“A long-term prospective assessment of 3-level ACDF outcomes is
needed to best compare to current 1- & 2-level outcomes.” – Nichols

Fuse study

We agree. That’s why we conducted the
largest ever randomized, prospective study evaluating 3-level ACDF vs 3-Level CCF.

FUSE Study initial results are expected in Fall 2024.

    
    Simple Table

            Design
            Multicenter, Prospective, Randomized, Controlled Trial
        
            Total Patients
            N=227 randomized
        
            Control Group
            ACDF with plate
        
            Test Group
            CCF (Circumferential Cervical Fusion):
Plated ACDF plus PCF with PCSS
        
            Target Population
			Subjects requiring 3 level fusion for the treatment of symptomatic DDD
        
            Primary Endpoint at 12 months
			   Fusion Success Superiority

– Bridging trabecular bone across endplates &

– Less than 2° angular motion in flexion/extension			   
			
            Secondary Endpoint at 24 months
            Composite Success Noninferiority

– Fusion success

– Improvement in Neck Disability Index (NDI)

– Neurological success

– Absence of secondary surgical interventions (SSI)	
			
            Follow-ups
            6 weeks; 3, 6, 12 & 24 months
        
            Study Hypothesis
            Circumferential fusion improves outcomes for patients undergoing 3-level procedures

CAVUX^® PCSS is non-segmental instrumentation with integrated screw fixation intended to provide immobilization & stabilization of spinal segments.

CAVUX PCSS is placed through a posterior surgical approach in up to three consecutive levels of the cervical spine (C3-C7) and achieves bilateral facet fixation by spanning the interspace at each level with points of fixation at each end of the construct.

CAUTION: PCSS is an investigational device. Limited by federal law to investigational use.

See ClinicalTrials.gov for more information https://clinicaltrials.gov/ct2/show/NCT04229017

Our purpose is to improve clinical
outcomes for high-risk patients and prevent surgical failures of the spine.

Design	Multicenter, Prospective, Randomized, Controlled Trial
Total Patients	N=227 randomized
Control Group	ACDF with plate
Test Group	CCF (Circumferential Cervical Fusion): Plated ACDF plus PCF with PCSS
Target Population	Subjects requiring 3 level fusion for the treatment of symptomatic DDD
Primary Endpoint at 12 months	Fusion Success Superiority – Bridging trabecular bone across endplates & – Less than 2° angular motion in flexion/extension
Secondary Endpoint at 24 months	Composite Success Noninferiority – Fusion success – Improvement in Neck Disability Index (NDI) – Neurological success – Absence of secondary surgical interventions (SSI)
Follow-ups	6 weeks; 3, 6, 12 & 24 months
Study Hypothesis	Circumferential fusion improves outcomes for patients undergoing 3-level procedures

“A long-term prospective assessment of 3-level ACDF outcomes isneeded to best compare to current 1- & 2-level outcomes.” – Nichols

We agree. That’s why we conducted thelargest ever randomized, prospective study evaluating 3-level ACDF vs 3-Level CCF.

“A long-term prospective assessment of 3-level ACDF outcomes is
needed to best compare to current 1- & 2-level outcomes.” – Nichols

We agree. That’s why we conducted the
largest ever randomized, prospective study evaluating 3-level ACDF vs 3-Level CCF.