Safety Study of Preservon-Treated Bone Implants for Cervical Fusion in the Treatment of Cervical Radiculopathy or Myelopathy

Inclusion Criteria: Patient is skeletally mature Patient has confirmed radiculopathy or myelopathy Pain unresponsive to non-operative treatment Radicular pain in either or both upper extremities Neurological deficit in distribution of nerve root from C3/4 to C6/7 Patient's lateral cervical spine x-rays show inferior aspect of lowest vertebral body to be fused Patient agrees to comply with protocol Patient can provide voluntary informed consent and follow-up information Exclusion Criteria: Patient has previous cervical spine surgery Patient requires concurrent posterior surgery at level to be treated, or anterior and posterior surgery at any other cervical level Patient has clinically compromised vertebral body structure Patient has multi-level fixed/ankylosed cervical spine Patient has signs of significant instability at level to be treated or adjacent level Patient has history of metabolic bone disease Patient is taking chronic oral/IV corticosteroid therapy OR medications that potentially interfere with bone/soft tissue healing Patient has progressive neuromuscular disease, rheumatoid arthritis, active malignancy, OR any other condition that interferes with self-assessment of pain, function, or quality of life Patient has OPLL at any level Patient has active infection, local or systemic Patient is pregnant or considering pregnancy (x-ray requirements) Patient is participating in another investigational study Patient belongs to vulnerable population