FUSE Study (H-47958)
Safety and Effectiveness of Posterior Cervical Stabilization System (PCSS) as an adjunct to posterior cervical fusion, when used in combination with ACDF in the treatment of multi-level cervical degenerative disease.
The objective of this study is to assess the safety and effectiveness of the posterior cervical stabilization system (PCSS) as an adjunct to posterior cervical fusion (PCF), when used in combination with anterior cervical discectomy and fusion (ACDF) in the treatment of multi-level cervical degenerative disease.
Randomization will place the patient into either the control arm or treatment arm. The control arm will consist of the standard of care in which an ACDF procedure will be completed with solid structural machined allograft and a semi-constrained plate. The treatment arm will consist of the use of the investigational device (PCSS) in which circumferential fusion (CCF) will take place, including the standard of care (ACDF) plus a posterior cervical fusion (PCF) with the PCSS.
The study primary endpoint is demonstration of superiority in fusion success in the treatment arm (CCF) as compared to the control arm (ACDF) at 12 months post procedure. The study secondary endpoint is demonstration of non-inferiority for the composite safety success in the treatment arm (CCF) as compared to the control arm (ACDF) at 24 months post procedure.
Study duration will consist of clinic visit follow-ups at 6 weeks, 3 months, 6 months, 12 months, and 24 months after the assigned surgical procedure.
- Age 18-80 years.
- Indicated for ACDF treatment of degenerative disc disease (DDD) between and including C3-C7 at 3 contiguous levels.
- Unresponsive to non-operative, conservative treatment (rest, heat, electrotherapy, physical therapy, chiropractic care and/or analgesics).