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.
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
A cervical spinal condition other than symptomatic cervical degenerative disc disease requiring surgical treatment at the involved levels.
Documented or diagnosed cervical instability relative to adjacent segments at either level, defined by dynamic (flexion/extension) radiographs showing sagittal plane translation >3.5 mm or sagittal plane angulation > 20°.
More than two cervical levels requiring surgical treatment.
An immobile or spontaneously fused level adjacent to the levels to be treated.