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PubMed1978

Evaluation of a precipitation hardened wrought cobalt-nickel-chromium-titanium alloy for surgical implants.

A Co-Ni-Cr-Ti precipitation hardening alloy is evaluated for use as a surgical implant alloy. Static and fatigue strength studies indicate that the alloy is equivalent, or superior to, present implant alloys. In vitro and in vivo corrosion studies indicate that the material has good general corrosion resistance but may be susceptible to crevice corrosion. However, there appear to be no inherent difficulties in using precipitation hardened alloys for surgical implants and therefore it may be possible to develop a new class of materials possessing ultra-high strength and excellent corrosion resistance for use in surgical implant applications.

Alloys↗

PubMed1999

[Histomorphometry of silicon nitride composite endosteal implant in dogs].

OBJECTIVE: To study the dynamic changes of bone interface with silicon nitride (Si3N4) composite implants. METHODS: 4 Beagle dogs were experimental animals, Si3N4-HA and pure Si3N4 implant were experimental group, and Ti and Ti-HA were used as comparisons. They were implanted into dogs' femurs by stages. Histomorphometry was used to analyse and compare bone growth metabolism of bone interface with implant as well as evaluation of biocompatibility from quantitative and dynamic aspects. RESULTS: Parameters expressing mineralization and speed of deposition at the Si3N4-HA bone interface were higher than comparisions' at the first month. After 6 months, pure Si3N4's bone histomorphometic parameters had no notable difference with others. CONCLUSION: New implant material is useful to the clinic. The histomorphometry is of much value for the study of interface bone metabolism from quantitative and dynamic point of view.

Animals↗

PubMed2004

Difference in metallic wear distribution released from commercially pure titanium compared with stainless steel plates.

INTRODUCTION: Stainless steel and commercially pure titanium are widely used materials in orthopedic implants. However, it is still being controversially discussed whether there are significant differences in tissue reaction and metallic release, which should result in a recommendation for preferred use in clinical practice. MATERIALS AND METHODS: A comparative study was performed using 14 stainless steel and 8 commercially pure titanium plates retrieved after a 12-month implantation period. To avoid contamination of the tissue with the elements under investigation, surgical instruments made of zirconium dioxide were used. The tissue samples were analyzed histologically and by inductively coupled plasma atomic emission spectrometry (ICP-AES) for accumulation of the metals Fe, Cr, Mo, Ni, and Ti in the local tissues. Implant corrosion was determined by the use of scanning electron microscopy (SEM). RESULTS: With grades 2 or higher in 9 implants, steel plates revealed a higher extent of corrosion in the SEM compared with titanium, where only one implant showed corrosion grade 2. Metal uptake of all measured ions (Fe, Cr, Mo, Ni) was significantly increased after stainless steel implantation, whereas titanium revealed only high concentrations for Ti. For the two implant materials, a different distribution of the accumulated metals was found by histological examination. Whereas specimens after steel implantation revealed a diffuse siderosis of connective tissue cells, those after titanium exhibited occasionally a focal siderosis due to implantation-associated bleeding. Neither titanium- nor stainless steel-loaded tissues revealed any signs of foreign-body reaction. CONCLUSION: We conclude from the increased release of toxic, allergic, and potentially carcinogenic ions adjacent to stainless steel that commercially pure Ti should be treated as the preferred material for osteosyntheses if a removal of the implant is not intended. However, neither material provoked a foreign-body reaction in the local tissues, thus cpTi cannot be recommend as the 'golden standard' for osteosynthesis material in general.

Adipose Tissue↗

PubMed2002

A study of the initial attachment and subsequent behavior of rat oral epithelial cells cultured on titanium.

BACKGROUND: The seal between an implant and the oral epithelium is an important factor for successful implant therapy. The purpose of this study was to evaluate the initial attachment and subsequent behavior of rat oral epithelial (OE) cells on pure titanium (Ti) used for dental implants. METHODS: OE cells derived from 4-day-old rats were cultured on Ti, polystyrene culture dishes, and glass coverslips. The number of attached cells, cell areas, number of colonies, and proliferation rates were measured. Additionally, immunostaining of vinculin and laminin-5 (LN5) was performed, and LN5-immunoreactive areas were measured. RESULTS: After 24 hours of culture, there were fewer cells attached to the Ti than to the polystyrene dishes or glass coverslips, and the area of cells was greater on the polystyrene than on the Ti or glass. OE cells reached their maximum proliferation rate after 48 hours of culture on the polystyrene and glass, and after 72 hours on Ti. LN5 was deposited behind cells as they migrated, and the LN5-immunoreactive area was smaller on Ti than on polystyrene after 96 hours of culture. CONCLUSIONS: The initial attachment of OE cells to Ti was inferior to that on polystyrene or glass, and the OE cell migration area indicated by the deposition of LN5 was smaller on Ti than on the other materials. Therefore, this study suggests that further improvement of Ti surface properties is needed for rapid attachment and spreading of oral epithelium to dental implants.

Analysis of Variance↗

PubMed2004

Effects of surface treatment of Ti-6Al-4V titanium alloy on biocompatibility in cultured human umbilical vein endothelial cells.

Among the titanium alloys employed as implant materials, the Ti-6Al-4V alloy is still widely used. Ti-6Al-4V titanium alloy samples, in untreated state and subjected to treatments in air by furnace or glow-discharge processes, were put in contact with human umbilical vein endothelial cells (HUVEC) in order to evaluate their effects on biocompatibility. In HUVEC kept for 48 h in the presence of the three sample types neither cell proliferation nor protein content nor lactate dehydrogenase release in the culture medium are affected, while apoptosis is induced after 48- and 96-h contact of the cells with the untreated sample type, and after 96-h contact with the plasma treated one, the furnace treated sample type being ineffective. The expression of two adhesion molecules, intercellular adhesion molecule-1 (ICAM-1) and vascular cell adhesion molecule-1 (VCAM-1) was also studied. The incubation of HUVEC with the three sample types for 48 or 96 h induces a significant increase in ICAM-1 protein levels, in comparison with control cells, while VCAM-1 expression is not detectable. In the same way, TNF-alpha release in the culture medium, assayed after 48- and 96-h contact of the cells with the three sample types, is significantly higher, in comparison with control, even if the highest values are registered in the presence of the untreated samples. Taken together, these data indicate that, although Ti-6Al-4V alloy samples, and in particular the treated ones, show a good biocompatibility, attention must be given to the first signs of inflammation.

Alloys↗

PubMed1999

Bone modeling and cell-material interface responses induced by nickel-titanium shape memory alloy after periosteal implantation.

The purpose of this study was to evaluate the new bone formation, modeling and cell-material interface responses induced by nickel-titanium shape memory alloy after periosteal implantation. We used a regional acceleratory phenomenon (RAP) model, in which a periosteal contact stimulus provokes an adaptive modelling response. NiTi has thermal shape memory and superelasticity properties uncommon in other implant alloys. So far, there are insufficient data concerning the biocompatibility of NiTi as a bone implant. NiTi was compared to stainless steel (stst) and Ti-6Al-4V. The test implant was placed in contact with the intact femur periosteum, but it was not fixed inside the bone. Histomorphometry with digital image analysis was used to determine the bone formation and resorption parameters. The ultrastructural features of cell-material adhesion were analysed with scanning electron microscopy (FESEM). A typical peri-implant bone wall modelation was seen due to the normal RAP. The maximum new woven bone formation started earlier (2 weeks) in the Ti-6Al-4V group than in the NiTi (P < 0.01) group, but also decreased earlier, and at 8 weeks the NiTi (P < 0.05) and stst (P < 0.005) groups had greater cortical bone width. At 12 and 26 weeks no statistical differences were seen in the histomorphometric values. The histological response of the soft tissues around the NiTi implant was also clearly non-toxic and non-irritating. Cell adhesion and focal contacts were similar between the materials studied by FESEM. We conclude that NiTi had no negative effect on total new bone formation or normal RAP after periosteal implantation during a 26-week follow-up.

Alloys↗

PubMed2000

Open magnetic resonance imaging using titanium-zirconium needles: improved accuracy for interstitial brachytherapy implants?

PURPOSE: To evaluate the benefit of using an open magnetic resonance (MR) machine and new MR-compatible needles to improve the accuracy of brachytherapy implants in pelvic tumors. METHODS AND MATERIALS: The open MR machine, foreseen for interventional procedures, allows direct visualization of the pelvic structures that are to be implanted. For that purpose, we have developed MR- and CT-compatible titanium-zirconium (Ti-Zr) brachytherapy needles that allow implantations to be carried out under the magnetic field. In order to test the technical feasibility of this new approach, stainless steel (SS) and Ti-Zr needles were first compared in a tissue-equivalent phantom. In a second step, two patients implanted with Ti-Zr needles in the brachytherapy operating room were scanned in the open MR machine. In a third phase, four patients were implanted directly under open MR control. RESULTS: The artifacts induced by both materials were significantly different, strongly favoring the Ti-Zr needles. The implantation in both first patients confirmed the excellent quality of the pictures obtained with the needles in vivo and showed suboptimal implant geometry in both patients. In the next 4 patients, the tumor could be punctured with excellent accuracy, and the adjacent structures could be easily avoided. CONCLUSION: We conclude that open MR using MR-compatible needles is a very promising tool in brachytherapy, especially for pelvic tumors.

Adult↗

PubMed2005

[Histomorphometric evaluation of bone ingrowth of porous titanium by a computer-assisted analyzing system].

The objective of this study was to evaluate the bone ingrowth of a new vacuum plasma sprayed titanium surface (vps-ti) in comparison to cs-titanium implants in a göttinger minipig model. Fifteen göttinger minipigs each received the two implants, vacuum plasma sprayed titanium with a porosity of 50% and a pore size of 200 microm (vps-ti) and an implant with a similar porosity but a different pore size 500 microm (cs-ti), at the proximal femur metaphysis by press-fit technique. The pigs were euthanized at three different postsurgical periods: 4, 8 and 12 weeks. Each femur was harvested and qualitative (macroscopic and microscopic) and quantitative (histomorphometric) histological analysis was done on histological slides. The results indicated that there was a difference in bone ingrowth between the two implants, whereas the bone ingrowth of vps-ti was superior to cs-ti after 4 and 8 weeks healing time. 12 weeks post implantationem no statistiscal difference was evident. The pore size of 200 microm seemed superior to a pore size of 500 microm. Whether or not these effects lead to a better mechanical stability remains unanswered.

Animals↗

PubMed2004

Biocompatible Mn2+-doped carbonated hydroxyapatite thin films grown by pulsed laser deposition.

Mn(2+)-doped carbonated hydroxyapatite (Mn-CHA) thin films were obtained by pulsed laser deposition on Ti substrates. The results of the performed complementary diagnostic techniques, X-ray diffraction, infrared spectroscopy, X-ray photoelectron spectroscopy, and energy dispersive X-ray spectroscopy investigations indicate that the films are crystalline with a Ca/P ratio of about 1.64-1.66. The optimum conditions, when nearly stoichiometric crystalline thin films were deposited, were found to be 10 Pa oxygen pressure, 400 degrees C substrate temperature, and postdeposition heat treatment in water vapors at the same substrate temperature. The films were seeded with L929 fibroblast and hFOB1.19 osteoblast cells and subjected to in vitro tests. Both fibroblast and osteoblast cells have a good adherence on the Mn-CHA film and on the Ti or polystyrene references. Proliferation and viability tests showed that osteoblast cells growth on Mn-CHA-coated Ti was enhanced as compared to uncoated pure Ti surfaces. Caspase-1 activity was not affected significantly by the material, showing that Mn-CHA does not induce apoptosis of cultured cells. These results demonstrate that Mn-CHA films on Ti should provoke a faster osteointegration of the coated implants as compared to pure Ti. (c) 2004 Wiley Periodicals, Inc. J Biomed Mater Res 71A: 353-358, 2004.

Animals↗

PubMed2005

Chemical nature of implant-derived titanium(IV) ions in synovial fluid.

Previous investigations have indicated a deleterious leakage of Ti(III) and/or Ti(IV) species from Ti-Al-V alloy joint prostheses into adjacent tissue, synovium or synovial fluid (SF) in vivo. In view of the importance of the particular chemical nature of such complexes in determining their biological activity, we have employed high field proton (1H) NMR spectroscopy to "speciate" Ti(IV) in inflammatory SF. Treatment of osteoarthritic SF samples with increasing concentrations of Ti(IV) (0.10-1.03 mM [TiO(C2O4)2]2-) gave rise to a specific broadening of the citrate proton resonances, indicating that this bioavailable oxygen-donor ligand plays an important role in complexing implant-derived Ti(IV). 1H NMR analysis of Ti(IV)-loaded SF samples subsequently treated with a large excess of ascorbate (0.05 M) showed that this added Ti(IV) chelator was only poorly effective in removing this metal ion from Ti(IV)-citrate/Ti(IV)-oxycitrate complexes. The results obtained here provide evidence for complexation of the low-molecular-mass (non-protein-bound) fraction of implant-derived Ti(IV) by citrate in vivo.

Arthroplasty, Replacement↗

PubMed1997

[An experimental study of morphologic and element analyses at the interface between bone and substitutive materials for human bone tissues].

The implant materials chosen in this study included hydroxy-poly (calcium natrium phosphate), hydroxyapatite, bioglass ceramic and Ti-6Al-4V. The implants were inserted into the mandibles of dogs. The samples from dogs were regularly observed by X-ray examination, optical microscope, scanning electron microscope and X-ray energy spectrograph. The results showed that all the implants had integrated into the surrounding bone tissue by the third month. During the early stage of the experiment, there were a lot of S, Si at the bone-implant interface. After new bone became mature, the contents of Ca, P increased, but the contents of S, Si decreased at the interface.

Animals↗

PubMed1988

The effect of post-sintering heat treatments on the fatigue properties of porous coated Ti-6Al-4V alloy.

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 as-received 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.

Alloys↗

PubMed1996

Evaluating sol-gel ceramic thin films for metal implant applications. II. Adhesion and fatigue properties of zirconia films on Ti-6AI-4V.

The degree to which ceramic coatings or thin films applied to bone-interfacing metallic implants can improve the overall performance of these implants with respect to implant fixation, wear, or corrosion relies especially on the response of these films to loading. In this study, the adhesion and fatigue properties of sol-gel zirconia films that could be reproducibly deposited onto polished Ti-6AI-4V substrates was investigated. For zirconia films on the order of 100 nm thick, a shear lag-based strain approach indicated a shear adhesion strength of approximately 275 MPa. Small variations in film thickness and substrate surface preparation had little effect on this adhesion, which was believed to be due to alkoxide molecule interactions with free hydroxyl groups on the substrate surface as well as some limited interfacial diffusion following the 500 degrees C anneal. Subsequent fatigue testing of these films in air using novel tapered rotating beam fatigue samples demonstrated their excellent fatigue characteristics, with films surviving up to 10(7) cycles, the endurance limit of the Ti-6AI-4V (approximately 635 MPa). Overall, the exceptional mechanical properties of this ZrO2/Ti-6AI-4V system along with the inherent advantages of sol-gel processing support continued studies to utilize this technology for implant surface modification.

Alloys↗

PubMed2002

Large-scale gene expression analysis of osteoblasts cultured on three different Ti-6Al-4V surface treatments.

To improve implant biocompatibility, we developed a simple cost-effective thermal surface treatment allowing an increase in the oxide layer thickness of a titanium (Ti) alloy used in orthopaedic implants. The goal of this study was to test in vitro the reaction of osteoblasts to the developed surface treatment and to compare it to the osteoblast reaction to two other surface treatments currently used in the practice of implant surgery. Quantification of osteoblast gene expression on a large scale was used in this study. The kinetics of gene expression over 120 h was followed for 58 genes to quantify the effect of the developed surface treatment. Twenty eight genes were further selected to compare the effects of surface treatments on osteoblasts. Based on the genes studied, we could propose a general pathway for the cell reaction according to the surface treatments used: (1) metal ion release changes the time course of gene expression in the FAK pathway; (2) once the accumulation of metal ions released from the Ti surface exceeds a threshold value, cell growth is diminished and apoptosis may be activated; (3) PTK up-regulation is also induced by metal ion release; (4) the expression of Bcl-2 family and Bax may suggest that metal ions induce apoptosis. The developed treatment seems to increase the Ti-6Al-4V biocompatibility as highlighted by the lower impact of this treatment by the different pathways studied, on the lower inflammatory reaction that could be induced, as well as by the lower induced osteoblast apoptosis compared to the two other surface treatments.

Alloys↗

PubMed1991

Release of metal ions from dental implant materials in vivo: determination of Al, Co, Cr, Mo, Ni, V, and Ti in organ tissue.

Little is known of the release of trace elements in vivo from dental implant materials. Conflicting data have been reported in the literature as to the levels of trace elements released and their potential consequences, mainly because of sampling and analytical methodological errors. In this study methods for average concentration levels of Al, Cr, Co, Mo, Ni, Ti, and V in organs were developed using rabbit tissue from an in vivo implantation study. At least 50% of the brain, liver, lung, kidney, and spleen were taken minimizing contamination. The tissue was homogenized by cryogenic milling at LN2 temperature and then freeze-dried. Samples were digested in nitric acid and hydrogen peroxide using microwave energy. Standard reference materials were utilized for quality control. One liver sample was analyzed 10 times to assess the method precision. Absorbance values in blanks, standards, and test samples were measured using a Varian GTA 95 graphite furnace and 875 spectrophotometer. Very satisfactory method precision and quality control were recorded. Low or very low levels of the trace elements were found in the various organs.

Alloys↗

PubMed2003

In vivo studies comparing the biocompatibility of various polypropylene meshes and their handling properties during endoscopic total extraperitoneal (TEP) patchplasty: an experimental study in pigs.

BACKGROUND: Polypropylene (PP) meshes are currently being used in millions of operations for hernial repair. We tested several recently modified PP meshes to evaluate them in terms of their biocompatibility and handling characteristics during minimally invasive procedures. METHODS: Four different PP meshes (a heavyweight PP, Atrium; a lightweight PP incorporating absorbable polyglactic acid, Vypro II; a lightweight PP, Parietene; and a titanium-coated lightweight PP, Ti-Mesh Extralight), all implanted using the endoscopic total extrapreperitoneal (TEP) technique, were investigated in groups comprising 11 pigs each. After 94 +/- 5 days, the animals were autopsied and tissue samples were studied histologically, immunohistochemically, and electron-microscopically. RESULTS: Whereas endoscopic handling of the Vypro II mesh proved difficult, the already good properties of the Atrium mesh were significantly improved on by Parietene and the Ti-Mesh. Clear differences were also found in the shrinkage characteristics of the implant materials. In comparison with Atrium (12%), Vypro II mesh shrinkage was significantly greater (28%), whereas Parietene (7%) and Ti-Mesh (5%) incurred less shrinkage. With regard to the chronic inflammatory reaction, the titanium-coated mesh showed a significantly lower inflammatory activity (13.1% partial volume [%PV] vs 34.1%PV and 29.0%PV) than the lightweight meshes Vypro II and Parietene, but-with the exception of the monocytic (0.2 vs 9.1, 5.1, and 7.9) and B-lymphocytic reaction (1.1 vs 18.0, 11.7, and 12.2)-no significant difference was seen in comparison with Atrium. The various mediators in the extracellular matrix (matrix metalloproteinases 1 [MMP-1 transforming growth factor beta [TGF-beta], urokinase plasminogen activator [uPA], and type I collagen) tended to show the highest expression with Vypro II (13.6, 113.2, 132.7, and 139.5, respectively) and the lowest expression with Ti-Mesh (11.9, 68.5, 92.8, and 75.0, respectively). With regard to cell proliferation, Parietene and Ti-Mesh appeared to have slight advantages, but no differences were observed in the apoptotic rate. CONCLUSION: In our opinion, despite a reduction in material, Vipro II, on account of the inflammatory reaction, does not represent a true improvement over the meshes currently used for hernia repair. In comparison, the two lightweight PP patches are characterized by a more favorable foreign body reaction, with the titanium coating of the Ti-Mesh providing an additional advantage in terms of its biocompatibility.

Abdominal Wall↗

PubMed1999

Osseointegration of sintered porous-surfaced and plasma spray-coated implants: An animal model study of early postimplantation healing response and mechanical stability.

The osseointegration and long-term success of bone-interfacing implants are dependent on mechanical stability of the implant relative to host bone during the early healing period. The geometric design of an implant surface may play an important role in affecting early implant stabilization, possibly by influencing tissue healing dynamics. In this study, we compared the early tissue healing response and resulting implant stability for two surface designs by characterizing the histological and mechanical properties of the healing tissue around Ti6Al4V sintered porous-surfaced and Ti plasma-sprayed implants. The implants were inserted transversely in rabbit femoral condyles and evaluated at 0, 4, 8, and 16 days postimplantation. At 4 and 8 days after implantation, the early healing tissue (fibrin and collagenous matrix) was more extensively integrated with the three-dimensional interconnected structure of the sintered porous surface than with the irregular geometry of the plasma-sprayed coating. In addition, histological examination indicated that initial matrix mineralization leading to osseointegration occurred more rapidly with the porous-surfaced implants. The more extensive tissue integration and more rapid matrix mineralization with the porous-surfaced implants were reflected in the mechanical test data, which demonstrated greater attachment strength and interfacial stiffness for the porous-surfaced implants 4 and 8 days postimplantation (p <.05). Sixteen days after implantation, both implant designs were osseointegrated and had comparable attachment characteristics. These data demonstrate that appropriate surface design selection can improve early implant stability and induce an accelerated healing response, thereby improving the potential for implant osseointegration.

Animals↗

PubMed2004

Thigh pain in primary total hip arthroplasty: the effects of elastic moduli.

Thigh pain after uncemented total hip arthroplasty (THA) remains a controversial topic. Our objective was to assess the effect of material composition in the development of thigh pain after primary THA. A cohort of 241 primary THAs was followed for a minimum of 2 years. All patients received identically shaped tapered cementless femoral components; the first half received a Cr-Co-Mo implant and the other half an identical implant made of Ti-6Al-4V. There were no statistically significant preoperative differences in the 2 component groups except that the percentage of blacks in the Cr-Co-Mo group was larger than in the Ti-6Al-4V group (26% vs. 14%; P <.05). The overall 1- and 2-year incidence of thigh pain was 9.5% and 8.7%, respectively. Implant composition was unrelated to reported thigh pain 1 and 2 years postoperatively. However, patients receiving larger versus smaller stems irrespective of material composition were more likely to report thigh pain at year 1 (relative risk = 4.68; 95% confidence interval = 1.41, 15.50). Thigh pain reported at year 2 was also higher in patients with larger versus smaller implants; however, this difference was not statistically significant (RR = 1.73; 95% CI = 0.68, 4.43). Material composition of this tapered stem design is unrelated to the incidence of thigh pain.

Adolescent↗