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[Studies on the tolerance of the organism to X 5 CrNiMo 18.10 steel (Königsee). IV. Studies on the tissue surrounding the X 5 CrNiMo 18.10 steel implants by means of an electron x-ray microprobe in the animal experiment].

Electron-x-ray micro-analysis was used for quantitative assess of element concentrations of alien materials in the tissue surrounding implantates of X 5 CrNiMo 18.10-steel. High amounts of iron were found whereas chromium and nickel concentrations were lower in the examined parts of the connective tissue around the metal. These examinations do not exclude that the iron partly comes from destructed erythrocytes. The amounts of chromium and nickel, however, suggest that the deposits of alien materials are sequels of electrolytic corrosion of the X 5 CrNiMo 18.10-steel implantates.

Animals

[Studies on the tolerance of the organism to X 5 CrNiMo 18.10 steel (Königsee). I. Detection of chrome and nickel traces in the spleen, liver, kidney and in the tissues surrounding metallic implants (X 5 CrNiMo 18.10 steel) in guinea pigs by means of flameless atomic absorption spectrophotometry].

Small bars of X 5 CrNiMo 18.10-steel were implanted under the dorsal muscles of 60 guinea-pigs, a number of which was preoperatively sensibilized against potassium-bichromate or nickel-II-sulfate. After various times of surviving the traces of chromium and nickel were assessed in the tissue around the graft, in spleen, liver, and kidney. The resulting values ranged widely, there was a tendency to increased values the longer the implantates remained in the tissue. Traces of the elements were also found in the organs of the guinea-pigs. After sensibilization, the animals showed no more aggressive behavior against the implantates than without sensibilization. The quality of the implantates' surface is more important - as to coming-off parts of the alloy by corroding - than the preoperative immune condition of the organism.

Biocompatible Materials

[Studies on the tolerance of the organism to X 5 CrNiMo 18.10 steel (Königsee). II. Light microscopic studies of the surrounding tissue of metal implants (X 5 CrNiMo 18.10 steel) in guinea pigs].

The tissue around X 5 CrNiMo 18.10-steel implantates with different surfaces was examined in 72 guinea-pigs. Aside from controls, these animals were preoperatively sensibilized against chromium and nickel. The results can be summarized since the histologic findings showed no different peculiarities. The authors describe an intussusception of the implantate in connective tissue which evidently depends on time and surface. Further the spreading of alien material in the surrounding of the implantate, and morphologic findings are reported. The morphologic evidences are described and discussed in detail, since they are interpreted as signs of cell-mediated immune reactions. The presence of lymphocytes, lymphoblasts, histiocytes (mostly carrying alien material), and granulocytes, as well as proliferations at the arterioles suggest an overlapping of immune reactions.

Animals

[Studies on the tolerance of the organism to X 5 CrNiMo 18.10 steel (Königsee). III. Electron microscopic studies on the tissues surrounding X 5 CrNiMo 18.10 steel implants in the animal experiment].

The surrounding tissue of X 5 CrNiMo 18.10-steel implantates in guinea-pigs was analyzed by electron microscopy. Corroding products of the implantates were marked by sulfide-silver-reaction. Metallic alien material was only proven in the cells of connective tissue covering the implantates. Immediately around the implantates one can not prove products of corroding, evidently depending on their minimal size and amount. In the cells of the intermediate and the vascular zone, however, single or accumulated particles in vesicular or vacuolary organellae, resp. without membraneous cover can be demonstrated. The findings are described and discussed with regard to damages which might arise by means of alloy parts and lysosomal structures.

Animals

In vivo evaluation of a high-strength, high-ductility stainless steel for use in surgical implants.

A high-strength, high-ductility, austenitic stainless steel has been evaluated for use in surgical implants by performing in vivo tests in rats, rabbits, dogs, and rhesus monkeys. This stainless steel, a TRIP (Transformation Induced Plasticity) steel containing about 4% Mo, was compared with two alloys in current clinical use: Type 316L stainless steel and cast Vitallium. Compared with the other two alloys, cast Vitallium generally had higher resistance to corrosion and superior biocompatibility in all animals. The tests in rats and dogs indicated that the corrosion resistances of the TRIP steel and the Type 316L stainless steel were similar and that the tissue reactions caused by these alloys were also similar. However, in rhesus monkeys, the TRIP steel was shown to be susceptible to stress-corrosion cracking and much more susceptible to crevice corrosion than Type 316L stainless steel. Limited tests in rabbits supported the observation that the TRIP steel is susceptible to stress-corrosion cracking. These inconsistencies in the in vivo tests underline the need for a reevaluation of the popular test techniques and of the animals commonly chosen for assessing the suitability of candidate implant materials. The "worst case" results from the rhesus monkey tests were entirely consistent with previous results obtained from in vitro studies. However, further work must be performed before the behavior of metals in humans, rhesus monkeys, or any other animal, can be predicted with confidence from an in vitro test program.

Animals

Tissue reaction to middle ear prostheses: in vivo observation (rabbit ear lobe) of polyethylene tube, stainless steel wire and absorbable gelatin sponge used in middle ear surgery.

Over the past ten years, polyethylene tube, stainless steel wire and absorbable gelatin sponge have come to be used in middle ear surgery. A modified Williams' steel chamber with a transparent central area was embedded in a rabbit ear lobe surgically, and cross-sectioned polyethylene tube, stainless steel wire or absorbable gelatin sponge were inserted respectively. The in vivo tissue reaction to each of these installed materials was observed daily microscopically. Finally, in the case of both the cross-sectioned polyethylene tube and the stainless steel wire, the chambers were fixed with 10% formalin solution and the contents stained for histological study. The results were as follows: Absorbable gelatin sponge was absorbed completely by phagocytosis in 62 days. Polyethylene tube was encapsulated by a layer of fibroblasts by day 110 in one case and by day 140 in another case; these findings were confirmed histologically on day 110 and 281. Almost all the surface of the stainless steel wire was encapsulated by a layer consisting of giant cells, on which a dense fibrous layer was superimposed by day 82. It is concluded that polyethylene tube, stainless steel wire, and absorbable gelatin sponge should be well tolerated in middle ear surgery.

Absorption

A specimen carrier, storage disc system for scanning electron microscopy (SEM): evaluation of stainless steel as a substratum for cell culture in vitro.

A method of sample preparation for scanning electron microscopy (SEM) studies based on the use of stainless steel discs as a cell culture substratum is described in detail. A number of different cell lines were grown on stainless steel, and the growth patterns and biocompatibility of cells cultured on stainless steel were compared to identical cells cultured on aluminium, glass and plastic substrata. Stainless steel provides cells with an excellent growth surface which allows these cells to retain their normal growth characteristics and appearance. The non-toxic stainless steel discs can be manipulated through any combination of fixatives and organic solvents. The discs have been incorporated into a versatile system of sample preparation for SEM.

Alloys

[Possible use of new corrosion-resistant steels in the manufacture of medical instruments].

Demands on metals intended for the manufacture of medical instruments call for the use of corrosion-resisting grades of steel with high strength characteristics. Grades of steel of the martensite class reinforced by age hardening (martensive-aging) and mild grades of steel (chrome-manganese and chrome-nickel) have a number of valuable advantages over the steel of other classes. The possibility of obtaining high strength with low carbon dontent ensures great plasticity, toughness and brittle failure resistance along with corrosion-resistance and the possibility of achieving a substantial simplification in technology of making the instruments. Investigations of martensite-aging grades of steel--ep832,ochX11H9M2d2Tyu, O3X11HMd2yu and O3X13g3Md2 demostrated them to hold good promise for the manufacture of surgical and atraumatic needles, and rod-type stomatological instruments.

Dental Instruments

In vitro corrosion of Ti-6Al-4V and type 316L stainless steel when galvanically coupled with carbon.

In vitro corrosion experiments were conducted employing potentiostatic polarization techniques, a saline environment and candidate biomaterial alloy/carbon combinations. Corrosion currents and potentials of carbon/metal couples were predicted by mixed-potential theory utilizing the polarization curves generated. The alloys examined were annealed ELI grade Ti-6A1-4V and cold-worked 316L stainless steel while the types of carbon examined were LTI pyrolytic carbon and vapor-deposited carbon. It was determined that galvanic couples of carbon to cold-worked 316L stainless steel with carbon/metal area ratios of 10:1 to 100:1 produced coupled corrosion potentials in the range of the observed breakdown potential of the stainless steel. It was therefore predicted that localized corrosion in the form of pitting could occur on the cold-worked stainless steel when coupled to carbon with area ratios of 10:1 or greater. The titanium alloy did not exhibit a breakdown potential up to a potential of 1.2 V. Therefore, accelerated corrosion was not predicted for the titanium alloy to carbon galvanic couples under these experimental conditions. Direct carbon/alloy coupling experiments were conducted to verify the corrosion currents and potentials predicted from mixed-potential theory and polarization curve analysis. The experimental and theoretical values showed good agreement.

Alloys

Mutagenicity of fume particles from metal arc welding on stainless steel in the Salmonella/microsome test.

Mutagenic activity of fume particles produced by metal arc welding on stainless steel (ss) is demonstrated by using the Salmonella/microsome mutagenicity test described by Ames et al., with strain TA100 (base-pair substitution) and TA98 (frame-shift reversion). Results of a representative but limited selection of processes and materials show that mutagenic activity is a function of process and process parameters. Welding on stainless steel produces particles that are mutagenic, whereas welding on mild steel (ms) produces particles that are not. Manual metal arc (MMA) welding on stainless steel produces particles of higher mutagenic activity than does metal inert gas (MIG) welding, and fume particles produced by MIG welding under short-arc transfer. Further studies of welding fumes (both particles and gases) must be performed to determine process parameters of significance for the mutagenic activity.

Gases

Quantitative histological evaluation of early fracture healing of cortical bones immobilized by stainless steel and composite plates.

Internal fixation devices of less bending stiffness than conventional plates made of stainless steel or vitallium were compared with conventional plates in a study of fracture healing. The material for this investigation was a fine graphite fiber reinforced methyl methacrylate resin composite with a modulus of elasticity approximately ten times less than that of stainless steel. Osteotomies were performed on canine radii. Internal fixation was accomplished by means of a composite plate on the left side, and a stainless steel plate on the right. Clinical assessment, as well as biomechanical and quantitative histological techniques, were used to compare osteotomy healing of the two sides. At four months, all osteotomies had healed and the bioengineering tests showed radii from the two sides had equivalent strength. However, significantly less cortical porosity was found in the side with the composite plate (6.8 per cent), as compared to that of the stainless steel plated side (14 per cent). These results suggest that a less stiff fixation plate may have some advantage in the treatment of long bone fracture if there is no implant failure, and if union rates are equivalent.

Animals

Allergic response to stainless steel wire.

A review of the literature indicates that an allergic response to stainless steel is rare, although nickel is a common allergen and is encountered continually in daily life. An allergic reaction could occur at a most inopportune time. Rational approaches in management of an allergic response to stainless steel appear to be either: (1) wire removal and symptomatic therapy, (2) application of fixation with other substances, or (3) administration of steroids with necessary stainless steel immobilization left in place. The report suggests the need for research to determine the chromium content or chromium-nickel ratio that would eliminate allergic manifestations to the nickel component in wrought or cast base metal dental appliances.

Adult

The comparison of steel and titanium dynamic compression plates used for internal fixation of 256 fractures of the tibia.

A consecutive series of 256 fractures of the shaft of the tibia treated by internal fixation with a narrow dynamic compression plate (DCP) is presented. In 123 cases the plates were made of titanium and in 133 cases they were made of stainless-steel. In both groups the age distribution of the patients, the period between operation and the final review and the time of removal of the metal were comparable. All these fractures resulted from skiing accidents. Eighty-six per cent of the 256 fractures were reviewed between 1 and 2 years after the operation. Ninety-one per cent of the titanium group and 93 per cent of the stainless-steel group showed full recovery without any loss of movement in the joints. In both groups there was the same number of refractures, which were chiefly due to subsequent accidents. There were no cases of local wound infection, osteitis or non-union. Furthermore, there was no difference to be seen between the radiological patterns of fracture healing in the two groups. In this series stainless-steel and titanium plates gave the same excellent results.

Adult

Leaching of nickel from stainless steel consumer commodities.

Sweat and household detergents were shown to have the capacity to release nickel from stainless steel. This finding substantiates the thesis that the American-style stainless steel kitchen and other stainless steel commodities can be sources of skin contact allergy with nickel. Furthermore, a negative spot test (DMG) does not reflect the "safety" of a nickel alloy.

Cooking and Eating Utensils

Tensile strength of wire-reinforced bone cement and twisted stainless-steel wire.

To assess the tensile strength of wire-reinforced bone cement as used for posterior spine fusion, standardized bone-cement specimens reinforced with stainless steel and Vitallium wires 0.5 and one millimeter in diameter were tested in tension. The results showed that tensile strength of bone cement was increased significantly by reinforcing it with metal wires, the increase in strength being proportional to the number of wires used. Even after failure of the cement, the reinforcing wires still carried an appreciable amount of load, thus avoiding the catastrophic failure of the cement alone. Specimens reinforced with Vitallium wires in general failed at higher loads than specimens reinforced with similar stainless-steel wires. Pull-out studies showed that a hook or a loop at the embedded end of straight wires significantly increased the load necessary to pull the wires out. The tensile strength of twisted stainless-steel wire composed of two 0.5-millimeter strands increased with the number of turns up to about eight turns per inch (2.54 centimeters) and then decreased.

Bone Cements

Effects of mutant steel alleles on leukemogenesis and life-span in the mouse.

Mutant alleles at the steel locus produce the pleiotropic effects of congenital anemia, sterility, and lack of hair pigmentation. Strain (WC/Re X C57BL/6)F1 Sl/Sld mice lived only half as long as heterozygotes and homozygous normal controls, differing only at the steel locus. Lymphocytic leukemia developed spontaneously in 37% of mice of the Sl/Sld genotype at an average age of 370 +/- 25 days and in 5% of heterozygotes and homozygous normal controls at 965 +/- 41 days. Severe ulcerative dermatitis occurred in 56% of Sl/Sld mice at an average age o4f 441 +/- 21 days and in 20% of heterozygotes and homozygous normal controls at 722 +/- 50 days. The mutant steel alleles provided an opportunity for study of the role of chronic anemia in life shortening and of a mechanism of gene action in spontaneous leukemogenesis.

Alleles

Abdominal wound closure: a trial of nylon, polyglycolic acid and steel sutures.

Failures after abdominal wound closure (early dehiscences and late incisional hernias) are due to breakage of sutures, slippage of knots or tearing out of sutures from the tissues. The suture-holding capacity of the entire thickness of muscle and aponeurosis is nearly twice that of the anterior rectus sheath, and deep bites (1-0 cm from the cut edges) are nearly twice as secure as bites of 0-5 cm. In a random controlled clinical trial of 357 major laparotomies, closure with either layered monofilament nylon or mass polyglycolic acid or steel resulted in 2 burst abdomens (0-56%), 10 incisional hernias due to suture failure (3-4%) and 8 incisional hernias caused by deep sepsis (2-7%). There were no statistically significant differences among the treatment groups, but 1 patient in the nylon and 3 in the steel groups had persistent sinuses until their sutures were removed.

Abdomen

A failed vitallium/stainless steel total hip replacement: a case report with histological and metallurgical examination.

A case of a failed total hip replacement consisting of a Vitallium hip socket and a stainless steel femoral head prosthesis is presented. The mixed-metal combination and inadequate design resulted in severe abrasive wear and fretting corrosion of the bearing surface, and the accumulation of stainless steel wear debris and corrosion products in the periarticular tissues was extensive. The tissue response was primarily fibrotic scarring with severe histiocytic and mild foreign body giant cell reaction. Despite the massive accumulation of wear debris and corrosion products, however, there was minimal chronic inflammation and no acute inflammation.

Aged