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Purpose: The aim of this study was to assess whether preoperative valgus or varus deformity affected survivorship after total knee arthroplasty (TKA) and to quantify the risk factors for implant failure in a registry-based population., Methods: The Emilia-Romagna Registry of Prosthetic Orthopedic Implants was examined regarding TKAs performed on patients with a preoperative diagnosis of valgus or varus deformity. Demographics, implant characteristic and survivorships were investigated and compared. A total of 2327 TKA procedures performed from 2000 to 2016 were included in the study. Six hundred and forty primary TKAs with a diagnosis of valgus deformity were evaluated with a median follow-up of 3.3 years; 1687 primary TKAs with a diagnosis of varus deformity were evaluated with a median follow-up of 2.5 years., Results: Bi-compartmental, cemented posterior stabilised fixed-bearing implants were preferred. For both diagnoses, the implant survivorship rate was greater than 98% in the first year. However, the survival curve of the TKAs implanted for valgus deformity showed a greater slope in the first 3 years as compared to the survival curve of those implanted for varus deformity. Valgus deformity had a 2.1-fold higher risk for revision as compared with varus deformity. Infection was a major cause of implant failure in TKAs for varus deformity, 9/24 (37.5%), while its incidence was lower for valgus deformity, 1/21 (4.8%)., Conclusions: Preoperative valgus alignment showed a twofold risk of failure as compared to varus alignment after TKA. This should be considered in daily practice, and surgeons are called on to pay more attention when performing TKAs on such patients. Prospective randomised controlled trials are, therefore, necessary to better understand the role of preoperative coronal knee deformity in implant failure., Level of Evidence: Prognostic study, level III.

The first clinical sign of ceramic hip prosthesis failure is hip noise. We therefore investigated whether isolation, observation at scanning electron microscopy, and chemical identification with microanalysis of particles from synovial fluid of "noisy hip" could be predictive of ceramic damage. Firstly, the level of "physiological wear" of well functioning ceramic-on-ceramic hip prostheses was assessed with this method, then the test was validated as diagnostic method for liner fracture. Twelve asymptomatic patients were enrolled to demonstrate the first aim; 39 cases of noisy hip (GROUP 1), and 7 cases of pending failure not related to ceramic (GROUP 2) were enrolled for the second aim. The analysis of the synovial fluid of the 12 asymptomatic patients allowed to set the "physiological wear" threshold. The analysis of GROUP 1 hips demonstrated the presence of ceramic particles (2 physiological, 12 mild, and 25 strong). The analysis of GROUP 2 showed a physiological presence of ceramic particles in all cases. Revision surgery in GROUP 1 was performed in 16 hips out 25 with strong ceramic particle presence and 2 out of 12 with mild ceramic particle presence. Failure of the ceramic component was evident in all but one of these cases, while the integrity of components was demonstrated in all seven hips of GROUP 2. Synovial fluid microanalysis can be a useful surrogate in predicting ceramic failure particularly when a strong presence of ceramic particles is observed. On the contrary there is not enough evidence to predict ceramic failure in presence of mild positivity., (Copyright © 2012 Orthopaedic Research Society.)

The effect of three methacrylate-based cements used for the fixation of joint prostheses on tissue-factor production by human umbilical vein endothelial cells was evaluated in vitro. The extracts in the culture medium of the cements were tested after 1-h and 7-day curing. The endothelial cells were incubated with the cement extracts for 4 h, and then the tissue factor was determined in cell lysates with both the recalcification time and enzyme immuno assay. The cements did not induce significant production of tissue factor and, therefore, did not activate the extrinsic pathway of coagulation within the limits of the mechanism considered.

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., (Copyright 2000 John Wiley & Sons, Inc.)

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.

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.

We evaluated the microstructural characteristics of newly formed bone tissue at the interface with cement. The bone-cement interfaces of the femoral components of nine hip prostheses retrieved after loosening were investigated by means of X-ray diffraction on microareas and microhardness. The bone far from the interface of two stable prostheses was used as a control. The newly formed bone adjacent to cement in the loosened prostheses showed a maturity degree lower than that of bone adjacent to cement in stable prostheses. The lattice parameters of bone apatite did not show significant variations as compared to the reference values. Bone trabeculae at the interface with loosened prostheses often showed an osteoid lining characterized by a strongly demineralized lamellar and haversian structure. Radioopaque cement particles are sometimes found in the trabecular bone tissue around the prosthesis.

The functional response of peripheral blood lymphocytes isolated from 22 patients with silicone gel-filled breast implants was assessed after in vitro re-exposure to silicone. Using cell culture test methods to quantify proliferation and viability and/or activation of lymphocyte microcultures, i.e., the uptake of tritiated thymidine (3H-TdR uptake test) and the reduction of formazan salts (MTT assay), interesting data were obtained. Peripheral blood lymphocytes purified from patients wearing silicone gel-filled breast implants react in vitro to silicone showing a statistically significant increase of both proliferation and viability, while healthy subjects do not respond on in vitro exposure to silicone. Differences resulted even more statistically significant when patients were divided into two groups depending on the type of surgery they underwent: patients with breast augmentation for aesthetic reasons seem to have an increased responsiveness in vitro to silicone compared to patients who experienced a reconstructive surgery of the breast. Although they are still preliminary, being referred to a limited population, these results suggest that the lymphocytes of patients with silicone gel-filled breast implants could be sensitized in vivo toward silicone; the re-exposure of these cells to silicone leads to a higher functional response which could be looked for by using quantitative in vitro test methods.

We evaluated the role of the immune system in the pathogenesis of the periprosthetic capsular contracture, the most frequently occurring complication following the implant of silicone prostheses. Peripheral blood samples from 22 patients with silicone-gel-filled implants were examined. In all cases a capsule was felt by palpation, and it was classified according to the Baker scale. Ten patients (group 1) had a Baker 2 contracture, and 12 (group 2) had severe contracture rated 3 and 4. The cells positive to antigens CD3, CD4, CD8, HLA-DR, CD19, CD25, CD57, CD16, and CD14, and the cytotoxic activity of the lymphocytes on target cells K562 were assessed by cytofluorimetric analysis. At time 0 there were no statistically significant differences between patients and normal subjects, nor between the two groups. At 48 h, the group 2 patients had a number/mm3 of cells CD57 + significantly higher than both group 1 and control group (P < .05). In group 1 patients, the cytotoxic activity was similar to that of normal subjects, whereas in group 2 it was significantly increased, in respect to both the controls (P < .05) and group 1 (P < .001). In all groups, the contact of the lymphocytes with the silicone extract did not modify either the antigen expression or the lymphocyte functional activity. On the basis of these results we hypothesize the involvement of the immune system in the formation of the capsular contracture around the prosthesis.

The mutagenic potential of 12 commercially available dental cements and of two 'pure substances' (zinc oxide and eugenol) used in root canal filling were examined. The cements were prepared according to the manufacturers' indications and set for defined times. Ames tests were performed in their extracts by using Salmonella typhimurium strains TA 98 and TA 100. The results showed that most cements present strong bactericidal activity that disappears or decreases remarkably in time. One of the tested cements showed mutagenicity with both Salmonella strains. Two cements yielded doubtful results. The remaining cements and the two 'pure substances' showed no mutagenic potential. The authors conclude that it is convenient to examine endodontic cements with the Ames test and to eliminate those that present mutagenicity in time.