Fuse study - Providence Medical Technology, Inc.

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