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Degenerative changes of the spinal column are the most common underlying cause of chronic low back pain (LBP). As individuals age, degenerative changes accumulate, affecting the vertebral discs, vertebra, facet joints, and ligaments in the lumbar region. These can lead to compression of spinal nerves and spinal nerve roots. Spondylolisthesis occurs when a vertebra slips forward on the vertebra below. When conservative treatment fails to control the pain, spinal fusion may be performed to prevent slippage and alleviate symptoms.
Dynamic stabilization, also known as soft stabilization or flexible stabilization, has been proposed as an alternative to the use of standard rigid frames as an adjunct to fusion and as an alternative to fusion. Dynamic stabilization uses flexible materials to stabilize the affected lumbar region while preserving the natural anatomy of the spine.
Current devices that are U.S. Food and Drug Administration (FDA) for dynamic stabilization of the spine include the Dynesys® System, which consists of a spacer, titanium pedicle screws, and flexible cord. Instead of using rigid rods for stabilization, the flexible cord is threaded through pedicles screws, which are placed lateral to the facets. The Dynesys® System has also been proposed for immobilization and stabilization or tethering of spinal segments without a spinal fusion procedure, which are off-label uses of the device.
Other systems that have received FDA clearance include but are not limited to the BioFlex® System, CD HorizoN® AGILE™ Dynamic Stabilization Device, DSS® Dynamic Soft Stabilization System, Dynabolt™ Dynamic Stabilization System, Isobar™ Spinal System, Satellite Spinal System, NFix™ II Dynamic Stabilization System, Stabilimax NZ Dynamic Spine Stabilization System, and the Zodiak DynaMo System.
Use of dynamic spine stabilization systems, with or without spinal fusion, is considered EXPERIMENTAL/INVESTIGATIVE due to the lack of clinical evidence demonstrating an impact on improved health outcomes.
No additional statements.
Summary of Evidence
The Dynesys® (Dynamic Neutralization System for the Spine) System is the only posterior dynamic stabilization system that has received clearance from the U.S. Food and Drug Administration (FDA). The use of the Dynesys system has been proposed as a method to improve the outcomes of spinal fusions. At this time, the absence of well-designed randomized clinical trials with long-term follow-up does not permit conclusions concerning the safety and efficacy of dynamic stabilization as a replacement for rigid stabilization in spinal fusion surgery nor are there sufficient studies to permit conclusions on its off-label use for spinal stabilization without fusion.
Rationale
The published evidence for dynamic stabilization systems is limited to low quality studies. Available evidence consists of retrospective or prospective case series with lack of a control group, length of follow-up extends to four years in a few studies but on average the follow-up period is two years, sample populations are small ranging on average from 25 to 100 subjects. While some authors reported improvement in pain and function adjacent segment degeneration has also been documented following insertion. Adjacent segment motion following Dynesys was evaluated by Cakir et al (2009) who reported that Dynesys had no beneficial effect on adjacent segment mobility compared with instrumented fusion. Kumar et al (2008) reported that disc degeneration at the bridged and adjacent segment continued despite Dynesys stabilization. Furthermore, some study participants have required reintervention revision surgery and/or a need for removal of the device has been reported. In a study comparing radiographic and clinical outcomes between posterior dynamic stabilization and posterior lumbar fusion. The authors noted that at follow-up there was no superior improvement in clinical outcomes, there were no advantages on leg and back VAS or ODI scores and randomized controlled trials are still needed. In a recent study comparing radiographic and clinical outcomes between fusion, the results showed the best evidence to date. Authors concluded that showed comparable clinical outcomes and provided benefits in preserving the motion at the stabilized segments, thus limiting the hypermobility at the adjacent segments and preventing adjacent segment disease compared with the fusion method in degenerative disease with or without grade I spondylolisthesis. Overall, the group of available evidence is insufficient to support that the use of dynamic stabilization systems improves health outcomes.
Clinical trials comparing posterior dynamic stabilization using Stabilimax™ NZ to patients receiving traditional fusion stabilization to treat degenerative lumbar spinal stenosis are ongoing under the investigational device exemption from the FDA. Additionally, there are some clinical trials that have been published reporting on the use of dynamic stabilization devices in the absence of fusion, however, none of these devices have received FDA approval for this indication. No clinical guidelines based on research recommend spinal dynamic stabilization devices were found.
Reference List
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Acknowledgements:
CPT® codes copyright American Medical Association® 2023. All rights reserved.
CDT codes copyright American Dental Association® 2023. All rights reserved.
