Advent™ Cervical Disc Versus ACDF for Treatment of One Level Degenerative Disc Disease (IDE Study)

This is an interventional treatment trial for Cervical Degenerative Disc Disease Read More

Inclusion Criteria:

• One cervical spine level between C3 and C7 which requires surgical treatment for intractable cervical radiculopathy and/or myelopathy demonstrated by herniated disc, and/or osteophyte formation leading to nerve root and/or spinal cord compression confirmed by patient history (e.g. neck and/or arm pain), functional and/or neurological deficit (e.g. numbness, weakness, diminished or pathologic reflexes, gait disturbances, etc.) and radiographic studies (e.g. CT, MRI, x-rays, etc.).
• Unresponsive to conservative care over a period of at least 6 weeks
• Neck Disability Index score ≥ 15/50 (30%)
• Willing and able to comply with the requirements of the protocol including follow-up requirements and to sign a study specific informed consent

Exclusion Criteria:

• More than 1 level requiring surgical treatment for intractable cervical radiculopathy and/or myelopathy.
• Active local (at the proposed surgical site) or systemic infection
• Prior anterior neck surgery at any level.
• Prior posterior cervical spine surgery at the index level except posterior decompressive surgery where the posterior elements are preserved.
• Currently undergoing treatment for disease of the thoracic or lumbar spine.
• Axial neck pain as the primary diagnosis, without evidence of neural compression
• Significant cervical anatomical deformity
• Any anatomical consideration which in the investigators opinion would make the anterior cervical approach excessively risky or impossible
• Severe obesity defined as a Body Mass Index (BMI) > 40
• Instability on AP, lateral neutral or flex/ext images: ≥2mm translation relative to the adjacent segment, and/or ≥ 11 degrees relative to adjacent segments
• Central disc height ≤ 2mm
• Advanced spondylosis (i.e. facet joints degeneration, anterior or posterior bridging of the interspace or lack of motion on the pre-operative flexion/extension x-rays)
• Severe cervical myelopathy as indicated by: Signs and/or symptoms > 6months duration, Nurick's Classification grades IV or V, and/or Myelomalacia as evidence on a MRI
• Metabolic bone disease such as osteoporosis to a degree that spinal instrumentation is contra-indicated (Males over 55 years of age, females over 50 years of age and/or subjects that in the investigators opinion are medical indicative of osteoporosis (e.g. early menopause, steroid use, etc.) are required to have a DEXA scan; If the DEXA scan is ≤ -2.5t in the spine, the patient must be excluded)
• Allergy to any component of the device (titanium, polycarbonated polyurethane, polyethylene terephthalate, or ethylene oxide residuals)
• Chronic steroid or other medication use that may interfere with bony/soft tissue healing
• History of endocrine or metabolic disorders (e.g. Paget's disease) known to effect bone and mineral metabolism
• Autoimmune diseases e.g., ankylosing spondylitis, rheumatoid arthritis, etc.
• Insulin dependent diabetes mellitus
• Active malignancy
• Currently pregnant or considering becoming pregnant during the follow-up period
• Advanced emphysema, Alzheimer's disease or other medical conditions that would interfere with patient self-assessment of function, pain or quality of life
• Medical condition (e.g. unstable cardiac disease, end-stage cancer) that may result in patient death prior to study completion
• Chemical dependency (e.g. alcohol or narcotic addiction) problem that may interfere with study requirements
• Mental incompetence as determined by the Investigator which may effect participation in the study
• Incarcerated
• Involved in any current or pending litigation relating to a spinal condition
• Concurrently participating in any other investigational study
• Anatomy (e.g. endplate dimensions) at the index level not consistent with the dimensions of the implants available (e.g. based on pre-operative radiographic evaluations and templates in the surgical technique manual).