<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/NCT04469231</url>
  </required_header>
  <id_info>
    <org_study_id>110-00001</org_study_id>
    <nct_id>NCT04469231</nct_id>
  </id_info>
  <brief_title>The Synergy Disc To Anterior Cervical Discectomy and Fusion</brief_title>
  <official_title>A Multi-Center, Prospective, Historically Controlled Pivotal Trial Comparing The Safety And Effectiveness Of The Synergy Disc To Anterior Cervical Discectomy And Fusion In Patients With One-Level Symptomatic Cervical Degenerative Disc Disease (DDD).</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Synergy Spine Solutions</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>MCRA</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Synergy Spine Solutions</source>
  <oversight_info>
    <has_dmc>No</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>
      A multicenter, prospective, non-randomized, historically controlled study. Demonstrate the&#xD;
      Synergy Disc is at least as safe and effective as conventional anterior cervical discectomy&#xD;
      and fusion (ACDF) to treat cervical degenerative disc disease (DDD) in subjects who are&#xD;
      symptomatic at only one level from C3 to C7 that are unresponsive to conservative management.&#xD;
      Patients will be evaluated preoperatively, at the time of surgery, and at 6 weeks, 3, 6, 12,&#xD;
      and 24 months after surgery. Follow-up will continue annually until the last patient reaches&#xD;
      24-month follow-up. The primary analysis will occur at 24 months.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The proposed investigation is a prospective, non-randomized, multi-center, historically&#xD;
      controlled comparison of the Synergy Disc to the control of conventional anterior cervical&#xD;
      discectomy and fusion (ACDF) surgery in patients with cervical DDD. A total of 175 patients&#xD;
      will be enrolled to the investigational group not including approximately 15 training cases.&#xD;
      The investigational group results will be compared to a historical control data from the ACDF&#xD;
      control group, which utilized an identical study design. A statistically rigorous&#xD;
      observational study design using propensity score (PS) subclassification will be used to&#xD;
      demonstrate covariate balance and enhance the quality of inferences regarding effectiveness&#xD;
      and safety relative to ACDF control. After investigational device enrollment is complete, but&#xD;
      before most investigational device subjects have reached their 24-month endpoint, a data set&#xD;
      containing only baseline covariates of prospectively enrolled investigational device patients&#xD;
      and historical ACDF control patients will be constructed. The propensity score methods&#xD;
      detailed below will be implemented by an outcomes-blinded statistician. A Propensity Score&#xD;
      Memo summarizing the proposed observational design will be developed and submitted for review&#xD;
      by stakeholders including FDA. The outcomes-blinded statistician will remain blinded until&#xD;
      after consensus is achieved that the design is acceptable. This will allow for additional&#xD;
      outcomes-blinded PS modeling if required. The objective of this clinical trial is to&#xD;
      demonstrate the Synergy Disc is at least as safe and effective as conventional ACDF to treat&#xD;
      cervical DDD in subjects who are symptomatic at only one level from C3 to C7 that are&#xD;
      unresponsive to conservative management.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">October 30, 2020</start_date>
  <completion_date type="Anticipated">January 1, 2026</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2024</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>
    <intervention_model_description>A multicenter, prospective, non-randomized, historically controlled study.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>NDI</measure>
    <time_frame>24 Month</time_frame>
    <description>≥ 15-point improvement in NDI Score (out of 100) in subjects at 24 months compared with baseline</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Neurological Assessment</measure>
    <time_frame>24 Month</time_frame>
    <description>Maintenance or improvement in neurological status (motor and sensory only) at 24 months compared to baseline</description>
  </primary_outcome>
  <primary_outcome>
    <measure>SSI</measure>
    <time_frame>24 Month</time_frame>
    <description>No study failure due to secondary surgical interventions (revision, removal, re-operation, supplemental fixation) at the index level</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Device Related AE</measure>
    <time_frame>24 Month</time_frame>
    <description>Absence of major device related adverse events defined as radiographic failure, neurological failure, or failure by adverse event as adjudicated by the CEC.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>SF-3</measure>
    <time_frame>6 Week, 3, 6, 12, and 24 Month</time_frame>
    <description>Health Survey (SF-36) at baseline and at each follow-up time-point</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>VAS</measure>
    <time_frame>6 Week, 3, 6, 12, and 24 Month</time_frame>
    <description>Visual analogue scale (VAS) will be used to evaluate pain where a change of at least 20mm will be considered clinically significant. Neck pain as measured on a 100mm VAS at baseline and at each follow-up time-point. Left and Right arm/shoulder pain as measured on a 100mm VAS at baseline and at each follow-up time-point. Please note, this assessment will include a &quot;Worst&quot; to pool together the left or right arm/shoulder scores with the higher baseline score. VAS Hoarseness on a 100mm scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Satisfaction</measure>
    <time_frame>6 Week, 3, 6, 12, and 24 Month</time_frame>
    <description>Patient Satisfaction Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BZ Score</measure>
    <time_frame>6 Week, 3, 6, 12, and 24 Month</time_frame>
    <description>Bazaz Dysphagia Score at 24 months compared to baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Odom's Criteria</measure>
    <time_frame>6 Week, 3, 6, 12, and 24 Month</time_frame>
    <description>Results at 24 months for the investigational Synergy Disc and at 24 months for the control ACDF will also be categorized by the physician according to Odom's Criteria.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">175</enrollment>
  <condition>Cervical Degenerative Disc Disease</condition>
  <arm_group>
    <arm_group_label>Synergy Disc</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The Synergy Disc is a cervical disc prosthesis that can be inserted between C3-C7 in skeletally mature patients after anterior discectomy to provide restoration of motion to the functional spinal unit. The Synergy Disc is designed to restoring kinematics to the cervical spine. The Synergy Disc is intended for use in the cervical spine for reconstruction of the disc following a single level discectomy for intractable radiculopathy and/or myelopathy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Anterior Cervical Discectomy &amp; Fusion</intervention_name>
    <description>ACDF</description>
    <arm_group_label>Synergy Disc</arm_group_label>
    <other_name>ACDF</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age 18 70 years;&#xD;
&#xD;
          2. Diagnosis of radiculopathy or myelopathy of the cervical spine, with either&#xD;
             radiculopathy symptoms - pain, paresthesia, or paralysis in a specific nerve root&#xD;
             distribution C4, C5, C6, or C7, including at least one of the following: arm/shoulder&#xD;
             pain (at least 30 mm on 100 mm VAS scale); decreased muscle strength of at least one&#xD;
             level on the 0-5 scale described below; abnormal sensation, including hyperesthesia or&#xD;
             hypoesthesia; and/or abnormal reflexes; or myelopathy symptoms including positive&#xD;
             Romberg evaluation, abnormal heel/toe walk, pathologic hyperreflexia or clonus in&#xD;
             lower extremity, positive Babinski, or positive Hoffman's;&#xD;
&#xD;
          3. Symptomatic at only one level from C3-C4 to C6-C7;&#xD;
&#xD;
          4. Radiographically determined pathology at level to be treated correlating to primary&#xD;
             symptoms, including at least one of the following:&#xD;
&#xD;
               1. Decreased disc height compared to adjacent levels on radiographic film, CT, or&#xD;
                  MRI&#xD;
&#xD;
               2. Degenerative spondylosis on CT or MRI&#xD;
&#xD;
               3. Disc herniation on CT or MRI.&#xD;
&#xD;
          5. Neck Disability Index (NDI) score ≥ 30/100;&#xD;
&#xD;
          6. Unresponsive to non-operative treatment for six weeks, or has the presence of&#xD;
             progressive symptoms or signs of nerve root/spinal cord compression in the face of&#xD;
             conservative treatment;&#xD;
&#xD;
          7. Appropriate for treatment using an anterior surgical approach, including having no&#xD;
             more than one previous anterior surgical approach to the cervical spine;&#xD;
&#xD;
          8. Ability and willingness to comply with follow-up regimen; and&#xD;
&#xD;
          9. Written informed consent given by subject or subject's legally authorized&#xD;
             representative.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Infection at the site of surgery;&#xD;
&#xD;
          2. History of, or anticipated treatment for, active systemic infection, including HIV&#xD;
             infection or hepatitis C;&#xD;
&#xD;
          3. Prior attempted or completed cervical spine surgery, except (1) laminoforaminotomy&#xD;
             (greater than 6 months prior to scheduled surgical treatment), which includes removal&#xD;
             of disc material necessary to perform a nerve root decompression, with less than&#xD;
             one-third facetectomy at any level, or (2) a successful single-level anterior cervical&#xD;
             fusion (greater than 6 months prior to scheduled surgical treatment);&#xD;
&#xD;
          4. More than one immobile vertebral level between C1-T1 from any cause, including but not&#xD;
             limited to congenital abnormalities, osteoarthritic &quot;spontaneous&quot; fusions, and prior&#xD;
             cervical spinal fusions;&#xD;
&#xD;
          5. Previous trauma to the C3-T1 levels resulting in significant bony or disco-ligamentous&#xD;
             cervical spine injury;&#xD;
&#xD;
          6. Axial neck pain in the absence of other symptoms of radiculopathy or myelopathy&#xD;
             justifying the need for surgical intervention;&#xD;
&#xD;
          7. Radiographic confirmation of severe facet joint disease or degeneration.&#xD;
&#xD;
          8. Osteoporosis: A screening questionnaire for osteoporosis, SCORE (Simple Calculated&#xD;
             Osteoporosis Risk Estimation) for females or MORES (Male Osteoporosis Risk Estimation&#xD;
             Score), will be used to screen patients to determine those patients who require a DEXA&#xD;
             bone mineral density measurement. If DEXA is required, exclusion will be defined as a&#xD;
             DEXA bone density measured T score ≤ -2.5 (The World Health Organization definition of&#xD;
             osteoporosis). DEXA scans within the last 6 months prior to surgical treatment may be&#xD;
             used;&#xD;
&#xD;
          9. Paget's disease, osteomalacia, or any other metabolic bone disease (excluding&#xD;
             osteoporosis which is addressed above);&#xD;
&#xD;
         10. Severe diabetes mellitus requiring daily insulin management;&#xD;
&#xD;
         11. Active malignancy: a history of any invasive malignancy (except non-melanoma skin&#xD;
             cancer), unless the patient has been treated with curative intent and there have been&#xD;
             no clinical signs or symptoms of the malignancy for at least 5 years;&#xD;
&#xD;
         12. Tumor as source of symptoms;&#xD;
&#xD;
         13. Symptomatic DDD or significant cervical spondylosis at two or more levels;&#xD;
&#xD;
         14. Marked cervical instability on resting lateral or flexion/extension radiographs&#xD;
             demonstrated by:&#xD;
&#xD;
               1. Translation &gt; 3.5 mm and/or&#xD;
&#xD;
               2. 11° angular difference to that of either adjacent level;&#xD;
&#xD;
         15. Known or suspected allergy to cobalt, chromium, molybdenum, titanium, or polyethylene;&#xD;
&#xD;
         16. Severe myelopathy to the extent that the patient is wheelchair bound;&#xD;
&#xD;
         17. Congenital canal stenosis resulting in a canal diameter of &lt; 10 mm, as measured by CT&#xD;
             or MRI;&#xD;
&#xD;
         18. Kyphotic segmental angulation of greater than 11 degrees at treatment or adjacent&#xD;
             levels;&#xD;
&#xD;
         19. Arachnoiditis;&#xD;
&#xD;
         20. Pregnant (verified in patients of childbearing potential by a negative urine pregnancy&#xD;
             test when pre-admission testing is obtained), or interested in becoming pregnant&#xD;
             during the duration of the study;&#xD;
&#xD;
         21. Autoimmune disorders that impact the musculoskeletal system (e.g., lupus, rheumatoid&#xD;
             arthritis; ankylosing spondylitis);&#xD;
&#xD;
         22. Congenital bony and/or spinal cord abnormalities that affect spinal stability;&#xD;
&#xD;
         23. Spinal axis disease (thoracic or lumbar) to the extent that surgical consideration is&#xD;
             likely anticipated within 6 months after the cervical procedure;&#xD;
&#xD;
         24. Other degenerative joint disease (e.g. shoulder, hip, knee) to the extent that&#xD;
             surgical consideration is likely anticipated within 6 months after the cervical&#xD;
             procedure;&#xD;
&#xD;
         25. Diseases or conditions that would preclude accurate clinical evaluation (e.g.&#xD;
             neuromuscular disorders such as diffuse idiopathic skeletal hyperostosis (DISH));&#xD;
&#xD;
         26. Medications that could interfere with fusion or other bone/soft tissue healing (e.g.&#xD;
             anticipated continued use of systemic steroid medication postoperatively);&#xD;
&#xD;
         27. Currently experiencing acute episode of major mental illness (psychosis, major&#xD;
             affective disorder, or schizophrenia), or manifesting physical symptoms without a&#xD;
             diagnosable medical condition to account for the symptoms, which may indicate symptoms&#xD;
             of psychological rather than physical origin;&#xD;
&#xD;
         28. Current or recent history of substance abuse (drug or alcohol) per site PI's&#xD;
             determination;&#xD;
&#xD;
         29. Morbid obesity, defined as body mass index (&quot;BMI&quot;) &gt; 40;&#xD;
&#xD;
         30. Currently using, or planning to use, bone growth stimulators in the cervical spine;&#xD;
&#xD;
         31. Use of any other investigational drug or medical device within the last 30 days prior&#xD;
             to surgery;&#xD;
&#xD;
         32. Currently a prisoner;&#xD;
&#xD;
         33. Currently pursuing personal litigation (defined as litigation that will likely&#xD;
             influence the patient's ability or willingness to accurately report their treatment&#xD;
             outcomes) related to the neck or cervical spine injury; however, involvement in&#xD;
             worker's compensation related litigation is not a required exclusion.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Barrow Brain and Spine</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85013</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HonorHealth Research Institute/Barrow Brain and Spine</name>
      <address>
        <city>Scottsdale</city>
        <state>Arizona</state>
        <zip>85251</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Todd H. Lanman, M.D.</name>
      <address>
        <city>Beverly Hills</city>
        <state>California</state>
        <zip>90210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Orthopedic Specialty Institute</name>
      <address>
        <city>Orange</city>
        <state>California</state>
        <zip>92868</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institute of Neuro Innovation</name>
      <address>
        <city>Santa Monica</city>
        <state>California</state>
        <zip>90404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Anschutz Medical Center</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kennedy White Orthopaedic Center</name>
      <address>
        <city>Sarasota</city>
        <state>Florida</state>
        <zip>34232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Indiana Spine Group</name>
      <address>
        <city>Carmel</city>
        <state>Indiana</state>
        <zip>46032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Michigan Orthopedic Surgeons</name>
      <address>
        <city>Southfield</city>
        <state>Michigan</state>
        <zip>48033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Upstate Medical University</name>
      <address>
        <city>East Syracuse</city>
        <state>New York</state>
        <zip>13057</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital for Special Surgery</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emerging Medical Research</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27704</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Summit Spine</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97225</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Center for Sports Medicine and Orthopaedic Surgery (CSMO)</name>
      <address>
        <city>Chattanooga</city>
        <state>Tennessee</state>
        <zip>37404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Texas Brain &amp; Spine</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Austin Neurosurgeons</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78746</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Spine Care Center</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78231</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Disc Replacement Center</name>
      <address>
        <city>West Jordan</city>
        <state>Utah</state>
        <zip>84088</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Atlantic Brain &amp; Spine</name>
      <address>
        <city>Reston</city>
        <state>Virginia</state>
        <zip>20190</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>July 7, 2020</study_first_submitted>
  <study_first_submitted_qc>July 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 13, 2020</study_first_posted>
  <last_update_submitted>June 1, 2023</last_update_submitted>
  <last_update_submitted_qc>June 1, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 2, 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>Intervertebral Disc Degeneration</mesh_term>
  </condition_browse>
  <!-- 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/NCT04469231
org study id: 110-00001
nct id: NCT04469231
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
A multicenter, prospective, non-randomized, historically controlled study. Demonstrate the
      Synergy Disc is at least as safe and effective as conventional anterior cervical discectomy
      and fusion (ACDF) to treat cervical degenerative disc disease (DDD) in subjects who are
      symptomatic at only one level from C3 to C7 that are unresponsive to conservative management.
      Patients will be evaluated preoperatively, at the time of surgery, and at 6 weeks, 3, 6, 12,
      and 24 months after surgery. Follow-up will continue annually until the last patient reaches
      24-month follow-up. The primary analysis will occur at 24 months.
The proposed investigation is a prospective, non-randomized, multi-center, historically
      controlled comparison of the Synergy Disc to the control of conventional anterior cervical
      discectomy and fusion (ACDF) surgery in patients with cervical DDD. A total of 175 patients
      will be enrolled to the investigational group not including approximately 15 training cases.
      The investigational group results will be compared to a historical control data from the ACDF
      control group, which utilized an identical study design. A statistically rigorous
      observational study design using propensity score (PS) subclassification will be used to
      demonstrate covariate balance and enhance the quality of inferences regarding effectiveness
      and safety relative to ACDF control. After investigational device enrollment is complete, but
      before most investigational device subjects have reached their 24-month endpoint, a data set
      containing only baseline covariates of prospectively enrolled investigational device patients
      and historical ACDF control patients will be constructed. The propensity score methods
      detailed below will be implemented by an outcomes-blinded statistician. A Propensity Score
      Memo summarizing the proposed observational design will be developed and submitted for review
      by stakeholders including FDA. The outcomes-blinded statistician will remain blinded until
      after consensus is achieved that the design is acceptable. This will allow for additional
      outcomes-blinded PS modeling if required. The objective of this clinical trial is to
      demonstrate the Synergy Disc is at least as safe and effective as conventional ACDF to treat
      cervical DDD in subjects who are symptomatic at only one level from C3 to C7 that are
      unresponsive to conservative management.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: A multicenter, prospective, non-randomized, historically controlled study.
primary purpose: Treatment
masking: None (Open Label)
measure: NDI
time frame: 24 Month
description: ≥ 15-point improvement in NDI Score (out of 100) in subjects at 24 months compared with baseline
measure: Neurological Assessment
time frame: 24 Month
description: Maintenance or improvement in neurological status (motor and sensory only) at 24 months compared to baseline
measure: SSI
time frame: 24 Month
description: No study failure due to secondary surgical interventions (revision, removal, re-operation, supplemental fixation) at the index level
measure: Device Related AE
time frame: 24 Month
description: Absence of major device related adverse events defined as radiographic failure, neurological failure, or failure by adverse event as adjudicated by the CEC.
measure: SF-3
time frame: 6 Week, 3, 6, 12, and 24 Month
description: Health Survey (SF-36) at baseline and at each follow-up time-point
measure: VAS
time frame: 6 Week, 3, 6, 12, and 24 Month
description: Visual analogue scale (VAS) will be used to evaluate pain where a change of at least 20mm will be considered clinically significant. Neck pain as measured on a 100mm VAS at baseline and at each follow-up time-point. Left and Right arm/shoulder pain as measured on a 100mm VAS at baseline and at each follow-up time-point. Please note, this assessment will include a "Worst" to pool together the left or right arm/shoulder scores with the higher baseline score. VAS Hoarseness on a 100mm scale.
measure: Patient Satisfaction
time frame: 6 Week, 3, 6, 12, and 24 Month
description: Patient Satisfaction Questionnaire
measure: BZ Score
time frame: 6 Week, 3, 6, 12, and 24 Month
description: Bazaz Dysphagia Score at 24 months compared to baseline
measure: Odom's Criteria
time frame: 6 Week, 3, 6, 12, and 24 Month
description: Results at 24 months for the investigational Synergy Disc and at 24 months for the control ACDF will also be categorized by the physician according to Odom's Criteria.
arm group label: Synergy Disc
arm group type: Experimental
description: The Synergy Disc is a cervical disc prosthesis that can be inserted between C3-C7 in skeletally mature patients after anterior discectomy to provide restoration of motion to the functional spinal unit. The Synergy Disc is designed to restoring kinematics to the cervical spine. The Synergy Disc is intended for use in the cervical spine for reconstruction of the disc following a single level discectomy for intractable radiculopathy and/or myelopathy.
intervention type: Device
intervention name: Anterior Cervical Discectomy & Fusion
description: ACDF
arm group label: Synergy Disc
other name: ACDF
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
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country: United States
responsible party type: Sponsor
mesh term: Intervertebral Disc Degeneration