Landmark Clinical Study Published in Spine Demonstrates Superiority of Tissue-Sparing Circumferential Cervical Fusion Over ACDF Alone in Multilevel Cervical Fusion Surgery

PLEASANTON, Calif., Aug. 14, 2025 /PRNewswire/ -- Providence Medical Technology announces publication of initial FUSE study results in Spine, a leading journal for spine surgery. The journal presents peer-reviewed results of a pivotal, multicenter randomized controlled trial showing that tissue-sparing circumferential cervical fusion (CCF) significantly outperforms anterior cervical discectomy and fusion (ACDF) alone in treating three-level degenerative disc disease (DDD). The findings establish a new benchmark for the surgical treatment of multi-level cervical pathology.

The article titled "Three-level anterior cervical discectomy and fusion with or without an investigational posterior stabilization system assessed through 24 months: a multi-center randomized controlled trial" is published in the Sep 1 issue of Spine. This represents the first peer-reviewed results from the FUSE IDE trial, which enrolled 227 patients across 18 U.S. sites and compared outcomes between standard three-level ACDF and ADCF with Providence's CORUS™ Posterior Cervical Stabilization System (PCSS). Results demonstrated statistically significant improvements in the CCF arm in fusion success, safety, and the reduction of reoperation rates without adding procedural risk or recovery burden.

Key findings published in Spine include:

• Superior Fusion Success at 12 Months: CCF achieved a 61.0% composite fusion success rate compared to just 17% in the ACDF group—a nearly fourfold improvement (p<0.001). Fusion was strictly defined by <2° motion at all levels on flexion-extension radiographs and contiguous bridging bone on thin-slice CT at each level, verified by independent imaging reviewers. At the final 24-month follow-up, 75% of CCF patients achieved fusion versus 33% of ACDF patients.
• Fewer Reoperations within 24 Months: The need for revision surgery was more than ten times lower in the CCF group (2% vs. 23%, p<0.001).
• Improved Composite Safety: CCF showed superior overall safety success at 2 years (50.8% vs. 22.8%, p<0.002), based on fusion success, absence of revision, neurological maintenance or improvement, and NDI score gains. Despite being a circumferential procedure, CCF demonstrated statistically fewer procedure-related complications than ACDF alone (p=0.005), with only 10cc of added blood loss and 98 minutes of additional operative time on average.

"The publication of this randomized controlled trial in Spine represents a significant advancement in our understanding of multi-level cervical fusion," said Dr. K. Brandon Strenge, Lead Author of the publication. "For the first time, we have Level I evidence demonstrating that supplementing 3-level ACDF with minimally invasive posterior stabilization and fusion not only substantially improves fusion rates, but also drastically reduces the need for subsequent revision surgeries. This rigorously conducted study, with its comprehensive fusion criteria and inclusive patient population, provides critical new clinical evidence that reshapes how we approach multi-level cervical fusion cases and how we improve outcomes in high-risk patients."

"The publication of the FUSE study in Spine represents a major milestone for the field of cervical spine surgery," said Jeff Smith, CEO of Providence Medical Technology. "The science is clear: tissue-sparing CCF with CORUS PCSS is safer, more effective, and more durable than ACDF alone in multilevel cervical fusion cases. As such, these results should prompt spine surgeons and payors alike to reconsider how we treat multilevel cervical DDD."

The CORUS PCSS system, now FDA-cleared for use in up to three cervical levels, is designed to achieve posterior fixation with minimal disruption to muscle and soft tissue. Its unique design enables stabilization across the facet joints through a posterior approach, avoiding the high morbidity associated with traditional open posterior fixation.

The FUSE study was conducted under FDA oversight as part of an Investigational Device Exemption (IDE) and formed the clinical basis for FDA clearance of the CORUS PCSS system in July 2024.

For more information about the FUSE study and to access the Spine publication, visit https://providencemt.com/fuse-study-spine-publication/. 

About Providence Medical Technology
Providence is a privately held medical device company focused on tissue-sparing solutions for cervical spinal surgery. The company develops innovative spinal fusion systems designed to improve long-term outcomes and reduce the need for costly revision procedures.

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SOURCE Providence Medical Technology, Inc.