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PubMed1997

Detrimental effect of aging on the endurance of bone cement. An in vivo and in vitro study in rabbits.

We investigated the effect of aging on the compressive strength of bone cement under in vivo and in vitro conditions. Cement molds were implanted in the dorsum of rabbits and other molds were kept under stable conditions and in darkness. Comparative measures taken at 15 days and 1, 3, 6, 12 and 24 months showed lower endurance of the implanted molds (p < 0.001). A reactive capsule surrounded the bone cement in vivo up to the 3rd month, its cellularity increased, and then almost disappeared by 1 year. Macrophages and foreign body cells reappeared at 2 years, indicating a "chemical aging" effect in the in vivo environment. Our findings suggest that aging may play an important role in the amelioration of the mechanical properties of bone cement.

Animals↗
PubMed2004

Estimation of the minimum number of test specimens for fatigue testing of acrylic bone cement.

In the literature on fatigue testing of acrylic bone cements, data sets of various sizes have been used in different test series for the same cement formulation. There are two important consequences of this situation. First, it means that some test series last much longer than others, with all the implications for the cost of testing. Second, it makes drawing conclusions about the fatigue performance of a cement, based on the results of different literature series, a problematic issue. Clearly then, a recommendation as to what should be the minimum number of test specimens to use that would allow for confidence in the results of the statistical treatment of the test results (Gmin) would be desirable. In the present work, a method that could be used to culminate in such a recommendation is described. This method involves (i) obtaining experimental fatigue test results and (ii) analyzing those results using the Weibull probability distribution function and other statistical methods. This methodology is illustrated using fatigue life results obtained from uniaxial tension-compression fatigue tests on specimens fabricated from the polymerizing dough of one commercially available acrylic bone cement. For a tolerable error of 5%, we estimated Gmin to be either 7 (if the fatigue life results are treated using the two-parameter Weibull distribution function) or 11 (if the fatigue life results are treated using the three-parameter Weibull distribution function). To be on the conservative side, we therefore recommend that Gmin be 11. Three key limitations of the methodology presented here are discussed.

Cementation↗
PubMed1991

Delayed contact hypersensitivity and surgical glove penetration with acrylic bone cements.

Skin hypersensitivity was investigated in guinea-pig maximization tests with extracts from pellets of conventional polymethyl-methacrylate (PMMA) bone cements (Palacos R, Simplex RO) and a new methylmethacrylate/n-decylmethacrylate/isobornylmethacrylate (MMA/DMA/IBMA) mixture (Boneloc), but none of the three cements produced evidence of delayed contact hypersensitivity. Testings of the pure monomer compounds showed MMA to be an extreme sensitizer, whereas DMA and IBMA were only mild sensitizers. Fingers from three brands of surgical rubber gloves and a polystyrene-butadiene glove were immersed in water and filled with conventional MMA monomer, MMA/DMA/IBMA monomer or bone cements in the dough state, allowing cure inside the glove. In the surrounding water, no DMA or IBMA could be detected. The MMA concentrations were lower with MMA/DMA/IBMA monomer and curing Boneloc cement. The most resistant to conventional PMMA cement was one of the rubber gloves, whereas the polystyrene-butadiene glove allowed the highest penetration, and even dissolved in MMA monomer. The potential occupational hazard of skin sensitization is reduced with MMA/DMA/IBMA bone cement, preferably in combination with rubber gloves; but also polystyrene-butadiene gloves provide adequate protection.

Animals↗
PubMed2004

The effect of Palamed G bone cement on early migration of tibial components in total knee arthroplasty.

OBJECTIVE: Migration of the tibial component in total knee arthroplasty (TKA) is subject of many studies using roentgen stereophotogrammetric analysis (RSA). In previous studies of cemented and uncemented tibial components, high migration values were found. Improvements in cementing technique, prosthetic design and pre-coating techniques reduced these values as shown in more recent studies. MATERIAL AND SUBJECTS: A total of 35 patients were initially included in the study and operated on between 12/1999 and 10/2000. All patients received a NexGen TKA cemented into the proximal tibia using Palamed G bone cement. The implants and the tibial metaphysis were marked with standard tantalum markers. Radiostereometric analysis was performed post-operatively and after 3, 6 and 12 months using a standard digital radiostereometric analysis. Functional parameters were assessed using the Knee Society Score (KSS) clinical rating system. RESULTS: There were no complications and failures within the first year. After 1 year radiostereometric measurements of the translational parameters along and the rotational parameters around the x-, y- and z-axis revealed: X-Trans -0.19 mm, Y-Trans +0.02 mm, Z-Trans +0.08 mm, X-Rot +0.26 degrees, Y-Rot -0.35 degrees, Z-Rot +0.09 degrees. The maximum total point motion was +0.96 mm and the mean maximum subsidence was -0.23 mm. Except for anterior-posterior, medio-lateral stability and extension leg all endpoints of the KSS clinical rating system showed a significant improvement. CONCLUSIONS: After 12 months, the use of Palamed G bone cement in total knee arthroplasty was demonstrated to be safe. Both the clinical and radiostereometric results were good and comparable to the results reported in other RSA studies in cemented total knee arthroplasty.

Aged↗
PubMed2006

Osteochondral graft fixation using a bioresorbable bone cement.

Multiple osteochondral grafts can be used to resurface large joint defects in both humans and horses. In humans, immediate postoperative weight bearing can be prevented, however in the equine, it is unavoidable. Early weight bearing can create detrimental graft micromotion. The aim of this study was to investigate the role of a bioresorbable cement in improving the initial stability of multiple osteochondral graft repairs of large subchondral cystic lesions in the horse. Configurations employed for filling a 20mm diameter cylindrical defect included: (A) twelve 4.5mm diameter grafts with cement, (B) five 6.5mm diameter grafts with cement, (C) four each of 4.5mm and 6.5mm grafts with cement and (D) cement only. Intact bone slices (E) were also tested. Push-out tests were used to quantify construct to host sidewall interface fixation. Configuration (A) proved clinically impractical (n=3). Configurations (B) (n=6), and (C) (n=4) had statistically similar interface stiffnesses and failure stresses (43+/-8 and 30+/-12 MPa and 0.96+/-0.1 and 1.2+/-0.3 Mpa, respectively) suggesting that they are equally susceptible to interface movement in the immediate postoperative period. By way of comparison, defects filled only with cement had an average stiffness of 53+/-7MPa and failure stress of 1.8+/-0.3 MPa (n=6) while the intact femoral condyle demonstrated a stiffness of 108+/-7 MPa and failure stress of 18+/-0.4 MPa (n=6). Cement augmentation improved immediate postoperative stability of multiple osteochondral graft constructs over uncemented constructs, although in all cases the observed moduli of elasticity and yield stress values were lower than those observed for cement only and intact bone test specimens. (all numbers are mean+/-SEM).

Absorbable Implants↗
PubMed2003

Fatigue and fracture toughness of acrylic bone cements modified with long-chain amine activators.

The composition of acrylic bone cement has been identified as one of the important parameters affecting its mechanical properties and may, in turn, ultimately influence the longevity of a cemented arthroplasty. Our aim in this study was to determine the influence of change of one compositional variable, the activator, on the fatigue performance and fracture toughness of specimens of the fully cured cement. To that end, three sets of cements were prepared, containing either the conventional activator, 4-N,N dimethyl p-toluidine (DMPT), or novel ones that are tertiary amines based on long-chain fatty acids, that is, 4-N,N dimethylaminobenzyl oleate (DMAO) and 4-N,N dimethylaminobenzyl laurate (DMAL). In the fatigue tests, the specimens were subjected to tension-tension loading, and the results (number of cycles to failure, Nf) were analyzed using the linearized form of the three-parameter Weibull equation. The fracture toughness (KIc) tests were conducted with rectangular compact tension specimens. All fracture surfaces were subsequently examined with scanning electron microscopy. We found that the Weibull mean fatigue lives for specimens fabricated using the DMPT, DMAL, and DMAO containing cements were 272,823, 453,551, and 583,396 cycles, respectively. The corresponding values for KIc were 1.94 +/- 0.05, 2.06 +/- 0.09, and 2.00 +/- 0.07 MPa radical m, respectively. Statistical analyses showed that for both the DMAL- and DMAO-containing cements, the mean values of Nf were significantly higher compared to the corresponding value for the DMPT-containing cement (Mann-Whitney test; alpha < 0.10). This result is attributed to the higher molecular weights of the former cements compared to the latter. The same trend was found for the mean KIc values (Mann-Whitney test; alpha < 0.05), with the trend being explained in terms of the differences seen in the crack morphologies. These results thus demonstrate that these novel amines are viable alternatives to DMPT for incorporation into acrylic bone cement formulations in the future.

Amines↗
PubMed2003

Antibiotic bone cement for the treatment of Pseudomonas aeruginosa in joint arthroplasty: comparison of tobramycin and gentamicin-loaded cements.

One hundred clinical isolates of Pseudomonas aeruginosa were collected from 22 medical centers throughout Europe and were challenged with two aminoglycoside-loaded bone cements, employing a modified in vitro Kirby-Bauer susceptibility model. The results of this study show that Simplex P with tobramycin exhibits antibacterial activity against 98% of the strains tested, compared to 93% for Palacos with gentamicin. Additionally, for strains that were susceptible to the antibiotic bone cement formulations, the average zone of inhibition produced around the tobramycin-loaded cement disks was approximately 25% greater than that seen around the gentamicin-loaded cement disks. This difference was statistically significant (p << 0.01). Tobramycin-loaded bone cement is therefore the preferred formulation when addressing Pseudomonas aeruginosa in septic joint arthroplasty.

Anti-Bacterial Agents↗
PubMed1980

[Antibiotic concentration in postoperative wound secretions and in serum of patients after implantation of hip endoprostheses having used neomycin-bacitracin loaded bone cement (author's transl)].

Antibiotic concentrations in postoperative wound secretions and in serum give some indication of the local and general effects of an antibiotic additive to bone cement. Ten patients received hip endoprostheses using a prepacked mixture of the bone cement Sulfix 6 with neomycin + bacitracin (Sulfix 6 A). After operation secretions from Redon drains were collected over the next 48 hours as well as venous blood over 14 days in order to measure neomycin and bacitracin levels. Neomycin was found in sera of some patients up to the eighth postoperative day, whereby concentrations did not exceed 0.75 mcg/ml. Bacitracin was not detected in any serum samples. In secretions from Redon drains neomycin as well as bacitracin reached effective levels during the first 48 hours. The results indicate that the addition of neomycin and bacitracin to the bone cement Sulfix 6 for local antibiotic prophylaxis is justified since effective antibiotic concentrations are thereby obtained in the wound without the danger of general toxicity arising when neomycin and bacitracin are administered by the usual method of topical application.

Aged↗
PubMed1992

Bone-cement removal with the excimer laser in revision arthroplasty.

The excimer laser was thought to be an appropriate tool for the removal of bone cement without damaging the bone. However, due to its low ablation rate, its clinical use in total hip revision arthroplasty proved to be impossible. This experimental study was designed to evaluate the maximal ablation rate by adjusting the laser's parameters. Energy density, frequency, pulse duration, radiation area, quantity of pulses, and environmental conditions were varied in the experimental setup. Even with the best set of parameters the excimer laser was about ten times slower than, e.g., the carbon dioxide laser. The removal of 10 g bone cement takes about 1 h. Thus, complete cement removal by means of the excimer laser alone is not possible. However, selective application of the excimer laser in combination with other techniques could be discussed.

Arthroplasty↗
PubMed2001

Bioactive bone cement: Effect of silane treatment on mechanical properties and osteoconductivity.

A novel bioactive bone cement (GBC) was developed with newly designed bioactive MgO-CaO-SiO(2)-P(2)O(5)-CaF(2) glass beads as the inorganic filler and high molecular weight poly(methyl methacrylate) as the organic matrix. The purpose of this study was to examine the relationship between the amount of the silane coupling agent (gamma-methacryloxy propyl trimethoxy silane) used to treat the glass beads and the mechanical and biological properties of the resultant bone cement. Serial changes in the cement over time were also investigated. Five different kinds of cement, in which the glass beads were treated with different amounts of the coupling agent, were prepared. The quantities of the coupling agent were 0 (control), 0.1, 0.2, 0.5, and 1.0% (w/w) of the glass beads, and the cements were designated GBCs0, GBCs0.1, GBCs0.2, GBCs0.5, and GBCs1.0, respectively. After soaking in water at 75 degrees C for 5 days, GBCs0.1 and GBCs0.2 had significantly higher bending strengths than the other cements. Each GBC was packed into intramedullar canals of rat tibiae to evaluate osteoconductivity, as determined by affinity indices. Rats were killed 4 and 8 weeks after the operation. The affinity index was calculated for each GBC and equaled the length of bone in direct contact with the cement and was expressed as a percentage of the total length of the cement surface. Histologically, new bone had formed along all of the GBC surfaces within 4 weeks. At each time interval, a decreasing trend in the affinity index of GBC was found as the amount of the coupling agent increased. At 8 weeks, no significant change in the affinity index occurred when the amount of the coupling agent increased from 0 to 0.2%, whereas a significant decrease in the affinity index was observed when the amount of the coupling agent increased from 0 to 0.5 or 1.0%. The affinity indices for all the GBCs increased significantly up to 8 weeks. When both the mechanical properties and osteoconductivity were taken into consideration, GBCs0.1 and GBCs0.2 were the best cements, and they showed excellent osteoconductivity and strong enough mechanical properties for clinical use.

Animals↗
PubMed1999

Effects of water-soluble component content on cephalexin release from bioactive bone cement consisting of bis-GMA/TEGDMA resin and bioactive glass ceramics.

The effect of the amount of a water-soluble, lactose, on cephalexin (CEX) release from bioactive bone cement consisting of bisphenol-alpha-glycidyl methacrylate (bis-GMA), triethylene-glycol dimethacrylate (TEGDMA) resin and apatite- and wollastonite-containing glass-ceramic (A-W GC) powder was investigated. A-W GC powder containing 5% CEX and lactose powders hardened within 5 min after mixing with bis-GMA/TEGDMA resin, and furthermore its compressive strength was expected to be higher than that of polymethylmethacrylate cement. In vitro CEX release from bioactive bone cement pellets in a simulated body fluid at pH 7.25 and 37 degrees C continued for more than 2 wk. The drug-release rate increased with increasing amount of lactose powder in the mixture. CEX release profiles followed the Higuchi equation in the initial stage, but not in later stages. As hydroxyapatite was precipitated out on the cement surface, the CEX release rate decreased. The micropore distribution of the cements measured by mercury porosimetry also supported the variation in drug release due to cement porosity being mainly a result of the dissolution of lactose in the cements. These results suggest that the rate of CEX release from bioactive bone cement could be controlled by varying the amount of lactose in the cement system.

Journal Article↗
PubMed2002

[Mechanical strength of antibiotic-impregnated bone cement on Day 0 and Day 15: a biomechanical study with Surgical Simplex P and teicoplanin].

OBJECTIVES: To determine the maximum amount of a specific antibiotic added to 40 g acrylic bone cement in terms of the effect on mechanical properties of the bone cement on Day 0 and after antibiotic release on Day 15. METHODS: In an experimental design, eight teicoplanin doses (0, 400 mg, 800 mg, 1200 mg, 1600 mg, 2000 mg, 3200 mg and 4000 mg) were added to bone cement (Surgical Simplex P). Specimens were prepared using the third generation cementing technique to determine the compressive strength and four-point bending strength according to ASTM and ISO standards, respectively. For each concentration, 10 samples were prepared for Day 0 and Day 15. Mechanical tests were performed on Day 0 and after antibiotic leaching in water at 37 degrees C on Day 15. 0 mg specimens served as controls and mechanical strengths for each antibiotic concentration on Day 0 and Day 15 were compared. RESULTS: In compression tests, Day 0 samples showed no significant differences, whereas Day 15 samples starting with 800 mg exhibited significant decreases in compressive strength. However, the compressive strengths were above the minimum standard of 70 MPa set by ASTM at all concentrations and in all groups. Four-point bending tests demonstrated significant decreases in strength starting with 1200 mg in Day 0 samples, and with 400 mg in Day 15 samples. Four-point bending strengths of 2000 mg, 3200 mg, and 4000 mg samples decreased below, or approximated closely the minimum standard of 50 MPa set by ISO on Day 15. CONCLUSION: Our results suggest that the maximum amount of teicoplanin dose to be safely added to 40 g of Surgical Simplex P is 1600 mg when third generation cement mixing and application techniques are employed.

Anti-Bacterial Agents↗
PubMed2002

Percutaneous vertebroplasty: a bone cement procedure for spinal pain relief.

Percutaneous vertebroplasty (PV), a procedure where bone cement is injected into a partially collapsed vertebral body, is used to relieve pain and provide mechanical stability in cases of osteoporosis or tumour infiltration. PV provided rapid pain relief and increased mobility in most patients according to the results from 15 uncontrolled studies in 882 persons where over 1,500 vertebrae were treated. Serious complications from bone cement leaks and adjacent vertebral fractures were rare. Despite the increasing use of PV there are no controlled prospective studies on safety and efficacy with long-term follow-up. Physician and supply costs range from C $300 -600 per vertebra treated. This figure excludes hospital or investigational costs.

Administration, Cutaneous↗
PubMed1984

Bone cement, thermal injury and the radiolucent zone.

Six patients, with giant cell tumors of bone treated by curettage and bone cementing, were followed radiographically for 4 (2-6) years postoperatively. The radiolucent zones between cortical bone and cement increased in width up to 0.5 mm during the first 6 months and then remained stationary. During the same period the zone adjacent to cancellous bone increased up to 2.5 mm and was surrounded by a sclerotic rim. In two cases the zone adjacent to cancellous bone diminished by 1-1.5 mm during the first 2 years after surgery. There was a positive correlation between the maximal width of the zone adjacent to cancellous bone and the volume of cement fillings. Our findings indicate that the radiolucent zone surrounding bone cement is caused by thermal necrosis.

Adolescent↗
PubMed1991

Bone cement not weakened by cefuzonam powder.

We report tensile, shearing, and bending tests on bone cement to which cefuzonam sodium (Cosmosin), a third generation cephalosporin, had been mixed. Mixing 3 g of cefuzonam sodium to 40 g of polymethyl methacrylate (PMMA) polymer did not diminish the strength of the bone cement in any of the tests. We speculated that this lack of influence was because the cefuzonam sodium powder used was in the form of relatively uniform-sized spheres and therefore did not become the origin of stress concentration within the cement.

Bone Cements↗
PubMed1991

Mechanical properties of bone cement. Importance of the mixing technique.

The compressive and shear strength and the modulus of elasticity were studied in three different bone cements (CMW, Simplex P, and Zimmer low-viscosity cement). One hundred four specimens were prepared by either a conventional manual mixing technique or mechanical vibration. Mechanical mixing gave a significant increase in shear strength for CMW and Simplex P. The compressive strength of Simplex P and Zimmer low-viscosity cement was significantly improved by mechanical mixing. The scatter of the results was significantly reduced by mechanical mixing. The modulus of elasticity was significantly increased by mechanical mixing for the three cements. The uniformity of the bone cement mass seems to be increased by a standardized mechanical mixing technique.

Bone Cements↗
PubMed2004

Injectable acrylic bone cements for vertebroplasty with improved properties.

Currently commercially available acrylic bone cements lack adequate radiopacity and viscosity when they are used in percutaneous vertebroplasty (PVP). In this work improved formulations of radiopaque and injectable poly(methyl methacrylate) bone cements were prepared with different amounts (10-50 wt.%) of BaTiO3 or SrTiO3 particles as the radiopaque agent. Two sets of cements were prepared by using untreated or silanated radiopaque particles, respectively. The influence of the content and nature of the radiopaque agent as well as its silanation with 3-(trimethoxysilyl) propyl methacrylate (gamma-MPS), on the curing parameters, residual monomer content, radiopacity, mechanical properties, and injectability of the resulting materials, was examined. Doughing and setting times, maximum temperature, and compressive strength of all formulations fulfilled the requirements of standard specifications, with values of peak temperature in the range 57-72 degrees C and those of compressive strength between 114 and 135 MPa. Formulations containing at least 20 wt.% BaTiO3 or SrTiO3 had radiopacities equal to or greater than that corresponding to 2 mm of Al as required for surgical plastics. Injectability of any of the formulations provided 75-80 wt.% of the total mass manually injected through a conventional biopsy needle 4 min after mixing. Silanation of the BaTiO3 or SrTiO3 particles led to formulations with improved mechanical properties and injectability compared to those obtained with the untreated fillers.

Barium Compounds↗
PubMed2005

Synthesis and characterization of polyamide of trans-4-hydroxy-L-proline used as porogen filler in acrylic bone cement.

The aim of this study was to synthesize on a larger scale, an experimental polyamide based on an amino acid of trans-4-hydroxy-L-proline. The polyamide of trans-4-hydroxy-L-proline has been used as porogen filler (i.e., a hydrophilic pore generating material) in nondegradable acrylic bone cement. In in vitro studies, this hydrophilic filling component has been shown to form porosity within the acrylic bone cement in an aqueous environment. The formation of in situ porosity in the acrylic polymer matrix is believed to improve the fixation between the cement and the living bone. Namely, a porous structure can support bone ingrowth and strengthen the mechanical connection between the acrylic bone cement and the bone. The monomer, trans-4-hydroxy-L-proline methyl ester, was prepared from trans-4-hydroxy-L-proline by means of two steps, and the monomer was then polymerized to polyamide of trans-4-hydroxy-L-proline. The polymerization was carried out using a melt polycondensation method. The molecular weights (M(psi)) of the produced polyamides were between 1800 and 3600. The products were characterized by FTIR and (1)H-NMR spectroscopy.

Hydroxyproline↗