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PubMed1995

In vivo effect of pressurization of polymethyl methacrylate bone-cement. Biomechanical and histologic analysis.

Sixteen goats underwent total hip arthroplasty, half with pressurized and half with unpressurized bone-cement. The animals underwent hemiarthroplasty of the contralateral hip immediately prior to sacrifice 6 weeks later. Samples were tested for interface strength and evaluated histologically. Pressurization of polymethyl methylacrylate improves the strength of the bone-cement interface in vivo, as well as in vitro. There is a regional variation in the strength of the bone-cement interface both in vivo and in vitro. The regional variation in the in vivo model is at least in part due to a biologic effect. Membranes forming at the bone-cement interface are usually fibrous and incomplete, allowing direct cement-to-bone contact. Membranes appear to be involved in the remodeling of bone. Polymethyl methacrylate causes significant necrosis of the cortex, with ensuing resorption of the cortical bone. There is a small, statistically insignificant trend toward increased resorption and decreased bone formation with pressurized cement. The amount of necrosis appears to be similar with pressurized and nonpressurized cement. Bone remodels to fill defects in the cement mantle.

Animals↗
PubMed1996

Kinetic study of the setting reaction of a calcium phosphate bone cement.

The setting reaction of a calcium phosphate bone cement consisting of a mixture of 63.2 wt % alpha-tertiary calcium phosphate (TCP)[alpha-Ca3(PO4)2], 27.7 wt % dicalcium phosphate (DCP) (CaHPO4), and 9.1 wt % of precipitated hydroxyapatite [(PHA) used as seed material] was investigated. The cement samples were prepared at a liquid-to-powder ratio of: L/P = 0.30 ml/g. Bi-distilled water was used as liquid solution. After mixing the powder and liquid, some samples were molded and aged in Ringer's solution at 37 degrees C. At fixed time intervals they were unmolded and then immediately frozen in liquid nitrogen at a temperature of TN = -196 degrees C, lyofilized, and examined by X-ray diffraction as powder samples. The compressive strength versus time was also measured in setting samples of this calcium phosphate bone cement. The crystal entanglement morphology was examined by scanning electron microscopy. The results showed that: 1) alpha-TCP reacted to a calcium-deficient hydroxyapatite (CDHA), Ca9(HPO4)(PO4)5O H, whereas DCP did not react significantly; 2) the reaction was nearly finished within 32 h, during which both the reaction percentage and the compressive strength increased versus time, with a strong correlation between them; and 3) the calcium phosphate bone cement showed in general a structure of groups of interconnected large plates distributed among agglomerations of small crystal plates arranged in very dense packings.

Bone Cements↗
PubMed2006

Antimicrobial efficacy of gentamicin-loaded acrylic bone cements with fusidic acid or clindamycin added.

The increasing gentamicin resistance among bacteria in septic joint arthroplasty has stimulated interest in adding a second antibiotic into gentamicin-loaded bone cement. A first aim of this in vitro study is to investigate whether addition of fusidic acid or clindamycin to gentamicin-loaded bone cement has an additional antimicrobial effect against a collection of 38 clinical isolates, including 16 gentamicin-resistant strains. A modified Kirby-Bauer test, involving measurement of the inhibition zone around antibiotic-loaded bone cement discs on agar plates, was used to investigate whether adding a second antibiotic has an additional antimicrobial effect. Second, a selected number of strains was used to study their survival in an interfacial gap made in the different bone cements to mimic the gap between bone and cement as existing near a prosthesis. Gentamicin-loaded bone cement had an antimicrobial activity against 58% of the 38 bacterial strains included in this study, while 68% of the strains were affected by bone cement loaded with a combination of gentamicin and clindamycin. Bone cement loaded with the combination of gentamicin and fusidic acid had antimicrobial activity against 87% of the bacterial strains. In the prosthesis-related gap model, there was a clear trend toward less bacterial survival for gentamicin-loaded bone cement after adding clindamycin or fusidic acid. Addition of clindamycin or fusidic acid into gentamicin-loaded bone cement yields an additional antimicrobial effect. The combination gentamicin and fusidic acid was effective against a higher number of clinical isolates than the combination of gentamicin with clindamycin, including gentamicin-resistant strains.

Anti-Bacterial Agents↗
PubMed2002

[Biomechanical study on the composite of allogenic decalcified bone matrix gelatin and bone cement].

OBJECTIVE: To evaluate the biomechanical properties and structural characteristics of various composites of partially decalcified allogenic bone matrix gelatin and bone cement at different ratios. METHODS: According to Urist method, partially decalcified allogenic bone matrix gelatin was prepared and mixed with bone cement at different ratios of 0, 400, 500, and 600 mg/g. Then the comparisons of these composites were performed in microstructure, ultimate compression strength and ultimate bending strength properties. RESULTS: The electronic microscope showed that the bone particles and bone cement were distributed evenly in the composite, irregularly connecting by multiple points; with the increase of bone particles and decrease of bone cement in the composite, there were more and more natural crevices, varying from 100 microns to 400 microns in width, in the biomaterials. Of all the composites with the ratios of 0, 400, 500, and 600 mg/g, the measurements of ultimate compression strength were (71.7 +/- 2.0) MPa, (46.9 +/- 3.3) MPa, (39.8 +/- 4.1) MPa, and (32.2 +/- 3.4) MPa, respectively; and the measurements of ultimate bending strength were (65.0 +/- 3.4) MPa, (38.2 +/- 4.0) MPa, (33.1 +/- 4.3) MPa and (25.3 +/- 4.6) MPa, respectively. CONCLUSION: The composite of partially decalcified allogenic bone matrix gelatin and bone cement has a good biomechanical property and could be easily fabricated and re-shaped, which make it available to be used clinically as an idea bone graft biomaterial.

Biomechanical Phenomena↗
PubMed1998

Regulatory perspective on characterization and testing of orthopedic bone cements.

This paper provides a general regulatory background of acrylic bone cements, chemical composition information on several commercially available bone cements, physical and chemical methods of analyses, mechanical test methods, and risks and failure mechanisms of acrylic bone cements. Suggestions and recommendations presented in Tables 2 and 3 are not mandatory requirements but reflect data and methodologies which the FDA's Orthopedic Devices Branch (ORDB) believes to be acceptable to evaluate most pre-clinical data. FDA may require information in addition to that contained in this paper. In some instances, a sponsor may be able to sufficiently justify the omission of some tests. Although this paper describes certain administrative requirements, it does not take the place of the requirements contained in Title 21 of the Code of Federal Regulations (21 CFR) Parts 801, 807, 812, and 814 or those found in the statute.

Animals↗
PubMedDate not supplied

The use and handling of acrylic bone cement in Danish orthopaedic departments.

In order to evaluate the use and handling of acrylic bone cement, questionnaire were presented to all Danish orthopaedic departments in 1987 and again in 1992. Marked improvements in the environmental safety precautions for handling of bone cement had taken place during the 5-year period. In 1992, the intraoperative handling and use of bone cement is thus generally considered safe. Further improvements are still to be advocated in some departments. The exposure to methylmethacrylate monomer (MMA) vapour during the cementation procedures should be eliminated by local punctual field suction or change to a bone cement with a lower content of monomer (MMA/n-decylmethacrylate/isobornylmethylacrylate bone cement). Unnecessary manual contact with the cement should be avoided, and if contact is necessary, special protective gloves (butyl rubber gloves or 4H-gloves) should be used in addition to ordinary surgical gloves.

Air Pollutants, Occupational↗
PubMed1989

In vivo histologic and biomechanical characterization of a biodegradable particulate composite bone cement.

A biodegradable particulate composite bone cement consisting of a crosslinked gelatin matrix and tricalcium phosphate particles was implanted intraosseously in rabbits for up to 12 weeks. Cured cylindrical implants were inserted in holes drilled in the proximal tibial metaphysis. Sequential fluorochrome labeling and radiographs were done, and specimens were processed for decalcified and nondecalcified histology. At 4 weeks, the cross-sectional diameter of the implant was slightly greater than at implantation. There was considerable dissolution of the matrix and some new bone ingrowth. At 12 weeks, the diameter was reduced to half the original diameter and bone had grown throughout the matrix. In the distal femur, freshly mixed cement was used to stabilize an osteochondral fracture. Mechanical testing of the cement-stabilized fracture revealed a decrease in compressive strength and modulus at 4 weeks followed by an increase to greater than initial values at 12 weeks. Over time, the osteochondral fragment subsided into the underlying cement, but the subsidence did not correlate with mechanical strength. This osteochondral fracture model permits measurement of the overall material properties of a cement simultaneously weakened by resorption and reinforced by ingrowing bone.

Animals↗
PubMed1983

Contrast bone cement.

The effects of adding 1.0 cc of aqueous methylene blue dye as a visual contrast agent to a standard 40 g pack of acrylic bone cement are determined. These cements are evaluated: Simplex P (Radiopaque), Zimmer Bone Cement, and Zimmer LVC Bone Cement. Seven tests were performed. Leach out is less than 2.0% and was undetectable after day 8. Biocompatibility using a rabbit model shows contrast and white cement to be equivalent. Tension, compression, and 3- and 4-point bending strengths are not significantly altered except for a slight increase in 4-point bending strength for contrast Zimmer (regular) bone cement. Dough, set, and working times are decreased by 30-150 s. The ASTM F451 intrusion standards are met for all three contrast cements. Viscosity increases more rapidly for contrast cement, but remains sufficiently low (less than 100 N-s/m2) early after mixing to allow good penetration into bone. Ease of removal and visualization of contrast cement are shown by revision of cemented femoral total hip components in synthetic and cadaver femurs and by debriding cement particles from a soft tissue background coated with blood. The use of contrast bone cement appears to be both safe and efficacious for use in initial and revision total joint replacements. Because of the decreased working times, its use is recommended only by experienced surgeons.

Animals↗
PubMed2003

The use of bone cement induces an increase in serum astroglial S-100B protein in patients undergoing total knee arthroplasty.

UNLABELLED: Cerebral microemboli can occur during arthroplasty with the use of bone cement. Astroglial S-100B protein is a sensitive marker of cerebral damage. Therefore, we designed this study to determine the effect of bone cement on the brain by investigating serum levels of S-100B protein in patients undergoing bone surgery with or without bone cement. Fourteen patients undergoing knee arthroplasty (n = 7) or reamed intramedullary nailing for tibial fracture (n = 7) requiring a pneumatic tourniquet were enrolled in this study. Bone cement containing polymethyl methacrylate and methyl methacrylate was used for every patient undergoing knee arthroplasty. Serum samples were obtained from venous blood before the induction of general anesthesia, 15 min after deflation of a pneumatic tourniquet, and 3 days after the operation. The serum level of S-100B protein was significantly increased 15 min after a pneumatic tourniquet deflation in the knee arthroplasty group compared with the tibial fracture group (0.41 and 0.08 ng/mL, respectively; P < 0.05). In all patients studied, no neurological abnormalities were noted in the postoperative period. These results suggest that, in patients undergoing knee arthroplasty, bone cement may transiently induce astroglial injury, although it does not alter neurological outcome. IMPLICATIONS: Serum S-100B protein was significantly increased 15 min after a pneumatic tourniquet deflation in patients undergoing knee arthroplasty with bone cement, but not in those undergoing reamed intramedullary nailing for tibial fracture without bone cement. These results suggest that bone cement may transiently induce astroglial injury.

Aged↗
PubMed1988

Sustained pressurization of polymethylmethacrylate: a comparison of low- and moderate-viscosity bone cements.

There is at present great uncertainty relating to the fixation of joint implants. The deficiencies of acrylic bone cement are well documented, but the limitations of cementless fixation are as yet imcompletely identified. The purpose of this study was to investigate the potential of sustained external pressurization to improve the mechanical characteristics of conventional acrylic bone cement. The effect of serially increasing sustained pressurization of two commerically available acrylic bone cements (Simplex-P and LVC) was evaluated in human cadaver femora. A new method for determination of the shear strength of the bone-cement interface in place of the traditional pushout tests was used. In this model, there was a significant increase in the bone-cement interfacial shear strength with increasing pressure, but no difference in the shear strength was found between the two cements. At all pressure levels, the shear strength of the cement was greater than that previously reported. Increased cement penetration into the cortical bone was demonstrated with increasing pressure and low-viscosity cement, but the extent of cement penetration did not correlate with the shear strength of the bone-cement interface.

Adult↗
PubMed1997

Effect of crosslinking agents on poly(ethylmethacrylate) bone cements.

Asceptic loosening of cemented joint prostheses in many cases is related to the mechanical failure of the acrylic bone cement. Poly(methylmethacrylate) bone cements are widely used in orthopaedic surgery although there are well-known disadvantages. A lower modulus bone cement based on poly(ethylmethacrylate)-n-butylmethacrylate with a lower polymerization exotherm, and a low monomer extractibility, is a promising alternative. The effect of incorporating crosslinking agents in order to improve the mechanical performance of the PEMA bone cement is reported. Three different bifunctional dimethacrylate crosslinking agents with different chain lengths and degrees of flexibility were incorporated in the monomer phase, and cements formulated. The setting time was found to decrease in the presence of the cross-linking agents and the polymerization exotherm decreased in the presence of triethylene glycol dimethacrylate and polyethylene glycol dimethacrylate, n=400. Incorporation of triethylene glycol dimethacrylate showed an increase in the tensile strength and modulus with a decrease in the strain at maximum stress. However, polyethylene glycol dimethacrylate, n=400, did not improve the mechanical properties appreciably which may be attributed to the low crosslinking density and higher flexibility of the spacer group in the crosslinking agent.

Journal Article↗
PubMed1995

The effects of centrifugation and titanium fiber reinforcement on fatigue failure mechanisms in poly(methyl methacrylate) bone cement.

The contributions to fatigue resistance in poly(methyl methacrylate) bone cement (PMMA) by centrifugation and titanium fiber addition were studied. Three modified bone cements were tested: porosity reduced cement (C-PMMA); titanium (Ti) fiber-reinforced cement (R-PMMA), using a novel method to incorporate fibers; and porosity reduced and Ti fiber-reinforced cement (C-R-PMMA). Specimens of untreated bone cement (PMMA) were included as controls. Non-notched and notched specimens were cyclically loaded in fully reversed bending. For the non-notched specimens, at all stress levels, C-R-PMMA had significantly greater fatigue life than either C-PMMA or R-PMMA (except C-PMMA at 30 MPa). R-PMMA had lower fatigue life than the control at 30 MPa (nominal maximum stress), but higher fatigue life at 20 and 15 MPa. At both 20 and 15 MPa, there was no statistical difference between the fatigue lives of C-PMMA and R-PMMA. Fractography revealed that, at 30 MPa, characteristics of rapid fracture predominated. At 20 and 15 MPa, in contrast, almost the entire fracture surface showed the characteristic fatigue morphology, indicating that subcritical crack growth was predominant. For the notched specimens, C-PMMA showed greater life than PMMA at the highest stress intensity, but the lifetimes converged with decreasing stress intensity. In contrast, the life-times for PMMA and R-PMMA diverged with decreasing stress intensity. The effect of centrifugation appeared to be strongest at higher stress intensities, and diminished with decreasing stress intensity. The reinforcing effect of Ti fiber addition increased the notched fatigue life at high initial stress intensities, and the reinforcing effect increased with decreased stress intensity.(ABSTRACT TRUNCATED AT 250 WORDS)

Biocompatible Materials↗
PubMed2005

Bone-cement interface of the glenoid component: stress analysis for varying cement thickness.

BACKGROUND: Although shoulder arthroplasty is an accepted treatment for osteoarthritis, loosening of the glenoid component, which mainly occurs at the bone-cement interface, remains a major concern. Presently, the mechanical effect of the cement mantel thickness on the bone-cement interface is still unclear. METHODS: Finite element analysis of a prosthetic scapula was used to evaluate the effect of cement thickness on stresses and micromotions at the bone-cement interface. The glenoid component was all-polyethylene, keeled and flat back. Cement mantel thickness was gradually increased from 0.5 to 2.0 mm. Two glenohumeral contact forces were applied: concentric and eccentric. Two extreme cases were considered for the bone-cement interface: bonded and debonded. FINDINGS: Within cement, stress increased as cement thickness decreased, reaching the fatigue limit below 1.0 mm. Bone stress was below its ultimate strength and was minimum between 1.0 and 1.5mm. Interface stress was close to the interface strength, and also minimum between 1.0 and 1.5 mm. Both the decentring of the load and the debonding of the interface increased the stress. INTERPRETATION: A cement thinning weakens the cement, but also the bone-cement interface, along the back-keel edges. Conversely, a cement thickening rigidifies the cemented implant, consequently increasing interfacial stresses and micromotions. To avoid both excessive cement fatigue and interface failure, an ideal cement thickness has been identified between 1.0 and 1.5 mm.

Bone Cements↗
PubMed2005

The effect of the antimicrobial peptide, Dhvar-5, on gentamicin release from a polymethyl methacrylate bone cement.

The objective of this study was to investigate the release mechanism and kinetics of the antimicrobial peptide, Dhvar-5, both alone and in combination with gentamicin, from a standard commercial polymethyl methacrylate (PMMA) bone cement. Different amounts of Dhvar-5 were mixed with the bone cement powders of Osteopal and the gentamicin-containing Osteopal G bone cement and their release kinetics from the polymerized cement were investigated. Additionally, the internal structure of the bone cements were analysed by scanning electron microscopy (SEM) of the fracture surfaces. Secondly, porosity was investigated with the mercury intrusion method and related to the observed release profiles. In order to obtain an insight into the mechanical characteristics of the bone cement mixtures, the compressive strength of Osteopal and Osteopal G with Dhvar-5 was also investigated. The total Dhvar-5 release reached 96% in the 100 mg Dhvar-5/g Osteopal cement, whereas total gentamicin release from Osteopal G reached only 18%. Total gentamicin release increased significantly to 67% with the addition of 50mg Dhvar-5/g, but the Dhvar-5 release was not influenced. SEM showed an increase of dissolved gentamicin crystals with the addition of Dhvar-5. The mercury intrusion results suggested an increase of small pores (< 0.1 microm) with the addition of Dhvar-5. Compressive strength of Osteopal was reduced by the addition of Dhvar-5 and gentamicin, but still remained above the limit prescribed by the ISO standard for clinical bone cements. We therefore conclude that the antimicrobial peptide, Dhvar-5, was released in high amounts from PMMA bone cement. When used together with gentamicin sulphate, Dhvar-5 made the gentamicin crystals accessible for the release medium presumably through increased micro-porosity (< 0.1 microm) resulting in a fourfold increase of gentamicin release.

Antimicrobial Cationic Peptides↗
PubMed2005

Vertebroplasty by use of a strontium-containing bioactive bone cement.

STUDY DESIGN: A review of the laboratory and clinical data for a new strontium-containing hydroxyapatite bioactive bone cement. OBJECTIVES: To compare the properties of the strontium-containing bioactive bone cement with those of polymethyl methacrylate (PMMA) and hydroxyapatite (HA) bone cements. SUMMARY OF BACKGROUND DATA: Vertebroplasty and kyphoplasty using conventional PMMA bone cements have been effectively used to treat osteoporotic spine fractures with good short- and medium-term results. However, PMMA has some undesirable properties, including its high setting temperature, lack of osseointegration, and large stiffness mismatch with osteoporotic bone. These properties are responsible for some postoperative complications. METHODS: Strontium-containing hydroxyapatite (Sr-HA) bioactive bone cement consists of a filler blend of strontium-containing hydroxyapatite, fumed silica and benzoyl peroxide; and a resin blend of bisphenol A diglycidylether methacrylate, triethylene glycol dimethacrylate, poly(ethylene glycol) methacrylate, and N, N-dimethyl-p-toluidine. Its properties, including mechanical strength, setting temperature, biocompatibility, and osseoinduction, were compared with other cements in vitro and in vivo. Early clinical results are presented. RESULTS: The Sr-HA cement has a setting time of 15 to 18 minutes, a maximum setting temperature of 58 degrees C, a compressive strength of 40.9 MPa, bending strength of 31.3 MPa, and a bending modulus of 1,408 MPa. The bending strength and modulus are closer to human cancellous bone. Sr-HA cement promotes osteoblast attachment and mineralization in vitro and bone growth and osseointegration in vivo. In a pilot study, 23 cases of osteoporotic fractures treated with this cement with a mean follow-up of 18 months suggest that it is as effective as PMMA in relieving pain. DISCUSSIONS: Oral strontium has been shown to induce new bone formation and is effective in reducing fracture risk in osteoporosis. Our data suggest that strontium delivered locally has the same effect; thus, the combination of strontium with HA in a cement with a low setting temperature, adequate stiffness, and low viscosity makes this a good bioactive cement for vertebroplasty and kyphoplasty.

Animals↗
PubMed1999

Biomechanical evaluation of fixation of intra-articular fractures of the distal part of the radius in cadavera: Kirschner wires compared with calcium-phosphate bone cement.

BACKGROUND: The purpose of this study was to compare the biomechanical efficacy of an injectable calcium-phosphate bone cement (Skeletal Repair System [SRS]) with that of Kirschner wires for the fixation of intraarticular fractures of the distal part of the radius. METHODS: Colles fractures (AO pattern, C2.1) were produced in ten pairs of fresh-frozen human cadaveric radii. One radius from each pair was randomly chosen for stabilization with SRS bone cement. These ten radii were treated with open incision, impaction of loose cancellous bone with use of a Freer elevator, and placement of the SRS bone cement by injection. In the ten control specimens, the fracture was stabilized with use of two horizontal and two oblique Kirschner wires. The specimens were cyclically loaded to a peak load of 200 newtons for 2000 cycles to evaluate the amount of settling, or radial shortening, under conditions simulating postoperative loading with the limb in a cast. Each specimen then was loaded to failure to determine its ultimate strength. RESULTS: The amount of radial shortening was highly variable among the specimens, but it was consistently higher in the Kirschner-wire constructs than in the bone fixed with SRS bone cement within each pair of radii. The range of shortening for all twenty specimens was 0.18 to 4.51 millimeters. The average amount of shortening in the SRS constructs was 50 percent of that in the Kirschner-wire constructs (0.51+/-0.34 compared with 1.01+/-1.23 millimeters; p = 0.015). With the numbers available, no significant difference in ultimate strength was detected between the two fixation groups. CONCLUSIONS: This study showed that fixation of an intra-articular fracture of the distal part of a cadaveric radius with biocompatible calcium-phosphate bone cement produced results that were biomechanically comparable with those produced by fixation with Kirschner wires. However, the constructs that were fixed with calcium-phosphate bone cement demonstrated less shortening under simulated cyclic load-bearing.

Biomechanical Phenomena↗