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Osteolysis in alloarthroplasty of the hip. The role of bone cement fragmentation.

Movement at the interface between bone and cement and fractures of the cement can cause fragmentation of the polymethylmethacrylate (PMMA) bone cement implant. In order to obtain further information about the effect of PMMA fragments on the surrounding tissue and the role of such particles in the development of bone resorption, the authors investigated 17 patients with cemented total hip endoprostheses showing osteolysis and implant loosening in the femoral shaft with (Group B) and without (Group A) involvement of the acetabulum. The roentgenographic follow-up examinations revealed an initially slow and later more rapid extension of the endosteal bone erosions, with a predilection for the tip of the stem, the lesser trochanter, and laterally for the middle of the stem. At revision surgery, tissue samples were taken from the joint capsule and the bone-cement interface, in particular from the osteolysis in the femoral shaft and the acetabulum. The tissue samples were processed for histology, microscopically examined, and semiquantitatively evaluated. The retrieved devices were also carefully inspected. Large foreign-body granulomas were found at the bone-cement interface and in the joint capsule. Histiocytes and foreign-body giant cells stored particles of PMMA and polyethylene, of which fragmented bone cement predominated. Granulomatous tissue invaded bone canals and marrow spaces and induced resorption of the surrounding bone. In four cases in Group A, tissue from the osteolysis contained only fragmented bone cement, demonstrating that PMMA particles alone may be responsible for triggering focal bone resorption. Osteolysis seems to begin at the site where disintegration of bone cement begins. In cases in which polyethylene particles were found in the tissue in addition to fragmented bone cement, wear from the ultrahigh molecular weight polyethylene socket has been increased by entrapment of PMMA particles between the joint surfaces. Thus, fragmentation of bone cement and abrasion of polyethylene enhance each other. Bone cement particles promote polyethylene wear, which in turn promotes granuloma formation, bone resorption, and subsequent bone cement disintegration.

Acetabulum↗

Comprehensive biocompatibility testing of a new PMMA-hA bone cement versus conventional PMMA cement in vitro.

For more than 50 years PMMA bone cements have been used in orthopaedic surgery. In this study attempts were made to show whether cultured human bone marrow cells (HBMC) show an osteogenetic response resulting in new bone formation, production of extracellular matrix (ECM) and cell differentiation when they were cultured onto polymerized polymethylmethacrylate (PMMA)-hydroxyapatite (HA), conventional PMMA bone cement being taken as reference. Biocompatibility parameters were collagen-I and -II synthesis, the detection of the osteoblast markers alkaline phosphatase (ALP) and osteocalcin, the number of adherent cells and the cytodifferentiation of immunocompetent cells. Cement surface structure, HA stability in culture medium and chemical element analysis of specimens were considered. Fresh marrow cells were obtained from the human femora during hip replacement. Incubation time was up to ten weeks. We used atomic forced microscopy (AFM) and scanning electron microscopy (SEM) for cement specimen analysis. Fluorescent activated cell sorter (FACS), immunohistochemical staining. SEM and light microscopy (LM) served us to judge the cellular morphology. Products of the extracellular matrix were analyzed by protein dot blot analysis, SEM energy dispersive X-ray analysis (SEM-EDX) and Ca2+/PO(4)3- detection. HA particles increased the osteogenetic potential of PMMA bone cement regarding the cellular production of collagen, alkaline phosphatase (AP), the number of osteoblasts and the cellular differentiation pattern in vitro. Both tested cements showed good biocompatibility in a human long-term bone marrow cell-culture system.

Bone Cements↗

New ferromagnetic bone cement for local hyperthermia.

We have developed a ferromagnetic bone cement as a thermoseed to generate heat by hysteresis loss under an alternate magnetic field. This material resembles bioactive bone cement in composition, with a portion of the bioactive glass ceramic component replaced by magnetite (Fe3O4) powder. The temperature of this thermoseed rises in proportion to the weight ratio of magnetite powder, the volume of the thermoseed, and the intensity of the magnetic field. The heat-generating ability of this thermoseed implanted into rabbit and human cadaver tibiae was investigated by applying a magnetic field with a maximum of 300 Oe and 100 kHz. In this system, it is very easy to increase the temperature of the thermoseed in bone beyond 50 degrees C by adjusting the above-mentioned control factors. When the temperature of the thermoseed in rabbit tibiae was maintained at 50 to 60 degrees C, the temperature at the interface between the bone and muscle (cortical surface) surrounding the material rose to 43 to 45 degrees C; but at a 10-mm distance from the thermoseed in the medullary canal, the temperature did not exceed 40 degrees C. These results demonstrate that ferromagnetic bone cement may be applicable for the hyperthermic treatment of bone tumors.

Animals↗

A small punch test technique for characterizing the elastic modulus and fracture behavior of PMMA bone cement used in total joint replacement.

Polymethylmethacrylate (PMMA) bone cement is used in total joint replacements to anchor implants to the underlying bone. Establishing and maintaining the integrity of bone cement is thus of critical importance to the long-term outcome of joint replacement surgery. The goal of the present study was to evaluate the suitability of a novel testing technique, the small punch or miniaturized disk bend test, to characterize the elastic modulus and fracture behavior of PMMA. We investigated the hypothesis that the crack initiation behavior of PMMA during the small punch test was sensitive to the test temperature. Miniature disk-shaped specimens, 0.5 mm thick and 6.4 mm in diameter, were prepared from PMMA and Simplex-P bone cement according to manufacturers' instructions. Testing was conducted at ambient and body temperatures, and the effect of test temperature on the elastic modulus and fracture behavior was statistically evaluated using analysis of variance. For both PMMA materials, the test temperature had a significant effect on elastic modulus and crack initiation behavior. At body temperature, the specimens exhibited "ductile" crack initiation, whereas at room temperature "brittle" crack initiation was observed. The small punch test was found to be a sensitive and repeatable test method for evaluating the mechanical behavior of PMMA. In light of the results of this study, future small punch testing should be conducted at body temperature.

Arthroplasty, Replacement↗

Exothermal characteristics and release of residual monomers from fiber-reinforced oligomer-modified acrylic bone cement.

The aim of this study is to determine the peak temperature of polymerization, the setting time and the release of residual monomers of a modified acrylic bone cement. Palacos R, a commercial bone cement, is used as the main component. The cement is modified by adding short glass fibers and resorbable oligomer fillers, and an additional cross-linking monomer. The test specimens are classified according to the composition of the bone cement matrix (i.e., oligomer-filler, glass-fiber reinforcement, and/or cross-linking monomer). The exothermal characteristics during autopolymerization are analyzed using a transducer connected with a computer. The quantities of residual monomers were analyzed from different test groups using high performance liquid chromatography (HPLC). The DeltaT value for the oligomer filler and the glass-fiber-containing acrylic bone cement is lower than that for the unmodified bone cement (2.1 +/- 0.8 vs. 23.5 +/- 4.2 degrees C). The addition of a cross-linking monomer, EGDMA, shortens the setting time of the autopolymerization of the unmodified bone cement (7.1 +/- 0.9 min vs. 3.3 +/- 0.3 min). The quantity of the residual monomers released is higher in the modified bone cement than that in the unmodified cement. The cement that contains glass fibers and oligomer fillers has a considerably lower exothermal peak, whereas the total quantity of residual monomers released is increased.

Cementation↗

Bone-particle-impregnated bone cement: an in vivo weight-bearing study.

To evaluate an experimental inorganic-bone-particle-impregnated bone cement, canine hip prostheses were implanted in dogs using a regular bone cement on one side and the experimental bone cement on the other. In a preliminary feasibility study, bone ingrowth into the resorbed bone-particle spaces was established 3 months after implantation in three dogs. In a more detailed study, twenty-eight (28) dogs were divided in four groups to delineate the effects of time on the phenomena of bony ingrowth. One month after implantation, active bone ingrowth into the bone cement was obvious. By 3 months postimplantation, the ingrowth appeared to have traversed the thickness of the bone-particle-impregnated cement. By the fifth month, most of the interconnected inorganic bone particles were replaced by new bone. At the end of a year, the ingrown bone was mature and negligible new bone activity was present. Biomechanical pushout tests closely corroborated the histologic observations. The maximum shear strength of the cement/bone interface of the experimental side reached 3.6 times that of the control side at 5 months postimplantation. No further improvements were seen at 12 months postimplantation. A viable bone/cement interface may result in a better orthopedic implant fixation system by combining the advantages of both cement for immediate rigidity and biological ingrowth for longterm stability.

Animals↗

Mechanical properties of bone cement: a review.

Many authors have examined the mechanical properties of bone cement and the various factors that affect its mechanical behavior. This article presents a comprehensive survey on the reported mechanical properties of bone cement. Variables that influence the mechanical properties, such as handling characteristics, strain rate, loading modes, additives, porosity, blood inclusion, in vivo environment, temperature, etc. have also been reviewed. The importance of specifying these variables in reporting test results on the mechanical properties of bone cement is pointed out. Previous attempts to improve the mechanical properties of bone cement are also summarized. Future research areas important for fully characterizing the physical properties of PMMA are also suggested.

Anti-Bacterial Agents↗

The science of bone cement: a historical review.

The use of PMMA bone cement has been a key factor in the advent of joint replacement as a surgical option. Despite revolutionary changes in joint replacement technology for the treatment of hip and knee arthritis, the use of PMMA bone cement in its intraoperative application has not significantly changed since Harris' description of third generation cement technique. Future answers to questions regarding cemented implant longevity may lie in the further improvement of existing PMMA technology and standardization of the manufacturing of PMMA bone cement intraoperatively.

Arthroplasty, Replacement↗

Some failure modes of four clinical bone cements.

The fracture or failure behaviours of four commercial acrylic-based bone cements have been examined in tensile, bending and compression modes, and their mechanical properties are reviewed. It was found that Palacos R-40 bone cement had high radiopaque agent concentration, with high surface hardness. It exhibited a much lower bending strength and bending modulus compared with the other three bone cements (CMW1, CMW2000 and Simplex P). The textures of tensile fracture surfaces produced were similar for the four bone cements studied. The fracture surface was fragmented by crevices, which developed through the matrix and around large undissolved polymethylmethacrylate (PMMA) beads. Three bands with different features existed on the bending fracture surfaces, with an abrupt transition between them. It appears that the agglomerates of zirconium dioxide particles are implicated in Palacos R-40 bone cement fracture surface. The examination of compressive failed specimens revealed that a 'yielded crack band' existed across the transverse section. Plastic deformation resulted in the PMMA beads being squashed in the longitudinal direction and dilated in the transverse direction.

Biomechanical Phenomena↗

Pre-coated orthopedic implants with bone cement.

A study on the feasibility of implants pre-coated with an acrylic bone cement has been performed. Four types of implants, an actual canine femoral prosthesis, a polished steel rod (0.49 cm dia. x 13 cm long) with and without pre-coating, and a sandblasted steel rod with pre-coating were implanted into canine femurs in vitro and in vivo to evaluate the interfacial shear strengths in addition to the bench test. After serial sectioning the samples in discs, push-out tests were made to evaluate the interfacial strengths of cement-bone-implant. The weakest interfacial shear strength was exhibited by the polished rod/cement interface (0.5 MPa) while the strongest was the "old" and "new" cement interface (23.4 MPa). The bone/cement interfacial strength was in between for in vitro (1.17 MPa) and in vivo (1.68 MPa). The shear strength of rod/cement interface increased substantially by sandblasting (6.84 MPa). The microscopic observation of the interface showed somewhat smaller gaps developed for the pre-coated rod than the uncoated rod due to the shrinkage effect. In addition to the overall increase in interfacial strength, the pre-coating may furthermore reduce the setting temperature, the shrinkage, and the amount of monomer released during operation due to the reduced amount of cement at the time of implantation. The more gradual transmission of load from implant to bone and "auto-centering" of implants during operation by pre-coating, are believed to be advantageous over conventional cement fixation method.

Animals↗

Radiopacity in bone cements using an organo-bismuth compound.

In a joint replacement surgery it is vital for bone cement to be radiologically detectable. Consequently, heavy metal salts of barium and zirconia are incorporated as a contrast medium for this purpose. The addition of such particulate additives, however, can be detrimental to some of the physical, mechanical and biological properties. The present study reports the feasibility of using an organo-bismuth compound, namely. triphenyl bismuth (TPB) as a radiopaque agent for orthopaedic bone cements. TPB was incorporated in the bone cement matrix by two methods, (i) blending: TPB was added to the polymer phase of the bone cement and (ii) dissolution: by dissolving TPB in the monomer phase methylmethacrylate. The results showed that the inclusion of TPB at concentrations of 15% and 25% by weight of the polymer, in the bone cement matrix did not affect the polymerisation exotherm temperature and setting time. Furthermore, the addition of TPB via the dissolution method provided a statistically significant increase in the strain to failure in comparison to commercial acrylic cements containing barium sulphate, thus reducing the brittleness of the cement. The detrimental effects on the mechanical properties post conditioning in water, was also much less pronounced in the homogeneous TPB cements in comparison to barium sulphate containing cements. These observations can be attributed to the formation of a homogeneous and continuous matrix of the resultant bone cement with a much lower porosity.

Bismuth↗

Does vacuum mixing of bone cement affect heat generation? Analysis of four cement brands.

Four different brands of bone cement (Palacos R, Simplex P, Sulfix, CMW 1) were tested for exothermic changes during polymerization at atmospheric pressure and under partial vacuum of 0.2 bar. Palacos R was also mixed at four pressure levels (1.0, 0.2, 0.12, and 0.05 bar). The peak temperature in the bone cement was 46 to 124 degrees C, depending on the measuring point. There was no difference in peak temperature or duration of temperature increase above 50 degrees C during the curing of cement whether mixed at atmospheric pressure or under partial vacuum at different pressure levels.

Biocompatible Materials↗

Free volume and mechanical properties of Palacos R bone cement.

The free volume and the mechanical properties of Palacos R bone cement were determined from positron annihilation lifetime spectroscopy (PALS) and from dynamic mechanical thermal analysis (DMA) in the temperature ranges 24-220 degrees C and 30-120 degrees C, respectively. The heating of bone cement caused an appreciable reduction of the free volume, measured as a decrease in the ortho-positronium lifetime tau(3) from 2.04 to 1.91 ns, as well as a clear increase in the storage modulus from 2.3 to 3.0 GPa. The changes in free volume and storage modulus after the heat treatment were interpreted as an effect of elimination of residual monomer from the bone cement. The free volume of the bulk-polymerized phase of bone cement was estimated from a simple difference method, suggesting that the residual monomer was eliminated from the bone cement between 60 and 90 degrees C, thus implying a glass transition temperature of only 60 degrees C for the bulk-polymerized phase. The spherical free volume cavity size estimated from the ortho-positronium lifetime V(tau(3)), and the storage modulus E'(storage) from DMA measurements were found to correlate by a linear relationship throughout the studied temperature range, and the correlation appeared to be independent of the presence of residual monomer.

Journal Article↗

Antibiotic-loaded bone cement for infection prophylaxis in total joint replacement.

Use of antibiotic-loaded bone cement for prophylaxis against infection is not indicated for patients not at high risk for infection who are undergoing routine primary or revision joint replacement with cement. The mechanical and elution properties of commercially available premixed antibiotic-loaded bone-cement products are superior to those of hand-mixed preparations. Use of commercially available antibiotic-loaded bone-cement products has been cleared by the United States Food and Drug Administration only for use in the second stage of a two-stage total joint revision following removal of the original prosthesis and elimination of active periprosthetic infection. Use of antibiotic-loaded bone cement for prophylaxis against infection in the second stage of a two-stage total joint revision involves low doses of antibiotics. Active infection cannot be treated with commercially available antibiotic-loaded bone cement as such treatment requires higher doses of antibiotics.

Anti-Bacterial Agents↗

A fractographic analysis of in vivo poly(methyl methacrylate) bone cement failure mechanisms.

Cementing with poly(methyl methacrylate) (PMMA) is a common means of fixing total hip prostheses. Bone cement fails mechanically, and subsequent loosening frequently requires correction via revision surgery. An initial step in optimizing bone cement properties is to establish which properties are critical to the material's in vivo performance. The objectives were to discern the critical in vivo failure mechanisms of bone cement. Fracture surfaces of bone cement specimens that failed in vivo were compared with fatigue and rapid fracture surfaces created in vitro. In vivo fracture processes of bone cement were positively identified and explained by the elucidation of PMMA fracture micromechanisms. The ex vivo fracture surfaces are remarkably similar to in vitro fatigue fracture surfaces. The fractographic data document that the primary in vivo failure mechanism of bone cement is fatigue, and the fatigue cracks grow by developing a microcraze shower damage zone. Agglomerates of BaSO4 particles can be implicated in some bone cement failures, large flaws or voids in vivo can lead to a rapid, unstable fracture, pores in the PMMA mass have a clear influence on a propagating crack, and wear of the fracture surfaces occurs, and may produce PMMA debris, exacerbating bone destruction.

Aged↗

Modeling the tensile behavior of the cement-bone interface using nonlinear fracture mechanics.

The tensile mechanical behavior of the cement-bone interface where there was a large process (plastic) zone at the interface was modeled using a nonlinear fracture mechanics approach. A finite element method was employed, which included a piecewise nonlinear interface, to investigate the behavior of experimental cement-bone test specimens and an idealized stem-cement-bone (SCB) structure. The interface model consisted of a linear elastic region with high stiffness until the yield strength was reached, followed by an exponential softening region, until zero stress. The yield strength and rate of exponential softening after yielding at the cement-bone interface were shown to have a marked effect on the structural stiffness of the SCB model. The results indicate that both yield strength and postyield behavior should be included to characterize the mechanics of the cement-bone interface fully.

Bone Cements↗

High-performance liquid chromatography assay of N,N-dimethyl-p-toluidine released from bone cements: evidence for toxicity.

Five commercially available bone cements were analysed by high-performance liquid chromatography for detecting the residual content of an accelerator, the amine N,N-dimethyl-p-toluidine (DMPT), after curing. It was found that the concentration of DMPT in aqueous extracts decreases with time, being almost absent 7 days after curing. Differences were noticed among the cements; residual DMPT is higher in cements prepared with higher content of the amine. It is verified that DMPT's toxic effect on cell cultures is dose-related; a delay in the cell replication cycle is induced in vitro. Damage is reversible, thus justifying the low bone cement toxicity that is clinically ascertained.

Bone Cements↗

The modulus of elasticity and flexural strength of some acrylic bone cements.

The modulus of elasticity and flexural strength were measured for three bone cements, CMW Bone Cement, Surgical Simplex, and Palacos R. with various additions and prepared as in actual use. A distinct afterpolymerization was demonstrated in all three brands. The addition of blood lowered the E-modulus wheras radio-opaque media seemed to render them somewhat stiffer. The rupture values demonstrated the inhomogeneity of the final product in all three brands. The possible clinical significance of the findings is discussed.

Bone Cements↗