Polyethylene insert damage in unicondylar knee replacement: a comparison of in vivo function and in vitro simulation.

Modification of knee joint wear simulation methods has included 'anatomic attachment' of unicondylar knee replacements (UKR) onto synthetic femurs with material properties and morphology similar to human femurs. The present study assesses the effect of such modification by comparing the damage patterns on UKR polyethylene inserts after in vitro simulation using standard and modified simulation methods with those on inserts retrieved after in vivo function. Three groups of UKR inserts were evaluated after retrieval (Explant Group, n = 17) or after knee joint wear simulation with the components attached to standard metal blocks (Standard Group, n = 6) or synthetic femurs (Anatomic Group, n = 6). All UKR had similar non-conforming articular surfaces. Articular damage patterns (mode, frequency, and area) were quantified using digital image photogrammetry. Although some common damage modes were noted, knee joint wear simulation with standard or 'anatomic' attachment did not generate damage pattern sizes similar to the explanted UKR. A focal damage pattern consistent with contact between the metal femoral articular surface and the polyethylene inserts was evident on all inserts, but only the Explant Group had evidence of dispersed damage dominated by abrasive modes. Synthetic femurs added complexity to the wear simulation without generating wear patterns substantially more similar to those observed on retrieved inserts.

First hip arthroplasty register in Italy: 55,000 cases and 7 year follow-up.

The Register for Orthopaedic Prosthetic Implantation (RIPO) has been prospectively collecting data on hip prostheses performed in all the orthopaedic units in the region Emilia-Romagna since January 2000. The register aims to determine the characteristics of patients, evaluate the effectiveness of prostheses, and allow internal audit. Adherence to the register is compulsory (93% capture). By 31 December 2006 the register contained data on 35,041 primary total hip arthroplasty (THA), 14,613 hemiarthoplasties, and 5,878 revisions. All prosthetic components are registered on an individual basis. Survival analysis is done following the Kaplan Meier method. Cumulative survival rate at 7 years is 96.8% (95% CI: 96.4-97.1%) for THA and 97.6% (97.0-98.3%) for hemiarthroplasties. Multivariate analysis verified that survival of the THA is affected by pathology, where the worst conditions are rheumatoid arthritis, femoral neck fracture, and sequelae of coxitis or Paget's disease. Results are comparable to other major registers of Northern Europe and Australia.

The biological acetabular reconstruction with bone allografts in hip revision arthroplasty.

BACKGROUND: Reconstructions in case of acetabular bone loss in hip revision arthroplasty are challenging. A few techniques have been proposed, with inconstant outcomes. Biological reconstructions using bone allografts may address the acetabular bone loss and restore the hip anatomy. Aim of this work was the description of the surgical technique and the evaluation of the outcomes using a regional arthroplasty register. MATERIALS AND METHODS: Minor or massive bone allografting was performed in hip revision arthroplasties in a tertiary center. Bulk allografts were used in severe acetabular bone losses. Fresh-frozen femoral heads were impacted in the bone cavity and porous cups were implanted; multihole sockets were used when necessary. In DeLee A zone, no grafts were used in order to reduce overstress graft resorption. The results were evaluated using a regional arthroplasty register, and a comparison with revisions without bone grafts was performed investigating re-revision rates and reasons for further revisions. RESULTS: At 10 years, acetabular revisions with bone allografts achieved a similar survival rate than revisions without bone grafts. The re-revisions occurred more frequently in revisions without bone allografts (10.8 vs. 9.7%). In the allograft cohort, septic loosening was lower (0.3 vs. 2.6%), whereas a higher rate of aseptic cup loosening was experienced (2.7 vs. 1.4%). CONCLUSIONS: Bone allografts may provide a good restoration of the acetabular bone stock and the hip biomechanics. Septic loosening does not seems a major concern, whereas a higher rate of aseptic cup loosening should be expected when bone grafts are used.

The experience of the RIPO, a shoulder prosthesis registry with 6-year follow-up.

BACKGROUND: Implant registries have proved valuable in assessing the outcomes of arthroplasty procedures. Moreover, by identifying lesser quality implants they have indirectly improved the quality of care. The registry of prosthetic shoulder implants was established in 2008. METHODS: It records information on all types of primary and revision arthroplasty procedures involving the glenohumeral joint, including reverse and total arthroplasty, hemiarthroplasty, resurfacing, removal, and any other surgical procedures that are required to manage these patients. The collected data include patient demographics, weight, height, operated side, cuff status, and diagnosis/reason for revision surgery, information on previous surgical procedures involving either shoulder, comorbidities, antibiotic and thromboembolic prophylaxis, blood transfusions, surgical approach, cuff repair procedures performed during arthroplasty, bone grafts, drains, and perioperative complications, and data about the prosthetic components implanted, including the fixation method. RESULTS: Procedures were performed on 3754 shoulders. They included 2226 RSA, 320 TSA, 730 HA, 233 resurfacing procedures, 245 revisions, and 77 "other" procedures. The survival curves of the implants are greater than 90%, and no differences were found among prosthesis from different manufacturers. The diagnosis that prompted to arthroplasty was: osteoarthritis in 60.9% of cases and fractures, bone necrosis, sequelae of fracture and rotator cuff tear arthropathy for the rest of implants. DISCUSSION AND CONCLUSION: This study describes the epidemiological data and mid-term implant outcomes of the shoulder arthroplasty procedures performed in our region, from 2008 to 2014, and compares them with published data from national registries of similar size. LEVEL OF EVIDENCE: III.

Albumin as marker for susceptibility to metal ions in metal-on-metal hip prosthesis patients.

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.

Determination of crystallinity and crystal structure of Hylamer polyethylene after in vivo wear.

Hylamer polyethylene is a crystalline form of polyethylene of 70% crystallinity whereas conventional polyethylene (PE) has 50% crystallinity. Crystallinity is the percentage by weight of the crystalline phase present in the whole polymer, which comprises both amorphous and crystalline phases. Clinical experience has shown that Hylamer components used in joint prostheses, if sterilized by gamma rays in the presence of oxygen, are easily affected by wear, which leads to osteolysis. The authors have analyzed the crystallinity of polyethylene liners removed from seven patients who had received Hylamer polyethylene implants sterilized by gamma rays in air and had suffered prosthetic loosening, using Raman spectroscopy coupled with partial least squares (PLS) analysis. The results have been compared to those of two controls who had received Hylamer polyethylene implants sterilized by gamma irradiation in a nitrogen atmosphere. The crystal structure of wear particles released into the tissues from the Hylamer liners sterilized by gamma rays in air is also studied. The materials undergoing two different types of sterilization methods show different crystallinity values (71.50 vs. 69.43), but the crystallinity do not change according to wear (worn and unworn liner region). Both monoclinic and orthorhombic phases are present in the liner, while in wear debris prevalently monoclinic crystals are found in both types of sterilized liners. Different crystallinity rates can explain different wear rates observed in vivo.

A case report of fracture of ceramic head in total hip arthroplasty: histological and biochemical features of perimplant tissues.

The authors analyzed the case of a patient with a non-cemented hip prosthesis with a ceramic-ceramic coupling. As a consequence of trauma the head fractured. Although the patient could feel the joint grinding, there was no pain and he continued daily living activities for nearly six months, which led to marked wearing of the ceramic head. SEM analysis with microprobe showed 'planed' surfaces on the ceramic head, suggesting repeated movements between the fractured components. Inside the cone of the head, signs of TiAlV, which is an alloy of the prosthetic stem, could be seen. Periprosthetic tissues were packed with ceramic wear particles of sizes ranging between 0.2 and 10 microns, according to the harvest site. Metal and mixed particles were also found. IL1, IL6, IL8 and IL10 assays in the synovial liquid confirmed the inflammatory state and a modest induction of bone resorption, which was less than that observed in patients with loosened metal-polyethylene couplings. The humoral picture was compatible with the radiological aspect, which did not show marked signs of bone resorption. In revision surgery both ceramic components were replaced by a metal head and polyethylene liner. The clinical outcome after 12 months was very good.

Isolation and characterization of wear debris generated in patients wearing polyethylene Hylamer inserts, gamma irradiated in air.

Hylamer polyethylene was used in the early 1990s to make hip-joint components. Clinical experience has shown that these components, if sterilized by gamma rays in the presence of oxygen, are easily affected by wear, which then leads to osteolysis. The authors analyzed polyethylene wear particles in seven patients who had received Hylamer polyethylene implants sterilized by gamma rays in air and had suffered prosthetic loosening. The results were compared to those of six controls, who had received traditional polyethylene implants, sterilized by the same method. The frequency distribution of globular and fibrillar particles was similar in both groups (38.5% in Hylamer, 45.2% in controls). The globular particles in the Hylamer samples had a mean area of 0.12 microm2, which was significantly lesser than that of the controls (0.30 microm2). The width of fibrillar particles in the Hylamer samples was significantly lesser than that of the controls. Therefore, the two materials, despite undergoing the same type of sterilization, produced different types of wear, due to their different properties. In conclusion, the difference in the morphology of Hylamer polyethylene wear particles in comparison with PCA might have caused a more intensive biological response, early and massive osteolysis, and therefore, early loosening.

Biocompatibility testing of prosthetic implant materials by cell cultures.

The main aspects of biocompatibility are discussed first then the methodology used and the results obtained. The cells used included epithelial cells, lymphocytes, fibroblasts, and macrophages. The most commonly used methods were morphological observation, radioactive tracer uptake, and chemotactic migration analysis. It is concluded that cell cultures are a reliable and sensitive method for initial screening in testing the biocompatibility of the materials used in the construction of prosthetic implants.

Results of histological grading on 100 cases of hip prosthesis failure.

One hundred cases of hip prosthesis failure were classified on the basis of the different types of tissue reaction occurring around alloplastic material. The results revealed infectious phlogosis in 32% of the cases, phlogosis due to wear in 42%, phlogosis due to allergy in 1% and mixed phlogosis in 25%. The distribution of the type and degree of intensity of the phlogosis, in relation to the duration of the implant, is also highlighted. This new grading technique yields reproducible results.

Microradiographic and histochemical evaluation of mineralization inhibition at the bone-alumina interface.

Microradiographic and histochemical tests were used to examine the behaviour of the bone tissue close to the alumina coating in cementless hip prostheses which were radiologically stable and explanted because of pain. The presence was detected of a decalcification stripe of the bone tissue with a thickness of about 300 microns, parallel to the prosthesis profile and in appearance not influenced by the roughness of the surface. This phenomenon was attributed to the presence of aluminium ions similarly to what happens in osteomalacic osteodystrophy in nephropathic dialysed patients. It was concluded that the phenomenon must be carefully considered because, in the long term, it could cause failure in the alumina coating.

Nitric oxide synthase in tissues around failed hip prostheses.

Nineteen patients who had undergone hip revision surgery for aseptic loosening of joint prostheses were studied. Tissue samples were harvested at the interface between bone and implant, either at the stem or at the cotyle level. Immunohistochemistry was performed on tissue sections to detect nitric oxide synthase (NOS), the enzyme which enables the synthesis of nitric oxide (NO), a molecule which can activate bone resorption. Quantitative analysis of the positive cells and correlation with the presence of particulate wear debris and radiological data were performed. The authors observed a trend towards a moderate increase in positive cells due to inducible NOS in tissues containing particulate wear debris, especially of a plastic material. This increase, however, did not achieve statistical significance. On the contrary, there was a statistical correlation between iNOS (inducible NOS) and the severity of osteolysis around the prosthetic implant. Pharmacological control of the biosynthesis of NO may be considered in the prevention or treatment of loosening.

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.

In vitro effects of bone cements on the cell cycle of osteoblast-like cells.

The effects of orthopaedic cements on the proliferation and cell cycle of in vitro cultured MG63 osteoblast-like cells were examined. Five different cements were mixed and extracted at different time intervals (15 and 60 min, 6, 24 and 48 h). Cell proliferation inhibition (CPI) was evaluated after 72 h culture as the toxicity parameter. As for the toxicity degree, the extracts were considered to have 'high toxicity' (CPI > or = 50%), 'medium toxicity' (50% > CPI > 25%), 'low toxicity' (CPI < or = 25%) and 'no toxicity' (CPI = 0). Cell cycle phases of MG63 cells were evaluated at 24, 48 and 72 h by flow cytometry; the DNA content was assessed using the propidium iodide uptake and the percentage of cells in the S phase was determined using 5'-bromodeoxyuridine uptake. According to our results, the toxicity is inversely correlated with the time interval between polymerization and extract preparation, and is different according to the cement type. For some cements the effects are still observed 48 h after polymerization. The damaging effect is not linked to a specific phase of the cell cycle, nor does it hamper the restarting of cell proliferation at 72 h.

Cytotoxicity testing of cyanoacrylates using direct contact assay on cell cultures.

The use of a tissue adhesive for surgical procedures has prompted a large number of clinical and experimental studies. Alkyl-2-cyanoacrylate esters constitute a family of adhesives with good mechanical properties but their biological compatibility has to be assessed. In this study the cytotoxicity of three commercially available cyanoacrylates and one of unknown composition has been determined. The first part of the study deals with direct contact testing procedures using L 929 cells challenged with drops of adhesives: cell morphology, cell growth and bacterial growth inhibition were assayed. Testing methods included cell viability assay using vital dyes, cell growth measurement using crystal violet staining uptake and bacterial growth assay using S. aureus growth inhibition. All the cyanoacrylate adhesives tested were found to be cytotoxic and to inhibit cell proliferation: differences between the cyanoacrylates were found.

Apoptosis in peri-implant tissue.

The authors examined 54 biopsies taken from the tissue surrounding loosened hip joint prostheses. In situ apoptotic cell identification was performed by the detection of single- and double-stranded DNA breaks that occurred in the early stages of apoptosis. Both types of breaks can be revealed by labeling the free 3'-OH termini with modified nucleotides (fluoresceine-dUTP) in an enzymatic reaction catalyzed by terminal deoxynucleotidyl transferase (TdT). Results were correlated with the presence of wear debris in the tissue and with the use of bone cement for prosthesis fixation. Apoptotic cells were present in a higher percentage in tissue sections where metal particles were present (24% apoptotic cells) if compared to areas where no wear (6%), or plastic wear (2.8%) or ceramic wear (1.5%) was observed. Apoptosis is neither related to bone cement, nor to the time it takes for the implant to fail. Cell death by apoptosis may be important in implants which release metal ions by corrosion or wear and may have been underestimated up to now, as it is a 'clean' way of cell death, leading to limited damage in the surrounding tissues.

Toxicity of cyanoacrylates in vitro using extract dilution assay on cell cultures.

Comparative cytotoxicity testing of four cyanoacrylate adhesives suggested for orthopaedic applications was performed. These substances were placed in complete culture medium with serum and the resulting extraction fluids were tested on L 929 cells and human lymphocytes. Testing procedures include cell morphology assessment using light microscopy and vital dyes, cell counting using a computer-assisted image analysis system, cell growth measurement using total protein content assay and cell viability assessment using the MTT method. Quantitation of the toxicity of the degradation products released by cyanoacrylates in the extracts was achieved and differences in the cytopathic effect related to the chemical composition of the cyanoacrylates were found. A toxicity rating of the assayed cyanoacrylate adhesives was obtained as follows (in order of increasing toxicity): BCA < xCA < ECAg < ECAl.

Comparative study of the thromboresistance of Dacron combined with various polyurethanes.

In vitro tests were carried out on Dacron samples differently knitted and on Dacron vascular prostheses coated with various urethanes. All the materials were put in contact with human platelet-rich plasma; the subsequent assay of three platelet released substances, i.e. beta-thromboglobulin, platelet factor 4 and thromboxane B2, as well as the quantification of platelet retention, were used to establish the degree of thrombogenicity of the material itself. In some cases Dacron-urethanes composites showed better thromboresistance than any other materials conventionally used in vascular surgery.

Morphometric and microanalytical analyses of alumina wear particles in hip prostheses.

We analysed tissues harvested during 24 retrievals of hip joint prostheses, with one or both articular components made of alumina. We describe the morphology of wear particles, measure their size and analyse their chemical composition. We relate histopathological aspects to the parameters that characterize ceramic wear particles, and notice that tissue reaction relates to the physical aspect and amount of wear debris and does not necessarily depend on their chemical composition.

In vitro cytokine production by mononuclear cells exposed to bone cement extracts.

The authors evaluated the ability of bone cement to modify the profile of pro-inflammatory cytokines secreted by the immune cells. Peripheral blood mononuclear cells (PBMC) collected from healthy individuals were cultured with cement extracts and tested to assess the release of IL-1beta, TNFalpha, GM-CSF and IL-6 in both unstimulated and PHA-stimulated PBMC. The cytokine release of unstimulated PBMC was very poor, and in particular the IL-1beta was undetectable: the addition of cement extract increased both TNFalpha and GM-CSF release and decreased IL-6, sometimes significantly. The most recurrent observation in PHA-stimulated PBMCs exposed to bone cement extract was the increase in both IL-1beta and IL-6 release, while both the mean concentration and the index of release of TNFalpha and GM-CSF were changeable. In conclusion our results showed that leachable components of some bone cements can induce in vitro the release of pro-inflammatory cytokines which are known to be involved in the bone resorption associated with aseptic loosening of hip prostheses. These findings allowed us to identify materials endowed with the highest inflammatory power.