RHINE™ Cervical Disc Clinical Study: A Prospective Observational Study for Patients Requiring 1-2 Level C-spine Surgery

Exclusion Criteria

• •More than two cervical levels requiring surgery, or has two levels requiring surgery that are not adjacent.
• •Previous surgical intervention at the target level(s)
• •Any of the following at the target level(s):
• •Significant cervical anatomical deformity, e.g., ankylosing spondylitis, rheumatoid arthritis, etc.
• •Moderate to advanced spondylosis. Patients who demonstrate advanced degenerative changes characterized by any of the following: bridging osteophytes, marked reduction or absence of motion (\< 2 degrees change from flexion to extension), collapse of the intervertebral disc space of greater than 50% of its normal height (compared to adjacent levels)
• •Radiographic signs of subluxation \> 3.5 mm
• •Angulation of the disc space more than 11 degrees greater than adjacent segments
• •Significant kyphotic deformity (\> 5 degrees) at a single level or significant reversal of lordosis (not corrected with extension)
• •Fused level adjacent to a level to be treated
• •Axial neck pain is the patient's solitary symptom
• •Severe pathology of the facet joints of the involved vertebral bodies
• •Previous diagnosis of osteopenia or osteomalacia
• •Has any of the following risk factors that may be associated with a diagnosis of osteoporosis.
• •Spinal metastases
• •Extreme obesity (BMI ≥ 40)
• •Overt or active bacterial infection, either local or systemic
• •Severe insulin dependent diabetes
• •Chronic or acute renal failure or prior history of renal disease
• •Fever (temp \> 38.3° C oral) at the time of surgery
• •Documented allergy or intolerance to titanium or polyurethane
• •Reported concomitant conditions requiring daily, high-dose oral and/or inhaled steroids.
• •Any medical condition that may interfere with the postoperative management program or preclude meaningful patient self-assessments, e.g., advanced emphysema, progressive neurological disease, or Alzheimer's disease
• •Any medical condition that may result in patient death prior to study completion, e.g., unstable cardiac disease, active malignancy
• •History of an endocrine or metabolic disorder known to affect osteogenesis
• •Active immunosuppressive disorder that may predispose patient to infection
• •Participating in or planning to participate in another clinical study that might influence the treatment outcomes or ability to comply with the study requirements
• •Member of a vulnerable population such as, mentally incompetent, prisoner
• •Pregnant, nursing, considering becoming pregnant during the study, or is of childbearing potential and unwilling to use an accepted form of birth control during the study.
• •History or suspicion of substance abuse or currently undergoing substance abuse treatment
• •In the judgment of the Investigator, patient is not likely to be able to fulfill the requirements of the study.