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“My Hip Resurfacing (HR) has been recalled. What will happen to me?” This is the question of every patient who underwent an implant recall, a highly stressful event for both patients and physicians. Triggered by a 11.64% failure rate at 7 years, a recall process started for Adept HR with head diameter less than 48 mm. We report our experience in the recall process of 40 patients with the above-mentioned components. One patient underwent revision surgery due to an adverse reaction to metal debris at 5-year follow-up. None of the patients were scheduled for revision, with an estimated survival rate of 97.6% at 7 years. Implants were well positioned with an average acetabular inclination angle of 37°. Cobalt and chromium blood levels were below the safety threshold of clinical relevance. Functional scores were excellent. In the case of a well-positioned device with normal ion levels, a good performance of the implant is generally observed. Even if we experienced a very low revision rate, this may certainly get worse over time since not all possible failures are predictable, thus requiring a careful periodic follow-up.

BACKGROUND Ischemia-modified albumin (IMA) derives from naive albumin, modified in the binding region of bivalent ions, as cobalt and iron. The cobalt, released from some types of hip prosthesis seems to be metabolized differently in males and females but the iron ion is more prevalent than cobalt and is detectable in the healthy population. Our aim was to verify if there are any gender- and age-related differences in IMA concentrations and if IMA correlates with cobalt and iron-related proteins. METHODS IMA, albumin, iron, ferritin, transferrin, and cobalt were measured in 50 men and 50 women divided into two age/fertility-homogeneous groups. RESULTS Men < 45-years-old showed a statistically significant lower IMA concentration than men ≥ 45 and fertile and menopausal women. Considering all the population studied, IMA does not seem to be correlated with age and is distributed differently by gender; also, Co distribution was different between males and females. CONCLUSIONS IMA did not correlate with cobalt, iron, ferritin, and transferrin in any group, except for fertile women where IMA presented a statistically significant correlation with serum iron values. Minor expression of IMA in young males together with the results obtained on serum iron in fertile females, could explain the higher accumulation of circulating Co in women compared to men and their different cobalt metabolism.

Recently, concerns have been raised about the potential effect of head-neck junction damage products at the local and systemic levels. Factors that may affect this damage process have not been fully established yet. This study investigated the possible correlations among head-neck junction damage level, implant design, material combination, and patient characteristics. Head-neck junctions of 148 retrieved implants were analysed, including both ceramic-on-ceramic (N = 61) and metal-on-metal (N = 87) bearings. In all cases, the male taper was made of titanium alloy. Damage was evaluated using a four-point scoring system based on damage morphology and extension. Patient age at implantation, implantation time, damage risk factor, and serum ion concentration were considered as independent potential predicting variables. The damage risk factor summarises head-neck design characteristics and junction loading condition. Junction damage correlated with both implantation time and damage factor risk when the head was made of ceramic. A poor correlation was found when the head was made of cobalt alloy. The fretting-corrosion phenomenon seemed mainly mechanically regulated, at least when cobalt alloy components were not involved. When a component was made of cobalt alloy, the role of chemical phenomena increased, likely becoming, over implantation time, the damage driving phenomena of highly stressed junctions.

Metal-on-metal (MoM) hip prostheses are known to release chromium and cobalt (Co), which negatively affect the health status, leading to prosthesis explant. Albumin (ALB) is the main serum protein-binding divalent transition metals. Its binding capacity can be affected by gene mutations or modification of the protein N-terminal region, giving the ischaemia-modified albumin (IMA). This study evaluated ALB, at gene and protein level, as marker of individual susceptibility to Co in MoM patients, to understand whether it could be responsible for the different management of this ion. Co was measured in whole blood, serum and urine of 40 MoM patients. A mutational screening of ALB was performed to detect links between mutations and metal binding. Finally, serum concentration of total ALB and IMA were measured. Serum total ALB concentration was in the normal range for all patients. None of the subjects presented mutations in the investigated gene. Whole blood, serum and urine Co did not correlate with serum total ALB or IMA, although IMA was above the normal limit in most subjects. The individual susceptibility is very important for patients’ health status. Despite the limited results of this study, we provide indications on possible future investigations on the toxicological response to Co.

BIOLOX delta is the newest ceramic composite material of the BIOLOX family and its use in hip devices represents a good alternative to Metal-on-Metal or Metal-on-Polyethylene coupling. Some Metal-on-Metal hip devices have shown chromium and cobalt release, which promoted toxic effects. Furthermore, the ceramic composite contains trivalent chromium, even if strongly bound to the alumina lattice. The present study is aimed at detecting any 'in vivo' release of chromium ions from BIOLOX delta bearings in the blood, erythrocytes and urine of patients. Twenty patients implanted with total hip arthroplasty (THA) with BIOLOX delta-BIOLOX delta couplings and 21 subjects with no implanted prostheses were studied. Inductively coupled plasma mass spectrometry equipped with dynamic reaction cell was used for analysis. In the THA group the Cr ions values were; in blood mean 0.21 µg/l (±0.09), in serum 0.21 µg/l (±0.12), in normalized erythrocytes 0.13 µg/l (±0.09), in normalized urine 0.12 µg/g creatinine (±0.13). In the control group the Cr ions values were; in blood mean 0.22 µg/l (st dev 0.14), in serum 0.17 µg/l (±0.08), in normalized erythrocytes 0.13 µg/l (±0.11), in normalized urine 0.07 µg/g creatinine (±0.08). The Lab reference values were 0.1-5.0 µg/l for blood, 0.1-0.5 µg/l for serum, 0.14-4.58 µg/l for normalised erythrocytes and 0.05-2.2 µg/l for urine. All samples in both groups resulted in chromium levels within the normal reference range and the safety of BIOLOX delta ceramics, in terms of chromium ions release, has been demonstrated.

Metal ion release and accumulation is considered to be a factor responsible for the high failure rates of metal-on-metal (MoM) hip implants. Numerous studies have associated the presence of these ions, besides other factors, including a hypoxia‑like response and changes in pH due to metal corrosion leading to the induction of the oxidative stress response. The aim of the present study was to verify whether, in patients with a MoM hip prosthesis, mRNA and protein expression of HMOX‑1 was modulated by the presence of metal ions and whether patients without prostheses exhibit a different expression pattern of this enzyme. The study was conducted on 22 matched pairs of patients with and without prostheses, for a total of 44 samples. Ion dosage was determined using inductively coupled plasma mass spectrometry equipped with dynamic cell reaction. HMOX‑1 gene expression was quantified by reverse transcription-quantitative polymerase chain reaction and HMOX‑1 protein expression was analyzed using an enzyme-linked immunosorbent assay. The results demonstrated that although there were significant differences in the metallic ion concentrations amongst the two groups of patients, there was no correlation between circulating levels of cobalt (Co) and chromium (Cr), and HMOX‑1 gene and protein expression. Additionally, there was no significant difference in the protein expression levels of HMOX‑1 between the two groups. In conclusion, it was demonstrated that circulating Co and Cr ions released by articular prosthetics do not induce an increase in HMOX‑1 mRNA and protein expression at least 3.5 years after the implant insertion. The present study suggests that involvement of HMOX‑1 may be excluded from future studies and suggests that other antioxidant enzymes, including superoxide dismutase, glutathione peroxidase and reductase should be investigated.

Aromatherapy is the controlled use of plant essences for therapeutic purposes. Its applications are numerous (i.e., wellbeing, labour, infections, dementia, and anxiety treatment) but often they have not been scientifically validated. The aim of the present study is to review the available literature to determine if there is evidence for effectiveness of aromatherapy in surgical patients to treat anxiety and insomnia, to control pain and nausea, and to dress wound. Efficacy studies of lavender or orange and peppermint essential oils, to treat anxiety and nausea, respectively, have shown positive results. For other aspects, such as pain control, essential oils therapy has shown uncertain results. Finally, there are encouraging data for the treatment of infections, especially for tea tree oil, although current results are still inconclusive. It should also be considered that although they are, allergic reactions and toxicity can occur after oral ingestion. Therefore, while rigorous studies are being carried out, it is important that the therapeutic use of essential oils be performed in compliance with clinical safety standards.

Hip prostheses with metal-on-metal (MoM) coupling can release cobalt-chromium particles and ions. The aim of this work is to verify the correlation between particles in the synovial fluid and circulating ions.Forty patients were enrolled; particles from synovial fluid were analysed by SEM–EDX (Scanning Electron Microscopy-Energy Dispersion X-rays analysis) and levels of circulating Co and Cr were assayed by ICP-MS (inductively-coupled plasma mass spectrometry).In 16 cases we did not find any particles in the synovial fluid and the Co level in whole blood was 0.05–4.42 ppb; in seven with few particles the blood level was 2.2–15.6 ppb; in six cases with several particles the level was 5.0–54.3 ppb; finally, in 11 cases we isolated not only Co-Cr particles, but also Cr particles with low or absent Co and in these patients the circulating level of Co was 23.8–109.6 ppb. Co in serumand Cr level both whole blood and serum have shown a similar trend to Co; the correlation between all these values and the corresponding particles is statistically significant in all cases.Co and Cr both in serum and whole blood represents a systemic representation of the particle release at local level and can therefore be used to confirm a diagnosis and monitor the wear process of MoM articular prostheses.

Detection of ceramic particles in synovial fluids allows early diagnosis of ceramic damage, but there is no evidence of a relationship between ceramic debris in the articular space and in the joint capsule. The aim of the present study is to verify if the particles isolated in the synovial fluid are comparable with those stored in the capsular tissue. Twenty-one patients were enrolled. Both synovial fluid and capsular samples were collected during revision surgery and ceramic particles were isolated and analyzed by scanning electron microscopy and energy-dispersive X-ray microanalysis. It resulted a significant correlation between the samples couples (18 out of 21). This study confirms that the synovial fluid analysis can give a clear definition of the presence of particles in the joint capsule.

Abstract 2429 Up to 80% of Chronic Lymphocytic Leukemia (CLL) harbour clonal chromosome aberrations having important clinical implications (i.e. 13q deletion, +12, 11q/ATM and 17p/TP53 deletions). 14q32/IGH rearrangements were recently found in 6–19% of CLL patients and were associated with therapy-demanding disease and inferior outcome. Whereas evidence was provided that some of the classical aberrations, such as 11q-, 17p-, may appear late in CLL clinical history, no information is presently available concerning 14q32/IGH translocations. The aim of this study was i) to analyze the incidence of 14q32/IGH translocations occurring at clonal evolution in CLL, ii) to analyze the clinicobiologic significance of late-appearing 14q32/IGH translocations. One hundred-five CLL cases seen at our institution in a 10-year period were submitted to FISH analysis at diagnosis or before 1st line treatment as part of routine diagnostic workup. In 47 patients with indolent disease (untreated or treated with 1 line without relapse, group 1) FISH analysis was repeated after 48–96 months (median 72). In 58 relapsed patients who started 2nd line treatment (group 2), FISH was performed sequentially before administration of the 2nd line and before each subsequent line of therapy. These 105 patients fulfilled the following criteria: a) diagnosis of bona fide CLL based on morphology and immunophenotyping (CD5/CD19+, CD23+ as minimal requirement), b) clinical records available for review, c) successful FISH analysis at diagnosis and during follow-up. Those cases with t (11;14)(q13;q32)/CCND1-IGH or other 14q32/IGH translocations present at diagnosis were excluded from this study. Sequential FISH studies were performed in all patients on peripheral blood (PB) samples using commercially available probes for the identification of deletions at 13q14, 11q22/ATM, 17p13/TP53, of trisomy 12 and of 14q32/IGH translocations. In 10 patients bone marrow (BM) aspiration and/or lymph node (LN) biopsy were studied by FISH as well. The patients were treated at disease progression as defined by NCI criteria. Refractory disease was defined by stable disease or progressive disease during treatment or disease progression within 6 months of from antileukemic treatment using fludarabine alone or in combination with other agents. Time to chemorefractoriness was measured from date of first line treatment to date of refractoriness to fludarabine containing regimen or date of last follow-up. Overall survival was measured from diagnosis to date of last follow-up or death and from initiation of first line treatment to the date of death or last follow-up. At diagnosis 39% of the cases had 13q-, 14% had +12, 7% had 11q- and 3% had 17p-. A late-appearing 14q32/IGH rearrangement was not detected among 47 patients in group 1, whereas 7/58 cases (12,1%) in group 2 showed a 14q32/IGH break in 16–25% of the cells. These 7 patients had the following aberrations at diagnosis: 13q- and 11q- in 1 case, 13q- in 2 cases; 11q- in 1 case, +12 in 2 cases, no aberrations 1 case. The 14q32 translocation appeared after a median time of 64 months (range 51–91). It was associated with the appearance of 17p- in 3/7 cases with one of these presenting also biallelic del13q. In two cases paired BM or LN sample and PB samples were available for FISH studies and the appearance of IgH translocation in the BM or in the LN sample preceded its appearance in PB by 13–58 months. All 7 cases with late appearing 14q32/IGH translocation developed chemorefractoriness to fludarabine regimen with a median TTC of 27 months (range 12–40 months), as compared with a TTC of 67 months (range 1–143 months) in 51 treated patients who did not develop the 14q32 translocation (p=0.0002). Overall survival did not differ significantly either when measured from diagnosis or from 1st line treatment in 7 patients with 14q32 translocation as compared with the appropriate control. We arrived at the following conclusions: i) a late-appearing 14q32/IGH translocation occurred at a relatively high incidence (12,1%) in patients with relapsing disease and not in patients with stable disease, ii) this aberration involved a minority of cells and, in approximately half of the cases, it was associated with other aberrations, reflecting complex clonal evolution, iii) in 2 assessable cases it first appeared first in the BM or LN; iv) the appearance of 14q32/IGH translocation was associated with shorter TTC. Disclosures: No relevant conflicts of interest to declare.