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

2019 ◽  
Vol 142 (1) ◽  
Author(s):  
Agnes Beckmann ◽  
Luis Fernando Nicolini ◽  
David Grevenstein ◽  
Hermann Backes ◽  
Stavros Oikonomidis ◽  
...  

Abstract 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.

2017 ◽  
Vol 27 (5) ◽  
pp. 570-577 ◽  
Author(s):  
Mohamed Macki ◽  
Rafael De la Garza-Ramos ◽  
Ashley A. Murgatroyd ◽  
Kenneth P. Mullinix ◽  
Xiaolei Sun ◽  
...  

OBJECTIVEAggressive sacral tumors often require en bloc resection and lumbopelvic reconstruction. Instrumentation failure and pseudarthrosis remain a clinical concern to be addressed. The objective in this study was to compare the biomechanical stability of 3 distinct techniques for sacral reconstruction in vitro.METHODSIn a human cadaveric model study, 8 intact human lumbopelvic specimens (L2–pelvis) were tested for flexion-extension range of motion (ROM), lateral bending, and axial rotation with a custom-designed 6-df spine simulator as well as axial compression stiffness with the MTS 858 Bionix Test System. Biomechanical testing followed this sequence: 1) intact spine; 2) sacrectomy (no testing); 3) Model 1 (L3–5 transpedicular instrumentation plus spinal rods anchored to iliac screws); 4) Model 2 (addition of transiliac rod); and 5) Model 3 (removal of transiliac rod; addition of 2 spinal rods and 2 S-2 screws). Range of motion was measured at L4–5, L5–S1/cross-link, L5–right ilium, and L5–left ilium.RESULTSFlexion-extension ROM of the intact specimen at L4–5 (6.34° ± 2.57°) was significantly greater than in Model 1 (1.54° ± 0.94°), Model 2 (1.51° ± 1.01°), and Model 3 (0.72° ± 0.62°) (p < 0.001). Flexion-extension at both the L5–right ilium (2.95° ± 1.27°) and the L5–left ilium (2.87° ± 1.40°) for Model 3 was significantly less than the other 3 cohorts at the same level (p = 0.005 and p = 0.012, respectively). Compared with the intact condition, all 3 reconstruction groups statistically significantly decreased lateral bending ROM at all measured points. Axial rotation ROM at L4–5 for Model 1 (2.01° ± 1.39°), Model 2 (2.00° ± 1.52°), and Model 3 (1.15° ± 0.80°) was significantly lower than the intact condition (5.02° ± 2.90°) (p < 0.001). Moreover, axial rotation for the intact condition and Model 3 at L5–right ilium (2.64° ± 1.36° and 2.93° ± 1.68°, respectively) and L5–left ilium (2.58° ± 1.43° and 2.93° ± 1.71°, respectively) was significantly lower than for Model 1 and Model 2 at L5–right ilium (5.14° ± 2.48° and 4.95° ± 2.45°, respectively) (p = 0.036) and L5–left ilium (5.19° ± 2.34° and 4.99° ± 2.31°) (p = 0.022). Last, results of the axial compression testing at all measured points were not statistically different among reconstructions.CONCLUSIONSThe addition of a transverse bar in Model 2 offered no biomechanical advantage. Although the implementation of 4 iliac screws and 4 rods conferred a definitive kinematic advantage in Model 3, that model was associated with significantly restricted lumbopelvic ROM.


Author(s):  
Héctor E Jaramillo S

The annulus fibrosus has substantial variations in its geometrical properties (among individuals and between levels), and plays an important role in the biomechanics of the spine. Few works have studied the influence of the geometrical properties including annulus area, anterior / posterior disc height, and over the range of motion, but in general these properties have not been reported in the finite element models. This paper presents a probabilistic finite element analyses (Abaqus 6.14.2) intended to assess the effects of the average disc height ( hp) and the area ( A) of the annulus fibrosus on the biomechanics of the lumbar spine. The annulus model was loaded under flexion, extension, lateral bending, and axial rotation and analyzed for different combinations of hpand A in order to obtain their effects over the range of motion. A set of 50 combinations of hp(mean = 18.1 mm, SD = 3.5 mm) and A (mean = 49.8%, SD = 4.6%) were determined randomly according to a normal distribution. A Yeoh energy function was used for the matrix and an exponential function for the fibers. The range of motion was more sensitive to hpthan to A. With regard to the range of motion the segment was more sensitive in the following order: flexion, axial rotation, extension, and lateral bending. An increase of the hpproduces an increase of the range of motion, but this decreases when A increases. Comparing the range of motion with the experimental data, on average, 56.0% and 73.0% of the total of data were within the experimental range for the L4–L5 and L5–S1 segments, respectively. Further, an analytic equation was derived to obtain the range of motion as a function of the hpand A. This equation can be used to calibrate a finite element model of the spine segment, and also to understand the influence of each geometrical parameter on the range of motion.


2019 ◽  
Vol 10 (8) ◽  
pp. 973-981
Author(s):  
Raymond J. Hah ◽  
Ram Alluri ◽  
Paul A. Anderson

Study Design: Biomechanics study. Objectives: To evaluate the biomechanical advantage of interfacet allograft spacers in an unstable single-level and 2-level anterior cervical discectomy and fusion (ACDF) pseudoarthrosis model. Methods: Nine single-level and 8 two-level ACDF constructs were tested. Range of motion in flexion-extension (FE), lateral bending (LB), and axial rotation (AR) at 1.5 N m were collected in 4 testing configurations: (1) intact spine, (2) ACDF with interbody graft and plate/screw, (3) ACDF with interbody graft and plate/loosened screws (loose condition), and (4) ACDF with interbody graft and plate/loosened screws supplemented with interfacet allograft spacers (rescue condition). Results: All fixation configurations resulted in statistically significant decreases in range of motion in all bending planes compared with the intact spine ( P < .05). One Level. Performing ACDF with interbody graft and plate on the intact spine reduced FE, LB, and AR 60.0%, 64.9%, and 72.9%, respectively. Loosening the ACDF screws decreased these reductions to 40.9%, 44.6%, and 52.1%. The addition of interfacet allograft spacers to the loose condition increased these reductions to 74.0%, 84.1%, and 82.1%. Two Level. Performing ACDF with interbody graft and plate on the intact spine reduced FE, LB, and AR 72.0%, 71.1%, and 71.2%, respectively. Loosening the ACDF screws decreased these reductions to 55.4%, 55.3%, and 51.3%. The addition of interfacet allograft spacers to the loose condition significantly increased these reductions to 82.6%, 91.2%, and 89.3% ( P < .05). Conclusions: Supplementation of a loose ACDF construct (pseudarthrosis model) with interfacet allograft spacers significantly increases stability and has potential applications in treating cervical pseudarthrosis.


2008 ◽  
Vol 63 (suppl_4) ◽  
pp. ONS303-ONS308 ◽  
Author(s):  
Şeref Doğan ◽  
Seungwon Baek ◽  
Volker K.H. Sonntag ◽  
Neil R. Crawford

Abstract Objective: To evaluate the differences in spinal stability and stabilizing potential of instrumentation after cervical corpectomy and spondylectomy. Methods: Seven human cadaveric specimens were tested: 1) intact; 2) after grafted C5 corpectomy and anterior C4–C6 plate; 3) after adding posterior C4–C6 screws/rods; 4) after extending posteriorly to C3–C7; 5) after grafted C5 spondylectomy, anterior C4–C6 plate, and posterior C4–C6 screws/rods; and 6) after extending posteriorly to C3–C7. Pure moments induced flexion, extension, lateral bending, and axial rotation; angular motion was recorded optically. Results: After corpectomy, anterior plating alone reduced the angular range of motion to a mean of 30% of normal, whereas added posterior short- or long-segment hardware reduced range of motion significantly more (P &lt; 0.003), to less than 5% of normal. Constructs with posterior rods spanning C3–C7 were stiffer than constructs with posterior rods spanning C4–C6 during flexion, extension, and lateral bending (P &lt; 0.05), but not during axial rotation (P &gt; 0.07). Combined anterior and C4–C6 posterior fixation exhibited greater stiffness after corpectomy than after spondylectomy during lateral bending (P = 0.019) and axial rotation (P = 0.001). Combined anterior and C3–C7 posterior fixation exhibited greater stiffness after corpectomy than after spondylectomy during extension (P = 0.030) and axial rotation (P = 0.0001). Conclusion: Circumferential fixation provides more stability than anterior instrumentation alone after cervical corpectomy. After corpectomy or spondylectomy, long circumferential instrumentation provides better stability than short circumferential fixation except during axial rotation. Circumferential fixation more effectively prevents axial rotation after corpectomy than after spondylectomy.


Neurosurgery ◽  
2001 ◽  
Vol 49 (6) ◽  
pp. 1399-1408 ◽  
Author(s):  
Andrzej Maciejczak ◽  
Michał Ciach ◽  
Maciej Radek ◽  
Andrzej Radek ◽  
Jan Awrejcewicz

ABSTRACT OBJECTIVE To determine whether the Cloward technique of cervical discectomy and fusion increases immediate postoperative stiffness of single cervical motion segment after application of interbody dowel bone graft. METHODS We measured and compared the stiffness of single-motion segments in cadaveric cervical spines before and immediately after interbody fusion with the Cloward technique. Changes in range of motion and stiffness of the C5–C6 segment were measured in a bending flexibility test (flexion, extension, lateral bending and axial rotation) before and after a Cloward procedure in 11 fresh-frozen human cadaveric specimens from the 4th through the 7th vertebrae. RESULTS The Cloward procedure produced a statistically significant increase in stiffness of the operated segment in flexion and lateral bending when compared with the intact spine. The less stiff the segment before the operation, the greater the increase in its postoperative flexural stiffness (statistically significant). The Cloward procedure produced nonuniform changes in rotational and extensional stiffness that increased in some specimens and decreased in others. CONCLUSION Our data demonstrate that Cloward interbody fusion increases immediate postoperative stiffness of an operated segment only in flexion and lateral bending in cadaveric specimens in an in vitro environment. Thus, Cloward fusion seems a relatively ineffective method for increasing the stiffness of a construct. This may add to discussion on the use of spinal instrumentation and postoperative management of patients after cervical discectomy, which varies from bracing in hard collars through immobilization in soft collars to no external orthosis.


2020 ◽  
Vol 43 (12) ◽  
pp. 803-810 ◽  
Author(s):  
Masud Rana ◽  
Sandipan Roy ◽  
Palash Biswas ◽  
Shishir Kumar Biswas ◽  
Jayanta Kumar Biswas

The aim of this study is to design a novel expanding flexible rod device, for pedicle screw fixation to provide dynamic stability, based on strength and flexibility. Three-dimensional finite-element models of lumbar spine (L1-S) with flexible rod device on L3-L4-L5 levels are developed. The implant material is taken to be Ti-6Al-4V. The models are simulated under different boundary conditions, and the results are compared with intact model. In natural model, total range of motion under 10 Nm moment were found 66.7°, 24.3° and 13.59°, respectively during flexion–extension, lateral bending and axial rotation. The von Mises stress at intact bone was 4 ± 2 MPa and at bone, adjacent to the screw in the implanted bone, was 6 ± 3 MPa. The von Mises stress of disc of intact bone varied from 0.36 to 2.13 MPa while that of the disc between the fixed vertebra of the fixation model reduced by approximately 10% for flexion and 25% for extension compared to intact model. The von Mises stresses of pedicle screw were 120, 135, 110 and 90 MPa during flexion, extension, lateral bending, and axial rotation, respectively. All the stress values were within the safe limit of the material. Using the flexible rod device, flexibility was significantly increased in flexion/extension but not in axial rotation and lateral bending. The results suggest that dynamic stabilization system with respect to fusion is more effective for homogenizing the range of motion of the spine.


2010 ◽  
Vol 66 (suppl_1) ◽  
pp. ons-126-ons-133 ◽  
Author(s):  
Bruno C.R. Lazaro ◽  
Leonardo B.C. Brasiliense ◽  
Anna G.U. Sawa ◽  
Phillip M. Reyes ◽  
Nicholas Theodore ◽  
...  

Abstract Objective: To study the alteration to normal biomechanics after insertion of a lumbar interspinous spacer (ISS) in vitro by nondestructive cadaveric flexibility testing. Methods: Seven human cadaveric specimens were studied before and after ISS placement at L1–L2. Angular range of motion, lax zone, stiff zone, sagittal instantaneous axis of rotation (IAR), foraminal height, and facet loads were compared between conditions. Flexion, extension, lateral bending, and axial rotation were induced using pure moments (7.5 Nm maximum) while recording motion optoelectronically. The IAR was measured during loading with a 400 N compressive follower. Foraminal height changes were calculated using rigid body methods. Facet loads were assessed from surface strain and neural network analysis. Results: After ISS insertion, range of motion and stiff zone during extension were significantly reduced (P &lt; .01). Foraminal height was significantly reduced from flexion to extension in both normal and ISS-implanted conditions; there was significantly less reduction in foraminal height during extension with the ISS in place. The ISS reduced the mean facet load by 30% during flexion (P &lt; .02) and 69% during extension (P &lt; .015). The IAR after ISS implantation was less than 1 mm from the normal position (P &gt; .18). Conclusion: The primary biomechanical effect of the ISS was reduced extension with associated reduced facet loads and smaller decrease in foraminal height. The ISS had little effect on sagittal IAR or on motion or facet loads in other directions.


2009 ◽  
Vol 3 (2) ◽  
Author(s):  
J. Bryndza ◽  
A. Weiser ◽  
M. Paliwal

Arthritis, degenerative disc disease, spinal stenosis, and other ailments lead to the deterioration of the facet joints of the spine, causing pain and immobility in patients. Dynamic stabilization and arthroplasty of the facet joints have advantages over traditional fusion methods by eliminating pain while maintaining normal mobility and function. In the present work, a novel dynamic stabilization spine implant design was developed using computational analysis, and the final design was fabricated and mechanically tested. A model of a fused L4–L5 Functional Spinal Unit (FSU) was developed using Pro/Engineer (PTC Corporation, Needham, MA). The model was imported into commercial finite element analysis software Ansys (Ansys Inc., Canonsburg, PA), and meshed with the material properties of bone, intervertebral disc, and titanium alloy. Physiological loads (600N axial load, 10 N-m moment) were applied to the model construct following the protocol developed by others. The model was subjected to flexion/extension, axial rotation, and lateral bending, and was validated with the results reported by Kim et al. The validated FSU was used as a base to design and evaluate novel spine implant designs, using finite element anlysis. A comparison of the flexion-extension curve of six designs and an intact spine was carried out. Range of motion of the new designs showed up to 4 degrees in flexion and extension, compared to less than one degree flexion/extension in a fused spine. The design that reproduced normal range of motion best was optimized, fabricated and prepared for mechanical testing. The finalized dynamic stabilization design with spring insert was implanted into a L4-L5 FSU sawbone (Pacific Research Laboratories, Vashon, WA) using Stryker Xia pedicle screws. The construct was potted using PMMA, and was subjected to flexion/extension, axial rotation, and lateral bending loads using MTS mechanical testing machine. The stiffness of the design was assessed and compared with computational analysis results.


2021 ◽  
pp. 1-9

OBJECTIVE Low fusion rates and cage subsidence are limitations of lumbar fixation with stand-alone interbody cages. Various approaches to interbody cage placement exist, yet the need for supplemental posterior fixation is not clear from clinical studies. Therefore, as prospective clinical studies are lacking, a comparison of segmental kinematics, cage properties, and load sharing on vertebral endplates is needed. This laboratory investigation evaluates the mechanical stability and biomechanical properties of various interbody fixation techniques by performing cadaveric and finite element (FE) modeling studies. METHODS An in vitro experiment using 7 fresh-frozen human cadavers was designed to test intact spines with 1) stand-alone lateral interbody cage constructs (lateral interbody fusion, LIF) and 2) LIF supplemented with posterior pedicle screw-rod fixation (360° constructs). FE and kinematic data were used to validate a ligamentous FE model of the lumbopelvic spine. The validated model was then used to evaluate the stability of stand-alone LIF, transforaminal lumbar interbody fusion (TLIF), and anterior lumbar interbody fusion (ALIF) cages with and without supplemental posterior fixation at the L4–5 level. The FE models of intact and instrumented cases were subjected to a 400-N compressive preload followed by an 8-Nm bending moment to simulate physiological flexion, extension, bending, and axial rotation. Segmental kinematics and load sharing at the inferior endplate were compared. RESULTS The FE kinematic predictions were consistent with cadaveric data. The range of motion (ROM) in LIF was significantly lower than intact spines for both stand-alone and 360° constructs. The calculated reduction in motion with respect to intact spines for stand-alone constructs ranged from 43% to 66% for TLIF, 67%–82% for LIF, and 69%–86% for ALIF in flexion, extension, lateral bending, and axial rotation. In flexion and extension, the maximum reduction in motion was 70% for ALIF versus 81% in LIF for stand-alone cases. When supplemented with posterior fixation, the corresponding reduction in ROM was 76%–87% for TLIF, 86%–91% for LIF, and 90%–92% for ALIF. The addition of posterior instrumentation resulted in a significant reduction in peak stress at the superior endplate of the inferior segment in all scenarios. CONCLUSIONS Stand-alone ALIF and LIF cages are most effective in providing stability in lateral bending and axial rotation and less so in flexion and extension. Supplemental posterior instrumentation improves stability for all interbody techniques. Comparative clinical data are needed to further define the indications for stand-alone cages in lumbar fusion surgery.


2005 ◽  
Vol 2 (3) ◽  
pp. 339-343 ◽  
Author(s):  
Patrick W. Hitchon ◽  
Kurt Eichholz ◽  
Christopher Barry ◽  
Paige Rubenbauer ◽  
Aditya Ingalhalikar ◽  
...  

Object. The authors compared the biomechanical performance of the human cadaveric spine implanted with a metallic ball-and-cup artificial disc at L4–5 with the spine's intact state and after anterior discectomy. Methods. Seven human L2—S1 cadaveric spines were mounted on a biomechanical testing frame. Pure moments of 0, 1.5, 3.0, 4.5, and 6.0 Nm were applied to the spine at L-2 in six degrees of motion (flexion, extension, right and left lateral bending, and right and left axial rotation). The spines were tested in the intact state as well as after anterior L4–5 discectomy. The Maverick disc was implanted in the discectomy defect, and load testing was repeated. The artificial disc created greater rigidity for the spine than was present after discectomy, and the spine performed biomechanically in a manner comparable with the intact state. Conclusions. The results indicate that in an in vitro setting, this model of artificial disc stabilizes the spine after discectomy, restoring motion comparable with that of the intact state.


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