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.
Single group
Cervical Fusion (ZetaFuse™ Bone Graft)
DeviceFusion of the C3-C7 cervical vertebral bodies
Subjects with Radiologic Determination of Bone Fusion of the Treated Cervical Vertebral Bones
Radiological Fusion of the cervical vertebral bones, assessed using planar X-radiographs or computed tomography. Fusion is defined as continuous bridging bone between the endplates of the operated cervical vertebral bones. Subjects with fusion will be assessed as having a successful outcome while subjects without fusion will have failed the procedure.
Quality of Life via Short Form (SF12v2) Health Survey
SF12 measures quality of life, pain, and activity in a survey using 12 questions, with scores \>50 showing a better outcome
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