A physical vapor deposition method for controlled evaluation of biological response to biomaterial chemistry and topography.

The purpose of this study was to characterize a technique to effectively mask surface chemistry without modifying surface topography. A thin layer of titanium was deposited by physical vapor deposition (PVD) onto different biomaterial surfaces. Commercially pure titanium disks were equally divided into three groups. Disks were either polished to a mirror finish, grit blasted with alumina particles, or grit blasted and subsequently plasma sprayed with a commercial grade of hydroxyapatite (HA). A subgroup of each of these treatment types was further treated by masking the entire disk surface with a thin layer of commercially pure titanium deposited by PVD. A comparison of surface topography and chemical composition was carried out between disks within each treatment group. Canine marrow cells were seeded on all disk surfaces to determine the stability of the PVD Ti mask under culture conditions. The PVD process did not significantly alter the surface topography of any samples. The thin titanium layer completely masked the underlying chemistry of the plasma sprayed HA surface and the chemistry of the plasma vapor deposited titanium layer did not differ from that of the commercially pure titanium disks. Aliquots obtained from the media during culture did not indicate any significant differences in Ti concentration amongst the Ti and Ti-masked surfaces. The PVD application of a Ti layer on HA coatings formed a stable, durable, and homogenous layer that effectively masked the underlying surface chemistry without altering the surface topography.

Effect of microstructure on the dry sliding friction behavior of CoCrMo alloys used in metal-on-metal hip implants.

The microstructure and its effect on the friction behavior of a medical grade wrought cobalt-chromium-molybdenum (CoCrMo) alloy for surgical implants were studied in this work. In particular, the effects of compression and carbon (C) content on the above characteristics were analyzed. Increasing amounts of deformation resulted in a decrease in the number of annealing twins in the microstructures. In addition, there was an increase in the volume fraction of the hexagonal closed-packed (HCP) phase due to a strain-induced transformation (SIT) from the metastable face-centered cubic (FCC) phase. The high C (HC) alloy had a lower volume fraction of this SIT phase. Friction studies conducted on these alloys revealed a higher coefficient of friction for the HC alloy and no significant effect of SIT on the friction characteristics.

The effect of microstructure on the wear of cobalt-based alloys used in metal-on-metal hip implants.

The influence of microstructure on the wear of cobalt-based alloys used in metal-on-metal hip implants was investigated in a boundary lubrication regime designed to represent the conditions that occurred some of the time in vivo. These cobalt-chromium-molybdenum alloys were either wrought, with a total carbon content of 0.05 or 0.23 wt %, cast with a solution-annealing procedure or simply as-cast but not solution annealed. Bars of these different alloy grades were subjected to various heat treatments to develop different microstructures. The wear was evaluated in a linear-tracking reciprocating pin-on-plate apparatus with a 25 per cent bovine serum lubricant. The wear was found to be strongly affected by the dissolved carbon content of the alloys and mostly independent of grain size or the carbide characteristics. The increased carbon in solid solution caused reductions in volumetric wear because carbon helped to stabilize a face-centred cubic crystal structure, thus limiting the amount of strain-induced transformation to a hexagonal close-packed crystal structure. Based on the observed surface twining in and around the contact zone and the potentially detrimental effect of the hexagonal close-packed phase, it was postulated that the wear of cobalt-based alloys in the present study was controlled by a deformation mechanism.

Wear particles from metal-on-metal total hip replacements: effects of implant design and implantation time.

Detailed characterization of wear particles is necessary to understand better the implant wear mechanisms and the periprosthetic tissue response. The purposes of the present study were to compare particle characteristics of current with older designs of metal-on-metal (MM) total hip replacements (THRs), and to determine the effect of implantation time on wear particle characteristics. Metal wear particles isolated from periprosthetic tissues from 19 patients with MM THRs of current and older designs and at different implantation times (very short, longer, and very long) were studied using transmission electron microscopy and energy dispersive X-ray analysis. The particles from the current design implants with implantation times of not more than 15 months (very short-term) were almost exclusively round to oval chromium oxide particles. In all other cases, although the predominance was still round to oval chromium oxide particles, greater proportions of cobalt-chromium-molybdenum (Co-Cr-Mo) particles, mainly needle-shaped, were detected. Very long-term THRs implanted for more than 20 years had the highest percentage of needle-shaped Co-Cr-Mo particles. Particle lengths were not markedly different between the different designs and implantation times except for the current design implants of not more than 15 months, which had a significantly smaller mean length of 39 nm. In conclusion, the implant design did not seem to have a significant influence on particle characteristics whereas the implantation time appeared to have the most effect on the particles. It should be noted that, because of the limited number of tissue retrievals available, some uncertainty remains regarding the generality of these findings.

Zoledronic acid causes enhancement of bone growth into porous implants.

The effect of zoledronic acid on bone ingrowth was examined in an animal model in which porous tantalum implants were placed bilaterally within the ulnae of seven dogs. Zoledronic acid in saline was administered via a single post-operative intravenous injection at a dose of 0.1 mg/kg. The ulnae were harvested six weeks after surgery. Undecalcified transverse histological sections of the implant-bone interfaces were imaged with backscattered scanning electron microscopy and the percentage of available pore space that was filled with new bone was calculated. The mean extent of bone ingrowth was 6.6% for the control implants and 12.2% for the zoledronic acid-treated implants, an absolute difference of 5.6% (95% confidence interval, 1.2 to 10.1) and a relative difference of 85% which was statistically significant. Individual islands of new bone formation within the implant pores were similar in number in both groups but were 69% larger in the zoledronic acid-treated group. The bisphosphonate zoledronic acid should be further investigated for use in accelerating or enhancing the biological fixation of implants to bone.

The porous-surfaced electrode: a new concept in pacemaker lead design.

Three major problems which may be encountered with endocardial pacemaker electrodes are a lack of stable position, a chronic increase in stimulation threshold, and a diminishing magnitude of the sensed endocardial signal. These problems are particularly manifest in the atrium. Having previously shown that porous metal surfaces can support stable tissue ingrowth in both bloodstream and soft tissue environments, we set out todetermine the performance of porous-surfaced endocardial pacing electrodes in the atrial position. In two groups of six dogs each, J-shaped atrial leads with Elgiloy electrode tips (2.3 mm. in diameter, 2.3 mm. in length), having either conventional smooth surfaces (control) or porous surfaces (20 to 50 micron particle size) produced by powder metallurgy techniques, were positioned in the right atrial a-pendage. Stimulation thresholds and P-wave amplitude were repeatedly measured until the dogs were put to death 30 w-eks following implantation. The presence or absence of electrode fixation was observed and the atrial tissue reaction was examined grossly and by both light and scanning electron microscopy (SEM). The porous-surfaced electrodes demonstrated superior long-term stimulation thresholds which, at 30 weeks, averaged less then one third of those in the control group. In addition, the porous group showed a small but significant improvement in the amplitude of the sensed P wave. None of the smooth-surfaced electrodes showed fixation, and the tissue reaction consisted of a thick layer of granulation and fibrous tissue on the underlying endocardium, widely separating the electrode from the myocardium. In contrast, all of the porous-surfaced electrodes were fexed to the endocardium by fibrous tissue ingrowth into the surface pores. This tissue fixation of the electrode tip in close proximity to underlying myocytes explains their superior performance.

Enhancement of bone growth into porous intramedullary implants using non-invasive low intensity ultrasound.

An in vivo study was designed to determine if non-invasive low intensity ultrasound could enhance bone growth into porous intramedullary implants. Fully porous intramedullary rods were implanted bilaterally into the ulnae of six dogs. In each dog, one ulna served as a control and the other was treated with 20 min of daily ultrasound stimulation for 6 consecutive weeks. Analysis of serial transverse sections indicated an average of 119% more bone growth into the ultrasound-treated implants compared with the contralateral controls (P < 0.001). In each of the 6 dogs, there was a significantly greater amount of bone ingrowth on the ultrasound-stimulated side. These data indicate a clear potential for externally applied ultrasound therapy to augment biological fixation.

Effect of noninvasive low intensity ultrasound on bone growth into porous-coated implants.

Noninvasive low intensity ultrasound has been shown to be an effective means of accelerating bone fracture healing in both animal and clinical studies. An in vivo canine study was designed to determine if noninvasive low intensity ultrasound could influence the rate and extent of bone growth into porous-coated implants. Twenty-two pairs of fully porous transcortical implants were inserted bilaterally into the femora of 12 dogs. In each dog, one femur served as a control and the other was subjected to daily ultrasound stimulation for 2, 3, or 4 weeks. Overall, the ultrasound-stimulated implants demonstrated an 18% increase in bone ingrowth compared with their contralateral controls (p = 0.02). Noninvasive low intensity ultrasound had its greatest effect in the first 2-3 weeks of stimulation. At 2 and 3 weeks, the ultrasound-stimulated implants showed 21 and 16% more ingrowth than their respective contralateral controls. Because noninvasive low intensity ultrasound had a positive effect on bone ingrowth in this experimental investigation, further research is suggested to assess the clinical potential for application to noncemented porous-coated total joint replacements.

The effect of proximally and fully porous-coated canine hip stem design on bone modeling.

Porous coated canine femoral hip replacement implants were evaluated for biological fixation by bone ingrowth and the effect of the extent of porous coating on bone modeling. The Co-Cr alloy implants were either fully porous coated or coated only on the proximal 40% of the stem. Two implants of each type were studied 9, 16, and 36 months after surgery. Implant fixation and bone modeling were assessed radiographically throughout the implant periods and histologically after the test animals were killed. All 12 implants appeared stably fixed within the femur and were bone-ingrown in the porous region. Radiographic features such as proximal medial and anterior cortical thinning, proximal cancellous bone hypertrophy, and new endosteal bone formation near the stem tip were noted within the first postoperative year, with no appreciable change thereafter. The extent of proximal cortical thinning varied from virtually none to as much as 40%, being more prominent with the proximally coated implants at 16 months and with the fully coated implants at 36 months. Of consistent note was cancellous hypertrophy at the junction of porous and smooth implant surfaces with proximally coated implants and new endosteal bone formation and ingrowth at the stem tip of fully coated implants. These results indicate that the proximally porous-coated implant design causes increased proximal stress transfer, but this does not necessarily preclude proximal cortical resorption.

A quantitative evaluation of periprosthetic bone-remodeling after cementless total hip arthroplasty.

Dual-energy x-ray absorptiometry analysis was used to determine the periprosthetic bone-mineral content of ten femora that had been obtained at the autopsies of five elderly patients who had had an AML (anatomic medullary locking) prosthesis in situ for seventeen to eighty-four months. Clinical radiographs showed resorptive remodeling changes characteristic of femora containing this implant. Before the absorptiometry was performed, an identical prosthesis had been inserted into the contralateral, normal femur of each cadaver. The mean difference in the periprosthetic bone-mineral content between the remodeled femora and the femora in which the prosthesis had been implanted post mortem ranged from 7 to 52 per cent, with the bone-mineral content always less in the remodeled femora. The greatest mean decrease in bone-mineral content (45 per cent) occurred adjacent to the proximal one-third of the remodeled femora. The percentage decrease in periprosthetic bone-mineral content in the remodeled femora had an inverse linear relationship with the corresponding bone-mineral content of the contralateral control femora. Preoperative analysis of bone density may therefore be useful for prediction of the extent of resorptive bone-remodeling after total hip replacement.

Fatigue fracture of a forged cobalt-chromium-molybdenum femoral component inserted with cement. A report of ten cases.

Ten patients who had had a total hip replacement with a forged cobalt-chromium-molybdenum femoral prosthesis (Precoat or Precoat Plus) inserted with cement were seen with a fatigue fracture of the stem an average of fifty months (range, nineteen to seventy-four months) postoperatively. The average age of the patients was sixty-one years (range, forty-three to seventy-three years), and the average weight was ninety-six kilograms (range, seventy to 130 kilograms). Eight patients had had a primary total hip replacement, and two had had a revision; all of the acetabular components had been inserted without cement. Radiographs that had been made before the fracture were available for four of the eight hips that had had a primary replacement; all four had radiographic evidence of debonding of the cement mantle from the proximal end of the stem. This probably caused exaggerated cantilever bending stresses on the proximal aspect of the stem as the distal end of the stem was well fixed. The radiographs of both hips that had had a revision demonstrated a non-union of the greater trochanter, which had resulted in separation at the cement-bone interface at the proximal portion of the femur before the fracture. Scanning electron micrographs of five of the ten fractured prostheses demonstrated a fatigue fracture that began near the anterolateral corner of the prosthesis, through characters that had been etched on the implant with a laser. Metallurgical analysis indicated subsurface voids or inclusions, or both, immediately under the region that had been etched. This finding is consistent with thermal changes to the microstructure of the alloy that probably caused a focal reduction in the material strength. A high proportion (seven) of the ten stems had a poor cement mantle. Also, of the seven small stems that were used, six had been implanted in patients who weighed more than eighty kilograms, so there was relative undersizing of the prostheses. Early debonding of the proximal end of a Precoat femoral prosthesis from the cement mantle may occur as a result of a thin cement mantle, leading to loosening and possibly to early fatigue fracture of the stem if the distal portion of the stem remains solidly fixed in the distal portion of the cement column. On the basis of our experience, we recommend that patients who have radiographic evidence of a debonded Precoat femoral component should be informed of the risk of fatigue fracture of the stem and be followed closely even though there may be no symptoms of loosening of the femoral component.

Evaluation of bone ingrowth in proximally and extensively porous-coated anatomic medullary locking prostheses retrieved at autopsy.

Three proximally (40 per cent) and five extensively (80 per cent) porous-coated anatomic medullary locking femoral components were retrieved from seven cadavera at autopsy. Each component (with the surrounding, intact femur), was sectioned transversely at one-centimeter intervals. Backscattered scanning electron microscopy was used to evaluate circumferentially the interface between the bone and the porous surface of each section. Bone ingrowth was considered to be present within a field when bone was in contact with the outermost layer of the sintered beads, it was detected within the porous space, and it had penetrated the porous space to a depth of at least one bead diameter. All eight components had some bone growth into the porous space. A mean of 35 per cent of the surface of the implants had bone ingrowth. In the areas where bone was present, 67 per cent of the available porous space on the extensively coated stems and 74 per cent on the proximally coated stems contained bone. With both types of implants, the greatest amount of compact bone ingrowth was found at the level where the porous coating ended. Transverse sections obtained at this level frequently demonstrated that bone ingrowth had occurred circumferentially and that the ingrowth was continuous with and an integral part of the femoral cortex. These direct connections to the cortex could be predicted from the appearance of the radiographs. In the most proximal transverse sections of both types of implants, bone was most frequently connected to the medial side and corners of the implant.(ABSTRACT TRUNCATED AT 250 WORDS)

Effect of flexibility of the femoral stem on bone-remodeling and fixation of the stem in a canine total hip arthroplasty model without cement.

The purpose of this study was to compare, with regard to fixation of the implant and femoral bone resorption, two fully porous-coated stems of different stiffnesses in a canine total hip arthroplasty model. A bilateral arthroplasty was carried out with insertion of a titanium-alloy stem (which had stiffness properties comparable with those of the canine femur) on one side and with insertion of a composite stem (which was three to fivefold more flexible than the canine femur) on the contralateral side. Eight femora were evaluated at six months and eight, at eighteen months after the operation, to determine the extent of bone ingrowth, periprosthetic cortical area, intracortical porosity, and bone-remodeling. Despite the markedly greater flexibility of the composite stems, no significant difference could be detected (with the numbers available), with regard to the overall degree of femoral stress-shielding, cortical area, or cortical porosity, between these stems and the stiffer, titanium-alloy stems at either time-period. However, the composite stems had less bone ingrowth and more formation of radiopaque lines than did the titanium-alloy stems. At eighteen months, the values for bone ingrowth were 9.7 +/- 5.38 percent (mean and standard deviation) for the composite stems compared with 28.1 +/- 5.31 percent for the titanium-alloy stems (p = 0.003). Furthermore, the histological sections from the femora containing a composite stem showed radiopaque lines indicative of fibrous ingrowth approximately threefold more often than did those from the femora containing a titanium-alloy stem (p = 0.02).

Porous-coated hip replacement. The factors governing bone ingrowth, stress shielding, and clinical results.

Total hip replacement using porous-coated cobalt-chrome femoral implants designed for biological fixation has been evaluated in 307 patients after two years and in 89 patients after five years. Histological study of 11 retrieved specimens showed bone ingrowth in nine and fibrous tissue fixation in two. Fixation by bone ingrowth occurred in 93% of the cases in which a press fit of the stem at the isthmus was achieved, but in only 69% of those without a press fit. The clinical results at two years were excellent. The incidence of pain and limp was much lower when there was either a press fit of the stem or radiographic evidence of bone ingrowth. Factors such as age, sex, and the disease process did not influence the clinical results. Most cases showed only slight resorptive remodelling of the upper femur, but in a few cases with a larger, more rigid stem, more extensive bone loss occurred. The results after five years showed no deterioration with time. Fixation by the ingrowth of bone or of fibrous tissue both appeared to be stable, but bone ingrowth gave better clinical results.

Radiography and histology of a threaded acetabular implant. One case studied at two years.

Threaded acetabular components are widely used in cementless total hip replacement, despite a poor understanding of the nature of the bone-implant interface. We have examined one case in which the threaded titanium ring appeared to be well incorporated with no discernible radiolucency. Microradiography and histology surprisingly showed that the threads were entirely encapsulated in fibrous tissue. This raises doubt about the relevance of plain radiography to the analysis of the acetabular interface.

Characteristics of bone ingrowth and interface mechanics of a new porous tantalum biomaterial.

We have studied the characteristics of bone ingrowth of a new porous tantalum biomaterial in a simple transcortical canine model using cylindrical implants 5 x 10 mm in size. The material was 75% to 80% porous by volume and had a repeating arrangement of slender interconnecting struts which formed a regular array of dodecahedron-shaped pores. We performed histological studies on two types of material, one with a smaller pore size averaging 430 microm at 4, 16 and 52 weeks and the other with a larger pore size averaging 650 microm at 2, 3, 4, 16 and 52 weeks. Mechanical push-out tests at 4 and 16 weeks were used to assess the shear strength of the bone-implant interface on implants of the smaller pore size. The extent of filling of the pores of the tantalum material with new bone increased from 13% at two weeks to between 42% and 53% at four weeks. By 16 and 52 weeks the average extent of bone ingrowth ranged from 63% to 80%. The tissue response to the small and large pore sizes was similar, with regions of contact between bone and implant increasing with time and with evidence of Haversian remodelling within the pores at later periods. Mechanical tests at four weeks indicated a minimum shear fixation strength of 18.5 MPa, substantially higher than has been obtained with other porous materials with less volumetric porosity. This porous tantalum biomaterial has desirable characteristics for bone ingrowth; further studies are warranted to ascertain its potential for clinical reconstructive orthopaedics.

Acid-etched microtexture for enhancement of bone growth into porous-coated implants.

We designed an in vivo study to determine if the superimposition of a microtexture on the surface of sintered titanium beads affected the extent of bone ingrowth. Cylindrical titanium intramedullary implants were coated with titanium beads to form a porous finish using commercial sintering techniques. A control group of implants was left in the as-sintered condition. The test group was etched in a boiling acidic solution to create an irregular surface over the entire porous coating. Six experimental dogs underwent simultaneous bilateral femoral intramedullary implantation of a control implant and an acid etched implant. At 12 weeks, the implants were harvested in situ and the femora processed for undecalcified, histological examination. Eight transverse serial sections for each implant were analysed by backscattered electron microscopy and the extent of bone ingrowth was quantified by computer-aided image analysis. The extent of bone ingrowth into the control implants was 15.8% while the extent of bone ingrowth into the etched implants was 25.3%, a difference of 60% that was statistically significant. These results are consistent with other research that documents the positive effect of microtextured surfaces on bone formation at an implant surface. The acid etching process developed for this study represents a simple method for enhancing the potential of commonly available porous coatings for biological fixation.

Biologic fixation arthroplasty in the treatment of osteonecrosis.

To provide a possible solution to the problem of aseptic loosening of prosthetic hip replacement components, the authors treated selected patients who had stage IV, V, or VI osteonecrosis with uncemented, porous-coated components on the femoral side. These stems are designed for bone ingrowth, with the goal of attaining a more viable and permanent interlocking bone between the implant and host bone. This article presents the necessary surgical principles and techniques for biologic fixation arthroplasty and reports the early results that have been obtained.

Principles, techniques, results, and complications with a porous-coated sintered metal system.

Experience with biologic fixation hip arthroplasty using the powder-made sintered porous system has been very encouraging over the past 8 years. With simple implant design, accurate instrumentation, and careful attention to surgical technique, the results of surgery can be made equal to those obtained with conventional cemented arthroplasty (using the current improved implant designs and cementing techniques). Most of the problems associated with this new technology have been recognized and solved. The most serious problem is probably that of stress shielding and disuse osteoporosis, and this may well be overcome through judicious design modification. It is the next decade that will determine whether the incidence of late aseptic loosening is reduced through design for a "living" interface between implant and bone.

Kinematics of the MATCO hip simulator and issues related to wear testing of metal-metal implants.

Metal-metal hip implants have been used clinically in Europe to reduce the risk of wear particle induced osteolysis. Joint simulator devices could provide useful information for design improvement of the modern generation of metal-metal hip implants. Early wear results for metal-metal hip specimens were obtained using a MATCO hip simulator. A detailed kinematic analysis was developed for the MATCO simulator and applied to two of the wear experiments to predict the starting surface motion, contact zone and lubricant film thickness. It was shown that points on cup surfaces were not subjected to a reciprocating interaction with the head during wear at the beginning of testing but as wear proceeded, it was suggested that, in some cases, reciprocating interaction did occur on the cup surface. Comparison between simulator and in vivo kinematics suggested a more realistic representation for cup than for head wear. In the simulator, the Hertzian contact zone moved in a circular path over the cup surface and changed in size in correspondence with the applied load. Elastohydrodynamic lubrication was considered to be possible in the simulator, with estimated fluid film thickness as great as 0.1 micron. However, such thick films were not likely to have occurred at the start of the two wear tests which were examined in detail, although some mixed film lubrication might have accounted for the relatively low wear of one of the specimens. The inclusion of kinematic details, contact mechanics and elastohydrodynamic lubrication analysis in simulator testing protocols and in design of metal metal hip implants was recommended.