The effect of pulsed jet lavage in vertebroplasty on injection forces of polymethylmethacrylate bone cement, material distribution, and potential fat embolism: a cadaver study

STUDY DESIGN: In vitro testing of vertebroplasty techniques including pulsed jet-lavage for fat and marrow removal in human cadaveric lumbar and thoracic vertebrae. OBJECTIVE: To develop jet-lavage techniques for vertebroplasty and investigate their effect on cement distribution, injection forces, and fat embolism. SUMMARY OF BACKGROUND DATA: The main complications of cement vertebroplasty are cement leakage and pulmonary fat embolism, which can have fatal consequences and are difficult to prevent reliably by current vertebroplasty techniques. METHODS: Twenty-four vertebrae (Th8-L04) from 5 osteoporotic cadaver spines were grouped in triplets depending on bone mineral density (BMD). Before polymethylmethacrylate (PMMA) vertebroplasty, a pulsatile jet-lavage for removal of intertrabecular fat and bone marrow was performed in 2 groups with 8 specimens each, performing radial and axial irrigation from the biopsy needles. One hundred mL of Ringer solution were injected through 1 pedicle and regained by low vacuum via the contralateral pedicle. Eight control vertebrae were not irrigated. All specimens underwent standardized PMMA cement augmentation injecting 20% of the vertebral volume. Injection forces, cement distribution, and extravasations were quantified. RESULTS: All irrigation solution could be retrieved with the vacuum applied. A Kruskal-Wallis test revealed significantly higher injection forces of the control group as compared with the irrigated groups (P = 0.021). Dilatation of the syringe at forces above 300 N occurred in 75% of the untreated compared with 12.5% of the lavaged specimens. CT distribution analysis showed more homogenous cement distribution of the cement and significantly less extravasation in the irrigated specimens. CONCLUSION: The developed lavage technique for vertebroplasty showed to be feasible and reproducible. The reduction of injection forces would allow the use of more viscous PMMA cement lowering the risk for cement embolization and results in a safer procedure. The wash-out of bone marrow and the possible reduction of pulmonary fat embolism have to be verified with in vivo models.

Long-term reaction to bone cement in osteoporotic bone: new bone formation in vertebral bodies after vertebroplasty

Elderly patients frequently suffer from osteoporotic vertebral fractures resulting in the need of vertebroplasty or kyphoplasty. Nevertheless, no data are available about the long-term consequences of cement injection into osteoporotic bone. Therefore, the aim of the present study was to evaluate the long-term tissue reaction on bone cement injected to osteoporotic bone during vertebroplasty. The thoracic spine of an 80-year-old female was explanted 3.5 years after vertebroplasty with polymethylmethacrylate. The treatment had been performed due to painful osteoporotic compression fractures. Individual vertebral bodies were cut in axial or sagittal sections after embedding. The sections were analysed using contact radiography and staining with toluidine blue. Furthermore, selected samples were evaluated with scanning electron microscopy and micro-compted tomography (in-plane resolution 6 microm). Large amounts of newly formed callus surrounding the injected polymethylmethacrylate were detected with all imaging techniques. The callus formation almost completely filled the spaces between the vertebral endplate, the cancellous bone, and the injected polymethylmethacrylate. In trabecular bone microfractures and osteoclast lacuna were bridged or filled with newly formed bone. Nevertheless, the majority of the callus formation was found in the immediate vicinity of the polymethylmethacrylate without any obvious relationship to trabecular fractures. The results indicate for the first time that, contrary to established knowledge, even in osteoporosis the formation of large amounts of new bone is possible.

Properties of an injectable low modulus PMMA bone cement for osteoporotic bone

The use of polymethylmethacrylate (PMMA) cement to reinforce fragile or broken vertebral bodies (vertebroplasty) leads to extensive bone stiffening. Fractures in the adjacent vertebrae may be the consequence of this procedure. PMMA with a reduced Young's modulus may be more suitable. The goal of this study was to produce and characterize stiffness adapted PMMA bone cements. Porous PMMA bone cements were produced by combining PMMA with various volume fractions of an aqueous sodium hyaluronate solution. Porosity, Young's modulus, yield strength, polymerization temperature, setting time, viscosity, injectability, and monomer release of those porous cements were investigated. Samples presented pores with diameters in the range of 25-260 microm and porosity up to 56%. Young's modulus and yield strength decreased from 930 to 50 MPa and from 39 to 1.3 MPa between 0 and 56% porosity, respectively. The polymerization temperature decreased from 68 degrees C (0%, regular cement) to 41 degrees C for cement having 30% aqueous fraction. Setting time decreased from 1020 s (0%, regular cement) to 720 s for the 30% composition. Viscosity of the 30% composition (145 Pa s) was higher than the ones received from regular cement and the 45% composition (100-125 Pa s). The monomer release was in the range of 4-10 mg/mL for all porosities; showing no higher release for the porous materials. The generation of pores using an aqueous gel seems to be a promising method to make the PMMA cement more compliant and lower its mechanical properties to values close to those of cancellous bone.

Vertebroplasty: experimental characterization of polymethylmethacrylate bone cement spreading as a function of viscosity, bone porosity, and flow rate

STUDY DESIGN: This is an experimental study on an artificial vertebra model and human cadaveric spine. OBJECTIVE: Characterization of polymethylmethacrylate (PMMA) bone cement distribution in the vertebral body as a function of cement viscosity, bone porosity, and injection speed. Identification of relevant parameters for improved cement flow predictability and leak prevention in vertebroplasty. SUMMARY OF BACKGROUND DATA: Vertebroplasty is an efficient procedure to treat vertebral fractures and stabilize osteoporotic bone in the spine. Severe complications result from bone cement leakage into the spinal canal or the vascular system. Cement viscosity has been identified as an important parameter for leak prevention but the influence of bone structure and injection speed remain obscure. METHODS: An artificial vertebra model based on open porous aluminum foam was used to simulate bone of known porosity. Fifty-six vertebroplasties with 4 different starting viscosity levels and 2 different injection speeds were performed on artificial vertebrae of 3 different porosities. A validation on a human cadaveric spine was executed. The experiments were radiographically monitored and the shape of the cement clouds quantitatively described with the 2 indicators circularity and mean cement spreading distance. RESULTS: An increase in circularity and a decrease in mean cement spreading distance was observed with increasing viscosity, with the most striking change occurring between 50 and 100 Pas. Larger pores resulted in significantly reduced circularity and increased mean cement spreading distance whereas the effect of injection speed on the 2 indicators was not significant. CONCLUSION: Viscosity is the key factor for reducing the risk of PMMA cement leakage and it should be adapted to the degree of osteoporosis encountered in each patient. It may be advisable to opt for a higher starting viscosity but to inject the material at a faster rate.

The effect of pulsed jet lavage in vertebroplasty on injection forces of PMMA bone cement: an animal study

Percutaneous vertebroplasty, comprising of the injection of polymethylmethacrylate (PMMA) into vertebral bodies, is an efficient procedure to stabilize osteoporotic compression fractures as well as other weakening lesions. Besides fat embolism, cement leakage is considered to be one of the major and most severe complications during percutaneous vertebroplasty. The viscosity of the PMMA during injection plays a key role in this context. It was shown in vitro that the best way to lower the risk of cement leakage is to inject the cement at higher viscosity, which is requires high injection forces. Injection forces can be reduced by applying a newly developed lavage technique as it was shown in vitro using human cadaver vertebrae. The purpose of this study was to prove the in vitro results in an in vivo model. The investigation was incorporated in an animal study that was performed to evaluate the cardiovascular reaction on cement augmentation using the lavage technique. Injection forces were measured with instrumentation for 1 cc syringes, additionally acquiring plunger displacement. Averaged injection forces measured, ranged from 12 to 130 N and from 28 to 140 N for the lavage group and the control group, respectively. Normalized injection forces (by viscosity and injection speed) showed a trend to be lower for the lavage group in comparison to the control group (P = 0.073). In conclusion, the clinical relevance on the investigated lavage technique concerning lowering injection forces was only shown by trend in the performed animal study. However, it might well be that the effect is more pronounced for osteoporotic vertebral bodies.

High-strength resorbable brushite bone cement with controlled drug-releasing capabilities

Brushite cements differ from apatite-forming compositions by consuming a lot of water in their setting reaction whereas apatite-forming cements consume little or no water at all. Only such cement systems that consume water during setting can theoretically produce near-zero porosity ceramics. This study aimed to produce such a brushite ceramic and investigated whether near elimination of porosity would prevent a burst release profile of incorporated antibiotics that is common to prior calcium phosphate cement delivery matrices. Through adjustment of the powder technological properties of the powder reactants, that is particle size and particle size distribution, and by adjusting citric acid concentration of the liquid phase to 800 mM, a relative porosity of as low as 11% of the brushite cement matrix could be achieved (a 60% reduction compared to previous studies), resulting in a wet unprecompacted compressive strength of 52 MPa (representing a more than 100% increase to previously reported results) with a workable setting time of 4.5 min of the cement paste. Up to 2 wt.% of vancomycin and ciprofloxacin could be incorporated into the cement system without loss of wet compressive strength. It was found that drug release rates could be controlled by the adjustable relative porosity of the cement system and burst release could be minimized and an almost linear release achieved, but the solubility of the antibiotic (vancomycin > ciprofloxacin) appeared also to be a crucial factor.

Finite element modeling of the cement-bone interface beneath the tibial tray of a total knee arthroplasty: Study of the stress shielding effect (modellazione agli elementi finiti dell'interfaccia cemento-osso sotto il piatto tibiale di protesi totale di ginocchio: Analisi dello stress shielding)

The goal of this thesis was the study of the cement-bone interface in the tibial component of a cemented total knee prosthesis. One of the things you can see in specimens after in vivo service is that resorption of bone occurs in the interdigitated region between bone and cement. A stress shielding effect was investigated as a cause to explain bone resorption. Stress shielding occurs when bone is loaded less than physiological and therefore it starts remodeling according to the new loading conditions. µCT images were used to obtain 3D models of the bone and cement structure and a Finite Element Analysis was used to simulate different kind of loads. Resorption was also simulated by performing erosion operations in the interdigitated bone region. Finally, 4 models were simulated: bone (trabecular), bone with cement, and two models of bone with cement after progressive erosions of the bone. Compression, tension and shear test were simulated for each model in displacement-control until 2% of strain. The results show how the principal strain and Von Mises stress decrease after adding the cement on the structure and after the erosion operations. These results show that a stress shielding effect does occur and rises after resorption starts.

Results using Trabecular Metal™ augments in combination with acetabular impaction bone grafting in deficient acetabula

We examined whether the use of trabecular metal wedges to fill segmental defects is an effective method of socket reconstruction when used in combination with impaction grafting and implantation of a cemented socket. Fifteen hips in 14 patients underwent impaction grafting in combination with a TM wedge with a minimum of 2 years follow-up. All patients had their defects assessed using the Paprosky classification. Patients were reviewed with x-rays and migration of the implant was measured. Outcome scores were also collected. Mean follow-up was 39 months (25-83). The mean age at surgery was 67.8 (49-85) years. Seven of the patients had previously undergone impaction grafting with the use of a stainless steel rim mesh to constrain the graft. None of the patients had failed either clinically or radiologically.

Incorporation of multiwalled carbon nanotubes to acrylic based bone cements: Effects on mechanical and thermal properties

Polymethyl methacrylate (PMMA) bone cement–multiwalled carbon nanotube (MWCNT) nanocomposites with a weight loading of 0.1% were prepared using 3 different methods of MWCNT incorporation. The mechanical and thermal properties of the resultant nanocomposite cements were characterised in accordance with the international standard for acrylic resin cements. The mechanical properties of the resultant nanocomposite cements were influenced by the type of MWCNT and method of incorporation used. The exothermic polymerisation reaction for the PMMA bone cement was significantly reduced when thermally conductive functionalised MWCNTs were added. This reduction in exotherm translated in a decrease in thermal necrosis index value of the respective nanocomposite cements, which potentially could reduce the hyperthermia experienced in vivo. The morphology and degree of dispersion of the MWCNTs in the PMMA matrix at different scales were analysed using scanning electron microscopy. Improvements in mechanical properties were attributed to the MWCNTs arresting/retarding crack propagation through the cement by providing a bridging effect into the wake of the crack, normal to the direction of crack growth. MWCNT agglomerations were evident within the cement microstructure, the degree of these agglomerations was dependent on the method used to incorporate the MWCNTs into the cement.

The relationship between cement fatigue damage and implant surface finish in proximal femoral prostheses

The majority of cemented femoral hip replacements fail as a consequence of loosening. One design feature that may affect loosening rates is implant surface finish. To determine whether or not surface finish effects fatigue damage accumulation in a bone cement mantle, we developed an experimental model of the implanted proximal femur that allows visualisation of damage growth in the cement layer. Five matt surface and five polished surface stems were tested. Pre-load damage and damage after two million cycles was measured. Levels of pre-load (shrinkage) damage were the same for both matt and polished stems; furthermore damage for matt vs. polished stems was not significantly different after two million cycles. This was due to the large variability in damage accumulation rates. Finite element analysis showed that the stress is higher for the polished (assumed debonded) stem, and therefore we must conclude that either the magnitude of the stress increase is not enough to appreciably increase the damage accumulation rate or, alternatively, the polished stem does not debond immediately from the cement. Significantly (P = 0.05) more damage was initiated in the lateral cement compared to the medial cement for both kinds of surface finish. It was concluded that, despite the higher cement stresses with debonded stems, polished prostheses do not provoke the damage accumulation failure scenario. (C) 2003 IPEM. Published by Elsevier Ltd. All rights reserved.

Biomechanics of Vertebroplasty: Effect of Cement Viscosity on Mechanical Behaviour

Vertebroplasty is a minimally invasive surgical procedure, which requires efficacious percutaneous cement delivery via a cannulated needle to restore the strength and stiffness in osteoporotic vertebral bodies. Cement viscosity is understood to influence the injectability, cohesion and cement retention within the vertebral body. Altering the liquid to powder ratio modifies the viscosity of bone cement; however, the cement viscosity-response association between cement fill and augmentation of strength and stiffness is unknown. The aim of this study was to determine the relationship between viscosity, cement fill and the potential augmentation of strength and stiffness in an open pore foam structure that was representative of osteoporotic cancellous bone using an in vitro prophylactic vertebroplasty model. The results showed a strong linear correlation between compressive strength and stiffness augmentation with percentage cement fill, the extent of which was strongly dependent on the cement viscosity. Significant forces were required to ensure maximum delivery of the high viscosity cement using a proprietary screw-driven cement delivery technology. These forces could potentially exceed the normal human physical limit. Similar trends were observed when comparing the results from this study and previously reported cadaveric and animal based in vitro models.

Acrylic bone cements modified with bioactive and biodegradable fillers

O cimento ósseo acrílico é o único material utilizado para a fixação de próteses em cirurgias ortopédicas, surgindo como uma alternativa às técnicas não cimentadas. Cerca de um milhão de pacientes são anualmente tratados para a substituição total da articulação do quadril e do joelho. Com a maior expectativa de vida da população e o aumento do número de cirurgias realizadas por ano espera-se que o uso do cimento ósseo aumente substancialmente. A fraca ligação do cimento ao osso é um problema comum que pode causar perda asséptica da prótese. Assim, torna-se necessário investir no desenvolvimento de cimentos ósseos alternativos que permitam promover maior estabilidade e melhor desempenho do implante. O principal objetivo desta tese foi desenvolver um cimento ósseo bioativo, capaz de ligar-se ao osso, com propriedades melhoradas relativamente aos sistemas convencionais. A preparação dos materiais foi realizada por dois processos diferentes, a polimerização por via térmica e a polimerização por via química. Inicialmente, utilizando o processo térmico, foram desenvolvidos compósitos de PMMA-co-EHA reforçados com vidro de sílica (CSi) e vidro de boro (CB) e comparados em termos do seu comportamento in vitro em meio acelular e celular. A formação de precipitados de fosfato de cálcio foi observada sobre a superfície de todos os compósitos indicando que estes materiais são potencialmente bioativos. Em relação à avaliação biológica o CSi demonstrou um efeito indutor da proliferação das células. As células apresentaram uma morfologia normal e alta taxa de crescimento quando comparadas com o padrão de cultura. Por outro lado ocorreu inibição da proliferação celular para o CB provavelmente devido à sua elevada taxa de degradação, levando a uma elevada concentraçao de iões de B e de Mg no meio de cultura. O efeito do vidro nos cimentos curados por via química, incorporando um activador de baixa toxicidade, também foi avaliado. Os resultados sugerem que as novas formulações podem diminuir o efeito exotérmico na cura do cimento e melhorar as propriedades mecânicas (flexão e compressão). Outro estudo conduzido neste trabalho explorou a possibilidade de incorporar ibuprofeno (fármaco anti-inflamatório) no cimento, dando origem a um material capaz de ser simultaneamente, bioativo e promotor da libertação controlada de fármacos. Neste contexto foi evidenciado que o desempenho do cimento desenvolvido pode contribuir para minimizar o processo inflamatório associado a uma cirurgia ortopédica. Finalmente, a fase sólida do cimento ósseo bioativo foi modificada por diferentes polímeros biodegradáveis. A adição deste enchimento deu origem a um cimento parcialmente biodegradável que pode permitir a formação de poros e o crescimento ósseo para o interior do cimento, resultando numa melhor fixação da prótese.

Evaluation of a double-setting alpha-tricalcium phosphate cement in eviscerated rabbit eyes

Purpose: To evaluate the macroscopy, microstructure, and tissue reaction of a double-setting a-tricalcium phosphate bone cement used as an intraocular implant in rabbits.Methods: the internal and external surface of the double-setting a-tricalcium phosphate implant was analyzed macroscopically and by scanning electron microscopy. Twelve New Zealand rabbits received 12-mm implants made of double-setting alpha-tricalcium phosphate cement after unilateral evisceration. Clinical evaluation was performed daily for the first 15 days after surgery and at 15-day intervals until the end of the study period. For histopathologic analysis, 3 animals per experimental period were submitted to enucleation at 15, 45, 90, and 180 days.Results: on gross inspection, the external surface of the implant was solid, smooth, and compact. The microarchitecture was characterized by the formation of columns of hexagonal crystals with interconnecting channels forming micropores. No wound dehiscence, signs of infection, or implant extrusion were observed in any animal throughout the study period. Histologic examination revealed the formation of fibrovascular tissue surrounding the implants, and there were signs of minimal integration of the surface limiting the fibrocellular cap with the space previously occupied by the implant.Conclusions: the double-setting alpha-tricalcium phosphate implant behaved as an inert and nonintegratable material. The lack of incorporation of this material by fibrovascular tissue is related to its characteristics of compactness and high resistance.

Double-setting alpha-tricalcium phosphate cement provided with interconection channels in rabbits after enucleation: a potential implant for the anophthalmic socket

The purpose of this study was to evaluate the macroscopy and microstructure of a double setting alpha-tricalcium phosphate bone cement sphere provided with interconnection channels (alpha-TCP-i), as well as the integration of the implant with the rabbits' orbital tissue, through macroscopic analysis and histopathology. The external and internal surfaces of the alpha-TCP-i were evaluated macroscopically and by electron microscopy. Twelve New Zealand rabbits received 12mm implants of alpha-TCP-i following enucleation of the left eye. The clinical assessment was undertaken daily during the first 15 days, followed by fortnightly assessment until the end of the study period. For the morphological analysis, exenteration was performed in 3 animals per experimental period (15, 45, 90 and 180 days). The external and internal surfaces of the implant appeared solid, smooth and compact, with six channels which interconnected centrally. The micro-architecture was characterized by the formation of columns of hexagonal crystals. No signs of infection, exposure, dehiscence of sutures or extrusion of the implant were noted in any of the animals during the entire period of the study. The morphological evaluation demonstrated the presence of a thin capsule around the implant, from whence appeared fibro-vascular projections, which penetrated it through the interconnecting channels. In the first days after the insertion of the implant, an intense inflammatory reaction was noted. At 180 days, however, there were no signs of inflammation. The alpha-tricalcium phosphate cement implant was well tolerated in this rabbit model and appeared to be relatively inert with some fibrovascular ingrowth through the large channels.