Evaluation of the Safety and Effectiveness of the CORUS™ Posterior Cervical Stabilization System 3D (PCSS 3D) for the Treatment of 2-level Cervical Degenerative Disease

• At least 18 years of age (Skeletally Mature)

• Indicated for ACDF treatment of degenerative disc disease (DDD) between and including C3-C7 at 2 contiguous levels as determined by the following:

  1. diagnosis of radiculopathy, myelopathy or myeloradiculopathy of the cervical spine, with pain, including at least one of the following: i. Neck and/or arm pain, ii. Decreased muscle strength, and iii. Abnormal sensation including hyperesthesia or hypoesthesia; and/or Abnormal reflexes.
  2. radiographically determined pathology at the levels to be treated correlating to primary symptoms including at least one of the following: i. Decreased disc height on radiography, computed tomography (CT), or magnetic resonance imaging (MRI) in comparison to a normal adjacent disc, ii. Degenerative spondylosis on MRI, and iii. Disc herniation on MRI.
• NDI Score of ≥ 15/50

• Unresponsive to non-operative, conservative treatment (rest, heat, electrotherapy, physical therapy, chiropractic care and/or analgesics) for:

  1. at least six weeks from radiculopathy or myeloradiculopathy symptom onset; or
  2. have the presence of progressive symptoms or signs of nerve root/spinal cord compression despite continued non-operative conservative treatment.
• Reported to be medically cleared for surgery
• Physically and mentally able and willing to comply with the Protocol, including the ability to read and complete required forms and willing and able to adhere to the scheduled follow-up visits and requirements of the Protocol;
• Written informed consent provided by subject.

Exclusion Criteria:

• Has, in the Investigator's opinion, any disease or condition that would preclude accurate radiographic evaluation of any treated vertebrae (e.g. morbid obesity)
• Active systemic infection or infection at the operative site
• History of or anticipated treatment for active systemic infection, including HIV or Hepatitis C
• Previous trauma to the C3 to C7 levels resulting in significant bony or disco-ligamentous cervical spine injury that may prevent device placement
• A prior spine surgery or pseudoarthrosis at the operative levels
• Axial neck pain in the absence of other symptoms of radiculopathy or myeloradiculopathy justifying the need for surgical intervention
• Symptomatic DDD or significant cervical spondylosis at more than two levels
• Diagnosis of Spondylolisthesis, grade >2
• Overt (Segmental) instability measured as a movement on dynamic flex/extend x-rays > 3.5 mm
• Congenital bony and/or spinal cord abnormalities that affect spinal stability
• Diagnosis of Paget's disease, osteomalacia, or any other metabolic bone disease other than osteopenia
• Osteoporosis, defined as either the SCORE or MORES ≥ 6 and a DEXA bone density measured T-score of ≤ -2.5
• Active malignancy or a history of any invasive malignancy (except non-melanoma skin cancer), unless treated with curative intent and without clinical signs or symptoms of the malignancy for at least five years
• Has an uncontrolled seizure disorder
• Use of epidural steroids within 14 days prior to surgery

• A concomitant condition requiring daily, high-dose oral and/or inhaled steroids. High dose steroid use is defined as:

  1. daily, chronic use of oral steroids of 5 mg/day or greater.
  2. use of short-term (less than 10 days) oral steroids at a daily dose greater than 40 mg within one month of the study procedure.
• Known allergy to titanium (Ti)
• Fixed or permanent neurologic deficit related to the target treatment levels that cannot be improved with surgical decompression
• Has, in the Investigator's opinion, any disease or condition that would preclude accurate clinical evaluation (e.g. neuromuscular disorders)
• Is pregnant or nursing at time of screening, or with plans to become pregnant throughout the duration of the study.
• A current or recent history (≤ 1 year prior to screening) of substance abuse (alcoholism and/or narcotic addiction) that required treatment
• Long term use (>6 months) of opioids (max. daily amount=120 mg morphine equivalents)
• A mental illness or belongs to a vulnerable population, as determined by the Investigator (e.g., prisoner or developmentally disabled), that would compromise ability to provide informed consent or compliance with follow-up requirements
• Any other condition or anatomy (e.g. fused facet) that makes posterior fusion treatment infeasible
• Use of any other investigational drug or medical device within the last 30 days prior to surgery
• Pending personal litigation relating to spinal injury (worker's compensation is not exclusionary)
• Anticipated or potential relocation greater than 50 miles that may interfere with completion of follow-up examinations.