<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/NCT03788200</url>
  </required_header>
  <id_info>
    <org_study_id>2018Kepler</org_study_id>
    <nct_id>NCT03788200</nct_id>
  </id_info>
  <brief_title>Randomized, Controlled Trial of Posterior C1-2 Fusion Versus Bracing Alone for Treatment of Type II Odontoid Process Fractures in the Elderly</brief_title>
  <official_title>Randomized, Controlled Trial of Posterior C1-2 Fusion Versus Bracing Alone for Treatment of Type II Odontoid Process Fractures in the Elderly</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rothman Institute Orthopaedics</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rothman Institute Orthopaedics</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>
      This prospective study addresses one of the most controversial topics in the treatment of&#xD;
      cervical spine trauma: the management of type II odontoid process fractures in the elderly.&#xD;
      It is the hypothesis that surgical treatment will result in improved functional outcome&#xD;
      measures, neck pain and mortality rates as compared with nonsurgical management. Furthermore,&#xD;
      it is hypothesized that surgical treatment of odontoid process fractures will limit hospital&#xD;
      re-admissions and development of medical complications secondary to prolonged immobilization&#xD;
      in a cervical orthosis and delayed surgery related to late fracture displacement, which are&#xD;
      often associated with non-operative care. Additionally, data from this study will be useful&#xD;
      in identifying patient-specific predictors of improved outcome which can be used to optimize&#xD;
      treatment algorithms and more effectively counsel patients who sustain these injuries.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">June 14, 2018</start_date>
  <completion_date type="Anticipated">October 2020</completion_date>
  <primary_completion_date type="Anticipated">October 2020</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>neck disability</measure>
    <time_frame>6 months post randomization</time_frame>
    <description>Measured by validated outcome measure NDI (Neck Disability Index)</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Odontoid Fracture</condition>
  <arm_group>
    <arm_group_label>post-injury bracing with rigid cervical collar</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Treatment arm #1 (8 weeks of post-injury bracing with rigid cervical collar): Participants randomized to this treatment arm will be treated with 8 weeks in a rigid cervical collar.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>posterior C1-2 instrumented fusion</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants randomized to this treatment arm will undergo posterior C1-2 instrumented fusion with either local bone grafting or autologous iliac crest bone grafting with or without allograft bone grafting. Bone grafting decision will be made by the treating surgeon. All remaining decisions surrounding medical and surgical care will be made by the attending spine surgeon involved in each case.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Bracing</intervention_name>
    <description>Treatment arm #1 (8 weeks of post-injury bracing with rigid cervical collar): Participants randomized to this treatment arm will be treated with 8 weeks in a rigid cervical collar.</description>
    <arm_group_label>post-injury bracing with rigid cervical collar</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>posterior C1-C2 instrumented fusion</intervention_name>
    <description>Treatment arm #2 (posterior C1-2 instrumented fusion): Participants randomized to this treatment arm will undergo posterior C1-2 instrumented fusion with either local bone grafting or autologous iliac crest bone grafting with or without allograft bone grafting. Bone grafting decision will be made by the treating surgeon. All remaining decisions surrounding medical and surgical care will be made by the attending spine surgeon involved in each case.</description>
    <arm_group_label>posterior C1-2 instrumented fusion</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients to be considered for trial enrollment will include those:&#xD;
&#xD;
          1. ages 65 and older;&#xD;
&#xD;
          2. presenting with type II odontoid fracture confirmed by CT scan to one of the study&#xD;
             centers;&#xD;
&#xD;
          3. deemed appropriate by the attending surgeon involved for C1-2 posterior cervical&#xD;
             fusion procedure if surgical management were to be indicated&#xD;
&#xD;
          4. able to independently cooperate in the completion of all study consents, forms and&#xD;
             documents.&#xD;
&#xD;
          5. able to speak, read and write English at an elementary school level&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients to be excluded from trial enrolment include:&#xD;
&#xD;
          1. those with previously documented type II odontoid fracture;&#xD;
&#xD;
          2. those with odontoid fracture related to malignancy or infection;&#xD;
&#xD;
          3. those with associated spinal cord injury&#xD;
&#xD;
          4. those with other cervical, thoracic or lumbar injuries requiring surgical intervention&#xD;
&#xD;
          5. those with aberrant/anomalous local anatomy which precludes posterior placement of&#xD;
             C1/2 instrumentation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Rothman Institute</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 26, 2018</study_first_submitted>
  <study_first_submitted_qc>December 26, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 27, 2018</study_first_posted>
  <last_update_submitted>December 26, 2018</last_update_submitted>
  <last_update_submitted_qc>December 26, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 28, 2018</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>Fractures, Bone</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03788200
org study id: 2018Kepler
nct id: NCT03788200
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This prospective study addresses one of the most controversial topics in the treatment of
      cervical spine trauma: the management of type II odontoid process fractures in the elderly.
      It is the hypothesis that surgical treatment will result in improved functional outcome
      measures, neck pain and mortality rates as compared with nonsurgical management. Furthermore,
      it is hypothesized that surgical treatment of odontoid process fractures will limit hospital
      re-admissions and development of medical complications secondary to prolonged immobilization
      in a cervical orthosis and delayed surgery related to late fracture displacement, which are
      often associated with non-operative care. Additionally, data from this study will be useful
      in identifying patient-specific predictors of improved outcome which can be used to optimize
      treatment algorithms and more effectively counsel patients who sustain these injuries.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: neck disability
time frame: 6 months post randomization
description: Measured by validated outcome measure NDI (Neck Disability Index)
arm group label: post-injury bracing with rigid cervical collar
arm group type: Active Comparator
description: Treatment arm #1 (8 weeks of post-injury bracing with rigid cervical collar): Participants randomized to this treatment arm will be treated with 8 weeks in a rigid cervical collar.
arm group label: posterior C1-2 instrumented fusion
arm group type: Active Comparator
description: Participants randomized to this treatment arm will undergo posterior C1-2 instrumented fusion with either local bone grafting or autologous iliac crest bone grafting with or without allograft bone grafting. Bone grafting decision will be made by the treating surgeon. All remaining decisions surrounding medical and surgical care will be made by the attending spine surgeon involved in each case.
intervention type: Procedure
intervention name: Bracing
description: Treatment arm #1 (8 weeks of post-injury bracing with rigid cervical collar): Participants randomized to this treatment arm will be treated with 8 weeks in a rigid cervical collar.
arm group label: post-injury bracing with rigid cervical collar
intervention type: Procedure
intervention name: posterior C1-C2 instrumented fusion
description: Treatment arm #2 (posterior C1-2 instrumented fusion): Participants randomized to this treatment arm will undergo posterior C1-2 instrumented fusion with either local bone grafting or autologous iliac crest bone grafting with or without allograft bone grafting. Bone grafting decision will be made by the treating surgeon. All remaining decisions surrounding medical and surgical care will be made by the attending spine surgeon involved in each case.
arm group label: posterior C1-2 instrumented fusion
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Fractures, Bone
sharing ipd: No