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Acrylic bone cements with bismuth salicylate: Behavior in simulated physiological conditions.

In a previous work, we reported the development of acrylic bone cement formulations for application in percutaneous vertebroplasty, by using bismuth salicylate (BS) as the radiopaque agent. Our objective was to obtain high radiopacity along with a therapeutical effect produced by the release of salicylic acid in situ. To follow that study, the setting kinetics and static and dynamical mechanical properties of the BS cements were studied in simulated physiological conditions. Moreover, radiopacity after various times of immersion in saline and the wettability of the cements surfaces were determined. The study finished with the analysis of the biological response. From the results, it can be concluded that physiological conditions did not affect negatively to the cements performance, since all BS-loaded cements fulfilled the ISO standard requirements. Radiopacity of the formulations was maintained over time and cements with BS were found to be biocompatible.

Acrylates↗

Vertical bone augmentation with granulated brushite cement set in glycolic acid.

Brushite cements are a biocompatible materials that are resorbed in vivo. A new cement composed of a mixture of monocalcium phosphate (MCP) and beta-tricalcium phosphate (beta-TCP) that sets using glycolic acid (GA) was synthesized and characterized. After setting, the cement composition, derived from X-ray diffraction, was 83 wt % brushite and 17 wt % beta-TCP with an average brushite crystal size of about 2.6 +/- 1.4 microm. The cement has a diametral tensile strength of 2.9 +/- 0.7 MPa. Granules prepared from the set-cement were used as grafting material in bone defects on rabbit calvaria for evaluating in vivo its bone regeneration capacity. Considerable cement resorption, improvement in the bone mineral density, and bone neoformation was observed after 4 weeks of the granules' implantation.

Absorbable Implants↗

Comparative study of bone cements prepared with either HA or alpha-TCP and functionalized methacrylates.

The properties of bone cements prepared with both hydroxyapatite (HA) and alpha-tricalcium phosphate (alpha-TCP) and methacrylates containing acidic or basic groups are the main interest of this article. The presence of methacrylic acid or diethyl amino ethyl methacrylate as comonomers in the bone cement and both ceramic types as filler were found not to affect the amount of residual monomer, which was generally less than 4.5 wt%. In contrast, setting times, maximum temperature, and glass transition temperature were found to be composition dependent. For samples with acidic comonomer, a faster setting time, a higher maximum temperature, and higher glass transition temperatures were observed compared to those with the basic comonomer. The presence of the fillers slightly increased the setting time but did not affect the other parameters. The mechanical properties of the filled bone cements depended mainly on composition and type of testing. Both HA or alpha-TCP filled systems fulfilled the minimum compressive strength required for bone cement application, although a significantly lower value was observed for the alkaline comonomer systems. The minimum bending strength was not satisfied by any of these formulations. The tensile and shear strength of these composites ranged from 20 to 37.9 and from 18 to 27 MPa, respectively. In all cases it was higher for bone cements containing methacrylic acid. The results of this study suggest that the properties of dry unfilled bone cements prepared with MAA are comparable to CMW 3 in mechanical terms but inferior in their setting properties.

Bone Cements↗

An experimental analogue to model the fibrous tissue layer in cemented hip replacements.

Fibrous tissue at the bone-cement interface of cemented joint replacements has been reported frequently in cases of revisions made necessary by aseptic loosening. This work describes the development of in vitro specimens suitable for biomechanical modeling of cemented femoral hip replacements with a fibrous tissue layer at the bone-cement interface. In particular, a series of uniaxial compression tests were performed on silicone elastomer specimens to identify a suitable analogue with similar mechanical characteristics to those reported for the fibrous tissue layer. A method was developed to apply the silicone elastomer at the bone-cement interface. This was examined for two types of cemented hip replacements implanted in composite femurs. The selected thickness of the elastomer layers was in the range of those found in clinical cases of aseptic loosening. Specimens produced by these methods could be used in preclinical biomechanical tests (such as stability or stress shielding tests) to assess the effects of a soft-tissue layer, to model in vitro a long-term-implant scenario, and to provide validation for similar finite element studies.

Biocompatible Materials↗

The behavior of novel hydrophilic composite bone cements in simulated body fluids.

Composite bone cements were formulated with bioactive glass (MgO--SiO(2)--3CaO. P(2)O(5)) as the filler and hydrophilic matrix. The matrix was composed of a starch/cellulose acetate blend (SCA) as the solid component and a mixture of methylmethacrylate/acrylic acid (MMA/AA) as the liquid component. The curing parameters, mechanical properties, and bioactive behavior of these composite cements were determined. The addition of up to 30 wt % of glass improved both compressive modulus and yield strength and kept the maximum curing temperature at the same value presented by a typical acrylic-based commercial formulation. The lack of a strongly bonded interface (because no coupling agent was used) had important effects on the swelling and mechanical properties of the novel bone cements. However, bone cements containing AA did not show a bioactive behavior, because of the deleterious effect of this monomer on the calcium phosphate precipitation on the polymeric surfaces. Formulations without AA were prepared with MMA or 2-hydroxyethyl methacrylate (HEMA) as the liquid component. Only these formulations could form an apatite-like layer on their surface. These systems, therefore, are very promising: They are bioactive, hydrophilic, partially degradable, and present interesting mechanical properties. This combination of properties could facilitate the release of bioactive agents from the cement, allow bone ingrowth in the cement, and induce a press-fitting effect, improving the interfaces with both the prosthesis and the bone.

Acrylates↗

Sorption and solubility testing of orthodontic bonding cements in different solutions.

To evaluate and compare the solubility and sorption of orthodontic bonding cements after immersion in different solutions, five different cements were used: a fluoride-containing resin composite, a light-cured glass ionomer cement, a light-cured resin composite, a paste-paste chemically cured resin composite, and a liquid-paste chemically cured resin composite. Five different solutions were employed: distilled water, artificial saliva, an alcohol-free mouthrinse solution (Orthokin), a 5% alcohol mouthrinse solution (Perioaid), and a 75% ethanol/water solution. Five disc specimens (15 mm x 0.85 mm) were used for each experimental condition. Materials were handled following manufacturers' instructions and were ground wet with silicon carbide paper. Solubility and sorption of the materials were calculated by means of weighing the samples before and after immersion and desiccation. Data were analyzed by two-way ANOVA and Student-Newman-Keuls test (p < 0.05). The light-cured glass ionomer cement showed the lowest solubility and the highest sorption values. When using alcohol-containing solutions as storage media, solubility of the paste-paste chemically cured resin composite increased, and sorption values for the tested chemically cured resin composites were also increased. The use of alcohol-free mouthrinses does not affect sorption and solubility of orthodontic cements. The chemically cured (paste-paste) composite resin cement, requiring a mixing procedure, was the most affected by immersion in alcohol-containing solutions.

Absorption↗

In vivo versus in vitro polymerization of acrylic bone cement: effect on material properties.

Flexural strength and molecular weight of polymethylmethacrylate bone cement were determined for cement polymerized in vivo in a canine total hip replacement and cement from the same batch polymerized in vitro. Both in vivo and in vitro samples showed a slight increase in flexural strength and modulus at 2 weeks, followed by a nearly equivalent decline at 8 weeks. In vitro and in vivo samples exhibit a comparable stress to failure, but the in vivo samples show a significantly increased strain and decreased modulus. Cement from the proximal region of the prosthesis has significantly decreased flexural strength, lower modulus, and lower molecular weight than cement from the distal region and plug, suggesting that failures in the proximal region of a prosthesis may be due to inferior physical and mechanical properties of the bone cement in that region.

Animals↗

In vitro evaluation of bonding of the cement-metal interface of a total hip femoral component using ultrasound.

Debonding of the cement-metal interface of a cemented femoral component is one mechanism associated with loosening of total hip replacement. An ultrasonic pulse-echo technique was developed to determine, nondestructively, the integrity of the cement-metal interface in vitro. The characteristics of the ultrasonic reflections of bonded and debonded interfaces were obtained by using a physical model that consisted of a flat slab of cement and a flat cobalt alloy plate with known conditions of bonded and debonded interfaces. The same model was used to establish that the ultrasonic technique could distinguish between two surfaces that were in direct opposition but not bonded and those that were actually bonded. This technique then was shown to be useful in nondestructively detecting bonded and debonded cement-metal interfaces of femoral prostheses cemented into fiberglass femurs and femurs from human cadavera.

Bone Cements↗

Augmentation of femoral neck fracture fixation with an injectable calcium-phosphate bone mineral cement.

The first goal of this study was to determine if augmentation with an injectable, in situ setting, calcium-phosphate cement that is capable of being remodeled and was designed to mimic bone mineral significantly improved the strength and stiffness of fixation in a cadaveric femoral neck fracture model. The second goal was to determine if greater increases in fixation strength were achieved as the bone density of the specimen decreased. Sixteen pairs of fresh cadaveric human femora with a mean age of 70.9 years (SD = 17.2 years) were utilized. The bone density of the femoral neck was measured with dual-energy x-ray absorptiometry. The femoral head was impacted vertically with the femoral shaft fixed in 12 degrees of adduction using a materials testing machine to create a fully displaced fracture. Following fracture, 30% inferior comminution was created in each specimen. One randomly chosen femur from each pair underwent anatomic reduction and fixation with three cannulated cancellous bone screws, 7 mm in diameter, in an inverted triangle configuration. The contralateral femur underwent the same fixation augmented with calcium-phosphate cement. Specimens were preconditioned followed by 1.000 cycles to one body weight (611.6 N) at 0.5 Hz to simulate single-limb stance loading. The stiffness in the first cycle was observed to be significantly greater in cement-augmented specimens compared with unaugmented controls (p < 0.05). After cycling, each specimen was loaded at 10 mm/min until complete displacement of the fracture surface and failure of fixation occurred. Specimens augmented with bone mineral cement failed at a mean of 4,573 N (SD = 1,243 N); this was significantly greater (p < 0.01) than the mean for controls (3,092 N, SD = 1,258 N). The relative improvement in fixation strength (augmented/control x 100%) was not inversely correlated to femoral neck bone density (p = 0.25, R2 = 0.09), was weakly correlated to the volume of cement injected (p = 0.07, R2 = 0.22), and was inversely related to the fixation failure load of the control specimen (p = 0.001, R2 = 0.54). There was a mean relative improvement in fixation strength of 169.6% (SD = 77.5). These findings suggest that calcium-phosphate cement provides initial beneficial augmentation to fixation of femoral neck fractures.

Adult↗

Failure of partial cementation to achieve implant stability and bone ingrowth: a long-term roentgen stereophotogrammetric study of tibial components.

Thirty patients with gonarthrosis were operated on with the PCA primary total knee prosthesis and had the tibial component fixed to the bone by partial cementation. In the first two groups of patients, cementation was by a peripheral rim of high and low-viscosity cement, respectively. In the third group, the pegs were cemented with the low-viscosity cement. Follow-up was performed with use of clinical parameters and roentgen stereophotogrammetric analysis. Clinically, the series was successful apart from a problem with tibial component wear, necessitating revision in five patients. At 8 years, the mean Hospital for Special Surgery score was 81 points. Venn-diagram scores revealed four failures and three acceptable cases; the remaining cases were satisfactory. Apart from one loose patellar component, there was no mechanical loosening. Roentgen stereophotogrammetric analysis showed that the tibial components moved relative to the bone; this indicated fibrous tissue fixation, which was corroborated histologically in two patients. The objective, to achieve bone ingrowth, was thus not successfully met. Radiolucent lines were consistently seen, and their size correlated with the migration as measured by roentgen stereophotogrammetric analysis. Furthermore, five continuously migrating prostheses showed significantly larger radiolucent zones than the prostheses that migrated only initially, and they were less well bonded to the bone at 1 year. In conclusion, partial cementation does not appear to be a way to achieve bone ingrowth in porous-coated implants under load.

Aged↗

Does vacuum-mixing improve the fatigue properties of high-viscosity poly(methyl-methacrylate) (PMMA) bone cement? Comparison between two different evacuation methods.

The objective was to verify different reports in the literature which show an increase of stability using vacuum-mixing of bone cement, by testing the fatigue properties of bone-cement specimens (Palacos R). Evacuation of the poly(methyl-methacrylate) (PMMA) and evacuation with additional pressurization (Draenert system) were used to manufacture the specimens. Although we found improvement in the ultimate bending strength for evacuated Palacos R, an increase of fatigue stability could not be found either for vacuum-mixed cement or for vacuum-mixed and compressed cement. As fatigue failure is one of the most important factors leading to aseptic loosening of cemented alloarthroplasties, we conclude that the long-term results cannot be improved by vacuum-mixing this cement.

Biomechanical Phenomena↗

Mechanical failure of the femoral component in cemented total hip replacement--a finite element evaluation.

The quality of cementation is of paramount importance for the long-term clinical outcome in cemented total hip replacement. Four "modes of failure" have been differentiated by various authors and correlated with the clinical findings. A finite element analysis was performed to simulate an ideally cemented femoral stem-type prosthesis as well as failure modes III (proximal anchorage of implant only) and IV (Distal anchorage of implant only). While failure mode III produces a stress distribution at the bone/acrylic cement interface, which is similar to the ideally cemented prosthesis, failure mode type IV leads to a hazardous rise of the interface stresses. This correlates well with the clinical findings given in the literature, thus validating the computer simulation used. Distal cementation only of a stem-type femoral component in total hip replacement should definitely be avoided.

Bone Cements↗

[Total prosthesis of the hip: procedure using cement--indications, technic and results].

The prosthesis must be adapted to the bone without motoric adaptation. For biomechanical reasons it is necessary to have as large a zone of contact as possible. It is impossible to introduce an "exact size prosthesis". Exact size can be achieved only with cement. The disadvantage of too much elasticity by a thicker cement layer must be compensated by the voluminous metallic implant wedged in the bone marrow. The combination of the osteosynthesis plate, shaft and cement yields a kind of "individual prosthesis". In the long-run the cement is biocompatible. The correct technique of the application of the cement is of utmost importance. 95% success-rate in 373 replacement operations between 1977 and 1985 using the same implant material proves the validity of biomechanical considerations. Allergy as the factor influencing the loosening of the implant can be practically disregarded. Bony defects should be filled out with bone and not with cement.

Biomechanical Phenomena↗

The effect of Palamed G bone cement on early migration of tibial components in total knee arthroplasty.

OBJECTIVE: Migration of the tibial component in total knee arthroplasty (TKA) is subject of many studies using roentgen stereophotogrammetric analysis (RSA). In previous studies of cemented and uncemented tibial components, high migration values were found. Improvements in cementing technique, prosthetic design and pre-coating techniques reduced these values as shown in more recent studies. MATERIAL AND SUBJECTS: A total of 35 patients were initially included in the study and operated on between 12/1999 and 10/2000. All patients received a NexGen TKA cemented into the proximal tibia using Palamed G bone cement. The implants and the tibial metaphysis were marked with standard tantalum markers. Radiostereometric analysis was performed post-operatively and after 3, 6 and 12 months using a standard digital radiostereometric analysis. Functional parameters were assessed using the Knee Society Score (KSS) clinical rating system. RESULTS: There were no complications and failures within the first year. After 1 year radiostereometric measurements of the translational parameters along and the rotational parameters around the x-, y- and z-axis revealed: X-Trans -0.19 mm, Y-Trans +0.02 mm, Z-Trans +0.08 mm, X-Rot +0.26 degrees, Y-Rot -0.35 degrees, Z-Rot +0.09 degrees. The maximum total point motion was +0.96 mm and the mean maximum subsidence was -0.23 mm. Except for anterior-posterior, medio-lateral stability and extension leg all endpoints of the KSS clinical rating system showed a significant improvement. CONCLUSIONS: After 12 months, the use of Palamed G bone cement in total knee arthroplasty was demonstrated to be safe. Both the clinical and radiostereometric results were good and comparable to the results reported in other RSA studies in cemented total knee arthroplasty.

Aged↗

[Good long term results with a cemented straight femoral shaft prosthesis made of titanium].

A higher-than-average rate of aseptic loosening has been postulated to be associated with the combination of a titanium stem and bone cement. In this prospective follow-up study we therefore investigated our first consecutive series of 250 implantations of a cemented femoral shaft prosthesis made of titanium alloy (BiCONTACT((R)), Aesculap, Tuttlingen, Germany). Average time of follow-up evaluation was 9.7 years (range 8.7-10.3 years). At follow-up, mean patient age was 81 years; 89 patients with 93 hips have deceased and two could not be located. Follow-up rate was 98.7% for the patients still alive at time of follow-up evaluation. Five patients have been revised, two for infection and one for aseptic loosening of a varus-malaligned stem; two radiologically well-fixed stems had been revised during acetabular revision. Survival estimate showed a calculated cumulative survival rate of 97.5% after 11 years [confidence limits: 99.0% (upper) and 94.1% (lower)]. The average Harris hip score at time of follow-up was 82.25 points.Radiologically, signs of loosening could be detected in 3 stems: in one case varus malalignement deteriorated with time and in 2 cases osteolyses developed together with significant polyethylene wear. All 3 patients experienced only mild pain and revision had not been indicated so far. In conclusion, the long-term follow-up results with this cemented titanium femoral component are encouraging and are comparable to other successful cemented femoral components in primary total hip arthroplasty. No increased risk for aseptical loosening was associated to the combination of titanium and cement in this specific stem. Design parameters seem to play an important role in the development of aseptic loosening in cemented titanium stems.

Adult↗

[CT-based analysis of cement distribution in unipedicular vertebroplasty].

BACKGROUND: Vertebroplasty and kyphoplasty are being increasingly used in the treatment of osteoporotic vertebral body fractures. Shortening the duration of operative time and radiation exposure as well as reduction of cannulation-related risks and costs are advantages of the unipedicular technique in contrast to less homogeneous cement distribution as a possible disadvantage. Biomechanical investigations have shown similar results with respect to strength and stiffness both for uni- and bipedicular vertebroplasty. Studies evaluating cement distribution with CT scans using a unipedicular approach have not been published yet. MATERIAL AND METHODS: We present a prospective study on 92 vertebral body fractures (Th8-L5) in 60 patients, aged 76.8 (60-95) years, which were treated by unipedicular vertebroplasty using a para-/transpedicular approach. We evaluated needle position, injected cement volume, and cement deposition based on CT scans. The vertebral body was divided into nine segments in a frontal plane view. The needle was placed in the middle third in 85.9% (79/92), in the right in 11.9% (11/92), and in the left third in 2.2% (2/92). Complications associated with cannulation were not observed. The injectable cement volume was 4.5 (1.5-9.0) ml. RESULTS: With respect to superior, middle, and inferior parts, filling of the middle third was achieved in 94.9%, of the right third in 76.1%, and of the left third in 80.4%. Only the right- and left-sided inferior segments showed a filling rate below 75%. Positioning the needle into the right or left third resulted in comparably high filling rates of the middle third (100/83.3%) but only 50.0/54.5% of the contralateral third of the vertebral body. CONCLUSION: Unipedicular vertebroplasty using a modified approach permits a reliable placement of the needle into the middle third of the vertebral body, which is the optimal position regarding cement distribution. Unipedicular vertebroplasty allows homogeneous filling and augmentation of vertebral bodies without need for a second cannulation.

Aged↗

[Stress levels in bones and bone cement in the thoracolumbar spine afer kyphoplasty. Finite element study].

The study quantified the stress levels in treated and untreated vertebral bodies following kyphoplasty. Three-dimensional FE models of treated and untreated T11, T12, L1, and L2 vertebral bodies were evaluated to examine the stress levels within the bone and bone cement. A validated T12-L1 model was used to investigate the effect of kyphoplasty treatment on adjacent vertebral stresses and strains. Using the single vertebral models, bone cement modulus changes had minimal effect on the stresses in the bone or the cement. The presence of bone cement had a minimal effect on the stress magnitudes or distribution in the adjacent T12 vertebra. This study provides quantification of the stress levels in bone cement and bone in vertebral bodies treated with kyphoplasty under in vivo-like loading conditions. The presence of bone cement immediately following kyphoplasty has only a slight effect on the stress magnitudes or distributions in adjacent vertebrae.

Biomechanical Phenomena↗

[The influence of jet-lavage systems on in vitro cement penetration].

The benefit of pulsatile lavage on cement penetration in femoral cancellous bone is well known. The aim of this study was to determine the influence of different jet-lavage systems on cement penetration in a standardized cadaver study. Four different jet-lavage systems were compared (right vs left) in 30 paired human femora. After broaching, the femoral canal was lavaged with 1 l saline. The specimens were embedded in plastic pots, bone cement was applied in a retrograde manner and cement was pressurized using a standard pressure protocol with a constant force of 3,000 N. Horizontal sections were obtained at predefined levels using an automatic saw. Microradiographs were taken and analysed using image analysis to assess the extent of cement penetration. There were no significant differences in cement penetration into cancellous bone using the different jet-lavage systems. This technique is of great importance for obtaining a good interdigitation with cancellous bone. The different jet-lavage systems investigated in our study, however, seemed to be equally effective.

Absorption↗