PCM Cervical Disc System

This is an interventional treatment trial for Radiculopathy Read More

Inclusion Criteria:

• Age 18-65 years;
• Diagnosis of radiculopathy or myelopathy of the cervical spine between C3-4 and C7-T1;
• Symptomatic at only one level from C3-C4 to C7-T1;
• Unresponsive to non-operative treatment for six weeks, or has the presence of progressive symptoms or signs of nerve root/spinal cord compression in the face of conservative treatment;
• Baseline NDI score of ≥30/100;
• Radiographically determined pathology at level to be treated correlating to primary symptoms, including at least one of the following: decreased disc height, degenerative spondylosis on CT or MRI, or disc herniation;
• Appropriate for treatment using an anterior surgical approach, including having no more than one previous anterior surgical approach to the cervical spine;
• Ability and willingness to comply with follow-up regimen; and
• Written informed consent given by subject or subject's legally authorized representative.

Exclusion Criteria:

• Infection at the site of surgery;
• History of, or anticipated treatment for, active systemic infection, including HIV infection or hepatitis C;
• Prior attempted or completed cervical spine surgery, except (1) laminoforaminotomy with less than one-third facetectomy at any level, or (2) a successful single-level anterior cervical fusion;
• More than one immobile vertebral level between C1-T1 from any cause, including but not limited to congenital abnormalities, osteoarthritic "spontaneous" fusions, and prior cervical spinal fusions;
• Previous trauma to the C3-T1 levels resulting in significant bony or disco-ligamentous cervical spine injury;
• Axial neck pain in the absence of other symptoms of radiculopathy or myelopathy justifying the need for surgical intervention;
• Radiographic confirmation of severe facet joint disease or degeneration.
• Osteoporosis:
• Severe diabetes mellitus requiring daily insulin management;
• Active malignancy: a history of any invasive malignancy (except non-melanoma skin cancer), unless the patient has been treated with curative intent and there have been no clinical signs or symptoms of the malignancy for at least 5 years;
• Tumor as source of symptoms;
• Symptomatic DDD or significant cervical spondylosis at two or more levels;
• Known or suspected allergy to cobalt, chromium, molybdenum, titanium, or polyethylene;
• Severe myelopathy to the extent that the patient is wheelchair bound;
• Pregnant (verified in patients of childbearing potential by a negative urine pregnancy test when preadmission testing is obtained), or interested in becoming pregnant during the duration of the study;
• Autoimmune disorders that impact the musculoskeletal system (e.g., lupus, rheumatoid arthritis; ankylosing spondylitis);
• Spinal axis disease (thoracic or lumbar) to the extent that surgical consideration is likely anticipated within 6 months after the cervical randomized procedure;
• Other degenerative joint disease (e.g. shoulder, hip, knee) to the extent that surgical consideration is likely anticipated within 6 months after the cervical randomized procedure;
• Previous spine surgery within the 6 months preceding the cervical randomized procedure;
• Current or recent history of substance abuse (drug or alcohol);
• Morbid obesity, defined as body mass index ("BMI") > 40 or more than 100 lbs. over ideal body weight;
• Currently using, or planning to use, bone growth stimulators in the cervical spine;
• Use of any other investigational drug or medical device within the last 30 days prior to surgery
• Currently a prisoner; or
• Currently pursuing personal litigation related to the neck or cervical spine injury; however, involvement in worker's compensation related litigation is not a required exclusion.