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  • 1
    Electronic Resource
    Electronic Resource
    Hoboken, NJ : Wiley-Blackwell
    Journal of Biomedical Materials Research 22 (1988), S. 287-302 
    ISSN: 0021-9304
    Keywords: Chemistry ; Polymer and Materials Science
    Source: Wiley InterScience Backfile Collection 1832-2000
    Topics: Medicine , Technology
    Notes: Porous coated Ti-6Al-4V alloy implant systems provide a biocompatible interface between implant and bone, resulting in firm fixation and potential long-term retention via bony ingrowth. In order to achieve an acceptable porous coating structure, the sintering protocol for Ti-6Al-4V alloy systems often requires that the material be heat treated above the beta transus. This transforms the as-received equiaxed microstructure, recommended for surgical implants, to a lamellar alpha-beta distribution, which has been shown to have the worst fatigue properties of the most common structures attainable in Ti-6Al-4V alloy. However, post-sintering heat treatments may be used to improve these properties by producing microstructures more resistant to crack initiation and propagation. This study investigated the influence of microstructural variations on the fatigue properties of porous coated Ti-6Al-4V alloy material. Nonporous coated and porous coated Ti-6Al-4V alloy fatigue specimens were subjected to a standard sintering heat treatment to produce a lamellar microstructure. In addition, two post-sintering heat treatments were used to produce coarse and fine acicular microstructures. Rotating beam (reversed bending) fatigue testing was performed and the endurance limits determined for the noncoated and porous coated microstructures. The values determined were 668 MPa (noncoated asreceived equiaxed), 394 MPa (noncoated lamellar), 488 MPa (non-coated coarse acicular), 494 MPa (noncoated fine acicular), 140 MPa (porous coated lamellar), 161 MPa (porous coated coarse acicular), and 162 MPa (porous coated fine acicular). The noncoated coarse and fine acicular specimens displayed an approximate 25% increase over the noncoated lamellar specimens. The porous coated coarse and fine acicular specimens showed an approximate 15% improvement over the porous coated lamellar specimens.
    Additional Material: 7 Ill.
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  • 2
    ISSN: 0021-9304
    Keywords: Chemistry ; Polymer and Materials Science
    Source: Wiley InterScience Backfile Collection 1832-2000
    Topics: Medicine , Technology
    Notes: This study evaluated the interaction of osteosynthetic plates to adjacent tissue. Eleven patients had 13 plates removed with simultaneous biopsies of the adjacent soft tissue. Four patients had pain localized to the area of the plate and 11 patients had routine removal or removal for fracture nonunion. Each plate was graded on a 0-5 point scale for the amount and severity of corrosion present at the screw - plate interface. The adjacent tissue was fixed in formalin and stained with hematoxylin and eosin. The tissue reaction was graded on a 0-5 point scale based on the inflammatory response. A positive correlation of corrosion and tissue reaction was found that was significant at p ≤ 0.005 in the assymptomatic group. The other good correlation showed that tissue reaction tends to decrease with time at p ≤ 0.005. There was no correlation of corrosion with tissue reaction in the symptomatic removal group. All patients with pain adjacent to the plates were relieved by implant removal. The findings suggest that stainless steel is minimally toxic to human tissue in most circumstances and that the toxic products are well tolerated. There was a significant group (4/11) that showed a different pattern of tissue response which did not appear to be toxic response. We do not recommend routine implant removal to prevent metal toxicity; however, there is a group of patients who have pain in the area of the implant that may be caused by an allergic reaction and is relieved by implant removal.
    Additional Material: 7 Ill.
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  • 3
    Electronic Resource
    Electronic Resource
    Hoboken, NJ : Wiley-Blackwell
    Journal of Biomedical Materials Research 20 (1986), S. 1347-1357 
    ISSN: 0021-9304
    Keywords: Chemistry ; Polymer and Materials Science
    Source: Wiley InterScience Backfile Collection 1832-2000
    Topics: Medicine , Technology
    Notes: Ultra low temperature isotropic (ULTI) carbon-coated polyester suture material was evaluated histologically and mechanically in dogs. These results were compared to those obtainedfor uncoated polyester and polybutylate coated polyester. The suture materials were used in therepair of the surgically incised medical collateral ligament and subcutaneous tissues to evaluate the potential of the carbon-coated system for ligamentous repairs. Following surgery, the dogs were sacrificed at periods of 1-48 weeks postoperatively for evaluation of tissue biocompatibility and mechanical strength of the materials. The polybutylate-coated polyester suture broke at lower force levels than did comparable sizes of uncoated or carbon-coated polyester. All three types showed a high retention (〉98%) of mechanical strength at 48weeks, often exhibiting an increase in tensile strength due to tissue ingrowth. The histologic response to carbon-coated polyester was equal to or better than the response to either the uncoated polyester or polybutylate-coated polyester. A greater degree of tissue growth into the carbon-coated material was evident at most time periods following an initial acute inflammatory response which was also present in the other materials.
    Additional Material: 11 Ill.
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  • 4
    Electronic Resource
    Electronic Resource
    Hoboken, NJ : Wiley-Blackwell
    Journal of Biomedical Materials Research 19 (1985), S. 608-609 
    ISSN: 0021-9304
    Keywords: Chemistry ; Polymer and Materials Science
    Source: Wiley InterScience Backfile Collection 1832-2000
    Topics: Medicine , Technology
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  • 5
    Electronic Resource
    Electronic Resource
    Hoboken, NJ : Wiley-Blackwell
    Journal of Biomedical Materials Research 29 (1995), S. 239-245 
    ISSN: 0021-9304
    Keywords: Chemistry ; Polymer and Materials Science
    Source: Wiley InterScience Backfile Collection 1832-2000
    Topics: Medicine , Technology
    Notes: The purpose of this study was to evaluate the interface attachment strength and histology of hydroxylapatite (HA) coated and uncoated titanium and cobalt-chromium alloy implants. The canine transcortical plug model was utilized. Four different hydroxylapatite coatings were evaluated. In vitro analysis confirmed that all coatings met FDA guidelines for HA coatings. An unspecified FDA parameter, porosity was found to range from 5-15%. Mechanical testing of the bone-implant interface demonstrated large variation in the performance of the coatings. However, further evaluation of two of the coatings did not demonstrate variations in mechanical characteristics. The histologic findings confirmed the mechanical testing results. The coatings which demonstrated the best mechanical characteristics had excellent bone apposition and uniformity and maintenance of the HA coating at all time periods upon histologic evaluation. Conversely, the coatings which demonstrated inferior mechanical characteristics demonstrated variable amounts of bone apposition and moderate to severe coating degradation and breakup. Cell-mediated osteolysis was observed in regions of severe coating degradation, and particle migration was noted in regions far from the interface. It was hoped that the four coatings would behave similarly as they all met current FDA guidelines. The only parameter which differed significantly among the coatings was coating porosity. Our results indicate that coatings with large porosities were associated with increased coating degradation and poor mechanical performance and osteolysis at the bone-coating interface. © 1995 John Wiley & Sons, Inc.
    Additional Material: 5 Ill.
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  • 6
    Electronic Resource
    Electronic Resource
    Hoboken, NJ : Wiley-Blackwell
    Journal of Biomedical Materials Research 18 (1984), S. 497-512 
    ISSN: 0021-9304
    Keywords: Chemistry ; Polymer and Materials Science
    Source: Wiley InterScience Backfile Collection 1832-2000
    Topics: Medicine , Technology
    Notes: A porous metal coating applied to a solid substrate implant has been shown, in vivo, to offer advantages over current polymethylmethacrylate cement fixation in orthopedic devices. These advantages may be lost, however, in devices requiring a sintering heat treatment to apply the coating since these treatments may have a detrimental effect on the substrate material mechanical properties. In addition, more biocompatible interface coating materials have come of interest with recent literature reports of metal ion release. These coatings may be of particular use in porous-coated systems since the surface area of implant in contact with the surrounding tissues is greatly increased. This study investigated the effects that both a porous Ti—6Al—4V alloy coating and a ULTI carbon coating have on the fatigue properties of a Ti—6Al—4V alloy substrate system. The fatigue properties of uncoated as-received, uncoated sinter heat treated and notched Ti—6Al—4V material were also investigated. The results of this study revealed endurance limits for Ti—6Al—4V alloy tested with a rotating beam system of 617 MN/m2 (uncoated as-received), 624 MN/m2 (ULTI carbon-coated), 377 MN/m2 (sinter heat treated), 220 MN/m2 (notched) and 138 MN/m2 (porous-coated). No effects on fatigue properties were observed when testing the material in saline compared with air. The slight increase in fatigue strength for the carbon-coated material is thought to be due to the increase in surface hardness resulting from the formation of titanium carbides on the surface. The low-endurance limit of the porous-coated material is due to both the transition from the as-received equiaxed microstructure to a lamellar microstructure upon sintering and to the notch effect created by the porous coating.
    Additional Material: 10 Ill.
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  • 7
    Electronic Resource
    Electronic Resource
    Hoboken, NJ : Wiley-Blackwell
    Journal of Biomedical Materials Research 19 (1985), S. 875-901 
    ISSN: 0021-9304
    Keywords: Chemistry ; Polymer and Materials Science
    Source: Wiley InterScience Backfile Collection 1832-2000
    Topics: Medicine , Technology
    Notes: A systematic mechanical and histologic evaluation of design variables affecting bone apposition to various biocompatible materials was undertaken. The variables investigated included material elastic modulus, material surface texture, as well as material surface composition. The implant materials included polymethylmethacrylate (PMMA), low-temperature isotropic (LTI) pyrolytic carbon, commercially pure (C.P.) titanium, and aluminum oxide (Al2O3). Implant surface texture was varied by either polishing or grit-blasting the various materials. Implant surface composition was varied by applying a coating of ultra-low temperature isotropic (ULTI) pyrolytic carbon to the various implants. A total of 12 types of implants were evaluated in vivo by placement transcortically in the femora of adult mongrel dogs for a period of 32 weeks. Following sacrifice, mechanical push-out testing was performed to determine interface shear strength and interface shear stiffness. The results obtained from mechanical testing indicate that for implants fixed by direct bone apposition, interface stiffness and interface shear strength are not significantly affected by either implant elastic modulus or implant surface composition. Varying surface texture, however, significantly affected the interface response to the implants. For each elastic modulus group the roughened surfaced implants exhibited greater strengths than the corresponding smooth surfaced implants. Undecalcified histologic evaluation of the implants demonstrated that the roughened implants exhibited direct bone apposition, whereas the smooth implants exhibited various degrees of fibrous tissue encasement. Thus, for implants utilizing direct bone apposition fixation, it appears that of the parameters investigated, implant surface texture is the most significant.
    Additional Material: 16 Ill.
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  • 8
    Electronic Resource
    Electronic Resource
    Hoboken, NJ : Wiley-Blackwell
    Journal of Biomedical Materials Research 26 (1992), S. 989-1001 
    ISSN: 0021-9304
    Keywords: Chemistry ; Polymer and Materials Science
    Source: Wiley InterScience Backfile Collection 1832-2000
    Topics: Medicine , Technology
    Notes: The effect of a plasma-sprayed hydroxylapatite (HA) coating on the degree of bone ingrowth and interface shear attachment strength was investigated using a canine femoral transcortical implant modeI. Cylindrical implants were fabricated by sintering spherical Co-Cr-Mo particles 500-710 μm in diameter; the nominal implant dimensions were 5.95 ± 0.05 inm diameter by 18 mm in length. One half of each implant was coated with hydroxylapatite, 25-30 μm in thickness, by a plasma-spray technique. Using strict aseptic technique, the implants were placed through both femoral cortices into defects approximately 0.05 mm undersized. After 2, 4, 6, 8, 12, 18, 26, and 52 weeks, the implants were harvested and subjected to mechanical pullout testing and undecalcified histologic evaluation. The application of the HA coating to porous implants enhanced both the amount of bone ingrowth and the interface attachment strength at all time periods. These differences were statistically significant for the percent of bone ingrowth at the 4-, 6-, 12-, 18-, 26-, and 52- week time periods, and interface shear strength values were significantly different at the 6-, 8-, 12-, 18-, and 26-week time periods. The rate of development of interface strength and bone ingrowth was also more rapid for the HA-coated implants. No evidence of any disruption, mechanical failure, or biologic resorption of the HA coating was observed. The results of the present study-demonstrating a beneficial effect of the HA coating at all time periods-are believed to be due to the use of paired comparisons, which allow assessment of subtle differences that might otherwise have been obscured by normal biological variability.
    Additional Material: 5 Ill.
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  • 9
    Electronic Resource
    Electronic Resource
    Hoboken, NJ : Wiley-Blackwell
    Journal of Biomedical Materials Research 17 (1983), S. 519-538 
    ISSN: 0021-9304
    Keywords: Chemistry ; Polymer and Materials Science
    Source: Wiley InterScience Backfile Collection 1832-2000
    Topics: Medicine , Technology
    Notes: The response of mandibular bone to identical geometry LTI carbon, carbon-coated aluminum oxide, and uncoated aluminum oxide blade-type dental implants in baboons for 2 years was evaluated using histologic, microradiographic, and scanning electron microscopic methods. In addition, a quantitative histologic analysis was performed identifying the type, amount, and distribution of tissue surrounding the dental implant systems. This is the final phase of a study investigating the effect of implant elastic modulus and implant surface chemical composition on the performance of dental implants. Previous studies have utilized clinical and radiographic evaluations, postretrieval mechanical testing, and finite element stress analysis to evaluate the dental implant performance. The results of the histologic study revealed a direct implant-bone interface with no intervening soft tissue in 16 of the 21 implants (76%). A fibrous tissue interface was observed in 5 of 21 implants (24%). Quantitative histologic results for the implants with a direct implant-bone interface showed statistically larger crestal cortical plates (p 〈 0.05) and greater area fraction crestal cancellous bone (p 〈 0.05) in the LTI carbon implant compared to the carbon-coated and uncoated aluminum oxide implants. The carbon-coated and uncoated aluminum oxide implants demonstrated statistically greater area fraction cancellous bone at the inferior region of the implant (p 〈 0.05) and thinned and reduced crestal cortical plates when compared to the LTI carbon implants. The results indicate that significant stress shielding of the crestal bone had occurred with the rigid carbon-coated and uncoated aluminum oxide implants when compared to the LTI carbon implants which had a material elastic modulus similar to cortical bone. Based upon the histologic results, it appears that the LTI carbon implants with the direct implant-bone interface exhibited a greater potential for long-term successful performance compared to the aluminum oxide substrate implants.
    Additional Material: 7 Ill.
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  • 10
    Electronic Resource
    Electronic Resource
    Hoboken, NJ : Wiley-Blackwell
    Journal of Biomedical Materials Research 21 (1987), S. 1395-1414 
    ISSN: 0021-9304
    Keywords: Chemistry ; Polymer and Materials Science
    Source: Wiley InterScience Backfile Collection 1832-2000
    Topics: Medicine , Technology
    Notes: A mechanical and histological evaluation of uncoated and hydroxylapatite-coated titanium implant materials was performed. Cylindrical implants of uncoated commercially pure (CP) titanium and hydroxyl-apatite-coated Ti-6Al-4V alloy were studied using a transcortical model, with implants evaluated after periods of 3,5,10, and 32 weeks. All implants had a surface macrotexture consisting of a series of semicircular annular grooves, approximately 750 m̈m in maximum depth. The attachment characteristics of interface shear stiffness and interface shear strength were determined by mechanical push-out testing. Nondecalcified histologic and microradiographic techniques, with implants in situ, were used to evaluate the response to the implant materials and the presence of the surface macrotexture. Mechanical testing results indicated that the hydroxyl-apatite-coated implants exhibited significantly greater values of maximum interface shear strength than the uncoated implants after all time periods. Interface shear stiffness was also significantly greater at all time periods for the hydroxylapatite-coated implants as compared to the uncoated implants. Histological evaluation after 3 weeks revealed an osteoid layer covering on all areas coated with the hydroxylapatite material; mineralization of this layer appeared to be complete after 10 weeks. In all cases, longer-term implants demonstrated mineralization of interface bone directly onto the hydroxylapatite coating, and in no case was a fibrous layer observed between the hydroxylapatite coating and the interface bone. Sections from the uncoated CP titanium implants revealed a thin fibrous layer present in nearly all areas. Only isolated regions of direct bone-implant apposition were observed for the uncoated implants. The presence of this fibrous tissue layer, however, apparently did not adversely affect the development of considerable attachment strength. The results from this study indicate that the hydroxylapatite coating can significantly increase the attachment strength of implants which rely upon bone apposition for fixation. In addition, the hydroxylapatite coating provides an osteophilic surface for bone deposition, and allows for a more rapid development of implant-bone attachment.
    Additional Material: 9 Ill.
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