A Biomechanical Evaluation of a Next-Generation Integrated and Modular ACDF Device Possessing Full-Plate, Half-Plate, and No-Profile Fixation Iterations

摘要

Study Design: In vitro biomechanical study. Objectives: The objective of this in vitro biomechanical range-of-motion (ROM) study was to evaluate spinal segmental stability following fixation with a novel anterior cervical discectomy and fusion (ACDF) device (“novel device”) that possesses integrated and modular no-profile, half-plate, and full-plate fixation capabilities. Methods: Human cadaveric (n = 18, C3-T1) specimens were divided into 3 groups (n = 6/group). Each group would receive one novel device iteration. Specimen terminal ends were potted. Each specimen was first tested in an intact state, followed by anterior discectomy (C5/C6) and iterative instrumentation. Testing order: (1) novel device (group 1, no-profile; group 2, half-plate; group 3, full-plate); (2) novel device (all groups) with lateral mass screws (LMS); (3) traditional ACDF plate + cage; (4) traditional ACDF plate + cage + LMS. A 2 N·m moment was applied in flexion/extension (FE), lateral bending (LB), and axial rotation (AR) via a kinematic testing machine. Segmental ROM was tracked and normalized to intact conditions. Comparative statistical analyses were performed. Results: Key findings: (1) the novel half- and full-plate constructs provided comparable reduction in FE and LB ROM to that of traditional plated ACDF ( P ≥ .05); (2) the novel full-plate construct significantly exceeded all other anterior-only constructs ( P ≤ .05) in AR ROM reduction; and (3) the novel half-plate construct significantly exceeded the no-profile construct in FE ( P .05). Conclusions: The novel ACDF device may be a versatile alternative to traditional no-profile and independent plating techniques, as it provides comparable ROM reduction in all principle motion directions, across all device iterations.