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Preparation of porous composite implant materials by in situ polymerization of porous apatite containing epsilon-caprolactone or methyl methacrylate.

Biodegradable and biostable composite foams were formed from porous apatite cement infiltrated with epsilon-caprolactone (CL) or methylmethacrylate (MMA) using a high over vacuum. For CL composites in situ polymerization was induced using trace water as an initiator and heating at 120 degrees C for up to 10 days or at 80 degrees C for 60 days. MMA composites were polymerized using AIBN initiator at 70 degrees C for 8 h. CL preparations gave composites with a polycaprolactone (PCL) number average of molecular weight (Mn) up to the maximum of 7.1 x 10(3) g/mol after 10 days and 16.8 x 10(3) g/mol after 60 days. The PCL and PMMA contents were close to 50 and 40 wt%, respectively, polymer was present as a thin coating on the apatite crystal plates and was evenly distributed throughout the samples. Re-evacuation of apatite saturated with monomer during preparation ensured that the upwards of 200 nm microchannels within the apatite cement were largely free of polymer, and the overall macroporous structure of the apatite foams was partly retained. Maximum compressive strengths increased from 9 MPa to 37 and 64 MPa for PCL and PMMA composites, respectively. The water drop contact angle of the PCL composite was 64 degrees, and therefore suitable for cell attachment. PMMA composite surfaces were more hydrophobic. Composites were subjected to corona discharge to induce suitable moderate hydrophilicity at the surface.

Apatites↗

Comparative study on the properties of acrylic bone cements prepared with either aliphatic or aromatic functionalized methacrylates.

Bone cements prepared with methacrylic acid (MAA) and diethyl amino ethyl methacrylate (DEAEM) were compared with formulations employing 4-methacryloyloxybenzoic acid (MBA) and 4-diethyaminobenzyl methacrylate (DEABM) as comonomer. The influence of these new aromatic monomers on various physicochemical, setting and mechanical properties was assessed. Surface characterization demonstrated that bone cements prepared with any of the functionalized monomers exhibited increasing hydrophilicity with monomer concentration and that the aromatic monomers provided more hydrophilic cements than their aliphatic counterparts for low concentrations of the functional monomer. It was also found that bone cements prepared with high amounts of the acidic aliphatic monomer provided the highest exotherm of reaction and their setting times were shorter than MBA based cements. On the other hand, DEABM containing bone cements exhibited shorter setting times than DEAEM formulations and slightly higher peak temperatures. In general, it was found that the glass transition temperature increased with the presence of acidic comonomer and decreased when alkaline comonomers were present, especially aliphatic ones. When aromatic methacrylates were used at 0.05 molar fraction, the highest tensile and compressive strength were achieved i.e. 46 and 118 MPa for MBA and 51 and 108 MPa for DEABM formulations. A further increase in the aromatic monomer concentration led to cements of low mechanical properties due to solubility problems as revealed by SEM.

Benzoates↗

[An improved vertebral body replacement for the thoracolumbar spine. A biomechanical in vitro test on human lumbar vertebral bodies].

BACKGROUND: In recent years, the use of expandable titanium cages for vertebral body replacement in the thoracolumbar spine has been well established for the treatment of tumors, unstable traumatic lesions, or posttraumatic deformity. Collapse of the implant into the vertebral body remains a point of concern. A biomechanical compression test was designed to assess implant subsidence for a newly developed prototype for vertebral body replacement in the thoracolumbar spine using human cadaveric lumbar vertebrae. The objective of this study was to compare the compressive performance of a new expandable cage with modified end-plate design with three commonly available expandable cages for vertebral body replacement. MATERIALS AND METHODS: The compressive strengths at the implant-vertebral body interface were measured via axial loading of the new prototype (Synex II) in comparison with three different expandable titanium cages: Synex I (Synthes), Obelisc (Ulrich Medical) and X-Tenz (DePuy Spine). Twenty-four intact, fresh frozen human lumbar vertebrae (L1-L4) were distributed into four identical groups according to BMD (determined by quantitative computed tomography) and the vertebral level. Specimens were loaded in the craniocaudal direction with a material testing machine at a constant speed of 5 mm/min. Load displacement curves were continuously recorded for each specimen until failure (diminishment of compressive force (F)/obvious implant migration through the vertebral body endplate). One-way analysis of variance and post-hoc tests (Bonferroni) were applied to detect differences at 1, 2, 3, 4 mm displacement (F1-4 mm), and Fmax between implant groups. RESULTS: The four expandable cages did not show statistically significant biomechanical differences in terms of maximum compression force (Fmax) until failure: Synex II (1,782 N/4.7 mm); Synex I (1,645 N/4.7 mm); Obelisc (1,314 N/4.2 mm); X-Tenz (1,470 N/6.9 mm). However, the mean compression force until 4 mm displacement (F1-4 mm: 300-1,600 N) was highest for Synex II. The difference at 2 mm displacement was significant (p=0.028) between Synex II (F2 mm=879 N) and X-Tenz (F2 mm=339 N). CONCLUSION: The modified endplate design of the new prototype was found to improve its compressive performance under constrained uniaxial loading conditions at the implant-bone interface. The improved compressive behaviour of the new implant might help to reduce the risk of implant subsidence and collapse into the vertebral body in vivo.

Aged↗

Preparation of bioactive nanotitania ceramics with biomechanical compatibility.

In this article, bioactive nanotitania ceramics with biomechanical compatibility was prepared by using an additive of hydroxyapatite or MgO as particle growth inhibitor. After sintering at 1000 degrees C, the particle size of nanotitania ceramics prepared by using HA as additive (HT) was much smaller than that prepared by using MgO as additive (MT). In simulated body fluid (SBF), HT could induce apatite formation in 4 days, while no apatite could be found on MT even after it was soaked in SBF for 14 days. After Ros17/28 osteoblasts were cultured on the materials for 1, 4, and 6 days, MTT results showed that the osteoblasts on the HT differentiated faster than that on the MT. Mechanical tests results showed that the bending and compressive strength of HT were 160 and 200 MPa, while those of MT were 70 and 88 MPa, respectively. These results demonstrated that it is suitable to prepare bioactive nanotitania ceramics, with biomechanical compatibility, by using HA as particle growth inhibitor.

Animals↗

Hydroxyapatite (HA) bone scaffolds with controlled macrochannel pores.

Hydroxyapatite (HA) macrochanneled porous scaffolds, with a controlled pore structure, were fabricated via a combination of the extrusion and lamination processes. The scaffold was architectured by aligning and laminating the extruded HA and carbon filaments. The macrochannel pores were formed by removing the carbon filaments after thermal treatments (binder removal and sintering). The porosity of the scaffolds was varied between 48 and 73% with a controlled pore size of approximately 450 microm, by adjusting the fractions of HA and carbon filaments. As the porosity was increased from 48 to 73%, the compressive strength decreased from 11.5 to 3.2 MPa. However, the osteoblast-like cell responses on the scaffold, such as the proliferation rate and alkaline phosphatase (ALP) activity, were significantly enhanced as the porosity was increased.

Alkaline Phosphatase↗

Hydroxyapatite/poly(epsilon-caprolactone) composite coatings on hydroxyapatite porous bone scaffold for drug delivery.

Hydroxyapatite (HA) porous scaffold was coated with HA and polycaprolactone (PCL) composites, and antibiotic drug tetracycline hydrochloride was entrapped within the coating layer. The HA scaffold obtained by a polymeric reticulate method, possessed high porosity ( approximately 87%) and controlled pore size (150-200 microm). Such a well-developed porous structure facilitated usage in a drug delivery system due to its high surface area and blood circulation efficiency. The PCL polymer, as a coating component, was used to improve the brittleness and low strength of the HA scaffold, as well to effectively entrap the drug. To improve the osteoconductivity and bioactivity of the coating layer, HA powder was hybridized with PCL solution to make the HA-PCL composite coating. With alteration in the coating concentration and HA/PCL ratio, the morphology, mechanical properties, and biodegradation behavior were investigated. Increasing the concentration rendered the stems thicker and some pores to be clogged; as well increasing the HA/PCL ratio made the coating surface be rough due to the large amount of HA particles. However, for all concentrations and compositions, uniform coatings were formed, i.e., with the HA particles being dispersed homogeneously in the PCL sheet. With the composite coating, the mechanical properties, such as compressive strength and elastic modulus were improved by several orders of magnitude. These improvements were more significant with thicker coatings, while little difference was observed with the HA/PCL ratio. The in vitro biodegradation of the composite coatings in the phosphate buffered saline solution increased linearly with incubation time and the rate differed with the coating concentration and the HA/PCL ratio; the higher concentration and HA amount caused the increased biodegradation. At short period (<2 h), about 20-30% drug was released especially due to free drug at the coating surface. However, the release rate was sustained for prolonged periods and was highly dependent on the degree of coating dissolution, suggesting the possibility of a controlled drug release in the porous scaffold with HA+PCL coating.

Absorbable Implants↗

Utilization of pulverized fuel ash in Malta.

In Malta all of the waste produced is mixed and deposited at various sites around the island. None of these sites were purpose built, and all of the waste is above groundwater level. The landfills are not engineered and do not contain any measures to collect leachate and gases emanating from the disposal sites. Another waste, which is disposed of in landfills, is pulverized fuel ash (PFA), which is a by-product of coal combustion by the power station. This has been disposed of in landfill, because its use has been precluded due to the radioactivity of the ashes. The aim of this study was to analyze the chemical composition of the pulverized fuel ash and to attempt to utilize it as a cement replacement in normal concrete mixes in the construction industry. The levels of radiation emitted from the ashes were measured by gamma spectrometry. The results of this study revealed that although at early ages cement replacement by PFA resulted in a reduction in compressive strength (P=0), when compared to the reference concrete at later ages the strengths measured on concrete cores were comparable to the reference concrete (P>0.05). The utilization of PFA up to 20% cement replacement in concrete did not raise the radioactivity of the concrete. In conclusion, utilization of PFA in the construction industry would be a better way of disposing of the ashes rather than controlling the leachate and any radioactivity emitted by the landfilled ashes.

Coal↗

The hydration properties of pastes containing municipal solid waste incinerator fly ash slag.

This study investigated the hydration properties of Type I, Type III and Type V cements, mixed with municipal solid waste incinerator fly ash, to produce slag-blended cement pastes. The setting time of slag-blended cement pastes that contained 40% slag showed significantly retardation the setting time compared to those with a 10% or even a 20% slag replacement. The compressive strength of slag-blended cement paste samples containing 10 and 20% of slag, varied from 95 to 110% that developed by the plain cement pastes at later stages. An increased blend ratio, due to the filling of pores by C-S-H formed during pozzolanic reaction tended to become more pronounced with time. This resulting densification and enhanced later strength was caused by the shifting of the gel pores. It was found that the degree of hydration was slow in early stages, but it increased with increasing curing time. The results indicated that it is feasible to use MSWI fly ash slag to replace up to 20% of the material with three types of ordinary Portland cement.

Carbon↗

Study of the reactivity and in vitro bioactivity of Sr-substituted alpha-TCP cements.

In this study the effect of strontium substitution on the hydrolysis of alpha -tricalcium phosphate (alpha-TCP) toward the formation of calcium deficient hydroxyapatite (CDHA) was investigated. For that purpose substituted alpha-TCP powders with 1, 5 and 10 mol% Sr substitution for Ca were synthesized by reacting at 1500 degrees C stoichiometric amounts of CaCO(3), SrCO(3), and Ca(2)P(2)O(7), followed by rapid quenching in air. XRD analysis of the powders revealed the presence of alpha-TCP (traces of beta-TCP) with enlarged unit cell volume at increased Sr contents, indicating the incorporation of Sr in the crystal structure. Strontium was also incorporated in the apatite phase as revealed by XRD analysis of the set cements. The hydrolysis of milled alpha-SrTCP powders and a pure alpha-TCP (control) was monitored by isothermal calorimetry and the compressive strength of set cements was tested. The results showed a decrease in the reactivity with increasing Sr content and similar final mechanical strength within the Sr series, though lower than the control. The in vitro bioactivity of the set cements after soaking in simulated body fluid for 4 weeks was also tested. The formation of a bone-like apatite layer on the surface of the set cements indicated a potential in vivo bioactivity.

Biocompatible Materials↗

Ionic modification of calcium phosphate cement viscosity. Part I: hypodermic injection and strength improvement of apatite cement.

A broadening of the indications for which calcium phosphate cements (CPC) can be used, for example, in the field of vertebroplasty, would require injectable and higher strength materials. Unmodified CPC are not injectable due to a filter-pressing effect during injection. In this work we demonstrated that an effective method for improving the injection properties of CPC was by the use of sodium citrate solution as a liquid component. Cement consisting of tetracalcium phosphate (TTCP) and monetite (DCPA) mixed with water up to a powder:liquid ratio (P:L) of 3.3 g/ml had an injectability of approximately 60%. The use of 500 mM trisodium citrate solution instead of water decreased the viscosity of the cement paste to a point, where complete injectability (>95%) through an 800 microm diameter hypodermic needle could be achieved at low loads. The reduction in water demand of the cement effected by the use of sodium citrate enabled high P:L mixes to be formed which were 400% stronger than cements made with water. The effect was less pronounced with compacted cements such that at 9 MPa applied pressure, 58% improvement was obtained and at 50 MPa 36% improvement was measured yielding a cement with a compressive strength of 154 MPa. The liquefying effect of sodium citrate was thought to derive from a strong increase in the surface charge of both the reactants and the product as determined by zeta-potential measurement.

Biocompatible Materials↗

Compressive properties of chemically cured, resin modified glass ionomer luting cements.

This study compared the responses of three proprietary chemically cured hybrid glass ionomer luting cements to compressive loading. These cements bear the trade names Advance, Fuji DUET and Vitremer Luting Cement, and are distributed and sold through ordinary domestic and international channels of dental commerce. The findings are as follows: 1. Advance, and Fuji DUET were stronger and stiffer than Vitremer Luting Cement. On the other hand, Vitremer exhibited the highest toughness. 2. The compressive properties of Advance were not affected significantly by increasing the specimen aging period to 28 days from seven days. 3. Prolonged aging of Fuji DUET and Vitremer specimens in a humid environment elicited significant changes in compressive strength and modulus of elasticity. Whereas the strength and elastic modulus changes for Fuji DUET were negative, the changes experienced by Vitremer were positive. 4. Extending the specimen aging period to 28 days from seven days did not affect significantly the toughness of either Fuji DUET or Vitremer Luting Cement. Relatively low elastic moduli limit the application of the chemically cured hybrid glass ionomers to the cementation of one- to three-unit cast fixed restorations.

Analysis of Variance↗

Experimental binder-free investments reused to cast dental precious alloys.

This study aimed to develop reusable dental investments. SiO2 and MgO were selected as refractory materials to prepare three types of investment (coded as 60S-40M, 80S-20M, 100S) with 40, 20, and 0 wt% of MgO. Each type of investment was reused twice. Thermal expansion and compressive strength were examined and statistically evaluated by ANOVA. To evaluate fit of castings, full crowns were cast by using a commercial Au-Ag-Pd alloy with all investment types. Marginal fit was statistically analyzed by cement thickness. It was found that although MgO strengthened the mold, it had little influence on expansion. The strength of 60S-40M was the highest, and 100S had the greatest advantage with regard to thermal expansion. In the evaluation for clinical applicability, all investments were able to cast successfully, but their castings might be undersized. Among the experimental binder-free investments reused for dental casting in this study, 100S in particular showed to be a good candidate for repeated fabrication of precision fit castings.

Compressive Strength↗

Bazedoxifene acetate: a selective estrogen receptor modulator with improved selectivity.

We assessed the preclinical characteristics of a novel, stringently screened selective estrogen receptor modulator, bazedoxifene acetate, including its ability to bind to and activate estrogen receptors and promote increased bone mineral density and bone strength in rats, and the effects impacting the uterine endometrium, breast cancer cell proliferation, and central nervous system-associated vasomotor responses in an animal model. Bazedoxifene bound to estrogen receptor-alpha with an IC50 of 26 nm, an affinity similar to that of raloxifene. Bazedoxifene did not stimulate proliferation of MCF-7 cells but did inhibit 17beta-estradiol-induced proliferation with an IC50 of 0.19 nm. In an immature rat uterine model, bazedoxifene (0.5 and 5.0 mg/kg) was associated with less increase in uterine wet weight than either ethinyl estradiol (10 microg/kg) or raloxifene (0.5 and 5.0 mg/kg). Histological analysis revealed that coadministration of bazedoxifene also appeared to reduce raloxifene-stimulated endometrial luminal epithelial cell and myometrial cell hypertrophy. In ovariectomized rats, bazedoxifene was associated with significant increases in bone mineral density at 6 wk, compared with control, and better compressive strength of bone samples from the L4 vertebrae, compared with samples from ovariectomized animals. In the morphine-addicted rat model of vasomotor activity, bone-sparing doses of bazedoxifene alone were not associated with 17beta-estradiol inhibition of increased vasomotor activity. Bazedoxifene acetate represents a promising new treatment for osteoporosis, with a potential for less uterine and vasomotor effects than selective estrogen receptor modulators currently used in clinical practice. Controlled clinical trial data will be needed to confirm these effects.

Animals↗

Mechanical properties of a biodegradable bone regeneration scaffold.

Poly (Propylene Fumarate) (PPF), a novel, bulk erosion, biodegradable polymer, has been shown to have osteoconductive effects in vivo when used as a bone regeneration scaffold (Peter, S. J., Suggs, L. J., Yaszemski, M. J., Engel, P. S., and Mikos, A. J., 1999, J. Biomater. Sci. Polym. Ed., 10, pp. 363-373). The material properties of the polymer allow it to be injected into irregularly shaped voids in vivo and provide mechanical stability as well as function as a bone regeneration scaffold. We fabricated a series of biomaterial composites, comprised of varying quantities of PPF, NaCl and beta-tricalcium phosphate (beta-TCP), into the shape of right circular cylinders and tested the mechanical properties in four-point bending and compression. The mean modulus of elasticity in compression (Ec) was 1204.2 MPa (SD 32.2) and the mean modulus of elasticity in bending (Eb) was 1274.7 MPa (SD 125.7). All of the moduli were on the order of magnitude of trabecular bone. Changing the level of NaCl from 20 to 40 percent, by mass, did not decrease Ec and Eb significantly, but did decrease bending and compressive strength significantly. Increasing the beta-TCP from 0.25 g/g PPF to 0.5 g/g PPF increased all of the measured mechanical properties of PPF/NVP composites. These results indicate that this biodegradable polymer composite is an attractive candidate for use as a replacement scaffold for trabecular bone.

Absorbable Implants↗

Quantification of the compactibility of pharmaceutical powders.

The purpose of this study is to investigate and to quantify the compactibility of pharmaceutical powders by a simple linear relationship between the diametral compressive strength of tablets and the applied compaction pressure. The mechanical strength of the tablets is characterized as the crushing force normalized with the dimension of the tablet and termed the specific crushing strength, SCS. The proposed model: SCS=Cp*P+b estimates the slope of the regression line Cp as a dimensionless compactibility parameter and is reported with the corresponding standard deviation SCp. The linear region of the compactibility profile is selected using the 95% predictability limits bordering the regression line. Eleven different materials were tested and acceptable fits to the linear model were observed in all cases. The ability of the model to discriminate between the investigated materials is excellent, in cases where the difference may be difficult to show a simple t-test is used as an inference tool. No difference was found between lactose tablets of different masses (500 and 1000 mg). A relationship between the compactibility parameter and the compressibility characterized by the Walker coefficient is demonstrated.

Chemistry, Pharmaceutical↗

Effect of pigmentation on the mechanical and polymerization characteristics of bone cement.

The impact on performance of additives to bone cement must be assessed before clinical use of the modified product. This study performed several standard acrylic bone cement tests on 3 commercially available products: Endurance, Surgical Simplex P, and Pigmented Endurance. The polymerization characteristics, consisting of doughing time, setting time, and maximum exothermic temperature, were found to be acceptable by the standards of the American Society for Testing and Materials/International Organization for Standards. For the mechanical characterization, analysis revealed statistical equivalence among all cement types, with the exception of compressive strength where Pigmented Endurance was stronger than Surgical Simplex P (P < .02). In mechanical fatigue, there were no significant differences in the log cycles to failure among the cements; however, Weibull analysis predicted Surgical Simplex P to have a higher characteristic life than the other cements. In conclusion, differences do exist among cement types, but the addition of pigment to Endurance did not alter its performance.

Biomechanical Phenomena↗

Physiologically clotted fibrin-calcined bone composite--a possible bone graft substitute.

Fibrin plays a major role in blood clotting and is important in wound healing. In the present study, physiologically clotted fibrin (PF) and calcined bone (CB) both of bovine origin were used in the preparation of a bone graft material with chitosan (C) as a binder. This bone graft (PF-CB) was characterized by stress-strain analysis, X-ray diffraction (XRD) studies, scanning electron microscopy, differential scanning calorimetry, thermogravimetric analysis, and FTIR spectroscopy. Thermal studies revealed that the incorporation of CB into PF did not alter the thermal stability of fibrin, although it affects the total loss percentage. The composition containing 24:1:15 (PF:C:CB) on dry weight basis exhibited maximum compressive strength, and the same composite was used for characterization studies. The XRD studies have shown the amorphous nature of the implant. SEM pictures revealed the heterogeneity and porous nature of the implant. PF in combination with CB is expected to exhibit osteoinductivity because fibrin, the osteoinductive protein, acts as an angiogenic factor, whereas CB provides calcium and phosphate ions that are needed for new bone formation.

Animals↗

Effect of particle configuration on structure and properties of dispersed Pd-containing dental amalgam.

The present work investigates the effect of particle configuration on the structure and properties of four dispersed type Pd-containing amalgams with the same chemical composition. The results indicate that particle configuration plays an important role not only in the structure and chemistry, but also in such properties as compressive strength, creep and mercury release rate. Compromises among the various properties of the present Pd amalgams are needed, when a decision on particle configuration is to be made. As mechanical properties or corrosion resistance is concerned, the amalgam should comprise at least one spherical alloy (matrix or dispersant). As far as mercury release is concerned, the amalgam should comprise irregular dispersant alloy. The amalgam fabricated from irregular dispersant and spherical matrix particles seems to serve all well.

Compressive Strength↗