In vivo aging test for a bioactive bone cement consisting of glass bead filler and PMMA matrix.

The degradation of a new bioactive bone cement (GBC), comprised of an inorganic filler (bioactive MgO-CaO-SiO(2)-P(2)O(5)-CaF(2) glass beads) and an organic matrix [high-molecular-weight polymethyl methacrylate (PMMA)], was evaluated in an in vivo aging test. Hardened rectangular specimens (20 x 4 x 3 mm) were prepared from two GBC formulations (containing 50% w/w [GBC50] or 60% w/w [GBC60] bioactive beads) and a conventional PMMA bone cement control (CMW-1). Initial bending strengths were measured with the use of the three-point bending method. Specimens of all three cements were then implanted into the dorsal subcutaneous tissue of rats, removed after 3, 6, or 12 months, and tested for bending strength. The bending strengths (MPa) of GBC50 at baseline (0 months), 3, 6, and 12 months were 136 +/- 1, 119 +/- 3, 106 +/- 5 and 104 +/- 5, respectively. Corresponding values were 138 +/- 3, 120 +/- 3, 110 +/- 2 and 109 +/- 5 for GBC60, and 106 +/- 5, 97 +/- 5, 92 +/- 4 and 88 +/- 4 for CMW-1. Although the bending strengths of all three cements decreased significantly from 0 to 6 months, those of GBC50 and GBC60 did not change significantly thereafter, whereas that of CMW-1 declined significantly between 6 and 12 months. Thus, degradation of GBC50 and GBC60 does not appear to continue after 6 months, whereas CMW-1 degrades progressively over 12 months. Moreover, the bending strengths of GBC50 and GBC60 (especially GBC60) were significantly higher than that of CMW-1 throughout. It is believed that GBC60 is strong enough for use under weight-bearing conditions and that its mechanical strength is retained in vivo; however, its dynamic fatigue behavior will need assessment before application in the clinical setting.

PMMA-based bioactive cement: effect of CaF2 on osteoconductivity and histological change with time.

A new bioactive bone cement (designated GBC), which is a polymethyl methacrylate- (PMMA-) based composite consisting of bioactive glass beads as an inorganic filler and high-molecular-weight PMMA (hPMMA) as an organic matrix, has been developed. The bioactive glass beads consist of MgO-CaO-SiO(2)-P(2)O(5)-CaF(2) glass. The purpose of the present study was to evaluate the effect of CaF(2) on osteoconductivity and to evaluate the degree of cement degradation with time. Three different types of cement were prepared. GBC(F +), which has been previously described, consisted of CaF(2)-containing bioactive glass beads and hPMMA. GBC(F -) consisted of CaF(2)-free bioactive glass beads and hPMMA. The third cement was hPMMA itself (as a reference material). These three types of cement were packed into the intramedullary canals of rat tibiae to evaluate osteoconductivity, as determined by an affinity index calculated as the length of bone in direct contact with the cement surface expressed as a percentage of the total length of the cement surface. Rats were killed at 4, 8, 25, and 52 weeks after implantation, and the affinity index was calculated for each type of cement at each time point. Histologically, new bone had formed along the surface of both GBC(F +) and GBC(F -) within 4 weeks, whereas hPMMA had little contact with bone, and an intervening soft tissue layer between bone and cement was detected. No significant difference in affinity index was found between GBC(F +) and GBC(F -) at any of the time points studied, although GBC(F -) showed higher affinity indices than GBC(F +) at 8, 25, and 52 weeks. The affinity indices for GBC(F +) and GBC(F -) were significantly higher than those for hPMMA at all time points. With GBC(F +) and GBC(F -), significant increases in the affinity indices were found as the implantation period increased, and the affinity index values at 52 weeks reached more than 70%. In hPMMA, no significant increase in affinity index was observed up to 52 weeks, and the value at 52 weeks was less than 30%. Although no significant difference in affinity index was found between GBC(F +) and GBC(F -), GBC(F -) is conclusively better than GBC(F +) because diseases such as chronic fluorosis might be caused by CaF(2)-containing glass beads. Regarding the cement degradation of both GBC(F +) and GBC(F -), the degree of the degradation at 25 weeks was the same as that at 52 weeks. Therefore, the cement degradation does not appear to proceed rapidly. Further studies are needed to better understand the degradation process.

Composites consisting of poly(methyl methacrylate) and alumina powder: an evaluation of their mechanical and biological properties.

We developed new composites consisting of comparatively high molecular weight poly(methyl methacrylate) (hPMMA) and delta-alumina powder or alpha-alumina powder (designated delta-APC and alpha-APC, respectively) that allowed direct bone formation on their surfaces in vivo. delta-Alumina powder was manufactured by the fusing and quenching of pulverized alumina powder. It was composed mainly of delta-crystal phases of alumina. The purpose of this study was to evaluate the static mechanical properties and biological properties of these composites. The hPMMA itself was used as a reference material. The bending strength and Young's modulus of both delta-APC and alpha-APC were significantly higher than those of hPMMA, and the alumina composites are believed to be strong enough for use under weight-bearing conditions. The three types of composites were packed into the intramedullary canals of rat tibiae to evaluate osteoconductivity, as determined by an affinity index. Rats were sacrificed 4 and 8 weeks after surgery. The affinity index, equal to the length of bone in direct contact with the composite surface and expressed as a percentage of the total length of the composite surface, was calculated for each composite at each interval. Histologically, new bone had formed along the surfaces of both delta-APC and alpha-APC within 4 weeks. The affinity indices for both delta-APC and alpha-APC increased significantly with time up to 8 weeks. At 8 weeks, the affinity index for delta-APC was significantly higher than the indices for alpha-APC and hPMMA. This study revealed that the excellent osteoconductivity of delta-APC was due to the delta-crystal phases of alumina and the high molecular weight of hPMMA. delta-APC shows promise as a base for developing a highly osteoconductive and mechanically strong biomaterial.

PMMA-based bioactive cement: effect of glass bead filler content and histological change with time.

A new bioactive bone cement (designated GBC), which is a polymethyl methacrylate (PMMA)-based composite consisting of bioactive glass beads as an inorganic filler and high molecular-weight PMMA as an organic matrix, has been developed. The purpose of the present study was to evaluate the effect of the filler content on the mechanical properties and osteoconductivity of GBC, to decide the most suitable filler proportion, and to evaluate the degree of cement degradation with time. The bioactive beads, consisting of MgO-CaO-SiO(2)-P(2)O(5)-CaF(2) glass, were added to the cement in various proportions (40-70 wt %). The bending strength of GBC did not differ among the proportions (approximately 136 MPa), but the elastic modulus of bending of GBC increased as the glass bead filler content increased (approximately 4.1-7.2 GPa). The all types of GBC were packed into the intramedullary canals of rat tibiae to evaluate osteoconductivity, as determined by an affinity index calculated as the length of bone in direct contact with the cement surface expressed as a percentage of the total length of the cement surface. Rats were sacrificed at 4, 8, 25, and 39 weeks after implantation, and the affinity index was calculated for each type of GBC at each time point. Histologically, new bone had formed along the surface of all types of GBC within 4 weeks, even in GBC containing only 40 wt % of glass beads. The affinity indices of GBC tended to increase as the proportion of glass bead filler increased and as the implantation period increased. In GBC containing 60 or 70 wt % of glass beads, significant rapid increases in the affinity indices were found from 4 to 8 weeks, and the high values (approximately 70%) were maintained up to 39 weeks. A sign of glass bead degradation was observed at the bone-cement interface in the rat tibiae at 39 weeks. We conclude that, when mechanical properties and osteoconductivity are both taken into consideration, GBC containing 60 or 70 wt % of glass beads is the most suitable formulation, but that further studies are needed to investigate and overcome the degradation.

Mechanical properties and osteoconductivity of new bioactive composites consisting of partially crystallized glass beads and poly(methyl methacrylate).

New bioactive composites consisting of partially crystallized glass beads as inorganic fillers and poly(methyl methacrylate) (PMMA) as an organic matrix were developed. Two kinds of partially crystallized glass beads, designated Cry820 and Cry850, were newly prepared by the heating of MgO-CaO-SiO(2)-P(2)O(5) glass at 820 and 850 degrees C, respectively. The glass beads were mixed with PMMA to form two new composites designated Cry820C and Cry850C, respectively. The goal of this study was to produce a highly osteoconductive and mechanically strong composite cement with these new fillers. A previously reported composite cement designated AWC, which was composed of apatite- and wollastonite-containing glass ceramic (AW-GC) as a powder filler and the same PMMA polymer used in the new composites, was used as a reference material. The quantity of filler added to each composite was 70 wt %. The bending strength of Cry820C was significantly higher than that of Cry850C. Composites were packed into intramedullary canals of rat tibiae to evaluate their osteoconductivity, as determined by an affinity index. The affinity index, which equaled the length of bone in direct contact with the composite surface expressed as a percentage of the total length of the composite surface, was calculated for each composite. The rats were euthanized at 4, 8, and 25 weeks after implantation. At each time interval studied, Cry820C showed a significantly higher affinity index than AWC up to 25 weeks after implantation. Cry850C showed a significantly higher affinity index than AWC up to 8 weeks and a higher affinity index than AWC at 25 weeks, although the difference was not significant. The values for each composite increased significantly with time up to 25 weeks. Our study revealed that the higher osteoconductivity of the new composites was due to the larger quantity of the glassy phase of the crystallized glass beads at the composite surface and the lower solubility of the PMMA powder to methyl methacrylate monomer. In addition, the spherical shape of the crystallized glass beads gave the new composites strong enough mechanical properties to be useful under weight-bearing conditions. The new composites show promise as alternatives, with improved properties, to conventional PMMA bone cement.

Interfacial tensile strength between polymethylmethacrylate-based bioactive bone cements and bone.

We have developed two types of polymethylmethacrylate (PMMA)-based bioactive bone cements containing bioactive glass beads (designated GBC) or apatite-wollastonite containing glass-ceramic powder (designated AWC) as the filler. A new method was used to evaluate the bone-cement interfacial strength of these bioactive bone cements. Two types of bioactive bone cements (GBC and AWC) and PMMA cement (CMW-1) were put in a frame attached to the smooth tibial metaphyseal cortex of the rabbit and polymerized in situ. The load required to detach the cement from the bone was measured at 4, 8, and 16 weeks after implantation. The interfacial tensile strength of GBC and AWC showed significantly higher values than PMMA cement from 4 weeks, and increased with time. For GBC, strength reached a maximum value of 12.39 +/- 1.79 kgf 16 weeks after implantation. Histological examination of rabbit tibiae up to 16 weeks demonstrated no intervening layer between the bioactive bone cements and the bone, whereas fibrous tissue was observed at the interface between the PMMA cement and the bone. From this study, we conclude that PMMA-based bioactive bone cements have a relatively higher adhesiveness at the interface than the conventionally used PMMA cement, showing potential as a promising alternative.