Assessment of a fully-parametric thoraco-lumbar spine model generator with articulated ribcage.

The present paper describes a novel user-friendly fully-parametric thoraco-lumbar spine CAD model generator including the ribcage, based on 22 independent parameters (1 posterior vertebral body height per vertebra + 4 sagittal alignment parameters, namely pelvic incidence, sacral slope, L1-L5 lumbar lordosis, and T1-T12 thoracic kyphosis). Reliable third-order polynomial regression equations were implemented in Solidworks to analytically calculate 56 morphological dependent parameters and to automatically generate the spine CAD model based on primitive geometrical features. A standard spine CAD model, representing the case-study of an average healthy adult, was then created and positively assessed in terms of spinal anatomy, ribcage morphology, and sagittal profile. The immediate translation from CAD to FEM for relevant biomechanical analyses was successfully demonstrated, first, importing the CAD model into Abaqus, and then, iteratively calibrating the constitutive parameters of one lumbar and three thoracic FSUs, with particular interest on the hyperelastic material properties of the IVD, and the spinal and costo-vertebral ligaments. The credibility of the resulting lumbo-sacral and thoracic spine FEM with/without ribcage were assessed and validated throughout comparison with extensive in vitro and in vivo data both in terms of kinematics (range of motion) and dynamics (intradiscal pressure) either collected under pure bending moments and complex loading conditions (bending moments + axial compressive force).

Carbon Fiber-Reinforced PolyEtherEtherKetone (CFR-PEEK) Instrumentation in Degenerative Disease of Lumbar Spine: A Pilot Study.

CFR-PEEK is gaining popularity in spinal oncological applications due to its reduction of imaging artifacts and radiation scattering compared with titanium, which allows for better oncological follow-up and efficacy of radiotherapy. We evaluated the use of these materials for the treatment of lumbar degenerative diseases (DDs) and considered the biomechanical potential of the carbon fiber in relation to its modulus of elasticity being similar to that of bone. Twenty-eight patients with DDs were treated using CRF-PEEK instrumentation. The clinical and radiographic outcomes were collected at a 12-month FU. Spinal fusion was evaluated in the CT scans using Brantigan scores, while the clinical outcomes were evaluated using VAS, SF-12, and EQ-5D scores. Out of the patients evaluated at the 12-month FU, 89% showed complete or almost certain fusion (Brantigan score D and E) and presented a significant improvement in all clinical parameters; the patients also presented VAS scores ranging from 6.81 ± 2.01 to 0.85 ± 1.32, EQ-5D scores ranging from 53.4 ± 19.3 to 85.0 ± 13.7, SF-12 physical component scores (PCSs) ranging from 29.35 ± 7.04 to 51.36 ± 9.75, and SF-12 mental component scores (MCSs) ranging from 39.89 ± 11.70 to 53.24 ± 9.24. No mechanical complications related to the implant were detected, and the patients reported a better tolerance of the instrumentation compared with titanium. No other series of patients affected by DD that was stabilized using carbon fiber implants have been reported in the literature. The results of this pilot study indicate the efficacy and safety of these implants and support their use also for spinal degenerative diseases.

On the need of a scale-dependent material characterization to describe the mechanical behavior of 3D printed Ti6Al4V custom prostheses using finite element models.

Additive manufacturing is widely used in the orthopaedic industry for the high freedom and flexibility in the design and production of personalized custom implants made of Ti6Al4V. Within this context, finite element modeling of 3D printed prostheses is a robust tool both to guide the design phase and to support clinical evaluations, possibly virtually describing the in-vivo behavior of the implant. Given realistic scenarios, a suitable description of the overall implant's mechanical behavior is unavoidable. Considering typical custom prostheses' designs (i.e. acetabular and hemipelvis implants), complex designs involving solid and/or trabeculated parts, and material distribution at different scales hinder a high-fidelity modeling of the prostheses. Moreover, uncertainties in the production and in the material characterization of small parts approaching the accuracy limit of the additive manufacturing technology still exist. While recent works suggest that the mechanical properties of thin 3D-printed parts may be peculiarly affected by specific processing parameters (i.e. powder grain size, printing orientation, samples' thickness) as compared to conventional Ti6Al4V alloy, the current numerical models make gross simplifications in describing the complex material behavior of each part at different scales. The present study focuses on two patient-specific acetabular and hemipelvis prostheses, with the aim of experimentally characterizing and numerically describing the dependency of the mechanical behavior of 3D printed parts on their peculiar scale, therefore, overcoming one major limitation of current numerical models. Coupling experimental activities with finite element analyses, the authors initially characterized 3D printed Ti6Al4V dog-bone samples at different scales, representative of the main material components of the investigated prostheses. Afterwards, the authors implemented the characterized material behaviors into finite element models to compare the implications of adopting scale-dependent vs. conventional scaleindependent approaches in predicting the experimental mechanical behavior of the prostheses in terms of their overall stiffness and the local strain distribution. The material characterization results highlighted the need for a scale-dependent reduction of the elastic modulus for thin samples compared to the conventional Ti6Al4V, which is fundamental to properly describe the overall stiffness and local strain distribution on the prostheses. The presented works demonstrate how an appropriate material characterization and a scale-dependent material description is needed to develop reliable FE models of 3D printed implants characterized by a complex material distribution at different scales.

Middle column Stent-screw Assisted Internal Fixation (SAIF): a modified minimally-invasive approach to rescue vertebral middle column re-fractures.

BACKGROUND: There is limited literature regarding the re-fracture of a previously augmented vertebral compression fracture (VCF). These re-fractures may present as an asymptomatic remodeling of the vertebral body around the cement cast while in other cases they involve the middle column, at the transition zone between the cement-augmented and non-augmented vertebral body. In the latter, a posterior wall retropulsion is possible and, if left untreated, might progress to vertebral body splitting, central canal stenosis, and kyphotic deformity. There is no consensus regarding the best treatment for these re-fractures. There are cases in which a repeated augmentation relieves the pain, but this is considered an undertreatment in cases with middle column involvement, posterior wall retropulsion, and kyphosis. METHODS: We report four cases of re-fracture with middle column collapse of a previously augmented VCF, treated with the stent-screw assisted internal fixation (SAIF) technique. A modified more postero-medial deployment of the anterior metallic implants was applied, to target the middle column fracture. This modified SAIF allowed the reduction and stabilization of the middle column collapse as well as the partial correction of the posterior wall retropulsion and kyphosis. RESULTS: Complete relief of back pain with stable clinical and radiographic findings at follow-up was obtained in all cases. CONCLUSIONS: In selected cases, the middle column SAIF technique is safe and effective for the treatment of the re-fracture with middle column collapse of a previously cement-augmented VCF. This technique requires precision in trocar placement and could represent a useful addition to the technical armamentarium for VCF treatment.

Proximal junctional failure after surgical instrumentation in adult spinal deformity: biomechanical assessment of proximal instrumentation stiffness.

STUDY DESIGN: Assessment of different proximal instrumentation stiffness features to minimize the mechanical proximal junctional failure-related risks through computer-based biomechanical models. OBJECTIVE: To biomechanically assess variations of proximal instrumentation and loads acting on the spine and construct to minimize proximal junctional failure (PJF) risks. The use of less-stiff fixation such as hooks or tensioned bands, compared to pedicle screws, at the proximal instrumentation level are considered to allow for a gradual transition in stiffness with the adjacent levels, but the impact of such flexible fixation on the loads balance and complications such as PJF remain uncertain. METHODS: Six patients with adult spine deformity who underwent posterior spinal instrumentation were used to numerically model and simulate the surgical steps, erected posture, and flexion functional loading in patient-specific multibody analyses. Three types of upper-level fixation (pedicle screws (PS), supralaminar hooks (SH), and sublaminar bands (SB) with tensions of 50, 250, and 350 N) and rod stiffness (CoCr/6 mm, CoCr/5.5 mm, Ti/5.5 mm) were simulated. The loads acting on the spine and implants of the 90 simulated configurations were analyzed using Kruskal-Wallis statistical tests. RESULTS: Simulated high-tensioned bands decreased the sagittal moment at the adjacent level proximal to the instrumentation (1.3 Nm at 250 N; 2.5 Nm at 350 N) compared to screws alone (PS) (15.6 Nm). At one level above, the high-tensioned SB increased the sagittal moment (17.7 Nm-SB vs. 15.5 Nm-PS) and bending moment on the rods (5.4 Nm and 5.7 Nm vs. 0.6 Nm) (p < 0.05). SB with 50 N tension yielded smaller changes in load transition compared to higher tension, with moments of 8.1 Nm and 16.8 Nm one and two levels above the instrumentation. The sagittal moment at the upper implant-vertebra connection decreased with the rod stiffness (1.0 Nm for CoCr/6 mm vs. 0.7 Nm for Ti/5.5 mm; p < 0.05). CONCLUSION: Simulated sublaminar bands with lower tension produced smaller changes in the load transition across proximal junctional levels. Decreasing the rod stiffness further modified these changes, with a decrease in loads associated with bone failure, however, lower stiffness did increase the rod breakage risk. LEVEL OF EVIDENCE: N/A.

Influence of spinal lordosis correction location on proximal junctional failure: a biomechanical study.

STUDY DESIGN: Assessment of sagittal lordosis distribution on mechanical proximal junctional failure-related risks through computer-based biomechanical models. OBJECTIVE: To biomechanically assess how lordosis distribution influences radiographical and biomechanical indices related to Proximal Junctional Failure (PJF). The "optimal" patient-specific targets to restore the sagittal balance in posterior spinal fusion are still not known. Among these, the effect of the lumbar lordosis correction strategy on complications such as PJF remain uncertain. METHODS: In this computational biomechanical study, five adult spinal deformity patients who underwent posterior spinal fixation were retrospectively reviewed. Their surgery, first erect posture and flexion movement were simulated with a patient-specific multibody model. Three pedicle subtraction osteotomy (PSO) levels (L3, L4, and L5) were simulated, with consistent global lordosis for a given patient and pelvic tilt adjusted accordingly to the actual surgery. Computed loads on the anterior spine and instrumentation were analyzed and compared using Kruskal-Wallis statistical tests and Spearman correlations. RESULTS: In these models, no significant correlations were found between the lordosis distribution index (LDI), PSO level and biomechanical PJF-related indices. However, increasing the sagittal vertical axis (SVA) and thoracolumbar junction angle (TLJ) and decreasing the sacral slope (SS) increased the bending moment sustained by the rods at the proximal instrumented level (r = 0.52, 0.57, - 0.56, respectively, p < 0.05). There was a negative correlation between SS and the bending moment held by the adjacent proximal segment (r = - 0.71, p < 0.05). CONCLUSION: Based on these biomechanical simulations, there was no correlation between the lordosis distribution and PJF-associated biomechanical factors. However, increasing SS and flattening the TLJ, as postural adjustment strategies required by a more distal PSO, did decrease such PJF-related factors. Sagittal restoration and PJF risks remain multifactorial, and the use of patient-specific biomechanical models may help to better understand the complex interrelated mechanisms.

Global stiffness and residual stresses in spinal fixator systems: A validated finite element study on the interconnection mechanism.

Posterior spinal fixation systems are the gold standard to treat different column disorders using rods and screws. The proper connection between them is guaranteed by the Interconnection Mechanism (IM), consisting of different metallic subcomponents held together through the application of tightening torque. The response of the fixation system is defined by its overall stiffness, which in turn is governed by the local residual stress field arising during tightening. Although literature computational models for studying spinal fixation are becoming increasingly anatomically complex, most studies disregard completely the realistic modeling of the IM, namely choosing elastic-plastic material models and proper contact interactions. In this frame, the present study aims at increasing awareness in the field of spinal fixation modeling by investigating the mechanical response of the IM in terms of overall stiffness and local residual stresses. Once validated through dedicated experiments, the results of the proposed model have been compared with the current literature, highlighting the key role of the IM in the reliable modeling of spinal fixation.

How do spine instrumentation parameters influence the 3D correction of thoracic adolescent idiopathic scoliosis? A patient-specific biomechanical study.

BACKGROUND: Patient-specific models promises to support the surgical decision-making process, particularly in adolescent idiopathic scoliosis. The present computational biomechanical study investigates how specific instrumentation parameters impact 3D deformity correction in thoracic scoliosis. METHODS: 1080 instrumentation simulations of a representative patient were run. The independent instrumentation parameters were: screw pattern, upper and lower instrumented vertebrae, rod curvature and rod stiffness. ANOVA and correlation analyses analyzed how the instrumentation parameters influenced the 3D correction. FINDINGS: Coronal plane correction was affected by the lower instrumented vertebra and rod stiffness (explaining 84% and 11%, respectively, of its overall variance). The sagittal profile was controlled by rod curvature and the upper vertebra (56% and 36%). The transverse plane vertebral rotation was influenced by lower, upper instrumented vertebra and screw pattern (35%, 32% and 19%). The Cobb angle correction was strongly correlated with the number of fused vertebrae, particularly when grouped by the upper instrumented vertebra (r = -0.91) and rod stiffness (r = -0.73). Thoracic kyphosis was strongly correlated with the number of fused vertebrae grouped by rod curvature (r = 0.84). Apical vertebral rotation was moderately correlated with the number of fused vertebrae grouped by upper/lower instrumented vertebra (r = 0.55/0.58), although variations were minimal. INTERPRETATION: Instrumenting the last vertebra touching the central sacral vertical line improves 3D correction. A trade-off between a more cranial vs. caudal upper instrumented vertebra, respectively beneficial for coronal/sagittal vs. transverse plane correction, is required. High rod stiffness, differential rod contouring, and screw pattern were effective for coronal correction, thoracic kyphosis, and axial vertebral derotation, respectively.

Load-sharing biomechanics of lumbar fixation and fusion with pedicle subtraction osteotomy.

Pedicle subtraction osteotomy (PSO) is an invasive surgical technique allowing the restoration of a well-balanced sagittal profile, however, the risks of pseudarthrosis and instrumentation breakage are still high. Literature studied primary stability and posterior instrumentation loads, neglecting the load shared by the anterior column, which is fundamental to promote fusion early after surgery. The study aimed at quantifying the load-sharing occurring after PSO procedure across the ventral spinal structures and the posterior instrumentation, as affected by simple bilateral fixation alone, with interbody cages adjacent to PSO level and supplementary accessory rods. Lumbar spine segments were loaded in vitro under flexion-extension, lateral bending, and torsion using an established spine tester. Digital image correlation (DIC) and strain-gauge (SG) analyses measured, respectively, the full-field strain distribution on the ventral surface of the spine and the local strain on posterior primary rods. Ventral strains considerably decreased following PSO and instrumentation, confirming the effectiveness of posterior load-sharing. Supplemental accessory rods considerably reduced the posterior rod strains only with interbody cages, but the ventral strains were unaffected: this indicates that the load transfer across the osteotomy could be promoted, thus explaining the higher fusion rate with decreased rod fracture risk reported in clinical literature.

Correction objectives have higher impact than screw pattern and density on the optimal 3D correction of thoracic AIS: a biomechanical study.

STUDY DESIGN: Assessment of screw pattern, implant density (ID), and optimization of 3D correction through computer-based biomechanical models. OBJECTIVE: To investigate how screw pattern and ID affect intraoperative 3D correction of thoracic curves in adolescent idiopathic scoliosis, and how different correction objectives impact the optimal screw pattern. Screw pattern, ID, correction objectives and surgical strategies for posterior fusion of AIS are highly variable among experienced surgeons. The "optimal" instrumentation remains not well defined. METHODS: 10 patient-specific multibody models of representative adolescent idiopathic scoliosis Lenke 1A cases were built and used to compare alternative virtual correction surgeries. Five screw patterns and IDs (average: 1.6 screws/instrumented level, range: 1.2-2) were simulated, considering concave rod rotation, en bloc derotation, and compression/distraction as primary correction maneuvers. 3D correction descriptors were quantified in the coronal, sagittal and transverse planes. An objective function weighting the contribution of intraoperative 3D correction and mobility allowed rating of the outcomes of the virtual surgeries. Based on surgeon-dependent correction objectives, the optimal result among the simulated constructs was identified. RESULTS: Low-density (ID ≤ 1.4) constructs provided equivalent 3D correction compared to higher (ID ≥ 1.8) densities (average differences ranging between 2° and 3°). The optimal screw pattern varied from case to case, falling within the low-density screw category in 14% of considered scenarios, 73% in the mid-density (1.4 < ID < 1.8) and 13% in the high-density. The optimal screw pattern was unique in five cases; multiple optima were found in other cases depending on the considered correction objectives. CONCLUSIONS: Low-density screw patterns provided equivalent intraoperative 3D correction to higher-density patterns. Simulated surgeon's choice of correction objectives had the greatest impact on the selection of the optimal construct for 3D correction, while screw density and ID had a limited impact. LEVEL OF EVIDENCE: N/A.

In silico patient-specific optimization of correction strategies for thoracic adolescent idiopathic scoliosis.

BACKGROUND: With modelling and simulation (or in silico) techniques, patient-specific optimization algorithms represent promising tools to support the surgical decision-making process, particularly in 3D correction of adolescent idiopathic scoliosis, where the best intraoperative instrumentation strategy and the correction goals are debated. METHODS: 1080 biomechanical intraoperative simulations of a representative pediatric thoracic curve were run according to a full-factorial design approach. Widely accepted instrumentation configurations (5 screw patterns, 4 upper and 3 lower instrumented vertebrae, 6 rod curvatures and 3 rod stiffnesses) were analyzed, assuming concave rod rotation and en bloc derotation as main correction maneuvers. Results in terms of 3D correction and mobility were rated using an objective function for thoracic scoliosis also including surgeon-dependent correction objectives. An extensive sensitivity analysis on correction objectives was performed. FINDINGS: Multiple optimal strategies were identified, depending on the selected correction objective. They provided significantly better coronal (67% vs. 55%) correction, using comparable instrumented levels (9.9 ± 1.6 vs. 10.7 ± 2.1), screw patterns and significantly higher implant density (1.6 ± 0.3 vs. 1.4 ± 0.2 screws/vertebra) compared to worst ones. Optimal strategies typically included the neutral and the last touching vertebrae in the construct and high stiffness (CoCr, 6 mm) differentially/highly contoured rods. INTERPRETATION: The computerized algorithm determined the best instrumentation parameters to achieve optimal correction for the considered thoracic case. Multiple clinically equivalent strategies may be used, as supported by the variety of considered correction objectives. The current approach could be translated to any scoliotic curves, including surgeon preferences in terms of instrumentation parameters, intraoperative correction maneuvers and correction objectives.

The 'armed concrete' approach: stent-screw-assisted internal fixation (SAIF) reconstructs and internally fixates the most severe osteoporotic vertebral fractures.

BACKGROUND: The treatment of severe osteoporotic vertebral compression fractures (VCFs) with middle-column (MC) involvement, high fragmentation, large cleft and/or pedicular fracture is challenging. Minimally invasive 'stent-screw-assisted internal fixation' (SAIF) can reduce the fracture, reconstruct the vertebral body (VB) and fix it to the posterior elements. OBJECTIVE: To assess feasibility, safety, technical and clinical outcome of the SAIF technique in patients with severe osteoporotic VCFs. METHODS: 80 treated vertebrae were analyzed retrospectively. Severe VCFs were characterized by advanced collapse (Genant grade 3), a high degree of osseous fragmentation (McCormack grade 2 and 3), burst morphology with MC injury, pediculo-somatic junction fracture, and/or large osteonecrotic cleft. VB reconstruction was evaluated on postprocedure radiographs and CT scans by two independent raters. Clinical and radiological follow-ups were performed at 1 and 6 months. RESULTS: SAIF was performed at 28 thoracic and 52 lumbar levels in 73 patients. One transient neurological complication occurred. VB reconstruction was satisfactory in 98.8% of levels (inter-rater reliability 96%, κ=1). Follow-up at 1 month was available for 78/80 levels and at 6 months or later (range 6-24, mean 7.9 months) for 73/80 levels. Significant improvement in the Visual Analog Scale score was noted at 1 and 6 months after treatment (p<0.05). Patients reported global clinical benefit during follow-up (Patient's Global Impression of Change Scale 5.6±0.9 at 1 month and 6.1±0.9 at 6 months). Fourteen new painful VCFs occurred at different levels in 11 patients during follow-up, treated with vertebral augmentation or SAIF. Target-level stability was maintained in all cases. CONCLUSIONS: SAIF is a minimally invasive, safe, and effective treatment for patients with severe osteoporotic VCFs with MC involvement.

The strain distribution in the lumbar anterior longitudinal ligament is affected by the loading condition and bony features: An in vitro full-field analysis.

The role of the ligaments is fundamental in determining the spine biomechanics in physiological and pathological conditions. The anterior longitudinal ligament (ALL) is fundamental in constraining motions especially in the sagittal plane. The ALL also confines the intervertebral discs, preventing herniation. The specific contribution of the ALL has indirectly been investigated in the past as a part of whole spine segments where the structural flexibility was measured. The mechanical properties of isolated ALL have been measured as well. The strain distribution in the ALL has never been measured under pseudo-physiological conditions, as part of multi-vertebra spine segments. This would help elucidate the biomechanical function of the ALL. The aim of this study was to investigate in depth the biomechanical function of the ALL in front of the lumbar vertebrae and of the intervertebral disc. Five lumbar cadaveric spine specimens were subjected to different loading scenarios (flexion-extension, lateral bending, axial torsion) using a state-of-the-art spine tester. The full-field strain distribution on the anterior surface was measured using digital image correlation (DIC) adapted and validated for application to spine segments. The measured strain maps were highly inhomogeneous: the ALL was generally more strained in front of the discs than in front of the vertebrae, with some locally higher strains both imputable to ligament fibers and related to local bony defects. The strain distributions were significantly different among the loading configurations, but also between opposite directions of loading (flexion vs. extension, right vs. left lateral bending, clockwise vs. counterclockwise torsion). This study allowed for the first time to assess the biomechanical behaviour of the anterior longitudinal ligament for the different loading of the spine. We were able to identify both the average trends, and the local effects related to osteophytes, a key feature indicative of spine degeneration.

Digital Image Correlation (DIC) Assessment of the Non-Linear Response of the Anterior Longitudinal Ligament of the Spine during Flexion and Extension.

While the non-linear behavior of spine segments has been extensively investigated in the past, the behavior of the Anterior Longitudinal Ligament (ALL) and its contribution during flexion and extension has never been studied considering the spine as a whole. The aims of the present study were to exploit Digital Image Correlation (DIC) to: (I) characterize the strain distribution on the ALL during flexion-extension, (II) compare the strain on specific regions of interest (ROI) of the ALL in front of the vertebra and of the intervertebral disc, (III) analyze the non-linear relationship between the surface strain and the imposed rotation and the resultant moment. Three specimens consisting of 6 functional spinal units (FSUs) were tested in flexion-extension. The full-field strain maps were measured on the surface of the ALL, and the most strained areas were investigated in detail. The DIC-measured strains showed different values of peak strain in correspondence with the vertebra and the disc but the average over the ROIs was of the same order of magnitude. The strain-moment curves showed a non-linear response like the moment-angle curves: in flexion the slope of the strain-moment curve was greater than in extension and with a more abrupt change of slope. To the authors' knowledge, this is the first study addressing, by means of a full-field strain measurement, the non-linear contribution of the ALL to spine biomechanics. This study was limited to only three specimens; hence the results must be taken with caution. This information could be used in the future to build more realistic numerical models of the spine.

Biomechanical in vitro comparison between anterior column realignment and pedicle subtraction osteotomy for severe sagittal imbalance correction.

PURPOSE: To investigate the biomechanical effects of anterior column realignment (ACR) and pedicle subtraction osteotomy (PSO) on local lordosis correction, primary stability and rod strains. METHODS: Seven cadaveric spine segments (T12-S1) underwent ACR at L1-L2. A stand-alone hyperlordotic cage was initially tested and then supplemented with posterior bilateral fixation. The same specimens already underwent a PSO at L4 stabilized by two rods, a supplemental central rod (three rods) and accessory rods (four rods) with and without adjacent interbody cages (La Barbera in Eur Spine J 27(9):2357-2366, 2018). In vitro flexibility tests were performed under pure moments in flexion/extension (FE), lateral bending (LB) and axial rotation (AR) to determine the range of motion (RoM), while measuring the rod strains with strain gauge rosettes. RESULTS: Local lordosis correction with ACR (24.7° ± 3.7°) and PSO (25.1° ± 3.9°) was similar. Bilateral fixation significantly reduced the RoM (FE: 31%, LB: 2%, AR: 18%), providing a stability consistent with PSO constructs (p > 0.05); however, it demonstrates significantly higher rod strains compared to PSO constructs with lateral accessory rods and interbody cages in FE and AR (p < 0.05), while being comparable in FE or slightly higher in AR compared to PSO constructs with two and three rods. CONCLUSION: Bilateral posterior fixation is highly recommended following ACR to provide adequate primary stability. However, primary rod strains in ACR were found comparable or higher than weak PSO construct associated with frequent rod failure; therefore, caution is recommended. These slides can be retrieved under Electronic Supplementary Material.

Stent screw-assisted internal fixation (SAIF): clinical report of a novel approach to stabilizing and internally fixating vertebrae destroyed by malignancy.

OBJECTIVE: Severe lytic cancerous lesions of the spine are associated with significant morbidity and treatment challenges. Stabilization and restoration of the axial load capability of the vertebral body (VB) are important to prevent or arrest vertebral collapse. Percutaneous stent screw-assisted internal fixation (SAIF), which anchors a VB stent/cement complex with pedicular screws to the posterior vertebral elements, is a minimally invasive, image-guided, 360° internal fixation technique that can be utilized in this patient cohort. The purpose of this study was to assess the feasibility, safety, and stabilization efficacy of VB reconstruction via the SAIF technique in a cohort of patients with extensive lytic vertebral lesions, who were considered to have an unstable or potentially unstable spine according to the Spinal Instability Neoplastic Score (SINS). METHODS: This study was a retrospective assessment of a prospectively maintained database of a consecutive series of patients with neoplastic extensive extracompartmental osteolysis (Tomita type 4-6) of the VB treated with the SAIF technique. VB reconstruction was assessed on postprocedure plain radiographs and CT by two independent raters. Technical and clinical complications were recorded. Clinical and imaging follow-ups were assessed. RESULTS: Thirty-five patients with extensive osteolytic metastatic lesions of the VB underwent 36 SAIF procedures. SAIF was performed as a stand-alone procedure in 31/36 cases and was associated with posterior surgical fixation in 5/36 (4/5 with decompressive laminectomy). In 1 case an epidural cement leak required surgical decompression. VB reconstruction was categorized as satisfactory (excellent or good rating) by the two raters in 34/36 cases (94.5%) with an interrater reliability of 94.4% (Cohen's kappa of 0.8). Follow-up, ranging from 1 to 30 months, was available for 30/36 levels. Long-term follow-up (6-30 months, mean 11.5 months) was available for 16/36 levels. Stability during follow-up was noted in 29/30 cases. CONCLUSIONS: SAIF provides 360° nonfusion internal fixation that stabilizes the VB in patients with extensive lytic lesions that would otherwise be challenging to treat.

Stent-Screw Assisted Internal Fixation of Osteoporotic Vertebrae: A Comparative Finite Element Analysis on SAIF Technique.

Vertebral compression fractures are one of the most relevant clinical consequences caused by osteoporosis: one of the most common treatment for such fractures is vertebral augmentation through minimally invasive approaches (vertebroplasty or balloon-kyphoplasty). Unfortunately, these techniques still present drawbacks, such as re-fractures of the treated vertebral body with subsidence of the non-augmented portions or re-fracture of the non-augmented middle column at the junction with the augmented anterior column. A novel minimally-invasive augmentation technique, called Stent-Screw Assisted Internal Fixation, has been recently proposed for the treatment of severe osteoporotic and neoplastic fractures: this technique uses two vertebral body stents and percutaneous cannulated and fenestrated pedicular screws, through which cement is injected inside the expanded stents to achieve optimal stents' and vertebral body's filling. The role of the pedicle screws is to anchor the stents-cement complex to the posterior column, acting as a bridge across the middle column and preserving its integrity from possible collapse. In order to evaluate the potential of the new technique in restoring the load bearing capacity of the anterior and middle spinal columns and in reducing bone strains, a Finite Element model of an osteoporotic lumbar spine has been developed. Both standard vertebroplasty and Stent-Screw Assisted Internal Fixation have been simulated: simulations have been run taking into account everyday activities (standing and flexion) and comparison between the two techniques, in terms of strain distribution on vertebral endplates and posterior and anterior wall, was performed. Results show that Stent-Screw Assisted Internal Fixation significantly decrease the strain distribution on the superior EP and the cortical wall compared to vertebroplasty, possibly reducing the re-fracture risk of the middle-column at the treated level.

Stent Screw-Assisted Internal Fixation (SAIF) of Severe Lytic Spinal Metastases: A Comparative Finite Element Analysis of the SAIF Technique.

OBJECTIVE: A new stent-screw-assisted internal fixation (SAIF) minimally invasive cement-augmentation technique has been introduced to treat patients with extreme osteolytic lesions of the vertebral body. The aim of the current finite element study, employing a spine model with an extreme osteolytic defect, was to assess the effect of the SAIF technique in reducing strains in the vertebral body in comparison with a standard surgical short posterior fixation. METHODS: Different finite element models of a L1-S1 spine were developed, representing an intact condition (reference configuration), an extreme osteolysis condition, and its treatment, respectively with stand-alone SAIF, SAIF and posterior fixation, and with stand-alone posterior fixation. Each model was loaded to reproduce standing and upper body bending. Principal strains were calculated on the superior endplate, anterior and posterior cortical walls. A paired Wilcoxon test with a 0.05 significance level was performed to statistically analyze the results. RESULTS: Median strains on the bony structures increased in the osteolysis model compared with the intact model, and the SAIF technique was effective in reducing such strains under both standing and flexion conditions. Additional posterior fixation, combined with the SAIF technique, produced minimal further reduction of the median strains on the bony structures. Stand-alone posterior fixation only shielded the osteolytic vertebra avoiding excessive displacements but failed in restoring the axial stiffness to values typical of the intact vertebra. CONCLUSIONS: The new SAIF technique resulted effective in restoring the load-bearing capacity of the extensively osteolytic vertebra; additional posterior fixation provided only further minor advantages.

Computational and Experimental Fatigue Analysis of Contoured Spinal Rods.

Posterior fixation with contoured rods is an established methodology for the treatment of spinal deformities. Both uniform industrial preforming and intraoperative contouring introduce tensile and compressive plastic deformations, respectively, at the concave and at the convex sides of the rod. The purpose of this study is to develop a validated numerical framework capable of predicting how the fatigue behavior of contoured spinal rods is affected by residual stresses when loaded in lordotic and kyphotic configurations. Established finite element models (FEM) describing static contouring were implemented as a preliminary simulation step and were followed by subsequent cyclical loading steps. The equivalent Sines stress distribution predicted in each configuration was compared to that in straight rods (SR) and related to the corresponding experimental number of cycles to failure. In the straight configuration, the maximum equivalent stress (441 MPa) exceeds the limit curve, as confirmed by experimental rod breakage after around 1.9 × 105 loading cycles. The stresses further increased in the lordotic configuration, where failure was reached within 2.4 × 104 cycles. The maximum equivalent stress was below the limit curve for the kyphotic configuration (640 MPa), for which a run-out of 106 cycles was reached. Microscopy inspection confirmed agreement between numerical predictions and experimental fatigue crack location. The contouring technique (uniform contouring (UC) or French bender (FB)) was not related to any statistically significant difference. Our study demonstrates the key role of residual stresses in altering the mean stress component, superposing to the tensile cyclic load, potentially explaining the higher failure rate of lordotic rods compared to kyphotic ones.

Vertebral body stent augmentation to reconstruct the anterior column in neoplastic extreme osteolysis.

BACKGROUND: Extensive lytic lesions of the vertebral body (VB) increase risk of fracture and instability and require stabilization of the anterior column. Vertebral augmentation is an accepted treatment option, but when osteolysis has extensively destroyed the VB cortical boundaries (a condition herein defined as 'extreme osteolysis'), the risk of cement leakage and/or insufficient filling is high. Vertebral body stents (VBSs) might allow partial restoration of VB height, cement containment, and reinforcement, but their use in extreme osteolysis has not been investigated. OBJECTIVE: To assess retrospectively the feasibility and safety of VBS augmentation in patients with 'extreme osteolysis' of the VB. METHODS: We retrospectively analyzed 41 treated vertebrae (from T1 to L5). VB reconstruction was assessed on postprocedure CT images and rated on a qualitative 4-point scale (poor-fair-good-excellent). Clinical and radiological follow-up was performed at 1 month and thereafter at intervals in accordance with oncological protocols. RESULTS: VBS augmentation was performed at 12 lumbar and 29 thoracic levels, with bilateral VBS in 23/41. VB reconstruction was judged satisfactory (good or excellent) in 37/41 (90%) of levels. Bilateral VBS received higher scores than unilateral (p=0.057, Pearson's X2). We observed no periprocedural complications. Cement leaks (epidural or foraminal) occurred at 5/41 levels (12.2%) without clinical consequences. Follow-up data were available for 27/29 patients, extending beyond 6 months for 20 patients (7-28 months, mean 15.3 months). VBS implant stability was observed in 40/41 cases (97.5%). CONCLUSIONS: Our results support the use of VBS as a minimally invasive, safe and effective option for reconstructing the anterior column in prominent VB osteolysis.