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Bone cement implantation syndrome. A prospective randomised trial for use of antihistamine blockade.

Bone cement implantation syndrome (BCIS) is characterised by hypotension, hypoxaemia, cardiac arrhythmias, cardiac arrest or any combination of these, leading to death in 0.6-1% of patients. One of the mechanisms suggested to explain these complications is diffuse microembolisation of the lungs as a consequence of extrusion of the bone marrow content by the pressurised bone cement. By reducing intramedullary pressure and changing the operative technique, BCIS can be diminished, but deaths still occur. An anaphylactoid mechanism as a major factor in BCIS is receiving renewed attention since increased plasma histamine levels were recently demonstrated after the implantation of bone cement and a prosthesis. Therefore, we conducted a prospective, randomised study to demonstrate the potential benefit of histamine-receptor-blocking agents in patients undergoing cemented hip arthroplasty. Thirty patients were divided into two groups: group 1, the control group, received no histamine-receptor-blocking agents; group 2, the antihistamine group, received H1 and H2-receptor-blocking agents in standard dosages preoperatively. Both groups were comparable concerning age, sex and physical status (ASA criteria). There was no hospital mortality in either group. Thirteen patients of group 1 demonstrated a sudden fall by more than 10% of their blood pressure, level of PaO2 or both. Fourteen patients of group 2 showed similar changes. The mean decrease of blood pressure in group 1 was 14.6 mmHg (SD 36.8) and in group 2 20.5 mmHg (SD 33.43). The difference is not significant (P = 0.65). The mean decrease of PaO2 in group 1 was 30.5 mmHg (SD 30.5) and in group 2 33.4 mmHg (SD 34.1). The difference is not significant (P = 0.81). Overall, we found even a slight disadvantage for patients receiving antihistamine drugs (statistically not significant). Therefore, histamine-receptor-blocking agents do not have a prophylactic potential in BCIS.

Bone Cements↗

Biomechanical assessment of a new adhesive bone cement for otologic surgery.

The adhesion of metallic prostheses to bone is a major problem in otologic surgery. Conventional bone cements lack significant adhesive strength, which predisposes the cemented prosthesis to loosening. The advent of surgically implantable hearing devices is one example where an adhesive cement to secure metal to bone would be useful. The biomechanical properties of a new cement, 4-META/MMA-TBB opaque resin, were evaluated in an animal model. The cement is composed of 4-methacryloyloxyethyl trimellitate anhydride (4-META) and methyl methacrylate (MMA) as monomers and tri-n-butyl borane (TBB) as an initiator. Titanium disks were cemented to the tibias of rabbits, which were sacrificed at 0 and 90 days. Tensile and shear bond strengths between bone and metal were tested at both times. The mean baseline tensile and shear bond strengths were 8.92 MPa and 11.96 MPa, respectively. Adhesive failure occurred at the bone-cement interface. The decrease in bond strength at 90 days was minimal. Thus, 4-META/MMA-TBB cement is a promising new metal-to-bone adhesive that may be useful for the surgical fixation of metallic prostheses in otologic surgery.

Adhesives↗

Biological response of new activated acrylic bone cements with antiseptic properties. Histomorphometric analysis.

The biological response to an acrylic bone cement cured with 4,4'-bis-dimethylamino benzydrol (BZN) as activator of reduced cytotoxicity and antiseptic properties, has been carried out and compared with that obtained for CMW 3 cement. Histomorphometrical data (undecalcified trichromic Goldner staining) were obtained by measuring the most significant variables at the bone-cement interface. Quantitative results of tissue response revealed that newly formed bone and connective tissue were maximum at 4 weeks whereas bone marrow increased with time of implantation for both cements. Statistical analysis (p < 0.05) showed no significant differences in newly formed bone and bone marrow with time and between both groups, however, connective tissue significantly decreased between 4 weeks and 12 weeks for BZN cement, and between 12 weeks and 24 weeks for CMW3. By comparing both cements at each time, lower significant percentage of connective tissue at the bone-cement interface of the BZN cement, was obtained at 12 and 24 weeks, however, a very low amount of connective tissue was found for both cements. All the results indicate that the new activated system could be applied clinically in a relatively short time, after the corresponding preclinical study.

Animals↗

Thrombomodulin expression in endothelial cells after contact with bone cement.

The expression of thrombomodulin after contact with CMW 1 bone cement extracts was studied in human umbilical vein endothelial cells. Cement extracts after 1 h and 7-day curing induced no significant variations in thrombomodulin antigen levels and in mRNA expression. Significant increase of thrombomodulin was observed when endothelial cells were treated with all-trans retinoic acid (ATRA). ATRA induced the increase of thrombomodulin also in cells incubated with cement extracts. These results suggest that CMW 1 bone cement does not impair the expression of thrombomodulin in endothelial cells.

Bone Cements↗

[New PMMA bone cements for vacuum mixing systems].

In cemented total hip replacement, fractures and cracks in the cement mantle may facilitate mechanical loosening of the prosthesis. Especially large voids and flaws within the cement can cause fatigue fractures. Reduction of cement porosity is a logical step in the attempt to improve the quality and durability of bone cement. An effective reduction of pores during vacuum mixing requires prechilling of Palacos R at 4 degrees C. For easier handling, new bone cements have been developed with characteristics similar to Palacos R, but with no chilling necessary prior to mixing under vacuum. In our study two newly developed bone cements (Palamed G, VersaBond) and a bone cement used widely in clinics (Palacos R) were mixed in three different vacuum mixing systems (Optivac, MixOR, Palamix). Macro-, micro-, and total porosity and bending strength (ISO 5833) were determined. All three mixing systems proved effective in reducing porosity and showed constant mixing results. All cement specimens that we tested fulfilled the ISO requirements for bending strength. VersaBond yielded the lowest porosities, but showed lower viscosity compared to Palacos R and Palamed G. The new cements are equal in vitro to Palacos R with regard to bending strength, but further clinical studies are necessary before widespread use is advisable.

Arthroplasty, Replacement, Hip↗

Bone cement X-ray contrast media: a clinically relevant method of measuring their efficacy.

It is important to compare different contrast media used in bone cement according to their ability to attenuate X-rays and thereby produce image contrast between bone cement and its surroundings in clinical applications. The radiopacity of bone cement is often evaluated by making radiographs of cement in air at an X-ray tube voltage of 40 kV. We have developed a method for ranking contrast media in bone cement simulating the clinical situation, by (1) choosing the same X-ray tube voltage as used in clinical work, and (2) using a water phantom to imitate the effects of the patients' soft tissue on the X-ray photons. In clinical work it is desirable to have low radiation dose, but high image contrast. The voltage chosen is a compromise, because both dose and image contrast decrease with higher voltage. Three contrast media (ZrO(2), BaSO(4), and Iodixanol) have been compared for degree of "image contrast." Comparing 10 wt % contrast media samples at an X-ray tube voltage of 40 kV, ZrO(2) produced higher image contrast than the other media. However, at 80 kV, using a water phantom, the results were reversed, ZrO(2) produced lower image contrast than both BaSO(4) and Iodixanol. We conclude that evaluations of contrast media should be made with voltages and phantoms imitating the clinical application.

Barium Sulfate↗

Additional mechanical tests of bone cements.

A revision of the ISO-standard for bone cement testing has been proposed to include compressive strength after 24 hours in air and 4-point bending testing after 50 hours in a 37 degrees water bath. Nine commercially available bone cements were tested in accordance with the new program. Compressive strength varied from 78 to 100 MPa, bending strength from 48 to 74 MPa and bending modulus from 2.2 to 2.8 GPa. The highest strengths, but also the highest stiffness, were encountered with Simplex brands and low-viscosity cements.

Acrylic Resins↗

Norian craniofacial repair system bone cement for the repair of craniofacial skeletal defects.

PURPOSE: To describe the use of the Norian Craniofacial Repair System (CRS) calcium phosphate bone cement in the restoration of craniofacial skeletal defects. METHODS: Consecutive case series. RESULTS: Calcium phosphate bone cement was used to repair craniofacial skeletal defects in three patients. Indications included repair of a posttraumatic orbital floor defect causing hypo-ophthalmos, reconstruction of frontal craniotomy and temporalis muscle donor sites in a patient who had undergone resection of an invasive squamous cell carcinoma, and augmentation of a post-traumatic anterior maxillary skeletal defect. The primary outcome measure was the restoration of bony volume and support. The use of calcium phosphate bone cement in these patients was effective and without complications. CONCLUSIONS: Norian CRS calcium phosphate bone cement is useful in the repair of craniofacial skeletal defects.

Adult↗

Tensile strength of wire-reinforced bone cement and twisted stainless-steel wire.

To assess the tensile strength of wire-reinforced bone cement as used for posterior spine fusion, standardized bone-cement specimens reinforced with stainless steel and Vitallium wires 0.5 and one millimeter in diameter were tested in tension. The results showed that tensile strength of bone cement was increased significantly by reinforcing it with metal wires, the increase in strength being proportional to the number of wires used. Even after failure of the cement, the reinforcing wires still carried an appreciable amount of load, thus avoiding the catastrophic failure of the cement alone. Specimens reinforced with Vitallium wires in general failed at higher loads than specimens reinforced with similar stainless-steel wires. Pull-out studies showed that a hook or a loop at the embedded end of straight wires significantly increased the load necessary to pull the wires out. The tensile strength of twisted stainless-steel wire composed of two 0.5-millimeter strands increased with the number of turns up to about eight turns per inch (2.54 centimeters) and then decreased.

Bone Cements↗

Adhesion enhancement of steel fibers to acrylic bone cement through a silane coupling agent.

The use of a silane coupling agent (methacryloxypropyl-trichlorosilane) to improve the mechanical properties of steel fiber-reinforced acrylic bone cements was assessed. Changes to the tensile and fracture properties of bone cements reinforced with silane-coated or uncoated 316L stainless steel fibers of different aspect ratios were studied. Contact-angle measurements indicated that the coupling agent coats the metal surface through room temperature treatments in a short time (within 2 h). Push-out tests indicated that the interfacial shear strength of silane-coated 316L stainless steel rods is 141% higher than the uncoated rods. The elastic moduli, ultimate stresses, and fracture toughness of the silane-coated, steel fiber-reinforced bone cements are significantly higher than the bone cements reinforced with uncoated steel fibers. There were no differences in the tensile mechanical properties of the silane-coated or uncoated, steel fiber-reinforced cements after aging in a physiological saline solution, indicating that the bonding effectiveness is decreased by the intrusion of water at the metal-polymer interface. Because of possible biocompatibility issues with leaching of the silane coupling agent and no long-term mechanical benefit in simulated aging experiments, the use of these agents is not recommended for in vivo use.

Adhesiveness↗

The addition of tobramycin to contrast bone cement. Effect on flexural strength.

Samples of polymethylmethacrylate (PMMA) bone cement were polymerized in vitro with no additives and with the following additives: methylene blue dye, tobramycin, methylene blue plus tobramycin. After storage for 7 days in saline, samples were tested to failure in three-point bending. Addition of the antibiotic significantly weakened the cement (to 87% of control). However, the combination of tobramycin plus methylene blue was no weaker than tobramycin alone, suggesting that addition of both dye and antibiotic to bone cement is probably a reasonable clinical practice.

Bone Cements↗

Alendronate in bone cement: fatigue life degraded by liquid, not by powder.

Bisphosphonates have the potential to reduce osteolysis, a phenomenon that has been postulated to play a key role in aseptic loosening of total joint replacements. Bisphosphonates may contribute to the in vivo longevity of total joint replacements. Some authors have suggested there are decreases in flexural strength and flexural modulus of the cured cement when a liquid form of disodium pamidronate is added to a commercially available acrylic bone cement (Palacos R). We proposed that it is comparatively easier to blend a bisphosphonate in powder form into an acrylic bone cement than it is when the drug is in liquid form; and that the cement's fatigue life is decreased when the bisphosphonate is added in liquid rather than in solid form. The bisphosphonate and bone cement used were alendronate sodium and Cemex XL, respectively. The fatigue tests were done using phosphate buffered saline solution at 37 degrees +/- 1 degrees C. The data supported both hypotheses. Our findings should guide orthopaedic surgeons when using bisphosphonate-impregnated acrylic bone cements in total joint replacements. Bisphosphonates are endogenous pyrophosphate analogs in which a carbon atom replaces the central oxygen atom. These therapeutic agents may be classified into nitrogen and non-nitrogen containing types. Some examples are alendronate, pamidronate, ibandronate, risedronate, etidronate, clodronate, and zoledronate. There are many targets and mechanisms of action of this family of drugs, therefore making them efficacious against diverse clinical conditions such as osteoporosis, periprosthetic bone loss subsequent to total joint replacement, tumor cell proliferation, apoptosis and angiogenesis, Charcot neuroarthropathy, rheumatoid arthritis, ankylosing spondylitis and spondyloarthropathies, and arterial calcification. It has been proposed that some bisphosphonates are effective against the mechanisms that have been suggested as being implicated in aseptic loosening of total joint replacements, these being osteoclast-mediated bone resorption and wear particle-induced osteolysis. A meta-analysis of randomized controlled trials showed that alendronate and pamidronate had beneficial effects maintaining periprosthetic bone for as much as 1 year after a total joint replacement.

Alendronate↗

In vitro characterization and in vivo properties of a carbonated apatite bone cement.

This study evaluated the in vivo behavior of an injectable calcium phosphate bone cement implanted in bone defects at the distal end of rabbit femora. After 3 weeks, samples were harvested and processed for undecalcified sectioning. Scanning electron microscopy, transmission electron microscopy, and Fourier transform infrared microspectroscopy showed direct contact of bone and cement without soft tissue interposition, biocompatibility, and bioactivity with osteoconductive properties.

Animals↗

Comparative elution of moxifloxacin from Norian skeletal repair system and acrylic bone cement: an in vitro study.

The objective of this study was to evaluate the efficacy of Norian skeletal repair system (SRS), a novel biodegradable and injectable form of calcium phosphate cement with a composition similar to that of cancellous bone, as a carrier for moxifloxacin, which is the most potent quinolone agent against staphylococci and Enterobacteriaceae. Norian SRS was mixed with moxifloxacin at a ratio of ca. 100:3 at room temperature and solidified in the bottom of a cylindrical vial. The same procedure was followed for acrylic bone cement. A total of five vials were prepared per system. Mueller-Hinton broth was placed over the free surface of both systems and the vials were transferred to a 37 degrees C incubator. The broth was replaced daily until visual degradation of both systems. Moxifloxacin was measured in aliquots of broth after passage through a high-performance liquid chromatography system. Optical degradation of both systems occurred after 450 days. Until Day 17, concentrations eluted from both systems were similar. After Day 18 until degradation, concentrations eluted by Norian SRS were statistically higher than those eluted by acrylic bone cement and ranged between 100 mg/L and 800 mg/L. The mean area under the concentration-time curve (AUC) over 450 days of sampling was 241 935.0 mg/L day for Norian SRS and 18 300.0 mg/L day for the acrylic bone cement system (P=0.043). Norian SRS is a novel biodegradable system providing excellent strength and mineralisation to bone. It was shown that this system allows in vitro elution of moxifloxacin at significant concentrations, making it a promising candidate for the therapy of chronic osteomyelitis.

Absorbable Implants↗

Streptomycin-loaded bone cement in the treatment of tuberculous osteomyelitis: an adjunct to conventional therapy.

Streptomycin-loaded bone-cement (7 g of streptomycin in 40 g of bone cement) beads were used in the treatment of tuberculous bursitis and osteomyelitis of the greater trochanter in a 76-year-old woman. Wound drainage, serum and urine concentrations of streptomycin were measured. For the first 96 hours, the streptomycin levels in the wound drainage ranged from 2932 mg/L to 414.4 mg/L, and in the serum, streptomycin levels ranged from 1.7 mg/L to 13.7 mg/L. The patient recovered without complication and at follow-up 2 years later was free of infection and walking without pain. The authors conclude that the use of streptomycin-loaded bone cement can safely and effectively eradicate mycobacterial tuberculosis osteomyelitis.

Aged↗

The use of bone cement as an adjunct to internal fixation of supracondylar fractures of osteoporotic femurs.

Bone cement was used as an adjunct to internal fixation of 14 supracondylar femoral fractures. The fractures were stabilized with ASIF plates. In all these fractures severe osteoporosis made a stable fixation impossible without the use of bone cement. The average age of the patients was 75 years. Eight of the patients had previously been operated on because of fractures of the same extremity and three suffered from disabling diseases. Twelve fractures healed without complications, despite early mobilization. One fracture needed additional external fixation before it healed and one lead to non-union. No infections were seen. It is concluded that use of bone cement as an adjunct to the internal fixation of supracondylar fractures secures a stable fixation of even the most severe osteoporotic femora, and this aids healing in most cases of such fractures. The method is recommended in selected cases of elderly patients.

Aged↗

Audiometric evaluation of an attempt to optimize the fixation of the transducer of a middle-ear implant to the ossicular chain with bone cement.

Typically, an implantable hearing device consists of a transducer that is coupled to the ossicular chain and electronics. The coupling is of major importance. The Vibrant Soundbridge (VSB) is such an implantable device; normally, the VSB transducer is fixed to the ossicular chain by means of a special clip that is crimped around the long process of the incus. In addition to crimping, bone cement was used to optimize the fixation in six patients. Long-term results were compared to those of five controls with crimp fixation alone. To assess the effect of bone cement (SerenoCem, Corinthian Medical Ltd, Nottingham, UK) on hearing thresholds, long-term post-surgery thresholds were compared to pre-surgery thresholds. Bone cement did not have any negative effect. Next, to test the hypothesis that aided thresholds might be better with the use of bone cement, aided thresholds were studied. After correction for the severity of hearing loss, only a small difference was found between the two groups at one frequency, viz. 2 kHz. It was concluded that there was no negative effect of using bone cement; however, there is also no reason to use bone cement in VSB users on a regular basis.

Adult↗