SECURE®-C Cervical Artificial Disc Clinical Study/ SECURE-C Cervical Artificial Disc Postmarket Approval Study

Exclusion Criteria

• •More than one vertebral level requiring treatment
• •Prior fusion surgery adjacent to the vertebral level being treated
• •Prior surgery at the level to be treated
• •Clinically compromised vertebral bodies at the affected level(s) due to current or past trauma
• •Radiographic confirmation of facet joint disease or degeneration, defined as apparent sclerosis and/or hypertrophy of the facets demonstrated on AP radiographs as a disruption of the normally smooth facet curve
• •Marked cervical instability on resting lateral or flexion/extension radiographs:
• •Translation greater than 3mm, and/or
• •More than 11° of rotational difference from that of either adjacent level.
• •Severe spondylosis at the level to be treated as characterized by any of the following:
• •Bridging osteophytes;
• •A loss of disc height greater than 50%; or
• •Absence of motion (\<2°)
• •Neck or arm pain of unknown etiology
• •Osteoporosis, osteopenia, Paget's disease, osteomalacia or any other metabolic bone disease
• •Pregnant or interested in becoming pregnant in the next 2 years
• •Active systemic or local infection
• •Known allergy to titanium, polyethylene, cobalt, chromium or molybdenum
• •Taking medications or any drug known to potentially interfere with bone/soft tissue healing (e.g., steroids)
• •Rheumatoid arthritis or other autoimmune disease
• •Systemic disease including AIDS, HIV, Hepatitis
• •Active malignancy: A patient with a history of any invasive malignancy (except non-melanoma skin cancer), unless he/she has been treated with curative intent and there has been no clinical signs or symptoms of the malignancy for at least 5 years
• •Neuromuscular disorders such as muscular dystrophy, spinal muscular atrophy, amyotrophic lateral sclerosis, etc.
• •Acute mental illness or substance abuse
• •Use of bone growth stimulator within past 30 days
• •Participation in other investigational device or drug clinical trials within 30 days of surgery
• •Prisoners