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