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Biomedical subjects

S Affatato

Publications and source records attributed to S Affatato.

At least 19 recordsLinked to original sources

Larger diameter bearings reduce wear in metal-on-metal hip implants.

Metal-on-metal hip arthroplasty has the longest clinical history of all total arthroplasties. We asked whether large diameter femoral heads would result in less wear than those with small diameters. We also asked if there is a threshold diameter that ensures good wear behavior. We tested three batches of cast high-carbon cobalt-chromium-molybdenum hip implants (28 mm, 36 mm, and 54 mm diameters) in a hip simulator for 5 million cycles. We used bovine serum as lubricant and weighed the samples at regular intervals during testing. The 28-mm configuration had almost twice the wear of the 54-mm configuration, but we observed no difference between the 36-mm and the 54-mm configurations. The similarity in the wear performances of the larger configurations supports the presence of a threshold diameter that ensures good wear behavior.

Femur Head↗

Meniscal wear at a three-component total ankle prosthesis by a knee joint simulator.

Despite the fundamental value of wear simulation studies to assess wear resistance of total joint replacements, neither specialised simulators nor established external conditions are available for the human ankle joint. The aim of the present study was to verify the suitability of a knee wear simulator to assess wear rates in ankle prostheses, and to report preliminary this rate for a novel three-component total ankle replacement design. Four intact 'small' size specimens of the Box ankle were analysed in a four-station knee wear simulator. Special component-to-actuator holders were manufactured and starting spatial alignment of the three-components was sought. Consistent load and motion cycles representing conditions at the ankle joint replaced exactly with the prosthesis design under analysis were taken from a corresponding mechanical model of the stance phase of walking. The weight loss for the three specimens, after two million cycles, was 32.68, 14.78, and 62.28mg which correspond to a linear penetration of 0.018, 0.008, and 0.034mm per million-cycle, respectively for the specimens #1, #2, and #3. The knee wear simulator was able to reproduce load-motion patterns typical of a replaced ankle. Motion of the meniscal bearing in between the tibial and talar components was smooth, this component remaining in place and in complete congruence with the metal components throughout the test.

Ankle Joint↗

Advanced nanocomposite materials for orthopaedic applications. I. A long-term in vitro wear study of zirconia-toughened alumina.

The use of ceramic-on-ceramic (alumina- and zirconia-based) couplings in hip joint prostheses has been reported to produce lower wear rates than other combinations (i.e., metal-on-polyethylene and ceramic-on-polyethylene). The addition of zirconia into an alumina matrix (zirconia-toughened alumina, ZTA) has been reported to result in an enhancement of flexural strength, fracture toughness, and fatigue resistance. The development of new processing routes in nonaqueous media has allowed to obtain high-density ZTA nanocomposites with a very homogeneous microstructure and a significantly smaller and narrower particle-size distribution of zirconia than conventional powder mixing methods. The aim of the present study was to set up and validate a new ZTA nanocomposite by testing its biocompatibility and wear behavior in a hip-joint simulator in comparison with commercial alumina and experimental alumina specimens. The primary osteoblast proliferation onto ZTA nanocomposite samples was found to be not significantly different from that onto commercial alumina samples. After 7 million cycles, no significant differences were observed between the wear behaviors of the three sets of cups. In this light, it can be affirmed that ZTA nanocomposite materials can offer the option of improving the lifetime and reliability of ceramic joint prostheses.

Aluminum Oxide↗

The predictive power of surface profile parameters on the amount of wear measured in vitro on metal-on-polyethylene artificial hip joints.

Various studies report a weak correlation between the average surface roughness R(a) of metallic ballheads and the observed wear rate of the polyethylene cups coupled to them. The aim of this study is to verify, with controlled in vitro experiments, whether other parameters such as the total roughness R(t), and the skewness R(sk) are better predictors of the polyethylene wear when the metallic heads present a surface conditioning that varies substantially from specimen to specimen, as is usually the case with retrieved specimens. Twelve CoCrMo (cobalt-chromium-molybdenum) ballheads were intentionally damaged in order to reproduce a wide spectrum of surface conditioning and were then subjected to the standard wear test against polyethylene cups, using a hip joint wear simulator. After 2 x 10(6) cycles the weight lost by the cups was assessed with a gravimetric procedure, and the surface roughness of the metallic ballheads was qualified in terms of R(a), R(t), and R(sk). The various parameters were correlated to the weight loss using a linear regression analysis. The skewness R(sk) showed a coefficient linear regression R2 = 0.80, while the average roughness R(a), used in most previous studies, presented an R2 = 0.56. It was concluded that when specimens with substantially different surface conditioning are compared, as in retrievals analysis, it is also important to report the skewness R(sk) so that qualify the surface roughness of the specimens can be qualified.

Coated Materials, Biocompatible↗

Sodium-azide versus ProClin 300: influence on the morphology of UHMWPE particles generated in laboratory tests.

Ultra-high molecular-weight polyethylene (UHMWPE) has been used in total joint replacement for the last three decades and is currently the best polymer available for this use. Nevertheless, the wear of UHMWPE remains a serious clinical problem. Polyethylene wear debris has been identified as a cause of osteolysis and a major factor reducing the life of the total hip arthroplasty. Debris generated at the articular surfaces enters the periprostethic tissue where it is phagocyted by macrophages. Studies have shown that particles in the 0.1-10microm size range are particularly important in causing adverse cellular reactions resulting in osteolysis. The morphology, size, mass, and number of wear particles produced in a hip joint simulator are influenced by the tribological conditions used during the experiment. This paper shows that the morphology of the UHMWPE particles generated in vitro is influenced by the type of lubricant used. This study compared, quantitatively and qualitatively, particles generated in vitro using bovine calf serum as lubricant with two different preservatives: sodium azide and ProClin 300. No significant difference was observed with regards to wear between the two types of lubricant used. Quantitative analysis of the wear particles showed that particles generated in serum with sodium azide were not [corrected] morphologically different from those produced in serum with ProClin 300 [corrected]

Animals↗

An easy technique to digest and isolate UHMWPE wear particles from a hip joint simulator.

The size and morphology of polyethylene wear particles isolated from in vitro tests were analysed in this study. There are some major controversies emerging in the literature that will only be resolved by careful particles analysis. Since it is difficult to identify the factors that affect size and morphology of the wear particles, the goal of this study was to compare four different polymer wear debris isolation techniques (base method and acid treatment) under identical conditions in a hip joint simulator to obtain polyethylene wear particles. We investigated achieving particulate isolation by using a different approach to the one reported in the literature that involved an easier and streamline method of particle debris isolation. The new method, compared to the previous one, used a strong base, normal centrifugation, and filtration to digest the serum constituents thus isolating the polyethylene particle debris from lubricant. In all four methods the isolation involved some or all of the following steps: density gradient separation, centrifugation or ultracentrifugation, and washing. However, a requirement for all these techniques was that the lubricant had to be devoid of organic compounds in order to effectively image and count the particle debris. The results from these studies clearly show that this new method of particle isolation is easier and more streamlined than the three methods analysed and reported in literature because it did not involve ultracentrifugation and is quicker.

Arthroplasty, Replacement, Hip↗

The performance of gamma- and EtO-sterilised UHMWPE acetabular cups tested under severe simulator conditions. Part 2: wear particle characteristics with isolation protocols.

Ultra-high molecular-weight polyethylene (UHMWPE) has been used in total joint replacement for the last three decades. Despite the recent advancements in prosthesis design, the wear of UHMWPE remains a serious clinical problem; the release of wear debris may induce osteolysis and implant loosening. Controlling the quality of the polyethylene is essential to improve its wear resistance and any potential adverse effect caused by processing, manufacturing or sterilisation should be avoided. To evaluate the influence of the sterilisation method (gamma-irradiation and ethylene oxide (EtO)-treatment) and third-body particles, gamma- and EtO-sterilised UHMWPE acetabular cups were tested against CoCrMo femoral heads in a hip joint simulator run for 2.5million cycles in bovine calf serum in the presence of third-body polymethylmethacrylate (PMMA) particles. A method not requiring ultra-centrifugation has been proposed for the isolation of polyethylene wear debris from the serum lubricant. SEM analysis allowed debris shape and morphology to be determined, and the wear mechanism operating in this study to be hypothesised. The morphological features of the wear debris were in agreement with clinical findings, enabling the hip simulator function to be validated. Micro-Raman spectroscopy coupled to PLS analysis showed that the mechanical friction during in vitro tests induced significant crystallinity changes in all the cups. The most significant changes were observed for the EtO-sterilised cups, which showed the highest weight loss.

Animals↗

Investigations on the wear behaviour of the temporary PMMA-based hip Spacer-G.

Total hip replacement has become one of the most successful orthopaedic procedures. However, complications due to infections may give serious problems and have devastating consequences for the hip implant. The use of a temporary three-dimensional polymethylmethacrylate (PMMA) cement spacer may be an alternative to solve infections in hip implants, improving the lives of patients awaiting reimplantation. In order to evaluate their wear behaviour, five PMMA Spacer-G femoral heads were tested against five post-mortem pelves in a hip joint simulator with bovine calf serum as lubricant. The surface of the worn spacers was characterized by scanning electron microscopy (SEM) analysis; all the samples revealed a similar morphology, showing areas characterized by different degrees of wear. Particle debris was isolated from the lubricant and PMMA particles and bone fractions were quantified. The amount of debris was found to be higher than where no-temporary prostheses were used. However, this result is acceptable since wear debris is removed by lavage irrigation when the Spacer-G is explanted. On the basis of these data, it is considered that the use of the cement Spacer-G could be a promising approach to the treatment of complicated infections of the hip joint. Therefore, Spacer-G is worthy of further research.

Arthroplasty, Replacement, Hip↗

Effects of the sterilisation method on the wear of UHMWPE acetabular cups tested in a hip joint simulator.

Ultra-high molecular-weight-polyethylene is the most commonly used bearing material in total joint replacement. Wear of polyethylene is a Serious Clinical problem that limits the longevity of orthopaedic implants. Information on degradative changes in the material properties and on the methods used for the sterilisation of polyethylene may help in the selection process of orthopaedic implants with the best wear resistance. This study was performed to investigate the effects of the sterilisation method (gamma irradiation and ethylene oxide treatment) on the wear and on the changes in physical properties of polyethylene acetabular cups. At this purpose, gamma-sterilised and ethylene oxide (EtO)-sterilised acetabular cups were tested against CoCr femoral heads in a hip joint simulator run for 5 million cycles in bovine calf serum. The crystallinity of the cups was evaluated by micro-Raman spectroscopy as a function of the inner surface position. The partial least square calibration was used to correlate the Raman spectra with the crystallinity of the polymer measured by differential scanning calorimetry. The analysis performed on soak control acetabular cups demonstrated that the gamma-sterilised cups are significantly more crystalline than the EtO-sterilised ones. The mean crystallinity values obtained for the gamma-sterilised and EtO-sterilised soak control cups were 65.0% and 63.4%, respectively. Weight loss measurements revealed that the gamma-sterilised acetabular cups exhibited a lower wear rate than that by EtO-sterilised. Thc Raman results obtained on gamma-sterilised and EtO-sterilised acetabular cups showed that the changes in surface crystallinity were mainly caused by irradiation rather than by the mechanical friction during the in vitro tests.

Analysis of Variance↗

The performance of gamma- and EtO-sterilised UHWMPE acetabular cups tested under severe simulator conditions. Part 1: role of the third-body wear process.

Due to its excellent combination of properties, ultra-high-molecular-weight-polyethylene has been used for the last 30 years in the replacement of damaged articulating cartilage for total joint replacement surgery. However, in some cases, wear, failure and delamination have been observed. Polyethylene performance may be affected by oxidation during consolidation of the resin, sterilisation of the finished specimens and post-irradiation storage. In order to evaluate the influence of the sterilisation method (gamma-irradiation and ethylene oxide(EtO)-treatment) and third-body particles on the ultra-high-molecular-weight-polyethylene wear behaviour, gamma- and EtO-sterilised ultra-high-molecular-weight-polyethylene acetabular cups were tested against CoCrMo femoral heads in a hip joint simulator run for 2.5 million cycles in bovine calf serum in the presence of third-body PMMA particles. Weight loss measurements revealed that the gamma-sterilised acetabular cups exhibited a significantly lower wear rate than those EtO-sterilised. Moreover, significant differences were found for each type of sterilisation between the gravimetric wear trends obtained until 2.5 million cycles in the presence and in the absence of PMMA particles.

Absorption↗

Surface characterization and debris analysis of ceramic pairings after ten million cycles on a hip joint simulator.

This study was aimed at characterizing the ceramic wear particles produced during tests on a hip joint wear simulator of up to 10 million cycles. Alumina and alumina-zirconia composites were studied as commercial or potential hip joint products respectively. No ceramic particles could be observed, even after a careful isolation procedure. This confirms the low wear rate found for these materials in previous works (of the order of tenths of milligrams per million cycles). Surface characterization was conducted by means of scanning electron microscopy. It confirms the low wear regime of ceramic pairings and allows ceramic wear debris morphology to be defined. The effect of microstructure on surface wear is discussed.

Aluminum Oxide↗

Mixed oxides prosthetic ceramic ball heads. Part 3: effect of the ZrO2 fraction on the wear of ceramic on ceramic hip joint prostheses. A long-term in vitro wear study.

Using ceramic materials it is possible to obtain a number of beneficial mechanical properties such as considerable hardness, good chemical resistance, high tensile strength, and a good fracture toughness. The use of ceramic-on-ceramic as bearing surfaces for hip joint prostheses has been reported to produce a lower wear rate than other combinations (i.e. metal-on-polyethylene and ceramic-on-polyethylene) in total hip artroplasty. These advantages may increase the life expectancy of hip implants and improve the life of patients. Two new types of mixed-oxide ceramics (alumina and yttria-stabilised zirconia) femoral heads and acetabular cups containing different ratios of alumina and zirconia were compared with pure commercial alumina in terms of wear behaviour in a hip joint simulator. Hip joint wear simulator studies were carried out with a full-peak load of 2030 N and a frequency of 1 Hz in bovine calf serum. After 10 million cycles the measured weight loss of all specimens was very low. However, the experimental results did not show any significant difference between the new experimental mixed-oxide ceramics prototype and the commercial ceramic material couplings.

Aluminum Oxide↗

Isolation and morphological characterisation of UHMWPE wear debris generated in vitro.

Wear tests are generally carried out on materials used in prosthetic hip implants, in order to obtain a better understanding of the tribological processes involved and improve the quality control of joint prostheses, directed towards reducing the risk of implant failure of innovative prostheses. Ceramic femoral heads of mixed alumina-zirconia oxides as well as zirconia and alumina single oxide heads were tested against UHMWPE acetabular cups in a hip joint simulator. Polyethylene cups and ceramic femoral heads were mounted in a simulator apparatus moving according to a sinusoidal function, under load and in the presence of bovine calf serum as lubricant. Wear particles were isolated from the bovine calf serum collected during the wear tests. An easy to follow method was used to separate the wear particles from the lubricant. Chemical digestive methods were used to separate the wear particles from the lubricant and the isolated particles were studied using scanning electron microscopy. The morphologies of the polyethylene debris showed considerable differences, both in size and shape of the particles, as a function of the coupled head material.

Animals↗

Fluid absorption study in ultra-high molecular weight polyethylene (UHMWPE) sterilized and unsterilized acetabular cups.

The weight gain due to fluid absorption was measured in gamma-sterilized, ethylene oxide (ETO) gas-sterilized, and unsterilized ultra-high molecular weight (UHMW) polyethylene acetabular cups. After about 2 months the total average fluid absorption gain of the polyethylene cups was: 1.76 +/- 0.45 mg (average +/- standard deviation) for the unsterilized polyethylene cups, 2.81 +/- 0.95 mg for the gamma-sterilized polyethylene cups and 1.51 +/- 0.34 for the ETO gas-sterilized polyethylene cups. There was little difference in fluid absorption between the sterilized and unsterilized specimens. In particular, the gamma-sterilized acetabular cups absorbed more than the ETO gas-sterilized and the unsterilized cups. However, the weight gain was higher in serum compared with that in water.

Absorption↗

Severe wear from retrieved alumina-on-alumina coupled implant: a case report.

This study details the in vivo wear behavior of an alumina acetabular cup and a femoral head on a retrieved non-cemented hip prosthesis. A commercial alumina ceramic-on-ceramic prosthesis was retrieved from a patient previously treated for bilateral hip arthrosis in "coxa profunda". Massive wear was found on the retrieved alumina ceramic head and acetabular cup. The total measured penetration depth was 1.9 mm while the total calculated weight loss for the acetabular cup was 6.06 g. The study underlines the head-cup instability caused by cup loosening as major cause of severe ceramic wear.

Aluminum Oxide↗

An in vitro investigation of diamond-like carbon as a femoral head coating.

Wear of polyethylene acetabular components of hip implants is a significant clinical problem. In prosthetic hip surgery, polyethylene wear is identified as a factor that limits the life of the implant; it is known that the production of debris can cause adverse tissue reactions that may lead to extensive bone loss around the implant, and consequently loosening of the fixation. A new class of so-called Diamond-Like Carbon coatings, applied to titanium femoral heads was compared to ceramic and metallic heads in terms of wear behavior against UHMWPE using a hip joint simulator with a bovine calf serum lubricant. A thin film of Diamond-Like Carbon was deposited directly onto titanium (Ti6Al4V) head using chemical vapor deposition. The wear of polyethylene coupled with Diamond-Like Carbon coated femoral heads was comparable to that obtained with the polyethylene coupled with commercial alumina femoral heads.

Alloys↗

Leg length measurement: a new method to assure the correct leg length in total hip arthroplasty.

The precise measurement of leg length plays an important role in total hip arthroplasty. Leg length inequality occurs frequently after total hip arthroplasty and may cause patient discomfort. Current clinical methods used for measuring leg length are not accurate enough to meet the demands of precision required for hip replacement. The aim of this study was to examine the validity of determining leg length differences using an ultrasound system. The proposed system measures the distance between three points, in millimetres, so that the difference between preoperative and postoperative measurements gives an indication about the leg length. The mean ultrasound variation observed in in vitro measurements showed a relative error of 1.7% (range: 52-133 mm) that means a leg length inequality of about 0.4 mm (range: 52-133 mm). The method is non-invasive (ultrasound is not limited by radiation hazards), easy, quick to use, and can be used for standard clinical screening.

Anthropometry↗

Alumina femoral head fracture: an in vitro study.

A fracture of a ceramic femoral head is reported in this study. Fractures of ceramic femoral heads are uncommon and reports on this complication are rare. After 3 million cycles, on a twelve station hip simulator that tested alumina femoral head against polyethylene acetabular cup, fracture of the ceramic ball was observed. The retrieved specimen consisted of three large ceramic fragments from the same ceramic femoral head, a polyethylene acetabular cup and a stainless steel jig. Careful and detailed examination of the removed components was made. The fracture of the ceramic ball resulted in damage to the metal taper of the jig component which was fixed into the simulator.

Acetabulum↗