Influence of electron beam melting manufactured implants on ingrowth and shear strength in an ovine model

Arthroplasty has evolved with the application of electron beam melting (EBM) in the manufacture of porous mediums for uncemented fixation. Osseointegration of EBM and plasma-sprayed titanium (Ti PS) implant dowels in adult sheep was assessed in graduated cancellous defects and under line-to-line fit in cortical bone. Shear strength and bony ingrowth (EBM) and ongrowth (Ti PS) were assessed after 4 and 12 weeks. Shear strength of EBM exceeded that for Ti PS at 12 weeks (P = .030). Ongrowth achieved by Ti PS in graduated cancellous defects followed a distinctive pattern that correlated to progressively decreasing radial distances between defect and implant, whereas cancellous ingrowth values at 12 weeks for the EBM were not different. Osteoconductive porous structures manufactured using EBM present a viable alternative to traditional surface treatments.     

Bilateral tibial components of different cementless designs and materials. Microradiographic, backscattered imaging, and histologic analysis

Postmortem evaluation was conducted on two cementless knee prostheses considered clinically successful. The two retrieved uncemented porous-coated tibial components of different designs, and materials were evaluated by microradiography, backscattered electron (BSE) imaging, and light microscopy. The right prosthesis, in place for 25 months, was a Porous-Coated Anatomic (PCA) implant with double-layered, sintered, cobalt-chromium alloy beads. The left prosthesis was a Natural-Knee (N-K) implant with a porous coating of cancellous-structured pure titanium implanted for 19 months. A quantitative microradiographic index, the appositional bone index (ABI), was developed to indicate the probability of bone ingrowth occurring into the porous coating. The ABI is a ratio of bone in apposition with porous coating divided by the total amount of porous coating available. The PCA had an average ABI of 9%, and the N-K, 67%. BSE images of the PCA demonstrated no bone within the porous coating. BSE images of the N-K implant showed bone ingrowth into 22% of the pore volume when porous coating was in apposition to host bone. Histology of the PCA revealed fibrous connective tissue throughout the porous coating and between the porous coating-bone interface. Histology of the N-K implant revealed bone ingrowth and osteoblastic activity along the bone within the porous coating.     

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.     

Osseointegration in arthroplasty: can simvastatin promote bone response to implants?

Cementless fixation depends on bone ingrowth for long-term success. Simvastatin as a lipid lowering agent has been demonstrated to have osteoanabolic effects. This study was designed to measure the possible effect of simvastatin on implant osseointegration. Bilateral femoral implantation of titanium cylinders was performed in 20 rabbits. Blood lipid levels were measured pre- and postoperatively. Scanning electron microscopy (SEM) was used to measure the percentage of the surface of each implant in contact with bone and mechanical pull-out testing was performed. The blood lipid levels were significantly reduced in the simvastatin group. Histomorphometric examination revealed increased bone ingrowth and mechanical examination showed increased interface strength in the simvastatin group. Mechanical and histological data showed superior stability and osseous adaptation at the bone/implant interface for the simvastatin group. We conclude that simvastatin has potential as a means of enhancing bone ingrowth, which is a key factor in the longevity of cementless implants.     

Effects of hydroxyapatite tricalcium phosphate coating and intracancellous placement on bone ingrowth in titanium fibermetal implants

The purpose of this study was to compare the host—bone response to hydroxyapatite/tricalcium phosphate (HA/TCP)-coated and noncoated titanium fibermetal implants placed in a load-sharing cancellous bone environment of the distal femurs of rabbits. The influence of implantation site was also investigated by comparing these intracancellous implants with intramedullary implants evaluated in a previous study. Three parameters were measured: percentage implant perimeter surface length in contact with new bone, percentage internal fibermetal surface length in contact with ingrown bone, and percentage of available pore space filled with bone. The HA/TCP coating significantly accelerated and increased bone ongrowth, new bone formation on the perimeter and internal surface of the implants. This effect was evident as early as 2 weeks after implantation. In contrast, there was no difference between HA/TCP-coated and noncoated implants in the bone ingrowth parameter, percentage of available pore space filled with bone, or pull-out strength. Scanning electron microscopy in the backscatter mode demonstrated that new bone formed directly onto the HA/TCP-coated fibers and did not usually form directly on noncoated fibers. Analysis of fluorochrome labeling revealed that bone formation in weeks 1 through 4 was primarily woven and there-after lamellar. Compared with intramedullary placement, intracancellous placement significantly accelerated the apposition of bone to the perimeter and internal surface of HA/TCP-coated implants and both accelerated and increased bone ingrowth as a percentage of available pore volume. These data show that the host response to titanium fibermetal implants is influenced both by HA/TCP coating and by the implantation site.     

Compliant prestress fixation in tumor prostheses: interface retrieval data

This article reports the first available human retrieval data following the use of a new fixation system for tumor prostheses. The compliant prestress (CPS) fixation system obviates the need for long intramedullary stems. The CPS was designed to provide a stable, high-pressure, motion-free bone-implant interface that would prevent aseptic loosening and allow osseointegration at the bone-implant interface. At 10 months, the fourth patient in the human trial required amputation. Backscatter electron microscopy revealed a buttress of new bone had formed along 70% of the bone-metal interface, with excellent bony ingrowth (average: 42%) into the transverse, porous-coated titanium interface.     

Effects of hydroxyapatite on titanium foam as a bone ingrowth surface in acetabular shells: a canine study

This study investigated a highly porous titanium foam with and without a PeriApetite coating as an alternative surface for implant fixation. Twelve mongrel canines received staged total hip replacements under International Animal Care and Use Committee (IACUC) approval from our institution. Animals were randomly placed in three- or six-month groups for sacrifice. Seventeen total hips were available for evaluation. The area and depth of ingrowth was measured by SEM. At three months, PeriApetite Ti foam had 37% more depth and almost 10% more bone ingrowth. Both groups were found not to be different at the six-month mark with over 36% of ingrowth calculated on SEM. The results prove not only that titanium foam is a viable ingrowth surface but also that PA coating can enhance the time to bony incorporation.     

Systemic alendronate treatment improves fixation of press-fit implants: a canine study using nonloaded implants.

Bone resorption associated with local trauma occurring during insertion of joint prostheses is recognized as an early event. Being an osteoclastic inhibitor, alendronate is a potential candidate means to decrease early periprosthetic bone resorption and thereby improve implant fixation. We investigated the influence of oral alendronate treatment on early implant fixation in two implant interface settings representing sites of an implant that are in contact with surrounding bone, and other sites without intimate bone contact. One plasma-sprayed cylindrical titanium implant (6 mm diameter) was inserted into each proximal tibia of 16 dogs. On one side the implant was inserted press-fit whereas on the contralateral side, the implants were surrounded by a 2 mm concentric gap. Oral alendronate (0.5 mg/kg/day) was given 2 weeks following surgery to eight dogs. The dogs were euthanized after 10 weeks of alendronate treatment. Bone ongrowth (bone in contact with implant surface) was estimated using the linear intercept technique and shear strength was calculated as the slope on a load-displacement curve. For the press fit implants, alendronate treatment significantly increased bone ongrowth from 24% to 29% and significantly increased ultimate shear strength from 1.26 to 3.72 MPa. Also, the fraction of periprosthetic bone significantly increased from 10% to 18%. For implants surrounded by a gap, alendronate neither stimulated nor impaired implant fixation, bone ingrowth, or new bone formation in the gaps. Because early implant stability is an important predictor of longevity, systemic alendronate treatment could be an important clinical tool to positively influence the early stages of implant incorporation.     

High Initial Stability in Porous Titanium Acetabular Cups: A Biomechanical Study

Initial stability with limited micromotion in uncemented total hip arthroplasty acetabular components is essential for bony attachment and long-term biomechanical fixation. This study compared porous titanium fixation surfaces to clinically established, plasma-sprayed designs in terms of interface stability and required seating force. Porous plasma-sprayed modular and metal-on-metal (MOM) cups were compared to a modular, porous titanium designs. Cups were implanted into polyurethane blocks with1-mm interference fit and subsequently edge loaded to failure. Porous titanium cups exhibited 23% to 65% improvement in initial stability when compared to plasma-sprayed cup designs (P = .01): a clinically significant increase, based on experience and prior literature. The results of this study indicate increased interface stability in porous titanium-coated cups without significantly increasing the necessary force and energy required for full seating.     

Implant fixation by bone ingrowth

The term osseointegration referred originally to an intimate contact of bone tissue with the surface of a titanium implant; the term bone ingrowth refers to bone formation within an irregular (beads, wire mesh, casting voids, cut grooves) surface of an implant. The section dealing with the historical background describes the development of macroporous, microporous, and textured surfaces with an emphasis on the evolution of porous and textured metal surfaces. The principal requirements for osseointegration and bone ingrowth are systematically reviewed as follows: i) the physiology of osseointegration and bone ingrowth, including biomaterial biocompatibility with respect to cellular and matrix response at the interface; ii) the implant surface geometry characteristics; iii) implant micromotion and fixation modes; and iv) the implant-bone interface distances. Based on current methods of bone ingrowth assessment, this article comparatively reviews and discusses the results of experimental studies with the objective of determining local and systemic factors that enhance bone ingrowth fixation.     

Clinical and histologic results related to a low-modulus composite total hip replacement stem

BACKGROUND: Osteolysis secondary to stress shielding in patients with a total hip arthroplasty has been attributed to greater stiffness of the prosthetic femoral stem compared with the stiffness of the femur. This concern led to the development of a composite femoral stem implant with a structural stiffness similar to that of the native femur. The stem consists of a cobalt-chromium-alloy core surrounded by polyaryletherketone and titanium mesh for bone ingrowth. The purpose of this study was to determine the intermediate-term clinical, radiographic, and histologic results of the use of this stem. METHODS: Twenty-eight patients (nineteen men and nine women) with an average age of 51.3 years underwent primary total hip arthroplasty with the Epoch stem and were followed for an average of 6.2 years. Harris hip scores were determined and radiographic studies were performed preoperatively, postoperatively, and at two-year intervals thereafter. In addition, dual x-ray absorptiometry scans were made up to two years postoperatively to evaluate osseous resorption. Two femora obtained at autopsy thirteen and forty-eight months after surgery were analyzed for bone ingrowth and ongrowth. RESULTS: The Harris hip scores averaged 56 points preoperatively and improved to 97 points at the time of the last follow-up. Dual x-ray absorptiometry scans demonstrated the greatest decrease in mean bone density (27.5%) in Gruen zone 7 at two years. Radiographs demonstrated no instances of migration, and only one hip had osteolysis. All stems had stable osseous fixation. Histologic evaluation of the two femora that had been retrieved at autopsy at thirteen and forty-eight months showed the mean bone ingrowth (and standard deviation) along the entire length of the stem to be 49.62% +/- 13.04% and 73.57% +/- 8.48%, respectively, and the mean bone ongrowth to be 54.18% +/- 7.68% and 80.92% +/- 6.06%, respectively. CONCLUSIONS: Intermediate-term follow-up of hips treated with the Epoch stem indicated excellent clinical success, radiographic evidence of osseous integration, and histologic findings of osseous ingrowth and ongrowth. Although the implant has been associated with excellent results in both the short and the intermediate term, longer follow-up will be necessary to assess the long-term function of the implant.     

Experimental study on the stability of cementless porous coated endoprosthesis]

This study investigated cementless fixation of titanium porous coated endoprosthesis using canine weight-bearing model. Though immature and thin, ingrown trabeculae reached the deepest region of porous coating four weeks after implantation, and gradually matured and thickened thereafter. Pull-out tests of the porous stem at eight weeks showed excellent fixation with average ultimate pull-out force of 142 kgf and average ultimate shear strength of 2.6 GPa. Bone ingrowth rate gradually increased at the proximal and distal region of the stem and, conversely, it gradually decreased at the middle level, suggesting the dependence of bone ingrowth upon the distribution of the amount of stress transferred from implant to the femur. Severe bone remodeling was found on some specimens in which stress transfer was not physiological. Porous coated femoral stems achieve excellent fixation by bone ingrowth, but require physiological stress transfer in order to avoid significant bone remodeling after implantation.     

Bone ingrowth and wear debris in well-fixed cementless porous-coated tibial components removed from patients

Bone ingrowth and the distribution of wear debris within the porous coating of 13 primary cementless porous-coated tibial components removed for reasons unrelated to fixation or infection were quantitatively described. The average length of implantation was 15.3 months (range, 3–30 months). The implants were all of the same design, made from Ti6A14V with a commercially pure titanium fiber-metal porous coating, which covered the undersurface of the tray and the four fixation pegs. In all but one component, supplemental screw fixation was used. The average extent of bone ingrowth within the tray was 27.1 ± 16.1%, and the average volume fraction was 9.5 ± 7.5%. There was significantly more bone ingrowth within the fixation pegs than within the tray and also more bone ingrowth in the anterior hall of the tray than posteriorly. There was no correlation between the amount of bone ingrowth and the length of implantation, age, or sex of the patient; however, the depth and orientation of the resection plane were found to correlate with the topographic distribution of bone ingrowth. Particulate debris appeared to gain access to the interface via soft tissue pathways both at the periphery and through the holes for adjuvant screw fixation.     

Bioactive porous titanium: an alternative to surgical implants

Abstract:  Porous titanium implants have been used to improve implant–bone attachment by the ingrowth of bone tissue within the porous structure. Despite the efficient bone adhesion of porous titanium implants, chemical bonds are required at bone–implant interface. These implants can become bioactive by a biomimetic precipitation process. The aim of this work was to enhance the bioactivity of pure porous titanium implants by biomimetic process. The samples immersed in a simulated body fluid promoted the nucleation and growth of calcium phosphate (Ca-P) crystals, such as hydroxyapatite (Hap), on the material surface. Scanning electron microscopy, energy dispersive spectroscopy, and Fourier transform infrared spectroscopy analyses revealed that a Ca-P deposition occurred without the need of pretreatments to improve the surface bioactivity. This present study indicates the potential for growing a bone-like Hap layer on porous titanium implants by biomimetic processes.     

Bone response to implant surface morphology

This study was designed to measure implant osseointegration using different surface treatments. Bilateral distal intramedullary implantation of titanium cylinders 25 mm × 5 mm was performed in 60 rabbits. The 3 surfaces tested were fiber mesh, mean pore size 400 μ; grit-blasted, mean surface roughness 6 μ; and acid-etched, mean surface roughness 18 μ. Scanning electron microscopy was used to measure the percentage of the surface of each implant in contact with bone at 2, 6, and 12 weeks postimplantation. Mechanical pull-out testing of the bone-implant interface was performed at 12 weeks. Overall, acid-etched surfaces demonstrated greater mean osseointegration than fiber mesh surfaces. All 3 surfaces demonstrated similar interface strengths. Acid etching has potential as a means of enhancing bony apposition in cementless fixation.     

Self-assembled Monolayer Films of Phosphonates for Bonding RGD to Titanium

Modification of the implant surface with the Arg-Gly-Asp tripeptide (RGD) putatively facilitates osteoblast attachment for improved implant fixation in the laboratory. We compared the histomorphometric and mechanical performance of titanium implants coated with RGD using a novel interface of self-assembled monolayers of phosphonates (RGD/SAMP) and implants coated with RGD using the more conventional thiolate-gold interface (RGD/thiolate-gold). We hypothesized RGD/SAMP-coated implants would show greater bone ongrowth and implant fixation than RGD/thiolate-gold-coated ones. We implanted an RGD/SAMP-coated implant in one femur and an RGD/thiolate-gold-coated in the contralateral femur of 60 rats. At 2, 4, and 8 weeks after implantation, 10 rats were sacrificed for histologic evaluation and another 10 for biomechanical testing. Bone-implant ongrowth and implant force-to-failure of the two implants were similar at all times. Although RGD/SAMP-coated implants did not show superior bone ongrowth and implant fixation, RGD/SAMP-coated implants have at least equally good histomorphometric and mechanical in vivo performance as RGD/thiolate-gold-coated ones. Additional in vivo characterization of self-assembled monolayer films of phosphonates as interface to bond RGD to titanium is needed to explore its full potential and seems justified based on the results of this study. Each author certifies that he or she has no commercial associations (eg, consultancies, stock ownership, equity interest, patent/licensing arrangements, etc) that might pose a conflict of interest in connection with the submitted article. Each author certifies that his or her institution has approved the animal protocol for this investigation and that all investigations were conducted in conformity with ethical principles of research.     

An evaluation of skeletal attachment to LTI pyrolytic carbon, porous titanium, and carbon-coated porous titanium implants

Porous titanium, carbon-coated porous titanium, and low-temperature isotropic (LTI) pyrolytic carbon transcortical implants were placed in the femora of mongrel dogs. Mechanical and histologic analyses were performed in specimens that remained in situ for six months. Qualitative histologic results indicated that the bone formed a direct appositional interface with as-deposited LTI carbon. The bone tissue response to the two systems with porous coatings was similar. Both systems showed little fibrous tissue interposition and a high degree of mineralized bone ingrowth. The ingrown bone was well organized. However, there was some evidence that the ingrown bone mineral differed significantly from the bulk bone mineral. The only difference between carbon-coated and uncoated porous systems was a significant increase in the percentage of bone ingrowth, with carbon-coated specimens having a 4% increase in bone volume. The strength of appositional attachment to LTI carbon was shown to be at least one order of magnitude weaker than bone ingrowth attachment to the porous systems. The interface shear stiffness of the two porous systems was equivalent; however, the attachment shear strength of bone growth into carbon-coated porous titanium was significantly increased compared with that of bone growth into the uncoated porous titanium. Correlation of the percentage of bone ingrowth and pushout strength was also found to be statistically significant, suggesting that the presence of the carbon coating enhanced bone ingrowth, which resulted in significantly increased shear strengths.     

Hydroxyapatite-coated total hip prostheses. Two-year clinical and roentgenographic results of 100 cases

Studies of implant fixation have shown that hydroxyapatite (HA) coatings provide early and strong fixation to bone. This is a report of 100 consecutive cases of total hip arthroplasties, using HA coating, which were mainly for osteoarthrosis, avascular necrosis, or revision for failed implants. The average prospective follow-up period was two years. Titanium femoral components had a proximal HA coating, usually with an HA-coated screw cup. For both HA-coated components, the average Harris hip score was 96 points after one year and 98 after two years. Analysis of data shows that the incidence of pain was low immediately after surgery and at 4% one year postoperatively. There was no difference between the results of primary cases and revisions after the one-year interval. On roentgenographic examination, there was a rapid bony integration of implants with bone apposition on the coating within six months, accompanied by specific patterns of remodeling. No radiolucent line formation was detected around HA-coated implant parts. There were no revisions for loose implants. After two years, 97% of the patients had positive roentgenographic evidence of femoral ingrowth compared to 55% for HA-coated acetabular cups, with a statistical significance between bone ingrowth and clinical results. Implant fixation using HA coatings is a reliable procedure for good bony fixation and clinical results.     

Anterior cervical interbody fusion with rhBMP-2 and tantalum in a goat model.

BACKGROUND CONTEXT: Tricortical autogenous iliac crest has long served as the gold standard for arthrodesis after cervical discectomy. The added morbidity resulting from bone graft harvest may be eliminated by the use of a biocompatible synthetic bone graft substitute with osteoconductive abilities, and when used with an osteoinductive agent, such as recombinant bone morphogenic protein (rhBMP)-2, it may facilitate arthrodesis similar to autograft. PURPOSE: To determine by radiographic and histologic analysis whether tantalum with and without rhBMP-2 can facilitate bony ingrowth and arthrodesis in an animal model. STUDY DESIGN/SETTING: Single-level anterior cervical discectomy and fusion was performed using a tantalum bone graft substitute with and without rhBMP-2 in a previously established goat model for anterior cervical fusion. METHODS: Eight goats underwent single-level anterior cervical discectomy and stabilization with a porous tantalum implant. There were four goats in each experimental group. Group A underwent anterior cervical stabilization with tantalum alone, whereas in Group B rhBMP-2 was added to the tantalum implant. The goats were sacrificed at 12 weeks, and their cervical spines were removed for histologic and radiological analysis. RESULTS: Only one of four goats in Group A had any bony ingrowth into the tantalum. Three of four goats in Group B demonstrated bony ingrowth. The average extent of bony ingrowth at the perimeter of the tantalum in Group A was 2.5% compared with 12.5% in Group B. Similarly, the volume of bony ingrowth within the tantalum was 2.5% in Group A and 10% in Group B. The difference was not statistically significant. CONCLUSIONS: The data in this pilot study suggest that tantalum may function as a synthetic osteoconductive bone graft substitute. The addition of rhBMP-2 may facilitate osteoinduction within a synthetic osteoconductive implant. The sample size in this study was too small for statistical significance. The present animal model as used in this study was inadequate for cervical arthrodesis where rigid implant fixation is desired.     

Powder metal-made orthopedic implants with porous surface for fixation by tissue ingrowth

Powder metal-made orthopedic implants with a porous coating provide an effective means for implant fixation by tissue ingrowth. Additionally, the use of metal alloy powders for forming porous surfaces offers the advantage of uniform coatings on complex part shapes. With proper processing, implants with strong, porous surface layers and good substrate mechanical properties can be formed. The in vivo tests have demonstrated the need for initial implant stability to achieve bony ingrowth. Animal studies indicate an optimum pore size range of 50-400 mu, and human hip prostheses with pores in this range appear to function well. A porous surface integrated with a compatible implant design avoids undesirable bone remodeling with these types of implants.