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/NCT06027827</url>
    </required_header>
    <id_info>
      <org_study_id>XuanwuACDF</org_study_id>
      <nct_id>NCT06027827</nct_id>
    </id_info>
    <brief_title>Impact of Lateral Bone Grafting With Intraoperative Fusion in ACDF on Clinical Outcomes</brief_title>
    <official_title>Impact of Lateral Bone Grafting With Intraoperative Fusion in ACDF on Clinical Outcomes</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 purpose of this trial was to investigate the safety and efficacy of fuser lateral bone&#xD;
        grafting in ACDF. By observing the intervertebral bony fusion rate and clinical outcome&#xD;
        scores of patients after fusion device lateral bone grafting, it was verified whether the&#xD;
        fusion device lateral bone grafting approach could improve the bony fusion rate and clinical&#xD;
        outcome of ACDF.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The study will include patients who underwent 1-2 segment ACDF surgery, in addition to&#xD;
        conventional surgical operations, the appropriate amount of allograft bone was implanted in&#xD;
        the joint space of the hook vertebrae lateral to the fusion device, and X-rays and CTs were&#xD;
        reviewed in the immediate postoperative period, March, June, and December, to verify&#xD;
        intervertebral osseous fusion, as well as to observe the patient's clinical outcomes.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">December 1, 2022</start_date>
    <completion_date type="Anticipated">December 2024</completion_date>
    <primary_completion_date type="Anticipated">December 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Intervertebral bone fusion rate</measure>
      <time_frame>3rd month (±15 days), 6th month (±15 days), 1 year (±30 days) postoperatively</time_frame>
      <description>primary Indicator</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>JOA</measure>
      <time_frame>Preoperative, 7 days postoperative, 3rd month (±15 days), 6th month (±15 days), 1 year (±30 days)</time_frame>
      <description>Japanese Orthopaedic Association Scores</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">58</enrollment>
    <condition>Cervical Spondylosis</condition>
    <arm_group>
      <arm_group_label>experimental group</arm_group_label>
      <description>In addition to the central bone graft of the fusion cage, the lateral bone graft of the fusion cage was added.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>control group</arm_group_label>
      <description>Conventional bone grafting in the center of the fusion</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Addition of fusion device lateral bone graft</intervention_name>
      <description>In addition to the central bone graft of the fusion cage, the lateral bone graft of the fusion cage was added.</description>
      <arm_group_label>experimental group</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Between the ages of 18-60 years; patients with cervical spondylosis about to undergo 1-2&#xD;
          segment ACDF surgery&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age between 18-60 years old; patients with cervical spondylosis who were about to&#xD;
               undergo 1-2 segment ACDF surgery; agreement with the surgical plan and willingness to&#xD;
               undergo long-term clinical follow-up; and signing of 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>Fengzeng Jian, MD, PhD</last_name>
      <phone>135 5206 7268</phone>
      <email>fengzengjian@hotmail.com</email>
    </overall_contact>
    <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>Fengzeng jian, MD,PhD</last_name>
        <phone>135 5206 7268</phone>
        <email>fengzengjian@hotmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <results_reference>
      <citation>Epstein NE. A Review of Complication Rates for Anterior Cervical Diskectomy and Fusion (ACDF). Surg Neurol Int. 2019 Jun 7;10:100. doi: 10.25259/SNI-191-2019. eCollection 2019.</citation>
      <PMID>31528438</PMID>
    </results_reference>
    <results_reference>
      <citation>Fountas KN, Kapsalaki EZ, Nikolakakos LG, Smisson HF, Johnston KW, Grigorian AA, Lee GP, Robinson JS Jr. Anterior cervical discectomy and fusion associated complications. Spine (Phila Pa 1976). 2007 Oct 1;32(21):2310-7. doi: 10.1097/BRS.0b013e318154c57e.</citation>
      <PMID>17906571</PMID>
    </results_reference>
    <results_reference>
      <citation>Wewel JT, Kasliwal MK, Adogwa O, Deutsch H, O'Toole JE, Traynelis VC. Fusion rate following three- and four-level ACDF using allograft and segmental instrumentation: A radiographic study. J Clin Neurosci. 2019 Apr;62:142-146. doi: 10.1016/j.jocn.2018.11.040. Epub 2019 Jan 25.</citation>
      <PMID>30692036</PMID>
    </results_reference>
    <results_reference>
      <citation>Godlewski B, Bebenek A, Dominiak M, Karpinski G, Cieslik P, Pawelczyk T. PEEK versus titanium-coated PEEK cervical cages: fusion rate. Acta Neurochir (Wien). 2022 Jun;164(6):1501-1507. doi: 10.1007/s00701-022-05217-7. Epub 2022 Apr 26.</citation>
      <PMID>35471708</PMID>
    </results_reference>
    <results_reference>
      <citation>Samartzis D, Shen FH, Lyon C, Phillips M, Goldberg EJ, An HS. Does rigid instrumentation increase the fusion rate in one-level anterior cervical discectomy and fusion? Spine J. 2004 Nov-Dec;4(6):636-43. doi: 10.1016/j.spinee.2004.04.010.</citation>
      <PMID>15541695</PMID>
    </results_reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 30, 2023</study_first_submitted>
    <study_first_submitted_qc>August 30, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 7, 2023</study_first_posted>
    <last_update_submitted>August 30, 2023</last_update_submitted>
    <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 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>Spondylosis</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/NCT06027827
  org study id: XuanwuACDF
  nct id: NCT06027827
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this trial was to investigate the safety and efficacy of fuser lateral bone
        grafting in ACDF. By observing the intervertebral bony fusion rate and clinical outcome
        scores of patients after fusion device lateral bone grafting, it was verified whether the
        fusion device lateral bone grafting approach could improve the bony fusion rate and clinical
        outcome of ACDF.
  The study will include patients who underwent 1-2 segment ACDF surgery, in addition to
        conventional surgical operations, the appropriate amount of allograft bone was implanted in
        the joint space of the hook vertebrae lateral to the fusion device, and X-rays and CTs were
        reviewed in the immediate postoperative period, March, June, and December, to verify
        intervertebral osseous fusion, as well as to observe the patient's clinical outcomes.
  observational model: Cohort
  time perspective: Prospective
  measure: Intervertebral bone fusion rate
  time frame: 3rd month (±15 days), 6th month (±15 days), 1 year (±30 days) postoperatively
  description: primary Indicator
  measure: JOA
  time frame: Preoperative, 7 days postoperative, 3rd month (±15 days), 6th month (±15 days), 1 year (±30 days)
  description: Japanese Orthopaedic Association Scores
  arm group label: experimental group
  description: In addition to the central bone graft of the fusion cage, the lateral bone graft of the fusion cage was added.
  arm group label: control group
  description: Conventional bone grafting in the center of the fusion
  intervention type: Procedure
  intervention name: Addition of fusion device lateral bone graft
  description: In addition to the central bone graft of the fusion cage, the lateral bone graft of the fusion cage was added.
  arm group label: experimental group
  study pop: 
  sampling method: Probability Sample
  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: Fengzeng Jian, MD, PhD
  phone: 135 5206 7268
  email: fengzengjian@hotmail.com
  facility: 
  status: Recruiting
  contact: 
  country: China
  citation: Epstein NE. A Review of Complication Rates for Anterior Cervical Diskectomy and Fusion (ACDF). Surg Neurol Int. 2019 Jun 7;10:100. doi: 10.25259/SNI-191-2019. eCollection 2019.
  PMID: 31528438
  citation: Fountas KN, Kapsalaki EZ, Nikolakakos LG, Smisson HF, Johnston KW, Grigorian AA, Lee GP, Robinson JS Jr. Anterior cervical discectomy and fusion associated complications. Spine (Phila Pa 1976). 2007 Oct 1;32(21):2310-7. doi: 10.1097/BRS.0b013e318154c57e.
  PMID: 17906571
  citation: Wewel JT, Kasliwal MK, Adogwa O, Deutsch H, O'Toole JE, Traynelis VC. Fusion rate following three- and four-level ACDF using allograft and segmental instrumentation: A radiographic study. J Clin Neurosci. 2019 Apr;62:142-146. doi: 10.1016/j.jocn.2018.11.040. Epub 2019 Jan 25.
  PMID: 30692036
  citation: Godlewski B, Bebenek A, Dominiak M, Karpinski G, Cieslik P, Pawelczyk T. PEEK versus titanium-coated PEEK cervical cages: fusion rate. Acta Neurochir (Wien). 2022 Jun;164(6):1501-1507. doi: 10.1007/s00701-022-05217-7. Epub 2022 Apr 26.
  PMID: 35471708
  citation: Samartzis D, Shen FH, Lyon C, Phillips M, Goldberg EJ, An HS. Does rigid instrumentation increase the fusion rate in one-level anterior cervical discectomy and fusion? Spine J. 2004 Nov-Dec;4(6):636-43. doi: 10.1016/j.spinee.2004.04.010.
  PMID: 15541695
  responsible party type: Sponsor
  mesh term: Spondylosis
  sharing ipd: No