The US Food and Drug Administration has officially approved Providence Medical Technology’s CORUS™ Posterior Cervical Stabilization System (PCSS), which is designed to treat up to 3-level cervical Degenerative Disc Disease (DDD). According to certain reports, the stated approval follows up on a particular FUSE IDE study. Essentially a prospective, multicenter, randomized controlled trial, the study compared safety and effectiveness of Circumferential Cervical Fusion (CCF) versus Anterior Cervical Discectomy and Fusion (ACDF) alone in high-risk cervical fusion patients. More on the FUSE IDE study would reveal how it was performed at 18 U.S. sites across 13 states and enrolled 227 patients aged 18 to 80 with symptomatic cervical DDD at three contiguous levels. After recruiting the participants, the study would randomize subjects to receive ACDF, the current standard of care. In a separate arrangement, it will randomize subjects to receive CCF, translating to ACDF plus posterior cervical fusion, and it did so with the company’s PCSS technology. All in all, Providence will perform an interim analysis on over 200 subjects at 1 year follow-up and 100 patients at 2 years follow-up. Going by the available details, the interim analysis demonstrated clear superiority of CCF in the study’s primary endpoint of fusion success,
Talk about the results on a slightly deeper level, the study’s primary endpoint would go on to display a 44.3% higher composite fusion rate of CCF over ACDF (61.0% vs 16.7%, p<0.001), a rate which was achieved using a strict definition of composite fusion. You see, the fusion was only deemed a success if all three consecutive levels demonstrated motion of less than 2 degrees on flexion-extension, radiographs, and continuous bridging bone across the endplates of all three segments on thin-slice CT scans. Enhancing their reliability even further is the fact that these reported results came from an independent core imaging lab and are already verified by multiple radiologists. Next up, we must into how the study showed significant variations when it came to revision rates, as across all ACDF subjects followed through study completion, 22.8% (13/57) required subsequent surgical intervention (primarily due to symptomatic nonunion). On the other hand, the stated percentage was no more than 1.7% (1/59) in the CCF arm.
“The results from this study provide very compelling evidence for the use of circumferential cervical fusion with PCSS over the standard ACDF treatment for multilevel cervical degenerative disc disease. CCF patients had significantly higher fusion rates and greater improvements in patient-reported symptoms and overall quality of life. This study should cause spine surgeons and payors to re-examine their preferred approach to treating 3-level cervical DDD,” said Dr. Pierce D. Nunley, MD, the Director of the Spine Institute of Louisiana and a Principal Investigator in the FUSE Study.
Another detail worth mention regarding this study came up after its secondary endpoint measured overall safety success at 2 years using a composite of fusion success, lack of subsequent surgical interventions, maintenance or improvement in neurological success, and Neck Disability Index (NDI) improvement. Here, too, the CCF arm exhibited a superior composite overall safety success rate at 24 months compared to the ACDF arm (CCF=50.8%, ACDF=22.8%, p<0.002). Finally, the 3-level CCF with PCSS study further reaffirmed that there were statistically lower procedure-related adverse events than 3-level ACDF (p=0.005).
“The findings from the FUSE study mark a milestone in spinal surgery. The high rates of 3-level ACDF failures and reoperation underscore how these patients need more to heal properly and achieve positive outcomes. The strength of this clinical evidence suggests that CCF with CORUS PCSS should become the new standard of care for multilevel fusion patients,” said Jeff Smith, Chief Executive Officer of Providence Medical Technology.