<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/NCT03786432</url>
  </required_header>
  <id_info>
    <org_study_id>2018-378</org_study_id>
    <nct_id>NCT03786432</nct_id>
  </id_info>
  <brief_title>Prospective Study of Fusion Rates Using Spira-C Device for Anterior Cervical Discectomy and Fusion Surgery</brief_title>
  <acronym>ACDF</acronym>
  <official_title>A Prospective Clinical Pilot Study Of Fusion Rates Using Spira™-C Titanium 3-D Printed Interbody Device For Anterior Cervical Discectomy And Fusion</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>William Beaumont Hospitals</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Camber Spine Technologies</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>William Beaumont Hospitals</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to perform a prospective, single-arm clinical evaluation&#xD;
      utilizing the Spira™-C 3-D printed titanium interbody device for treatment of degenerative&#xD;
      disc disease and spinal stenosis of the cervical spine to evaluate fusion status and patient&#xD;
      reported outcomes. The primary objective is fusion status or bony healing within the device.&#xD;
      Patient reported outcomes, i.e. pain, function, and quality of life will also be measured&#xD;
      postoperatively.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a post-market, single-arm, prospective clinical study to evaluate fusion status and&#xD;
      patient reported outcomes using the Spira-C titanium interbody cage for degenerative disc&#xD;
      disease where single-level ACDF surgery is indicated. The treatment group will consist of 40&#xD;
      subjects treated with the Spira™-C interbody device at one level. Patients with a diagnosis&#xD;
      of cervical degenerative disc disease and/or spinal stenosis, radiculopathy or myelopathy and&#xD;
      planning to undergo a 1-level ACDF surgery between C3-C7 will be screened and consented, if&#xD;
      eligibility requirements are met. Once the subject has been enrolled and the surgery has&#xD;
      taken place; data will be collected regarding the surgical details will be collected.&#xD;
      Subjects will be followed up postoperatively at 6-weeks, 3-months, 6-months, and 12-months as&#xD;
      per standard of care, at the private practice or clinic. Subjects will be asked to complete&#xD;
      questionnaires regarding pain, function, and quality of life before and after surgery during&#xD;
      the postoperative follow-up visits. Radiographic assessments will be performed at all&#xD;
      postoperative visits; fusion status will be measured using cervical x-rays and CT scan at 12&#xD;
      months. Radiographs will also be utilized to assess for device-related complications,&#xD;
      including implant failure. Any clinically significant complications related to the device&#xD;
      will be recorded as an adverse event. This study design reflects the current standard of care&#xD;
      for cervical degenerative disc disease and spinal stenosis with symptoms of radiculopathy or&#xD;
      myelopathy. Data collected from subjects treated with the Spira™-C Interbody Device will be&#xD;
      compared to historical data based on literature review of polyetheretherketone (PEEK) cage&#xD;
      fusion rates and patient reported outcomes. Anterior cervical discectomy and fusion using an&#xD;
      interbody device with plate and screw fixation is the treatment of choice after conservative&#xD;
      therapies (non-surgical, i.e., physical therapy, epidural steroid injections, pain&#xD;
      medications) have been exhausted.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Could not continue enrollment due to discontinuation of funding&#xD;
  </why_stopped>
  <start_date type="Actual">January 10, 2019</start_date>
  <completion_date type="Actual">June 30, 2022</completion_date>
  <primary_completion_date type="Actual">June 30, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Successful Cervical Fusion Measured Radiographically</measure>
    <time_frame>12 months postoperative</time_frame>
    <description>Count of participants with successful cervical fusion as measured by CT scan and flexion/extension x-rays at 12-months as evidenced by the following three criteria: bony bridging, no development of pseudoarthrosis, and no presence of radiolucency at the treated cervical level</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Decreased Visual Analog Scale for Neck Pain</measure>
    <time_frame>12 months postoperative</time_frame>
    <description>Count of participants with equal to or greater than a 2-point decrease in patient reported outcomes as measured by Visual Analog Scale for pain (0-10 point scale, 0 = no pain and 10 = severe amount of pain) from baseline to 12-months in the neck region.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Decreased Neck Disability Index for Pain and Function</measure>
    <time_frame>12 months postoperative</time_frame>
    <description>Count of participants with equal to or greater than a 15-point decrease in patient reported outcomes as measured by Neck Disability Index (0-100 point scale, 0 = least amount disability, 100 = most severe disability) from baseline to 12-months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Increased Quality of Life Measured by Short Form Health Survey-36 (SF-36)</measure>
    <time_frame>12 months postoperative</time_frame>
    <description>Count of participants with Equal to or greater than 15-point increase in patient reported general health score as measured by SF-36 (0-100 point scale, 0 = low favorable health state and 100 = most favorable health state) from baseline to 12-months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Eating Assessment Tool-10 for Dysphagia</measure>
    <time_frame>12 months postoperative</time_frame>
    <description>Count of participants with score of less than 3 or equal to baseline in patient reported outcomes as measured by Eating Assessment Tool-10 from baseline to 12-months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Worsening Neurological Deficit Per Cervical Spine Examination</measure>
    <time_frame>12 months postoperative</time_frame>
    <description>Count of participants with new or worsening neurological cervical spine deficit as evaluated by cervical spine (motor and sensory) examination from baseline to 12-months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Count of Participants With Revision Surgery by Month 12</measure>
    <time_frame>12 months postoperative</time_frame>
    <description>Count of participants with revision surgery by month 12</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Count of Participants With Development of Pseudoarthrosis by Month 12</measure>
    <time_frame>12 months postoperative</time_frame>
    <description>Count of participants with development of pseudoarthrosis by month 12</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">13</enrollment>
  <condition>Cervical Radiculopathy</condition>
  <condition>Cervical Disc Disease</condition>
  <arm_group>
    <arm_group_label>Spira-C Interbody Device</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>40 subjects undergoing anterior cervical discectomy and fusion surgery using Spira-C titanium interbody device</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Spira-C Interbody Device</intervention_name>
    <description>40 subjects undergoing anterior cervical discectomy and fusion surgery using Spira-C titanium interbody device</description>
    <arm_group_label>Spira-C Interbody Device</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. ≥ 18 years of age and skeletally mature&#xD;
&#xD;
          2. Able to provide consent&#xD;
&#xD;
          3. Undergoing a primary, single-level ACDF between C3-C7&#xD;
&#xD;
          4. Diagnosis of symptomatic degenerative disc disease&#xD;
&#xD;
          5. Neck pain and/or radicular symptoms with a baseline Visual Analog Scale score of ≥ 4cm&#xD;
             (0-10cm scale)&#xD;
&#xD;
          6. Baseline Neck Disability Index score of ≥ 20&#xD;
&#xD;
          7. Attempted at least 6-weeks of conservative non-operative treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Any prior history of cervical fusion&#xD;
&#xD;
          2. Requires cervical fusion of more than one level&#xD;
&#xD;
          3. Acute cervical spine trauma requiring immediate intervention&#xD;
&#xD;
          4. BMI &gt; 40&#xD;
&#xD;
          5. Active systemic bacterial or fungal infection or infection at the operative site&#xD;
&#xD;
          6. History of vertebral fracture or osteoporotic fracture&#xD;
&#xD;
          7. Current treatment with chemotherapy, radiation, immunosuppression or chronic steroid&#xD;
             therapy&#xD;
&#xD;
          8. History of osteoporosis, osteopenia, or osteomalacia that would contraindicate spinal&#xD;
             surgery&#xD;
&#xD;
          9. Psychological or physical condition in the opinion of the investigator that would&#xD;
             interfere with completing study participation including completion of patient reported&#xD;
             outcomes&#xD;
&#xD;
         10. History of neurological condition in the opinion of the investigator that may affect&#xD;
             cervical spine function and pain assessments&#xD;
&#xD;
         11. Subjects with a history of cancer must be disease free for at least 3 years; with the&#xD;
             exception of squamous cell skin carcinoma&#xD;
&#xD;
         12. Pregnant, or plans on becoming pregnant&#xD;
&#xD;
         13. History of allergy to titanium&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jad G Khalil, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>William Beaumont Hospitals</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>William Beaumont Hospital</name>
      <address>
        <city>Royal Oak</city>
        <state>Michigan</state>
        <zip>48073</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>McGilvray KC, Easley J, Seim HB, Regan D, Berven SH, Hsu WK, Mroz TE, Puttlitz CM. Bony ingrowth potential of 3D-printed porous titanium alloy: a direct comparison of interbody cage materials in an in vivo ovine lumbar fusion model. Spine J. 2018 Jul;18(7):1250-1260. doi: 10.1016/j.spinee.2018.02.018. Epub 2018 Feb 26.</citation>
    <PMID>29496624</PMID>
  </reference>
  <reference>
    <citation>Li ZJ, Wang Y, Xu GJ, Tian P. Is PEEK cage better than titanium cage in anterior cervical discectomy and fusion surgery? A meta-analysis. BMC Musculoskelet Disord. 2016 Sep 1;17(1):379. doi: 10.1186/s12891-016-1234-1.</citation>
    <PMID>27585553</PMID>
  </reference>
  <reference>
    <citation>Cabraja M, Oezdemir S, Koeppen D, Kroppenstedt S. Anterior cervical discectomy and fusion: comparison of titanium and polyetheretherketone cages. BMC Musculoskelet Disord. 2012 Sep 14;13:172. doi: 10.1186/1471-2474-13-172.</citation>
    <PMID>22978810</PMID>
  </reference>
  <reference>
    <citation>Rao PJ, Pelletier MH, Walsh WR, Mobbs RJ. Spine interbody implants: material selection and modification, functionalization and bioactivation of surfaces to improve osseointegration. Orthop Surg. 2014 May;6(2):81-9. doi: 10.1111/os.12098.</citation>
    <PMID>24890288</PMID>
  </reference>
  <reference>
    <citation>Hsu MR, Haleem MS, Hsu W. 3D Printing Applications in Minimally Invasive Spine Surgery. Minim Invasive Surg. 2018 Apr 1;2018:4760769. doi: 10.1155/2018/4760769. eCollection 2018.</citation>
    <PMID>29805806</PMID>
  </reference>
  <reference>
    <citation>Niu CC, Liao JC, Chen WJ, Chen LH. Outcomes of interbody fusion cages used in 1 and 2-levels anterior cervical discectomy and fusion: titanium cages versus polyetheretherketone (PEEK) cages. J Spinal Disord Tech. 2010 Jul;23(5):310-6. doi: 10.1097/BSD.0b013e3181af3a84.</citation>
    <PMID>20124907</PMID>
  </reference>
  <reference>
    <citation>Lee YS, Kim YB, Park SW. Risk factors for postoperative subsidence of single-level anterior cervical discectomy and fusion: the significance of the preoperative cervical alignment. Spine (Phila Pa 1976). 2014 Jul 15;39(16):1280-7. doi: 10.1097/BRS.0000000000000400.</citation>
    <PMID>24827519</PMID>
  </reference>
  <reference>
    <citation>Chen Y, Wang X, Lu X, Yang L, Yang H, Yuan W, Chen D. Comparison of titanium and polyetheretherketone (PEEK) cages in the surgical treatment of multilevel cervical spondylotic myelopathy: a prospective, randomized, control study with over 7-year follow-up. Eur Spine J. 2013 Jul;22(7):1539-46. doi: 10.1007/s00586-013-2772-y. Epub 2013 Apr 9.</citation>
    <PMID>23568254</PMID>
  </reference>
  <reference>
    <citation>Seaman S, Kerezoudis P, Bydon M, Torner JC, Hitchon PW. Titanium vs. polyetheretherketone (PEEK) interbody fusion: Meta-analysis and review of the literature. J Clin Neurosci. 2017 Oct;44:23-29. doi: 10.1016/j.jocn.2017.06.062. Epub 2017 Jul 21.</citation>
    <PMID>28736113</PMID>
  </reference>
  <reference>
    <citation>Wilcox B, Mobbs RJ, Wu AM, Phan K. Systematic review of 3D printing in spinal surgery: the current state of play. J Spine Surg. 2017 Sep;3(3):433-443. doi: 10.21037/jss.2017.09.01.</citation>
    <PMID>29057355</PMID>
  </reference>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>December 20, 2018</study_first_submitted>
  <study_first_submitted_qc>December 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 26, 2018</study_first_posted>
  <results_first_submitted>May 25, 2023</results_first_submitted>
  <results_first_submitted_qc>July 11, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">July 28, 2023</results_first_posted>
  <last_update_submitted>July 11, 2023</last_update_submitted>
  <last_update_submitted_qc>July 11, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 28, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>William Beaumont Hospitals</investigator_affiliation>
    <investigator_full_name>Jad Khalil MD</investigator_full_name>
    <investigator_title>Orthopaedic Spine surgeon and Assistant Professor of Orthopaedic Surgery</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Radiculopathy</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>December 18, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/32/NCT03786432/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>This is a single-arm, post market study to evaluate fusion status and patient reported outcomes using the FDA approved Spira-C Titanium Interbody Device at one level. Patients with a diagnosis of cervical degenerative disc disease and/or spinal stenosis, radiculopathy or myelopathy and planning to undergo a 1-level ACDF surgery between C3-C7 were screened and enrolled in the study.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Spira-C Interbody Device</title>
          <description>40 subjects undergoing anterior cervical discectomy and fusion surgery using Spira-C titanium interbody device&#xD;
Spira-C Interbody Device: 40 subjects undergoing anterior cervical discectomy and fusion surgery using Spira-C titanium interbody device</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Completed 12 Month Visit</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Completed 12 Month CT Scan</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Screen Failure after consent</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>did not complete 12 month CT scan</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Demographics not collected for 1 participants who was a screen failure.</population>
      <group_list>
        <group group_id="B1">
          <title>Spira-C Interbody Device</title>
          <description>subjects undergoing anterior cervical discectomy and fusion surgery using Spira-C titanium interbody device&#xD;
Spira-C Interbody Device: subjects undergoing anterior cervical discectomy and fusion surgery using Spira-C titanium interbody device</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="12"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>Age in years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="53" lower_limit="39" upper_limit="65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Successful Cervical Fusion Measured Radiographically</title>
        <description>Count of participants with successful cervical fusion as measured by CT scan and flexion/extension x-rays at 12-months as evidenced by the following three criteria: bony bridging, no development of pseudoarthrosis, and no presence of radiolucency at the treated cervical level</description>
        <time_frame>12 months postoperative</time_frame>
        <population>4 were lost to follow-up, 1 did not complete CT scan and 1 screen failure-no data out of 13 enrolled.</population>
        <group_list>
          <group group_id="O1">
            <title>Spira-C Interbody Device</title>
            <description>Subjects undergoing anterior cervical discectomy and fusion surgery using Spira-C titanium interbody device&#xD;
Spira-C Interbody Device: subjects undergoing anterior cervical discectomy and fusion surgery using Spira-C titanium interbody device</description>
          </group>
        </group_list>
        <measure>
          <title>Successful Cervical Fusion Measured Radiographically</title>
          <description>Count of participants with successful cervical fusion as measured by CT scan and flexion/extension x-rays at 12-months as evidenced by the following three criteria: bony bridging, no development of pseudoarthrosis, and no presence of radiolucency at the treated cervical level</description>
          <population>4 were lost to follow-up, 1 did not complete CT scan and 1 screen failure-no data out of 13 enrolled.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Decreased Visual Analog Scale for Neck Pain</title>
        <description>Count of participants with equal to or greater than a 2-point decrease in patient reported outcomes as measured by Visual Analog Scale for pain (0-10 point scale, 0 = no pain and 10 = severe amount of pain) from baseline to 12-months in the neck region.</description>
        <time_frame>12 months postoperative</time_frame>
        <population>4 were lost to follow-up and 1 screen failure-no data out of 13 enrolled.</population>
        <group_list>
          <group group_id="O1">
            <title>Spira-C Interbody Device</title>
            <description>subjects undergoing anterior cervical discectomy and fusion surgery using Spira-C titanium interbody device&#xD;
Spira-C Interbody Device: subjects undergoing anterior cervical discectomy and fusion surgery using Spira-C titanium interbody device</description>
          </group>
        </group_list>
        <measure>
          <title>Decreased Visual Analog Scale for Neck Pain</title>
          <description>Count of participants with equal to or greater than a 2-point decrease in patient reported outcomes as measured by Visual Analog Scale for pain (0-10 point scale, 0 = no pain and 10 = severe amount of pain) from baseline to 12-months in the neck region.</description>
          <population>4 were lost to follow-up and 1 screen failure-no data out of 13 enrolled.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Decreased Neck Disability Index for Pain and Function</title>
        <description>Count of participants with equal to or greater than a 15-point decrease in patient reported outcomes as measured by Neck Disability Index (0-100 point scale, 0 = least amount disability, 100 = most severe disability) from baseline to 12-months.</description>
        <time_frame>12 months postoperative</time_frame>
        <population>4 were lost to follow-up and 1 screen failure-no data out of 13 enrolled.</population>
        <group_list>
          <group group_id="O1">
            <title>Spira-C Interbody Device</title>
            <description>subjects undergoing anterior cervical discectomy and fusion surgery using Spira-C titanium interbody device&#xD;
Spira-C Interbody Device: subjects undergoing anterior cervical discectomy and fusion surgery using Spira-C titanium interbody device</description>
          </group>
        </group_list>
        <measure>
          <title>Decreased Neck Disability Index for Pain and Function</title>
          <description>Count of participants with equal to or greater than a 15-point decrease in patient reported outcomes as measured by Neck Disability Index (0-100 point scale, 0 = least amount disability, 100 = most severe disability) from baseline to 12-months.</description>
          <population>4 were lost to follow-up and 1 screen failure-no data out of 13 enrolled.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Increased Quality of Life Measured by Short Form Health Survey-36 (SF-36)</title>
        <description>Count of participants with Equal to or greater than 15-point increase in patient reported general health score as measured by SF-36 (0-100 point scale, 0 = low favorable health state and 100 = most favorable health state) from baseline to 12-months.</description>
        <time_frame>12 months postoperative</time_frame>
        <population>4 were lost to follow-up and 1 screen failure-no data out of 13 enrolled.</population>
        <group_list>
          <group group_id="O1">
            <title>Spira-C Interbody Device</title>
            <description>subjects undergoing anterior cervical discectomy and fusion surgery using Spira-C titanium interbody device&#xD;
Spira-C Interbody Device: subjects undergoing anterior cervical discectomy and fusion surgery using Spira-C titanium interbody device</description>
          </group>
        </group_list>
        <measure>
          <title>Increased Quality of Life Measured by Short Form Health Survey-36 (SF-36)</title>
          <description>Count of participants with Equal to or greater than 15-point increase in patient reported general health score as measured by SF-36 (0-100 point scale, 0 = low favorable health state and 100 = most favorable health state) from baseline to 12-months.</description>
          <population>4 were lost to follow-up and 1 screen failure-no data out of 13 enrolled.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Eating Assessment Tool-10 for Dysphagia</title>
        <description>Count of participants with score of less than 3 or equal to baseline in patient reported outcomes as measured by Eating Assessment Tool-10 from baseline to 12-months.</description>
        <time_frame>12 months postoperative</time_frame>
        <population>4 were lost to follow-up and 1 screen failure-no data out of 13 enrolled.</population>
        <group_list>
          <group group_id="O1">
            <title>Spira-C Interbody Device</title>
            <description>subjects undergoing anterior cervical discectomy and fusion surgery using Spira-C titanium interbody device&#xD;
Spira-C Interbody Device: subjects undergoing anterior cervical discectomy and fusion surgery using Spira-C titanium interbody device</description>
          </group>
        </group_list>
        <measure>
          <title>Eating Assessment Tool-10 for Dysphagia</title>
          <description>Count of participants with score of less than 3 or equal to baseline in patient reported outcomes as measured by Eating Assessment Tool-10 from baseline to 12-months.</description>
          <population>4 were lost to follow-up and 1 screen failure-no data out of 13 enrolled.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Worsening Neurological Deficit Per Cervical Spine Examination</title>
        <description>Count of participants with new or worsening neurological cervical spine deficit as evaluated by cervical spine (motor and sensory) examination from baseline to 12-months.</description>
        <time_frame>12 months postoperative</time_frame>
        <population>4 were lost to follow-up, 1 did not complete CT scan and 1 screen failure-no data out of 13 enrolled.</population>
        <group_list>
          <group group_id="O1">
            <title>Spira-C Interbody Device</title>
            <description>subjects undergoing anterior cervical discectomy and fusion surgery using Spira-C titanium interbody device&#xD;
Spira-C Interbody Device: subjects undergoing anterior cervical discectomy and fusion surgery using Spira-C titanium interbody device</description>
          </group>
        </group_list>
        <measure>
          <title>Worsening Neurological Deficit Per Cervical Spine Examination</title>
          <description>Count of participants with new or worsening neurological cervical spine deficit as evaluated by cervical spine (motor and sensory) examination from baseline to 12-months.</description>
          <population>4 were lost to follow-up, 1 did not complete CT scan and 1 screen failure-no data out of 13 enrolled.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Count of Participants With Revision Surgery by Month 12</title>
        <description>Count of participants with revision surgery by month 12</description>
        <time_frame>12 months postoperative</time_frame>
        <population>4 were lost to follow-up and 1 screen failure-no data out of 13 enrolled.</population>
        <group_list>
          <group group_id="O1">
            <title>Spira-C Interbody Device</title>
            <description>subjects undergoing anterior cervical discectomy and fusion surgery using Spira-C titanium interbody device&#xD;
Spira-C Interbody Device: subjects undergoing anterior cervical discectomy and fusion surgery using Spira-C titanium interbody device</description>
          </group>
        </group_list>
        <measure>
          <title>Count of Participants With Revision Surgery by Month 12</title>
          <description>Count of participants with revision surgery by month 12</description>
          <population>4 were lost to follow-up and 1 screen failure-no data out of 13 enrolled.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Count of Participants With Development of Pseudoarthrosis by Month 12</title>
        <description>Count of participants with development of pseudoarthrosis by month 12</description>
        <time_frame>12 months postoperative</time_frame>
        <population>4 were lost to follow-up, 1 did not complete CT scan and 1 screen failure-no data out of 13 enrolled.</population>
        <group_list>
          <group group_id="O1">
            <title>Spira-C Interbody Device</title>
            <description>subjects undergoing anterior cervical discectomy and fusion surgery using Spira-C titanium interbody device&#xD;
Spira-C Interbody Device: subjects undergoing anterior cervical discectomy and fusion surgery using Spira-C titanium interbody device</description>
          </group>
        </group_list>
        <measure>
          <title>Count of Participants With Development of Pseudoarthrosis by Month 12</title>
          <description>Count of participants with development of pseudoarthrosis by month 12</description>
          <population>4 were lost to follow-up, 1 did not complete CT scan and 1 screen failure-no data out of 13 enrolled.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>12 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Spira-C Interbody Device</title>
          <description>subjects undergoing anterior cervical discectomy and fusion surgery using Spira-C titanium interbody device&#xD;
Spira-C Interbody Device: subjects undergoing anterior cervical discectomy and fusion surgery using Spira-C titanium interbody device</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Early termination leading to small numbers of participants analyzed.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Grace San Agustin</name_or_title>
      <organization>William Beaumont University Hospital</organization>
      <phone>248 551 6679</phone>
      <email>grace.sanagustin@beaumont.org</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03786432
org study id: 2018-378
nct id: NCT03786432
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
The objective of this study is to perform a prospective, single-arm clinical evaluation
      utilizing the Spira™-C 3-D printed titanium interbody device for treatment of degenerative
      disc disease and spinal stenosis of the cervical spine to evaluate fusion status and patient
      reported outcomes. The primary objective is fusion status or bony healing within the device.
      Patient reported outcomes, i.e. pain, function, and quality of life will also be measured
      postoperatively.
This is a post-market, single-arm, prospective clinical study to evaluate fusion status and
      patient reported outcomes using the Spira-C titanium interbody cage for degenerative disc
      disease where single-level ACDF surgery is indicated. The treatment group will consist of 40
      subjects treated with the Spira™-C interbody device at one level. Patients with a diagnosis
      of cervical degenerative disc disease and/or spinal stenosis, radiculopathy or myelopathy and
      planning to undergo a 1-level ACDF surgery between C3-C7 will be screened and consented, if
      eligibility requirements are met. Once the subject has been enrolled and the surgery has
      taken place; data will be collected regarding the surgical details will be collected.
      Subjects will be followed up postoperatively at 6-weeks, 3-months, 6-months, and 12-months as
      per standard of care, at the private practice or clinic. Subjects will be asked to complete
      questionnaires regarding pain, function, and quality of life before and after surgery during
      the postoperative follow-up visits. Radiographic assessments will be performed at all
      postoperative visits; fusion status will be measured using cervical x-rays and CT scan at 12
      months. Radiographs will also be utilized to assess for device-related complications,
      including implant failure. Any clinically significant complications related to the device
      will be recorded as an adverse event. This study design reflects the current standard of care
      for cervical degenerative disc disease and spinal stenosis with symptoms of radiculopathy or
      myelopathy. Data collected from subjects treated with the Spira™-C Interbody Device will be
      compared to historical data based on literature review of polyetheretherketone (PEEK) cage
      fusion rates and patient reported outcomes. Anterior cervical discectomy and fusion using an
      interbody device with plate and screw fixation is the treatment of choice after conservative
      therapies (non-surgical, i.e., physical therapy, epidural steroid injections, pain
      medications) have been exhausted.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Successful Cervical Fusion Measured Radiographically
time frame: 12 months postoperative
description: Count of participants with successful cervical fusion as measured by CT scan and flexion/extension x-rays at 12-months as evidenced by the following three criteria: bony bridging, no development of pseudoarthrosis, and no presence of radiolucency at the treated cervical level
measure: Decreased Visual Analog Scale for Neck Pain
time frame: 12 months postoperative
description: Count of participants with equal to or greater than a 2-point decrease in patient reported outcomes as measured by Visual Analog Scale for pain (0-10 point scale, 0 = no pain and 10 = severe amount of pain) from baseline to 12-months in the neck region.
measure: Decreased Neck Disability Index for Pain and Function
time frame: 12 months postoperative
description: Count of participants with equal to or greater than a 15-point decrease in patient reported outcomes as measured by Neck Disability Index (0-100 point scale, 0 = least amount disability, 100 = most severe disability) from baseline to 12-months.
measure: Increased Quality of Life Measured by Short Form Health Survey-36 (SF-36)
time frame: 12 months postoperative
description: Count of participants with Equal to or greater than 15-point increase in patient reported general health score as measured by SF-36 (0-100 point scale, 0 = low favorable health state and 100 = most favorable health state) from baseline to 12-months.
measure: Eating Assessment Tool-10 for Dysphagia
time frame: 12 months postoperative
description: Count of participants with score of less than 3 or equal to baseline in patient reported outcomes as measured by Eating Assessment Tool-10 from baseline to 12-months.
measure: Worsening Neurological Deficit Per Cervical Spine Examination
time frame: 12 months postoperative
description: Count of participants with new or worsening neurological cervical spine deficit as evaluated by cervical spine (motor and sensory) examination from baseline to 12-months.
measure: Count of Participants With Revision Surgery by Month 12
time frame: 12 months postoperative
description: Count of participants with revision surgery by month 12
measure: Count of Participants With Development of Pseudoarthrosis by Month 12
time frame: 12 months postoperative
description: Count of participants with development of pseudoarthrosis by month 12
arm group label: Spira-C Interbody Device
arm group type: Experimental
description: 40 subjects undergoing anterior cervical discectomy and fusion surgery using Spira-C titanium interbody device
intervention type: Device
intervention name: Spira-C Interbody Device
description: 40 subjects undergoing anterior cervical discectomy and fusion surgery using Spira-C titanium interbody device
arm group label: Spira-C Interbody Device
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jad G Khalil, MD
role: Principal Investigator
affiliation: William Beaumont Hospitals
facility: 
country: United States
citation: McGilvray KC, Easley J, Seim HB, Regan D, Berven SH, Hsu WK, Mroz TE, Puttlitz CM. Bony ingrowth potential of 3D-printed porous titanium alloy: a direct comparison of interbody cage materials in an in vivo ovine lumbar fusion model. Spine J. 2018 Jul;18(7):1250-1260. doi: 10.1016/j.spinee.2018.02.018. Epub 2018 Feb 26.
PMID: 29496624
citation: Li ZJ, Wang Y, Xu GJ, Tian P. Is PEEK cage better than titanium cage in anterior cervical discectomy and fusion surgery? A meta-analysis. BMC Musculoskelet Disord. 2016 Sep 1;17(1):379. doi: 10.1186/s12891-016-1234-1.
PMID: 27585553
citation: Cabraja M, Oezdemir S, Koeppen D, Kroppenstedt S. Anterior cervical discectomy and fusion: comparison of titanium and polyetheretherketone cages. BMC Musculoskelet Disord. 2012 Sep 14;13:172. doi: 10.1186/1471-2474-13-172.
PMID: 22978810
citation: Rao PJ, Pelletier MH, Walsh WR, Mobbs RJ. Spine interbody implants: material selection and modification, functionalization and bioactivation of surfaces to improve osseointegration. Orthop Surg. 2014 May;6(2):81-9. doi: 10.1111/os.12098.
PMID: 24890288
citation: Hsu MR, Haleem MS, Hsu W. 3D Printing Applications in Minimally Invasive Spine Surgery. Minim Invasive Surg. 2018 Apr 1;2018:4760769. doi: 10.1155/2018/4760769. eCollection 2018.
PMID: 29805806
citation: Niu CC, Liao JC, Chen WJ, Chen LH. Outcomes of interbody fusion cages used in 1 and 2-levels anterior cervical discectomy and fusion: titanium cages versus polyetheretherketone (PEEK) cages. J Spinal Disord Tech. 2010 Jul;23(5):310-6. doi: 10.1097/BSD.0b013e3181af3a84.
PMID: 20124907
citation: Lee YS, Kim YB, Park SW. Risk factors for postoperative subsidence of single-level anterior cervical discectomy and fusion: the significance of the preoperative cervical alignment. Spine (Phila Pa 1976). 2014 Jul 15;39(16):1280-7. doi: 10.1097/BRS.0000000000000400.
PMID: 24827519
citation: Chen Y, Wang X, Lu X, Yang L, Yang H, Yuan W, Chen D. Comparison of titanium and polyetheretherketone (PEEK) cages in the surgical treatment of multilevel cervical spondylotic myelopathy: a prospective, randomized, control study with over 7-year follow-up. Eur Spine J. 2013 Jul;22(7):1539-46. doi: 10.1007/s00586-013-2772-y. Epub 2013 Apr 9.
PMID: 23568254
citation: Seaman S, Kerezoudis P, Bydon M, Torner JC, Hitchon PW. Titanium vs. polyetheretherketone (PEEK) interbody fusion: Meta-analysis and review of the literature. J Clin Neurosci. 2017 Oct;44:23-29. doi: 10.1016/j.jocn.2017.06.062. Epub 2017 Jul 21.
PMID: 28736113
citation: Wilcox B, Mobbs RJ, Wu AM, Phan K. Systematic review of 3D printing in spinal surgery: the current state of play. J Spine Surg. 2017 Sep;3(3):433-443. doi: 10.21037/jss.2017.09.01.
PMID: 29057355
responsible party type: Principal Investigator
investigator affiliation: William Beaumont Hospitals
investigator full name: Jad Khalil MD
investigator title: Orthopaedic Spine surgeon and Assistant Professor of Orthopaedic Surgery
mesh term: Radiculopathy
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Early termination leading to small numbers of participants analyzed.
point of contact: 