Bone response to hydroxyapatite-coated and commercially pure titanium implants in the human arthritic knee

Rough and smooth commercially pure (c.p.) titanium implants and hydroxy-apatite-coated (HA-C) implants were inserted in arthritic human knees and left in situ in order to compare the response of bone to these three implants. Radiographic examination alone could not determine if bone apposition had occurred. After 3 and 6 months, histomorphometric analyses of undecalcified sections, 10 μm thick, revealed a statistical significance in the amount of bone apposition to rough-surfaced and HA-C implants as compared with smooth uncoated implants. Most of the rough-surfaced c.p. titanium implants and the HA-C implants had achieved bone apposition on the order of 50%. No statistically significant differences in apposition were seen between the rough-surfaced and HA-C implants. The smooth c.p. titanium implants were mostly encapsulated in fibrous tissue.     

Allergic reaction to platinum in silicone breast implants

Platinum is used as a catalyst in the manufacture of silicone breast implants. Because platinum is recognized as a potent sensitizer in certain circumstances, some have expressed concern that women with silicone breast implants are exposed to platinum, which is causing allergic reactions. We searched the literature for information on the level of platinum in breast implants and reports of sensitization that clearly related to platinum in women with breast implants. We found no published report with convincing evidence that platinum causes allergic reactions in women with breast implants or that women with breast implants are any more likely to have allergic reactions than women without breast implants.     

Difference in metallic wear distribution released from commercially pure titanium compared with stainless steel plates

INTRODUCTION: Stainless steel and commercially pure titanium are widely used materials in orthopedic implants. However, it is still being controversially discussed whether there are significant differences in tissue reaction and metallic release, which should result in a recommendation for preferred use in clinical practice. MATERIALS AND METHODS: A comparative study was performed using 14 stainless steel and 8 commercially pure titanium plates retrieved after a 12-month implantation period. To avoid contamination of the tissue with the elements under investigation, surgical instruments made of zirconium dioxide were used. The tissue samples were analyzed histologically and by inductively coupled plasma atomic emission spectrometry (ICP-AES) for accumulation of the metals Fe, Cr, Mo, Ni, and Ti in the local tissues. Implant corrosion was determined by the use of scanning electron microscopy (SEM). RESULTS: With grades 2 or higher in 9 implants, steel plates revealed a higher extent of corrosion in the SEM compared with titanium, where only one implant showed corrosion grade 2. Metal uptake of all measured ions (Fe, Cr, Mo, Ni) was significantly increased after stainless steel implantation, whereas titanium revealed only high concentrations for Ti. For the two implant materials, a different distribution of the accumulated metals was found by histological examination. Whereas specimens after steel implantation revealed a diffuse siderosis of connective tissue cells, those after titanium exhibited occasionally a focal siderosis due to implantation-associated bleeding. Neither titanium- nor stainless steel-loaded tissues revealed any signs of foreign-body reaction. CONCLUSION: We conclude from the increased release of toxic, allergic, and potentially carcinogenic ions adjacent to stainless steel that commercially pure Ti should be treated as the preferred material for osteosyntheses if a removal of the implant is not intended. However, neither material provoked a foreign-body reaction in the local tissues, thus cpTi cannot be recommend as the 'golden standard' for osteosynthesis material in general.     

Tissue Reaction and Metal Sensitivity: An Animal Study

An animal study is presented in which nickel sensitivity as determined by an in vitro test for leukocyte migration inhibition (LIF) is correlated with results of skin tests with NiCl₂ and with the degree of adverse tissue reaction to implanted stainless steel screws. Screws were implanted in the humeri of New Zealand white rabbits, one group of which received repeated injections of nickel chloride following an initial injection of nickel chloride in Freun d?s adjuvant. All the injected rabbits became skin test positive to nickel and demonstrated LIF production in the presence of nickel chloride. Some of the injected rabbits, 6–9 weeks after implantation of the screws, developed an inability for leukocyte migration even when the cells were incubated only with saline and serum. the tissue reaction to screws in the nickel sensitive animals showed a significant increase in inflammatory cells and foreign body giant cells when compared with the reaction in nonsensitive animals. the most severe reactions, some of which included regions of necrosis, were seen in animals which developed the condition of no leukocyte migration in the LIF test. the correlation between skin test and LIF test results demonstrates the effectiveness of the LIF assay for sensitivity testing without the risk of sensitization associated with skin testing. the histological results support the hypothesis that the condition of no cell migration in the LIF test is diagnostic for severe reactions to implants associated with metal sensitivity.     

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.     

Microscopic metallic wear and tissue response in failed titanium hallux metatarsophalangeal implants: two cases

The membranes present at the implant-bone interface were retrieved from two patients with titanium single stem hallux implants that had failed. Both patients had pain and valgus deformity of the hallux, and radiographs showed a radiolucent shadow around the implant stem, with thinning of the dorsal cortex of the proximal phalanx in one patient. After removal of the implants, arthrodesis of the first metatarsophalangeal (MP) joint was performed. Histologic analysis of the membrane tissue at the implant-bone interface showed a synovial-like appearance. There was a fibrous tissue stroma adjacent to the bone surface, with multiple regions of scalloping covered by mononuclear cells. Fine metallic debris was seen throughout the fibrous tissue. Multinucleated foreign body giant cells were sparsely observed associated with fine particulate metallic wear debris similar to observations from failed total hip arthroplasties. The histologic appearance is evidence that foreign-body granulomatous infiltration associated with metallic wear debris may be a causative factor of peri-implant osteolysis leading to aseptic loosening and failure of titanium single stem hallux implants.     

Late postoperative infection following spinal instrumentation: stainless steel versus titanium implants

Late postoperative infection following instrumented spinal surgery is a clinical entity that has emerged in recent years. The extended surface of the spinal instrumentation in combination with hematogenous seeding or intraoperative inoculation is the main predisposing factor. In order to investigate the contribution of the instrumentation material (stainless steel versus titanium implants) and mechanical loosening, two groups of patients are presented. The first group includes 50 idiopathic scoliotic patients who were treated with first-generation posterior stainless steel spinal segmental multihook instrumentation [Texas Scottish Rite Hospital (TSRH) instrumentation system], and the second group includes 45 similar patients who were treated with newer titanium implants (MOSS MIAMI, XIA, and CD). Follow-up ranged from 3 to 13 years. Six patients from the first group and one patient from the second group presented with late infections 1 to 7 years postoperatively. Common intraoperative findings were excessive inflammatory tissue and some degree of instrumentation loosening and corrosion (stainless steel). Removal of instrumentation in combination with appropriate antibiotics was an effective treatment. Further study with long-term follow-up is necessary in order to understand the exact incidence and pathology of such infections.     

A histologic analysis of the effects of stainless steel and titanium implants adjacent to tendons: an experimental rabbit study

PURPOSE: The current trend is to treat distal radius fractures with open reduction and internal fixation with either titanium or stainless steel plates. Both provide stable fixation; however, there is minimal evidence concerning the soft-tissue response to these materials. Our objective was to evaluate the response of adjacent extensor tendons to titanium and stainless steel in a rabbit in vivo model and to evaluate the influence of time. METHODS: Forty rabbits were divided into 5 groups of 8 rabbits each. Groups I and II had unilateral osteotomy of the distal radius followed by dorsal fixation with titanium and stainless steel plates, respectively. Groups III and IV had fixation with titanium and stainless steel, respectively, but without osteotomy. Group V had surgical dissection without osteotomy or plates. Two animals per group were killed at 1, 4, 12, and 24 weeks. The specimens (distal radius, plate, overlying soft tissue, and extensor tendon) were harvested en bloc for histologic analysis. For interface preservation between implant and tissues the specimens were embedded in methylmethacrylate, sectioned, and stained with hematoxylin-eosin. RESULTS: Histologic analysis showed a fibrous tissue layer formed over both implants between the plate and the overlying extensor tendons in the groups treated with plating independently of the material and the presence or absence of osteotomy. This fibrous layer contained the majority of debris. Metallic particles were not observed in the tendon or muscle substance of any animals; however, they were visualized in the tenosynovium. Hematoxylin-eosin-stained sections of groups I through IV showed proliferative fibroblasts and metallic particles; however, this layer was not observed in group V. Statistical analysis did not show differences between the groups regarding the number of cells or metallic particles. CONCLUSIONS: Our results indicate that both implants generated adjacent reactive inflammatory tissue and particulate debris. There was no difference in cell or particle number produced by both materials. There is a statistically significant increase in inflammatory cells with increasing time of implantation.     

Combining dissimilar metals in orthopaedic implants: revisited

The use of metals as implant materials has become common practice in the field of orthopaedics. A wide variety of conditions are treated with metallic implants, and designers have used an assortment of materials to meet the unique mechanical demands of each application. The majority of implants used today, whether pins, plates, screws, or total joints, are made of cobalt-chrome alloy, stainless steel, or titanium. Common metallurgic wisdom cautions against bonding dissimilar metals in a biologically active environment. Surgeons have therefore shied away from combining dissimilar metal implants because of the fear of inciting corrosion that could potentially compromise the implants and lead to aseptic loosening, implant failure, or adverse biological reaction in host tissue. As surgical reconstruction and arthroplasty options expand with the advent of newer implants and expanded operative techniques, the orthopaedic surgeon will increasingly be faced with weighing the risks and benefits of combining implants made of dissimilar metals in a patient. Here, the authors examine the origins of the concern over using mixed metals, discuss mechanisms of corrosion as they relate to surgical implants, and review both in vitro and in vivo studies concerning the most common combinations of dissimilar metals in order to guide the surgeon in choosing implants.     

Causes of the clinical tissue response to polyglycolide and polylactide implants with an emphasis on the knee

The causes of a clinical tissue response to self-reinforced polyglycolide (SR-PGA) and self-reinforced polylactide (SR-PLLA) implants were studied in the first 2500 polymeric fixations. The incidence was 8.0% in fixations with implants made of SR-PGA (n = 1879) and 0% in SR-PLLA fixations (n = 621). A small number of fixations per site seemed to increase the incidence of a tissue response. In diagnoses involving over 50 fixations, except for ankle fractures, the incidence was 4.2%. The site of fixation influenced the incidence; the lowest incidence was seen for radial head fracture fixation (1.1%). The aromatic dye which has not been used since 1988 in the SR-PGA implant increased the response. A large total implant volume and a large number of implants increased the incidence of a tissue response. In the knee (n = 131), the incidence of a clinical tissue response was 4.3%, with four fluid accumulations and one synovitis of the knee after fixation with SR-PGA implants. Received: 6 February 2000     

Osseointegration of titanium implants

Forty-eight screws, six double cylindrical implants and six T-plates were inserted into the tibia or femur of 6 dogs. Two titanium screws were inserted into the proximal tibia of 5 patients to anchor a titanium mould. The implants were removed en bloc with adjacent bone tissue after 3 to 14 months. They were sectioned using a technique that allowed analysis of the intact tissue-to-metal specimens. Osseointegration, defined as a direct bone-to-implant contact without interposed soft tissue, was confirmed in all screw-shaped implants while the cylindres had only partial bone contact as did the T-plates. We conclude that osseointegrated implants may be applicable in joint reconstruction for arthrosis or rheumatoid arthritis.     

Osseointegration of titanium implants

Forty-eight screws, six double cylindrical implants and six T-plates were inserted into the tibia or femur of 6 dogs. Two titanium screws were inserted into the proximal tibia of 5 patients to anchor a titanium mould. The implants were removed en bloc with adjacent bone tissue after 3 to 14 months. They were sectioned using a technique that allowed analysis of the intact tissue-to-metal specimens. Osseointegration, defined as a direct bone-to-implant contact without interposed soft tissue, was confirmed in all screw-shaped implants while the cylindres had only partial bone contact as did the T-plates. We conclude that osseointegrated implants may be applicable in joint reconstruction for arthrosis or rheumatoid arthritis.     

Bone formation in porous implants of delrin and commercially pure titanium

Summary Clinicians have been using implants made by titanium or delrin with varying results. In this study dividable implants, bone growth chambers (BGC), of titanium and delrin were inserted into the rabbit tibia. The ingrowth of hard tissue into a canal in the implant was evaluated after 3 weeks by microradiography and numerically determined by computer analysis. Results showed that bone ingrowth into titanium implants was significantly larger than into delrin implants (P < 0.005). The possible reasons for this are discussed.This study was supported by grants from the Swedish Medical Research Council (B 84-12P-6475-02) and B 84-12X-6533-02), King Gustaf V Jubilee Foundation, Trygg-Hansa Research Fund, the Gothenburg Medical Society, and the Greta and Einar Askers Foundation.     

Unalloyed titanium for implants in bone surgery

Commercially pure (c.p.) titanium has proven its suitability as an implant material in bone surgery over many years in the fields of osteosynthesis, oral implantology, and in certain applications in joint prosthetics. Excellent biocompatibility and corrosion resistance are outstanding features. Furthermore, c.p. titanium is known for not causing allergic reactions. The different grades of c.p. titanium and their minimum mechanical properties are specified in ISO and ASTM standards for implant materials. Typical mechanical properties are given for AO ASIF implant applications. The properties and clinical performance of c.p. titanium are discussed and compared to those of implant stainless steel and titanium alloys. In brief some specific features relating to c.p. titanium implant material are treated, including biocompatibility and soft tissue and bone response and taking into account the effects of implant surface configurations at the same time. In addition, issues are addressed which arise from frequent inquiries from clinics.     

New nasal fracture classification for patients with silicone implants

Abstract

Aesthetic nasal augmentation has increased in popularity among Asian populations, and nasal bone fracture is the most common type of facial bone fracture. In Asia, the frequency of nasal bone fractures is also increasing among patients who have undergone silicone augmentation rhinoplasty. The increasing prevalence of this injury presents a challenge to the surgeon. Thirty-six patients who had previously undergone augmentation rhinoplasty with silicone implant presented with nasal bone fracture from June 2007 through December 2011. The patients were grouped into three categories: patients with fractures in the high level (type I), patients with fractures in the low level (type II), and patients with fractures throughout the entire nasal bone, from base to top (type III). The largest group comprised patients with type I fractures (n = 24, 67%), followed by type II (n = 4, 11%), and Type III (n = 8, 22%) fractures. Symptoms and surgical outcomes for nasal bone fractures may be different in patients with silicone implants. A novel classification system for nasal bone fractures is required, as is a new approach to diagnosis and treatment.     

Metallic orthopaedic implants and airport metal detectors.

Airport security can detect in vivo metallic implants. We hypothesized that a soft tissue shield and fast transit through archway detectors would decrease implant detectability, whereas greater implant mass would increase detectability. Twelve patients with 8 orthopaedic implants in vivo and 60 trauma and arthroplasty implants in vitro were subjected to standard airport security measures at Stanstead Airport (British Airports Authority), including arch and standard and nonstandard hand-held detectors. Archway detectors failed to detect some implants; hand-held detectors detected almost all implants except an ankle arthroplasty. Positive archway detection was related to implant transit speed through the detection field. The implant mass consistently affected detection in stainless steel and titanium implants, and a 1-inch wax shield had no effect. Patients with metallic implants should prepare routinely with documentation of their implant before traveling through security ports.     

RANKL in the osteolysis of AES total ankle replacement implants

Peri-implant tissue reactions in failed total ankle replacement (TAR) are characterized by early developing peri-implant osteolysis. The hypothesis of the study was that this reaction is mediated by receptor activator of nuclear factor kappa B ligand (RANKL). Samples of peri-prosthetic tissues from failed TAR implants were stained for macrophages, RANKL, its receptor RANK and osteoprotegerin (OPG), and compared to control samples. The failed TAR implants were surrounded by implant capsule, synovial lining-like interface membrane or necrotic tissues. Infiltrating scavenger receptor I positive CD163(+) macrophages were frequent, in particular around necrotic soft tissues or bone sequestrate, and possibly in part formed due to ischemia and mechanical factors. In contrast, implant-derived wear debris was scanty. Still many RANK(+) macrophages were often seen in close contact with RANKL(+) mesenchymal cells, whereas OPG was mostly located at a distance in vascular endothelial cells. Foreign body giant cells were frequent. RANKL seems to stimulate locally accumulated CD163(+) RANK-expressing cells to fusion, which leads to the local formation of multinuclear foreign body giant cells (and probably of osteoclasts). Therefore, peri-implant osteolysis in early TAR implant failure seems to be caused by the RANKL-driven chronic foreign body inflammation directed against, not implant-derived particles, but against necrotic autologous tissues.     

Update on anaplastic large cell lymphoma in women with breast implants

Since 1997, reports from the scientific community have suggested a possible association, without causation, between breast implants and anaplastic large cell lymphoma (ALCL). Analysis of these patients has been challenging. Many studies have been under-reported while others have been duplicated. In 2011, a United States Food & Drug Administration (FDA) ‘white paper’ analyzed 34 of the 60 cases reported worldwide. All 34 patients had undergone secondary surgery for breast swelling, firmness or pain. ALCL was an incidental finding. Diagnosis of ALCL is made by hematoxylin and eosin histology and immunochemistry for the CD30 marker. ALCL occurred with all types of implants. Subsequent studies have suggested that textured implants may have a greater risk. In all cases, ALCL cells were found in the capsule, in the seroma or within a mass adjacent to the implant. There was no invasion of cells beyond the capsule into the breast parenchyma. From the FDA study, the risk of developing ALCL after receiving implants appears to be approximately one in one million per year. All cases appear to be negative for the anaplastic lymphoma kinase marker. ALCL in most of these patients may represent a new entity with less aggressive behaviour. In most patients with capsule-confined disease, proper management may prove to be implant removal and capsulectomy. Patients with a distinct mass adjacent to their implant may have a more aggressive clinical course that may become systemic. They may require chemotherapy in addition to implant removal and capsulectomy. All cases of ALCL should be referred to an appropriate specialist and reported to the FDA.     

Adhesion of Staphylococcus to orthopaedic metals, an in vivo study.

This study describes a new model of biofilm study in rabbits. The primary focus of this study was to assess biofilm adhesion to orthopaedic metals in their first 48 h in a femoral intramedullary implantation model. Two previous inoculation methods i.e. that of pre- and direct inoculation were studied with two bacterial isolates namely Staphylococcus aureus and epidermidis, on titanium and stainless steel metallic implants. A method of sonication and log dilution/plating was used to assess biofilm bacteria adhering to implants. Silver coated metals were then compared with their respective control metals in the new model. The direct inoculation model gave larger and more reproducible biofilm adhesion to implanted metals. Staphylococcus epidermidis shows lower adhesion ability to metals, and biofilms adhere in greater numbers to stainless steel over titanium. Silver coated metals show no statistical difference over control metals when exposed to orthopaedic biofilms.     

Titanium hip implants for improved magnetic resonance and computed tomography examinations.

The value of magnetic resonance imaging (MRI) for assessment of the hip has been demonstrated, particularly in cases of avascular necrosis. Magnetic resonance imaging can be used to provide anatomic evaluation of the femoral head, acetabulum, hip joint, joint fluid, and the surrounding structures. MR examinations of two patients with hip fractures fixed with stainless steel hip implants were compared with nine patients with hip fractures fixed with titanium hip implants, one of which showed avascular necrosis of the femoral head. The titanium implants resulted in less MRI artifacts, allowing for improved depiction of the femoral head and surrounding soft tissue. For this reason titanium fixation devices are recommended as a substitute for stainless steel in the hip joint region in a patient who may need future MR examination.