Periprosthetic femoral fractures in sideways fall configuration: comparative numerical analysis of the influence of femoral stem design.

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.

In vitro analysis of thoracic spinal motion segment flexibility during stepwise reduction of all functional structures.

PURPOSE: The aim of this study was to quantify the stabilizing effect of the passive structures in thoracic spinal motion segments by stepwise resections. These data can be used to calibrate finite element models of the thoracic spine, which are needed to explore novel surgical treatments of spinal deformities, fractures, and tumours. METHOD: Six human thoracic spinal motion segments from three segmental levels (T2-T3, T6-T7, and T10-T11) were loaded with pure moments of 1 and 2.5 Nm in flexion/extension, lateral bending, and axial rotation. After each loading step, the ligaments, facet capsules, and the nucleus pulposus were stepwise resected from posterior to anterior direction, while the segmental relative motions were measured using an optical motion tracking system. RESULTS: Significant increases (p < 0.05) in the range of motion were detected after resecting the anterior spinal structures depending on loading magnitude, motion direction, and segmental level. The highest relative increases in the range of motion were observed after nucleotomy in all motion directions. The vertebral arch mostly stabilized the thoracic spinal motion segments in flexion and extension, while the facet joint capsules mainly affected the segmental stability in axial rotation. Coupled motions were not observed. CONCLUSIONS: The anulus fibrosus defines the motion characteristics qualitatively, while the ligaments and the presence of the nucleus pulposus restrict the mobility of a thoracic spinal motion segment solely in a quantitative manner. The posterior ligaments do not predominantly serve for primary stability but for the prevention of hyperflexion. These slides can be retrieved under Electronic Supplementary Material.

Bone-Preserving Decompression Procedures Have a Minor Effect on the Flexibility of the Lumbar Spine.

OBJECTIVE: To mitigate the risk of iatrogenic instability, new posterior decompression techniques able to preserve musculoskeletal structures have been introduced but never extensively investigated from a biomechanical point of view. This study was aimed to investigate the impact on spinal flexibility caused by a unilateral laminotomy for bilateral decompression, in comparison to the intact condition and a laminectomy with preservation of a bony bridge at the vertebral arch. Secondary aims were to investigate the biomechanical effects of two-level decompression and the quantification of the restoration of stability after posterior fixation. METHODS: A universal spine tester was used to measure the flexibility of six L2-L5 human spine specimens in intact conditions and after decompression and fixation surgeries. An incremental damage protocol was applied : 1) unilateral laminotomy for bilateral decompression at L3-L4; 2) on three specimens, the unilateral laminotomy was extended to L4-L5; 3) laminectomy with preservation of a bony bridge at the vertebral arch (at L3-L4 in the first three specimens and at L4-L5 in the rest); and 4) pedicle screw fixation at the involved levels. RESULTS: Unilateral laminotomy for bilateral decompression had a minor influence on the lumbar flexibility. In flexion-extension, the median range of motion increased by 8%. The bone-preserving laminectomy did not cause major changes in spinal flexibility. Two-level decompression approximately induced a twofold destabilization compared to the single-level treatment, with greater effect on the lower level. Posterior fixation reduced the flexibility to values lower than in the intact conditions in all cases. CONCLUSION: In vitro testing of human lumbar specimens revealed that unilateral laminotomy for bilateral decompression and bone-preserving laminectomy induced a minor destabilization at the operated level. In absence of other pathological factors (e.g., clinical instability, spondylolisthesis), both techniques appear to be safe from a biomechanical point of view.

Residual Stresses in Titanium Spinal Rods: Effects of Two Contouring Methods and Material Plastic Properties.

Posterior spinal fixation based on long spinal rods is the clinical gold standard for the treatment of severe deformities. Rods need to be contoured prior to implantation to fit the natural curvature of the spine. The contouring processes is known to introduce residual stresses and strains which affect the static and fatigue mechanical response of the implant, as determined through time- and cost-consuming experimental tests. Finite element (FE) models promise to provide an immediate understanding on residual stresses and strains within a contoured spinal rods and a further insight on their complex distribution. This study aims at investigating two rod contouring strategies, French bender (FB) contouring (clinical gold standard), and uniform contouring, through validated FE models. A careful characterization of the elastoplastic material response of commercial implants is led. Compared to uniform contouring, FB induces highly localized plasticizations in compression under the contouring pin with extensive lateral sections undergoing tensile residual stresses. The sensitivity analysis highlighted that the assumed postyielding properties significantly affect the numerical predictions; therefore, an accurate material characterization is recommended.

A comparative analysis of a disposable and a reusable pedicle screw instrument kit for lumbar arthrodesis: integrating HTA and MCDA.

OBJECTIVE: Lumbar arthrodesis is a common surgical technique that consists of the fixation of one or more motion segments with pedicle screws and rods. However, spinal surgery using these techniques is expensive and has a significant impact on the budgets of hospitals and Healthcare Systems. While reusable and disposable instruments for laparoscopic interventions have been studied in literature, no specific information exists regarding instrument kits for lumbar arthrodesis. The aim of the present study was to perform a complete health technology assessment comparing a disposable instrument kit for lumbar arthrodesis (innovative device) with the standard reusable instrument. METHODS: A prospective and observational study was implemented, by means of investigation of administrative records of patients undergoing a lumbar arthrodesis surgical procedure. The evaluation was conducted in 2013, over a 12- month time horizon, considering all the procedures carried out using the two technologies. A complete health technology assessment and a multi-criteria decision analysis approach were implemented in order to compare the two alternative technologies. Economic impact (with the implementation of an activity based costing approach), social, ethical, organisational, and technology-related aspects were taken into account. RESULTS: Although the cost analysis produced similar results in the comparison of the two technologies (total cost equal to € 4,279.1 and € 4,242.6 for reusable instrument kit and the disposable one respectively), a significant difference between the two instrument kits was noted, in particular concerning the organisational impact and the patient safety. CONCLUSIONS: The replacement of a reusable instrument kit for lumbar arthrodesis, with a disposable one, could improve the management of this kind of devices in hospital settings.

Anterior support reduces the stresses on the posterior instrumentation after pedicle subtraction osteotomy: a finite-element study.

STUDY DESIGN: The investigation was based on finite-element simulations. OBJECTIVE: Pedicle subtraction osteotomy (PSO) is an effective but technical demanding surgical technique, associated with a high risk of rod failure. The present study aims at investigating the role of the anterior support in combination with PSO, with a numerical comparative analysis. METHODS: An osteotomy was simulated at the L3 level of a lumbosacral spine. An implantation of various combinations of devices for the anterior (1 or 2 cages of different material) and posterior stabilization (1 or 2 rods) was then performed. ROM, loads, and stresses acting on the rods were calculated. RESULTS: A 4-8% reduction of the ROM was obtained introducing one or two cages in the instrumented model. However, the anterior support had only a minor influence on the ROM. The load on the posterior instrumentation decreased up to 8% using one cage and about 15% with two anterior devices. A 20-30% reduction of the stresses on the rods was calculated inserting one cage and up to 50% using two cages. Following the introduction of the anterior support, the greatest stress reduction was observed in the model having two cages and spinal fixators with two rods. CONCLUSIONS: The use of cages is crucial to ensure anterior support and decrease loads and stresses on the posterior instrumentation.

Semiautomated 3D Spine Reconstruction from Biplanar Radiographic Images: Prediction of Intervertebral Loading in Scoliotic Subjects.

The present study proposes a semiautomatic software approach to reconstruct 3D subject-specific musculoskeletal model of thoracolumbar spine from radiographic digitized images acquired with EOS system. The approach is applied to evaluate the intervertebral loads in 38 standing adolescents with mild idiopathic scoliosis. For each vertebra, a set of landmarks was manually identified on radiographic images. The landmark coordinates were processed to calculate the following vertebral geometrical properties in the 3D space (i) location (ii) dimensions; and (iii) rotations. Spherical joints simulated disks, ligaments, and facet joints. Body weight distribution, muscles forces, and insertion points were placed according to physiological-anatomical values. Inverse static analysis, calculating joints' reactions in maintaining assigned spine configuration, was performed with AnyBody software. Reaction forces were computed to quantify intervertebral loads, and correlation with the patient anatomical parameters was then checked. Preliminary validation was performed comparing the model outcomes with that obtained from other authors in previous modeling works and from in vivo measurements. The comparison with previous modeling works and in vivo studies partially fulfilled the preliminary validation purpose. However, minor incongruities were pointed out that need further investigations. The subjects' intervertebral loads were found significantly correlated with the anatomical parameters in the sagittal and axial planes. Despite preliminary encouraging results that support model suitability, future investigations to consolidate the proposed approach are necessary. Nonetheless, the present method appears to be a promising tool that once fully validated could allow the subject-specific non-invasive evaluation of a deformed spine, providing supplementary information to the routine clinical examination and surgical intervention planning.

Instrumentation failure following pedicle subtraction osteotomy: the role of rod material, diameter, and multi-rod constructs.

PURPOSE: Pedicle subtraction osteotomy (PSO) has a complication rate noticeably higher than other corrective surgical techniques used for the treatment of spinal sagittal imbalance. In particular, rod breakage and pseudoarthrosis remain burning issues of this technique. Goal of this study was to investigate the biomechanical performance of several hardware constructs. METHODS: The study was performed using two validated finite element models of the lumbosacral spine (L1-S1) incorporating a PSO on L3 and L4, respectively. Both models were instrumented two levels above and below the osteotomy site. Different combinations of materials (Ti6Al4V and Cr-Co) and device configurations (bilateral single vs. double rod, rod diameters of 5 and 6 mm) were investigated. The loading was represented considering a force of 500 N (imposed along the spinal curvature and connecting the vertebral bodies) and pure moments of 7.5 Nm in flexion-extension, lateral bending and axial rotation. The results were evaluated in terms of range of motion (ROM), load, and stresses acting on the instrumentation. RESULTS: A comparable ROM was found for all the models. The simulations showed a different behavior of the devices: increasing the stiffness an 8-19% increase of the load was calculated on the rod. However, the stress on the instrumentation resulted higher on Cr-Co devices and on smaller rods. The highest stress reduction (up to 50%) was ensured using double rod constructs. CONCLUSIONS: The bilateral double parallel rods configuration resulted the best to reduce the stresses on the spinal fixators at the osteotomy site. However, the high loads acting on the rods with respect to the physiologic condition could slow down the bone healing at the osteotomy site.

Vertebroplasty and kyphoplasty for the treatment of thoracic fractures in osteoporotic patients: a finite element comparative analysis.

BACKGROUND: Vertebral compression fractures occur in the thoracolumbar junction, causing the collapse of the vertebral body. For their treatment, vertebroplasty and kyphoplasty are used, but it is still unknown which technique is to be preferred. METHODS: Finite element models of the thoracic spine were developed to evaluate the outcomes of vertebroplasty and kyphoplasty. A mild and severe collapse of T10 treated with vertebroplasty or kyphoplasty was studied. Stresses on the endplates and intradiscal pressures were extrapolated to determine the stress distribution in the adjacent structures. RESULTS: The validation ensured a correct stiffness and a proper kinematic of each functional spinal unit. The results demonstrated that a consolidation following vertebroplasty caused slight variations of intradiscal pressures and stresses. If a kyphoplasty was performed after a mild collapse of the vertebral body, a 25% stress reduction on endplates was found. In cases of severe collapse, when a partial height restoration was achieved, a 15% stress reduction was obtained, while with a full recovery of the anterior wall of the collapsed vertebra, there was a further reduction of 40%. CONCLUSIONS: To reduce the stresses on the adjacent endplates and the risk of fracture, the results suggest a kyphoplasty is to be preferred, trying to restore the initial vertebral body height.

Finite element analysis of the lumbar destabilization following pedicle subtraction osteotomy.

This study aims to analyze the destabilization produced following a pedicle subtraction osteotomy (PSO), with a calibrated numerical model. A 30° resection was created on L3 and L4. Range of Motion (ROM) and the force acting on the vertebral body were calculated. Osteotomies consistently increased the ROMs. In the intact model, 87% of the compressive load was acting on the vertebral bodies whereas in the destabilized models all the load was on the fractured surface. Osteotomies at both levels induced a marked instability but the PSO at L4 seemed to have a greater influence on the ROM. Despite the significant deformity corrections which could be achieved with PSO, this technique needs further analyses.

Planning the Surgical Correction of Spinal Deformities: Toward the Identification of the Biomechanical Principles by Means of Numerical Simulation.

In decades of technical developments after the first surgical corrections of spinal deformities, the set of devices, techniques, and tools available to the surgeons has widened dramatically. Nevertheless, the rate of complications due to mechanical failure of the fixation or the instrumentation remains rather high. Indeed, basic and clinical research about the principles of deformity correction and the optimal surgical strategies (i.e., the choice of the fusion length, the most appropriate instrumentation, and the degree of tolerable correction) did not progress as much as the implantable devices and the surgical techniques. In this work, a software approach for the biomechanical simulation of the correction of patient-specific spinal deformities aimed to the identification of its biomechanical principles is presented. The method is based on three-dimensional reconstructions of the spinal anatomy obtained from biplanar radiographic images. A user-friendly graphical user interface allows for the planning of the desired deformity correction and to simulate the implantation of pedicle screws. Robust meshing of the instrumented spine is provided by using consolidated computational geometry and meshing libraries. Based on a finite element simulation, the program is able to predict the loads and stresses acting in the instrumentation as well as those in the biological tissues. A simple test case (reduction of a low-grade spondylolisthesis at L3-L4) was simulated as a proof of concept, and showed plausible results. Despite the numerous limitations of this approach which will be addressed in future implementations, the preliminary outcome is promising and encourages a wide effort toward its refinement.

Comparative analysis of international standards for the fatigue testing of posterior spinal fixation systems: the importance of preload in ISO 12189.

BACKGROUND CONTEXT: Preclinical evaluation of the mechanical reliability of fixation devices is a mandatory activity before their introduction into market. There are two standardized protocols for preclinical testing of spinal implants. The American Society for Testing Materials (ASTM) recommends the F1717 standard, which describes a vertebrectomy condition that is relatively simple to implement, whereas the International Organization for Standardization (ISO) suggests the 12189 standard, which describes a more complex physiological anterior support-based setup. Moreover, ASTM F1717 is nowadays well established, whereas ISO 12189 has received little attention: A few studies tried to accurately describe the ISO experimental procedure through numeric models, but these studies totally neglect the recommended precompression step. PURPOSE: This study aimed to build up a reliable, validated numeric model capable of describing the stress on the rods of a spinal fixator assembled according to ISO 12189 standard procedure. Such a model would more adequately represent the in vitro testing condition. STUDY DESIGN: This study used finite element (FE) simulations and experimental validation testing. METHODS: An FE model of the ISO setup was built to calculate the stress on the rods. Simulation was validated by comparison with experimental strain gauges measurements. The same fixator has been previously virtually mounted in an L2-L4 FE model of the lumbar spine, and stresses in the rods were calculated when the spine was subjected to physiological forces and moments. RESULTS: The comparison between the FE predictions and experimental measurements is in good agreement, thus confirming the suitability of the FE method to evaluate the stresses in the device. The initial precompression induces a significant extension of the assembled construct. As the applied load increases, the initial extension is gradually compensated, so that at peak load the rods are bent in flexion: The final stress value predicted is thus reduced to about 50%, if compared with the previous model where the precompression was not considered. CONCLUSIONS: Neglecting the initial preload due to the assembly of the overall construct according to ISO 12189 standard could lead to an overestimation of the stress on the rods up to 50%. To correctly describe the state of stress on the posterior spinal fixator, tested according to the ISO procedure, it is important to take into account the initial preload due to the assembly of the overall construct.