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Clinical response to intravenous nitroglycerin infused through polyethylene or polyvinyl chloride tubing.

The effects of polyethylene and polyvinyl chloride (PVC) administration sets on the clinical response to i.v. nitroglycerin were studied. Patients with ischemic heart disease were randomly assigned to receive nitroglycerin solution through either a polyethylene administration set or a PVC set. The rate of the infusion was 5-10 micrograms/min initially and was adjusted upward by 5-10 micrograms/min every 5-10 minutes until anginal symptoms were relieved or an adverse effect limited further increases. The data collected included patient demographics, the indication for nitroglycerin, nitroglycerin dosages, the initial dosage-adjustment time (the time necessary to reach the initial effective dosage), the number of dosage adjustments and the indications for them, the duration of the infusion, the time of tubing changes, the total dose of nitroglycerin, the amounts of sublingual nitroglycerin and i.v. morphine used, and the occurrence of various clinical events. There were 78 courses of therapy in the PVC group and 62 in the polyethylene group. The two groups were comparable in all respects except gender. There were no significant differences between the two groups in any of the primary study variables. Patients who received i.v. nitroglycerin through a PVC administration set had the same clinical response as patients given the drug through a polyethylene set.

Aged↗

Posteromedial tibial polyethylene failure in total knee replacements.

This report details 16 cases of focal posteromedial tibial polyethylene wear and failure after total knee arthroplasty. This wear phenomenon was associated with an external rotatory subluxation of the tibial component relative to the femoral component. Failure occurred in ten Miller Galante 1, three Porous Coated Anatomic, two Kinematic, and one Press-Fit Condylar knee designs at a mean time of 45 months from their implantation. With this type of failure, there did not seem to be a relationship with metal type, fixation, polyethylene manufacturing method, or polyethylene thickness. A relatively flat design of the tibial articular surface was common to all of these components. In certain patients this articular design may allow excessive component translation, which leads to polyethylene deformity, wear, and subluxation. Some methods for preventing this failure mode are reported here.

Aged↗

The correlation between fusion defects and damage in tibial polyethylene bearings.

Recent reports of fatigue failures of polyethylene tibial and patellar components have led to investigation of the role of design and material properties in these failures. Earlier investigations, concluding that high contact stress designs suffered greater damage in service, could not account for some of the fatigue failures. The current study hypothesizes that this failure is related to variations in the material properties of the polyethylene due to incomplete consolidation of the powder during manufacture, resulting in fusion defects. Retrieved polyethylene components and samples of polyethylene stock were examined to gain insight into the relationship between fusion defects, component failure, material forming processes, and powder grade. Statistically significant correlations (p < 0.05) were observed between the extent of defects and cracking, delamination, total wear damage, and duration in vivo. These correlations indicate that components manufactured from material with fusion defects may be less resistant to fatigue than components formed of fully consolidated material.

Acetabulum↗

Failure of a polyethylene total knee component presenting as a thigh mass. Report of a rare complication of total knee arthroplasty.

Early failure caused by wear of the polyethylene bearing surface of a metal-backed tibial platform or a metal-backed patellar component in a total knee prosthesis has been a recognized complication; patients with these problems initially have pain and instability. A patient who had a cystic mass in the distal thigh was evaluated, and osteolysis of the distal femur was detected. Polyethylene debris and reactive synovium were confirmed surgically and histologically, indicating a cause-effect relationship of polyethylene wear debris and failure of the total knee arthroplasty. Regular and long-term patient follow-up evaluation after total joint arthroplasty is essential for the detection of early evidence of occult polyethylene wear.

Aged↗

Characteristics of metal and ceramic total hip bearing surfaces and their effect on long-term ultra high molecular weight polyethylene wear.

The micromechanics of ultra high molecular weight polyethylene (UHMWPE) wear in total hip replacement are very complex. Polyethylene wear from the metal head and debris formation are two common types of wear. There are additional wear-related processes occurring at the metal-bearing surfaces that are not well-known, however. This study outlines these processes, including (1) surface wettability changes, (2) oxidative wear of metal surfaces, (3) microabrasion of metal surfaces from oxide film damage, and (4) surface abrasion from three-body polymethylmethacrylate and bone debris. These processes can contribute to metal ion release and a gradual increase in the roughness of the metal surfaces. This can lead to increased long-term UHMWPE wear. Of the metal alloys currently used in total hip replacements, Co-Cr-Mo alloy is significantly more resistant to roughening processes. Hard, stable, oxide: ceramic surfaces articulating against UHMWPE are essentially immune to these surface-roughening processes, however. In addition, they provide a more wettable surface, further minimizing polyethylene wear relative to metal surfaces. By analyzing metal release rates from metal-polyethylene wear tests, it is shown here that Co-Cr-Mo is gradually removed at a rate of about 0.1 micron per year (10(6) cycles), whereas 316L stainless steel is removed on the order of 0.2 microns per year and Ti-6Al-4V on the order of 1 micron per year. The wear rate of Co-Cr-Mo articulating against itself is reported to be still greater, at about 2-4 microns per year after an initial wear-in period. Because metal is gradually removed with articulation time, surface-hardening methods such as nitrogen ion implantation can be expected to provide only temporary resistance to these metal removal and surface-roughening processes. Hard, stable ceramic surfaces such as Al2O3 and ZrO2, however, can be expected to maintain their initial surface finish and thus minimize UHMWPE wear in the long term.

Alloys↗

Slow-release verapamil poisoning. Use of polyethylene glycol whole-bowel lavage and high-dose calcium.

OBJECTIVE: To present three cases of slow-release verapamil poisoning that demonstrate the prolonged absorption of the drug and the role of polyethylene glycol and high-dose calcium in management. CLINICAL FEATURES: Three patients with slow-release verapamil poisoning are presented. An 18-year-old woman took 2.3 g and developed hypotension and bradyarrhythmias 18 hours after ingestion, despite gastric lavage and administration of charcoal at three hours. A 23-year-old woman took 4.8 g and presented two hours later clinically unaffected. A 44-year-old woman presented 24 hours after taking 15-20 g. She had a systolic blood pressure of 50 mmHg, no measurable diastolic blood pressure and bradyarrhythmias. INTERVENTION AND OUTCOME: Case 1 responded to administration of 30 g of calcium and fluids intravenously. Case 2 was given polyethylene glycol on admission which resulted in passage of a tablet bezoar and no toxicity. Polyethylene glycol was ineffective in Case 3. She responded initially to high doses of calcium and other treatments, but subsequently died of hypotension and cardiac conduction block 39 hours after the overdose. CONCLUSION: The severity of poisoning with slow-release verapamil warrants aggressive pre-emptive treatment. Polyethylene glycol should be used routinely irrespective of the clinical state. High doses of calcium may be required to treat conduction block and hypotension.

Adolescent↗

Wear of polyethylene acetabular components in total hip arthroplasty. An analysis of one hundred and twenty-eight components retrieved at autopsy or revision operations.

We evaluated the rates of volumetric wear and the patterns of wear of 128 acetabular components retrieved during an autopsy or a revision operation between one and twenty-one years after total hip arthroplasty. Twenty-two all-polyethylene components were retrieved at autopsy from hips that had been functioning well at the time of death (Group A). The remaining 106 components--eighty-four all-polyethylene components (Group B) and twenty-two metal-backed components (Group C)--were retrieved during revision operations. All 128 components had been inserted with cement. The mean rate of volumetric wear, determined directly with a fluid-displacement method, was thirty-five cubic millimeters per year (range, eight to 116 cubic millimeters per year) for Group A, sixty-two cubic millimeters per year (range, eight to 256 cubic millimeters per year) for Group B, and ninety-four cubic millimeters per year (range, twelve to 284 cubic millimeters per year) for Group C. Multivariate regression analysis showed a significant relationship (p < 0.05) between the size of the femoral head and the calculated mean annual rate of volumetric wear. The rate of volumetric wear was highest in association with thirty-two-millimeter femoral heads and lowest in association with twenty-two-millimeter heads; according to linear regression analysis, this represented a 7.5 per cent increase (Group A) or a 10 per cent increase (Group B) in the rate of wear for every one-millimeter increase in the size of the head. Linear regression analysis also showed a significant relationship between the duration that the implant had been in situ and the rate of wear (p < 0.05), with the rate being highest initially after the operation and decreasing with an increasing duration in situ. With the numbers available, the patient's age and gender and the side of the arthroplasty did not have a significant relationship to the annual rate of volumetric wear. Increased thickness of the polyethylene was related to a decreased rate of wear (p < 0.05) in the group of metal-backed components, which had a 25 per cent increase in the rate of wear for every one-millimeter decrease in thickness, but not in the other groups. The estimated median annual rates of wear, after adjustment of confounding variables to a hypothetical constant set of median values for the parameters (duration in situ, 132 months; diameter of the femoral head, twenty-six millimeters; and thickness of the polyethylene, eight millimeters), were significantly different among the three groups of components (p < 0.05). Histological evaluation of the worn surfaces showed the predominant mechanisms of wear to be abrasion and adhesion rather than fatigue-cracking or delamination. The highly worn areas were polished to a glassy finish on gross examination, but scanning electron microscopy showed numerous multidirectional scratches along with fine, drawn-out fibrils with a diameter of one micrometer or less oriented parallel to each other. These fibrils are the most likely source of submicrometer wear particles. Thus, wear appeared to occur mostly at the surface of the components and to be due to large-strain plastic deformation and orientation of the surface layers into fibrils that subsequently ruptured during multidirectional motion.

Acetabulum↗

Postirradiation aging affects stress and strain in polyethylene components.

Ultrahigh molecular weight polyethylene components oxidatively degrade because of gamma radiation sterilization and subsequent shelf aging in air. The effects of shelf aging on the stresses and strains associated with surface damage in tibial and acetabular components were examined. A material model was developed to predict the stress and strain relationship of oxidatively degraded polyethylene as a function of density using samples of polyethylene that were gamma radiation sterilized and evaluated immediately after irradiation and after 42 months of shelf aging. The finite element method was used to determine the stresses and strains before and after shelf aging for two tibial components with different conformities between the articulating surfaces and for an acetabular component. The stresses increased by 10% to 14% in the conforming tibial model after 42 months of aging, whereas the stresses in the nonconforming tibial model and in the acetabular model increased by only 4% to 8%. Aging decreased the principal strains by 5% to 10% in both tibial models and by 15% to 17% in the acetabular model. Postirradiation aging during shelf storage of polyethylene joint components is likely to worsen long term wear, based on the increased stresses and decreased strains predicted to occur as a result of aging.

Gamma Rays↗

[Effect of physicochemical properties of polyethylene glycol derivatives on drug release from wax matrices].

The purpose of the present study was to investigate the effect of the various types and amounts of polyethylene glycols on the potassium chloride release from wax matrices. Potassium chloride as a highly water-soluble model drug was embedded into wax containing surfactants to produce sustained release dosage form. Various kinds of polyethylene glycols were chosen to control the dissolution profile. The dissolution profile of the matrix samples was characterized by the Weibull distribution. The physico-chemical characteristics--surface tension, HLB value, refractive index--of the aqueous solutions of the polyethylene glycols were also determined. On the basis of the examined physicochemical characteristics of various polyethylene glycols it is possible to select the optimal concentration of surfactant to formulate matrix dosage forms of required dissolution profile.

Chemistry, Pharmaceutical↗

Crystallization of proteins from polyethylene glycol.

Twenty-two proteins available to this laboratory were examined for their ability to crystallize from polyethylene glycol (PEG). Of the 22, 8 had been crystallized previously by conventional means and the remainder had yielded no crystals by other methods. Using a single broad screen with four different concentrations of five different molecular weight sizes of polyethylene glycol, 13 of these proteins were crystallized. Of the 13, 6 proteins were crystallized for the first time, one yielded crystals readily where only infrequent and irreproducible results were obtained before, and one other produced excellent quality crystals where only very disordered or twinned crystals were previously grown. In only one case did polyethylene glycol fail to yield crystals where other agents had succeeded. It is concluded that polyethylene glycol may be the best initial trial reagent for crystallization of proteins for x-ray diffraction analyses.

Animals↗

Non-uniformity of contact stress on polyethylene inserts in total knee arthroplasty.

This study examined tibiofemoral contact stresses in 15 commercially available TKR designs, using digitally imaged pressure-sensitive film. The objectives were (1) to determine the correlation between minimization of spatial mean contact stress and minimization of the amount of overloaded (>10 MPa) polyethylene contact area, and (2) to ascertain the difference in contact stresses for machined versus moulded polyethylene inserts. The data showed that there was no statistically significant (design rank-order) correlation of spatial mean contact stress with overloaded polyethylene area. The data also showed that machining cutter preparation of the polyethylene insert caused substantial local contact stress non-uniformities that corresponded to the pattern of grossly visible machining marks.

Journal Article↗

Nuclear Magnetic Resonance Detection of Two Distinctly Different Chains in the Orthorhombic Crystalline Phase of Polyethylenes.

Several commercial and noncommercial, high- and low-density and ultraoriented polyethylene samples, as well as polyethylene samples with inorganic fillers, have been investigated by inversion-recovery cross-polarization magic angle spinning carbon-13 nuclear magnetic resonance (NMR). In all these samples two types of all-trans chains in orthorhombic crystalline domains are detected, which give two overlapping carbon-13 lines with different line widths and different relaxation times. From the NMR relaxation parameters we conclude that one type of the crystalline chains, which composes 60-90% of the crystalline fraction in all samples, can execute at room temperature 180 degrees flips with a frequency in the kilohertz domain. The other crystalline chains are more rigid and probably are found in more perfect structures in which such chain flips do not occur or occur on a much slower time scale. Adding kaoline filler particles to polyethylene enhances the contribution of the more mobile crystalline chains. The presence of the two distinctly different types of crystalline environments is found in all polyethylene samples investigated so far (more than 25 samples).

Journal Article↗

Surface characterization and platelet adhesion studies on polyethylene surface with hirudin immobilization.

Hirudin, a protein composed of 65 or 66 amino acid, is a newly risen anticoagulant agent and has been considered as the most potent thrombin inhibitor. Hirudin can block the active site of thrombin by means of its carboxylic acid reaction with the active regime of thrombin, and becomes a tightly bound complex, and thus controls the formation of thrombus. Hirudin was covalently immobilized onto the water-soluble carbodiimide preactivated and chromic acid oxidized PE surface. Surface chemistry analysis indicated that a certain amount of carboxylic acid groups was generated on the polyethylene surface after oxidation with chromic acid solution. The amount of carboxylic acid functional group increased with the oxidation time. In addition, polyethylene surface was etched by chromic acid solution, and a rougher surface was created. The morphology of oxidized polyethylene surface was similar to each other among the samples with oxidation time from 1 to 8 min. ESCA results indicated the number of hirudin molecules immobilized was constant at the reaction time studied. In vitro platelet adhesion assay indicated the number of adhered platelets on the oxidized polyethylene surface increased significantly after oxidation. In contrast, surface with hirudin immobilization showed a reduction in adhered platelet density than the chromic acid oxidized counterpart due to the decrease of platelet-activating capability by the hirudin-thrombin complex and the differences in the adsorbed protein composition.

Journal Article↗

Biological and biochemical properties of the carbon composite and polyethylene implant materials.

We studied the biocompatibility of the carbon composites and polyethylene materials with and without collagen or collagen and proteoglycan cover. We used the in vitro technology to study the adhesion of model cells evalution, their metabolic activity and the production of TNF-alpha as a cytokine model. Under in vivo condition, the biocompatibility of tested polymers were studied in the implantation experiment, subcutaneously in the interscapular region in the laboratory rat. We have found in the in vitro assay favorable proliferation and the smallest production of pro-inflammatory TNF-alpha cytokine in cells adherent to the hydrophobic polyethylene material coated with biological macromolecules. Using in vivo tests performed by the implantation of materials to the rat we demonstrated that the materials are not cytotoxic. The tissue capsule surrounding the implants was not significantly influenced by the type of the implant and the pre-treatment by the biological molecules. However, the foreign-body giant multinucleated cells were observed only in the vicinity of the collagen - covered hydrophobic polyethylene implant. Interestingly, while the collagen coating improved the biocompatibility of tested polymers in vitro, the inflammatory reaction against this covered materials was higher under in vivo conditions. The pre-treatment of carbon composites by both types of biological macromolecules reduced the occurrence of carbon debris in the implantation site. The tested carbon composites and polyethylene materials are not toxic. The pre-treatment of the materials by extracellular matrix components increased their biological tolerance in vitro and reduced implant wears in animal experiment, which can be important for the medical application.

Journal Article↗

Review Article: Polyethylene wear and osteolysis in total hip arthroplasty.

Polyethylene wear has been accepted as a major cause of osteolysis in total hip arthroplasty. Submicron particles, which are secondary to abrasive wear, migrate into the effective joint space and stimulate a foreign-body response resulting in bone loss which is mainly mediated by macrophages. Diagnosis depends on serial radiographic evaluation and frequent follow-up. Polyethylene wear and osteolysis can be prevented by reducing the wear such as using a small femoral head, adaptive polyethylene thickness, suitable surgical techniques, non-polyethylene articulation, etc. The presence of cement or circumferential coatings may also retard the distal migration of particles. Medicines such as NSAIDs and bisphosphonate appear to inhibit the progress of osteolysis. As far as treatment, revision surgery is able to reconstruct the joint by replacing partial or total prosthesis and repair the defect by bone grafting according to intraoperative assessment.

Journal Article↗

Polyethylene wear with an entirely HA-coated total hip replacement: 79 hips followed for 5 years.

We measured the eccentricity of the femoral head in the metal backing annually during 5 years in 79 consecutive total hip replacements (73 patients). The mean age of the patients was 57 (32-73) years and the female/male ratio 63/22. The prostheses were entirely coated with hydroxyapatite. Modular 32 mm stainless steel heads and hemispherical, self-tapping screw cups with polyethylene liners were used. We found accelerating eccentricity throughout the observation period. The mean eccentricity at 5 years was 0.71 mm (95% CI 0.53-0.90), resulting in a mean eccentricity rate of 0.14 mm (0.11-0.18) per year. The 5-year eccentricity was 0.5 mm or less in 45 hips and more than 1.5 mm in 13 hips, 2 in the latter group apparently having worn through the polyethylene liner. The true wear may be twice as great. The use of 32 mm stainless steel heads and thin polyethylene inlays may have aggravated the wear problems. These HA-coated prostheses must all be checked regularly, so that cases with excessive polyethylene wear can be reoperated on before wear-through of the liner.

Adult↗

Comparison of copper levels in runoff from fresh-market vegetable production using polyethylene mulch or a vegetative mulch.

Runoff from tomato (Lycopersicon esculentum Mill.) production with polyethylene mulch has been implicated in the failure of commercial shellfish farms in the Mid-Atlantic Region of the United States. Copper, applied in the form of copper hydroxide, is the most widely used fungicide-bactericide for control of tomato diseases and recently has been detected in the Chesapeake Bay (USA) watershed. Elevated levels of copper have been shown to have adverse effects on shellfish, finfish, and other aquatic organisms. This research evaluates the off-site movement of copper with the dissolved phase and the particulate phase of runoff from controlled field plots containing tomato plants grown in either polyethylene mulch or a vegetative mulch, hairy vetch (Vicia villosa Roth.). Overall, runoff collected from polyethylene mulch plots contained significantly (p < or = 0.05) greater loads of dissolved- and particulate-phase copper than runoff from hairy vetch mulch plots. However, the loss of copper associated with the particulate phase was significantly greater (p < or = 0.05) than that associated with the dissolved phase of runoff from both mulch treatments, with the particulate phase accounting for more than 80% of the copper loads. The reported toxicity of copper to aquatic organisms and the greater runoff volume, soil loss, and off-site loading of copper measured in runoff from the polyethylene mulch suggests that this management practice is less sustainable and may have a more harmful impact on aquatic ecosystems.

Agriculture↗

Wear behaviour of cross-linked polyethylene assessed in vitro under severe conditions.

The polyethylene (PE) for hip implants presents serious clinical problems; the production of debris may induce adverse tissue reactions that may lead to extensive bone loss around the implant and consequently osteolysis and implant loosening. Several attempts have been made to improve the wear properties of ultra-high molecular weight polyethylene (UHMWPE). More recently the attention of various researchers has been focused on cross-linked polyethylene (XLPE), due to its improved wear resistance with respect to conventional UHMWPE. This study was aimed at comparing the wear performances of clinically available acetabular liners (Zimmer Inc.) made of electron beam XLPE and conventional UHMWPE. To evaluate the influence of the material properties on wear, conventional UHMWPE and XLPE acetabular cups were tested against deliberately scratched CoCrMo femoral heads (Ra = 0.12-0.14 microm) in a hip joint wear simulator run for 3 million cycles with bovine calf serum as lubricant. Gravimetric measurements revealed significant differences between the wear behaviours of the two sets of acetabular cups: XLPE exhibited a wear rate about 40 times lower than conventional UHMWPE. Raman spectroscopy coupled to partial least-squares analysis was used to evaluate the possible crystallinity changes induced by mechanical stress (and thus the material wear resistance): only the UHMWPE cup which showed the highest weight loss displayed significant crystallinity changes. These results were correlated to the thickness of the plasticity-induced damage layer. The wear debris produced during the tests were isolated according to a validated protocol and imaged by scanning electron microscopy . The wear particles produced by XLPE were smaller than those produced by UHMWPE; the latter were observed as fibrillar and agglomerated particles. The mean equivalent circle diameter was 0.71 and 0.26 microm for UHMWPE and XLPE, respectively.

Arthroplasty, Replacement, Hip↗