<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/NCT03028402</url>
  </required_header>
  <id_info>
    <org_study_id>PRO16020186</org_study_id>
    <nct_id>NCT03028402</nct_id>
  </id_info>
  <brief_title>Adjacent Segment Mechanics in Cervical Arthrodesis Patients</brief_title>
  <official_title>Adjacent Segment Mechanics in Cervical Arthrodesis Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pittsburgh</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Pittsburgh</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to determine to what extent patient-specific factors, iatrogenic factors, and&#xD;
      biomechanical factors influence cervical spine mechanics after single-level and two-level&#xD;
      arthrodesis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The etiology of adjacent segment pathology following cervical fusion remains highly&#xD;
      controversial. Adjacent segment disease is believed to result from one or more of the&#xD;
      following distinct causes:&#xD;
&#xD;
        1. the natural history of the adjacent disc;&#xD;
&#xD;
        2. disruption of the adjacent segment anatomy due to the initial surgery; and&#xD;
&#xD;
        3. biomechanical stress on the adjacent level following the fusion.&#xD;
&#xD;
      The long-term goal of our research is to reduce or prevent symptomatic adjacent segment&#xD;
      degeneration in the spine. The overall hypothesis of this study is that adjacent segment&#xD;
      kinematics (i.e. translations, rotations, helical axis of motion) and arthrokinematics (i.e.&#xD;
      disc deformation and facet joint surface interactions) after ACDF are determined primarily by&#xD;
      patient-specific anatomy and iatrogenic factors, and not by increased biomechanical stress&#xD;
      due to the fusion.&#xD;
&#xD;
      A prospective longitudinal study is proposed to determine to what extent patient-specific&#xD;
      factors (Specific Aim 1), iatrogenic factors (Specific Aim 2), and altered biomechanics&#xD;
      (Specific Aim 3) affect dynamic cervical spine function following fusion. Participants will&#xD;
      be C56 (n=22) and C67 (n=22) single-level fusion patients, C456 (n=22) and C567 (n=22)&#xD;
      two-level fusion patients, and asymptomatic controls similar in age to the fusion patients&#xD;
      (n=22). Patients will be tested prior to surgery, one year post-surgery, and three years&#xD;
      post-surgery. At each test, participants will complete clinical questionnaires to assess pain&#xD;
      and function, and they will perform full range of motion flexion\extension and axial rotation&#xD;
      of the head and cervical spine while biplane radiographs are recorded at 30 images per&#xD;
      second. A highly accurate and validated volumetric model-based tracking process and custom&#xD;
      data analysis software will be utilized to determine intervertebral kinematics (i.e.&#xD;
      translations, rotations, helical axis of motion) and arthrokinematics (i.e. disc deformation&#xD;
      and facet joint surface interactions) at each test session.&#xD;
&#xD;
      This prospective study will identify the factors that have the greatest effect on adjacent&#xD;
      segment mechanics after cervical fusion. If the hypotheses are confirmed, this will provide&#xD;
      support for increased attention to patient-specific factors and surgical technique.&#xD;
      Alternatively, if the results indicate that adjacent segment mechanics are influenced&#xD;
      primarily by increased stress after arthrodesis, this will provide support for increased&#xD;
      attention to the design of motion-sparing devices.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date>April 2016</start_date>
  <completion_date type="Anticipated">April 30, 2024</completion_date>
  <primary_completion_date type="Anticipated">April 30, 2024</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Kinematics</measure>
    <time_frame>pre-surgery to 3 years post-surgery</time_frame>
    <description>range of motion (ROM) in degrees</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Iatrogenic factors</measure>
    <time_frame>pre-surgery to 3 years post-surgery</time_frame>
    <description>adjacent segment disc height and sagittal alignment; graft height, plate placement</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Kinematics</measure>
    <time_frame>pre-surgery to 3 years post-surgery</time_frame>
    <description>The helical axis of motion (HAM)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Kinematics</measure>
    <time_frame>pre-surgery to 3 years post-surgery</time_frame>
    <description>The continuous 3D intervertebral kinematics (translations and rotations).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Arthrokinematics</measure>
    <time_frame>pre-surgery to 3 years post-surgery</time_frame>
    <description>Disc deformation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Arthrokinematics</measure>
    <time_frame>pre-surgery to 3 years post-surgery</time_frame>
    <description>Facet joint capsule deformation</description>
  </primary_outcome>
  <number_of_groups>5</number_of_groups>
  <enrollment type="Actual">106</enrollment>
  <condition>Intervertebral Disc Degeneration</condition>
  <arm_group>
    <arm_group_label>Asymptomatic Controls</arm_group_label>
    <description>Individuals who have no history of neck pain, trauma or surgery, similar in age and sex to the surgical patients</description>
  </arm_group>
  <arm_group>
    <arm_group_label>C5-C6 arthrodesis</arm_group_label>
    <description>Patients scheduled to undergo C5-C6 anterior cervical arthrodesis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>C6-C7 arthrodesis</arm_group_label>
    <description>Patients scheduled to undergo C6-C7 anterior cervical arthrodesis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>C4-C5-C6 arthrodesis</arm_group_label>
    <description>Patients scheduled to undergo C4-C5-C6 anterior cervical arthrodesis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>C5-C6-C7 arthrodesis</arm_group_label>
    <description>Patients scheduled to undergo C5-C6-C7 anterior cervical arthrodesis</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>C5-C6 arthrodesis</intervention_name>
    <description>A standard Smith Robinson anterior medial approach to the cervical spine. Vertebral endplates will be prepared by removing the cartilage endplate. Tricortical anterior iliac crest autografts will be harvested with a low-speed oscillating saw. Allografts will be fresh-frozen, vacuum-sealed, nonradiated tricortical grafts. All grafts will be fashioned in a typical Smith-Robinson formation. The motion segment will be distracted approximately 2-mm beyond the graft height before the insertion of each graft. Fusion plate will be contoured to cervical lordosis. Cervical plates will be positioned using surgical midline markers. All rigid anterior plate fixations will be performed using titanium anterior fixed-angle screw systems.</description>
    <arm_group_label>C4-C5-C6 arthrodesis</arm_group_label>
    <arm_group_label>C5-C6 arthrodesis</arm_group_label>
    <arm_group_label>C5-C6-C7 arthrodesis</arm_group_label>
    <arm_group_label>C6-C7 arthrodesis</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients will be between 21 and 60 years of age and will be scheduled to undergo&#xD;
        single-level or two-level anterior cervical discectomy and fusion (ACDF) at the C56, C67,&#xD;
        C456 or C567 levels. Indications for surgical intervention will be progressive symptoms&#xD;
        refractory to conservative treatment for myelopathy, radiculopathy, or myeloradiculopathy&#xD;
        resulting from degenerative spondylosis, symptomatic cervical disc herniation, or&#xD;
        symptomatic disc degeneration.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients must agree to return for all follow-up visits and provide informed consent.&#xD;
&#xD;
          -  Control subjects will be asymptomatic, with no injury or disease that will interfere&#xD;
             with spine function, such as previous spine surgery or trauma.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants will have no other injury or disease that will interfere with spine&#xD;
             function, such as previous spine surgery or trauma&#xD;
&#xD;
          -  Individuals who have been previously clinically diagnosed with poor bone quality and&#xD;
             those who do not intend to stay in the Pittsburgh area for a period of at least 3&#xD;
             years post-surgery will be excluded.&#xD;
&#xD;
          -  Females who are pregnant or plan to be pregnant within 3 years of surgery will be&#xD;
             excluded.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>William Anderst, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pittsburgh</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Pittsburgh Biodynamics Lab</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>February 10, 2016</study_first_submitted>
  <study_first_submitted_qc>January 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 23, 2017</study_first_posted>
  <last_update_submitted>May 1, 2023</last_update_submitted>
  <last_update_submitted_qc>May 1, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Pittsburgh</investigator_affiliation>
    <investigator_full_name>William Anderst</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </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>


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/NCT03028402
org study id: PRO16020186
nct id: NCT03028402
lead sponsor: 
has dmc: No
This study aims to determine to what extent patient-specific factors, iatrogenic factors, and
      biomechanical factors influence cervical spine mechanics after single-level and two-level
      arthrodesis.
The etiology of adjacent segment pathology following cervical fusion remains highly
      controversial. Adjacent segment disease is believed to result from one or more of the
      following distinct causes:

        1. the natural history of the adjacent disc;

        2. disruption of the adjacent segment anatomy due to the initial surgery; and

        3. biomechanical stress on the adjacent level following the fusion.

      The long-term goal of our research is to reduce or prevent symptomatic adjacent segment
      degeneration in the spine. The overall hypothesis of this study is that adjacent segment
      kinematics (i.e. translations, rotations, helical axis of motion) and arthrokinematics (i.e.
      disc deformation and facet joint surface interactions) after ACDF are determined primarily by
      patient-specific anatomy and iatrogenic factors, and not by increased biomechanical stress
      due to the fusion.

      A prospective longitudinal study is proposed to determine to what extent patient-specific
      factors (Specific Aim 1), iatrogenic factors (Specific Aim 2), and altered biomechanics
      (Specific Aim 3) affect dynamic cervical spine function following fusion. Participants will
      be C56 (n=22) and C67 (n=22) single-level fusion patients, C456 (n=22) and C567 (n=22)
      two-level fusion patients, and asymptomatic controls similar in age to the fusion patients
      (n=22). Patients will be tested prior to surgery, one year post-surgery, and three years
      post-surgery. At each test, participants will complete clinical questionnaires to assess pain
      and function, and they will perform full range of motion flexion\extension and axial rotation
      of the head and cervical spine while biplane radiographs are recorded at 30 images per
      second. A highly accurate and validated volumetric model-based tracking process and custom
      data analysis software will be utilized to determine intervertebral kinematics (i.e.
      translations, rotations, helical axis of motion) and arthrokinematics (i.e. disc deformation
      and facet joint surface interactions) at each test session.

      This prospective study will identify the factors that have the greatest effect on adjacent
      segment mechanics after cervical fusion. If the hypotheses are confirmed, this will provide
      support for increased attention to patient-specific factors and surgical technique.
      Alternatively, if the results indicate that adjacent segment mechanics are influenced
      primarily by increased stress after arthrodesis, this will provide support for increased
      attention to the design of motion-sparing devices.
observational model: Case-Control
time perspective: Prospective
measure: Kinematics
time frame: pre-surgery to 3 years post-surgery
description: range of motion (ROM) in degrees
measure: Iatrogenic factors
time frame: pre-surgery to 3 years post-surgery
description: adjacent segment disc height and sagittal alignment; graft height, plate placement
measure: Kinematics
time frame: pre-surgery to 3 years post-surgery
description: The helical axis of motion (HAM)
measure: Kinematics
time frame: pre-surgery to 3 years post-surgery
description: The continuous 3D intervertebral kinematics (translations and rotations).
measure: Arthrokinematics
time frame: pre-surgery to 3 years post-surgery
description: Disc deformation
measure: Arthrokinematics
time frame: pre-surgery to 3 years post-surgery
description: Facet joint capsule deformation
arm group label: Asymptomatic Controls
description: Individuals who have no history of neck pain, trauma or surgery, similar in age and sex to the surgical patients
arm group label: C5-C6 arthrodesis
description: Patients scheduled to undergo C5-C6 anterior cervical arthrodesis
arm group label: C6-C7 arthrodesis
description: Patients scheduled to undergo C6-C7 anterior cervical arthrodesis
arm group label: C4-C5-C6 arthrodesis
description: Patients scheduled to undergo C4-C5-C6 anterior cervical arthrodesis
arm group label: C5-C6-C7 arthrodesis
description: Patients scheduled to undergo C5-C6-C7 anterior cervical arthrodesis
intervention type: Procedure
intervention name: C5-C6 arthrodesis
description: A standard Smith Robinson anterior medial approach to the cervical spine. Vertebral endplates will be prepared by removing the cartilage endplate. Tricortical anterior iliac crest autografts will be harvested with a low-speed oscillating saw. Allografts will be fresh-frozen, vacuum-sealed, nonradiated tricortical grafts. All grafts will be fashioned in a typical Smith-Robinson formation. The motion segment will be distracted approximately 2-mm beyond the graft height before the insertion of each graft. Fusion plate will be contoured to cervical lordosis. Cervical plates will be positioned using surgical midline markers. All rigid anterior plate fixations will be performed using titanium anterior fixed-angle screw systems.
arm group label: C4-C5-C6 arthrodesis
arm group label: C5-C6 arthrodesis
arm group label: C5-C6-C7 arthrodesis
arm group label: C6-C7 arthrodesis
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 21 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: William Anderst, PhD
role: Principal Investigator
affiliation: University of Pittsburgh
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Pittsburgh
investigator full name: William Anderst
investigator title: Assistant Professor
mesh term: Intervertebral Disc Degeneration
sharing ipd: No