Landmark Clinical Study Demonstrates Superiority of 3-Level Circumferential Cervical Fusion Over Anterior Cervical Fusion Alone
FDA clears CORUS™ PCSS for multilevel circumferential cervical fusion procedures based on results from the prospective, multicenter, randomized, controlled FUSE Study
Excerpt from the Press Release:
PLEASANTON, Calif., July 11, 2024 /PRNewswire/ — Providence Medical Technology announces FDA Clearance of its CORUS™ Posterior Cervical Stabilization System (PCSS) for the treatment of up to 3-level cervical Degenerative Disc Disease (DDD). The FDA clearance was based on results from the FUSE IDE study, a prospective, multicenter, randomized controlled trial comparing safety and effectiveness of Circumferential Cervical Fusion (CCF) versus Anterior Cervical Discectomy and Fusion (ACDF) alone in high-risk cervical fusion patients.
The FUSE Study 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. The study randomized subjects to receive ACDF, the current standard of care, or CCF (ACDF plus posterior cervical fusion with the company’s PCSS technology). Interim analysis was performed on over 200 subjects at 1 year follow-up and 100 patients at 2 years follow-up.
The interim analysis demonstrated the superiority of CCF in the study’s primary endpoint of fusion success, highlighting the profound benefits of tissue-sparing CCF over ACDF alone:
- Superior Fusion Success at 1 year: The study’s primary endpoint demonstrated a 44.3% higher composite fusion rate of CCF over ACDF (61.0% vs 16.7%, p<0.001) using a strict definition of composite fusion. Fusion was deemed a success if all three consecutive levels demonstrated motion of less than 2 degrees on flexion-extension radiographs and continuous bridging bone was exhibited across the endplates of all three segments on thin-slice CT scans. Results were reported by an independent core imaging lab and verified by multiple radiologists.
Click the button below to read the entire Press Release:
Discover What Sets TrialStat Apart From Ordinary EDC Platforms
Click the image or button below to explore our eClinical Suite Platform and discover what sets TrialStat apart from competing EDC platforms.
Request Your Demo Today!
From rapid database build through database lock, we deliver consistent quality on-time and on-budget. Ready to upgrade your eClinical toolkit?