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In-vivo comparisons of clot formation on titanium and hydroxyapatite-coated titanium.

We investigated in vivo clot formation on the surface of hydroxyapatite (HA)-coated titanium (Ti) implants and on non-coated Ti implants. Immediately after tooth extraction implant samples were inserted into the blood clot, in the same extraction site, for 1, 30, 60, or 120 seconds. Samples were processed for scanning electron microscopy (SEM). Qualitative observations of clotting topography were made by direct SEM viewing. Neither of the implant surfaces appeared to differ markedly in the degree of clotting during the 120 seconds of implantation; they revealed very early clot formation and limited clot attachment. These results were compared to the findings obtained in a previous study using identical methods with an intact periodontal ligament (PDL), root planed roots, and roots planed and treated with pH 1 citric acid. The PDL surface had the most rapid clot formation at all time periods. By 120 seconds, all root surfaces had completed clot formation.

Alloys

Proteomic insights into the immunomodulatory effects of Ca/Sr co-doped sol-gel coatings for titanium implants.

Ionic functionalization of biomaterial coatings has emerged as a powerful strategy to regulate early host responses at the implant interface. However, how combined Ca/Sr incorporation governs the adsorbed proteome and downstream immune signaling remains poorly understood. This study analyses, employing in vitro tests and proteomics, the effect of adding Sr and Ca to Si-based coatings designed to bioactivate Ti implants. Hybrid Si-based coatings were synthesized by the sol-gel route with a fixed Ca content (0.5 wt%) and increasing Sr contents (0.5, 1.0, 1.5 wt%), and their physicochemical properties, ion release kinetics, and hydrolytic stability were characterized. The coatings remained highly crosslinked despite Ca/Sr incorporation, whereas the highest Sr content increased hydrolytic degradation to around 70% after 56 days. Proteomic analysis identified 183 adsorbed proteins, of which 56 were differentially adsorbed on Ca/Sr-coatings, mainly associated with immune and coagulation pathways. In vitro, RAW 264.7 showed increased gene expression of TNF-α and TGF-β; with an enhanced TNF-α secretion by the addition of Ca and Sr. In parallel, MC3T3-E1 indicated that Ca/Sr-coatings were not cytotoxic and did not impair cell proliferation. However, ALP activity was reduced in the co-doped groups, indicating that the immunomodulatory effects induced by Ca/Sr incorporation were not accompanied by enhanced early osteogenic differentiation. The Ca/Sr combination induced alterations in the adsorption of immune-related proteins, which correlated with the in vitro findings. The deeper insight into how Ca/Sr mixtures modulate protein adsorption on biomaterial surfaces may be key to understanding the immunomodulatory capacity of these bioactive cations.

Animals

Tissue ingrowth into titanium and hydroxyapatite-coated implants during stable and unstable mechanical conditions.

Lack of initial mechanical stability of cementless prostheses may be responsible for fibrous tissue fixation of prosthetic components to bone. To study the influence of micromovements on bony ingrowth into titanium alloy (Ti) and hydroxyapatite (HA)-coated implants, a loaded unstable device producing movements of 500 microns during each gait cycle was developed. Mechanically stable implants served as controls. The implants were inserted into the weight-bearing regions of all four femoral condyles in each of seven mature dogs. Histological analysis after 4 weeks of implantation showed a fibrous tissue membrane surrounding both Ti and HA-coated implants subjected to micromovements, whereas variable amounts of bony ingrowth were obtained in mechanically stable implants. The pushout test showed that the shear strength of unstable Ti and HA implants was significantly reduced as compared with the corresponding mechanically stable implants (p less than 0.01). However, shear strength values of unstable HA-coated implants were significantly greater than those of unstable Ti implants (p less than 0.01) and comparable to those of stable Ti implants. The greatest shear strength was obtained with stable HA-coated implants, which was threefold stronger as compared with the stable Ti implants (p less than 0.001). Quantitative determination of bony ingrowth agreed with the mechanical test except for the stronger anchorage of unstable HA implants as compared with unstable Ti implants, where no difference in bony ingrowth was found. Unstable HA-coated implants were surrounded by a fibrous membrane containing islands of fibrocartilage with higher collagen concentration, whereas fibrous connective tissue with lower collagen concentration was predominant around unstable Ti implants. In conclusion, micromovements between bone and implant inhibited bony ingrowth and led to the development of a fibrous membrane. The presence of fibrocartilage and a higher collagen concentration in the fibrous membrane may be responsible for the increased shear strength of unstable HA implants. Mechanically stable implants with HA coating had the strongest anchorage and the greatest amount of bony ingrowth.

Analysis of Variance

Luteal function and reproductive response in suckled beef cows after metestrus administration of a norgestomet implant and injection of estradiol valerate with various dosages of injectable norgestomet.

In an experiment replicated over 2 yr, 149 suckled beef cows were administered Syncro-Mate-B (SMB), a 6-mg Norgestomet (NOR) ear implant (in situ 9 d) in conjunction with an i.m. injection of 5 mg of estradiol valerate (EV), and either 3.0, 4.5, or 6.0 mg of NOR, 2 d after estrus. All cows were artificially inseminated at 48 h (timed insemination; TI) after implant removal (IR) and cows were reinseminated at any estrus subsequent to 24 h of TI through 30 d. Blood samples collected before treatment, every 3 d through IR, and at TI were assayed for progesterone (P4). At TI, 44, 39, and 12% of cows treated with 3.0, 4.5, or 6.0 mg of NOR, respectively, had serum concentrations of P4 greater than 1 ng/mL (3.0 and 4.5 mg vs 6.0 mg, P less than .01). Fifty-eight, 63, and 84% of cows treated with 3.0, 4.5, or 6.0 mg of NOR, respectively, exhibited a synchronized (within 5 d of IR) estrus (3.0 and 4.5 mg vs 6.0 mg, P less than .05). Pregnancy rates for the 5-d synchronized period were 38, 45, and 66% for cows treated with 3.0, 4.5, or 6.0 mg of NOR, respectively (3.0 and 4.5 mg vs 6.0 mg, P less than .05). First-service pregnancy rates were 66, 71, and 79% for cows treated with 3.0, 4.5, or 6.0 mg of NOR, respectively (P greater than .10).(ABSTRACT TRUNCATED AT 250 WORDS)

Animals

Reduced corrosion of CP Ti and Ti-6A1-4V alloy endosseous dental implants after glow-discharge treatment: a preliminary report.

Inductively coupled argon plasma spectroscopic analysis was used to quantify titanium, aluminum, and vanadium corrosion products released by superficial layers of identically shaped commercially pure titanium and Ti-6A1-4V alloy dental implants. Halves of each of two originally sterile groups were analyzed directly from the manufacturer's packaging and the other halves received glow-discharge treatment prior to their corrosion assay. The implants were incubated in pH 3 modified saline solution and were analyzed after 2- and 12-week corrosion periods. Implants treated with glow discharge showed statistically significant reduction in the amounts of corrosion products released, apparently as a result of glow-discharge-produced surface oxides of greater passivity than originally present.

Aluminum

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

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

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

Joint replacement components made of hot-forged and surface-treated Ti-6Al-7Nb alloy.

We have developed a titanium-aluminium alloy with the inert alloying element niobium. The optimal composition was found to be Ti-6Al-7Nb (Protasul-100). This custom-made alloy designed for implants shows the same alpha/beta structure as Ti-6Al-4V and exhibits equally good mechanical properties. The corrosion resistance of Ti-6Al-7Nb in sodium chloride solution is equivalent to that of pure titanium and Ti-6Al-4V. This is due to a very dense and stable passive layer. Highly stressed anchorage stems of different hip prosthesis designs have been made from hot-forged Ti-6Al-7Nb. The polished surfaces of hip, knee and wrist joints made of Ti-6Al-7Nb and articulating against polyethylene are surface-treated by means of a very hard and 3-5 microns thick titanium nitride coating (Tribosul-TiN) or by oxygen diffusion hardening (Tribosul-ODH) to a depth of 30 microns.

Humans

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

Mechanical failure of hydroxyapatite- and polysulfone-coated titanium rods in a weight-bearing canine model.

Three types of material that have shown potential as coatings for orthopaedic implants were studied. Using a weight-bearing canine model, Ti-6A1-4V femoral intramedullary rods coated with (1) sintered titanium beads, (2) plasma-sprayed hydroxyapatite, and (3) silyl coupled polysulfone beads were evaluated for mechanical strength and bone ingrowth. The model was designed to secure optimal prosthetic stability by obtaining maximal bony ingrowth during an initial non-weight-bearing phase, then stressing the implant during a full-weight-bearing phase. None of the rods coated with titanium beads failed. All 17 polysulfone-coated rods failed, 13 of them at the interface between the polysulfone coating and the titanium core. Of 18 rods coated with hydroxyapatite, 15 suffered implant breakdown at the interface between the hydroxyapatite coating and the titanium core. This may be due to dissolution of the plasma-sprayed hydroxyapatite in vivo. Testing of retrieved specimens from both hydroxyapatite- and polysulfone-coated implants showed that the shear strength at the coating-rod interface had decreased to less than 40% of the shear strength at manufacture. Despite mechanical failure, histologic study showed extensive bone ingrowth or apposition onto both the polysulfone and hydroxyapatite coatings.

Animals

A new thermal shape memory Ti-Ni alloy stent covered with silicone.

An attempt was made to develop an airway stent for nonsurgical transluminal implantation using a bronchofiberscope. The stent is composed of a single wire with a diameter of 0.5 mm. The wire is made of thermal shape memory titanium nickel alloy, with a transition temperature of 25-30 degrees C. To avoid direct contact between the metal and the tissue, the wire is covered with a 300 microns thick coating of silicone. The stent is horseshoe shaped in cross-section. It is 15 mm in outer transverse diameter and 40 mm long. Ten stents were implanted in 10 dogs whose tracheal cartilages had been previously broken. The stents were first cooled in ice water to reduce their diameter and then inserted into the target site. The wire was warmed to body temperature and recovered its initial shape within 10 sec. The dogs were killed for examination between 1 week and 6 months after implantation. All the stents were located at the implantation sites and were patent. Tissue reactions, such as ulceration and granulation formation, were less severe than in those with previously implanted non-silicone covered stents. Microscopic observation showed that the wires became gradually covered with epithelium within 2 months. This transluminal technique for preserving airway patency shows promise for clinical application.

Alloys

New prospects for a prolonged functional life-span of artificial hip joints by using the material combination polyethylene/aluminium oxide ceramin/metal.

Investigations over the years have shown that the mirror-finished Al2O3 ceramic is a much more suitable frictional counterpart to ultrahigh molecular weight (UHMW) polyethylene than metal. Despite the extremely gread hardness difference between polyethylene and Al2O3 ceramic, a considerable lower wear rate is obtained for the polyethylene socked with this new low-friction material combination. The unexpectedly favorable tribological behavior of this ceramic material in contact with polyethylene may be attributed to the following factors: better values for corrosion resistance characteristics, wettability with liquids, surfact gloss, hardness, and scratch resistance of the ceramic material in comparison with those of the hitherto used metallic implant materials (AISI-316L steel or cast Co-Cr-Mo alloy). It appears that, by using this new combination of materials for the socket and the ball, it will be possible to prolong the service life of artificial hip joints considerably without having effecy any fundamental changes in the present design and implantation principle retaining the hitherto used anchorage shaft made of wrought Co-Ni-Cr-Mo-Ti alloy Protasul-10 of extremely high corrosion fatigue strength.

Alloys

Evaluation of couple/crevice corrosion by prosthetic alloys under in vivo conditions.

Alloys of cast Co-Cr-Mo, wrought Co-Cr-W, wrought, Co-Ni-Cr-Mo(MP35N), Ti-60% Al-4% V, and graphite were incorporated in specimens which simulated both a couple and a crevice corrosion condition. These specimens were implanted in a dog for 30 months. Post-sacrifice examination showed no substantial evidence of corrosion activity on the surfaces of the metals except for a tarnish film on the titanium alloy specimens. The presence of the tarnish film is taken as more evidence of corrosion activity and this correlated with a thicker average fibrous membrane, cellular activity in and near the fibrous membrane, and some increased vascularity. These must be regarded as preliminary observations.

Alloys

Successful replacement of the aortic valve, mitral valve and ascending aorta with re-implantation of the coronary arteries.

A 63-year-old man was operated upon with replacement of the aortic valve, mitral valve and ascending aorta with re-implantation of the coronary arteries. A composite graft with a 27 mm Björk-Shiley tilting disc prosthesis was inserted with 3 continuous Prolene sutures in the aortic position. The coronary arteries were thereafter re-implanted in holes made in the graft. A 31 mm Björk-Shiley valve was sutured in the mitral position with about 20 isolated mattress sutures of Ti-Cron. Selective myocardial hypothermia was instituted with Ringer's solution of 4 degrees C. The total perfusion time was 185 min compared with 240 and 275 min in two previously reported, similar cases. We consider that the use of cardioplegia, a composite graft and continuous sutures makes it possible to reduce the operation time in these complex cases. Our patient is in good condition 9 months postoperatively.

Aortic Aneurysm

The influence of chronic cerebellar stimulation on respiratory muscle coordination in a patient with cerebral palsy.

The effect of chronic cerebellar stimulation on respiratory muscle coordination has been evaluated using a relatively simple and objective target breathing test on one patient. Seven normal subjects were used as controls. Magnetometer recordings were used to determine whether abdominal and rib cage expansion were in phase. Subjects were asked to match their breathing frequency to a metronome signal. Their ability to control respiratory timing voluntarily was assessed in terms of the coefficient of variation (CV) of inspiratory time (Ti) and of expiratory time (Te). The CV's of Ti and Te were much greater in the patient in the absence of cerebrellar stimulation than they were in normal subjects. Both at 3 weeks and 6 months after implantation of the stimulator, a significant improvement in the performance of the patient was demonstrable with the stimulator on, although normal values were never achieved. This demonstrable influence of chronic cerebellar stimulation on respiratory muscle coordination has important implications for both the avoidance of respiratory complications and the potential improvement of speech in patients with cerebral palsy.

Adolescent

Potential applications of certain nickel-titanium (nitinol) alloys.

The mechanical behavior ("shape memory") associated with martensitic solid-state transformation in nearly equiatomic Ni-Ti alloy (55-Nitinol) has been studied. Potential dental and medical applications for 55-Nitinol (55% Ni, 1.5% Co, balance Ti, by weight) and for 60-Nitinol (60% Ni, by weight) have been suggested.

Dental Alloys

Exit-site/tunnel infection and catheter outcome in peritoneal dialysis patients.

STUDY OBJECTIVE: To study exit-site/tunnel infections and catheter outcomes in peritoneal dialysis patients. DESIGN: The study was designed to investigate exit-site (ESI)/tunnel infections (TI) and catheter losses in all chronic PD catheters inserted in ESRD patients from 9/88 to 9/91. SETTING: Tertiary-referral university hospital. PATIENTS AND METHODS: Seventy-three patients (40 males, 33 females) underwent 78 double-cuff coiled swan-neck catheter implantations surgically. The curettage of exit site was performed weekly for tunnel infection refractory to medical management. The subcutaneous cuff was excised in persistent ESI/TI. RESULTS: Fifty-nine episodes of ESI/TI in 34 patients were observed over 946 patient-months. Thirty-nine patients experienced no ESI/TI, 27 patients had one and seven had two or more episodes of ESI/TI. Four patients had five episodes of peritonitis associated with ESI/TI. Eight recurrent episodes of ESI/TI with S. aureus in 8 patients were treated successfully with Rifampin. Seven subcutaneous cuffs were excised successfully in 7 patients with tunnel infection, five with S. aureus and two with Pseudomonas aeruginosa. No catheter was removed due to ESI/TI or ESI/TI associated peritonitis. CONCLUSIONS: Aggressive exit site care including repeated curettage, excision of the subcutaneous cuff and appropriate antibiotics reduced significantly catheter losses related to ESI/TI.

Bacterial Infections