Biomechanical In Vitro and Finite Element Study on Different Sagittal Alignment Postures of the Lumbar Spine During Multiaxial Daily Motion.

Lumbar lordotic correction (LLC), the gold standard treatment for sagittal spinal malalignment (SMA), and its effect on sagittal balance have been critically discussed in recent studies. This paper assesses the biomechanical response of the spinal components to LLC as an additional factor for the evaluation of LLC. Human lumbar spines (L2L5) were loaded with combined bending moments in flexion (Flex)/extension (Ex) or lateral bending (LatBend) and axial rotation (AxRot) in a physiological environment. We examined the dependency of AxRot range of motion (RoM) on the applied bending moment. The results were used to validate a finite element (FE) model of the lumbar spine. With this model, the biomechanical response of the intervertebral discs (IVD) and facet joints under daily motion was studied for different sagittal alignment postures, simulated by a motion in Flex/Ex direction. Applied bending moments decreased AxRot RoM significantly (all P < 0.001). A stronger decline of AxRot RoM for Ex than for Flex direction was observed (all P < 0.0001). Our simulated results largely agreed with the experimental data (all R2 > 0.79). During the daily motion, the IVD was loaded higher with increasing lumbar lordosis (LL) for all evaluated values at L2L3 and L3L4 and posterior annulus stress (AS) at L4L5 (all P < 0.0476). The results of this study indicate that LLC with large extensions of LL may not always be advantageous regarding the biomechanical loading of the IVD. This finding may be used to improve the planning process of LLC treatments.

Motion preservation surgery for scoliosis with a vertebral body tethering system: a biomechanical study.

PURPOSE: There is a paucity of studies on new vertebral body tethering (VBT) surgical constructs especially regarding their potentially motion-preserving ability. This study analyses their effects on the ROM of the spine. METHODS: Human spines (T10-L3) were tested under pure moment in four different conditions: (1) native, (2) instrumented with one tether continuously connected in all vertebrae from T10 to L3, (3) additional instrumented with a second tether continuously connected in all vertebrae from T11 to L3, and (4) instrumented with one tether and one titanium rod (hybrid) attached to T12, L1 and L2. The instrumentation was inserted in the left lateral side. The intersegmental ROM was evaluated using a magnetic tracking system, and the medians were analysed. Please check and confirm the author names and initials are correct. Also, kindly confirm the details in the metadata are correct. The mentioned information is correct RESULTS: Compared to the native spine, the instrumented spine presented a reduction of less than 13% in global ROM considering flexion-extension and axial rotation. For left lateral bending, the median global ROM of the native spine (100%) significantly reduced to 74.6%, 66.4%, and 68.1% after testing one tether, two tethers and the hybrid construction, respectively. In these cases, the L1-L2 ROM was reduced to 68.3%, 58.5%, and 38.3%, respectively. In right lateral bending, the normalized global ROM of the spine with one tether, two tethers and the hybrid construction was 58.9%, 54.0%, and 56.6%, respectively. Considering the same order, the normalized L1-L2 ROM was 64.3%, 49.9%, and 35.3%, respectively. CONCLUSION: The investigated VBT techniques preserved global ROM of the spine in flexion-extension and axial rotation while reduced the ROM in lateral bending.

Biomechanical In Vitro Test of a Novel Dynamic Spinal Stabilization System Incorporating Polycarbonate Urethane Material Under Physiological Conditions.

Posterior dynamic stabilization systems (PDSS) were developed to provide stabilization to pathologic or hypermobile spinal segments while maintaining the healthy biomechanics of the spine. Numerous novel dynamic devices incorporate the temperature and moisture dependent material polycarbonate urethane (PCU) due to its mechanical properties and biocompatibility. In this study, standardized pure moment in vitro tests were carried out on human lumbar spines to evaluate the performance of a device containing PCU. An environmental chamber with controlled moisture and temperature was included in the setup to meet the requirements of testing under physiological conditions. Three test conditions were compared: (1) native spine, (2) dynamic instrumentation, and (3) dynamic instrumentation with decompression. The ranges of motion, centers of rotation, and relative pedicle screw motions were evaluated. The device displayed significant stiffening in flexion-extension, lateral bending, and axial rotation load directions. A reduction of the native range of motion diminished the stiffening effect along the spinal column and has the potential to reduce the risk of the onset of degeneration of an adjacent segment. In combination with decompression, the implant decreased the native range of motion for flexion-extension and skew bending, but not for lateral bending and axial rotation. Curve fittings using the sigmoid function were performed to parameterize all load-deflection curves in order to enhance accurate numerical model calibrations and comparisons. The device caused a shift of the center of rotation (COR) in the posterior and caudal direction during flexion-extension loading.

Material failure in dynamic spine implants: are the standardized implant tests before market launch sufficient?

PURPOSE: International Standards Organization (ISO) 12189 and American Society for Testing and Materials F2624 are two standard material specification and test methods for spinal implant devices. The aim of this study was to assess whether the existing and required tests before market launch are sufficient. METHODS: In three prospective studies, patients were treated due to degenerative disease of the lumbar spine or spondylolisthesis with lumbar interbody fusion and dynamic stabilization of the cranial adjacent level. The CD HORIZON BalanC rod and S4 Dynamic rod were implanted in 45 and 11 patients, respectively. RESULTS: A fatigue fracture of the material of the topping off system has been found in five cases (11%) for the group fitted with the CD HORIZON BalanC rod. In the group using the S4 Dynamic rod group, a material failure of the dynamic part was demonstrated in seven patients (64%). All three studies were interrupted due to these results, and a report to the Federal Institute for Drugs and Medical Devices was generated. CONCLUSION: Spinal implants have to be checked by a notified body before market launch. The notified body verifies whether the implants fulfil the requirements of the current standards. These declared studies suggest that the current standards for the testing of load bearing capacity and stand ability of dynamic spine implants might be insufficient. Revised standards depicting sufficient deformation and load pattern have to be developed and counted as a requirement for the market launch of an implant. These slides can be retrieved under Electronic Supplementary Material.

An experimental-numerical method for the calibration of finite element models of the lumbar spine.

We present a systematic and automated stepwise method to calibrate computational models of the spine. For that purpose, a sequential resection study on one lumbar specimen (L2-L5) was performed to obtain the individual contribution of the IVD, the facet joints and the ligaments to the kinematics of the spine. The experimental data was prepared for the calibration procedure in such manner that the FE model could reproduce the average motion of the 10 native spines from former cadaveric studies as well as replicate the proportional change in ROM after removal of a spinal structure obtained in this resection study. A Genetic Algorithm was developed to calibrate the properties of the intervertebral discs and facet joints. The calibration of each ligament was performed by a simple and novel technique that requires only one simulation to obtain its mechanical property. After calibration, the model was capable of reproducing the experimental results in all loading directions and resections.

Biomechanical testing of a polycarbonate-urethane-based dynamic instrumentation system under physiological conditions.

BACKGROUND: Posterior dynamic stabilization systems are developed to maintain the healthy biomechanics of the spine while providing stabilization. Numerous dynamic systems incorporate polycarbonate urethane with temperature- and moisture-dependent material properties. In the underlying study, a novel test rig is used to evaluate the biomechanical performance of a system containing polycarbonate urethane. METHODS: The test rig is composed of two hydraulic actuators. An environmental chamber, filled with water vapor at body temperature, is included in the set up. The translational and rotational degrees of freedom of vertebrae and pedicle screws are measured using a magnetic tracking system. The Transition® device is tested in five lumbar spines (L2-L5) of human cadavers. Pure moment tests are performed for flexion-extension, lateral bending, and axial rotation. Three test conditions are compared: 1. native specimens, 2. dynamic instrumentation at L4-L5, 3. dynamic instrumentation with decompression at L4-L5. FINDINGS: The ranges of motion, the centers of rotation, and the pedicle screw loosening are calculated and evaluated. During daily motions such as walking, the loads on the lumbar spine differ from the standardized test protocols. To allow a reproducible data evaluation for smaller deformations, all moment-rotation curves are parameterized using sigmoid functions. INTERPRETATION: In flexion-extension, the Transition® device provides the highest stiffening of the segment and the largest shift of the center of rotation. No shift in the center of rotation, and the smallest supporting effect on the segment is observed for axial rotation. In lateral bending, a mediate reduction of the range of motion is observed.

Assessment of the viscoelastic mechanical properties of polycarbonate urethane for medical devices.

The underlying research work introduces a study of the mechanical properties of polycarbonate urethane (PCU), used in the construction of various medical devices. This comprises the discussion of a suitable material model, the application of elemental experiments to identify the related parameters and the numerical simulation of the applied experiments in order to calibrate and validate the mathematical model. In particular, the model of choice for the simulation of PCU response is the non-linear viscoelastic Bergström-Boyce material model, applied in the finite-element (FE) package Abaqus®. For the parameter identification, uniaxial tension and unconfined compression tests under in-laboratory physiological conditions were carried out. The geometry of the samples together with the applied loadings were simulated in Abaqus®, to insure the suitability of the modelling approach. The obtained parameters show a very good agreement between the numerical and the experimental results.

A new in vitro spine test rig to track multiple vertebral motions under physiological conditions.

In vitro pure moment spine tests are commonly used to analyse surgical implants in cadaveric models. Most of the tests are performed at room temperature. However, some new dynamic instrumentation devices and soft tissues show temperature-dependent material properties. Therefore, the aim of this study is to develop a new test rig, which allows applying pure moments on lumbar spine specimens in a vapour-filled chamber at body temperature. As no direct sight is given in the vapour-filled closed chamber, a magnetic tracking (MT) system with implantable receivers was used. Four human cadaveric lumbar spines (L2-L5) were tested in a vapour atmosphere at body temperature with a native and rigid instrumented group. In conclusion, the experimental set-up allows vertebral motion tracking of multiple functional spinal units (FSUs) in a moisture environment at body temperature.

Biomechanical testing of a PEEK-based dynamic instrumentation device in a lumbar spine model.

BACKGROUND: The purpose of this study was to investigate the range-of-motion after posterior polyetheretherketone-based rod stabilisation combined with a dynamic silicone hinge in order to compare it with titanium rigid stabilisation. METHODS: Five human cadaveric lumbar spines with four vertebra each (L2 to L5) were tested in a temperature adjustable spine-testing set-up in four trials: (1) native measurement; (2) kinematics after rigid monosegmental titanium rod instrumentation with anterior intervertebral bracing of the segment L4/5; (3) kinematics after hybrid posterior polyetheretherketone rod instrumentation combined with a silicone hinge within the adjacent level (L3/4) and (4) kinematics after additional decompression with laminectomy of L4 and bilateral resection of the inferior articular processes (L3). During all steps, the specimens were loaded quasi-statically with 1°/s with pure moment up to 7.5Nm in flexion/extension, lateral bending and axial rotation. FINDINGS: In comparison to the native cadaveric spine, both the titanium device and polyetheretherketone-based device reduce the range-of-motion within the level L4/5 significantly (flexion/extension: reduction of 77%, p<0.001; lateral bending: reduction of 62%, p<0.001; axial rotation: reduction of 71%, p<0.001). There was a clear stabilisation effect after hybrid-instrumentation within the level L3/4, especially in flexion/extension (64%, p<0.001) and lateral bending (62%, p<0.001) but without any effect on the axial rotation. Any temperature dependency has not been observed. INTERPRETATION: Surprisingly, the hybrid device compensates for laminectomy L4 and destabilising procedure within the level L3/4 in comparison to other implants. Further studies must be performed to show its effectiveness regarding the adjacent segment instability.