Design and development of a novel expanding flexible rod device (FRD) for stability in the lumbar spine: A finite-element study

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.

2020 ◽  
Vol 2020 ◽  
pp. 1-9
Author(s):  
Jia Li ◽  
Li-Cheng Zhang ◽  
Jiantao Li ◽  
Hao Zhang ◽  
Jing-Xin Zhao ◽  
...  

Purpose. A hybrid pedicle screw system for minimally invasive spinal fixation was developed based on the uniplanar pedicle screw construct and a new intermediate screw. Its biomechanical performance was evaluated using finite element (FE) analysis. Methods. A T12-L2 FE model was established to simulate the L1 vertebral compression fracture with Magerl classification A1.2. Six fixation models were developed to simulate the posterior pedicle screw fracture fixation, which were divided into two subgroups with different construct configurations: (1) six-monoaxial/uniplanar/polyaxial pedicle screw constructs and (2) four-monoaxial/uniplanar/polyaxial pedicle screw constructs with the new intermediate screw. After model validation, flexion, extension, lateral bending, and axial rotation with 7.5 Nm moments and preloading of 500 N vertical compression were applied to the FE models to compare the biomechanical performances of the six fixation models with maximum von Mises stress, range of motion, and maximum displacement of the vertebra. Results. Under four loading scenarios, the maximum von Mises stresses were found to be at the roots of the upper or lower pedicle screws. In the cases of flexion, lateral bending, and axial rotation, the maximum von Mises stress of the uniplanar screw construct lay in between the monoaxial and polyaxial screw constructs in each subgroup. Considering lateral bending, the uniplanar screw construct enabled to lower the maximum von Mises stress than monoaxial and polyaxial pedicle screw constructs in each subgroup. Two subgroups showed comparable results of the maximum von Mises stress on the endplates, range of motion of T12-L1, and maximum displacement of T12 between the corresponding constructs with the new intermediate screw or not. Conclusions. The observations shown in this study verified that the hybrid uniplanar pedicle screw system exhibited comparable biomechanical performance as compared with other posterior short-segment constructs. The potential advantage of this new fixation system may provide researchers and clinical practitioners an alternative for minimally invasive spinal fixation with vertebral augmentation.


2022 ◽  
Vol 23 (1) ◽  
Author(s):  
Chia-En Wong ◽  
Hsuan-Teh Hu ◽  
Li-Hsing Kao ◽  
Che-Jung Liu ◽  
Ke-Chuan Chen ◽  
...  

Abstract Background Semi-rigid lumbar fusion offers a compromise between pedicle screw-based rigid fixation and non-instrumented lumbar fusion. However, the use of semi-rigid interspinous stabilization (SIS) with interspinous spacer and ligamentoplasty and semi-rigid posterior instrumentation (SPI) to assist interbody cage as fusion constructs remained controversial. The purpose of this study is to investigate the biomechanical properties of semi-rigidly stabilized lumbar fusion using SIS or SPI and their effect on adjacent levels using finite element (FE) method. Method Eight FE models were constructed to simulate the lumbosacral spine. In the non-fusion constructs, semi-rigid stabilization with (i) semi-rigid interspinous spacer and artificial ligaments (PD-SIS), and (ii) PI with semi-rigid rods were simulated (PD + SPI). For fusion constructs, the spinal models were implanted with (iii) PEEK cage only (Cage), (iv) PEEK cage and SIS (Cage+SIS), (v) PEEK cage and SPI (Cage+SPI), (vi) PEEK cage and rigid PI (Cage+PI). Result The comparison of flexion-extension range of motion (ROM) in the operated level showed the difference between Cage+SIS, Cage+SPI, and Cage+PI was less than 0.05 degree. In axial rotation, ROM of Cage+SIS were greater than Cage+PI by 0.81 degree. In the infrajacent level, while Cage+PI increased the ROM by 24.1, 27,7, 25.9, and 10.3% and Cage+SPI increased the ROM by 26.1, 30.0, 27.1, and 10.8% in flexion, extension, lateral bending and axial rotation respectively, Cage+SIS only increased the ROM by 3.6, 2.8, and 11.2% in flexion, extension, and lateral bending and reduced the ROM by 1.5% in axial rotation. The comparison of the von Mises stress showed that SIS reduced the adjacent IVD stress by 9.0%. The simulation of the strain energy showed a difference between constructs less than 7.9%, but all constructs increased the strain energy in the infradjacent level. Conclusion FE simulation showed semi-rigid fusion constructs including Cage+SIS and Cage+SPI can provide sufficient stabilization and flexion-extension ROM reduction at the fusion level. In addition, SIS-assisted fusion resulted in less hypermobility and less von Mises stress in the adjacent levels. However, SIS-assisted fusion had a disadvantage of less ROM reduction in lateral bending and axial rotation. Further clinical studies are warranted to investigate the clinical efficacy and safety of semi-rigid fusions.


Author(s):  
Ming Xu ◽  
Thomas Scholl ◽  
Pedro Berjano ◽  
Jazmin Cruz ◽  
James Yang

Rod fracture and nonunion are common complications associated with pedicle subtraction osteotomies (PSO). Supplementary rods and interbody cage (IB) are added to reduce the primary rod stress. As supplementary rods, delta rods and cross rods have been proposed to reduce more stress on the primary rods compared to conventional supplementary rods (accessary rods) in PSO. The objective of this study is to investigate the effects of cross rods and delta rods on reducing primary rod stress in PSO subject. A validated 3D finite element model of a T12-S1 spine segment with 25° PSO at L3 and bilateral rods fixation from T12-S1 was used to compare different rod configurations: 1) PSO and two primary rods (PSO+2P); 2) PSO with an IB at L2-L3 (PSO+2P+IB); 3) PSO with accessory rods and an IB at L2-L3 (PSO+2P+IB+2A); 4) PSO with delta rods and an IB at L2-L3 (PSO+2P+IB+2D); 5) PSO with single cross rod and an IB at L2-L3 (PSO+2P+IB+1C); 6) PSO with double cross rods and an IB at L2-L3 (PSO+2P+IB+2C). The spine model was loaded with a follower load of 400 N combined with pure moments of 7.5 Nm in flexion, extension, right lateral bending, and right axial rotation. Von Mises stress of the primary rods were predicted for all test conditions. The PSO without IB condition had the largest primary rod stress in flexion. With IB at L2-L3, the rod stress in flexion reduced by 15%. Adding 2 conventional supplementary rods reduced the rod stress in flexion by 29%, which was achieved by adding single cross rod. The maximum von Mises stress occurred in the middle of the primary rods without supplementary rods whereas the maximum stress concentrated adjacent to the contact region between the connectors and the primary rods. Delta rods and double cross rods reduced the most rod stress in flexion, which were by 33% and 32% respectively. Under lateral bending, 2 delta rods reduced the most primary rod stress (−33%). Under axial rotation, the single cross rod reduced the most primary rod stress (−48%). Interbody cages and supplementary rods reduced the primary rod stress in a comparable way. Primary rod stress with 2 delta rods and double cross rods were comparable, which were marginally lower than those with conventional supplementary rods. Adding single cross rod was comparable to adding 2 conventional accessory rods in rod stress reduction in flexion. Under lateral bending, delta rods reduced most rod stress whereas under axial rotation, cross rods reduced most rod stress. This study suggested that both delta rods and cross rods reduce more primary rod stress than conventional accessory rods do.


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.


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 ◽  
Vol 11 (13) ◽  
pp. 5764
Author(s):  
Jen-Chung Liao ◽  
Michael Jian-Wen Chen ◽  
Tung-Yi Lin ◽  
Weng-Pin Chen

Vertebroplasty (VP), balloon kyphoplasty (BKP), and vertebral stent (VS) are usually used for treating osteoporotic compression fractures. However, these procedures may pose risks of secondary adjacent level fractures. This study simulates finite element models of osteoporotic compression fractures treated with VP, BKP, and VS Vertebral resection method was used to simulate vertebra fracture with Young’s modulus set at 70 MPa to replicate osteoporosis. A follower load of (1175 N for flexion, and 500 N for all others) was applied in between vertebral bodies to simulate the muscle force. Moment loadings of 7.5 N-m in flexion, extension, lateral bending, axial rotation were applied respectively. The VS model had the highest von Mises stresses on the bone cement under all different loading conditions (flexion/5.91 MPa; extension/3.74 MPa; lateral bending/3.12 MPa; axial rotation/3.54 MPa). The stress distribution and maximum von Mises stresses of the adjacent segments, T11 inferior endplate and L1 superior endplate, showed no significant difference among three surgical models. The postoperative T12 stiffness for VP, BKP, and VS are 2898.48 N/mm, 4123.18 N/mm, and 4690.34 N/mm, respectively. The VS model led to superior surgical vertebra stiffness without significantly increasing the risks of adjacent fracture.


2015 ◽  
Vol 22 (2) ◽  
pp. 166-172 ◽  
Author(s):  
Graham C. Calvert ◽  
Brandon D. Lawrence ◽  
Amir M. Abtahi ◽  
Kent N. Bachus ◽  
Darrel S. Brodke

OBJECT Cortical trajectory screw constructs, developed as an alternative to pedicle screw fixation for the lumbar spine, have similar in vitro biomechanics. The possibility of one screw path having the ability to rescue the other in a revision scenario holds promise but has not been evaluated. The objective in this study was to investigate the biomechanical properties of traditional pedicle screws and cortical trajectory screws when each was used to rescue the other in the setting of revision. METHODS Ten fresh-frozen human lumbar spines were instrumented at L3–4, 5 with cortical trajectory screws and 5 with pedicle screws. Construct stiffness was recorded in flexion/extension, lateral bending, and axial rotation. The L-3 screw pullout strength was tested to failure for each specimen and salvaged with screws of the opposite trajectory. Mechanical stiffness was again recorded. The hybrid rescue trajectory screws at L-3 were then tested to failure. RESULTS Cortical screws, when used in a rescue construct, provided stiffness in flexion/extension and axial rotation similar to that provided by the initial pedicle screw construct prior to failure. The rescue pedicle screws provided stiffness similar to that provided by the primary cortical screw construct in flexion/extension, lateral bending, and axial rotation. In pullout testing, cortical rescue screws retained 60% of the original pedicle screw pullout strength, whereas pedicle rescue screws retained 65% of the original cortical screw pullout strength. CONCLUSIONS Cortical trajectory screws, previously studied as a primary mode of fixation, may also be used as a rescue option in the setting of a failed or compromised pedicle screw construct in the lumbar spine. Likewise, a standard pedicle screw construct may rescue a compromised cortical screw track. Cortical and pedicle screws each retain adequate construct stiffness and pullout strength when used for revision at the same level.


PLoS ONE ◽  
2020 ◽  
Vol 15 (12) ◽  
pp. e0243771
Author(s):  
In-Suk Bae ◽  
Koang-Hum Bak ◽  
Hyoung-Joon Chun ◽  
Je Il Ryu ◽  
Sung-Jae Park ◽  
...  

Purpose This study aimed to investigate the biomechanical effects of a newly developed interspinous process device (IPD), called TAU. This device was compared with another IPD (SPIRE) and the pedicle screw fixation (PSF) technique at the surgical and adjacent levels of the lumbar spine. Materials and methods A three-dimensional finite element model analysis of the L1-S1 segments was performed to assess the biomechanical effects of the proposed IPD combined with an interbody cage. Three surgical models—two IPD models (TAU and SPIRE) and one PSF model—were developed. The biomechanical effects, such as range of motion (ROM), intradiscal pressure (IDP), disc stress, and facet loads during extension were analyzed at surgical (L3-L4) and adjacent levels (L2-L3 and L4-L5). The study analyzed biomechanical parameters assuming that the implants were perfectly fused with the lumbar spine. Results The TAU model resulted in a 45%, 49%, 65%, and 51% decrease in the ROM at the surgical level in flexion, extension, lateral bending, and axial rotation, respectively, when compared to the intact model. Compared to the SPIRE model, TAU demonstrated advantages in stabilizing the surgical level, in all directions. In addition, the TAU model increased IDP at the L2-L3 and L4-L5 levels by 118.0% and 78.5% in flexion, 92.6% and 65.5% in extension, 84.4% and 82.3% in lateral bending, and 125.8% and 218.8% in axial rotation, respectively. Further, the TAU model exhibited less compensation at adjacent levels than the PSF model in terms of ROM, IDP, disc stress, and facet loads, which may lower the incidence of the adjacent segment disease (ASD). Conclusion The TAU model demonstrated more stabilization at the surgical level than SPIRE but less stabilization than the PSF model. Further, the TAU model demonstrated less compensation at adjacent levels than the PSF model, which may lower the incidence of ASD in the long term. The TAU device can be used as an alternative system for treating degenerative lumbar disease while maintaining the physiological properties of the lumbar spine and minimizing the degeneration of adjacent segments.


2012 ◽  
Vol 17 (3) ◽  
pp. 232-242 ◽  
Author(s):  
Prasath Mageswaran ◽  
Fernando Techy ◽  
Robb W. Colbrunn ◽  
Tara F. Bonner ◽  
Robert F. McLain

Object The object of this study was to evaluate the effect of hybrid dynamic stabilization on adjacent levels of the lumbar spine. Methods Seven human spine specimens from T-12 to the sacrum were used. The following conditions were implemented: 1) intact spine; 2) fusion of L4–5 with bilateral pedicle screws and titanium rods; and 3) supplementation of the L4–5 fusion with pedicle screw dynamic stabilization constructs at L3–4, with the purpose of protecting the L3–4 level from excessive range of motion (ROM) and to create a smoother motion transition to the rest of the lumbar spine. An industrial robot was used to apply continuous pure moment (± 2 Nm) in flexion-extension with and without a follower load, lateral bending, and axial rotation. Intersegmental rotations of the fused, dynamically stabilized, and adjacent levels were measured and compared. Results In flexion-extension only, the rigid instrumentation at L4–5 caused a 78% decrease in the segment's ROM when compared with the intact specimen. To compensate, it caused an increase in motion at adjacent levels L1–2 (45.6%) and L2–3 (23.2%) only. The placement of the dynamic construct at L3–4 decreased the operated level's ROM by 80.4% (similar stability as the fusion at L4–5), when compared with the intact specimen, and caused a significant increase in motion at all tested adjacent levels. In flexion-extension with a follower load, instrumentation at L4–5 affected only a subadjacent level, L5–sacrum (52.0%), while causing a reduction in motion at the operated level (L4–5, −76.4%). The dynamic construct caused a significant increase in motion at the adjacent levels T12–L1 (44.9%), L1–2 (57.3%), and L5–sacrum (83.9%), while motion at the operated level (L3–4) was reduced by 76.7%. In lateral bending, instrumentation at L4–5 increased motion at only T12–L1 (22.8%). The dynamic construct at L3–4 caused an increase in motion at T12–L1 (69.9%), L1–2 (59.4%), L2–3 (44.7%), and L5–sacrum (43.7%). In axial rotation, only the placement of the dynamic construct at L3–4 caused a significant increase in motion of the adjacent levels L2–3 (25.1%) and L5–sacrum (31.4%). Conclusions The dynamic stabilization system displayed stability characteristics similar to a solid, all-metal construct. Its addition of the supraadjacent level (L3–4) to the fusion (L4–5) did protect the adjacent level from excessive motion. However, it essentially transformed a 1-level lumbar fusion into a 2-level lumbar fusion, with exponential transfer of motion to the fewer remaining discs.


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.


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