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[Hip prosthetic stem biological fixation by compound bone-cement].

Thirty rabbits were subjected to hemiarthroplasty for the right hip. The prosthetic stems were fixed by DBM + bone-cement in group I, BMG + bone-cement in group II, bone-cement only in group III, and uncemented inserting stem in group IV. They were periodically examined roentgenologically, histologically and biomechanically. Group I and II attained early mechanical fixation and new bone grew into the compound bone-cement (CBC), which was fused together with the host bed. Their shearing strength of the contact surface of CBC was increased with time. The differences between group I, II and group III, IV were obvious (P < 0.01). In later stage, group III showed bone absorption and destruction, and pseudo-membraneous tissue between the bone and cement. Group IV failed in fixation and had loosening and subsidence of the stems even in the early stage. The histology and biomechanics of compound bone-cement were also discussed.

Animals↗

Biomechanical properties of bone cement with addition of cefuroxime antibiotic.

Antibiotic-loaded bone cement has been used as prophylaxis against infection in total joint replacement surgery. Its effect on the mechanical strength of cement is a major concern as high dose of antibiotic was associated with a significant reduction in mechanical strength of bone cement. However, the cut-off antibiotic that weakens the mechanical strength of cement remains to be determined. This study was undertaken to observe the changes in the mechanical properties of bone cement with gradual increments of Cefuroxime antibiotic. Cefuroxime at different doses: 0, 1.5, 3.0 and 4.5gm were added to a packet of 40gm bone cement (Simplex P) and study samples were prepared by using third generation cementing technique. Mechanical impact, flexural and tensile strength were tested on each sample. Significant impact and tensile strength reduction were observed after addition of 4.5 gm of Cefuroxime. However, flexural strength was significantly reduced at a lower dose of 3.0 gm. The maximum dose of Cefuroxime to be safely added to 40mg Surgical Simplex P is 1.5gm when third generation cementing technique is used. Further study is needed to determine whether it is an effective dose as regards to microbiological parameters.

Anti-Bacterial Agents↗

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

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

Benzoates↗

The influence of ultrasound on the release of gentamicin from antibiotic-loaded acrylic beads and bone cements.

Gentamicin-loaded acrylic beads are loosely placed in infected bone cavities, whereas gentamicin-loaded acrylic bone cement is used as a mechanical filler in bone to anchor prosthetic components. Both drug delivery systems are used to decrease infection rates by gentamicin release. The objective of this study is to investigate the effects of pulsed ultrasound on gentamicin release from both materials. Gentamicin release from gentamicin-loaded beads (Septopal) and from three commercially-available brands of gentamicin-loaded bone cement (CMW 1, Palacos R-G, and Palamed G) was measured after 18 h of exposure in PBS to an ultrasonic field of 46.5 kHz in a 1:3 duty cycle with an average acoustic intensity of 167 mW/cm(2). Samples not exposed to ultrasound were used as controls. Pulsed ultrasound significantly enhanced gentamicin release from gentamicin-loaded beads, whereas gentamicin release from the gentamicin-loaded bone cements was not significantly enhanced. Mercury intrusion porosimetry revealed an increased distribution of pores between 0.1 and 0.01 microm in beads after gentamicin release, while in bone cements no increase in the number of pores was found. Increased gentamicin release in beads due to ultrasound may be explained by micro-streaming in a porous structure, whereas the absence of changes in pore structure after gentamicin release in bone cement is concurrent with the lack of an enhanced release of the antibiotic by ultrasound. As an effective treatment of infections requires high local concentrations of antibiotic, increased gentamicin release due to ultrasound may be of clinical significance, especially since ultrasound has been demonstrated to increase bacterial killing by antibiotics.

Anti-Bacterial Agents↗

A theoretical and experimental analysis of polymerization shrinkage of bone cement: A potential major source of porosity.

A theoretical basis for understanding polymerization shrinkage of bone cement is presented based on density changes in converting monomer to polymer. Also, an experimental method, based on dilatometry and the Archimedes' principle is presented for highly precise and accurate measurement of unconstrained volumetric shrinkage of bone cement. Furthermore, a theoretical and experimental analysis of polymerization shrinkage in a constrained deformational state is presented to demonstrate that porosity can develop due to shrinkage. Six bone-cement conditions (Simplex-Ptrade mark vacuum and hand mixed, Endurancetrade mark vacuum mixed, and three two-solution experimental bone cements with higher initial monomer levels) were tested for volumetric shrinkage. It was found that shrinkage varied statistically (p< or = 0.05) from 5.1% (hand-mixed Simplex-Ptrade mark) to 6.7% (vacuum-mixed Simplex-Ptrade mark) to 10.5% for a 0.6:1 (polymer g/monomer mL) two-solution bone cement. Shrinkage was highly correlated with initial monomer content (R(2) = 0.912) but with a lower than theoretically expected rate. This discrepancy was due to the presence of residual monomer after polymerization. Using previously determined residual monomer levels, the theoretic shrinkage analysis was shown to be predictive of the shrinkage results with some residual monomer left after polymerization. Polymerization of a two-solution bone cement in a constrained state resulted in pores developing with volumes predicted by the theory that they are the result of shrinkage. The results of this study show that shrinkage of bone cement under certain constrained conditions may result in the development of porosity at the implant-bone cement interface and elsewhere in the polymerizing cement mantle.

Animals↗

[Bone cement containing cytostatic drugs: new aspects in the treatment of malignant bone tumors. I. Experimental studies].

Radical surgery in malignant bone tumors can either be limited by anatomical structures or seems inadequate in the palliative stabilization of bone metastases. Incomplete removal of the tumor and stabilization by compound osteosynthesis or endoprosthesis contains two problems: 1) the wide spread of malignant cells by manipulation in the tumor bearing area; 2) progressive destruction of bone due to remaining tumor. To overcome these problems we developed methotrexate bone cement (MTX-Palacos) with the aim to obtain high local concentrations of methotrexate in order to destroy remaining tumor cells and avoid systemic side effects. In vitro studies showed that methotrexate is released continuously from this cement without relevant changes of its biomechanical properties. Animal studies with transplanted osteosarcomas and mamma carcinomas in mice showed a considerable decrease of tumor growth when a plug of MTX-Palacos was inserted in the center of the tumor. Histological findings showed that in the surroundings of the plug the tumor was destroyed considerably contrary to normal bone cement which had no effect on the tumor at all. The results are discussed with regard to clinical application of MTX-Palacos.

Animals↗

[Blood lamination in bone cement--effect of cementing technique].

The quality of the cement layer influences the long-term survival of cemented endoprostheses. However, blood and fluid laminations within the cement layer, which can form during implantation of endoprostheses, lead to the deterioration of bone cement. Since the bone cement is the weakest part in the construction consisting of prosthesis, bone and bone cement, further weakening of the bone cement should be avoided if possible. By means of in vitro studies, three different cementing techniques were tested, measuring quantitatively the amount of fluid within the cement layer after implantation. The least amount of fluid within the cement layer was found in the cement-canal technique, and the highest amount in anterograde cement injection. Retrograde cement injection led to intermediate values.

Biomechanical Phenomena↗

Creep properties of three low temperature-curing bone cements: a preclinical assessment.

The mechanical characteristics of new bone cements should be assessed before these cements are released on the orthopedic market in great quantities. In this study, we present the deformational response of 3 relatively new, low-curing temperature bone cements (Cemex RX, Cemex System, and Cemex Isoplastic) to a dynamic compressive force in comparison to Simplex P bone cement. For this purpose, dynamic compressive creep tests were performed on cylindrical shaped specimens at a maximal load level of 20 MPa for a period of 250,000 cycles. The results showed that Cemex System and Cemex RX produced creep rates that were higher (20% and 30%, respectively) as compared to Simplex P bone cement. The creep behavior of Cemex Isoplastic was very similar to that of Simplex P. It was concluded that although Cemex RX and Cemex System produced higher creep rates than Simplex P, these differences were not considered excessive. Hence, although other tests are required to assess the safety and efficacy of these new cements, the dynamic creep properties under compression can be considered adequate for clinical use.

Biocompatible Materials↗

In vivo behavior of acrylic bone cement in total hip arthroplasty.

Polymethylmethacrylate (PMMA) bone cement serves as the primary fixation material between bone and the prosthetic component in cemented total hip arthroplasty. In vivo degradation of bone cement may lead to a decrease in mechanical properties of PMMA and result in aseptic loosening. However, other factors such as porosity and location of the cement relative to the bone implant interface may also contribute to mechanical behavior in vivo. This study investigated the mechanical properties of Simplex cement retrieved from 43 patients undergoing revision total hip arthroplasty. The time in vivo was between 1 month and 27 years. The variables studied included fracture toughness (KIC), porosity, molecular weight, time in vivo of the cement, and relative in vivo location of the cement with respect to the implant and bone. KIC did not correlate with time in vivo of the samples or with molecular weight. This suggests that time in vivo may not be the limiting factor in the mechanical integrity of the bone cement, A significant and inverse relationship was found between porosity and KIC. This implies that porosity is the most important factor in the mechanical behavior of bone cement during in vivo use.

Arthroplasty, Replacement, Hip↗

Gentamicin-loaded bone cement with clindamycin or fusidic acid added: biofilm formation and antibiotic release.

The formation of staphylococcal biofilms on experimental bone cements, loaded with 0.5 or 1.0 g of active gentamicin and an additional equivalent amount of gentamicin, clindamycin, or fusidic acid was investigated. The biofilms were formed in a modified Robbins device over a 3-day time span and the influence of the additional antibiotics was quantified by expressing the number of colony forming units relative to the corresponding bone cement containing only gentamicin. Combinations of gentamicin with either fusidic acid or clindamycin reduced growth of clinical isolates of both gentamicin-sensitive Staphylococcus aureus and gentamicin-resistant coagulase-negative staphylococci to approximately 28%. To determine whether adding a second antibiotic has influence on the gentamicin release, cement blocks were placed in phosphate buffer and aliquots were taken at designated sampling intervals. The influence of the additional antibiotics was quantified by expressing the percentage released of the total amount of antibiotic incorporated in the different bone cements. After 3 days, all bone cements had released similar percentages of gentamicin, whereas more clindamycin and fusidic acid were released after doubling their concentration in the bone cements. In conclusion, bone cements loaded with combinations of gentamicin and clindamycin or fusidic acid are more effective in preventing biofilm formation than bone cements with gentamicin as a single drug. In addition, the presence of clindamycin or fusidic acid in gentamicin-loaded bone cement has no influence on the total gentamicin release.

Biofilms↗

Radiopacity of tantalum-loaded acrylic bone cement.

Radiopacifying agents are commonly added to bone cements to enhance the visibility of the cement in radiography. The radiopacifiers usually employed may, however, have undesired effects on the mechanical properties of the cement. A potentially new radiopacifier is tantalum, which in the present work was evaluated in terms of radiopacity. Bone cements containing different percentages of tantalum were compared with plain bone cement as well as with formulations containing different percentages of the commonly used radiopacifier barium sulphate. The radiopacity was assessed quantitatively and qualitatively, by measuring with a digital densitometer the optical density of the cement on X-ray films, and consulting the expertise of ten orthopaedic surgeons. It was found that tantalum does present radiopacity, but not as high as barium sulphate under the specific conditions applied to this study.

Absorptiometry, Photon↗

[Acute tissue toxicity of PMMA bone cements].

AIM: Local toxic reactions are one possible reason for fibrous tissue formation at the interface between bone and PMMA bone cement. Most of the numerous in vitro studies have shown severe cytotoxicity of bone cements and their components. However, in vivo investigations of the local tissue toxicity of bone cements have so far seldom been performed. METHODS: The in-vivo hens-egg chorion-allantoic-membrane test (HET-CAM), a well established replacement procedure for experiments with higher vertebrates, is used for the testing of potentially toxic solid and fluid substances. It was performed with PMMA bone cements, their components and their monomer extracts to measure in vivo biocompatibility. RESULTS: We showed that local toxic tissue reactions occurred, especially at the beginning of the processing phase of PMMA bone cements. We also proved that certain components of PMMA bone cements have poor tissue compatibility and sometimes cause severe local tissue changes. CONCLUSIONS: In the development of PMMA bone cements and when drafting the recommendations for their use, attention should be paid to their biocompatibility as well as their mechanical properties.

Animal Testing Alternatives↗

Production of TNF-alpha and bone resorbing activity by macrophages in response to different types of bone cement particles.

We have compared the capacity of clinically relevant wear debris from seven different cement types to activate macrophages to produce TNF-alpha, IL-1beta, IL-6 and bone resorbing activity in vitro. The bone cements were: CMW 1 original (PMMA only); CMW 1RO (1 microm BaSO4; 9.2%); CMW copolymer bone cement 1 (10 microm BaSO4; 10%); CMW copolymer bone cement 2 (1 microm BaSO4; 10%); Palacos R (10 microm ZrO2; 15.6%); CMW Calcium phosphate cement 20% (10 microm tri-calcium phosphate; 20%) and CMW calcium phosphate cement 30% (10 microm tri-calcium phosphate; 30%). Cement debris was produced aseptically using a simple configuration wear test. The majority of particles were in the size range 0.1-0.5 microm for each cement type. The cement particles were co-cultured with the U937 macrophage cell line at ratios of 10 and 100 microm3 particle volumes to macrophage cell numbers for 24 h. At the 10:1 ratio the particles had no effect on the cells. At the 100:1 ratio, the major cytokine produced was TNF-alpha and there were no statistical differences between the different types of cement debris. The bone resorption activity of the co-culture supernatants was significantly greater than the control (U937 cells without particles) for particles of CMW 1RO, CMW copolymer bone cement 1, CMW copolymer bone cement 2 and Palacos R (P < 0.05, ANOVA). However there were no statistical differences between the levels of bone resoprtion evoked by these four cement types. The CMW1 original and CMW calcium phosphate containing cements failed to induce the macrophages to elaborate bone resorption activity at the 100:1 ratio. These data suggest that the addition of radio-opaque additives to bone cement may increase the capacity of the debris to induce osteolysis.

Acrylic Resins↗

Thermal manipulation of bone cement.

Many factors affect the rate of polymerization of polymethylmethacrylate (PMMA) and, therefore, the working time of bone cement. Surgeons may control some factors, but not all. A surgeon may change the temperature of the powder and the monomer, whereas the temperature and relative humidity of the operating room are more difficult to alter. The temperature of the mixing vessels may also be controlled. However, a surgeon has no control over the industrial mixture of the components of the bone cement, which can vary considerably from batch to batch. This article reviews the effect of temperature of cement mixtures on the working time of the cement, the interfacial strength of the cement-metal interface as well as the cement-bone interface, and tissue viability and cellular change at the bone-cement interface.

Arthroplasty, Replacement, Hip↗

Malignant acetabular osteolyses: percutaneous injection of acrylic bone cement.

Percutaneous osteoplasty with acrylic bone cement was performed in 12 acetabular osteolytic lesions in 11 patients with inoperable metastases (n = 8) and myeloma (n = 3). Complementary radiation therapy was started 15-30 days after injection in each case. Pain diminished within hours to 4 days in nine patients, and walking improved in each patient within 1-5 days. Five patients died during the follow-up period. Clinical improvement was maintained in all but two patients.

Acetabulum↗

Static and fatigue properties of two new low-viscosity PMMA bone cements improved by vacuum mixing.

With the objectives of reducing toxicity and improving the mechanical properties of the prior Sulfix-6 cement, a new low-viscosity bone cement with a new catalyst (Sulfix-60), and a gentamycin containing cement (Allofix-G) were developed. Although static strength could be improved in comparison with the older Sulfix-6 cement, investigations regarding improved fatigue strength and the influence of vacuum mixing on the mechanical properties were missing. Dynamic weakness was the major disadvantage of the older Sulfix-6 cement. To investigate fatigue strength specimens of the new bone cements were tested with load guiding until breakage or 20 million cycles. In the three series, hand mixing, vacuum mixing, and vacuum mixing with additional pressurization were performed, respectively. Vacuum mixing led to increased fatigue stability from 6.3 to 9.1 MPa for Sulfix-60, and from 6.3 to 8.2 MPa for Allofix-G. Additional compression had no significant effect. A 200% increased fatigue strength was detectable in comparison with the older cement. In the four-point bending test, similar results were found. It could be proved that an increased polymerization rate achieved with the use of the new catalyst was responsible for the improved mechanical properties of the new bone cement Sulfix-60.

Bone Cements↗

Improved bonding strength of polyethylene/polymethylmetacrylate bone cement--a preliminary study.

The adhesion of polymethylmetacrylate (PMMA) bone cement and low density polyethylene (LDPE) substrate by means of corona discharge treatment are presented. The surfaces were characterized by water contact angle goniometer, Fourier-transform infrared spectroscopy in the attenuated total reflectance mode (FTIR-ATR), electron spectroscopy for chemical analysis (ESCA), and scanning electron microscopy (SEM) for surface morphology. The bonding strength between bone cement and LDPE with varying intensity of corona treatment was evaluated by a 180 degrees peel test. The water contact angles decreased with increasing treatment intensity from 95.0 +/- 1.8 to around 43.5 degrees. It was observed that the oxygen containing groups as hydroxyl, ether, carboxylic acid, ester, ketone or aldehyde groups were introduced on the LDPE surfaces by corona treatment. The peel strength steeply increased from 0 to 1.75 kgf/cm with increasing the intensity of corona treatment. The improved adhesion of bone cement onto LDPE substrate may be due to only secondary force such as hydrogen bonding between PMMA bone cement and hydrophilized LDPE substrate.

Adhesiveness↗

Evaluation of bioactive bone cement in canine total hip arthroplasty.

Total hip arthroplasties (THAs) were performed in beagle dogs using a bioactive bone cement (BABC) consisting of a silane-treated apatite- and wollastonite-containing glass-ceramic (AW glass-ceramic) powder and a silica glass powder as the filling particles and a bisphenol-A-glycidyl dimethacrylate-based resin (Bis-GMA-based resin) as the organic matrix. The outcomes were compared with the results of polymethylmethacrylate (PMMA) bone cement. The mechanical properties of the BABC were stronger than those of PMMA bone cement. The bonding strength of the BABC to bone in the dogs' femora increased with time and reached 3.7 MPa at 24 months after implantation whereas that of PMMA bone cement was 2.0 MPa (p < 0.05). Histological examination showed direct bonding between the BABC and the femoral bone for up to 24 months after implantation. However, with PMMA bone cement an intervening soft-tissue layer consistently was observed at the bone-cement interface. Direct bonding at the interface between the BABC and the bone through a calcium phosphorous layer 30 microm-thick was revealed by scanning electron microscopy. Femoral bone resorption was observed at 24 months after implantation in the BABC group, but it was not observed in the PMMA bone cement group. Direct bonding between BABC and the bone may have accelerated femoral bone resorption. Cement fractures of the BABC were observed on the acetabular side 24 months after implantation. Weak bonding between the BABC and an acetabular component made of ultrahigh molecular weight polyethylene (UHMWPE), relatively high elastic characteristics of BABC, and weakness of the calcium phosphorous layer formed on the surface of this cement seemed to lead to failure at 24 months on the acetabular side.

Animals↗