The equivalence of multi-axis spine systems: Recommended stiffness limits using a standardized testing protocol

Author's accepted manuscriptFinal version available from Elsevier via the DOI in this recordThe complexity of multi-axis spine testing often makes it challenging to compare results from different studies. The aim of this work was to develop and implement a standardized testing protocol across three six-axis spine systems, compare them, and provide stiffness and phase angle limits against which other test systems can be compared. Standardized synthetic lumbar specimens (n = 5), comprising three springs embedded in polymer at each end, were tested on each system using pure moments in flexion–extension, lateral bending, and axial rotation. Tests were performed using sine and triangle waves with an amplitude of 8 Nm, a frequency of 0.1 Hz, and with axial preloads of 0 and 500 N. The stiffness, phase angle, and R2 value of the moment against rotation in the principal axis were calculated at the center of each specimen. The tracking error was adopted as a measure of each test system to minimize non-principal loads, defined as the root mean squared difference between actual and target loads. All three test systems demonstrated similar stiffnesses, with small (<14%) but significant differences in 4 of 12 tests. More variability was observed in the phase angle between the principal axis moment and rotation, with significant differences in 10 of 12 tests. Stiffness and phase angle limits were calculated based on the 95% confidence intervals from all three systems. These recommendations can be used with the standard specimen and testing protocol by other research institutions to ensure equivalence of different spine systems, increasing the ability to compare in vitro spine studies.This research was completed with the support of the Catherine Sharpe Foundation, the Enid Linder Foundation, and the University of Bath Alumni Fun

Spine system equivalence: A new protocol for standardized multi-axis comparison tests

This is the final version of the paper.Accurately replicating the in-vivo loads of the spine is a critical aspect of in-vitro spine testing, but the complexity of this structure renders this challenging. The design and control capabilities of multi-axis spine systems vary considerably, and though recommendations have been made [1, 2], standardized in-vitro methods have not yet been established. As such, it is often difficult to compare different biomechanical studies [3]. The aim of this study was to use international standards [4, 5], and spine testing recommendations [1-3] to develop a standardized protocol for the evaluation of different multi-axis spinal test systems. The protocol was implemented on three six-axis spine systems, and the data used to establish stiffness and phase angle limits. [...]This research was supported by the Catherine Sharpe Foundation, the Enid Linder Foundation, the Higher Education Innovation Fund, and the University of Bath Alumni Fund