Robert M. Urban

Current Concepts Review - Corrosion of Metal Orthopaedic Implants

In situ degradation of metal-alloy implants is undesirable for two reasons: the degradation process may decrease the structural integrity of the implant, and the release of degradation products may elicit an adverse biological reaction in the host. Degradation may result from electrochemical dissolution phenomena, wear, or a synergistic combination of the two. Electrochemical processes may include generalized corrosion, uniformly affecting the entire surface of the implant, and localized corrosion, affecting either regions of the device that are shielded from the tissue fluids (crevice corrosion) or seemingly random sites on the surface (pitting corrosion). Electrochemical and mechanical processes (for example, stress corrosion cracking, corrosion fatigue, and fretting corrosion) may interact, causing premature structural failure and accelerated release of metal particles and ions. The clinical importance of degradation of metal implants is evidenced by particulate corrosion and wear products in tissue surrounding the implant, which may ultimately result in a cascade of events leading to periprosthetic bone loss. Furthermore, many authors have reported increased concentrations of local and systemic trace metal in association with metal implants1,4,5,9-11,14,18,25,26,28,29,47,49-55,58,71,72,75-77,87,90,108-110. There also is a low but finite prevalence of corrosion-related fracture of the implant. This review focuses on electrochemical corrosion phenomena in alloys used for orthopaedic implants. A summary of basic electrochemistry is followed by a discussion of retrieval studies of the response of the implant to the host environment and the response of local tissue to implant corrosion products. The systemic implications of the release of metal particles also are presented. Finally, future directions in biomaterials research and development …

Dissemination of Wear Particles to the Liver, Spleen, and Abdominal Lymph Nodes of Patients with Hip or Knee Replacement*

Background: The importance of particles generated by wear and corrosion of joint replacement prostheses has been understood primarily in the context of the local effects of particle-induced periprosthetic osteolysis and aseptic loosening. We studied dissemination of wear particles in patients with total hip and knee replacement to determine the prevalence of and the histopathological response to prosthetic wear debris in the liver, spleen, and abdominal para-aortic lymph nodes. Methods: Postmortem specimens from twenty-nine patients and biopsy specimens from two living patients with a failed replacement were analyzed. Specimens of tissue obtained from the cadavera of fifteen patients who had not had a joint replacement served as controls. The concentration of particles and the associated tissue response were characterized with the use of light microscopy of stained histological sections. Metallic particles were identified by electron microprobe analysis. Polyethylene particles were studied with the use of oil-red-O stain and polarized light microscopy. The composition of polyethylene particles was confirmed in selected cases by Fourier transform infrared spectroscopy and hot-stage thermal analysis. Twenty-one of the patients studied post mortem had had a primary total joint replacement. Eleven of them had had a hip prosthesis for a mean of sixty-nine months (range, forty-three to 171 months), and ten had had a knee replacement for a mean of eighty-four months (range, thirty-one to 179 months). The other eight patients studied post mortem had had a hip replacement in which one or more components had loosened and had been revised. The mean time between the initial arthroplasty and the time of death was 174 months (range, forty-seven to 292 months), and the mean time between the last revision procedure and the time of death was seventy-one months (range, one to 130 months). Results: Metallic wear particles in the liver or spleen were more prevalent in patients who had had a failed hip arthroplasty (seven of eight) than in patients who had had a primary hip (two of eleven) or knee replacement (two of ten). The principal source of wear particles in the majority of these patients involved secondary nonbearing surfaces rather than wear between the two primary bearing surfaces as intended. In one living patient, dissemination of titanium alloy particles from a hip prosthesis with mechanical failure was associated with a visceral granulomatous reaction and hepatosplenomegaly, which required operative and medical treatment. Metallic wear particles were detected in the para-aortic lymph nodes in 68 percent (nineteen) of the twenty-eight patients with an implant from whom lymph nodes were available for study. In 38 percent (eleven) of all twenty-nine patients with an implant who were studied post mortem, metallic particles had been further disseminated to the liver or spleen, where they were usually found within small aggregates of macrophages occurring as infiltrates without apparent pathological importance. Polyethylene particles elicited a similar response. They were identified in the para-aortic lymph nodes of 68 percent (nineteen) of the twenty-eight patients and the liver or spleen of 14 percent (four) of the twenty-nine patients. The majority of the disseminated wear particles were less than one micrometer in size. Currently available methods lack the sensitivity and specificity necessary to detect very low concentrations of submicrometer polyethylene particles and probably underestimated the prevalence of polyethylene wear debris in the liver and spleen. Conclusions: In this study, systemic distribution of metallic and polyethylene wear particles was a common finding, both in patients with a previously failed implant and in those with a primary total joint prosthesis. The prevalence of particles in the liver or spleen was greater after reconstructions with mechanical failure. In the majority of patients, the concentration of wear particles in these organs was relatively low and without apparent pathological importance. However, in one rare case, granulomas formed in the liver, spleen, and abdominal lymph nodes in response to heavy accumulation of wear debris from a hip prosthesis with mechanical failure and compromised hepatic function. Clinical Relevance: These findings underscore the necessity of minimizing the production of particulate debris by joint replacement devices and the need for the surgeon to consider expeditious revision in patients in whom large amounts of particulate debris may be generated. Serum and urine trace-metal analyses may provide early confirmation of failure and aid in the timing of a revision operation in a patient with a symptomatic or failed device.

Migration of corrosion products from modular hip prostheses. Particle microanalysis and histopathological findings.

Migration of solid corrosion products from the modular head-neck junction of fifteen total hip replacements to the periprosthetic tissues was studied. The devices and tissues were recovered at the time of a revision procedure or at autopsy after a mean of sixty-four months (range, eight to ninety-seven months). The prostheses had a cobalt-chromium-alloy head coupled with a cobalt-chromium-alloy or a titanium-alloy stem. The solid corrosion product was identified by electron microprobe analysis and Fourier transform infrared microprobe spectroscopy as a chromium orthophosphate hydrate-rich material. The product was present at the junction of the modular head and neck and as particles within the periprosthetic tissues as early as eight months postoperatively. In several hips, it was also present on the polyethylene bearing surface. The particles in the tissues ranged in size from less than one to 500 micrometers. They were present within histiocytes or were surrounded by foreign-body giant cells in the pseudocapsule of the hip joint; in the membranes of the femoral bone-implant interface; and at sites of femoral endosteal erosions, with and without loosening of the femoral component.

Release and excretion of metal in patients who have a total hip-replacement component made of titanium-base alloy.

Serum concentration and urinary excretion of titanium, aluminum, and vanadium were measured for patients who had a well functioning cementless primary total hip replacement of one of two different designs, for patients who had a loose total hip replacement that was to be revised, and for control subjects who had no implant. Serum concentrations of titanium were elevated approximately twofold in the patients who had a loose implant, compared with the values for the control subjects. No major differences in terms of urine concentration of titanium, serum concentration of aluminum, or urine concentration of aluminum were observed among any of the groups that were studied. Concentrations of vanadium were uniformly low in all groups.

Adverse Local Tissue Reaction Arising from Corrosion at the Femoral Neck-Body Junction in a Dual-Taper Stem with a Cobalt-Chromium Modular Neck

BACKGROUND Femoral stems with dual-taper modularity were introduced to allow additional options for hip-center restoration independent of femoral fixation in total hip arthroplasty. Despite the increasing availability and use of these femoral stems, concerns exist about potential complications arising from the modular neck-body junction. METHODS This was a multicenter retrospective case series of twelve hips (eleven patients) with adverse local tissue reactions secondary to corrosion at the modular neck-body junction. The cohort included eight women and three men who together had an average age of 60.1 years (range, forty-three to seventy-seven years); all hips were implanted with a titanium-alloy stem and cobalt-chromium-alloy neck. Patients presented with new-onset and increasing pain at a mean of 7.9 months (range, five to thirteen months) following total hip arthroplasty. After serum metal-ion studies and metal artifact reduction sequence (MARS) magnetic resonance imaging (MRI) revealed abnormal results, the patients underwent hip revision at a mean of 15.2 months (range, ten to twenty-three months). Tissue specimens were examined by a single histopathologist, and the retrieved implants were studied with use of light and scanning electron microscopy. RESULTS Serum metal levels demonstrated greater elevation of cobalt (mean, 6.0 ng/mL) than chromium (mean, 0.6 ng/mL) or titanium (mean, 3.4 ng/mL). MRI with use of MARS demonstrated adverse tissue reactions in eight of nine patients in which it was performed. All hips showed large soft-tissue masses and surrounding tissue damage with visible corrosion at the modular femoral neck-body junction. Available histology demonstrated large areas of tissue necrosis in seven of ten cases, while remaining viable capsular tissue showed a dense lymphocytic infiltrate. Microscopic analysis was consistent with fretting and crevice corrosion at the modular neck-body interface. CONCLUSIONS Corrosion at the modular neck-body junction in dual-tapered stems with a modular cobalt-chromium-alloy femoral neck can lead to release of metal ions and debris resulting in local soft-tissue destruction. Adverse local tissue reaction should be considered as a potential cause for new-onset pain in patients with these components, and early revision should be considered given the potentially destructive nature of these reactions. A workup including serologic studies (erythrocyte sedimentation rate and C-reactive protein), serum metal levels, and MARS MRI can be helpful in establishing this diagnosis.

Enhancement of bone ingrowth by transforming growth factor-beta.

Enhancement of bone ingrowth with transforming growth factor-beta was evaluated in a canine model. Ten dogs had bilateral implantation of a titanium-fiber-metal-coated rod in the proximal part of the humerus. A three-millimeter gap between the outer surface of the porous coating and the surrounding cancellous bone was created to impair bone ingrowth. All of the implants were plasma-flame-sprayed with hydroxyapatite and tricalcium phosphate. In each animal, one implant was also treated with recombinant transforming growth factor-beta 1 while the other implant, which was not so treated, served as a paired control. Two doses of transforming growth factor-beta 1 were used: 335 micrograms in five animals and 120 micrograms in the other five. At four weeks, the amount of bone ingrowth in the implants that had been treated with 120 micrograms of transforming growth factor-beta 1 was threefold higher than that in the paired controls (p = 0.009), but with the numbers available there was no significant increase in bone ingrowth with the higher dose. The amount of new-bone formation in the three-millimeter gaps adjacent to the treated implants was twice that in the gaps of the paired controls, regardless of the dose. The differences between the treated and control implants with regard to the architecture of the new bone in the gap indicate that the mechanism of action of transforming growth factor-beta 1 may include both proliferation of osteoprogenitor cells and production of matrix by committed osteoblasts. Compared with the findings in a previous study in which this canine model was used, the data from the present investigation indicate that enhancement of bone ingrowth in implants that have been treated with a combination of a hydroxyapatite-tricalcium phosphate coating and transforming growth factor-beta 1 may exceed that obtainable with grafting of the gap with autogenous cancellous bone.

Functional adaptation and ingrowth of bone vary as a function of hip implant stiffness

The purpose of the present study was to test the hypothesis that cortical bone loss, trabecular bone density and the amount of bone ingrowth vary as a function of stem stiffness in a canine cementless hip replacement model. The study was motivated by the problem of cortical bone atrophy in the proximal femur following cementless total hip replacement. Two stem stiffnesses were used and both designs were identical in external geometry and porous coating placement. The high stiffness stem caused approximately 26% cortical bone stress-shielding and the low stiffness stem caused approximately 7.5% stress-shielding, as assessed by beam theory. Each group included nine adult, male canines who received unilateral arthroplasties for a period of six months. The animals with the low stiffness stems tended to lose less proximal cortical bone than the animals with high stiffness stems (4% +/- 9 as opposed to 11% +/- 14), but the difference was not statistically significant (p = 0.251). However, the patterns of bone ingrowth into the implant and change in medullary bone density adjacent to the implant were fundamentally different as a function of stem stiffness (p < 0.01). Most importantly, while the high stiffness group had peaks in these variables at the distal end of the stem, the low stiffness group had peak values proximally. These different patterns of functional adaptation are consistent with the idea that reduced stem stiffness enhances proximal load transfer.

A comparative study of porous coatings in a weight-bearing total hip-arthroplasty model.

The purposes of this study were to compare ingrowth of bone into three types of porous coating and to determine the effect of the type of porous coating and the degree of coverage of the stem on the remodeling of bone on the femoral side in cementless hip arthroplasty. A left total hip arthroplasty was performed in forty dogs. Thirty of the dogs had a titanium-alloy femoral prosthesis that had had one of three types of commercially pure titanium porous material applied along the length of the anterior and posterior surfaces of the stem: ten with sintered fiber-metal, ten with sintered beads, and ten with plasma flame-spray coating. The remaining ten dogs had a femoral component that was circumferentially coated with commercially pure titanium that was plasma flame-sprayed along the length of the stem. In each group, five animals were killed at one month and five were killed at six months. Ingrowth of bone into all three types of porous coating was observed, indicating secure fixation of all components. By six months, there was more ingrowth of bone and new medullary bone adjacent to the proximal and distal aspects of the stems compared with the middle level of the stems in all groups. No significant difference in ingrowth of bone was observed in the beaded surface (25.2 per cent) and the fiber-metal surface (16.6 per cent) at one month, but at six months there was significantly less ingrowth into the beaded surface (23.3 per cent) than into the fiber-metal surface (37.3 per cent). In all groups, a proximal-to-distal gradient of loss of cortical bone was observed by six months. The group of dogs that had the stem with the circumferential coating experienced more severe loss of bone than did the three groups that had a stem with a partial coating. The magnitude of loss of bone was dependent on the extent rather than the type of porous coating.

A quantitative study of bone and soft tissues in cementless porous-coated acetabular components retrieved at autopsy

The authors examined 11 cementless acetabular components of one design retrieved at autopsy and made observations concerning tissue ingrowth and local tissue reaction, radiographic-histologic correlation, and the distribution of particulate wear debris. The cups were hemispherical in design with a commercially pure titanium fiber-metal porous coating. All of the prostheses were implanted with screws. The implants were in place for an average of 41 months (range, 5 weeks to 75 months). Ten of the cups had bone ingrowth, with the average volume fraction being 12.1 +/- 8.2%. There were no differences in the amount of bone ingrowth when the component was partitioned into nine anatomic regions. However, there was more bone adjacent to screw holes through which screws were inserted compared with empty screw holes. As the number of radiolucent zones increased on the clinical radiographs less bone ingrowth was observed histologically. The amount of metal debris in holes with screws and holes without screws was similar. In the longest term cases, polyethylene debris was noted within empty screw holes, but no granulomatous reactions or osteolytic processes were observed.

Metal-on-metal bearing surfaces.

Metal-on-metal bearing couples remain a popular option in total hip arthroplasty and are the only currently available option for surface replacement arthroplasty. In general, the intermediate-term clinical performance of metal-on-metal bearings has been favorable. There are, however, lingering concerns about the biologic consequences of metal release from these bearings in terms of both local tissue effects, including delayed-type hypersensitivity reactions in a subset of patients, and potential systemic effects as a consequence of chronic elevations in serum cobalt and chromium content. Advances in the understanding of the operant wear mechanisms in these bearings provide strategies for reducing the burden of metal released into the periprosthetic milieu, which in turn will mitigate the concerns about the biologic response to the metal debris. Continued surveillance of patients with these bearings is warranted to determine whether metal-on-metal bearing couples provide a long-term survivorship advantage over other bearing couple options and to evaluate whether chronic elevations in the body burden of cobalt and chromium is well tolerated over the long term.