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/NCT05978375</url>
    </required_header>
    <id_info>
      <org_study_id>XW-NS-PROIAAD</org_study_id>
      <nct_id>NCT05978375</nct_id>
    </id_info>
    <brief_title>A Prospective Cohort Study of for Surgical Treatment of Irreducible Atlantoaxial Dislocation</brief_title>
    <official_title>A Prospective Cohort Study of for Surgical Treatment of Irreducible Atlantoaxial Dislocation</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 management of irreducible atlantoaxial dislocation associated is challenging. Direct&#xD;
        posterior distraction technique we proposed in 2010 could achieve satisfactory reduction. In&#xD;
        2020, we modified this technique and proposed a posterior intra-articular distraction&#xD;
        technique. The intra-articular distraction technique could theoretically achieve satisfactory&#xD;
        reduction and fusion. However, its superiority has not been proven. Therefore, we design a&#xD;
        prospective study to compare the reduction rate and fusion rate of different strategies.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">September 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">September 1, 2025</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>Fusion Rates</measure>
      <time_frame>12 months</time_frame>
      <description>Atlantoaixal fusion rates</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Japanese Orthopaedic Association Scores</measure>
      <time_frame>12 months</time_frame>
      <description>0-17 Scores</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Visual Analogue Scale</measure>
      <time_frame>12 months</time_frame>
      <description>0-10 Scores</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Neck Disability Index</measure>
      <time_frame>12 months</time_frame>
      <description>0-5 Scores</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Atlantoaxial Dislocation</condition>
    <arm_group>
      <arm_group_label>Irreducible Atlantoaxial Dislocation</arm_group_label>
      <description>Atlantoaxial dislocation which could not be reducted under anesthesia traction with 1/6 weight.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Posterior intra-articular distraction and fusion</intervention_name>
      <description>Using reduction using posterior intra-articular distraction and fusion technique.</description>
      <arm_group_label>Irreducible Atlantoaxial Dislocation</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Anterior transoral release and posterior cantilever reduction and fusion</intervention_name>
      <description>Using anterior transoral release and posterior cantilever reduction and fusion technique.</description>
      <arm_group_label>Irreducible Atlantoaxial Dislocation</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>TARP</intervention_name>
      <description>Using TARP technique.</description>
      <arm_group_label>Irreducible Atlantoaxial Dislocation</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          18-70, exclude traumatic, RA and previous surgery.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          CT indicated atlantoaxial dislocation Agree with the operation plan Agree to be followed up&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          The pathology is traumatic or RA Underwent operations in occipital-cervical region before&#xD;
          With mortal diseases Without ability to sign papers&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Zan Chen, MD</last_name>
      <phone>+8613911712120</phone>
      <email>chenzan66@163.com</email>
    </overall_contact>
    <reference>
      <citation>Chen Z, Duan W, Chou D, Guan J, Liu Z, Jian Q, Zhang B, Bo X, Jian F. A Safe and Effective Posterior Intra-Articular Distraction Technique to Treat Congenital Atlantoaxial Dislocation Associated With Basilar Invagination: Case Series and Technical Nuances. Oper Neurosurg (Hagerstown). 2021 Mar 15;20(4):334-342. doi: 10.1093/ons/opaa391.</citation>
      <PMID>33372978</PMID>
    </reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 30, 2023</study_first_submitted>
    <study_first_submitted_qc>July 30, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>August 20, 2023</last_update_submitted>
    <last_update_submitted_qc>August 20, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 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>Joint Dislocations</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</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/NCT05978375
  org study id: XW-NS-PROIAAD
  nct id: NCT05978375
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The management of irreducible atlantoaxial dislocation associated is challenging. Direct
        posterior distraction technique we proposed in 2010 could achieve satisfactory reduction. In
        2020, we modified this technique and proposed a posterior intra-articular distraction
        technique. The intra-articular distraction technique could theoretically achieve satisfactory
        reduction and fusion. However, its superiority has not been proven. Therefore, we design a
        prospective study to compare the reduction rate and fusion rate of different strategies.
  observational model: Cohort
  time perspective: Prospective
  measure: Fusion Rates
  time frame: 12 months
  description: Atlantoaixal fusion rates
  measure: Japanese Orthopaedic Association Scores
  time frame: 12 months
  description: 0-17 Scores
  measure: Visual Analogue Scale
  time frame: 12 months
  description: 0-10 Scores
  measure: Neck Disability Index
  time frame: 12 months
  description: 0-5 Scores
  arm group label: Irreducible Atlantoaxial Dislocation
  description: Atlantoaxial dislocation which could not be reducted under anesthesia traction with 1/6 weight.
  intervention type: Procedure
  intervention name: Posterior intra-articular distraction and fusion
  description: Using reduction using posterior intra-articular distraction and fusion technique.
  arm group label: Irreducible Atlantoaxial Dislocation
  intervention type: Procedure
  intervention name: Anterior transoral release and posterior cantilever reduction and fusion
  description: Using anterior transoral release and posterior cantilever reduction and fusion technique.
  arm group label: Irreducible Atlantoaxial Dislocation
  intervention type: Procedure
  intervention name: TARP
  description: Using TARP technique.
  arm group label: Irreducible Atlantoaxial Dislocation
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: No
  last name: Zan Chen, MD
  phone: +8613911712120
  email: chenzan66@163.com
  citation: Chen Z, Duan W, Chou D, Guan J, Liu Z, Jian Q, Zhang B, Bo X, Jian F. A Safe and Effective Posterior Intra-Articular Distraction Technique to Treat Congenital Atlantoaxial Dislocation Associated With Basilar Invagination: Case Series and Technical Nuances. Oper Neurosurg (Hagerstown). 2021 Mar 15;20(4):334-342. doi: 10.1093/ons/opaa391.
  PMID: 33372978
  responsible party type: Sponsor
  mesh term: Joint Dislocations
  sharing ipd: Undecided