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PubMed2000

Toward standardization of methods of determination of fracture properties of acrylic bone cement and statistical analysis of test results.

A succinct critical review of the literature on the fatigue, fatigue crack propagation, and fracture toughness (herein collectively termed "fracture properties") of acrylic bone cement is presented, whereby it is pointed out that a plethora of test conditions have been used. This situation precludes meaningful interstudy comparisons and mitigates against a definitive delineation of the effect of a named variable on a specified fracture property. A case for standardization of test conditions is thus made, culminating in the presentation of a recommended set of such conditions. In addition, it is shown that many literature parametric studies employed inappropriate statistical methods for performing pairwise comparisons, and all these studies have not addressed the issue of possible interactions between the parameters being investigated. A methodology for addressing these deficiencies is presented in the present report, and its use is illustrated with a set of notional fatigue test results.

Acrylates↗
PubMed2002

Release of gentamicin sulphate from a modified commercial bone cement. Effect of (2-hydroxyethyl methacrylate) comonomer and poly(N-vinyl-2-pyrrolidone) additive on release mechanism and kinetics.

The influence of the (2-hydroxyethyl methacrylate) (HEMA) monomer addition as a comonomer to the cement liquid component and of a polymer, poly(N-vinyl-2-pyrrolidone) (PVP) to the solid component of a standard CMW-1 bone cement on gentamicin sulphate (GS) on its drug release properties have been studied. The addition of HEMA modifies the habit of the delivery curves. The incorporation of PVP into the cement matrix, apparently, did not very much modify the shape of the HEMA modified cement release curves, but led to a remarkable increase of the maximum amount of GS released. This effect was proportional to the PVP concentration incorporated. From the matrix composition and SEM data, a model based on the morphology of the matrix has been proposed. The cumulative amount of GS released by each slab Mt is most adequately fitted and represented by the equation Mt = c + at 1/2 + b[1 - exp(-nt)], which corroborates that the release occurs according to the model proposed. by means of three discrete mechanisms, namely: (i) a short-term initial elution due to the imperfections in the poly(methyl methacrylate) covering of the most external GS beads, burst effect by the buffer solution; (ii) followed by a fracture by stress cracking in an active media of the coated GS beads located on the external surface of the matrix where water molecules enter to dissolve GS molecules releasing them into the buffer solution by a diffusion-controlled process; and (iii) a third process in which the buffer solution penetrates into the internal voids and cracks creating a series of channels in a labyrinthic structure, which may facilitate the access of water molecules to the plastic-coated GS beads within the bulk matrix. This third process is enhanced by the incorporation of PVP beads as dissolved molecules within the matrix. This water-soluble additive is leachable, generating a highly porous structure in the cement. This HEMA and PVP modified cement may be used as a drug delivery system to modulate the GS release rate.

Anti-Bacterial Agents↗
PubMedDate not supplied

[Effect of the bone cement on human fibroblast culture and possible ways of its correction by cytoprotector preparations].

The results of in vitro investigation are used to assess the effect of poly(methyl methacrylate) based bone cements (BCs) upon human fibroblast culture. The dose dependent cytotoxic effect of BCs (Polacris) was manifested by the development of oxidative stress and hypoxia (on the cell level) and by a decrease in the cell ability to multiplication. The drugs possessing antihypoxant (mafusol) and antioxidant (erysod) activity, introduced into the incubation medium in clinically adequate doses, significantly reduced the toxic effect of BCs. The maximum positive effect was observed upon a combined administration of both drugs.

Antioxidants↗
PubMed2002

Gentamicin sulphate release from a modified commercial acrylic surgical radiopaque bone cement. I. Influence of the gentamicin concentration on the release process mechanism.

The purpose of the present work was the study of the gentamicin sulphate (GS) release from a commercial acrylic bone cement CMW-1 with the aims of establishing the influence of the slabs preparation as well as the release mechanism and kinetics. The effect of the amount of GS on the release kinetic parameters has been also investigated. In vitro release studies were performed in a buffered saline solution at pH 7.4 and 37 degrees C. The GS concentration was determined using an indirect spectrophotometric method with an o-phthaldialdehyde as a derivatizing reagent. A commercial and three modified samples were tested. The free and fractured surfaces of the GS cement slabs before and after the release studies were observed by means of scanning electron microscopy (SEM). For low GS concentration loading the release was very incomplete because most of the GS beads were encapsulated by the hydrophobic PMMA matrix. A higher amount of antibiotic was released from cement that has a higher amount incorporated. A model and therefore a mechanism of release based on this model have been proposed. It has allowed us to explain the changes in dissolution kinetics of an acrylic matrix type controlled release system up to 12% GS loading. The cumulative amount of GS released M(t)/M(i), was fitted as a function of time. For lower amounts of GS, the regression analysis (R(2)>0.99) revealed that the release is most adequately represented by M(t)/M(i)=b+kt(n), where b represents a burst effect. The goodness of fit decreases as the amount of GS increases. The influence of some other type of release mechanism for higher amounts of GS must be taken into account and a second model for the release, M(t)/M(i)=b+k x [1-exp(-kt)], is proposed.

Acrylates↗
PubMed1981

Mechanical properties of poly(methyl methacrylate) bone cements.

Samples of low viscosity poly(methyl methacrylate) (PMMA), graphite reinforced PMMA, and graphite reinforced low viscosity PMMA were evaluated for their compression strength and fracture toughness. These results were compared with two currently used plain PMMA bone cements. There were no statistically significant differences in compression strength between the five cements. Graphite reinforcement of plain cement produced a 32% increase in fracture toughness over plain cement. Graphite reinforcement of low viscosity cement also produced a significant increase in toughness (31%) over low viscosity cement with fiber reinforcement. However, low viscosity cement demonstrated significantly less fracture toughness than plain PMMA.

Analysis of Variance↗
PubMed2001

Effects of environment on the creep properties of a poly(ethylmethacrylate) based bone cement.

The effect of test environment on the creep behavior of a poly(ethylmethacrylate) bone cement was investigated. The aim of the study was to assess the influence of environment on the inherent material behavior, and so it was convenient to perform tests in tension on well-prepared samples. In addition to control tests in air, the liquid environments studied were water, Ringer's solution and Intralipid. Creep tests were performed in each of these environments with a range of aging times, test temperatures and applied stresses. In order to compare the effects of the environments, the creep curves were fitted to a generalized form, from which a creep rate was determined. The ratio of these creep rates between different environments at each testing condition was then used as a basis for a comparison of the detailed effects of environment. It was found that in all cases the water-based environments (water and Ringer's) had similar effects and gave the largest creep rates. Intralipid was then intermediate and air gave the lowest creep rates. These effects are mainly due to plasticization by water, although with Intralipid, some increased monomer leaching occurred, which served to reduce the creep rates. The influence of environment on the effects of aging time, temperature and stress were complex, although in general any conditions which increased water plasticization (longer aging, higher temperature and to a lesser extent, higher stress) gave an increase in creep rate. The major exception to this was at temperatures of 40 degrees C and above, where the effects of water plasticization were diminished, due to the inherent increase in molecular mobility of the material.

Journal Article↗
PubMed2003

Effect of test frequency on the in vitro fatigue life of acrylic bone cement.

The goal of the present work was to test the hypothesis that test frequency, f, does not have a statistically significant effect on the in vitro fatigue life of an acrylic bone cement. Uniaxial constant-amplitude tension-compression fatigue tests were conducted on 12 sets of cements, covering three formulations with three very different viscosities, two different methods of mixing the cement constituents, and two values of f (1 and 10 Hz). The test results (number of fatigue stress cycles, N(f)) were analyzed using the linearized form of the three-parameter Weibull equation, allowing the values of the Weibull mean (N(WM)) to be determined for each set. Statistical analysis of the lnN(f) data, together with an examination of the N(WM) estimates, showed support for the hypothesis over the range of f used. The principal use and explanation of the present finding are presented.

Acrylates↗
PubMed2002

Mechanical performance of acrylic bone cements containing different radiopacifying agents.

The effect that three different radiopacifying agents, two of them inorganic (BaSO4, ZrO2) and one organic (an iodine containing monomer, IHQM) have on the static and dynamic mechanical properties of acrylic bone cements was studied. Compressive and tensile strength, fracture toughness and fatigue crack propagation were evaluated. The effect of the inorganic fillers depends on their size and morphology. In relation to the radiolucent cement, the addition of zirconium dioxide improved significantly the tensile strength, the fracture toughness and the fatigue crack propagation resistance. In contrast, the addition of barium sulphate produced a decrease of the tensile strength, but did not affect the fracture toughness and improved the crack propagation resistance. When the iodine containing monomer was used, although the tensile strength and the fracture toughness increased, the fatigue crack propagation resistance remained as low as it was for the radiolucent cement.

Barium Sulfate↗
PubMed2002

Rheological properties of acrylic bone cement during curing and the role of the size of the powder particles.

A dynamic compressive rheometric technique was used to determine the true or complex viscosity (eta*) of three poly (methyl methacrylate), PMMA-based bone cement formulations (one commercially available and two experimental), as a function of the time that elapsed from commencement of hand mixing of the cement constituents (t). For each cement, two rheological parameters [namely, the time of onset of cure (t(ons)) and the critical cure rate (CCR), which is herein defined as the complex viscosity rate computed at t(ons)] were determined from the eta*-t data. For each cement, particle analysis was used to obtain the powder particle size distribution, from which the following parameters were obtained: (a) the overall mean particle diameter D(m), and (b) the relative amounts of small-sized PMMA beads (mean diameter d between 0 and 40 mum) (alpha) and large-sized PMMA beads (d > 75 mum) (beta). It is seen that the key particle parameter is not D(m) per se but alpha and beta. Thus, the highest values of t(ons) and CCR were obtained from a cement with the highest values of alpha and beta. An explanation for these trends is given, and two areas for further research work in this field are outlined.

Bone Cements↗
PubMed2007

Control of crystallinity of hydrated products in a calcium phosphate bone cement.

In this study, a calcium phosphate cement (CPC), consisting of partially crystallized calcium phosphate (PCCP), was synthesized. X-ray diffraction (XRD), Fourier transform infrared spectrometry (FTIR) and scanning electronic microscope (SEM) were used to characterize the cement. The results showed that by changing the ratio of amorphous calcium phosphate (ACP) to PCCP in the cement, hydrated products of controllable crystallinity were obtained. With increase in the relative amount of PCCP, the hydrated products changed gradually from very poor crystallinity with little needle-like hydroxyapatite (Hap) crystallites to relatively high crystallinity with more needle-like Hap crystallites; the compressive strength of the cement increased, and the degradation of the cement decreased. The cement was implanted into the tibia tubercle of healthy mature Zelanian white rabbits and the histological specimens were obtained after 4 and 16 weeks of implantation. The result revealed that this bone cement was biocompatible and showed very early osteoconductive properties. Thus, the CPC has potential for use in orthopedic surgery for filling non- load-bearing bone defects.

Animals↗
PubMed1979

Effect of an in vivo environment on the strength of bone cement.

Bar-shaped polymethylmethacrylate test specimens removed from rabbits after implantation for times up to 26 months showed a significant change in fracture stress as determined by three-point bending in the period between 12 and 26 months. There were no adverse findings in the tissue which developed around the bone-cement test bars.

Animals↗
PubMed1982

Mechanical properties of the fibrous tissue found at the bone-cement interface following total joint replacement.

A long-term problem associated with total joint replacements is the formation of a fibrous tissue at the bone-cement interface which may compromise the fixation of the prosthesis. In this study, harvestable amounts of interfacial fibrous tissue were generated using a prosthetic replacement of the canine stifle joint as an animal model. The collected tissues were examined histologically and by uniaxial, unconfined compression tests. The fibrous tissue had a matlike structure. The heavy collagen fibers were distributed at random in sheets and the sheets themselves were layered to form a mat. Such a structure may be able to resist compressive stresses normal to the plane of the mat but is probably not well suited to resist shearing stresses. The fibrous tissue proved to be a very compliant, deformable material and to undergo very large strains with load. The stress-strain curve for the tissue was nonlinear and was characterized by large deformations at low loads. But with increasing loads, the material became stiffer, and at high loads, the stress-strain curve became linear with a short-term tangent modulus of 1.9 MPa at a stress level of 0.5 MPa and a compressive strain level of 50%. With regard to total joint replacement systems which consist of an outer bone shell followed by a thin layer of fibrous tissue, a mantle of PMMA cement and a central core of metal or UHMW polyethylene, the fibrous tissue is substantially more yielding and deformable than the other elements of the structure and may have a significant effect on the structural behavior of the system.

Animals↗
PubMed1991

Methods for improving drug release from poly(methyl)methacrylate bone cement.

Poly(methylmethacrylate) (PMMA) is a widely used material with both dental and orthopaedic applications. The acrylic cement is produced by the combination of polymethylacrylate beads with methylmethacrylate monomer. After polymerisation, a heterogeneous and porous matrix is formed which can be used to deliver therapeutic agents. In this work, the release of antibiotic, growth hormone and serum albumin is demonstrated. The mechanism is similar for all agents; a rapid release followed by a slow continuous release. The quantity of drug released depends upon the formulation of both the PMMA and the drug. The polymer-to-monomer ratio can greatly affect the ratio of drug release; increased polymer-to-monomer ratio leads to increased release of antibiotic. Optimum release is achieved if a crystalline formulation of the drug is used rather than a fine powder. Experimental methods to improve the drug release performance of bone cements are presented.

Bone Cements↗
PubMed2003

Injectable calcium phosphate bone cement Norian SRS for the treatment of intra-articular compression fractures of the distal radius in osteoporotic women.

BACKGROUND: Distal radius fracture often presents a metaphyseal void which is more extended in elderly, osteoporotic patients. Bone graft and bone substitutes are reported to be beneficial in maintaining metaphyseal reduction. METHODS: We performed a prospective study on 52 menopausal, osteoporotic women with unstable intra-articular distal radius fractures to compare the outcome of percutaneous pinning and immobilisation in a cast for 6 weeks with that using injectable calcium phosphate bone cement (Norian Skeletal Repair System, SRS) to supplement pin and screw fixation and immobilisation in a cast for 3 weeks. All patients were reviewed 2 years (range 21-29 months) after surgery. RESULTS: Patients treated with SRS had better functional outcome, restoration of movement and grip strength ( p<0.001). In this group there was 1 mm loss of radial length, 3 degrees loss of radial inclination and 7 degrees loss of palmar tilt. In the control group radial length decreased 3 mm, radial inclination decreased 11 degrees and palmar tilt 12 degrees. Loss of reduction was significantly higher in the control group ( p<0.001). CONCLUSION: We conclude that the use of Norian SRS to supplement pin and screw fixation is effective in maintaining the reduction of unstable intra-articular distal radius fractures in osteoporotic patients and provides a better clinical outcome than percutaneous pinning.

Aged↗
PubMed1987

A comparison of systemic cefuroxime and cefuroxime loaded bone cement in the prevention of early infection after total joint replacement.

A controlled prospective randomised trial of 295 arthroplasties of the hip and knee joints was carried out to compare the effect of systemic Cefuroxime with Cefuroxime in bone cement in the prevention of early infection. There was no statistical difference in the incidence of early superficial or deep infection between the two groups. Both methods of administering Cefuroxime appear to be satisfactory in the prevention of early infection after total joint replacement.

Adult↗
PubMed2002

Development of resistant strains of Staphylococcus epidermidis on gentamicin-loaded bone cement in vivo.

We have compared the rates of infection and resistance in an animal model of an orthopaedic procedure which was contaminated with a low-dose inoculum of Staphylococcus epidermidis. We randomised 44 Sprague-Dawley rats to have bone cement implanted subcutaneously containing either gentamicin or saline (control). The wound was inoculated with a dilute solution of gentamicin-sensitive Staphylococcus epidermidis. At two weeks the cement was retrieved and microbiologically tested. A lower overall rate of infection was seen in the gentamicin-loaded cement group, but there was a significantly higher rate of gentamicin-resistant infection in this group (Fisher's exact test, p < 0.01). Antibiotic-impregnated cement has an optimum surface for colonisation and prolonged exposure to antibiotic allows mutational resistance to occur. Gentamicin-loaded cement may not be appropriate for revision surgery if it has been used already in previous surgery.

Animals↗