Pilot Study of ZetaFuse™ Bone Graft for the Treatment of Cervical Degenerative Disc Disease
Trial Parameters
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Age 22 to 75 years (inclusive) at the time of enrollment. 2. 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. 3. Symptomatic at one or two contiguous levels from C3 to C7. 4. 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. 5. Neck Disability Index Score ≥ 30/1