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PubMed2004

Gentamicin release from two-solution and powder-liquid poly(methyl methacrylate)-based bone cements by using novel pH method.

The release of gentamicin as a function of time was measured for Palacos and two-solution bone cements by using a novel pH technique. The pH of an aqueous solution of gentamicin is a function of the gentamicin concentration and it decreases linearly over concentrations of 0.0-0.1 wt %. Therefore, a new, direct, and inexpensive in vitro technique was developed based on continuous readings of the pH in phosphate-buffered saline (PBS) at 37 degrees C to determine the release kinetics of gentamicin from poly(methyl methacrylate) (PMMA)-based bone cement. In addition, this method was used to compare the release profiles of Palacos R-40 bone cement with a two-solution bone cement developed in our laboratory and loaded with two different concentrations of gentamicin sulfate. Finally, the pH-based method was used to track the elution of gentamicin in both mixed and static conditions to determine the effect of mixing on the diffusion of gentamicin out of the cement. It was found that Palacos R-40 released 4.95 +/- 0.22 wt % of its gentamicin after 24 h in PBS solution. This data compares favorably with previously reported values of gentamicin elution from Palacos R-40, which ranged from 3 to 8 wt % of the total amount of incorporated gentamicin, depending on the size and the surface area of the samples. The results show that Palacos samples released 4.84 +/- 0.27 mg after 24 h, a two-solution cement loaded with an equivalent concentration of gentamicin sulfate released 3.81 +/- 0.52 mg, and two-solution cement loaded with twice the concentration of Palacos released 5.53 +/- 0.26 mg of gentamicin. A higher percentage of release was recorded from Palacos than from the two-solution bone cement, and the effect of PBS mixing conditions on the release kinetics was only significant in the early stages of release and not at 24 h. It was concluded that monitoring the pH is an effective technique to measure gentamicin release from PMMA-based bone cements in PBS solution.

Anti-Bacterial Agents↗

PubMed2003

Mechanical properties of oligomer-modified acrylic bone cement.

The aim of this study was to determine the mechanical properties of acrylic bone cement modified with an experimental oligomer filler, based on an amino acid of trans-4-hydroxy-L-proline synthesized in the laboratory. The test specimens were tested either dry, or after being stored in distilled water or in simulated body fluid (SBF) for 1 week and then tested in distilled water. The three-point bending test was used to measure the flexural strength and flexural modulus of the cement, and the compression tests were used to measure the compression strength and modulus. One test specimen from each group was examined under a scanning electron microscope (SEM) to determine the nature of the oligomer filler in the polymethylmethacrylate-polymethylacrylate copolymer-based (PMMA-PMA/PMMA) polymer blend. In dry conditions, the flexural strength of the test specimens tested in air was 66 MPa, and the compression strength was 93 GPa (p<0.001) for the plain bone cement. For the test specimens including 20 wt% of oligomer filler, the flexural strength was 37 MPa, and the compression strength was 102 MPa(p<0.001) in dry conditions. The storage in wet conditions (in distilled water and the SBF) decreased the flexural strength of the test specimens with 20 wt% of oligomer filler (p<0.001) by 60% and the flexural modulus by 44% compared to the plain bone cement specimens stored in the same conditions. The reduction in compression strength in wet conditions was 32%, and that of the compression modulus was 30% (p<0.001). No significant differences were found between test specimens stored in distilled water or SBF (ANOVA, p<0.001). In the SEM examinations, random voids were observed in the oligomer-PMMA-PMA/PMMA polymer blend after water or SBF storage. The results suggest that both water and SBF storage decrease the mechanical properties of the PMMA-PMA/PMMA bone cement modified with oligomer, while at the same time, there was porous formation in the bone cement structure.

Analysis of Variance↗

PubMed2004

Hydroxyapatite/PMMA composites as bone cements.

Currently PMMA is the polymer most commonly used as a bone cement for the fixation of total hip prostheses. Ideally, a bone cement material should be easy to handle, biologically compatible, nonsupporting of oral microbial growth, available in the particulate and molded forms, easy to obtain, nonallergenic, adaptable to a broad range of dental and medical applications, in possession of high compressive strength, and effective in guided tissue regenerative procedures. One of the problems associated with the conventional types of bone cement used is their unsatisfactory mechanical and exothermic reaction properties. The purpose of this in vitro study was to investigate and compare the mechanical properties (three-point bending strength, energy-to-break, and modulus of elasticity) and physical properties (setting time, water sorption, and exothermic heat) of HA/PMMA (HA group) and bovine-bone originated HA/PMMA (BB group) composites. Composites samples were fabricated by admixing method. It was found that the addition of HA and BB particles increased the water sorption. Generally 10 v/o 20 v/o HA and 0 v/o to 10 v/o BB ratio combinations had significant beneficial effects on the mechanical properties. The heat generated during polymerization was influenced by the different admixtures. More than 40 v/o HA and 40 v/o BB should be mixed into PMMA to reduce the peak temperature. Overall evaluation indicated that the BB group had better properties than the HA group.

Bone Cements↗

PubMed2001

Improvement of the long-term adhesive strength between metal stem and polymethylmethacrylate bone cement by a silica/silane interlayer system.

A loss of adhesive strength between metal stem and bone cement is clinically found to be a serious problem in total hip arthroplasty and causes many operative revisions. The objective of this study was to improve the long-term adhesive strength at this interface. A new silica/silane interlayer coating system is introduced. The layers are designed to bond the metal stem surface to the polymethylmethacrylate bone cement marginally leakage free. In vitro tensile tests were performed on specimens of TiAl6V4 and CoCrMo that were cemented by pairs with different bone cements with and without the new coating system. The specimens were stored in isotonic saline solution up to 150 days. The adhesive strength decreased about 75% within 30 days of storage on specimens of both metal alloys that were conventionally cemented without the new interlayer system. With the new coating, the high initial adhesive strength (40-50 MPa) could be stabilized for TiAl6V4 over 150 days. For the same 150-day storage period, the adhesive strength of the coated CoCrMo alloy still decreased but the decrease was only half that experienced by the uncoated CoCrMo. The loss of adhesive strength on CoCrMo specimens could be reduced if the metal surface was activated by a plasma treatment. The new coating interface system could help to considerably reduce revision operations caused by debonding effects at the interface metal/polymethylmethacrylate bone cement.

Adhesiveness↗

PubMed1989

[A bone cement containing methotrexate in an experiment and in clinical practice].

The authors submit their initial experience with the use of bone cement with methotrexate in the treatment of primary and secondary malignities of bones. As a basis they use the analogy of using bone cement with gentamycin the molecular structure of which is similar to that of methtrexate. In the experimental part of the work in vitro evidence was provided of methotrexate stability when exposed to heat or oxidation; and the kinetics of its release from pores of bone cement were revealed. In experimental dogs the effect of cement with methotrexate on neighbouring bone was investigated in the early period in the immediate vicinity necrosis of the trabeculae was found, during the late period healing processes. The clinical use of bone cement with methotrexate was started in 1986. In 17 surviving patients only in one case local progression of a tumour in the vicinity of cement with methotrexate was found. The aim of the work is to find a possible local treatment of bone malignities, in particular metastatic ones, which will be not only an emergency solution but will extend our therapeutic possibilities.

Animals↗

PubMed2005

Quantitative analysis of monomer vapor release from two-solution bone cement by using a novel FTIR technique.

Methyl methacrylate monomer can evaporate from bone cement to reach cytotoxic levels of concentrations in the implant bed of total joint prosthesis. Therefore, this study was performed by using a novel Fourier transform infrared spectroscopy method to quantify the release of monomer vapor from experimental two-solution bone cement in vitro during polymerization, to examine the effect of surface area versus cement mass, and to explore the effect of initiation chemistry. The results revealed that monomer vapor release is a surface phenomenon. In addition, initiation chemistry plays a major role in controlling the reaction time, and therefore heat concentration and dissipation, which resulted in a higher absorbance peak as initiation chemicals concentration increased. It was concluded that using the FTIR to monitor MMA vapors is an effective technique to obtain quantitative information about monomer vapor release from bone cements during polymerization and provides insight on the polymerization kinetics of two-solution acrylic bone cement.

Biocompatible Materials↗

PubMed2004

Addition of hand-blended generic tobramycin in bone cement: effect on mechanical strength.

This study compared the mechanical strength of commercially prepared antibiotic bone cement (Simplex With Tobramycin; Stryker, Mahwah, NJ), cement with generic tobramycin (Pharma-Tek, Huntington, NY) blended in by the orthopedic nursing staff, and standard nonantibiotic bone cement. The results showed an approximate 36% decrease in the strength of the cement with hand-mixed generic tobramycin, while the commercial antibiotic cement remained unchanged relative to the nonantibiotic control. These results indicate the mechanical properties of bone cement can be severely compromised by hand-mixing antibiotics into bone cement at the time of surgery.

Anti-Bacterial Agents↗

PubMed2006

Mechanical and histological evaluation of a PMMA-based bone cement modified with gamma-methacryloxypropyltrimethoxysilane and calcium acetate.

Polymethylmethacrylate (PMMA) bone cement is widely used for prosthetic fixation in orthopaedic surgery; however, the interface between bone and cement is a weak zone. We developed a bioactive PMMA cement through modification with gamma-methacryloxypropyltrimethoxysilane (MPS) and calcium acetate. The purpose of this study was to compare the handling, mechanical and histological properties of the modified bone cement with those of the conventional cement. The modified specimens exhibited higher bonding strength between bone and implant. Histological observation and micro-focus X-ray computed tomogram (micro-CT) images showed that the modified cement exhibited osteoconduction, which the conventional PMMA bone cement lacked. The modification was found to be effective in enabling osteoconduction with PMMA bone cement, thus providing stable fixation for a long period after implantation.

Acetates↗

PubMed2006

[Preparation and properties of calcium silicate-phosphate composite bone cements].

In this paper, alpha-tricalcium phosphate (alpha-TCP) and tetracalcium phosphate (TTCP) respectively were chosen as basic compositions of phosphate bone cements. Other auxiliary materials such as hydroxyapatite (HAP), dicalcium phosphate dihydrate (DCPD), calcium carbonate (CaCO3), calcium oxide (CaO) and amorphous calcium silicate (CaSiO3) were added in the cements. Six kinds of composite bone cements were decided with 1.50 as their Ca/P ratio. Then the primary properties of them were studied. Ringer's simulated body fluid (SBF) tests were carried out for the samples. The changes of pH value in SBF and the compressive strength of the samples with the immersion time were studied. The results showed: the mixing liquid 0.25 M K2HPO4/KH2PO4 and amorphous CaSiO3 were effective for accelerating the setting of the cements; the initial setting time (It) was about 4-5.5 min and the final setting time (Ft) was about 18-19. 5 min. Amorphous calcium silicate can increase the compressive strength of the bone cements remarkably; the compressive strength of the alpha-TCP bone cement with the addition of suitable amount amorphous CaSiO3 reached 45.3 MPa after immersion in SBF for 14 days.

Bone Cements↗

PubMed2005

Acute renal failure after placement of tobramycin-impregnated bone cement in an infected total knee arthroplasty.

Tobramycin-impregnated bone cement is frequently used in revision procedures of infected total hip and knee arthroplasties. Aminoglycoside-impregnated cement is typically fashioned into beads or block spacers, which are temporarily placed in infected joint spaces. The use of aminoglycoside-impregnated bone cement has allowed the local concentration to exceed the minimum inhibitory concentration breakpoint of susceptible organisms while serum concentrations after 48 hours were usually not detected. Nephrotoxic complications are rarely encountered with this type of antibiotic delivery method. However, we report the case of an 85-year-old man with a history of renal insufficiency who experienced acute renal failure after undergoing revision treatment of an infected knee arthroplasty with the combined use of tobramycin-cefazolin bone cement and a block spacer. Clinicians should be aware of the potential for aminoglycoside-induced nephrotoxicity from the use of this combination.

Acute Kidney Injury↗

PubMed2003

Finite element thermal analysis of bone cement for joint replacements.

A finite element technique was developed to investigate the thermal behavior of bone cement in joint replacement procedures. Thermal tests were designed and performed to provide the parameters in a kinetic model of bone cement exothermic polymerization. The kinetic model was then coupled with an energy balance equation using a finite element formulation to predict the temperature history and polymerization development in the bone-cement-prosthesis system. Based on the temperature history, the possibility of the thermal bone necrosis was then evaluated. As a demonstration, the effect of cement mantle thickness on the thermal behavior of the system was investigated. The temperature profiles in the bone-cement-prosthesis system have shown that the thicker the cement, the higher the peak temperature in the bone. In the 7 mm thick cement case, a peak temperature of over 55 degrees C was predicted. These high temperatures occurred in a small region near the bone/cement interface. No damage was predicted in the 3 mm and 5 mm cement mantle thickness cases. Although thermal damage was predicted in the bone for the 7 mm mantle thickness case, the amount of thermal necrosis predicted was minimal. If more cement is used in the surgical procedure, more heat will be generated and the potential for thermal bone damage may rise. The systems should be carefully selected to reduce thermal tissue damage when more cement is used. The methodology developed in this paper provides a numerical tool for the quantitative simulation of the thermal behavior of bone-cement-prosthesis designs.

Animals↗

PubMed2004

Depot local anesthetic in polymethylmethacrylate bone cement: a preliminary study.

Acrylic bone cement has been used successfully as a slow-release depot for antibiotics after orthopaedic surgery. The feasibility of administering local anesthetics in this way was examined in this preliminary in vitro study. Discs weighing approximately 4 g were prepared from five brands of acrylic cement (40 g) containing as much as 2 g of anesthetic base. Elution of the anesthetics into saline was measured during 72 hours. Prilocaine eluted the fastest and bupivacaine the slowest, with lidocaine between them. The elution rates were greatest in the first hour, declining thereafter. Rates also depended on the brand of cement with the quickest elution from CMW3 and the slowest from Surgical Simplex P. Using cement as a depot, therapeutic levels of a drug should be achievable in vivo at a negligible risk of toxicity. Before in vivo trials it is necessary to optimize elution of drugs in relation to the cement (brand, microstructure, method of preparation) and the concentration of a drug in the cement above which the cements' mechanical and adhesive properties are compromised.

Anesthetics, Local↗

PubMed1980

Methyl methacrylate concentrations in tissues adjacent to bone cement.

The amount of methyl methacrylate monomer present in bone tissue immediately adjacent to implanted bone cement that has polymerized in vivo has been determined. Poly(methyl methacrylate) was implanted into the distal femoral condyle of the dog and allowed to polymerize. At various times following polymerization, samples were removed and sections adjacent to the cement were cut and subjected to homogenization followed by liquid gas chromatographic determination of the amount of methyl methacrylate monomer present. The highest concentration of methyl methacrylate monomer present in bone tissue was 0.140% in the 1000 micrometers of bone tissue adjacent to bone cement immediately after polymerization of the cement. The concentration was very similar (0.137%) 1 hr after cement polymerization, but dropped off rapidly following that with no free methyl methacrylate monomer present in bone tissue adjacent to cement after 4 hr following cement polymerization.

Animals↗

PubMed2004

Investigating the effects of bone cement, cyanoacrylate glue and marine mussel adhesive protein from Mytilus edulis on human osteoblasts and fibroblasts in vitro.

Bone cement is a widely used standard fixation substance in Orthopaedic Surgery. Cyanoacrylate glue is available for wound closure to supplement suturing. The mussel adhesive protein extracted from Mytilus edulis (Cell-Tak, BD Biosciences, Heidelberg, Germany) is an experimental fixation device used for in vitro purposes of cell adhesion. The aim of this study is to introduce a cell culture model investigating the effects of commonly applied and experimental glues on human fibroblasts and osteoblasts in vitro. Cells cultured without additives served as a control group. Microscopic examination was performed to evaluate the morphologic changes. An apoptosis test (Apo-Tag, Chemicon International, Temecula, CA, U. S. A.) was applied to determine the rate of natural cell death at the end of the study. It could be demonstrated that morphological changes in bone cement are different in fibroblasts and osteoblasts. Osteoblasts seem to grow on bone cement and develop an orderly formation. Fibroblasts grow in a confluent monolayer around bone cement but do not adhere to the cement itself. This is a desirable effect since most Orthopaedic applications aim at osteointegration as opposed to fibrous tissue overgrowth. Apoptosis attributed to bone cement is comparable to the respective natural rate of apoptosis. Cyanoacrylate glue and the mussel adhesive protein lead to an almost complete apoptosis in the investigated cells. Their routine application should be avoided. The developed cell culture model seems appropriate for performing further investigations.

Animals↗

PubMed2004

Effect of a bisphosphonate, disodium pamidronate, on the quasi-static flexural properties of Palacos R acrylic bone cement.

Aseptic loosening is a major complication of joint replacements and is thought to be associated with a heavy macrophage infiltrate in response to wear particles. Bisphosphonates are compounds known to inhibit osteoclastic activity and are used to reduce osteolysis in Paget's disease, osteoporosis, and metastatic bone disease. Oral bisphosphonates have also been used to decrease osteolysis and therefore prevent aseptic loosening of joint replacements. It has been suggested that bisphosphonates mixed in bone cement can reduce bone resorption in joint replacement surgery. This would be an excellent therapeutic option to prevent or control osteolysis. The present aim was to study the mechanical properties of a commercially available acrylic bone cement, Palacos R, mixed with the bisphosphonate pamidronate. The liquid monomer of Palacos R was mixed with liquid pamidronate. Two groups of bone-cement strips were produced, one with added pamidronate and one without. The flexural properties of the cement strips were examined. A significant reduction in both the bending modulus and bending strength of the specimens with added pamidronate was found. In conclusion, the use of liquid pamidronate mixed with the acrylic bone cement Palacos R in order to reduce osteolysis is not recommended because of its effect on the mechanical properties of Palacos R.

Algorithms↗

PubMed1997

Laser ablation of dyed acrylic bone cement.

Revision surgery of cemented implants is indicated when mechanical failure causes severe pain and/or loss of function for the patient. Successful revision arthroplasty of cemented implants requires complete removal of the existing cement. Removal of old cement is an arduous task often causing damage to the surrounding bone tissue. In this study, the authors investigate the use of an Argon laser and the addition of dyes to enhance the laser ablation of bone cement. Methylene blue and red dye #13 were each added separately to polymethylmethacrylate (PMMA) bone cement powder. A continuous wave Argon ion laser (lambda = 514 nm) was used for cement ablation. Cement samples were ablated at different power levels (1.5, 2.3, and 3.0 W) and exposure times (30, 60, 90, 120 sec). The results show that the Argon laser was unable to ablate undyed PMMA. However, the addition of either methylene blue or red dye #13 greatly improved cement ablation by altering the cements' absorption characteristics. Results of Student's t-tests show a statistical difference between red and blue dyed PMMA mean ablation areas at all energy levels tested (P < .0002). As expected, all red ablation areas were greater than blue ablation areas at each energy level tested since red dye absorbs more energy at 514 nm than methylene blue dye. The results of this study suggest that by selectively altering the absorption characteristics of PMMA, laser removal of bone cement can be achieved. In addition, this study also shows that bone tissue does not absorb visible light energy at 514 nm, suggesting that bone cement may be removed with minimal damage to the surrounding bone tissue.

Bone Cements↗

PubMed2006

Estimation of the optimum loading of an antibiotic powder in an acrylic bone cement: gentamicin sulfate in SmartSet HV.

BACKGROUND: In some countries, commercially available antibiotic powder-loaded acrylic bone cement is routinely used in joint replacement, while, in others, "off-label" formulations are used in selected procedures (where the antibiotic powder is blended manually with the powder of a plain cement in the operating room/theater by either the surgeon or approved personnel). In the latter situation, an arbitrary rather than a rational approach is used for deciding on the amount of the antibiotic that is blended with the cement powder (herein referred to as "the antibiotic powder loading"). METHODS AND RESULTS: The first objective of this study was to present two methods for estimating the optimum loading of gentamicin sulfate powder that may be blended manually with the powder of a commercially available acrylic bone cement, ABC (Wopt). The second objective was to define the challenges associated with each of these methods. The loading (W) was optimized with respect to two key properties of the cured cement that were obtained simultaneously, namely (1) fatigue life in phosphate-buffered saline solution (PBS) at 37 degrees C, and (2) the rate of elution of the gentamicin from the cement (E) in that medium. Three sets of specimens were used, containing 2.25, 4.25 and 11.50 wt/wt% of the gentamicin that was blended manually with the cement powder. The fatigue tests involved determining the number of cycles at which a specimen fractured (Nf) when subjected to fully-reversed tension-compression sinusoidal load, +/- 15 MPa at 2 Hz. E was determined from the concentration of gentamicin in the PBS solution when the specimen fractured, using fluorescence polarization immunoassay for the measurement. Consistent with a priori expectations, it was found that, with increase in W, Nf decreased while E increased. Two approaches for obtaining an estimate of Wopt are described, a mathematical method and an empirical one, that lead to Wopt values of 6.50 wt/wt% and 4.78 wt/wt%, respectively. Thus, this antibiotic loading ranges from about the same to about 92% greater than that in SmartSet GHV Gentamicin, which is a commercially available bone cement used clinically and which has the same composition as SmartSet HV except for the presence of gentamicin sulfate in its powder (blended in by the manufacturer). INTERPRETATION: We present and critically compare two rational methods of determining the optimum loading of an antibiotic powder in an acrylic bone cement, which should serve as a guide when using "off-label" antibiotic powder-loaded acrylic bone cements in cemented joint replacements.

Anti-Bacterial Agents↗

PubMed2002

Platelet release of transforming growth factor-beta and beta-thromboglobulin after in vitro contact with acrylic bone cements.

Three methacrylate-based bone cements used for the fixation of joint prostheses were evaluated: Sulfix-60 (Sulzer Orthopedic Inc., Baar, Switzerland). CMW1 (DePuy International Ltd., England). and CMW2 (DePuy International Ltd., England). The cements after polymerization were put in contact in vitro with platelet-rich plasma. Plasma, in contact only with siliconized glass, was used as a negative control. After contact, platelet number. beta-thromboglobulin (beta-TG), and transforming growth factor-beta1 (TGF-beta1) were determined. The Student's paired t test showed that the ccments induced no significant modifications of platelet number. CMWI and Sulfix-60 determined a significant increase in beta-TG compared with the negative control. All cements determined a significant increase in TGF-beta1. Significant differences were also seen in the levels of beta-TG and TGF-beta1 between cements with a content of benzoyl peroxide < 1 (Sulfix-60) and those with a content > 1 (CMW1 and CMW2). The cement with zirconium dioxide (Sulfix-60) produced higher levels of beta-TG and TGF-beta1, compared to those with barium sulphate (CMW1 and CMW2). In conclusion, all the cements induced the secretion of TGF-beta1 CMW1 and Sulfix-60 determined also a significant release of beta-TG. Platelet activation induced by the cements from one side could contribute to the pathogenesis of deep venous thrombosis, that often occurs after prosthetic implant and is caused also by other factors, including surgical trauma and venous stasis. From the other side, activated platelets can release growth factors favoring bone formation.

Acrylic Resins↗