LDR Spine USA Mobi-C(R) Cervical Disc Prosthesis IDE

Inclusion Criteria:

1. Age 18-69 years.

2. Diagnosis of radiculopathy or myeloradiculopathy of the cervical spine, with pain, paresthesias or paralysis in a specific nerve root distribution C3 through C7, including at least one of the following:

   • Neck and/or arm pain (at least 30mm on the 100mm VAS scale).
   • Decreased muscle strength of at least one level on the clinical evaluation 0 to 5 scale.
   • Abnormal sensation including hyperesthesia or hypoesthesia; and/or
   • Abnormal reflexes
3. Symptomatic at one or two adjacent levels from C3 to C7;

4. Radiographically determined pathology at one or two adjacent level(s) to be treated correlating to primary symptoms including at least one of the following:

   • Decreased disc height on radiography, CT, or MRI in comparison to a normal adjacent disc.
   • Degenerative spondylosis on CT or MRI.
   • Disc herniation on CT or MRI;
5. Neck Disability Index Score of ≥15/50 or ≥30%;

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

   • Approximately six weeks from radiculopathy or myeloradiculopathy symptom onset; or
   • Have the presence of progressive symptoms or signs of nerve root/spinal cord compression despite continued non-operative conservative treatment.

Note: Not a complete listing

Exclusion Criteria:

1. Reported to have an active systemic infection or infection at the operative site;
2. Reported to have a history of or anticipated treatment for active systemic infection, including HIV or Hepatitis C;
3. More than one immobile vertebral level between C1 to C7 from any cause including but not limited to congenital abnormalities and osteoarthritic "spontaneous" fusions;
4. Previous trauma to the C3 to C7 levels resulting in significant bony or disco-ligamentous cervical spine injury;
5. Reported to have had any prior spine surgery at the operative level;
6. Reported to have had prior cervical fusion procedure at any level;
7. Axial neck pain in the absence of other symptoms of radiculopathy or myeloradiculopathy justifying the need for surgical intervention;
8. Disc height less than 3mm as measured from the center of the disc in a neutral position and disc height less than 20% of the anterior-posterior width of the inferior vertebral body;
9. Radiographic confirmation of severe facet joint disease or degeneration;

Note: Not a complete listing