Pilot Study to Evaluate the Safety and Effectiveness of ZetaFuse Bone Graft for Cervical Spine Fusion in Adults with Degenerative Disc Disease

What this Trial Is About

This research aims to evaluate the safety and early performance of the ZetaFuse Bone Graft in adults needing fusion of cervical vertebral bones C3 through C7 due to pain or neurological problems. It focuses on patients with confirmed cervical spine issues such as herniated discs, spondylosis, or disc height loss, who have symptoms including radiculopathy or myelopathy. The purpose is to assess fusion success and improvements in quality of life following surgery. Participants will receive the ZetaFuse Bone Graft packed into a PEEK interbody device during surgery to fuse one or two adjacent cervical vertebrae. This device is implanted through an anterior surgical approach to treat degenerative disc disease affecting the cervical spine levels C3 to C7. The study is a pilot clinical trial with no placebo or comparison group. During the study, participants will be monitored for bone fusion at one year post-surgery through radiologic imaging. Researchers will also assess quality of life using the Short Form SF12v2 Health Survey at the same time point. The study includes medical clearance, adherence to medication restrictions, and follow-up visits to evaluate surgical outcomes and safety over time. Total participation may last up to one year after surgery.

Pilot Study of ZetaFuse™ Bone Graft for the Treatment of Cervical Degenerative Disc Disease