The effect of centrifugation on the fracture properties of acrylic bone cements

In this study, centrifugation did not alter the static or cyclic fracture properties of bone cement. Tests of fracture toughness and fatigue-crack propagation of centrifuged specimens of commercial cements (with and without antibiotic additions) demonstrated no significant difference from control values. Among the cements tested, Palacos (with and without antibiotic) was found to have a significantly higher fracture toughness than either Simplex or Zimmer. We attributed this difference in fracture toughness to the higher molecular weight measured for the Palacos cements. For the tested cements, only Simplex had a significantly greater volume contraction on setting due to centrifugation. The results of our study demonstrate that centrifugation of bone cement does not improve the cement's resistance to fracture in the presence of surface imperfections, such as those found at the bone-cement interface.     

Fracture and fatigue properties of acrylic bone cement: the effects of mixing method, sterilization treatment, and molecular weight

The purpose of this study was to characterize the relative and combined effects of sterilization, molecular weight, and mixing method on the fracture and fatigue performance of acrylic bone cement. Palacos R brand bone cement powder was sterilized using ethylene oxide gas (EtO) or gamma irradiation. Nonsterile material was used as a control. Molecular weights of the bone-cement powders and cured cements were measured using gel permeation chromatography. Hand and vacuum mixing were employed to mold single edge-notched bend specimens for fracture toughness testing. Molded dog-bone specimens were used for fatigue tests. Electron microscopy was used to study fracture mechanisms. Analysis of variance and Student t-tests were used to compare fracture and fatigue performance between sterilization and mixing groups. Our results indicate that vacuum mixing improved significantly the fracture and fatigue resistance (P<.05, P<.07) over hand mixing in radiation-sterilized and EtO-sterilized groups. In vacuum-mixed cement, the degradation in molecular weight resulting from gamma irradiation decreased fracture resistance significantly when compared with EtO sterilization and control (P<.05). A corresponding decrease in fatigue resistance was observed in the cement that was degraded severely by a radiation dose of 10 MRad (P<.05). In contrast, EtO sterilization did not result in a significantly different fracture resistance when compared with unsterilized controls for vacuum-mixed cement (P>.1). For hand-mixed cement, fracture and fatigue resistance appeared to be independent of sterilization method. This independence is believed to be the result of higher porosity that compromised the mechanical properties and obscures any effect of sterilization. Our results indicate that a combination of nonionizing sterilization and vacuum mixing resulted in the best mechanical performance and is most likely to contribute to enhanced longevity in vivo.     

Prechilling and vacuum mixing not suitable for all bone cements: Handling characteristics and exotherms of bone cements

Nine bone cements were tested for handling characteristics, intrusion, doughing time, setting time, and exothermic temperature. Comparative studies were made of manual mixing and vacuum mixing of cement components stored at room temperature or chilled to 5 degrees C. Vacuum mixing of cement packages stored at room temperature was inapplicable except for the low-viscosity brands, as the cements became too viscous to mold test specimens. Prechilling and vacuum mixing prolonged the setting time and preserved a lower viscosity during the handling period. Palacos R and Palacos G were most suitable for this method, whereas a considerable increase in exothermic temperature was experienced with the other brands. The method might, however, be considered for Zimmer and Cerafix also, as the exotherm was of the same magnitude as for Palacos brands.     

Mechanical characteristics of antibiotic-laden bone cement

We studied the mechanical characteristics of cement-antibiotic combinations in vitro. Palacos R was tested without antibiotics, with gentamicin alone and with gentamicin plus vancomycin or flucloxacillin. Palacos LV was studied only with gentamicin added. CMW 1 was studied with gentamicin added, with gentamicin plus vancomycin, and with gentamicin plus flucloxacillin. We performed four-point bending tests on beams of cement to establish bending strength and modulus, and compared the values to ISO standards. Density was also assessed. Palacos R was the strongest of the cements (bending strength 80 MPa). Palacos formulations (apart from Palacos LV) had a higher density and bending modulus than CMW 1. Statistical comparison of various cements with plain Palacos R showed lower density in 4 of the mixtures, and lower bending strength and modulus in 6 of the mixtures. Palacos R/gentamicin plus vancomycin and CMW 1/gentamicin plus vancomycin had bending strength slightly above minimum ISO standards, suggesting that the addition of vancomycin during cement mixing may compromise the outcome in revision surgery for sepsis.     

Porosity of various preparations of acrylic bone cements

The total porosity and mean pore sizes of various bone cement preparations were measured using image analysis. The porosity in different commercial bone cements varied from 5% to 16% when these cements were prepared in the usual fashion. Centrifugation for 30 seconds resulted in a substantial reduction in the overall porosity of Simplex P, AKZ, Zimmer Regular, and CMW bone cements by reducing both the mean pore size and the number of pores per unit area. In contrast, the porosity of LVC, Palacos R, and Palacos R with gentamicin bone cements was not significantly decreased by centrifugation. Chilling the monomer before mixing resulted in higher porosity of both the centrifuged and uncentrifuged Simplex P, Zimmer Regular, and CMW bone cements. Simplex P mixed with chilled monomer and centrifuged for 120 seconds has one of the lowest porosities of the various cements, while retaining good handling characteristics and excellent fatigue strength.     

Comparative Study of Antibiotic Elution Profiles From Alternative Formulations of Polymethylmethacrylate Bone Cement

BackgroundPolymethylmethacrylate (PMMA) bone cement is commonly used in orthopedic surgery for implant fixation and local antibiotic delivery following surgical debridement. The incidence of nephrotoxicity necessitates the balance of antiinfective properties with the potential for toxicity. Thus, understanding antibiotic elution characteristics of different PMMA formulations is essential. We sought to address this by assessing elution of vancomycin, daptomycin, and tobramycin from Palacos LV (Palacos), Stryker Surgical Simplex P (Simplex), BIOMET Cobalt HV (Cobalt), and Zimmer Biomet Bone Cement R (Zimmer) radiopaque bone cements.MethodsAntibiotics were mixed with each cement formulation, and molds were used to produce beads of cement. Beads were incubated in phosphate-buffered saline at 37°C, and antibiotic elution was measured daily for 10 days with vancomycin and 5 days with daptomycin and tobramycin. Active antibiotic was quantified by serial dilution and comparison to the minimum inhibitory concentration.ResultsThe elution profiles of Simplex were significantly lower than all other cements with all antibiotics (P < .00093). Palacos exhibited a significantly higher vancomycin elution profile than all other cements (P < .00001). The difference in daptomycin elution profiles for Cobalt and Palacos was not significant (P > .43), but both were significantly higher than Zimmer (P < .0006).ConclusionOverall, Stryker Surgical Simplex P exhibits a significantly lower elution profile than all other cements tested. In general, Palacos LV exhibits an increased elution profile compared with other cements. This elution information may assist the surgeon in choosing different cement formulations for the local delivery of antibiotics.     

In-vitro-Freisetzung von Antibiotika aus SmartSet HV- und Palacos R-Knochenzement und deren Einfluss auf die mechanischen Eigenschaften

BACKGROUND: The continuing emergence of new bone cements with additional antibiotics makes it important to establish which one will provide the most favourable antibiotic elution. An in vitro antibiotic elution and mechanical study was therefore carried out to compare a newer bone cement, SmartSet, with the established Palacos R cement. METHODS: Samples were prepared with each cement adding 1 g gentamicin, 1 g of vancomycin, or 1 g of gentamicin and vancomycin. The samples were analysed using fluorescence polarisation immunoassay. Mechanical tests were performed to determine whether any significant degradation in the cement strength occurred following addition of the antibiotic. RESULTS: With regards to gentamicin release Palacos R eluted significantly more antibiotic over the study period than SmartSet (p<0.001). Both cements eluted significantly more gentamicin when two antibiotics were added. With respect to vancomycin release there was no significant difference. Palacos R was significantly stronger than SmartSet in the 4-point bending test when the gentamicin + vancomycin antibiotic groups were compared (p=0.01). Palacos R also demonstrated a higher elastic modulus than SmartSet when the gentamicin and gentamicin + vancomycin groups were compared (p=0.03, p=0.005). CONCLUSIONS: Gentamcin shows better release characteristics from Palacos R. Both cements exhibited synergistic release of combined antibiotics.     

Mechanical characteristics of antibiotic-laden bone cement

We studied the mechanical characteristics of cement-antibiotic combinations in vitro. Palacos R was tested without antibiotics, with gentamicin alone and with gentamicin plus vancomycin or flucloxacillin. Palacos LV was studied only with gentamicin added. CMW 1 was studied with gentamicin added, with gentamicin plus vancomycin, and with gentamicin plus flucloxacillin.

We performed four-point bending tests on beams of cement to establish bending strength and modulus, and compared the values to ISO standards. Density was also assessed. Palacos R was the strongest of the cements (bending strength 80 MPa). Palacos formulations (apart from Palacos LV) had a higher density and bending modulus than CMW 1.

Statistical comparison of various cements with plain Palacos R showed lower density in 4 of the mixtures, and lower bending strength and modulus in 6 of the mixtures. Palacos R/gentamicin plus vancomycin and CMW 1/gentamicin plus vancomycin had bending strength slightly above minimum ISO standards, suggesting that the addition of vancomycin during cementmixing may compromise the outcome in revision surgery for sepsis.     

Mechanical characteristics of antibiotic-laden bone cement

We studied the mechanical characteristics of cement-antibiotic combinations in vitro. Palacos R was tested without antibiotics, with gentamicin alone and with gentamicin plus vancomycin or flucloxacillin. Palacos LV was studied only with gentamicin added. CMW I was studied with gentamicin added, with gentamicin plus vancomycin, and with gentamicin plus flucloxacillin.

We performed four-point bending tests on beams of cement to establish bending strength and modulus, and compared the values to ISO standards. Density was also assessed. Palacos R was the strongest of the cements (bending strength 80 MPa). Palacos formulations (apart from Palacos LV) had a higher density and bending modulus than CMW 1.

Statistical comparison of various cements with plain Palacos R showed lower density in 4 of the mixtures, and lower bending strength and modulus in 6 of the mixtures. Palacos R/gentamicin plus vancomycin and CMW 1/gentamicin plus vancomycin had bending strength slightly above minimum ISO standards, suggesting that the addition of vancomycin during cementmixing may compromise the outcome in revision surgery for sepsis.     

Fracture and fatigue properties of acrylic bone cement

The purpose of this study was to characterize the relative and combined effects of sterilization, molecular weight, and mixing method on the fracture and fatigue performance of acrylic bone cement. Palacos® R brand bone cement powder was sterilized using ethylene oxide gas (EtO) or gamma irradiation. Nonsterile material was used as a control. Molecular weights of the bone-cement powders and cured cements were measured using gel permeation chromatography. Hand and vacuum mixing were employed to mold single edge-notched bend specimens for fracture toughness testing. Molded dog-bone specimens were used for fatigue tests. Electron microscopy was used to study fracture mechanisms. Analysis of variance and Student t-tests were used to compare fracture and fatigue performance between sterilization and mixing groups. Our results indicate that vacuum mixing improved significantly the fracture and fatigue resistance (P < .05, P < .07) over hand mixing in radiation-sterilized and EtO-sterilized groups. In vacuum-mixed cement, the degradation in molecular weight resulting from gamma irradiation decreased fracture resistance significantly when compared with EtO sterilization and control (P < .05). A corresponding decrease in fatigue resistance was observed in the cement that was degraded severely by a radiation dose of 10 MRad (P < .05). In contrast, EtO sterilization did not result in a significantly different fracture resistance when compared with unsterilized controls for vacuum-mixed cement (P > .1). For hand-mixed cement, fracture and fatigue resistance appeared to be independent of sterilization method. This independence is believed to be the result of higher porosity that compromised the mechanical properties and obscures any effect of sterilization. Our results indicate that a combination of nonionizing sterilization and vacuum mixing resulted in the best mechanical performance and is most likely to contribute to enhanced longevity in vivo.     

Gentamicin release from polymethylmethacrylate bone cements and Staphylococcus aureus biofilm formation

We measured the formation of a Staphylococcus aureus biofilm in vitro on unloaded and gentamicin-loaded bone cements (CMW3 and Palacos R) and related the formation to antibiotic release rates. All experiments were done in triplicate. Microbial growth on gentamicin-loaded cements occurred despite the release of antibiotic. Biofilm formation on gentamicin loaded CMW3 bone cement was one fourth to one fifth less than on the unloaded bone cement, while biofilm formation on Palacos R bone cement was not significantly affected by antibiotic loading. More gentamicin was released from CMW3 (79 mg) than from Palacos R (70 mg), but the percentage gentamicin released after one week relative to the total amount incorporated was significantly lower for CMW3 (4.7%) than for Palacos R (8.4%). After one day, subinhibitory concentrations of antibiotics were eluted from the cements. We concluded that antibiotic-loaded bone cement does not necessarily inhibit the formation of an infectious biofilm in vitro.     

The clinical significance of vacuum mixing bone cement

This controlled study compared the strength and porosity of 48 polymethylmethacrylate cement-implant constructs prepared with open bowl versus vacuum mix technique. Forty-eight blast finished stainless steel rods of 13 mm diameter were implanted with centralizers into 17-mm inner diameter tubes that had been retrograde filled with polymethylmethacrylate cement. The eight cement preparations used were open bowl and vacuum mixed Simplex, Osteobond, Zimmer Dough Type, or Palacos R. Six replications of each condition were performed. The tubes were maintained at 37 degrees C. Each tube was cut transversely into five segments. The center three segments were used for data analysis: pushout strength, cycles to failure, and interface porosity analysis. Rod pushout data showed there was no significant difference between open bowl and vacuum mixed samples when all cement brands were combined. Mean sheer force for Palacos R vacuum mixed samples was greater than open bowl (634+/-47 versus 423+/-171), whereas the force for the Zimmer Dough Type cement open bowl was greater than that of the vacuum mixed samples (901+/-71 versus 705 +/-82). Cycles to failure data did not show significant differences when open bowl and vacuum mixed samples were compared when cements were analyzed individually or combined. Image analysis of cement-implant interfaces showed that vacuum mixing reduced void area significantly compared with open bowl mixing in the Palacos R and Osteobond preparations. Vacuum mixing does not appear to reduce cement prosthesis interface porosity or improve its mechanical properties in all cements.     

Gentamicin release from polymethylmethacrylate bone cements and Staphylococcus aureus biofilm formation

We measured the formation of a Staphylococcus aureus biofilm in vitro on unloaded and gentamicin-loaded bone cements (CMW3 and Palacos R) and related the formation to antibiotic release rates. All experiments were done in triplicate. Microbial growth on gentamicin-loaded cements occurred despite the release of antibiotic. Biofilm formation on gentamicin loaded CMW3 bone cement was one fourth to one fifth less than on the unloaded bone cement, while biofilm formation on Palacos R bone cement was not significantly affected by antibiotic loading. More gentamicin was released from CMW3 (79 mg) than from Palacos R (70 mg), but the percentage gentamicin released after one week relative to the total amount incorporated was significantly lower for CMW3 (4.7%) than for Palacos R (8.4%). After one day, subinhibitory concentrations of antibiotics were eluted from the cements. We concluded that antibiotic-loaded bone cement does not necessarily inhibit the formation of an infectious biofilm in vitro.     

Gentamicin release from polymethylmethacrylate bone cements and Staphylococcus aureus biofilm formation

We measured the formation of a Staphylococcus aureus biofilm in vitro on unloaded and gentamicin-loaded bone cements (CMW3 and Palacos R) and related the formation to antibiotic release rates. All experiments were done in triplicate. Microbial growth on gentamicin-loaded cements occurred despite the release of antibiotic. Biofilm formation on gentamicin loaded CMW3 bone cement was one fourth to one fifth less than on the unloaded bone cement, while biofilm formation on Palacos R bone cement was not significantly affected by antibiotic loading. More gentamicin was released from CMW3 (79 mg) than from Palacos R (70 mg), but the percentage gentamicin released after one week relative to the total amount incorporated was significantly lower for CMW3 (4.7%) than for Palacos R (8.4%). After one day, subinhibitory concentrations of antibiotics were eluted from the cements. We concluded that antibiotic-loaded bone cement does not necessarily inhibit the formation of an infectious biofilm in vitro.     

Bone cement product and failure in total knee arthroplasty

Background and purpose — The bone cement market for total knee arthroplasty (TKA) in Norway has been dominated by a few products and distributors. Palacos with gentamicin had a market share exceeding 90% before 2005, but it was then withdrawn from the market and replaced by new slightly altered products. We have compared the survival of TKAs fixated with Palacos with gentamicin with the survival of TKAs fixated with the bone cements that took over the market.

Patients and methods — Using data from the Norwegian Arthroplasty Register for the period 1997–2013, we included 26,147 primary TKAs in the study. The inclusion criteria were TKAs fixated with the 5 most used bone cements and the 5 most common total knee prostheses for that time period. 6-year Kaplan-Meier survival probabilities were established for each cement product. The Cox proportional hazards regression model was used to assess the association between bone cement product and revision risk. Separate analyses were performed with revision for any reason and revision due to deep infection within 1 year postoperatively as endpoints. Adjustments were made for age, sex, diagnosis, and prosthesis brand.

Results — Survival was similar for the prostheses in the follow-up period, between the 5 bone cements included: Palacos with gentamicin, Refobacin Palacos R, Refobacin Bone Cement R (Refobacin BCR), Optipac Refobacin Bone Cement R (Optipac Refobacin BCR), and Palacos R?+?G.

Interpretation — According to our findings, the use of the new bone cements led to a survival rate that was as good as with the old bone cement (Palacos with gentamicin).     

Palamed G compared with Palacos R with gentamicin in Charnley total hip replacement. A randomised, radiostereometric study of 60 HIPS

We performed a randomised, radiostereometric study comparing two different bone cements, one of which has been sparsely clinically documented. Randomisation of 60 total hip replacements (57 patients) into two groups of 30 was undertaken. All the patients were operated on using a cemented Charnley total hip replacement, the only difference between groups being the bone cement used to secure the femoral component. The two cements used were Palamed G and Palacos R with gentamicin. The patients were followed up with repeated clinical and radiostereometric examinations for two years to assess the micromovement of the femoral component and the clinical outcome. The mean subsidence was 0.18 mm and 0.21 mm, and the mean internal rotation was 1.7 degrees and 2.0 degrees at two years for the Palamed G and Palacos R with gentamicin bone cements, respectively. We found no statistically significant differences between the groups. Micromovement occurred between the femoral component and the cement, while the cement mantle was stable inside the bone. The Harris hip score improved from a mean of 38 points (14 to 54) and 36 (10 to 57) pre-operatively to a mean of 92 (77 to 100) and 91 (63 to 100) at two years in the Palamed G and Palacos R groups, respectively. No differences were found between the groups. Both bone cements provided good initial fixation of the femoral component and good clinical results at two years.     

Orthopaedic bone cement: do we know what we are using?

Bone cements produced by different manufacturers vary in their mechanical properties and antibiotic elution characteristics. Small changes in the formulation of a bone cement, which may not be apparent to surgeons, can also affect these properties. The supplier of Palacos bone cement with added gentamicin changed in 2005. We carried out a study to examine the mechanical characteristics and antibiotic elution of Schering-Plough Palacos, Heraeus Palacos and Depuy CMW Smartset bone cements. Both Heraeus Palacos and Smartset bone cements performed significantly better than Schering-Plough Palacos in terms of mechanical characteristics, with and without additional vancomycin (p < 0.001). All cements show a deterioration in flexural strength with increasing addition of vancomycin, albeit staying above ISO minimum levels. Both Heraeus Palacos and Smartset elute significantly more gentamicin cumulatively than Schering-Plough Palacos. Smartset elutes significantly more vancomycin cumulatively than Heraeus Palacos. The improved antibiotic elution characteristics of Smartset and Heraeus Palacos are not associated with a deterioration in mechanical properties. Although marketed as the 'original' Palacos, Heraeus Palacos has significantly altered mechanical and antibiotic elution characteristics compared with the most commonly-used previous version.     

The effect of centrifuging bone cement

We have tested the porosity and fatigue life of five commonly used bone cements: Simplex P, LVC, Zimmer regular, CMW and Palacos R. Tests were conducted with and without centrifugation and with the monomer at room temperature and, except for LVC, at 0 degrees C. We found that the fatigue life of different specimens varied by a factor of nearly 100. It did not depend on porosity alone, but was more influenced by the basic composition of the cement. Simplex P when mixed with monomer at 0 degrees C and centrifuged for 60 seconds had the highest fatigue life and was still sufficiently liquid to use easily.     

In vitro comparison of Refobacin-Palacos R with Refobacin Bone Cement and Palacos R + G

Background Refobacin Palacos R (RPR) is no longer produced and Palacos R + G (PRG) and Refobacin Bone Cement R (RBC) have been introduced to supersede it. We performed an in vitro study to ascertain whether the handling and mechanical properties of the more recent cement preparations are different to those of their predecessor.

Methods The 3 cements were tested to ISO 5833 and German DIN 53435 standards. In addition, their gentamicin elution, shrinkage, viscosity, and handling characteristics were studied.

Results All 3 cements had comparable mechanical properties exceeding the ISO 5833 and DIN 53435 standards. They eluted similar amounts of gentamicin and had comparable shrinkage. In the batches tested, RBC showed statistically significantly longer handling curves. Both PRG and RBC had statistically significantly lower viscosities as they cured compared to their predecessor.

Interpretation Surgeons must be aware that both successor cements do not appear to have handling curves and viscoelastic properties identical to those of RPR.     

Liquid gentamicin in bone cement: a laboratory study of a potentially more cost-effective cement spacer

BACKGROUND: Liquid gentamicin is approved by the Food and Drug Administration, is readily available, and is much less costly than tobramycin, the more commonly used antibiotic in cement spacers. The purpose of the present study was to test the mechanical properties, elution characteristics, and antibacterial activity of liquid gentamicin in an acrylic bone cement spacer. METHODS: Standardized specimens consisting of Palacos cement combined with liquid gentamicin, powdered tobramycin, or no antibiotic were fashioned, and the three groups were tested with regard to compressive and tensile strength, elution characteristics (with use of radioimmunoassays), and antibacterial activity (with use of bioassays). RESULTS: The ultimate compression strength decreased by 49% (from 64.65 +/- 3.89 MPa to 32.96 +/- 3.33 MPa) and the ultimate tension strength decreased by 46% (from 35.85 +/- 2.97 MPa to 19.20 +/- 0.36 MPa) when the specimens containing 480 mg of liquid gentamicin were compared with the controls. The addition of tobramycin had no significant effect compared with the controls. The majority of gentamicin was released from the cement during the initial twenty-four hours (mean concentration, 26.4 mcg/mL). The mean concentrations at three and six weeks were 4.15 and 0.65 mcg/mL, respectively. The bioassays confirmed the bactericidal activity of the gentamicin released from the cement. CONCLUSIONS: Liquid gentamicin in bone cement is potent and bactericidal. Although the mechanical properties of the cement are significantly diminished by the addition of liquid gentamicin, the temporary nature of the cement spacer makes its use potentially worthwhile given the substantial cost savings to the hospital and the patient.