Functional and radiographic evaluation of an interspinous device as an adjunct for lumbar interbody fusion procedures.

ABSTRACT

In the last decades, several interspinous process devices were designed as a minimally invasive treatment option for spinal stenosis. In order to minimise surgical trauma, interspinous process devices were recently discussed as an alternative posterior fixation in vertebral interbody fusions. Therefore, the purpose of this study was to evaluate the effect of a newly designed interspinous device with polyester bands (PBs) on range of motion (RoM) and centre of rotation (CoR) of a treated motion segment in comparison with an established interspinous device with spikes (SC) as well as with pedicle screw instrumentation in lumbar fusion procedures. Flexibility tests with an applied pure moment load of 7.5 Nm were performed in six monosegmental thoracolumbar functional spinal units (FSUs) in the following states (a) native, (b) native with PB device, (c) intervertebral cage with PB device, (d) cage with SC and (e) cage with internal fixator. The resulting RoM was normalised to the native RoM. The CoR was determined of X-ray images taken in maximal flexion and extension during testing. In flexion and extension, the PB device without and with the cage reduced the RoM of the native state to 58% [standard deviation (SD) 17.8] and 53% (SD 15.7), respectively. The SC device further reduced the RoM to 27% (SD 16.8), while the pedicle screw instrumentation had the most reducing effect to 17% (SD 17.2) (p < 0.01). In lateral bending and axial rotation, the interspinous devices had the least effect on the RoM. Compared to the native state, for all instrumentations the CoR showed a small shift towards cranial. In the anterior-posterior direction, the SC device and the pedicle screw instrumentation shifted the CoR towards the posterior wall. The interspinous devices significantly reduced the RoM in flexion/extension, while in axial rotation and lateral bending only the internal fixator had a significant effect on the RoM.