Biomedical subjects

S Stea

Publications and source records attributed to S Stea.

At least 19 recordsLinked to original sources

PubMed2000

Sister chromatid exchanges and ion release in patients wearing fracture fixation devices.

The quantification of sister chromatid exchange (SCE) during mitosis is a useful index for evaluating genotoxic effects in subjects occupationally or incidentally exposed to potentially toxic substances. The authors investigated the hypothesis that ions released by corrosion from prosthetic components of fracture fixation devices are associated with change in SCE incidence. In the present study, ten patients with implants were examined, and fifteen subjects with no implants were used as controls. SCE and high frequency cell (HFC) numbers were evaluated in circulating lymphocytes. In addition, nickel (Ni) and chromium (Cr) ion values in the serum were measured because, after iron, these metals are major components of stainless steel. A significant increase in SCE numbers was observed in patients compared to the control population (4.9 +/- 1.3 vs. 3.5 +/- 1.4). Ni concentration was 1.71 +/- 1.49 ng/mL in patients and 0.72 +/- 0.52 ng/mL in control subjects; Cr concentration was, respectively, 1.01 +/- 0.77 ng/mL and 0.19 +/- 0. 27 ng/mL. The increase of serum Cr and Ni was statistically significant. No correlation was found between the increased Cr concentrations and SCE number while Cr ion levels were found to be significantly correlated to HFC. An inverse correlation between Ni level and SCE numbers was observed. Our findings suggest that Cr release by stainless steel implants could have a genotoxic effect; thus it would be useful to carefully monitor implanted subjects with regard to serum ion dosage, SCE analysis, and HFC evaluation. In any case, it would be appropriate to remove the implant when fracture fixation is reached.

Adolescent↗

PubMed1999

Effects of metal ions on white blood cells of patients with failed total joint arthroplasties.

In this study twenty-two patients who had revision surgery for aseptic loosening of joint prostheses were examined. The concentration in serum of soluble products of corrosion from the implant, that is, chromium (Cr), cobalt (Co), and nickel (Ni) ions, and the number of white blood cells (leucocytes, myeloid cells, lymphocyte subpopulations) were measured. Twenty patients with no implants were used as controls. The patients who had revision surgery showed normal Ni concentration whereas by statistical analysis that same patient group was shown to have serum Cr and Co levels significantly higher than those of the control. By flow cytometry, a significant decrease of leucocytes, myeloid cells, lymphocytes, and CD16 populations as found in patients versus controls whereas CD3, CD4, CD8, and CD20 positive cells were decreased, but not significantly. In the arthroplasty patients the Cr concentrations were inversely correlated with some of the immunologic parameters while no significant correlation was found between Co levels and decreased lymphocyte subpopulations. Only in revision surgery patients with high Cr concentrations did we find a significant decrease of lymphocytes, namely of CD4 and CD16 positive cells; revision surgery patients with normal Cr concentrations did not show a significant decrease of lymphocyte subpopulations. These data suggest that the presence of metal ions, especially chromium, released from prosthesis components could be associated with changes of lymphocyte subpopulations in patients with loosening of joint prostheses.

Adult↗

PubMed1999

Cytokine release in mononuclear cells of patients with Co-Cr hip prosthesis.

The aim of this study was the evaluation of the release of bone-resorbing cytokines in peripheral blood mononuclear cells (PBMC) of patients with aseptic loosening of Co-Cr hip prostheses. TNF-alpha, IL-6, and GM-CSF were measured in both unstimulated and PHA-stimulated PBMC, and in PBMC cultured in the presence of chromium and cobalt extracts. Blood samples from healthy donors were used as controls. Serum samples of both patients and healthy donors were tested to determine the concentration of metal ions. The proportion of lymphocyte, monocyte and lympocyte subpopulation in cultured PBMC did not differ in patients and the control group. In unstimulated PBMC the release of TNF was significantly higher in patients than in the control group, while IL-6 was significantly decreased and no change was observed for GM-CSF. When the PBMC were challenged with chromium extract, all the 'index of cytokine release' resulted higher in patients than in the control group; cobalt extract increased both the TNF and GM-CSF index, but not the index of IL-6 release. Metal concentrations in serum from patients were significantly increased and correlated with the TNF release in PBMC stimulated with both metal extract. Our results suggest that a CoCr-implant releases a large amount of metal ions which could mediate the priming or the renewal of a cell-mediated hypersensitivity reaction. The prevalence of circulating lymphocytes responsible for the delayed hypersensitivity, namely Thl, would justify both the significant increase of TNF and the significant decrease of IL6 in unstimulated PBMC of patients, as well as the significant increase of the 'index of cytokine release' after the challenge with metal ions.

Adult↗

PubMed1999

Wear debris and cytokine production in the interface membrane of loosened prostheses.

In this study, thirty-nine patients were examined. All of them suffered from hip joint prostheses loosening and underwent revision surgery. Bioptic samples were collected at the interface between bone and implant either at the stem or cotyle level. Immunohistochemistry was performed to detect IL-1alpha, IL-1beta, IL-6 and TNF, cytokines that directly cause bone resorption and indirectly induce synthesis of other bone resorbing cytokines. Quantitative analysis of the positive cells and correlation with clinical data was performed. It resulted that there is a great variability in positive cells for cytokines according to the harvest site; anyway, cytokines tend to be higher in patients carrying a joint prosthesis with polyethylene acetabular component and it is associated with plastic wear particles, even though there is no direct correlation between wear amount and cytokine levels. There is a statistically significant negative correlation between metal wear and a cytokine (IL-6); cytokines levels do not depend on the implant time to failure and do not correlate with pain score. As expected, cytokines levels tend to be lower in subjects being treated with non-steroidal antiinflammatory drugs. It can be concluded that plastic wear is the factor inducing the highest cytokine levels in the tissues around the prosthesis at the interface; cytokines that are an indicator of osteolysis risk.

Adult↗

PubMed1999

Hydroxyapatite fully coated conic hip prosthetic stem: a long term animal study.

The purpose of this paper is to evaluate in an animal model the long term results obtained with a prosthetic stem fully coated with hydroxyapatite. The cup was manufactured in polyethylene and was cemented. Six arthroplasties were performed in six sheep. After twelve months, the animals were euthanized and the femurs were harvested and processed for undecalcified sectioning. Twelve cross sections were cut perpendicularly to the longitudinal stem axis. Sections one to five corresponded to the area of the stem which, at the time of surgery, had a full initial contact between the bone and the prosthesis; sections six to ten corresponded to the area of the stem which, at the time of surgery, had a gap from 0 to 2 mm between the bone and the prosthesis; sections eleven and twelve had an initial gap larger than 2 mm. At one year after implantation, in the sections one to five, morphological analyses showed extensive direct contact between the bone and the hydroxyapatite coating. Bone prosthesis contact was lower in the sections six to ten. No contact was seen in sections eleven and twelve. Comparing bone to prosthesis contact of each subsequent section, from proximal to distal, the difference becomes significant with section five compared to section six (p < 0.00005). No detachment of the hydroxyapatite coating from the metallic substrate was observed in any section. In conclusion, this study shows that a conic shaped femoral stem, fully coated with hydroxyapatite gives very good histological and histomorphometric results at one year. Prosthesis osteointegration showed to be influenced by the initial bone to prosthesis contact. No direct bone to prosthesis contact was achieved if the initial bone to prosthesis gap was larger than 2 mm.

Animals↗

PubMed1998

Cytotoxicity testing of materials with limited in vivo exposure is affected by the duration of cell-material contact.

Silicones for dental impression largely are used to record the geometry of hard and soft dental tissues. They are considered to be medical devices, and the assessment of cytotoxicity is a necessary step in the evaluation of their biocompatibility. Extracts of six addition-type and six condensation-type silicones have been tested with L929 cells according to the ISO 10993-Part 5 standard. The cytotoxicity was evaluated by three different methods: neutral red uptake, propidium iodide (PI) staining, and amido black staining. According to the selected specific assay, contact between cells and material extracts was maintained for 24 h in the first series of experiments; then, considering that in vivo application of these materials is restricted to a few minutes, additional experiments were performed after 1 h of cell/extract contact. Analysis of the results showed that the addition-type silicones are nontoxic even when tested after prolonged exposure of the cells to the materials while the condensation-type silicones were cytotoxic at 24 h of incubation. Nevertheless, harm to the patient actually could be negligible, considering its very short time of exposure in vivo. This is supported by our finding that most are not toxic after 1 h. We suggest that the experimental conditions of cytotoxicity testing have to be relevant to the in vivo situation; accordingly, the time of exposure should be designed carefully.

Amido Black↗

PubMed1998

In vitro sister chromatid exchange induced by glass ionomer cements.

The genotoxicity of three glass ionomer cements used in dentistry, manufactured by American (Vitrebond), Japanese (Fuji I), and European (Ketac Cem) companies were examined. The cement components were mixed according to the manufacturers' instructions and allowed to set for two defined times: 1 h or 1 week, before extracting them, as established by ISO standard 10993 part 12. To highlight sister chromatid exchange during mitosis, the extracts then were tested with human peripheral lymphocytes in the presence or absence of metabolic activation with S9 mix. The test performed was a genotoxicity test as provided for in standard EN 30993 part 3. Vitrebond resulted in direct genotoxicity and was strongly cytotoxic both in the extracts performed at 1 h and those at 1 week if they were allowed to set without photoactivation. Fuji I was noncytotoxic and showed only uncertain indirect genotoxicity in the extracts at 1 h; genotoxicity was not present in the extracts at 1 week. Ketac Cem cement was not genotoxic nor was it cytotoxic either at 1 h or 1 week. The authors concluded that of the three cements tested the European cement Ketac Cem passed one of the tests suggested by the EEC standard for assessing genotoxicity.

DNA Damage↗

PubMed1998

False positive results in cytotoxicity testing due to unexpectedly volatile compounds.

We investigated the cytotoxicity of different dental materials according to the study protocol adopted by our lab for the screening of new materials. Experimental parameters used in such testing are addressed mainly in documents EN 30993 "Biological evaluation of medical devices, Part 5: Tests for cytotoxicity: in vitro methods" and "Biological evaluation of medical devices, Part 12: Sample preparation and reference materials." Cells were cultured in microplates and challenged with aqueous extracts of the materials. The assay methods were neutral red- and propidium iodide-uptake assays, both indicative of cell viability and able to provide quantitative data. The observation of contrasting results for one material using the above-mentioned methods raised some concern about the assay system used. With further experimentation, it appeared that a sustained release of volatile substances still present in one extract exerted a toxic effect in neighboring cultures. It is concluded that in the microenvironment of a microplate the distribution of samples cannot be disregarded, as it may be responsible for toxicity cross-contamination. Moreover, the use of more than one single method has to be recommended in cytotoxicity testing, in order to avoid false positive results due to experimental artifacts.

Animals↗

PubMed1998

The interface of bone microstructure and an innovative coating: an X-ray diffraction study.

The in vivo compatibility and degradation aspects of an innovative coating to be sprayed onto titanium implants were investigated. The surface of fluorinated apatite (fHA), consisting of fluorhydroxyapatite plasma sprayed in a vacuum atmosphere, was treated with carbonate to improve its biological compatibility. fHA coating was compared with titanium implants coated (a) with hydroxyapatite (HA) by the traditional plasma spraying, and (b) with titanium oxide (TiOx). Screw-shaped implants were inserted in the cortical bone of sheep tibiae. X-ray diffraction (XRD) analysis of bone tissue and coatings was carried out at 2, 4, 12 and 36 weeks after surgery. The crystallographic habit of the implant-facing bone, as well as the structural stability of the coating, were evaluated. For each time period and type of ceramic bone apatite lattice at the interface, no significantly different reference apatite lattice and no foreign peak were recorded. Two weeks after implantation, the bone at the interface was strongly unmineralized in all samples; after 4 weeks, poorly mineralized bone microareas decreased. At 12 weeks, the newly formed bone tissue at the interface with both the new coating and HA coating was shown to be fully mineralized; this crystallographic habit was retained at 36 weeks, when particle release from the tested material was lower compared to the controls. The XRD pattern of bone apatite surrounding the coating particles was unmodified. The innovative coating did not alter the mineralization process at the interface. It improved implant osteointegration, mainly due to a limited release of particles. Consequently, clinical performance of external fixation treatment could be improved by modifying the chemical composition of the implant surface.

Animals↗

PubMed1998

Bone-resorbing cytokines in serum of patients with aseptic loosening of hip prostheses.

Our aim was to determine if the serum levels of bone-resorbing cytokines (IL-1beta, TNF-alpha, IL-6, GM-CSF) are altered in patients with aseptic loosening of a total hip prosthesis, and if such levels are influenced by the type of implant. We determined cytokine levels in sera from 35 patients before revision for failed total hip arthroplasty and compared them with those in 25 healthy donors. We also assessed the soluble receptor of interleukin-2 (sIL-2r) in serum as an indication of a specific immune reaction against the implant. Our findings showed that the sIL-2r and TNF-alpha serum level did not change. The IL-6 level was not significantly altered, but was higher in patients with TiAIV prostheses than in those with a CrCoMo implant and in patients with cemented prostheses. The IL-1beta level was found to be higher in those with a TiAIV cemented prosthesis than in the control group (p=0.0001) and other groups of patients (p=0.003 v uncemented TiAIV, p=0.01 v cemented CrCoMo, p=0.001 v uncemented CrCoMo). The GM-CSF level significantly increased in patients compared with healthy subjects (p=0.008), and it was higher in those with cemented than with uncemented implants (p=0.01). Only patients with cementless CrCoMo prostheses had levels of GM-CSF similar to those of the control group. The highest GM-CSF concentrations were observed in patients treated with non-steroidal anti-inflammatory drugs (NSAIDs) in the last months before revision (p=0.04). In addition, when massive osteolysis was observed, the level of GM-CSF tended to decrease to that of the control group.

Acetabulum↗

PubMed1998

A comparison of hydroxyapatite-coated, titanium-coated, and uncoated tapered external-fixation pins. An in vivo study in sheep.

Three types of surfaces for external fixation pins were compared. One hundred and eight stainless-steel tapered 5/6-millimeter pins were divided into three groups: thirty-six pins remained uncoated (Group A), thirty-six were plasma-sprayed with hydroxyapatite (Group B), and thirty-six were plasma-sprayed with titanium (Group C). The pins were implanted in the left tibia of eighteen sheep, with each sheep receiving six pins from the same group. A unilateral fixator then was assembled on the pins. The medial aspect of the mid-part of the tibial diaphysis was exposed, and a five-millimeter-long cylinder of bone was removed so that load would be borne by the bone-pin interfaces. Six weeks after the procedure, radiographs demonstrated rarefaction of twenty-nine pin tracks in Group A, fifteen in Group B, and thirty in Group C (p = 0.021 for Group A compared with Group B and p = 0.016 for Group B compared with Group C). The mean final insertion torque (and standard deviation) was 4360+/-1050 newton-millimeters in Group A, 3420+/-676 newton-millimeters in Group B, and 3740+/-643 newton-millimeters in Group C. With the numbers available, no significant differences could be detected among these values. The mean extraction torque was 253+/-175 newton-millimeters in Group A, 3360+/-1260 newton-millimeters in Group B, and 1720+/-1030 newton-millimeters in Group C (p = 0.002 for Group A compared with Group B, p = 0.017 for Group A compared with Group C, and p = 0.03 for Group B compared with Group C). The extraction torque was significantly lower than the corresponding insertion torque in both Group A (p < 0.001) and Group C (p = 0.003); no significant difference could be found, with the numbers available, in Group B (hydroxyapatite-coated pins). At sixty times magnification, direct contact was seen along a mean of 16+/-9 per cent of the bone-pin interface in Group A, 30+/-12 per cent of the interface in Group B, and 28+/-15 per cent of the interface in Group C (p = 0.042 for Group A compared with Group C). However, at 10,000 times magnification, direct bone-pin contact was found only in Group B.

Animals↗

PubMed1998

Growth hormone secretion and bone histomorphometric study in thalassaemic patients with acquired skeletal dysplasia secondary to desferrioxamine.

An auxological and endocrinological study was performed in 21 thalassaemic patients with growth retardation and skeletal dysplasia secondary to desferrioxamine. Bone metaphyseal proximal tibial or iliac crest biopsy was performed in six patients with severe genu valgum or non-traumatic vertebral compression. GH insufficiency/deficiency (GH deficiency: peak after stimulation test below 6 ng/ml) was found in 72% of our thalassaemic patients with skeletal dysplasia, but in only 41% of patients without skeletal dysplasia. Bone histology showed abnormal chondrocytes, alteration of staining pattern of cartilage, irregular columnar cartilage and lacunae in the cartilaginous tissue. The behaviour of bone tissue was unpredictable (presence of thick or thin osteoid layer). Bone microfractures were sometimes present. The bone microstructure showed scarce mineralization, which was evenly or irregularly distributed. The bone tissue apatitic phase was quantitatively reduced. The hardness of bone tissue was remarkably lower than that of normal bone in three out of six patients. In conclusion, iron chelation therapy in patients with acquired skeletal dysplasia seems to interfere with GH secretion. The early identification of clinical and radiological abnormalities of skeletal dysplasia is of paramount importance in preventing severe bone destruction.

Adolescent↗

PubMed1998

Comparison among three different biocoatings for orthopaedic prostheses. An experimental animal study.

One-hundred-eighty cylindrical monocortical titanium implants, 4mm diameter and 12mm long, with three different coatings: fluorohydroxyapatite (group A), hydroxyapatite (group B), and titanium oxide (group C), all applied by vacuum plasma spray were bilaterally, randomly implanted into the femurs and tibiae of twelve adult mongrel sheep. The sheep were divided into four groups (1, 2, 3 and 4) numbering three sheep each. Sheep of groups 1, 2, 3 and 4 were euthanized at two weeks, one month, three and nine months after implantation, respectively Biomechanical and histomorphological analysis were performed. Extraction torque increased over time in all groups until the nine months period. At all the studied periods, the bone-implant contact was higher in Groups A and B compared to Group C. However, only at nine months did this difference reach statistical significance (p<0.005 comparing Groups A and B to C). The results of this study show that all the three coatings could be recommended for clinical applications.

Animals↗

PubMed1997

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↗

PubMed1997

Biomechanical, scanning electron microscopy, and microhardness analyses of the bone-pin interface in hydroxyapatite coated versus uncoated pins.

OBJECTIVE: To evaluate the bone-pin interface in hydroxyapatite coated versus uncoated pins. DESIGN: Eighty-four bicylindrical stainless steel external fixation pins were implanted in a test group of 14 sheep. One-half of the pins were coated with hydroxyapatite and the rest remained uncoated. INTERVENTION: Six coated pins were implanted in the left tibia of seven sheep, and six uncoated pins were implanted in the left tibia of the other seven sheep. In all sheep, the right tibia was left intact. During pin implantation, the final insertion torque was measured, and a linear external fixator was mounted on the pins. Then the medial tibial mid-diaphysis was exposed and a 5-mm resection osteotomy was performed. The sheep were killed six weeks after surgery. MAIN OUTCOME MEASURES: The extraction torque was measured on four pins removed from each sheep. Radiographic pin tract rarefaction was measured on all the pins. Two pins from each sheep were used for histologic, scanning electron microscopy (SEM), and microhardness analysis. Histomorphometric analysis was carried out on the SEM specimens at x 36 magnification. RESULTS: Radiographic pin tract rarefaction was significantly lower in the hydroxyapatite coated pins than in the uncoated pins (P < 0.001). Group average insertion torque was 960 +/- 959 N/mm in the hydroxyapatite coated pins, and 709 +/- 585 N/mm in the uncoated pins (p = not significant). Group average extraction torque was 1485 +/- 1308 N/mm and 298 +/- 373 N/mm, respectively (p = 0.0001). Histomorphometric analysis showed that the group average bone-pin contact was 50.7 +/- 16.9% in the hydroxyapatite coated pins and 27.6 +/- 7.1% in the uncoated pins (p < 0.01). Microhardness analysis showed that bone tissue close to the pins was softer than bone tissue far from them. CONCLUSION: Hydroxyapatite coating is an effective method of refining the bone-pin interface and may improve the clinical results of the external fixation technique.

Animals↗

PubMed1997

[Plasma protein adsorption on variously treated +polybutylene terephthalate].

BACKGROUND: The aim of the research was the evaluation of plasmatic protein adsorption on untreated polybutylene terephthalate, corona treated polybutylene terephthalate and polyvinylacetate coated corona treated polybutylene terephthalate. METHODS: Total proteins, albumin, immunoglobulins, fibrinogen, insulin and ostecalcin were determined on plasma after contact with these polymers. RESULTS: Unsignificant variations were observed for the assayed proteins. CONCLUSIONS: The conclusions are drawn that the tested materials do not adsorbe significantly the most important plasmatic proteins.

Adsorption↗

PubMed1996

Improvement of the bone-pin interface with hydroxyapatite coating: an in vivo long-term experimental study.

The present study was designed to comparatively evaluate the bone-pin interface in a long-term unloaded experimental study in two groups of pins, uncoated and coated with hydroxyapatite. Forty pins made of stainless steel were used. Half of the pins were plasma-sprayed with hydroxyapatite, and the other half remained uncoated. Four adult sheep were selected. Each sheep tibia was implanted with five pins. Two sheep were euthanized 4 months after surgery and the remaining two 12 months after surgery. Extraction torque was higher in the hydroxyapatite-coated pins compared with the uncoated ones at both 4 (p < or = 0.0005) and 12 months (p < or = 0.0005) after implantation. The histological patterns observed in the sheep euthanized 4 and 12 months after implantation were very similar. An extensive bony coverage of the hydroxyapatite-coated pins without any coating resorption and delamination from the metallic substrate was observed. Fibrous tissue encapsulation was found in the uncoated pins. These results demonstrate that the hydroxyapatite coating significantly improved the bone-pin interface. A similar improvement of bone-pin interface rigidity in many clinical situations is likewise possible.

Animals↗

PubMed1996

Disposition and bioavailability of ceftazidime after intraperitoneal administration in patients receiving continuous ambulatory peritoneal dialysis.

This study investigated the disposition and bioavailability of ceftazidime when it was given intraperitoneally. Seven patients were given 1 gm of ceftazidime intravenously, and 1 wk later, the same dose was given intraperitoneally. After both intravenous and intraperitoneal dosing, serum and peritoneal dialysate samples were obtained at set time intervals over a 24-h period. High-performance liquid chromatography was used to determine the ceftazidime concentrations in the serum and dialysate samples. Inspection of the concentration versus time data after intraperitoneal dosing demonstrated that serum ceftazidime concentrations reached therapeutic (> 8 micrograms/mL) levels within 30 min and remained in the therapeutic range for the entire 24-h period. Simulation of a variety of ceftazidime dosing regimens using the mean pharmacokinetic parameters from this population of patients suggests that a regimen of 1.5 gm administered intraperitoneally every 24 h produces trough serum drug concentrations (approximately 40 micrograms/mL) similar to those achieved with a standard regimen of 1.0 gm given intravenously every 24 h in patients undergoing continuous ambulatory peritoneal dialysis. It was concluded that the intraperitoneal dosing of ceftazidime in these patients is an equally effective and a more convenient alternative to its administration.

Aged↗