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PubMed1993

[Results of cementless implantation of 150 "Erlangen Model" hip prostheses of titanium alloy Ti Al5 Fe2.5].

Between March 17, 1984 and August 20, 1987, 142 patients with osteoarthritis of one or both hips were treated by joint replacement with the uncemented "Erlangen" hip prosthesis (Prof. H. Beck/P. Brehm Chirurgie-Mechanik GmbH). The causes of the osteoarthritis varied. Hip replacement was carried out for the following conditions: rheumatoid arthritis including ankylosing spondylitis, aseptic necrosis of the femoral head, including posttraumatic and idiopathic forms, osteoarthritis of unknown origin, osteoarthritis following dysplasia or subluxation of the hips, and loosened cemented hip prostheses (131 primary implantations and 19 revisions). Full weight-bearing was not permitted for 50 days postoperatively, but mobilization and isometric exercises were started 2 days after operation and isotonic exercises were introduced later. Complications included fracture of the femoral shaft during operation and aseptic loosening. Our results in the 142 patients (150 joints) at 32-65 months (average 44 months) after surgery are encouraging. Good results based on patient satisfaction were obtained in 92.7% (81.3% after revision) and poor results in 7.3% (18.7% after revision). Most (90.2%) of the patients can walk without a stick (50.0% after revision), and 90.2% of the patients can walk more than 1000 m (68.8% after revision).

Alloys↗
PubMed1995

Acute toxicity of metal ions in cultures of osteogenic cells derived from bone marrow stromal cells.

The effects of metal ions released from orthopedic implants on nearby bone cells remain largely unknown. The purpose of this study was to examine the acute toxicity of metal ions on osteogenic cells derived from bone marrow. Bone marrow stromal cells were cultured with metal ions found in commonly used orthopedic implants, that is, Ti-6Al-4V, Co-Cr-Mo, and 316L stainless steel. Solutions of individual ions and combinations representing the alloy composition were prepared from atomic absorption standards and added to the cultures to give concentrations ranging from 50 ppb to 50 ppm. After a 48-h period of exposure to ions, the bone marrow cultures were examined for effects of cytotoxicity by measuring total cell number, total cell protein, and mitochondrial activity. Cr6+ was grossly cytotoxic; Co2+, Mo6+, Fe3+, and Ni2+ were moderately cytotoxic; and Ti4+, Al3+, V5+, and Mn2+ were minimally toxic, as determined by the assays used. Ion solutions representing Co-Cr-Mo and 316L stainless steel were moderately toxic; solutions representing Ti-6Al-4V were toxic at only the highest concentrations used. The observed cytotoxicity was time-dependent, with irreversible toxic effects being initiated following as short as a 3- to 6-hour exposure. These results show that metal ions associated with Co-Cr-Mo and 316L stainless steel are toxic to osteogenic cells at concentrations approximating those measured in the fibrous membrane encapsulating orthopedic implants.

Animals↗
PubMed1996

Bone bonding behavior of titanium and its alloys when coated with titanium oxide (TiO2) and titanium silicate (Ti5Si3).

It has been proposed that the essential requirement for artificial materials to bond to living bone is the formation of bonelike apatite on their surfaces in the body. Recent studies have shown that titanium hydrogel and silica gel induce apatite formation on their surface in a simulated body fluid. In this study, the influence of titanium oxide and titanium silicate on the bonding of titanium alloys to bone was studied. Rectangular implants (15 x 10 x 2.2 mm) of titanium, Ti-6Al-4V, Ti-6Al-2Nb-Ta, Ti-6Al-4V coated with TiO2, and Ti-6Al-4V coated with Ti5Si3 were implanted into the tibial metaphyses of mature rabbits. At 8 and 24 weeks after implantation, the tibiae containing the implants were dissected out and subjected to a detaching testing. The failure load for titanium, Ti-6Al-4V, Ti-6Al-2Nb-Ta, Ti-6Al-4V coated with TiO2, and Ti-6Al-4V coated with Ti5Si3 were, respectively, 0.68 +/- 0.48, 0.22 +/- 0.46, 0.67 +/- 0.59, 2.18 +/- 0.71 and 2.03 +/- 0.41 kgf at 8 weeks, and 2.7 +/- 0.91, 2.58 +/- 1.29, 2.38 +/- 0.41, 3.79 +/- 1.7, and 2.79 +/- 0.87 kgf at 24 weeks after implantation. Histological examination by Giemsa surface staining, CMR, and SEM-EPMA revealed the coated titanium alloy implants directly bonded to bone tissue during early implantation. A Ca-P layer was observed at the interface of the coated implants and the bone. The results of this study indicated that TiO2 and Ti5Si3 can enhance the early bonding of titanium alloys to bone by inducing a Ca-P layer (chemical apatite) on the surface of titanium alloys. It also is suggested that the direct bone contact occurs in relation to the calcium and phosphorus adsorption onto the surface of the titanium passive layer formed during long-term implantation.

Alloys↗
PubMed2000

Adhesion of microvascular endothelial cells to metallic implant surfaces.

The objective of this study was to explore the molecular mechanisms of adhesion of endothelial cells (ECs) to implant grades of titanium alloy (Ti) and stainless steel (SS), compared to tissue culture polystyrene (PS). The idea is that promotion of EC adhesion to implant surfaces during the initial stages of healing may be critical in the formation of a capillary bed intimately associated with the implant surface. Ultimately this could be expected in turn to promote bone formation close to the surface and a more stable implant/bone interface. Surfaces were coated with either peak 1 fibrinogen gammaAgammaA, fibrinogen Fr I-9, fibrinogen fragment D1, fibronectin, vitronectin, or fetal calf serum and then post-coated with bovine serum albumin (BSA) to block non-specific cell adhesion. Surfaces with BSA alone and no other protein coating were also evaluated. Fibronectin coating maximized cell adhesion on all three surfaces, and adhesion was highest on PS. BSA blocked cell adhesion to PS (and most adhesion to SS) much better than to Ti. These results provide evidence that BSA adsorption on the metal surface is unable to effectively block the adhesion of the cells to the Ti. These data may provide a basis for understanding in vivo observations that soft tissue becomes attached to a Ti surface more rapidly and with more bone formation than to SS. Evidence is also presented that alphavbeta3 plays an important role in adhesion of ECs to the Ti surface. These experiments also provide preliminary data which may reflect some of the features of initial EC adhesion to metal implants.

Journal Article↗
PubMed2005

Fibrillar assembly and stability of collagen coating on titanium for improved osteoblast responses.

Collagen, as a major constituent of human connective tissues, has been regarded as one of the most important biomaterials. As a coating moiety on Ti hard-tissue implants, the collagen has recently attracted a great deal of attention. This article reports the effects of fibrillar assembly and crosslinking of collagen on its chemical stability and the subsequent osteoblastic responses. The fibrillar self-assembly of collagen was carried out by incubating acid-dissolved collagen in an ionic-buffered medium at 37 degrees C. The degree of assembly was varied with the incubation time and monitored by the turbidity change. The differently assembled collagen was coated on the Ti and crosslinked with a carbodiimide derivative. The partially assembled collagen contained fibrils with varying diameters as well as nonfibrillar aggregates. On the other hand, the fully assembled collagen showed the complete formation of fibrils with uniform diameters of approximately 100-200 nm with periodic stain patterns within the fibrils, which are typical of native collagen fibers. Through this fibrillar assembly, the collagen coating had significantly improved chemical stability in both the saline and collagenase media. The subsequent crosslinking step also improved the stability of the collagen coating, particularly in the unassembled collagen. The fibrillar assembly and the crosslinking of collagen significantly influenced the osteoblastic cell responses. Without the assembly, the collagen layer on Ti adversely affected the cell attachment and proliferation. However, those cellular responses were improved significantly when the collagen was assembled to fibrils and the assembly degree was increased. After crosslinking the collagen coating, these cellular responses were significantly enhanced in the case of the unassembled collagen but were not altered much in the assembled collagen. Based on these observations, it is suggested that the fibrillar assembly and the crosslinking of collagen require careful considerations in the collagen administration as a coating moiety.

Cell Line↗
PubMed1992

Alumina versus polyethylene in total knee arthroplasty.

The cementless alumina total knee prosthesis, which uses alumina in the portions coming in contact with the bone and a combination of alumina and ultra-high molecular-weight polyethylene (UHMWPE) in the sliding portions, is referred to as a total condylar. Alumina total knee arthroplasty was performed on 137 patients, including 103 rheumatoid arthritis (RA) and 34 osteoarthrosis (OA) patients, from January 1982 to February 1985. The follow-up period was seven years 11 months and four years ten months, respectively. At follow-up evaluation, 108 patients were available for clinical and roentgenographic examinations, amounting to a 79% follow-up rate. At follow-up examination, 67 joints (62%) were completely pain free and 28 joints (26%) caused slight pain on bearing weight. Walking ability was recovered moderately in RA and markedly in OA. In RA, 14 of 84 knees were cemented and one knee was treated with loosening. Of 72 cementless implantations, 55 sustained displacing distally and one sustained loosening in the tibia, whereas 31 sustained displacing proximally and six sustained loosening in the femur. In OA, 21 cementless knees had 17 displacings in the tibia, and ten displacings and two loosenings in the femur. Scanning electron microscopy (SEM) observation of the UHMWPE surface in tibial plates revealed smoothing and burnishing. Alumina is far superior to metal for the sliding part, although it is not always best for the portion in contact with the bone. To resolve these problems, for cementless fixation, anchoring portions of Ti alloy and alumina implants were covered with beads and coated with hydroxyapatite. For cement fixation, "the interface bioactive bone cement technique" interposing hydroxyapatite granules between bone and cement was performed.

Adult↗
PubMed2001

Electrochemical studies on the stability and corrosion resistance of titanium-based implant materials.

The corrosion susceptibility of Ti, Ti-6A1-4V and Ti-45Ni was studied in a buffered saline solution using anodic polarisation and electrochemical impedance measurements. Pitting potentials as low as + 250 mV(SCE) were recorded for Ti-45Ni and once initiated pits continued to propagate at potentials as low as -150 mV(SCE). It was possible to increase the pitting potential of Ti-45Ni to values greater than +800 mV(SCE) using a H2O2 surface treatment procedure; however, this surface modification process had no beneficial effect on the rate of pit repassivation. Impedance spectra, recorded under open-circuit conditions, were modelled using a dual oxide film model; a porous outer layer and an inner barrier oxide layer. The nature of this porous outer layer was found to depend on the nature of the electrode material and the presence of phosphate anions in the saline-buffered solution. The porous layers formed on Ti-45Ni and Ti-6Al-4V in the presence of phosphate anions had low resistances typically between 10 and 70 ohm cm2. Much higher porous layer resistances were recorded for Ti and also for Ti-45Ni and Ti-6Al-4V in the absence of the phosphate anions.

Alloys↗
PubMed1993

Comparison of bone-implant interface shear strength of solid hydroxyapatite and hydroxyapatite-coated titanium implants.

The interface shear strength of uncoated Ti-6Al-4V, dense sintered hydroxyapatite (HA), and HA-coated Ti-6Al-4V were compared. Interface shear strength was determined using a transcortical push-out model in dogs 4 and 12 weeks after implantation. The interface shear strength of dense sintered HA and HA-coated Ti-6Al-4V was significantly higher than that of uncoated Ti-6Al-4V (P < .001). There was no significant difference between the interface shear strength of dense sintered HA and HA-coated Ti-6Al-4V. After the push-out test for HA-coated implants, the regions fractured at the bone-coating interface and at the coating-titanium interface coexisted at 4 weeks after implantation. At 12 weeks, the fracture site was, in all cases, the HA coating-titanium interface, and, in a few samples, fractures inside the coating layer also were visible.

Alloys↗
PubMed1985

Titanium: the mystery metal of implant dentistry. Dental materials aspects.

A number of important points concerning titanium and its alloys have been discussed. They are summarized as follows. Ti and its alloys, particularly the alpha-beta alloys, possess mechanical properties that make them ideal implant materials. Ti and its alloys oxidize readily in air. This surface oxide is extremely stable in the physiologic environment of the body. The stability and inertness of this surface oxide layer acts to protect Ti from corrosive breakdown when used in the body. The elimination of surface irregularities and contaminants is important when preparing a metal for implantation. Titanium can be coupled with equally passive metals in the body without causing galvanic corrosion.

Chemical Phenomena↗
PubMed2005

In vivo evaluation of plasma-sprayed titanium coating after alkali modification.

In this paper, plasma-sprayed titanium coatings were modified by alkali treatment. The changes in chemical composition and structure of coatings were examined by SEM and AES. The results obtained indicated that a net-like microscopic texture feature, which was full of the interconnected fine porosity, appeared on the surface of alkali-modified titanium coatings. The surface chemical composition was also altered by alkali modification. A sodium titanate compound was formed on the surface of the titanium coating and replaced the native passivating oxide layer. Its thickness was measured as about 150 nm which was about 10 times of that of the as-sprayed coating. The bone bonding ability of titanium coatings were investigated using a canine model. The histological examination and SEM observation demonstrated that more new bone was formed on the surface of alkali-modified implants and grew more rapidly into the porosity. The alkali-modified implants were found to appose directly to the surrounding bone. In contrast, a gap was observed at the interface between the as-sprayed implants and bone. The push-out test showed that alkali-modified implants had a higher shear strength than as-sprayed implants after 1 month of implantation. An interfacial layer, containing Ti, Ca and P, was found to form at the interface between bone and the alkali-modified implant by EDS analysis.

Alloys↗
PubMed2001

Tissue reaction around metal implants observed by X-ray scanning analytical microscopy.

The soft tissues implanted with Cu, Ni, Fe, Ag, Ti, Ni-Ti, SUS304 and SUS316 wires were investigated with XSAM and compared with histological observation. The relationship between the distribution of dissolved metal elements and the tissue response was evaluated. Of the metals whose dissolution was clearly observed by XSAM, severe tissue damage was observed around Ni and Cu implants, while fibrous connective tissue was formed around the Fe implant. The concentration in surrounding tissue was estimated by XSAM using the newly prepared standard specimens. The dissolved concentration was approximately 10-20 mm for Ni and Cu and was considered to be in the order of ten times higher in Fe. The results indicated that the toxicity at the same concentration was from greater Ni > Cu > Fe. For Ag, Ti, Ni-Ti, SUS304 and SUS316 implants, significant dissolution and severe tissue damage were not observed. The XSAM was especially useful to obtain the information of dissolution and distribution behavior of rare content of toxic and chemically unstable metals in the soft tissue.

Alloys↗
PubMed2003

Pharmacokinetic and toxicity study of an intraocular cyclosporine DDS in the anterior segment of rabbit eyes.

PURPOSE: To establish the safety and pharmacokinetic efficacy of an Oculex Drug Delivery System (DDS; Oculex Pharmaceuticals, Inc., Sunnyvale, CA) containing cyclosporin A (CsA) in the anterior segment of the rabbit eye. METHODS: The Oculex DDS is an intraocular, sustained-release, drug delivery system comprising a biodegradable lactic acid-glycolic acid copolymer. A controlled prospective study was performed that involved implanting a DDS containing 0.5 mg of CsA into the anterior chamber (AC) of the right eyes of 16 New Zealand White rabbits. A placebo DDS was implanted into the left eyes of these same rabbits as the control. Slit lamp examinations and AC taps were performed serially, and the rabbits were killed and the globes removed at 2, 4, 8, and 12 weeks for histology and determination of CsA drug levels. Analysis of CsA levels was performed with high-performance liquid chromatography-mass spectrometry. RESULTS: High concentrations of CsA were detectable in all layers of the cornea (epithelium, corneal stroma and endothelium) throughout the 3-month period. Low CsA levels were detected in the aqueous, whereas no CsA was detectable in the blood. There were no adverse reactions observed. CONCLUSIONS: The Oculex DDS CsA device is effective in delivering long-term levels of CsA to corneal tissues, without adverse effects. Further studies in an animal model of corneal transplant rejection should be performed to determine the potential of this device in the prophylaxis and treatment of corneal transplant rejection in humans.

Absorbable Implants↗
PubMed1997

Histomorphometric analysis of the response of rat tibiae to shape memory alloy (nitinol).

The bone reaction to nitinol (Ni-Ti), a metal with shape memory, and other materials inserted transcortically and extending into the medullary canal of rat tibiae was quantitatively assessed using an image processing system. The materials examined were implants, all of the same shape and size, composed of nitinol, pure titanium (Ti), anodic oxidized Ti (AO-Ti), a titanium alloy (Ti-6Al-4V) and pure nickel (Ni). While the other four implant materials were progressively encapsulated with bone tissues, Ni was encapsulated with connective tissues through the 168-day experimental period, and the Ni implants showed no bone contact at any time during the experimental period. Histometric analysis revealed no significant difference among the tissue reactions to Ti, AO-Ti and Ti-6Al-4V, but Ni-Ti implants showed significantly (P < 0.01) lower percentage bone contact and bone contact area than any of the other titanium or titanium alloy materials.

Alloys↗
PubMed1994

Calcium phosphate precipitation on the surface of HA-G-Ti composite under physiologic conditions.

Hydroxyapatite-glass-titanium (HA-G-Ti) functionally gradient composite plates bound face-to-face by nylon wire were soaked in a simulated body fluid. The gap between the plates was filled with the precipitates after soaking for 6 months, and a tight chemical bond was formed between them. Field emission-type (FE) scanning electron microscopy (SEM) and transmission electron microscopy observations revealed that the growth rate and morphology of the precipitates differed widely from the outside portion to the inside one on the surface region of the composite plates. In the portion relatively near the outside, the mutually bonded portion, needle-like precipitates with preferred orientation to the c-axis were markedly observed. From the results of Fourier transform infrared spectroscopy and energy dispersive x-ray microanalysis, it was found that the precipitates were Ca-deficient carbonate apatite with low crystallinity. On the other hand, HA-G-Ti composite rods were implanted in the femur of beagle dogs for 3 months. FE-SEM observations demonstrated that needle-like precipitates were deposited on both the surfaces of the composite and bone at the portion having a narrow gap, about 0.1-0.2 mm between them prepared deliberately before implantation. It was found that both the morphologies and the composition of the precipitates in vivo were similar to those in vitro. It is concluded that the HA particles on the surface of the composite act as nucleation sites for precipitation in physiologic environments, whereas the glass matrix is independent to it.

Animals↗
PubMed2002

Biocompatibility and performance of the Wallstent and the Wallgraft, Jostent, and Hemobahn stent-grafts in a sheep model.

PURPOSE: Three recently developed stent-grafts and the Wallstent were compared directly in an ovine animal model with regard to performance and biocompatibility. MATERIALS AND METHODS: Three stent-grafts, the Hemobahn (polytetrafluoroethylene [ePTFE]/nitinol), Wallgraft (polyester/Ni-Co-Ti-steel alloy), and Jostent peripheral stent-graft (balloon-expandable ePTFE/stainless steel), and the Wallstent (Ni-Co-Ti-steel alloy), were implanted in sheep iliac arteries (one type of each stent or stent-graft per animal, n = 8). Pre- and postimplantation luminal diameters were measured for each prosthesis and implantation site. Angiography, intravascular ultrasonography (IVUS), and histomorphometric, histologic, and scanning electron microscopic analyses were performed at 3 months. RESULTS: Early lumen gain, late lumen loss, and patent vessel diameter at angiography were not significantly different. Two stent-grafts had significantly more neointima formation (Hemobahn, 9.88 mm(2) +/- 0.94; Wallgraft, 14.98 mm(2) +/- 0.90) than the other stent-graft (Jostent, 6.52 mm(2) +/- 0.46) and the Wallstent (5.24 mm(2) +/- 0.62; P <.01). Patent lumen area was not significantly different (Hemobahn, 42.57 mm(2) +/- 1.41; Jostent, 39.76 mm(2) +/- 2.04; Wallgraft, 40.22 mm(2) +/- 1.04; Wallstent, 41.64 mm(2) +/- 1.59; P =.57). The Hemobahn had significantly more inflammatory reaction (inflammation score of 0.83 +/- 0.03) than the Jostent (0.58 +/- 0.03), Wallgraft (0.55 +/- 0.04), or Wallstent (0.16 +/- 0.01). Angiography and IVUS demonstrated absence of anastomotic neointima formation. Endothelialization was incomplete and immature for all prostheses. CONCLUSIONS: The stent-grafts caused a greater degree of neointima formation and inflammatory vessel wall reaction than the bare stent. However, these changes did not interfere with patent lumen areas and occurred in the absence of excessive anastomotic neointima formation.

Alloys↗
PubMed1988

A histological evaluation of a functional endosseous, porous-surfaced, titanium alloy dental implant system in the dog.

We have previously reported the clinical and radiographic findings of a trial in dogs of a new dental implant system after a functional period of eight months. The present report consists of the corresponding qualitative and quantitative histological data. The implant system was fabricated from Ti-6A1-4V and employed a porous-surfaced configuration to achieve implant fixation by bone ingrowth. A similar porous surface was used on the apical 1/3 of the transgingival collar in an attempt to gain ingrowth and attachment of gingival connective tissue. The qualitative histological data confirmed that while such attachment to the collar did occur for some implants, in the majority of implants (22 of 32) the porous region of the collar became contaminated with bacterial plaque, resulting in implant failure (four implants) or suggesting future implant failure (18 implants). Statistical analyses of the quantitative histological data indicated that there were no significant differences in surface contact of bone with the middle third of the porous implant surface (CLF) when initial healing interval (four or eight weeks), implant location, or aspect of implant (buccal vs. lingual vs. mesial vs. distal) were compared. However, comparison of the current group of functional implants with an earlier group of similarly implanted non-functional implants indicated that function produced a highly significant increase in CLF.

Alloys↗
PubMed1992

A simulator study of friction in total replacement hip joints.

Frictional behaviour of 22 different femoral head-acetabular cup combinations was studied on a new servo-hydraulic microcomputer-controlled hip joint simulator using various flexion-extension angle and superior-inferior load set value waveforms and using distilled water at 37 +/- 1 degrees C as lubricant. Six different head materials were included in the study, whereas all cups were ultra-high molecular weight polyethylene (UHMWPE). Most head-cup combinations studied are commercially available. No distinctly superior joint design can be pointed out, but the frictional behaviour of alumina ceramic against UHMWPE proved overall most favourable (mu min was 0.02), whereas that of non-ion-implanted titanium alloy Ti-6Al-4V against UHMWPE proved strikingly poor (mu max was 0.15). The lowest frictional torque was in 22 mm joints, but frictional torque did not always increase straightforwardly with increasing diameter of the femoral head. The measurements form an extensive comparison between a wide variety of head-cup combinations. The simulator is apparently a useful instrument in the study of frictional behaviour of new designs, materials, surface treatments and coatings that are frequently introduced.

Friction↗