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Release of gentamicin from acrylic bone cement.

The pharmacokinetics of gentamicin were studied after total hip joint arthroplasties performed with "Palacos R plus gentamicin' in 10 patients. Urine was collected at 12-hour intervals for 15 days after operation, and drainage fluids for 48, 72 or 108 hours. Blood samples were taken 3 and/or 5 hours after prosthesis implantation. High concentrations of gentamicin were found in drainage fluids. Excretion curves in drainage fluids or urine were fitted by a computer-aided design program (SIAM) and the mean curves established. Elimination of gentamicin was biphasic in both cases. The rapid phases had a half-life of 2.97 hours in drainage fluids and 7.16 hours in urine. Half-lives of the slow phases were 13.5 and 47.12 hours, respectively. The mean percentage of total gentamicin released by the two routes was 5.78% of the quantity implanted. The calculated peak blood concentration was 0.12 mg/L. It is concluded that gentamicin concentrations locally reach levels higher than minimum inhibitory concentrations of most of the likely pathogens in patients undergoing total hip joint arthroplasties with "Palacos R plus gentamicin' bone cement. However, as blood concentrations appear to be low, patients may not be protected against systemic infections.

Adult↗

Water uptake and release from iodine-containing bone cement.

Water uptake and release characteristics of PMMA cement containing the water-soluble contrast media iohexol or iodixanol have been investigated. The water uptake study revealed that iohexol had the highest uptake of water (3.7%) and that iodixanol had an uptake close to that of Palacos R (2.3% and 1.9%). The curves obtained showed the materials to follow classic diffusion theory, with an initial linearity with respect to t(1/2) making it possible to calculate the diffusion coefficients. This showed iohexol to have the lowest diffusion coefficient, Palacos R the highest, and iodixanol close to that of Palacos R. The release study showed that more iohexol than iodixanol was released from the bone cement; the long-term release was above 25 microg/mL for iohexol compared to slightly above 10 microg/mL for iodixanol. A microCT investigation showed that the risk of developing an observable radiolucent zone is negligible.

Absorption↗

Evaluation of corrosion on plasma sprayed and anodized titanium implants, both with and without bone cement.

The corrosion behavior of titanium with vacuum plasma sprayed titanium coatings and with anodized surfaces, both with and without polymeric bone cement were evaluated. Electrochemical extraction tests were carried out with subsequent analysis of the electrolyte by ICP-MS in order to verify our hypothesis of the ionic permeability of the polymer cement. The complexity of the situation resides in the existence of two interfaces: electrolyte-polymer and polymer-metal. The surface preparation (treatment of the surface) plays an important role in the corrosion resistance of titanium. The electrochemical magnitudes that were examined reveal that the plasma spray surfaces have the lowest corrosion resistance. The cement, in spite of having reduced electrical conductivity in comparison to metal, is an ionic transporter, and therefore capable of participating in the corrosion process. In the present study, we observed in fact crevice corrosion at the metal-cement interface. In the case of plasma spray surfaces, a process of diffusion of titanium particles in the electrolyte could accompany the crevice corrosion. In this study, we have shown that there is a corrosion process at the surface of the titanium through the cement which has as a consequence on the one hand the formation of titanium cations and on the other hand the growth of a passive layer on the titanium. In conclusion, we identified two principal factors that influence the corrosion process: [1] the type of surface treatment for the titanium, and [2] the ionic conductivity of the cement. There is indeed ionic transport through the cement; as evidenced by the presence of titanium in the electrolyte solution (ICP-MS analysis) and chloride at the surface of the titanium sample (EDX analysis). We show that the polymer cement is an ionic conductor and participates in the corrosion of the embedded titanium. We cannot deduce from our results, however, whether the polymer itself possesses corrosive properties. Long-term experiments will be necessary to study the degradation behavior of the polymer cement.

Coated Materials, Biocompatible↗

On the importance of considering porosity when simulating the fatigue of bone cement.

Fatigue cracking in the cement mantle of total hip replacement has been identified as a possible cause of implant loosening. Retrieval studies and in vitro tests have found porosity in the cement may facilitate fatigue cracking of the mantle. The fatigue process has been simulated computationally using a finite element/continuum damage mechanics (FE/CDM) method and used as a preclinical testing tool, but has not considered the effects of porosity. In this study, experimental tensile and four-point bend fatigue tests were performed. The tensile fatigue S-N data were used to drive the computational simulation (FE/CDM) of fatigue in finite element models of the tensile and four-point bend specimens. Porosity was simulated in the finite element models according to the theory of elasticity and using Monte Carlo methods. The computational fatigue simulations generated variability in the fatigue life at any given stress level, due to each model having a unique porosity distribution. The fracture site also varied between specimens. Experimental validation was achieved for four-point bend loading, but only when porosity was included. This demonstrates that the computational simulation of fatigue, driven by uniaxial S-N data can be used to simulate nonuniaxial loadcases. Further simulations of bone cement fatigue should include porosity to better represent the realities of experimental models.

Biocompatible Materials↗

In vitro bacterial adherence to teicoplanin and calcium sulfate-soaked bone cement.

The aim of this study was to assess in vitro the improvement in release kinetics for teicoplanin and the inhibition of bacterial adhesion on calcium sulfate-soaked PMMA discs. Calcium sulfate has been used in vivo and shown to be biocompatible, and prevention of bacterial adhesion may be expected with calcium sulfate-soaked polymethylmethacrylate (PMMA). Discs were made by adding teicoplanin and calcium sulfate in powder form to PMMA powder. The antibiotic concentration eluted from PMMA discs was assayed by agar diffusion assay. Nonadherent bacteria were removed by washing and adherent bacteria were detached by sonication. The suspension including nonadherent bacteria was seeded on sheep blood agar plate and incubated for 24 h at 37 degrees C for the growth of microorganisms. The teicoplanin released from discs containing calcium sulfate was higher than that released from discs which had not been soaked with calcium sulfate. The count of bacteria adhering to the calcium sulfate-soaked discs was lower than that from the discs without calcium sulfate. In conclusion, the addition of calcium sulfate to teicoplanin-loaded PMMA bone cement may provide local antibiotic concentrations higher than MIC values due to increased antibiotic release. Furthermore, calcium sulfate was found to be effective in reducing bacterial adherence to treated discs.

Bacterial Adhesion↗

Inferior performance of Boneloc bone cement in total knee arthroplasty: a prospective randomized study comparing Boneloc with Palacos using radiostereometry (RSA) in 19 patients.

We compared Boneloc bone cement with conventional cement (Palacos) in fixating the tibial component during 2-5 years in 19 patients with gonarthrosis undergoing total knee arthroplasty in a prospective randomized study. Boneloc displayed significantly larger migration, subsidence and lift-off than Palacos. The difference was identifiable already within 3 months postoperatively, but became significant at 12 months. In the Boneloc group, all components showed subsidence of the posterior part and lift-off of the anterior part of the tibial component, whereas in the Palacos group, the locations of subsidence and lift-off were evenly distributed about the edge of the implant. At 5 years, both Boneloc knees so far investigated were clinical failures with high migration rates. We conclude that, even in total knee arthroplasty, there is a substantial risk that Boneloc leads to inferior clinical results, but later than in hip replacements.

Aged↗

Factors affecting the mechanical and viscoelastic properties of acrylic bone cement.

The aim of this paper is to report a series of experiments investigating the factors that influence the viscoelastic properties of acrylic bone cement. The effects of the brand of cement, the length of time since mixing, temperature, the hydration of the cement, and the influence of fat and or blood in the environment on the creep and stress relaxation behavior of the cement have been studied in laboratory-prepared specimens in tension, compression and four point bending. Although there are significant differences in the viscoelastic behavior of some of the different brands of polymethylmethacrylate based cements, these differences are small by comparison with the major effects that can be exerted by the length of time since mixing and some environmental factors. These effects have important practical consequences, especially with regard to the ability of bench top and theoretical studies to predict reliably the mechanical and viscoelastic behavior of acrylic cement in vivo.

Journal Article↗

Influence of a pre-blended antibiotic (gentamicin sulfate powder) on various mechanical, thermal, and physical properties of three acrylic bone cements.

The aim of this work was to determine an array of mechanical, physical, and thermal properties of three pairs of commercially available acrylic bone cement brands, with the brands in each pair having the same compositions except that one contains 4.22 wt/wt% gentamicin sulfate blended with the powder by the manufacturer and the other one does not. The difference between the pairs was in the viscosity of the curing cement dough, with one pair of 'low-viscosity', one pair of 'medium-viscosity', and one pair of 'high-viscosity' brands being used. Thus, the brands studied cover the range of those used in anchoring some total joint replacements (TJRs). The properties determined were the strength, modulus, and work-to-fracture (all under four-point bending), plane-strain fracture toughness, Weibull mean fatigue life (fatigue conditions: 15 MPa; 2 Hz), activation energy and frequency factor for the cement polymerization process (both determined, using differential scanning calorimetry, at heating rates of 5, 10, 15, and 20 K min (1)), and the diffusion coefficient for the absorption of phosphate-buffered saline at 37 C by the cured cement. For each property determined, there was no significant difference in the mean values for the brands in each of the pairs. These results indicate that over the range of cement brands that are widely used in the anchoring of cemented TJRs, the addition of gentamicin sulfate powder does not degrade the properties of the cement, and, hence, may not adversely affect the in vivo longevity of the replacement.

Adhesiveness↗

Degradable injectable bone cement in maxillofacial surgery: indications and clinical experience in 27 patients.

BACKGROUND: A carbonated apatite cement (NORIAN SRS) was used as a bone mineral substitute for the calvaria or viscerocranium in 27 patients. It has the consistency of a paste and hardens at physiologic pH and body temperature due to dahllite crystallization, which has the stoichiometric formula Ca(8.8)(HPO(4))(0.7)(PO(4))(4.5)(CO(3))(0.7)(OH)(1.3). MATERIAL AND METHODS: The cement was used for posttraumatic bone defects in the orbital, periorbital or malar regions (nine patients), posttraumatic deformities of the frontal bone (six patients), tumour-dependent bony defects of the calvaria (two patients) and posttraumatic or cystic defects of the mandible (five patients). In another five patients, the material was used to augment the atrophic anterior mandible in combination with the insertion of dental implants. Follow-up varied between 6 and 40 months (mean: 29 months). RESULTS: There was no inflammatory reaction surrounding the implanted material. There was no sign of infection in any of the patients and only one case of partial wound dehiscence with superficially exposed material. The defect fillings and augmentations were successful in all patients. None of the 19 dental implants which were inserted in combination with the material showed any sign of infection or loosening. Also, there was no loosening of the implants after loading (mean follow-up: 15 months). From the check-up radiographs, the material could be seen as a dense, radio-opaque structure. There were no material fractures or dislocations. Radiologically, the material seemed to be completely replaced by bony tissue after 30 months. CONCLUSION: Our 5-year clinical experience suggests that the material is a suitable bone mineral substitute for cranio-maxillofacial surgery especially for moderate-sized defects of the calvaria and forehead bone. It has advantages over preformed, solid bone substitute materials, and, due to its initial plasticity and eventual great compressive strength, it can also stabilize dental endosseous implants in the atrophic mandible.

Absorbable Implants↗

Treatment of distal radius fracture with the use of calcium phosphate bone cement as a filler.

A new procedure for unstable fractures of the distal radius is presented. It uses a nonbridging external fixator in conjunction with calcium phosphate bone cement through a limited exposure. The best indication for the new procedure is intra-articular fracture with some large displaced fragments in young adults. In the C2 or C3 type fractures according to AO classification, it is very difficult to obtain satisfactory fixation with a plate and screws due to comminution of the articular surface and metaphysical bone defects in many instances. After reduction of the articular surface, this new technique allows fixation of the comminuted fragments using half pins of a nonbridging external fixator. Furthermore, injection of calcium phosphate bone to the bone defect helps to make both the articular surface and the cortical bone stable. The nonbridging external fixator allows early exercises. However, it cannot be applied to all types of the fracture because of its structural limitations. The combination of nonbridging external fixation and calcium phosphate bone applications assures early exercise of the wrist.

Journal Article↗

Monitoring the setting of calcium-based bone cements using pulse-echo ultrasound.

We present a new technique, based on pulse-echo ultrasound, for monitoring the entire setting process of injectable bone cement. This research has been motivated by the lack of satisfying standards. The main problem with existing standards is the subjectivity, which leads to poor reproducibility. Because of this the results are not comparable between different research groups. A strong advantage with the proposed technique is that if low-intensity ultrasound is used, it provides a non-destructive analysis method. Once the cement paste has been applied to the measurement cell, no manipulation is needed throughout the entire setting process. The problem of the ultrasound affecting the setting of certain cement materials has been investigated, and solutions are discussed. The propagation of ultrasound is temperature-dependent, and therefore a technique for automatic compensation for temperature variations is discussed briefly. The testing was performed on alpha-calcium sulfate hemihydrate (CSH) and mixtures of CSH and alpha-tricalcium phosphate (alpha-TCP). The results show that the acoustic properties of the cement are strongly correlated with the setting time, the density, and the adiabatic bulk modulus. The measured initial and final setting times agree well with the Gillmore needles standard. An important difference compared to the standards, is that the technique presented here allows the user to follow the entire setting process on-line.

Journal Article↗

Reliability of PMMA bone cement fixation: fracture and fatigue crack-growth behaviour.

Fracture mechanics tests were performed to characterize the fracture toughness and fatigue crack-growth behaviour of polymethylmethacrylate (PMMA) bone cement, commonly used in joint replacement surgery. Compact tension specimens of various thicknesses were prepared and tested in both air and Ringer's solution. Contrary to previous reports citing toughness as a single valued parameter, the PMMA was found to exhibit resistance-curve behaviour with a plateau toughness of approximately 0.6 MPa m1/2 in air, and approximately 2.0 MPa m1/2 in Ringer's solution. The increased toughness in Ringer's solution is thought to arise from the plasticizing effect of the environment. Under cyclic loads, the material displayed true mechanical fatigue failure in both environments; fatigue crack-growth rates, da/dN, were measured over the range approximately 10(-10) to 10(-6) m/cycle and found to display a power-law dependence on the stress intensity range, DeltaK. The cement was found to be more resistant to fatigue-crack propagation in Ringer's solution than in air. Wear debris was observed on the fatigue fracture surfaces, particularly those produced in air. These findings and the validity of using a linear-elastic fracture mechanics approach for viscoelastic materials are discussed in the context of providing more reliable and fracture-resistant cemented joints.

Journal Article↗

Effects of lamination on the strength of bone cement.

To improve cement penetration into the cancellous bone of the acetabulum in hip arthroplasty, sequential cementation of each anchoring hole may be feasible. Since this procedure creates laminations in the cement, we have determined the conditions under which such laminations affect the strength of the cement. Cement bars made at 2, 3 or 4 minutes after the start of cement mixing and with either dry laminations or laminations including blood or saline were tested for tensile strength. Solid unlaminated bars were used as references. Dry and saline laminations made up to 4 minutes after the start of cement mixing did not reduce the strength of the cement. However, there was a time-dependent decrease in cement strength if blood was entrapped in the interface. In such cases, there was a decrease in strength for laminations made at 4 minutes, at 3 minutes this was less pronounced and at 2 minutes no weakening at all was noted. Our findings indicate that a sequential cementation procedure is permissible as regards cement strength, provided it is performed with 2-3 minutes after the start of cement mixing. If the cement area is kept free from blood, the time may be prolonged up to 4 minutes, without the risk of weakening the cement strength.

Biomechanical Phenomena↗