[Repeated Sterilization of Articular Components of Joint Replacements with Ethylene Oxide Does Not Affect the Structure and Properties of UHMWPE]. / Opakovaná sterilizace artikulacních komponent kloubních náhrad etylenoxidem nemá vliv na strukturu a vlastnosti UHMWPE.

PURPOSE OF THE STUDY In clinical practice UHMWPE is the most commonly used material for manufacturing articular components of joint replacements. The purpose of this study is to find out whether repeated ethylene oxide sterilization results in oxidative degradation of UHMWPE or not and also whether the oxidative degradation of various types of ethylene oxide-sterilized UHMWPE depends on storage time or not. MATERIAL AND METHODS The set included 12 samples of UHMWPE (three samples with different modifications (virgin PE, with E vitamin and cross-linked with thermal treatment) and different number of sterilizations (0×-3×)). The set also included 8 samples of commercial components of hip or knee replacements sterilized with ethylene oxide and stored for different storage periods. The oxidative degradation was assessed by infrared microspectroscopy, based on which the oxidation index (OI), transvinylene index (VI), crystallinity index (CI) and E vitamin index (EI) were calculated. Mechanical properties of UHMWPE were obtained through microhardness measurements. Statistical processing of the results was performed. RESULTS In all the samples, very low oxidative degradation values were reported (most OI values < 0.1). All radiation crosslinked UHMWPE samples showed an increased VI index and a slightly lower crystallinity index. All unmodified samples (irrespective of whether or not and how many times or how long ago the samples were sterilized with EtO) had almost zero value of VI. Changes in crystallinity were negligible (in the rage of 0.56-0.63), which required very accurate measurements of micromechanical properties. Yet, linear correlation was established between microhardness and crystallinity. DISCUSSION All the mentioned indices changed as anticipated: OIs were very low and slightly increased with time of storage, VIs of radiation crosslinked samples grew in proportion to the total gama radiation dose, CIs decreased in samples thermally treated by remelting, and EIs were very low due to negligible concentration of stabiliser (0.1%) in the samples of medical grade UHMWPE. CONCLUSIONS All samples showed zero or minimum oxidative degradation. This confirmed that neither ethylene oxide sterilization, nor multiple EtO sterilization or longer storage of polymer after ethylene oxide sterilization result in major oxidative degradation. Key words: UHMWPE, ethylene oxide, sterilization, oxidation, infrared spectroscopy, microhardness.

[Comparison of the Quality of the Most Frequently Used New UHMWPE Articulation Inserts of the Total Hip Replacement]. / Porovnání kvality nejcasteji pouzívaných nových UHMWPE artikulacních vlozek náhrady kycelního kloubu.

PURPOSE OF THE STUDY For an orthopedic surgeon it is difficult or even impossible to estimate the real quality of ultrahigh molecular weight polyethylene (UHMWPE) liners that are used in the total joint replacements (TJR) just on the basis of information given by the manufacturers. At the same time, the quality of the UHMWPE liner can impact strongly on the total lifespan of the implanted TJR. This work aims at independent, objective comparison of properties of the UHMWPE liners for total hip replacements (THR), which are most frequently used in the Czech Republic. MATERIAL AND METHODS We analyzed seventeen most frequently implanted UHMWPE cups of different manufacturers implanted in the Czech Republic between 2014 and 2015 and four control samples prepared by standard industrial-scale procedures according to our instructions, whose modification (crosslinking, thermal treatment, stabilization and sterilization) was known in detail. The UHMWPE polymer was characterized by four independent microscale methods, suitable for relatively small and irregular specimens such as THR cups: infrared microspectroscopy (IR), differential scanning calorimetry (DSC), and thermogravimetric analysis (TGA). RESULTS The employed methods yielded quite complete information about the investigated UHMWPE materials. IR spectra enabled us to calculate oxidation indexes (OI, measure of oxidative damage), trans-vinylene indexes (VI, measure of absorbed radiation dose during crosslinking and/or sterilization) and crystallinity indexes (CI, amount of crystalline phase that strongly influences mechanical performance). DSC curves were employed in calculation of crystallinities (wc, proportional to CI) and melting points (Tm, proportional to the average thickness of crystalline lamellae). MH measurements confirmed that the observed structure changes showed a real impact on mechanical properties. TGA experiments gave rough estimate of stabilization and, consequently, possible long-term oxidation resistance. Significant correlations among oxidative damage (OI), crystallinity (CI, wc) and microhardness (Hv) were statistically proven. The highest oxidative degradation was usually observed in samples thermally treated by annealing and/or sterilized by gamma irradiation. DISCUSSION The results confirmed our expectations that the UHMWPE liners from various manufacturers can be significantly different as far as their molecular structure, supermolecular structure, and mechanical properties are concerned. The differences among the various UHMWPE can be expected to increase after the implantation during in vivo. CONCLUSIONS From the clinical practice point of view, the results showed the following facts: (i) In the field of THR, all manufactures prefer crosslinked types of UHMWPE due to their increased wear resistance; non-crosslinked UHMWPEs are regarded as obsolete. (ii) Most of the manufacturers prefer ethylene oxide or gas plasma sterilization to gamma sterilization because the gammasterilized UHMWPEs exhibit lower long-term oxidation resistance. (iii) Modern trend is the stabilization of UHMWPEs with vitamin E. Key words: UHMWPE, hip replacements, oxidative degradation, infrared spectroscopy, microhardness.

[Comparison of Explanted UHMWPE Hip Replacement Components of Various Manufacturers after 10 Years in vivo]. / Porovnání explantovaných UHMWPE komponent náhrady kycelního kloubu ruzných výrobcu po 10 letech in vivo.

PURPOSE OF THE STUDY Considered to be one of the most common causes of aseptic loosening of endoprostheses is the THA failure due to the wear of articulating components, UHMWPE in particular. The purpose of this study is to verify, in terms of oxidative damage and other parameters, the differences between the UHMWPE implants made by various manufacturers explanted for aseptic loosening with the same life span in vivo. MATERIAL AND METHODS In the period 2010-2015, a total of 21 THA articulating components (cups) made of Ultrahigh molecular weight polyethylene by seven different manufacturers were explanted. For each manufacturer, three UHMWPE cups with the same life span (10-12 years after the primary implantation) were evaluated. The damage to the examined joint replacements was described in complexity using three different criteria, namely independently by three evaluators - experienced orthopaedic surgeons. The evaluated criteria were the following: degree of osteolysis determined based on the preoperative radiographs, wear rate of the explanted UHMWPE component, and extent of perioperatively detected granuloma. Oxidative damage and other structural characteristics of explanted cups were studied by means of infrared spectroscopy and microhardness testing. The correlation between the clinical orthopaedic assessment and oxidative damage were statistically processed. RESULTS Strong correlations between the oxidative damage and crystallinity, strong correlations between all types of orthopaedic assessments, negligible correlations between trans-vinylene index and all the other quantities, and moderate correlations between the oxidative damage and clinical evaluation were identified. It was confirmed by experimental measurement that the observed high oxidative damage, resulting in increased crystallinity, manifested itself also in micromechanical properties of the material at the respective site of the THA articulating component. DISCUSSION The discussion includes the comparison of correlations of individual quantities as well as potential effects on the differences in values of components made by individual manufacturers. The values are related to the data in literature and generally accepted claims. CONCLUSIONS At the time of failure almost all the components showed severe or even critical oxidative damage that strongly correlated with the overall clinical evaluation of the damage to the implant. This confirmed that the oxidative degradation is one of the main causes of THA failure. Key words: UHMWPE, oxidation index, crystallinity, THA failure, wear.

[The Risk of Total Joint Replacement Infectious Complications in Relation to the UHMWPE Particle Adhesion Area]. / Riziko infekcních komplikací po náhrade nosného kloubu ve vztahu k adhezní plose UHMWPE cástic.

PURPOSE OF THE STUDY Periprosthetic joint infection is a major complication which in most of the cases requires a long-term administration of antibiotics and often necessitates undergoing multiple challenging surgeries. Bacterial adhesion to foreign material is one of the key risk factors associated with periprosthetic joint infection. The foreign material with large adhesion area might be also the UHMWPE (Ultrahigh molecular weight polyethylene) particles released during the wear process from the surface of articulating components. The purpose of this study is to evaluate potential adhesion areas of wear particles in relation to diverse distribution of the size and shapes of wear particles in periprosthetic tissue and to assess an increase in the risk of infectious complications associated with an increase in the adhesion area of wear particles. MATERIAL AND METHODS The size and morphology of model and real UHMWPE particles were determined with the use of light microscopy and scanning electron microscopy. By determining the morphological descriptors, the surfaces of individual particles for different distributions of polyethylene particles were calculated. When measuring the model wear particles, 6 model situations were simulated, in which comparisons with the control measurement by the BET (Brunauer-Emmet-Teller) method were made. RESULTS The variability of individual morphological descriptors demonstrates the effect on the total surface of particles. The calculated coefficient defines how many times the particle surface increases when corrected to the given descriptor (elongation, flattening, roughness, porosity). The total area of real wear particles at 1 year is 4,622 cm2, at 20 years it is 92,440 cm2. Based on our calculations, the area of particles where a biofilm is actually formed (approximately 50 bacteria may adhere to a particle of 3µm in diameter) is 809.5 cm2 at 1 year and 16,190 cm2 at 20 years. DISCUSSION According to the measurements, the size of the potential adhesion area of metal parts and polyethylene particles becomes equal already after several weeks of endoprosthesis usage and after a few years it is many times larger. The question is whether the risk of bacterial adhesion, i.e. also the risk of infectious complications of TEP actually increases. The clinical practice suggests that the number of infections e.g. 10, 15 or 20 years after the primary implantation is not statistically higher, despite the confirmed growth of potential adhesion area in the form of UHMWPE particles. This fact could be explained by a partially equal regulatory pathway of infection and polyethylene disease. The immune system stimulated by wear particles might better resist the hematogenic infection. CONCLUSIONS The study outcomes clearly indicate that the area of polyethylene wear particles considerably increases over time. In spite of the fact that only approximately 10% of wear particles show parameters (also with respect to the size of particles and bacteria) for potential bacterial adhesion, this area is many times larger than the area of metal parts of the endoprosthesis. Key words: UHMWPE particle, adhesion, biofilm, wear, TJR infection.

Thermoplastic starch composites with TiO2 particles: Preparation, morphology, rheology and mechanical properties.

Composites of thermoplastic starch (TPS) with titanium dioxide particles (mTiO2; average size 0.1µm) with very homogeneous matrix and well-dispersed filler were prepared by a two-step method, including solution casting (SC) followed by melt mixing (MM). Light and scanning electron microscopy confirmed that only the two-step procedure (SC+MM) resulted in ideally homogeneous TPS/mTiO2 systems. The composites prepared by single-step MM contained non-plasticized starch granules and the composites prepared by single-step SC suffered from mTiO2 agglomeration. Dynamic mechanical measurements showed an increase modulus with increasing filler concentration. In TPS containing 3wt.% of mTiO2 the stiffness was enhanced by >40%. Further experiments revealed that the recommended addition of chitosan or the exchange of mTiO2 for anisometric titanate nanotubes with high aspect ratio did not improve the properties of the composites.

[Use of the immunoblotting method in serodiagnosis of M. kansasii mycobacteriosis]. / Vyuzití imunoblotové metody v sérodiagnostice mykobakteriózy M. kansasii.

The indirect enzyme test ELISA with soluble complex antigen of M. kansasii, used for assessment of the titre of IgG serum antibodies in a group of patients suffering from mycobacteriosis M. kansasii and in a control group of patients suffering from tuberculosis did not reveal statistically significant differences between serological responses of these two groups. On the other hand, the immunoblot analysis revealed in sera selected at random from these two groups differences at the level of subprotein units against the complex antigen of M. kansasii. In a group of 15 sera of patients with M. kansasii the immunodominant area was 42-45 kD protein subunits, in the control group of 10 sera with M. tuberculosis the area was 35-39 kD. The western blot technique is more perspective for improvement of the serum diagnosis of M. kansasii, in particular where a specific antigen is not available.