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

Ages Eligible for Study: 18 to 60 years

Genders Eligible for Study: Both

Accepts Healthy Volunteers: No

Inclusion criteria

• Symptomatic cervical disc disease (SCDD) in one vertebral level between C3-C7, defined as neck or arm (radicular) pain, or functional or neurological deficit and radiographic confirmation (by CT, MRI, X-ray, etc.) of any of the following:
• Herniated nucleus pulposus;
• Radiculopathy or myelopathy;
• Spondylosis (defined by the presence of osteophytes); or
• Loss of disc height.
• Age between 18 and 60 years
• Failed at least 6 weeks of conservative treatment
• Neck Disability Index (NDI) Questionnaire score of at least 30 (as percentage of 50 point total)
• Able to understand and sign informed consent form
• Psychosocially, mentally and physically able to fully comply with this protocol including adhering to follow-up schedule and filling out forms
• Able to meet the proposed follow-up schedule at 6 weeks, 3 months, 6 months, 12 months and 24 months
• Able to follow postoperative management program

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