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Human intraperitoneal response to a left ventricular assist device with a Ti-6AI-4V alloy surface.

The soft tissue reaction to long-term implantation of an intraperitoneal left ventricular assist device (LVAD) was investigated. The HeartMate 1000 (Thermo Cardiosystems, Inc., Woburn, MA) is a pneumatically driven blood pump with smooth titanium alloy (Ti-6AI-4V) outer surfaces that is placed intraperitoneally in the left upper quadrant and sutured to the anterior abdominal wall. It is being used currently as a bridge to cardiac transplant, which sometimes requires extended support times. We examined the tissue capsule that formed around the rigid circular pump housing of four LVADs (duration of implant: 61, 86, 128, and 153 days) for gross, histologic, immunohistochemical, and ultrastructural analysis. Immunostaining was performed using monoclonal and polyclonal antibodies against cytoskeletal tissue markers (vimentin, desmin, alpha-smooth muscle actin), T and B lymphocytes, carcinoembryonic antigen, factor VIII, and cytokeratins (CAM 5.2 AE1/AE3, 34 beta E12, and 35 beta H11). Direct fluorescent immunolabeling for fibrinogen was also performed to characterize cell and tissue type. Histologic analysis of the 3 to 4 mm thick capsule with white, glistening inner surfaces showed fibrovascular tissue with multipotential subserosal cells (MSCs), capillary endothelium, collagen, and a few mononuclear infiltrates. The immunohistochemical profile of the MSCs differed from myofibroblasts despite a morphologic similarity. Transmission electron microscopy revealed abundant rough endoplasmic reticulum and peripherally arranged myofilaments within the spindle shaped cells. It was hypothesized that capsule formation was initiated by fibrin deposition, followed by proliferation of MSCs and subsequent formation of fibrovascular tissue.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗

Analysis of titanium dental implants after failure of osseointegration: combined histological, electron microscopy, and X-ray photoelectron spectroscopy approach.

A multitechnique approach has been used to characterize the surface of nonosseointegrated titanium implants and the surrounding biological tissues. Five pure titanium dental implants were used as reference, and 25 removed implants were studied. Surface and in-depth chemical compositions of the implants (from a total of 16 patients) were investigated by X-ray photoelectron spectroscopy (XPS). Histological slides of the surrounding tissues were examined by light microscopy, XPS, and electron microprobe analysis. None of the failed implants presented the regular surface composition and depth profile of the TiO2 overlayer; foreign elements (Ca, Na, P, Si, Cl, Zn, Pb, and Al) were observed on some implants. Fibrosis, lymphocytic and plasmocytic infiltrates, and granulomatous lesions were detected in the surrounding tissues. XPS and electron microprobe analysis indicated the presence of Zn, Fe, Sn, and Ti in the tissues. As a possible scenario for implant failure, we propose and discuss a oxidoreduction mechanism, leading to a partial dissolution or the complete dissociation of the protective titanium dioxide overlayer and to ion diffusion through the surrounding tissues.

Connective Tissue↗

An experimental investigation of osseointegration and stability of implants used as orthodontic anchorage in dogs.

OBJECTIVE: To investigate osseointegration and stability of three kinds of implants used as orthodontic anchorage in dogs. METHODS: HA-coated, titanium plasma-coated, and uncoated titanium implants were inserted into each femur of two dogs. After a healing period of three months, orthodontic force of 200 g was applied by means of Ni-Ti springs which were connected to the two adjacent implants for two months. Position change of the implant was first measured and then calculated. The shear bond strength of the interface between implant and bone was measured with a push test. After the test, the fracture surface at the interface was observed with a scanning electronic microscope. RESULTS: All implants were stable, without mobility. The highest bond strength and mature bone compactness were found at the interface between HA-coated implant and bone. The other two showed no significant difference in bond strength. However, osseointegration existed at the interface between all three kinds of implants and bone. CONCLUSION: HA-coated, titanium plasma-coated, and uncoated titanium implants can each serve as orthodontic anchorage as well as prosthodontic abutment.

Animals↗

[An experimental investigation between osseointegration and stability of implants used as orthodontic anchorage in dogs].

OBJECTIVE: To investigate the relation between osseointegration and stability of three kinds of implants used as orthodontic anchorage in dogs. METHODS: HA-coated, titanium coated, and uncoated titanium implants were inserted into each femur of two dogs. After heal period of three months, the orthodontic force of 200 g was applied by means of Ni-Ti springs, which were connected to the two adjacent implants, for two months. The position change of implants was measured and calculated. The shear bond strength of interface between implant and bone was measured with push-test. The interface was observed with scanning electronic microscope. RESULTS: The distance changes of HA-coated, T-coated and uncoated groups were (-0.50 +/- 1.78) mm, (-0.05 +/- 1.76) mm and (0.29 +/- 1.77) mm, respectively, which showed no statistical difference. The shear strength values were (2.88 +/- 0.55) MPa, (1.89 +/- 0.81) MPa and (2.14 +/- 0.49) MPa, respectively. HA-coated implant contacted with bone closely and the bond strength was the highest. The other two implants were found no significant difference in bond strength. CONCLUSION: The osseointegration was found at the interface among all three kinds of implants and bone and no displacement was found during application of clinical orthodontic force.

Animals↗

Fracture resistance of single-tooth implant-supported all-ceramic restorations after exposure to the artificial mouth.

The purpose of this in vitro study was to evaluate the fracture resistance of single-tooth implant-supported all-ceramic restorations, composed of zirconium dioxide all ceramic restorations on different implant abutments, and to identify the weakest component of the restorative system. Forty-eight standardized maxillary central incisor zirconia crowns (Procera) were fabricated for two test groups and one control group (group Al: alumina abutments; group Zr: zirconia abutments; control group Ti: titanium abutments). All abutments were placed on the implants (Replace) using titanium screws. The crowns were adhesively luted using a resin luting agent (Panavia 21) and artificially aged through dynamic loading and thermal cycling. Afterwards, all specimens were tested for fracture resistance using compressive load on the palatal surfaces of the crowns. Pair-wise Wilcoxon rank tests were performed to test for differences in fracture resistance values with a global significance level of 0.05. All test specimens survived aging in the artificial mouth. No screw loosening was recorded. The median fracture resistance was 1251, 241 and 457 N for groups Ti, Al and Zr respectively. Statistically significant differences were found for the comparisons of group Ti with groups Al and Zr (P < 0.00001), and for the comparison of group Al with Zr (P < 0.00001). Results of this study showed that all tested implant-supported restorations have the potential to withstand physiological occlusal forces applied in the anterior region. Because of the low fracture resistance values of group Al, the combination of zirconia crowns and alumina abutments should carefully be considered before clinical application.

Aluminum Oxide↗

A novel combinatorial approach for understanding microstructural evolution and its relationship to mechanical properties in metallic biomaterials.

The new generation of metallic biomaterials for prosthesis implantation (orthopedic and dental) typically have a Ti base with fully biocompatible alloying additions such as Nb, Ta, Zr, Mo, Fe and Sn. While the binary Ti-Ta and the ternary Ti-Nb-Ta systems are promising, the large composition space afforded by these systems offers tremendous scope in terms of alloy design via optimization of alloy composition and thermomechanical treatment. In the present paper a novel combinatorial approach has been developed for rapidly exploring the microstructural evolution and microstructure-microhardness (or elastic modulus) relationships in these systems. Using directed laser deposition, compositionally graded alloy samples have been fabricated and subsequently heat-treated to affect different microstructures in terms of the volume fraction and distribution of the alpha phase in the beta matrix as a function of composition. Subsequently, composition-specific indentation-based hardness and modulus information has been obtained from these graded samples, and the resulting data have been used to develop relationships between the composition, microstructure and mechanical properties. Such rapid combinatorial assessments can be very useful in optimizing not only the alloy composition but also the desired microstructure for achieving the best combination of properties for specific orthopedic or dental applications.

Alloys↗

Characterization of functionally graded hydroxyapatite/titanium composite coatings plasma-sprayed on Ti alloys.

Bioceramic coatings like hydroxyapatite (HA) have shown promising bioactive properties in load-bearing implant applications. The aim of this work is to deposit functionally graded HA/Ti layers consisting of an underlying Ti bond coat, the alternating layer, and an HA top-layer on Ti6Al4V substrates using plasma spray to improve the coating-substrate interface properties. The alternating layers were created by means of changing the feeding rate and input power of Ti and HA powders, which gradually decrease Ti content with increasing depth from the Ti bond-coat. The major consideration is to examine the stability of the graded coatings. Experimental results indicated that surface chemistry and morphology of the graded coatings were similar to those of monolithic HA coatings. The bond strength values of the as-sprayed graded coatings were much superior to those of monolithic HA coatings. The cyclic fatigue did have a statistically significant effect on bond strength of monolithic HA coatings, with a decrease of 23%. However, the graded coatings were able to survive 1 million cycles of loading in air without significantly reduced bond strength. The in vitro electrochemical measurement results also indicated that the graded coatings had a more beneficial and desired behavior than monolithic HA coatings after fatigue.

Alloys↗

ICP-MS multielemental determination of metals potentially released from dental implants and articular prostheses in human biological fluids.

A sector field high-resolution (HR)-ICP-MS and an octapole reaction system (ORS)-ICP-MS have been compared for the simultaneous determination of traces of metals (Ti, V, Cr, Co, Ni, and Mo) released from dental implants and articular prostheses in human biological fluids. Optimum sample treatments were evaluated to minimize matrix effects in urine and whole blood. Urine samples were diluted tenfold with ultrapure water, whereas whole blood samples were digested with high-purity nitric acid and hydrogen peroxide and finally diluted tenfold with ultrapure water. In both matrices, internal standardization (Ga and Y) was employed to avoid potential matrix interferences and ICP-MS signal drift. Spectral interferences arising from the plasma gases or the major components of urine and whole blood were identified by (HR)-ICP-MS at 3,000 resolving power. The capabilities of (HR)-ICP-MS and (ORS)-ICP-MS for the removal of such spectral interferences were evaluated and compared. Results indicate that polyatomic interferences, which hamper the determination of such metallic elements in these biological samples, could be overcome by using a resolving power of 3,000. Using (ORS)-ICP-MS, all those elements could be quantified except Ti and V (due to the polyatomic ions 31P16O and 35Cl16O, respectively). The accuracy of the proposed methodologies by (HR)- and (ORS)-ICP-MS was checked against two reference materials. Good agreement between the given values and the concentrations obtained for all the analytes under scrutiny was found except for Ti and V when analyzed by (ORS)-ICP-MS.

Cartilage, Articular↗

Resurfacing knee arthroplasty in patients with allergic sensitivity to metals.

BACKGROUND: The problem of metal sensitivity (Ni, Cr, and Co) in arthroplasty is still unsolved. To prevent the risk of allergy in cases with proved metal allergy in an epicutaneous test, a Natural Knee total knee arthroplasty, made totally from titanium (Ti-6Al-4V) and polyethylene, can be implanted. The results of this device have to be compared to the results of normal knee arthroplasty designed with a femoral component out of CrCoNi alloy. The mechanical resistance of this alloy is much higher than that of titanium, and therefore it is the standard for the femoral components of most knee-resurfacing devices. METHODS: Thirty-five patients with a titanium Natural Knee were examined retrospectively after a mean follow-up of 2 years and 5 months (range 6 months to 5 years and 4 months). In comparison, 36 patients with a Genesis-I knee with a CrCoNi alloy femoral component were studied after a mean follow-up of 2 years and 4 months (range 8 months to 6 years and 2 months). RESULTS: In spite of the lower mechanical resistance of titanium, the Natural Knee showed better results (knee score 84.1 points, function score 77.7 points, HSS score 80.1 points, 82.9% excellent and good results) than the Genesis-I knee (knee score 80.6 points, function score 76.4 points, HSS score 76.4 points, 68.5% excellent and good results), although these differences had no statistical significance. CONCLUSIONS: The titanium Natural Knee prosthesis has proven to be a reliable knee joint replacement in the medium term.

Adult↗

Auger electron spectroscopy and its use for the characterization of titanium and hydroxyapatite surfaces.

This review paper provides the basic background and underlying theory behind Auger electron spectroscopy (AES). Among the many surface analytical tools, AES has been shown to be very effective for surface composition analysis. These analyses are critically needed to better understand the interactions between the host and implant. The use of AES for titanium (Ti) and hydroxyapatite (HA) biomaterials characterization is demonstrated in this paper. The relative peak heights of TiL(2,3)M(2,3)V can be used as 'fingerprints' for TiO2 surfaces which have undergone different degrees of reduction. Similarly, for HA coatings, a shift in the phosphorus Auger peaks to a higher kinetic energy indicates the presence of a phosphate group, with strong P-O bonds. Depth compositional profiling and thin-film analysis can be performed using AES. In our studies, oxide thicknesses on Ti surfaces range from 36.8 +/- 7.4 A to 436 +/- 49 A depending on the surface treatment. Depth profiling can also be used to determine the subsurface composition of biomaterials. For HA coatings, a phosphorus concentration at the oxide/metal interface has been observed to be higher than at the outermost oxide surface. The HA coatings have also been observed to coexist within the titanium oxide, suggesting the occurrence of chemical bonding between the coatings and the metallic substrates. However, like other analytical tools, AES has its limitations. The electron beam damage can severely limit useful analysis of organic and biological materials and occasionally ceramic materials. Carbide buildup during long beam exposure times has been shown to affect the relative peak-to-peak intensities of the oxygen and metal Auger signals. The determination of film thickness requires a standard of known thickness and depth profiling of overlapping peaks can be very problematic. Even with these limitation, AES can be a powerful analytical tool for the characterization of biomaterial surfaces.

Biocompatible Materials↗

Osteoinductive activity of composites of bone morphogenetic protein and pure titanium.

Titanium sponges were infused with bone morphogenetic protein (BMP-Ti), and the osteoinductivity of the resultant composite was measured. New bone formation occurred three weeks after implantation and was identified by soft x-ray analysis. Quantitative analysis showed no significant difference between BMP-Ti composites and control samples (BMP only). Consequently, pure titanium neither inhibited nor promoted BMP activity. Chondrocytes and new bone formation occurred in direct contact with the surfaces of the titanium. X-ray microanalysis demonstrated new bone formation inside the pores of the titanium sponges. The BMP-Ti composite has interesting properties as an osteoinductive implant and has potential practical clinical applications.

Animals↗

In vivo/ex vivo cellular interactions with titanium and copper.

Machined, commercially pure titanium (Ti) disks were coated with approximately 400 nm copper (Cu) by physical vapor deposition or left uncoated. The kinetics of inflammatory cell recruitment, distribution and viability was evaluated around Ti, Cu, and in sham sites after 1, 3, 12, 18, 24, and 48 h in a rat subcutaneous (s.c.) model. Further analysis of the cells on implant surfaces was performed by ex vivo incubation of the disks. Ti and Cu stimulated an increased recruitment of inflammatory cells in comparison with sham sites. A markedly higher amount of cells, predominantly polymorpho-nuclear granulocytes (PMN), was detected around Cu after 18 h and onwards. More cells were found at the implant surfaces than in the surrounding exudates after 18 h. The total amount of lactate dehydrogenase (LDH), an indicator of plasma membrane injury, was higher in Cu exudates after 18 h in comparison with Ti and sham. In contrast, no differences in the proportion of dead cells (trypan blue dye uptake) were detected in the exudates. Further, LDH levels were higher around Ti than Cu during the initial 18 h of ex vivo incubation. The results of this study indicate that the early inflammatory process associated with a cytotoxic material in soft tissues is largely attributed to the induction of a markedly strong and prolonged chemotactic response. In contrast, this process is characterized by a higher amount of inflammatory cells around a biocompatible material than in sham sites, but with a transient course and total LDH similar to sham sites.

Journal Article↗

Gene expression profiling of bone cells on smooth and rough titanium surfaces.

Titanium (Ti) and Ti alloys are widely used as dental and orthopaedic implants, but the effects of the surface characteristics of these materials on the response of cells and target tissues is not well understood. The present study has therefore examined the effects of a rough Ti (RT) and a smooth Ti (ST) surface on human bone cells in vitro. Scanning electron microscopy showed attachment and spreading of cells on both surfaces. Expression profiling using ATLAS gene arrays showed marked differences in gene responses after 3 h of culture. A number of osteoblast genes were identified as "roughness response" genes on the basis of changes in expression on the RT compared with the ST surfaces. The surface roughness of Ti was thus found to have a profound effect on the profile of genes expressed by the bone cells, and suggests that improvements in the biological activity and possibly the clinical efficacy of these materials could be achieved by selective regulation of gene expression mediated by controlled modification of Ti surface.

Adult↗

Contact angle, protein adsorption and osteoblast precursor cell attachment to chitosan coatings bonded to titanium.

Chitosan, a derivative of the bio-polysaccharide chitin, has shown promise as a bioactive material for implant, tissue engineering and drug-delivery applications. The aim of this study was to evaluate the contact angle, protein adsorption and osteoblast precursor cell attachment to chitosan coatings bonded to titanium. Rough ground titanium (Ti) coupons were solution cast and bonded to 91.2% de-acetylated chitosan (1 wt% chitosan in 0.2% acetic acid) coatings via silane reactions. Non-coated Ti was used as controls. Samples were sterilized by ethylene oxide gas prior to experiments. Contact angles on all surfaces were measured using water. 5 x 10(4) cells/ml of ATCC CRL 1486 human embryonic palatal mesenchyme (HEPM) cells, an osteoblast precursor cell line, were used for the cell attachment study. SEM evaluations were performed on cells attached to all surfaces. Contact angles and cell attachment on all surfaces were statistically analyzed using ANOVA. The chitosan-coated surfaces (76.4 +/- 5.1 degrees) exhibited a significantly greater contact angle compared to control Ti surfaces (32.2 +/- 6.1 degrees). Similarly, chitosan-coated surfaces exhibited significantly greater (P < 0.001) albumin adsorption, fibronectin adsorption and cell attachment, as compared to the control Ti surfaces. Coating chitosan on Ti surfaces decreased the wettability of the Ti, but increased protein adsorption and cell attachment. Increased protein absorption and cell attachment on the chitosan-coated Ti may be of benefit in enhancing osseointegration of implant devices.

Adsorption↗

Hydroxyapatite clay used to fill the gap between implant and bone.

A clay containing hydroxyapatite (HA) was developed for use as a filling material between an uncemented implant and bone. It consists of 55% HA granules greater than 0.1 mm in size with a homogeneous pore distribution and a porosity of 35% to 48% in a saline solution of sodium alginate (6%). Ti-6A1-4V alloy rods with smooth surfaces were implanted into the distal medullary canal of one osteotomised tibia of 32 Japanese white rabbits. Sixteen rods were inserted with HA clay and 16 without the clay to act as a control group. Six of each group were killed at one week and ten at 12 weeks postoperatively. The pull-out strength of the implants with HA clay was significantly greater at 12 weeks (p < 0.05), as was the percentage of the area of the new bone (p < 0.05). The study suggests that HA clay has an osteoconductive property, allowing adequate bone fixation across a gap at an early stage. The use of HA clay to enhance the early stability of uncemented components may help to improve the functional outcome of total joint arthroplasty.

Alloys↗

Five-year results of two cemented hip stem models each made of two different alloys.

INTRODUCTION: The aim of this study was to compare the influence of two different cemented hip stems each made of two different alloys concerning survival and outcome. MATERIALS AND METHODS: The 5-year results with 161 Mueller straight stems made of cobalt chromium (SS CoCr), 272 Mueller straight stems made of titanium (SS Ti), 233 Mueller SL stems made of titanium (SL Ti) and 255 SL stems made of cobalt chromium (SL CoCr) implanted consecutively in this order were compared. All patients were followed up prospectively during the first 5 years after implantation. The evaluation of the results was retrospective. RESULTS: The survival rates for aseptic loosening were 100% (SS CoCr), 92.8% (SS Ti), 81.6% (SL Ti) and 97.8% (SL CoCr). Clinical and radiological outcomes like pain occurrence, use of pain medication, ability to climb stairs, amount of stem subsidence and osteolysis correlated statistically significantly with the results of the survival rates. Concerning the two alloys, chromium cobalt showed better results, and concerning the two designs, the straight stem had a better outcome. For the four prostheses being compared, the results were influenced more by the alloy than by the design, and the small-sized titanium stems were more susceptible to undergoing revision than the large-sized prostheses. CONCLUSION: Stem design and even more alloy may influence the survival rate and clinical outcome. Evaluating the results, we recommend the use of the classic straight stem prosthesis made of cobalt chromium.

Adult↗

Mechanical and histological evaluations of hydroxyapatite-coated and noncoated Ti6Al4V implants in tibia bone.

This paper evaluates the behavior of hydroxyapatite (HAP) coated and noncoated Ti6Al4V implants in dog tibia after 3 and 5 months implantation. HPA-coated implants were obtained by plasma spraying. XRD, SEM, and EPMA were employed to estimate the coating characteristics and their behavior in vivo. Investigation of material characteristics showed that the as-received coatings consisted mainly of amorphism and HAP phase. Other phases such as TCP and CaO were identified due to thermal changes of HAP particles in plasma flame. SEM micrographs showed a typical microstructure of plasma-sprayed coating. The as-received coating was formed by well-melted pancake-like splats that lead to a dense coating with a rough surface. Lamellar structure, micropores, and microcracks, observed inside the coating, are characteristic of plasma spraying. Push-out tests revealed that HAP coating had a significant promotion of interfacial shear strength. The shear strength between bone and HAP-coated implants was much higher than that between bone and noncoated implants due to the different bone-implant interfaces formed after implantation. SEM observation revealed a direct attachment between HAP coating and newly formed bone. However, noncoated implants were separated from newly formed bone by fibrous tissues. Ti ions were found to be released into the surrounding environment after long time immersion in body fluid, and thus caused low shear strength. Prolongation of implantation time had different effects on shear strength. It improved the shear strength between HAP-coated implant and newly formed bone. However, it had little effect on that between noncoated implant and surrounding tissues.

Alloys↗

Bone-implant interface and remaining tissues on the implant surface after push-out test: an SEM observation.

The purpose of this study was to compare the morphology of the tissues remaining on smooth and dimpled surfaces of a ceramic composite of zirconia-hydroxyapatite (TZ-2Y/25HA) with commercially pure titanium (cp Ti) after a push-out test. The tissue-material interface was viewed on the specimens without being tested mechanically. Cylindrical implants were inserted in the femurs of rabbits for three months. Each femur received three implants. After sacrificing the animals, the target tissues were collected and divided into two groups: group I was fixed in 4% formalin immediately, and group II was tested mechanically by push-out before fixation. Specimens were then dehydrated for SEM observation. The results showed that no remaining tissue appeared on the smooth cp Ti surface, whereas remaining tissues, mineralized and collagenous tissues, were seen on the smooth surface of the TZ-2Y/25HA. New bone had grown into and filled the most of dimple spaces of both the cp Ti and TZ-2Y/25HA implant. A submicron gap between the bone and cp Ti was found, whereas the TZ-2Y/25HA was occasionally in direct contact with new bone. Thus TZ-2Y/25HA showed an intimate contact to bone in some areas, and cp Ti showed an unmineralized tissue separated interface to bone continuously. Taken together, the laser machining seems to have no adverse effects on tissue response and is a potential technique for producing micro-patterned surfaces on dental and medical implants.

Animals↗