Search

Study Design Basic science (finite element analysis).Objectives Pedicle subtraction osteotomy (PSO) at L5 is an effective treatment for sagittal imbalance, especially in select cases of patients showing kyphosis with the apex at L4-L5 but has been scarcely investigated. The aim of this study was to simulate various “high-demand” instrumentation approaches, including varying numbers of rods and sacropelvic implants, for the stabilization of a PSO at L5.Methods A finite element model of T10-pelvis was modified to simulate posterior fixation with pedicle screws and rods from T10 to S1, alone or in combination with an L5 PSO. Five additional configurations were then created by employing rods and novel porous fusion/fixation implants across the sacroiliac joints, in varying numbers. All models were loaded using pure moments of 7.5 Nm in flexion-extension, lateral bending, and axial rotation.Results The osteotomy resulted in a general increase in motion and stresses in posterior rods and S1 pedicle screws. When the number of rods was varied, three- and four-rod configurations were effective in limiting the maximal rod stresses; values approached those of posterior fixation with no osteotomy. Maximum stresses in the accessory rods were similar to or less than those observed in the primary rods. Multiple sacropelvic implants were effective in reducing range of motion, particularly of the SIJ.Conclusions Multi-rod constructs and sacropelvic fixation generally reduced maximal implant stresses and motion in comparison with standard posterior fixation, suggesting a reduced risk of rod breakage and increased joint stability, respectively, when a high-demand construct is utilized for the correction of sagittal imbalance.

Study design: Biomechanical finite-element study. Objective: To directly compare the biomechanical effects of two different techniques for sagittal plane correction of adult spine deformity based on the anterior longitudinal ligament (ALL) resection and use of hyperlordotic cages, namely, the anterior column realignment (ACR) in L3–4, and ALIF in L5–S1 in terms of primary stability and rod stresses using finite-element models. Methods: A finite-element model of the thoracolumbar spine was used to perform the analysis. Starting from this "intact” model, three further models were constructed through the insertion of spinal instrumentation, i.e., pedicle screws, rods and cages: Results: All models presented a significant reduced ROM when compared to the intact model; the ROM reduction was higher both at L3–4 in the ACR model and at L5–S1 in the ALIF model. At L3–4, the ACR model had, in all cases, the lowest maximum values of Von Mises stresses on the rods, especially in flexion–extension. At L4–5, the ALIF model had the lowest stresses during flexion–extension and axial rotation, while the ACR model had the lowest stresses during lateral bending. At L5–S1, the ALIF model had, in all cases, the lowest stresses on the rods. Conclusions: This finite-element study showed how both ACR at L3–4 and ALIF–ACR at L5–S1 are effective in restoring lumbar lordosis (LL), stabilizing the spine and reducing stress on posterior rods at the index level when compared to a simple fixation model. Interestingly, ALIF–ACR reduces rod stress even at L4–5 in flexion–extension and axial rotation, possibly due to a better distribution of LL, especially on the lower arch, while ACR reduces the stress at L4–5 in lateral bending, possibly thanks to the larger footprint of the cage that increases the area of contact with the lateral side of the endplates.

BackgroundThe 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.ObjectiveTo assess feasibility, safety, technical and clinical outcome of the SAIF technique in patients with severe osteoporotic VCFs.Methods80 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.ResultsSAIF 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.ConclusionsSAIF is a minimally invasive, safe, and effective treatment for patients with severe osteoporotic VCFs with MC involvement.

Introduction: The aim of this study was to investigate the mechanisms of periprosthetic fractures occurring as a result of a sideways fall in total hip arthroplasty patients, and to compare the predictions of numerical models in terms of load distribution on the implanted femur with clinical data.Materials and methods: 3 numerical models were built: 1 for intact femur and 2 for implanted femur with a straight stem (resembling PBF, Permedica) and with an anatomical stem (resembling ABG II, Stryker). 4 loading configurations were simulated; 1 simulates a vertical load, and 3 simulate a fall with impact on the greater trochanter in different directions. Stress state calculated in the implanted femur was compared for the 2 models with reference to the intact case. These were compared with clinical data collected at a single centre (Istituto Ortopedico Gaetano Pini, Milan, Italy) where 41 patients were investigated after periprosthetic fracture: 26 patients had a straight uncemented stem and 15 an anatomical uncemented stem.Results: The maximum calculated strain in compression in the case of ABG II implanted femur was 2 times higher than in the presence of PBF stem in the vertical loading configuration. For configurations of sideways fall, in both models, there was a progressive increase of stress state in the bone with increasing angle. Simulations of sideways fall elicited results in accordance with clinical observations: due to the peculiar stem design and consequent state of stress in the bone, anatomical stems seem to induce trochanteric fractures more frequently, while for straight stems type B fractures are more likely to occur.Conclusions: Clinical findings confirmed numerical model predictions: stem design seems to highly influence distribution of stress in the bone and consequent localisation of the fracture site.

Xenografts are commonly used for bone regeneration in dental and orthopaedic domains to repair bone voids and other defects. The first-generation xenografts were made through sintering, which deproteinizes them and alters their crystallinity, while later xenografts are produced using cold-temperature chemical treatments to maintain the structural collagen phase. However, the impact of collagen and the crystalline phase on physicochemical properties have not been elucidated. We hypothesized that understanding these factors could explain why the latter provides improved bone regeneration clinically. In this study, we compared two types of xenografts, one prepared through a low-temperature chemical process (Treated) and another subsequently sintered at 1100°C (Sintered) using advanced microscopy, spectroscopy, X-ray analysis and compressive testing. Our investigation showed that the Treated bone graft was free of residual blood, lipids or cell debris, mitigating the risk of pathogen transmission. Meanwhile, the sintering process removed collagen and the carbonate phase of the Sintered graft, leaving only calcium phosphate and increased mineral crystallinity. Microcomputed tomography revealed that the Treated graft exhibited an increased high porosity (81%) and pore size compared to untreated bone, whereas the Sintered graft exhibited shrinkage, which reduced the porosity (72%), pore size and strut size. Additionally, scanning electron microscopy displayed crack formation around the pores of the Sintered graft. The Treated graft displayed median mechanical properties comparable to native cancellous bone and clinically available solutions, with an apparent modulus of 166 MPa, yield stress of 5.5 MPa and yield strain of 4.9%. In contrast, the Sintered graft exhibited a lower median apparent modulus of 57 MPa. It failed in a brittle manner at a median stress of 1.7 MPa and strain level of 2.9%, demonstrating the structural importance of the collagen phase. This indicates why bone grafts prepared through cold-temperature processes are clinically favourable.

Background: The further functionalization of natural existing biomaterials is a very efficient method to introduce additional advanced characteristics on a unique structural composition and architecture. Objective: As an example, different animal sources, if properly treated, can be used to develop bone xenograft active in hard tissues regeneration. In this sense, it is also important to consider that the selected process has to take into consideration the intrinsic variability of the base material itself and possibly being able to compensate for it. Methods: In this work we characterize cancellous bovine bone treated by deposition of polymer and collagen and we show that the added components not only lead to a more resistant and more hydrophilic material, but also reduce the conventional correlation between apparent density and elastic modulus, which, in general, is a major source of uncertainty and risk in xenografts usage. Results: Moreover, though intrinsically reinforcing the material, the deposition process leaves the specific open-porous structure, that allows cells proliferation and vessels ingrowth, basically unaltered. Conclusion: The final material combines in a single piece and at the same time, mechanical resistance, homogeneous mechanical response and proper structural characteristics that allow further integration within the patient autochthonous tissues.

Background: The further functionalization of natural existing biomaterials is a very efficient method to introduce additional advanced characteristics on a unique structural composition and architecture. Objective: As an example, different animal sources, if properly treated, can be used to develop bone xenograft active in hard tissues regeneration. In this sense, it is also important to consider that the selected process has to take into consideration the intrinsic variability of the base material itself and possibly being able to compensate for it. Methods: In this work we characterize cancellous bovine bone treated by deposition of polymer and collagen and we show that the added components not only lead to a more resistant and more hydrophilic material, but also reduce the conventional correlation between apparent density and elastic modulus, which, in general, is a major source of uncertainty and risk in xenografts usage. Results: Moreover, though intrinsically reinforcing the material, the deposition process leaves the specific open-porous structure, that allows cells proliferation and vessels ingrowth, basically unaltered. Conclusion: The final material combines in a single piece and at the same time, mechanical resistance, homogeneous mechanical response and proper structural characteristics that allow further integration within the patient autochthonous tissues.

Mechanical reliability tests on posterior spine stabilization devices are based on standard F1717 by the American Society for Testing and Materials, which describes how to assemble the implant with vertebrae-like test blocks in a corpectomy model. A recent study proposed to revise the standard to describe the anatomical worst-casescenario, instead of the average one currently implemented, and introduce the unsupported screw length as a mechanical parameter. This article investigates the implications of such revisions on the endurance properties of an implant already on the market. Experimental fatigue tests demonstrate that the revision of F1717 standard leads to a reduction of 3.2 million cycles in the fatigue strength of the tested implant: this amount is comparable to the run-out number of cycles (5 million cycles) currently recommended. The numerical analysis, validated with static tests and strain gauges, supports the experimental findings and demonstrates that the stress on the implant may increase upon revision up to a 50% on the screw (most recurrent failure mode), with the unsupported screw length contributing alone up to 40%. The revision of ASTM F1717 standard would guarantee higher safety for the implant to test, potentially covering for a wider population of patients.

The International Standardization Organization introduced standard 12189 for the preclinical evaluation of the mechanical reliability of posterior stabilization devices. The well-known vertebrectomy model formalized in standard F1717 by the American Society for Testing and Materials was modified with the introduction of a modular anterior support made up of three calibrated springs, which allows to describe a more realistic scenario, closer to the effective clinical use, as well to test even very flexible and dynamic posterior stabilization implants. Despite these important improvements, ISO 12189 received very little attention in the literature. The aim of the work is to provide a systematic procedure for the assembly and validation of a finite element model capable of describing the experimental test according to ISO 12189. The validated finite element model is able to catch very well the effective stiffness of the unassembled and assembled constructs (percentage differences <2% and <10%, respectively). As concern the assembled construct, the experimentally measured and predicted strains were found in a good agreement (R2> 0.75, root mean square error < 30%), but the procedure without precompression lead to much better results (R2> 0.96, root mean square error < 10%). Given the prediction errors of the assembled construct fall within the experimental range of repeatability, the finite element model can be systematically implemented to support the mechanical design of a variety of spinal implants, to quantitatively investigate the load-sharing mechanism, as well as to investigate the loading conditions set by ISO 12189 standard.

The International Standardization Organization (ISO) 12189 standard was recently introduced to preclinically evaluate and compare the mechanical properties of posterior stabilization devices. This scenario presents some new significant steps ahead over the vertebrectomy model recommended by American Society for Testing and Materials (ASTM) F1717 standard: the modular anterior support allows for describing a closer scenario to the effective clinical use as well as to test very flexible and dynamic posterior stabilization devices. Despite these significant advantages, ISO 12189 received little attention in the literature. Anatomical parameters depending on the spinal level were compared to the published data or original measurements on biplanar stereoradiography on 13 patients. Other mechanical variables, describing the test set-up design, were considered and all parameters were investigated using a numerical parametric finite element model. Stress values were calculated by also considering their worst-case combination. The standard set-up represents quite well the anatomy of an instrumented average thoracolumbar segment. The parametric comparative analysis demonstrates a significant (even beyond +350%) maximum increase in the stress on the device, compared to the standard currently in use. The anterior support stiffness plays the most detrimental effect (maximum stress increases up to 396%). The initial precompression step has an important role in determining the final stress values achieved at peak load (up to +76%). Moreover, when combining these two contributions, an even higher stress increase may be achieved (up to 473%). Despite the other anatomical parameters playing a secondary role, their worst-case combination demonstrates that a device could potentially undergo higher stresses than those reached according to standard suggestions (maximum increase of 22.4% at L1). Any user/designer should be aware of these effects when using ISO 12189 standard for the preclinical evaluation of posterior spinal stabilization devices.

Preclinical evaluation of spinal implants is a necessary step to ensure their reliability and safety before implantation. The American Society for Testing and Materials reapproved F1717 standard for the assessment of mechanical properties of posterior spinal fixators, which simulates a vertebrectomy model and recommends mimicking vertebral bodies using polyethylene blocks. This set-up should represent the clinical use, but available data in the literature are few. Anatomical parameters depending on the spinal level were compared to published data or measurements on biplanar stereoradiography on 13 patients. Other mechanical variables, describing implant design were considered, and all parameters were investigated using a numerical parametric finite element model. Stress values were calculated by considering either the combination of the average values for each parameter or their worst-case combination depending on the spinal level. The standard set-up represents quite well the anatomy of an instrumented average thoracolumbar segment. The stress on the pedicular screw is significantly influenced by the lever arm of the applied load, the unsupported screw length, the position of the centre of rotation of the functional spine unit and the pedicular inclination with respect to the sagittal plane. The worst-case combination of parameters demonstrates that devices implanted below T5 could potentially undergo higher stresses than those described in the standard suggestions (maximum increase of 22.2% at L1). We propose to revise F1717 in order to describe the anatomical worst case condition we found at L1 level: this will guarantee higher safety of the implant for a wider population of patients.