigator.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Fengzeng Jian, MD,PhD</last_name>
      <role>Study Chair</role>
      <affiliation>Xuanwu Hospital, Beijing</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Hao Wu, MD,PhD</last_name>
      <phone>13901397527</phone>
      <email>13901397527@139.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Fengzeng Jian, MD,PhD</last_name>
      <phone>135 5206 7268</phone>
      <email>fengzengjian@hotmail.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Xuanwu Hospital, Capital Medical University</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Hao Wu, MD,PhD</last_name>
        <phone>139 0139 7527</phone>
        <email>13901397527@139.com</email>
      </contact>
      <contact_backup>
        <last_name>Fengzeng jian, MD,PhD</last_name>
        <phone>135 5206 7268</phone>
        <email>fengzengjian@hotmail.com</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <results_reference>
      <citation>Kanna RM, Hajare S, Thippeswamy PB, Shetty AP, Rajasekaran S. Advanced disc degeneration, bi-planar instability and pathways of peri-discal gas suffusion contribute to pathogenesis of intradiscal vacuum phenomenon. Eur Spine J. 2022 Mar;31(3):755-763. doi: 10.1007/s00586-022-07122-0. Epub 2022 Jan 28.</citation>
      <PMID>35089418</PMID>
    </results_reference>
    <results_reference>
      <citation>Wang T, Ding W. Risk factors for adjacent segment degeneration after posterior lumbar fusion surgery in treatment for degenerative lumbar disorders: a meta-analysis. J Orthop Surg Res. 2020 Dec 3;15(1):582. doi: 10.1186/s13018-020-02032-7.</citation>
      <PMID>33272288</PMID>
    </results_reference>
    <results_reference>
      <citation>Ghiselli G, Wang JC, Bhatia NN, Hsu WK, Dawson EG. Adjacent segment degeneration in the lumbar spine. J Bone Joint Surg Am. 2004 Jul;86(7):1497-503. doi: 10.2106/00004623-200407000-00020.</citation>
      <PMID>15252099</PMID>
    </results_reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>September 1, 2023</study_first_submitted>
    <study_first_submitted_qc>September 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 8, 2023</study_first_posted>
    <last_update_submitted>September 1, 2023</last_update_submitted>
    <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</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>Intervertebral Disc Degeneration</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06029764
  org study id: XuanwuASD
  nct id: NCT06029764
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The main objective of this study was to validate the clinical effectiveness of interbody
        fusion with a one-segment extension for the treatment of adjacent segmental space discs in
        the surgical treatment of lumbar degeneration.
  The study will include patients with lumbar degeneration who underwent 1-2 segment interbody
        fusion, and for patients with vacuum signs but no symptoms and no instability of the discs in
        the adjacent segments of the operated segments, lumbar interbody fusion will be extended by
        one segment, and the patients will be followed up annually in the immediate postoperative
        period, in March, June, and in the period of 1-5 years, and lumbar MR will be taken at the
        time of follow-up to determine the degree of progression of the degeneration in the
        neighboring segments, and whether or not revision surgery is needed. The lumbar spine was
        photographed in the frontal and lateral + anterior flexion and posterior extension X-rays and
        CT-3D reconstruction to determine the bony fusion of the interbody fusion. In addition, the
        lumbar spine ODI score was applied for evaluation at the follow-up visit, and the total
        lumbar spine-related expenses of the patients up to the follow-up visit were recorded.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: This study will use a simple randomization method to group patients who meet the inclusion criteria using a computer-generated randomization scheme.
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Surgical revision rate
  time frame: Postoperative month 3 (±15 days), month 6 (±15 days), yearly for 5 years (±30 days)
  description: MR of the lumbar spine was taken at follow-up to determine the degree of progression of degeneration in the neighboring segments and the need for revision surgery.
  arm group label: experimental group
  arm group type: Experimental
  description: The study will enroll patients with lumbar degeneration undergoing 1-2 level intervertebral fusion, and for patients with asymptomatic and non-instability intervertebral discs adjacent to the operative level with vacuum signs, extended one-level interbody fusion will be performed.
  arm group label: control group
  arm group type: No Intervention
  description: The control group underwent intervertebral fusion only at the responsible segment.
  intervention type: Procedure
  intervention name: extended one-level interbody fusion
  description: For patients who have vacuum signs in the intervertebral disc adjacent to the surgical segment but are asymptomatic and not unstable, the intervertebral fusion surgery is extended to one segment and followed up immediately after surgery, 3 months, 6 months, and annually within 1 to 5 years. Take lumbar spine MR to determine the degree of degeneration progression of adjacent segments and whether revision surgery is needed. Take X-rays of the lumbar spine in frontal and lateral + flexion and extension positions, and CT-three-dimensional reconstruction to judge the bony fusion of the intervertebral fusion.
  arm group label: experimental group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 60 Years
  healthy volunteers: No
  last name: Fengzeng Jian, MD,PhD
  role: Study Chair
  affiliation: Xuanwu Hospital, Beijing
  last name: Hao Wu, MD,PhD
  phone: 13901397527
  email: 13901397527@139.com
  last name: Fengzeng Jian, MD,PhD
  phone: 135 5206 7268
  email: fengzengjian@hotmail.com
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: China
  citation: Kanna RM, Hajare S, Thippeswamy PB, Shetty AP, Rajasekaran S. Advanced disc degeneration, bi-planar instability and pathways of peri-discal gas suffusion contribute to pathogenesis of intradiscal vacuum phenomenon. Eur Spine J. 2022 Mar;31(3):755-763. doi: 10.1007/s00586-022-07122-0. Epub 2022 Jan 28.
  PMID: 35089418
  citation: Wang T, Ding W. Risk factors for adjacent segment degeneration after posterior lumbar fusion surgery in treatment for degenerative lumbar disorders: a meta-analysis. J Orthop Surg Res. 2020 Dec 3;15(1):582. doi: 10.1186/s13018-020-02032-7.
  PMID: 33272288
  citation: Ghiselli G, Wang JC, Bhatia NN, Hsu WK, Dawson EG. Adjacent segment degeneration in the lumbar spine. J Bone Joint Surg Am. 2004 Jul;86(7):1497-503. doi: 10.2106/00004623-200407000-00020.
  PMID: 15252099
  responsible party type: Sponsor
  mesh term: Intervertebral Disc Degeneration
  sharing ipd: No