Pre-clinical testing protocols for the evaluation of spinal biomechanics

Chronic back pain is the leading cause of disability worldwide, affecting millions of people throughout the world. The source of pain is usually the intervertebral disc (IVD), thus there has been a growing interest in developing new improved implants such as disc replacements to treat the condition. However, to ensure the artificial devices being designed replicate the intact disc, the biomechanical behaviour of the IVD must be well understood (Adams and Dolan, 2005). The two most widely used testing procedures in the spinal industry to characterise the behaviour of the disc are the flexibility and the stiffness protocols (Stokes et al, 2002 and Panjabi et al, 1976).

For elastic specimens, the results produced by the flexibility and the stiffness protocols should in theory be identical. However, this does not hold true for inelastic specimens, such as the IVD. For this reason, the custom developed Spine Simulator (Holsgrove et al, 2014) at the University of Bath has been used to compare, in six degrees of freedom, the extent of the difference produced by these two different testing protocols.

A biomechanical model of the IVD consisting of two cylindrical nylon blocks, representing the vertebral bodies (VB), attached with a layer of nitrile rubber, representing the disc, was tested. Two steel pins were inserted on the VB, spanning the thickness of the disc, to ensure the stiffness raise either side of the neutral zone was replicated by the model. Tests were performed at a frequency of 0.1 Hz using triangular wave cycles. The specimen was tested firstly using the stiffness protocol, characterised by displacements of ±0.5 mm in anterior-posterior and lateral shear, ±0.35 mm in axial compression and ±1.5 ° in all rotational axes. The resulting loads were applied to the specimen when subjected to the flexibility protocol. In addition, the effect of including a preload was studied by testing specimens with an axial compressive load of 250 N.

The stiffness matrix was calculated for each test and the main diagonal terms produced for the two protocols were compared using the Mann-Whitney test. Overall, results showed that there was a significant difference in the stiffness terms produced by the two protocols when tests were performed with (p ≤ 0.016) and without (p = 0.004) preload. The only exception was found in flexion-extension tests with preload (p = 0.337). Additionally, differences were also recorded when comparing the shape and linearity of the load-displacement hysteresis curve (Figure 1) and the area enclosed by the curve.

This preliminary study has provided important information regarding the differences in the data produced by the flexibility and the stiffness protocols, it is therefore impractical to compare results produced using these two methods. To ensure that in the future results can be compared across laboratories, a standardised testing procedure is needed in the spinal industry.