Pilot Study of ZetaFuse™ Bone Graft for the Treatment of Cervical Degenerative Disc Disease
The goal of this pilot clinical trial is to test the safety and preliminary performance of the ZetaFuse Bone Graft in patient requiring fusion of the C3-C7 vertebral bones due to pain or loss of neurological function. Participants will be treated with ZetaFuse during surgical intervention to reduce pain and the loss of neurological function.
• Age 22 to 75 years (inclusive) at the time of enrollment.
• Diagnosis of radiculopathy and/or myelopathy 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 3 on the 0 - 10 numeric rating scale for pain.
⁃ 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.
• Symptomatic at one or two contiguous levels from C3 to C7.
• Radiographically determined pathology at the level to be treated correlating to primary symptoms including at least one of the following:
‣ Decreased disc height on radiography, computed tomography (CT), or magnetic resonance imaging (MRI) in comparison to a normal adjacent disc.
⁃ Degenerative spondylosis on CT or MRI.
⁃ Disc herniation on CT or MRI.
• Neck Disability Index Score ≥ 30/100.
• Unresponsive to non-operative treatment (e.g., rest, heat, physical therapy, chiropractor, massage, pain medication) for approximately six weeks from the symptom onset; or has the presence of progressive symptoms or signs of nerve root/spinal cord compression in the face of continued non-operative management.
• No previous surgical intervention at the involved levels or any subsequent, planned/staged surgical procedure at the involved or adjacent levels.
• Appropriate for treatment using an anterior surgical approach.
• Skeletally mature at the time of the surgery.
⁃ Medically cleared for surgery.
⁃ If a female of child-bearing potential, subject is non-pregnant, nonnursing, and agrees not to become pregnant during the study period.
⁃ Willing and able to comply with the study plan.
⁃ Signed written Patient Informed Consent Form.
⁃ Willing to discontinue use of non-steroidal anti-inflammatory drugs (NSAIDs) from one week before the surgery to 3 months after the surgery.