Radiological factors affecting functional outcome after the implantation of BDYN™ dynamic stabilization system for low-grade lumbar degenerative spondylolisthesis.

BACKGROUND: The objectives of this study are to identify radiological factors associated with good functional outcomes after the implantation of BDYN™ dynamic stabilization system in the setting of painful low-grade degenerative lumbar spondylolisthesis (DLS). MATERIAL AND METHODS: In this monocentric, retrospective study, we followed 50 patients, a 5-years period, with chronic lower back pain, radiculopathy and/or neurogenic claudication evolving for at least one year that failed conservative treatment. All patients presented low-grade DLS and underwent lumbar dynamic stabilization. Radiological and clinical outcomes were assessed preoperatively and 24months after surgery. Functional evaluation was based on the Oswestry Disability Index (ODI), the Numerical Rating Scale (NRS), and the Walking Distance (WD). Radiological analysis was based on lumbar X-rays and MRI parameters. Patients were divided into two groups according to the reduction in the postoperative ODI score (more or less than 15 points), and statistical analysis was performed between both groups to find predictive radiological factors for a satisfying functional outcome. RESULTS: Clinically, 80% (40 patients) had a satisfying functional result, and 20% (10 patients) were considered having a poor outcome according to the ODI score. Radiologically, the loss in segmental lordosis was statistically associated with bad functional outcomes (18° for ODI decrease>15 versus 11° for ODI decrease<15). There is also a tendency showing that a higher Pfirmann disc signal grade (grade IV) and a severe canal stenosis according to Schizas classification (grade C & D) are predictive of a poor clinical result, but that must be confirmed in future studies. CONCLUSIONS: BDYN™ appears safe and well-tolerated. This new device should be effective for the treatment of patients with low-grade DLS. It provides significant improvement in terms of daily life activity and pain. Moreover, we have been able to deduce that a kyphotic disc is associated with a bad functional outcome after BDYN™ device implantation. It may represent a contraindication for the implantation of such DS device. Moreover, it seems that it is better to implant BDYN™ in DLS with mild or moderate disc degeneration and canal stenosis.

In vitro oxidative degradation of a spinal posterior dynamic stabilization device.

This study quantified the changes of the frequency-dependant viscoelastic properties of the BDyn (S14 Implants, Pessac, France) spinal posterior dynamic stabilization (PDS) device due to in vitro oxidation. Six polycarbonate urethane (PCU) rings and six silicone cushions were degraded using a 20% hydrogen peroxide/0.1 M cobalt (II) chloride hexahydrate, at 37°C, for 24 days. The viscoelastic properties of the individual components and the components assembled into the BDyn PDS device were determined using Dynamic Mechanical Analysis at frequencies from 0.01 to 30 Hz. Attenuated Total Reflectance Fourier Transform Infra-Red spectra demonstrated chemical structure changes, of the PCU, associated with oxidation while Scanning Electron Microscope images revealed surface pitting. No chemical structure or surface morphology changes were observed for the silicone cushion. The BDyn device storage and loss stiffness ranged between 84.46 N/mm to 99.36 N/mm and 8.13 N/mm to 21.99 N/mm, respectively. The storage and loss stiffness for the components and BDyn device increased logarithmically with respect to frequency. Viscoelastic properties, between normal and degraded components, were significantly different for specific frequencies only. This study demonstrates the importance of analyzing changes of viscoelastic properties of degraded biomaterials and medical devices into which they are incorporated, using a frequency sweep. © 2017 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 106B: 1237-1244, 2018.

Viscoelastic properties of a spinal posterior dynamic stabilisation device.

The purpose of this study was to quantify the frequency dependent viscoelastic properties of two types of spinal posterior dynamic stabilisation devices. In air at 37°C, the viscoelastic properties of six BDyn 1 level, six BDyn 2 level posterior dynamic stabilisation devices (S14 Implants, Pessac, France) and its elastomeric components (polycarbonate urethane and silicone) were measured using Dynamic Mechanical Analysis. The viscoelastic properties were measured over the frequency range 0.01-30Hz. The BDyn devices and its components were viscoelastic throughout the frequency range tested. The mean storage stiffness and mean loss stiffness of the BDyn 1 level device, BDyn 2 level device, silicone component and polycarbonate urethane component all presented a logarithmic relationship with respect to frequency. The storage stiffness of the BDyn 1 level device ranged from 95.56N/mm to 119.29N/mm, while the BDyn 2 level storage stiffness ranged from 39.41N/mm to 42.82N/mm. BDyn 1 level device and BDyn 2 level device loss stiffness ranged from 10.72N/mm to 23.42N/mm and 4.26N/mm to 9.57N/mm, respectively. No resonant frequencies were recorded for the devices or its components. The elastic property of BDyn 1 level device is influenced by the PCU and silicone components, in the physiological frequency range. The viscoelastic properties calculated in this study may be compared to spinal devices and spinal structures.