Carbon Nanotube Reinforced High Density Polyethylene Materials for Offshore Sheathing Applications.

Multiwall carbon nanotube (CNT)-filled high density polyethylene (HDPE) nanocomposites were prepared by extrusion and considered for their suitability in the offshore sheathing applications. Transmission electron microscopy was conducted to analyse dispersion after bulk extrusion. Monolithic and nanocomposite samples were subjected to accelerated weathering and photodegradation (carbonyl and vinyl indices) characterisations, which consisted of heat, moisture (seawater) and UV light, intended to imitate the offshore conditions. The effects of accelerated weathering on mechanical properties (tensile strength and elastic modulus) of the nanocomposites were analysed. CNT addition in HDPE produced environmentally resilient nanocomposites with improved mechanical properties. The energy utilised to extrude nanocomposites was also less than the energy used to extrude monolithic HDPE samples. The results support the mass substitution of CNT-filled HDPE nanocomposites in high-end offshore applications.

[Tolerance of hypofractionated stereotactic radiotherapy for hepatic tumours]. / Tolérance de l'irradiation stéréotaxique hypofractionnée des tumeurs hépatiques.

PURPOSE: The purpose of the study was to evaluate the outcomes of stereotactic radiation therapy for primary and secondary liver tumours in Jean-Perrin cancer centre (Clermont-Ferrand, France) in terms of efficacy and safety. MATERIALS AND METHODS: Between December 2013 and June 2016, 25 patients were included. Treatment was performed on a linear accelerator Novalis TX®. The prescription dose was 42 to 60Gy in three to five fractions. Local control at 1 year was evaluated with modified Response Evaluation Criteria in Solid Tumours (mRECIST) and RECIST criteria. Acute and late toxicity were evaluated with Common Terminology Criteria for Adverse Events (CTCAE) v4.0 criteria. RESULTS: Median follow-up was 10.5 months. Treatment tolerance was good with few side effects grade 3 or above, no acute toxicity and only one late toxicity. We have highlighted that hepatic artery haemorrhage was associated with the presence of a biliary prosthesis in contact with the artery (P=0.006) and in the irradiation field. There was no correlation with the dose delivered to the artery and hepatic artery haemorrhage. CONCLUSION: Stereotactic radiation therapy for liver tumours allows a good local control with few secondary effects. Caution should be exercised when treating patients with biliary prostheses in the vicinity of the target volume because there is a risk of haemorrhage of the hepatic artery in contact with the prosthesis.

Reconciliation of pH, conductivity, total organic carbon with carboxylic acids detected by ion chromatography in solution after contact with multilayer films after γ-irradiation.

The impact of γ-irradiation on polymers in multilayer films was studied by means of the study of the diffusion and release (spontaneous migration of the molecules from the container into the product) of chemical species in aqueous solution. A series of different measurements have been performed: pH, conductivity, total organic carbon (TOC) and ion chromatography (IC). Their evolution according to γ-irradiation dose was studied. More several rinsings made over several months allowed to quantify well the impact of the irradiation on these polymers. The samples are irradiated at several γ-doses, up to 270 kGy, and compared with a non-irradiated sample used as reference. It shows that quantity of generated carboxylic acids depends on the film material (PE/EVOH/PE and EVA/EVOH/EVA) and increases with γ-dose.

Wear and Osteolysis of Highly Crosslinked Polyethylene at 10 to 14 Years: The Effect of Femoral Head Size.

BACKGROUND: Highly crosslinked polyethylene (XLPE) was introduced to decrease periprosthetic osteolysis related to polyethylene wear, a major reason for revision of total hip arthroplasty. However, there are few reports of wear and osteolysis at 10 years postoperatively. QUESTIONS/PURPOSES: (1) What are the linear and volumetric wear rates of XLPE at 10 to 14 years? (2) What is the relationship among linear wear, volumetric wear, and femoral head size? (3) What proportion of hips developed osteolysis and was there a relationship between osteolysis and femoral head size or polyethylene wear? METHODS: We evaluated a previously reported cohort of 84 hips (72 patients) with one design of an uncemented acetabular component and one electron beam 10-kGy irradiated and remelted XLPE at a mean followup of 11 years (range, 10-14 years). The choice of femoral head size was based on several factors, including the outer diameter size of the acetabular component implanted, the perceived risk of dislocation (including the history of alcohol abuse and patient age), and liner availability from the manufacturer. The femoral head sizes used were 26 mm in 10 hips (12%), 28 mm in 31 hips (37%), 32 mm in 31 hips (37%), 36 mm in eight hips (10%), and 40 mm in four hips (5%). Measurements of linear and volumetric wear were performed in one experienced laboratory by the Martell method and analyzed using the first-to-last method. Standard radiographs, with additional Judet views, were used to detect periprosthetic osteolysis. Statistical analysis of wear and osteolysis compared with head size was performed. RESULTS: For the entire cohort, the median linear wear rate as 0.024 mm/year (95% confidence interval [CI], 0.016-0.030) and the median volumetric wear rate was 12.19 mm(3)/year (95% CI, 6.6-15.7). With the numbers available, we found no association between femoral head size and linear wear rate. However, larger femoral heads were associated with more volumetric wear; 36/40-mm femoral heads had higher volumetric wear (median 26.1; 95% CI, 11.3-47.1) than did 26-mm heads (median 3.1; 95% CI, 0.7-12.3), 28-mm heads (median 12.3; 95% CI, 3.0-19.3), and 32-mm heads (median 12.9; 95% CI, 6.6-16.8; p = 0.02). Small osteolytic lesions were noted in 12 hips (14%), but with the numbers available, there was no association with head size or volumetric wear rates. CONCLUSIONS: This uncemented acetabular component and this particular XLPE had low rates of linear and volumetric wear. Small osteolytic lesions were noted at 10 to 14 years but were not related to femoral head size or linear or volumetric wear rates. We recommend additional longer-term clinical followup studies and perhaps alternative imaging studies of patients with XLPE and osteolysis. LEVEL OF EVIDENCE: Level III, therapeutic study.

Inactivation of Escherichia coli O157:H7 and Listeria monocytogenes in biofilms by pulsed ultraviolet light.

BACKGROUND: The inactivation of biofilms formed by pathogenic bacteria on ready-to-eat and minimally processed fruits and vegetables by nonthermal processing methods is critical to ensure food safety. Pulsed ultraviolet (PUV) light has shown promise in the surface decontamination of liquid, powdered, and solid foods. In this study, the antimicrobial efficacy of PUV light treatment on nascent biofilms formed by Escherichia coli O157:H7 and Listeria monocytogenes on the surfaces of food packaging materials, such as low-density polyethylene (LDPE), and fresh produce, such as lettuce (Lactuca sativa) leaves, was investigated. RESULTS: The formation of biofilms on Romaine lettuce leaves and LDPE films was confirmed by crystal violet and Alcian blue staining methods. Inactivation of cells in the biofilm was determined by standard plating procedures, and by a luminescence-based bacterial cell viability assay. Upon PUV treatment of 10 s at two different light source to sample distances (4.5 and 8.8 cm), viable cell counts of L. monocytogenes and E. coli O157:H7 in biofilms on the lettuce surface were reduced by 0.6-2.2 log CFU mL(-1) and 1.1-3.8 log CFU mL(-1), respectively. On the LDPE surface, the efficiency of inactivation of biofilm-encased cells was slightly higher. The maximum values for microbial reduction on LDPE were 2.7 log CFU mL(-1) and 3.9 log CFU mL(-1) for L. monocytogenes and E. coli O157:H7, respectively. Increasing the duration of PUV light exposure resulted in a significant (P < 0.05) reduction in biofilm formation by both organisms. The results also revealed that PUV treatment was more effective at reducing E. coli biofilms compared with Listeria biofilms. A moderate increase in temperature (~7-15°C) was observed for both test materials. CONCLUSIONS: PUV is an effective nonthermal intervention method for surface decontamination of E. coli O157:H7 and L. monocytogenes on fresh produce and packaging materials.

Analysis of long-term degradation behaviour of polyethylene mulching films with pro-oxidants under real cultivation and soil burial conditions.

Apart from the conventional polyethylene and the bio-based or mainly bio-based biodegradable in soil mulching films, polyethylene mulching films of controlled degradation in soil are already used in agriculture. The use of special pro-oxidants as additives is expected to accelerate the abiotic oxidation and the subsequent chain scission of the polymer under specific UV radiation or thermal degradation conditions, according to the literature. The role of pro-oxidants in the possible biodegradation of polyethylene has been theoretically supported through the use of controlled laboratory conditions. However, results obtained in real soil conditions, but also several laboratory test results, are not supporting these claims and the issue remains disputed. Mulching films made of linear low-density polyethylene (LLDPE) with pro-oxidants, after being used for one cultivation period in an experimental field with watermelon cultivation, were buried in the soil under real field conditions. This work presents the analysis of the degradation of the mulching films during the cultivation period as compared to the corresponding changes after a long soil burial period of 8.5 years. The combined effects of critical factors on the photochemical degradation of the degradable mulching LLDPE films with pro-oxidants under the cultivation conditions and their subsequent further degradation behaviour in the soil are analysed by testing their mechanical properties and through spectroscopic and thermal analysis.

Ion acceleration and D-D nuclear fusion in laser-generated plasma from advanced deuterated polyethylene.

Deuterated polyethylene targets have been irradiated by means of a 1016 W/cm2 laser using 600 J pulse energy, 1315 nm wavelength, 300 ps pulse duration and 70 micron spot diameter. The plasma parameters were measured using on-line diagnostics based on ion collectors, SiC detectors and plastic scintillators, all employed in time-of-flight configuration. In addition, a Thomson parabola spectrometer, an X-ray streak camera, and calibrated neutron dosimeter bubble detectors were employed. Characteristic protons and neutrons at maximum energies of 3.0 MeV and 2.45 MeV, respectively, were detected, confirming that energy spectra of reaction products coming from deuterium-deuterium nuclear fusion occur. In thick advanced targets a fusion rate of the order of 2 × 108 fusions per laser shot was calculated.

Analysis and evaluation of single-use bag extractables for validation in biopharmaceutical applications.

This paper describes an approach of extractables determination and gives information on extractables profiles for gamma-sterilized single-use bags with polyethylene inner contact surfaces from five different suppliers. Four extraction solvents were chosen to capture a broad spectrum of extractables. An 80% ethanol extraction was used to extract compounds that represent the bag resin and the organic additives used to stabilize or process the polymer films which would not normally be water-soluble. Extractions with1 M HCl extract, 1 M NaOH extract, and 1% polysorbate 80 were used to bracket potential leachables in biopharmaceutical process fluids. The objective of this study was to obtain extractables data from different bags under identical test conditions. All the bags had a nominal capacity of 5 L, were gamma-irradiated prior to testing, and were tested without modification except that connectors, if any, were removed prior to filling. They were extracted at 40 °C for 30 days. Extractables from all bag extracts were identified and the concentration estimated using headspace gas chromatography-mass spectrometry and flame ionization detection for volatile compounds and for semi-volatile compounds, and liquid chromatography-mass spectrometry for targeted compounds. Metals and other elements were detected and quantified by inductively coupled plasma mass spectrometry analysis. The results showed a variety of extractables, some of which are not related to the inner polyethylene contact layer. Detected organic compounds included oligomers from polyolefins, additives and their degradation products, and oligomers from the fill tubing. The concentrations of extractables were in the range of parts-per-billion to parts-per-million per bag under the applied extraction conditions. Toxicological effects of the extractables are not addressed in this paper. LAY ABSTRACT: Extractables and leachables characterization supports the validation and the use of single-use bags in the biopharmaceutical manufacturing process. This paper describes an approach for the identification and quantification of extractable substances for five commercially available single-use bags from different suppliers under identical analytical conditions. Four test formulations were used for the extraction, and extractables were analyzed with appropriately qualified analytical techniques, allowing for the detection of a broad range of released chemical compounds. Polymer additives such as antioxidants and processing aids and their degradation products were found to be the source of most of the extracted compounds. The concentration of extractables ranged from parts-per-billion to parts-per-million under the applied extraction conditions.

Thermal, creep-recovery and viscoelastic behavior of high density polyethylene/hydroxyapatite nano particles for bone substitutes: effects of gamma radiation.

BACKGROUND: High Density Polyethylene (HDPE) is one of the most often used polymers in biomedical applications. The limitations of HDPE are its visco-elastic behavior, low modulus and poor bioactivity. To improve HDPE properties, HA nanoparticles can be added to form polymer composite that can be used as alternatives to metals for bone substitutes and orthopaedic implant applications. METHOD: In our previous work (BioMedical Engineering OnLine 2013), different ratios of HDPE/HA nanocomposites were prepared using melt blending in a co-rotating intermeshing twin screw extruder. The accelerated aging effects on the tensile properties and torsional viscoelastic behavior (storage modulus (G') and Loss modulus (G")) at 80°C of irradiated and non-irradiated HDPE/HA was investigated. Also the thermal behavior of HDPE/HA were studied. In this study, the effects of gamma irradiation on the tensile viscoelastic behavior (storage modulus (E') and Loss modulus (E")) at 25°C examined for HDPE/HA nanocomposites at different frequencies using Dynamic Mechanical Analysis (DMA). The DMA was also used to analyze creep-recovery and relaxation properties of the nanocomposites. To analyze the thermal behavior of the HDPE/HA nanocomposite, Differential Scanning Calorimetry (DSC) was used. RESULTS: The microscopic examination of the cryogenically fractured surface revealed a reasonable distribution of HA nanoparticles in the HDPE matrix. The DMA showed that the tensile storage and loss modulus increases with increasing the HA nanoparticles ratio and the test frequency. The creep-recovery behavior improves with increasing the HA nanoparticle content. Finally, the results indicated that the crystallinity, viscoelastic, creep recovery and relaxation behavior of HDPE nanocomposite improved due to gamma irradiation. CONCLUSION: Based on the experimental results, it is found that prepared HDPE nanocomposite properties improved due to the addition of HA nanoparticles and irradiation. So, the prepared HDPE/HA nanocomposite appears to have fairly good comprehensive properties that make it a good candidate as bone substitute.

Conversion of post consumer polyethylene to the biodegradable polymer polyhydroxyalkanoate.

A process for the conversion of post consumer (agricultural) polyethylene (PE) waste to the biodegradable polymer medium chain length polyhydroxyalkanoate (mcl-PHA) is reported here. The thermal treatment of PE in the absence of air (pyrolysis) generated a complex mixture of low molecular weight paraffins with carbon chain lengths from C8 to C32 (PE pyrolysis wax). Several bacterial strains were able to grow and produce PHA from this PE pyrolysis wax. The addition of biosurfactant (rhamnolipids) allowed for greater bacterial growth and PHA accumulation of the tested strains. Some strains were only capable of growth and PHA accumulation in the presence of the biosurfactant. Pseudomonas aeruginosa PAO-1 accumulated the highest level of PHA with almost 25 % of the cell dry weight as PHA when supplied with the PE pyrolysis wax in the presence of rhamnolipids. The change of nitrogen source from ammonium chloride to ammonium nitrate resulted in faster bacterial growth and the earlier onset of PHA accumulation. To our knowledge, this is the first report where PE is used as a starting material for production of a biodegradable polymer.

Low wear of a second-generation highly crosslinked polyethylene liner: a 5-year radiostereometric analysis study.

BACKGROUND: A sequentially irradiated and annealed, second-generation highly crosslinked polyethylene (XLPE) liner was introduced clinically in 2005 to reduce in vivo oxidation. This liner design has also been shown to reduce wear in vitro when compared with conventional and first-generation crosslinked liners. To date, there is only one study reporting an in vivo wear rate of this liner at 5 years' followup. However, that study used measurements made from plain radiographs, which have limited sensitivity, particularly when monitoring very low amounts of wear. QUESTIONS/PURPOSES: What is the amount and direction of wear at 5 years using radiostereometric analysis (RSA) in patients who had THAs that included second-generation XLPE? METHODS: We prospectively reviewed 21 patients who underwent primary cementless THA with the same design of XLPE acetabular liner and 32-mm articulation. Tantalum markers were inserted during surgery and all patients had RSA radiographs at 1 week, 6 months, and 1, 2, and 5 years postoperatively. Femoral head penetration within the acetabular component was measured with UmRSA(®) software. One patient died and two had incomplete radiographs leaving 18 radiographic series for analysis. RESULTS: The mean amounts of proximal, two-dimensional, and three-dimensional head penetration between 1 week and 5 years were 0.018, 0.071, and 0.149 mm, respectively. The mean proximal, two-dimensional, and three-dimensional wear rates calculated between 1 year and 5 years were all less than 0.001 mm/year with no patient recording a wear rate of more than 0.040 mm/year. CONCLUSIONS: The head penetration of a second-generation XLPE liner remained low at 5 years and the wear rate calculated after the first year was low in all directions. This low level of wear remains encouraging for the future clinical performance of this material.

Wear of a 5 megarad cross-linked polyethylene liner: a 6-year RSA study.

BACKGROUND: One cross-linked polyethylene (XLPE) liner is manufactured using a lower dose of radiation, 5 Mrad, which may result in less cross-linking. The reported in vivo wear rate of this XLPE liner in patients undergoing THA has varied, and has included some patients in each reported cohort who had greater than 0.1 mm/year of wear, which is an historical threshold for osteolysis. Previous studies have measured wear on plain radiographs, an approach that has limited sensitivity. QUESTIONS/PURPOSES: We therefore measured the amount and direction of wear at 6 years using Radiostereometric analysis (RSA) in patients who had THAs that included a cross-linked polyethylene liner manufactured using 5 Mrad radiation. METHODS: We prospectively reviewed wear in 30 patients who underwent primary THAs with the same design of cross-linked acetabular liner and a 28-mm articulation. Tantalum markers were inserted during surgery and all patients had RSA radiographic examinations at 1 week, 6 months, 1, 2, and 6 years postoperatively. RESULTS: The mean proximal, two-dimensional (2-D) and three-dimensional (3-D) wear rates calculated between 1 year and 6 years were 0.014, 0.014, and 0.018 mm/per year, respectively. The direction of the head penetration recorded between 1 week and 6 years was in a proximal direction for all patients, proximolateral for 16 of 24 patients, and proximomedial for eight of 24 patients. CONCLUSIONS: The proximal, 2-D and 3-D wear of a XLPE liner produced using 5 Mrad of radiation was low but measurable by RSA after 6 years. No patients had proximal 2-D or 3-D wear rates exceeding 0.1 mm/year. Further followup is needed to evaluate the effect of XLPE wear particles on the development of long-term osteolysis.

The John Charnley Award: an accurate and sensitive method to separate, display, and characterize wear debris: part 1: polyethylene particles.

BACKGROUND: Numerous studies indicate highly crosslinked polyethylenes reduce the wear debris volume generated by hip arthroplasty acetabular liners. This, in turns, requires new methods to isolate and characterize them. QUESTIONS/PURPOSES: We describe a method for extracting polyethylene wear particles from bovine serum typically used in wear tests and for characterizing their size, distribution, and morphology. METHODS: Serum proteins were completely digested using an optimized enzymatic digestion method that prevented the loss of the smallest particles and minimized their clumping. Density-gradient ultracentrifugation was designed to remove contaminants and recover the particles without filtration, depositing them directly onto a silicon wafer. This provided uniform distribution of the particles and high contrast against the background, facilitating accurate, automated, morphometric image analysis. The accuracy and precision of the new protocol were assessed by recovering and characterizing particles from wear tests of three types of polyethylene acetabular cups (no crosslinking and 5 Mrads and 7.5 Mrads of gamma irradiation crosslinking). RESULTS: The new method demonstrated important differences in the particle size distributions and morphologic parameters among the three types of polyethylene that could not be detected using prior isolation methods. CONCLUSION: The new protocol overcomes a number of limitations, such as loss of nanometer-sized particles and artifactual clumping, among others. CLINICAL RELEVANCE: The analysis of polyethylene wear particles produced in joint simulator wear tests of prosthetic joints is a key tool to identify the wear mechanisms that produce the particles and predict and evaluate their effects on periprosthetic tissues.

Effect of crystallinity and irradiation on thermal properties and specific heat capacity of LDPE & LDPE/EVA.

In this paper a series of low-density polyethylene (LDPE) blends with different percentages (10%, 20%, and 30%) of EVA and sets of low-density polyethylene sheets were prepared. This set consists of four subsets, which were made under different cooling methods: fast cooling in liquid nitrogen, cooling with cassette, exposing in open air, and cooling in oven, to investigate the crystallinity effects. All of the samples were irradiated with 10MeV electron-beam in the dose range of 0-250kGy using a Rhodotron accelerator system. The variation of thermal conductivity (k) and specific heat capacity (C(p)) of all of the samples were measured. We found that, for the absorption dose less than 150kGy, k of the LDPE samples at a prescribed temperature range decreased by increasing the amount of dose, but then the change is insignificant. With increasing the crystallinity, k of the LDPE samples increased, whereas C(p) of this material is decreased. In the case of LDPE/EVA blends, for the dose less than 150kGy, C(p) (at 40°C) and k (in average) decreased, but then the change is insignificant. With increasing the amount of additive (EVA), C(p) and k increased.

The effect of poly sterilization on wear, osteolysis and survivorship of a press-fit cup at 10-year followup.

BACKGROUND: During the mid-1990s when our institution was using a press-fit porous-coated cup without supplemental initial fixation for primary THA, the manufacturer transitioned from gamma irradiation to gas plasma for the terminal sterilization of their polyethylene liners. QUESTIONS/PURPOSES: At minimum 10-year followup, we asked whether the fixation achieved by solely relying on a press-fit would be durable and how different liner sterilization methods affected radiographic wear, osteolysis, and survivorship. PATIENTS AND METHODS: We retrospectively reviewed 373 patients who underwent 398 primary THAs with a press-fit porous-coated cup between March 1995 and December 1996. Mean age at time of surgery was 61.5 ± 13.3 years and mean followup was 10.4 ± 3.7 years. We determined reasons for revision, survivorship, femoral head penetration, osteolysis, and wear-related complications. RESULTS: Among 20 revisions involving any component, seven were associated with wear and osteolysis. Kaplan-Meier survivorship, using component revision for any reason as an end point, was 95.7% (95% confidence interval, 93.6%-97.9%) at 10 years. Noncrosslinked liners sterilized with gas plasma demonstrated a mean head penetration rate of 0.20 ± 0.09 mm/year compared with 0.13 ± 0.07 mm/year for liners sterilized with gamma irradiation in air and 0.09 ± 0.04 mm/year for liners sterilized with gamma-irradiation with barrier packaging without oxygen. THAs with increased volumetric wear tended to demonstrate larger osteolytic lesions (r = 0.40) and there tended to be less osteolysis among the liners sterilized with gamma-irradiation with barrier packaging without oxygen. However, there was no difference in survivorship among the sterilization groups and there has been no cup or stem loosening associated with osteolysis. CONCLUSIONS: Durable biologic fixation through 10-year followup can be achieved by solely relying on an initial press-fit. Noncrosslinking gas plasma for terminal sterilization of the polyethylene liners was associated with greater head penetration rate than gamma irradiation. LEVEL OF EVIDENCE: Level IV, therapeutic study. See Guidelines for Authors for a complete description of levels of evidence.

The relative effects of radiation crosslinking and type of counterface on the wear resistance of ultrahigh-molecular-weight polyethylene.

The lifetime of total joint replacement prostheses utilizing ultrahigh-molecular-weight polyethylene (UHMWPE) components has historically been determined by their wear resistance. It has been discovered that radiation crosslinking of UHMWPE can substantially increase its wear resistance. However, it is also well recognized that there is a radiation-dose-dependent decrease in several important mechanical properties of UHMWPE, such as fracture toughness and resistance to fatigue crack propagation. In this study, the effect of radiation crosslinking (followed by remelting) on the morphology, tensile properties and wear resistance of UHMWPE was investigated. Wear tests were conducted against both the commonly used cobalt-chromium counterface polished to implant grade smoothness as well as a smoother ceramic (alumina) counterface. The results showed that 50kGy dose radiation crosslinking increased the wear resistance of UHMWPE against the cobalt-chromium counterface 7-fold, but the coupling of remelted, crosslinked UHMWPE against the smoother alumina counterface led to a 20-fold increase in wear resistance. This study shows that the use of an alumina counterface would circumvent the need to use a high radiation dose in crosslinking UHMWPE, associated with poor mechanical properties, without compromising wear resistance.

Second-generation highly cross-linked X3™ polyethylene wear: a preliminary radiostereometric analysis study.

BACKGROUND: First-generation highly cross-linked polyethylene liners have reduced the incidence of wear particle-induced osteolysis. However, failed acetabular liners have shown evidence of surface cracking, mechanical failure, and oxidative damage. This has led to the development of second-generation highly cross-linked polyethylene, which has improved wear and mechanical properties and resistance to oxidation in vitro. Owing to its recent introduction, there are no publications describing its clinical performance. QUESTIONS/PURPOSES: We assessed early clinical wear of a second-generation highly cross-linked polyethylene liner and compared its clinical performance with the published results of hip simulator tests and with first-generation highly cross-linked polyethylene annealed liners. PATIENTS AND METHODS: Twenty-one patients were enrolled in a prospective cohort study. Clinical outcome and femoral head penetration were measured for 19 patients at 6 months and 1 and 2 years postoperatively. RESULTS: The median proximal head penetration was 0.009 mm and 0.024 mm at 1 and 2 years, respectively. The median two-dimensional (2-D) head penetration was 0.083 mm and 0.060 mm at 1 and 2 years, respectively. The median proximal wear rate between 1 and 2 years was 0.015 mm/year. CONCLUSIONS: The wear rate calculated was similar to the in vitro wear rate reported for this material; however, it was less than the detection threshold for this technique. Although longer followup is required for wear to reach a clinically quantifiable level, this low level of wear is encouraging for the future clinical performance of this material. LEVEL OF EVIDENCE: Level IV, therapeutic study. See the Guidelines for Authors for a complete description of levels of evidence.

Cyclodextrin-functionalized polyethylene and polypropylene as biocompatible materials for diclofenac delivery.

Polyethylene (PE) and polypropylene (PP) were surface functionalized with beta-cyclodextrin (beta-CD) and hydroxypropyl-beta-cyclodextrin (HP-beta-CD) with the aim of providing PE and PP with the capability of behaving as drug delivery systems. Functionalization was carried out according to a two-step procedure: (i) glycidyl methacrylate (GMA) was grafted by means of gamma radiation and (ii) the epoxy groups of GMA reacted with the hydroxyl groups of CDs forming ether bonds. For a fix radiation dose and GMA concentration, grafting yield (ranging from 1 to 100 micromol GMA cm(-2)) depended on the time during which the preirradiated PE and PP films and slabs were immersed in the GMA solution. CD grafting (from 0.013 to 0.734 micromol cm(-2)) was confirmed by infrared analysis, DSC and the organic compound approach (using 3-methylbenzoic acid as a probe). Functionalization with CDs rendered as highly cytocompatible materials as the starting ones, did not cause relevant changes in the water contact angle and the friction coefficient of PE and PP, but remarkably improved their capability to uptake diclofenac through formation of inclusion complexes with the CDs. Furthermore, the functionalized materials released the drug for 1 h, which could be useful for management of initial pain, inflammation at the insertion site as well as adhesion of certain microorganisms if these materials are used as medicated medical devices.