What do we know about taper corrosion in total hip arthroplasty?

Mechanically assisted crevice corrosion (MACC) at metal/metal modular junctions in which at least one of the components is fabricated from cobalt-chromium alloy, has reemerged as a potential clinically significant complication in total hip arthroplasty. The clinical manifestation of MACC may include the development of an adverse local tissue reaction (ALTR), similar to what has been described in association with metal-on-metal bearing total hip and resurfacing arthroplasty. The clinical presentation of MACC-associated ALTRs may include pain and possibly late recurrent dislocations. Abnormal metal artifact reduction sequence magnetic resonance images and elevated serum metal levels (cobalt elevations out of proportion to chromium elevations) can be helpful in the diagnosis of these MACC-associated ALTRs.

Malignant neoplasms associated with orthopedic implant materials in rats.

The carcinogenic potential of 22 orthopedic prosthetic materials was studied by implantation in bone in Sprague-Dawley rats and evaluated by complete autopsy examination performed at the time of death or at the end of the 30 month experimental period. When the number of malignancies in these rats was compared with control and sham-operated animals, a small increase in sarcomata was observed in animals bearing metal alloy implants containing high contents of cobalt, chromium, or nickel. An increased incidence of lymphomata with bone involvement was also observed in rats bearing metal implants when compared with control and sham-operated animals.

Remodeling and ingrowth of bone at two years in a canine cementless total hip-arthroplasty model.

Remodeling and ingrowth of bone in association with the use of uncemented femoral components were examined at two years in a canine total hip-arthroplasty model. Twenty-two dogs received a unilateral uncemented femoral stem that was made of Ti6A14V and was covered with one of three types of titanium porous coating: fiber-metal, beads, or plasma flame-spray. The amount and distribution of ingrowth of bone differed somewhat among the groups at two years, but the patterns of remodeling of bone in the medullary canal and cortex were similar. In general, about 15 to 18 per cent of the cortical bone was lost adjacent to the levels of the stem that were covered with the porous coating. Most of the loss of cortical bone was due to subperiosteal resorption proximally and endosteal resorption at the middle and distal levels of the stem. Increased cortical porosity accounted for only a small fraction of the loss of cortical bone. The amount of medullary bone increased proximally and distally, so that the loss of total bone mass was significantly only at the mid-part of the stem. The amount of loss of cortical bone was similar to that observed in a previous six-month study, suggesting that a steady state was achieved in the present model.

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.

Maintenance of proximal cortical bone with use of a less stiff femoral component in hemiarthroplasty of the hip without cement. An investigation in a canine model at six months and two years.

A canine model of hemiarthroplasty of the hip was used to determine if the use of a less stiff femoral stem can reduce the amount of bone loss induced by stress-shielding. Two types of stem were used: the stiffer stems were made of a titanium alloy, and the less stiff stems were composed of a cobalt-chromium-alloy core with an outer polymer layer. The stems were identical in shape, and both types were circumferentially coated along their entire length (except for the distal five millimeters) with commercially pure titanium fiber metal. Ten dogs with each type of stem were followed for six months, and twelve dogs with each type of stem were followed for two years. Loss of cortical bone from the proximal part of the femur was associated with both types of stem, but typically 50 per cent less bone was lost with the less stiff implants. Most of the cortical loss occurred at the subperiosteal surface. The amount of medullary bone adjacent to the proximal and distal aspects of both types of stem increased; the less stiff stems were associated with a greater increase in the proximal region, and the stiffer stems were associated with a greater increase in the distal region. Similarly, there were peaks in the amount of bone growth into the proximal and distal portions of both types of stem, with a greater peak in proximal bone growth into the less stiff stems and a greater peak in distal bone growth into the stiffer stems.

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 paraaortic 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 paraaortic 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. (ABSTRACT TRUNCATED)

Revision, without cement, of aseptically loose, cemented total hip prostheses. Quantitative comparison of the effects of four types of medullary treatment on bone ingrowth in a canine model.

A model that replicated the radiographic and histological features of aseptic loosening of the femoral component of a total hip replacement that had been done with cement was created in thirty-seven dogs. A deep wound infection developed in one dog, and that dog was excluded from the study. Revision was performed without cement in twenty-nine dogs, which were then followed for six months. The remaining seven dogs were used for histological study only. The components that were used for revision were made from Ti-6-Al-4-V, and a titanium fiber-metal porous surface had been applied to the anterior, posterior, and medial surfaces of the proximal part of the stem. The femora were revised either with no graft material applied to the osseous defect; with hydroxyapatite/beta-tricalcium phosphate placed in the defect; with application of an autologous cancellous bone graft as part of a one-stage revision; or with application of an autologous cancellous bone graft as the first part of a two-stage revision, with implantation of the component four months later. The use of an autologous bone graft led to greater and more consistent ingrowth of bone. The greatest amount of bone ingrowth was found in the group in which the procedure had been done in two stages (18 +/- 4.1 per cent), followed by the group in which the prosthesis and the graft had been inserted in a single stage (15 +/- 5.0 per cent), the group that had been treated with hydroxyapatite/beta-tricalcium phosphate (10 +/- 9.1 per cent), and the control group, in which no graft had been used (7 +/- 7.0 per cent). Notably, all of the components in the animals in which an autologous graft had been used were well fixed by bone ingrowth, while the component in two of the animals in the group in which no graft had been used in one animal in the hydroxyapatite/beta-tricalcium phosphate group had only fibrous-tissue ingrowth. In contrast to the findings with respect to bone ingrowth, there was more medullary bone adjacent to the lateral aspect of the implant in the groups in which hydroxyapatite/beta-tricalcium phosphate or no graft had been inserted than in the groups that had had an autologous graft.(ABSTRACT TRUNCATED AT 400 WORDS)

Effects of radiation on fixation of non-cemented porous-coated implants in a canine model.

A non-weight-bearing porous-coated rod was implanted bilaterally in the proximal part of the humerus in thirty-five adult male mongrel dogs. In all of the animals, one limb was treated with radiation and the opposite limb served as the control. In twenty-one animals, the dose was 1000 centigrays (rads) and in fourteen, it was 500 centigrays. The strength of fixation and the volume fraction of ingrowth of bone were determined two, four, and eight weeks after the operation in the group that received 1000 centigrays and two and four weeks after the operation in the group that received 500 centigrays. Treatment with 500 centigrays had no significant effect on the strength of fixation or the amount of ingrowth of bone. In contrast, at two weeks, treatment with 1000 centigrays had reduced the strength of fixation to 50 per cent of the control value (p less than 0.01), although, at four and eight weeks, the strength of fixation was not significantly different than that in the control limb. The amount of ingrowth of bone in the irradiated limb was significantly reduced at two weeks (30 per cent of the control value) (p less than 0.01), four weeks (70 per cent of the control value) (p less than 0.05), and eight weeks (56 per cent of the control value) (p less than 0.05).

Focal osteolysis at the junctions of a modular stainless-steel femoral intramedullary nail.

BACKGROUND: During routine follow-up of patients treated with a three-piece stainless-steel modular femoral nail, osteolysis and periosteal reaction around the modular junctions of some of the nails were noted on radiographs. The purpose of this study was to evaluate the prevalence, etiology, and clinical relevance of these radiographic findings. METHODS: Forty-four femoral fractures or nonunions in forty-two patients were treated with a modular stainless-steel femoral intramedullary nail. Seventeen nails were excluded, leaving twenty-seven intramedullary nails in twenty-seven patients for this study. All patients had had a femoral diaphyseal fracture; nineteen had had an acute fracture and eight, a nonunion. These twenty-seven patients returned for radiographs, a physical examination, assessment of functional outcomes, assessment of thigh pain with a visual analog scale, determination of serum chromium levels, and nail removal if desired. A control group of sixteen patients treated with a one-piece stainless-steel femoral intramedullary nail was evaluated with use of the same outcome measures and was compared with the group treated with the modular femoral nail with regard to prevalence of thigh pain and serum chromium levels. Twelve modular femoral nails were removed according to the study protocol. The modular nail junctions were analyzed for corrosion products, and histopathologic analysis of tissue specimens from the femoral canal was performed. RESULTS: The twenty-seven patients were seen at a mean of twenty-one months after fracture fixation; twenty-six of the twenty-seven fractures healed. Twenty-three femora had at least one of three types of abnormalities-osteolysis, periosteal reaction, or cortical thickening--localized to one or both modular junctions. Eighteen patients had severe reactions, defined as osteolysis of > or =2 mm, cortical thickening of > or =5 mm, and/or a periosteal reaction (group 1). Nine patients had mild or no reactions (group 2). Serum chromium levels in group 1 (mean, 1.27 ng/ mL; range, 0.34 to 3.12 ng/mL) were twice as high as those in group 2 (mean, 0.53 ng/mL; range, 0.12 to 1.26 ng/mL). However, this difference did not reach significance with the numbers available. The differences in serum chromium levels between group 1 and the control group with a one-piece nail (mean, 0.26 ng/mL; range, 0.015 to 1.25 ng/mL) (p<0.01) and a control group without an implant (mean, 0.05 ng/mL; range, 0.015 to 0.25 ng/ mL) (p<0.01) were significant. The level of thigh pain recorded on the visual analog scale was also significantly different between group 1 and the control group with a one-piece implant (p = 0.03). Retrieved modular nails had signs of fretting corrosion as well as stainless-steel corrosion products adherent to the junction where the osteolysis occurred. Histologic and spectrographic analysis revealed two types of corrosion products that were consistent with stainless-steel within the peri-implant tissue and were associated with a foreign-body granulomatous response. CONCLUSIONS: The presence of corrosion products at the taper junctions suggests that particulate debris was a major factor in the etiology of the radiographic findings of osteolysis, periosteal reaction, and cortical thickening. Serum chromium levels were substantially elevated in the patients with a modular femoral nail, and such levels may serve as a marker of fretting corrosion of these devices.

Calcium phosphate-coated porous titanium implants for enhanced skeletal fixation.

Porous titanium fiber implants for cementless skeletal fixation by bone ingrowth were treated with a calcium phosphate coating applied by a plasma flame-spray technique. In a paired experiment, treated and control implants were inserted in the humeri and olecranons of 36 adult dogs for periods of 1, 2, 4, and 6 weeks. After the animals were sacrificed, a biomechanical evaluation of the strength of skeletal fixation of the implants and a histologic evaluation of bone ingrowth was done. The mean shear strength of skeletal fixation at four weeks for the calcium phosphate-coated implants was 24% greater (P less than .01) than for paired controls. No difference in strength of fixation between treated and control implants was present at other time periods. The osteoconductive properties of the ceramic coating were demonstrated by bone forming in direct contact with the calcium phosphate coating on the metal fibers of the treated implants. No significant increase for the volume of bone ingrowth was established for treated implants compared to paired controls at any time period.

Experimental studies of bone remodeling in total hip arthroplasty.

Experimental studies of bone remodeling after total hip arthroplasty are reviewed. Most of the studies have been motivated by the introduction of cementless hip replacements in which porous coatings are used to provide fixation by bone ingrowth. Stress shielding is thought to be the main factor responsible for bone loss after hip replacement. Experimentally, design features related to (1) the nature of the bone-implant interface and (2) stem stiffness have been tested to determine if the effects of stress shielding can be decreased. The dominant long-term design feature controlling bone remodeling in hip replacement appears to be stem stiffness.

Biocompatibility of Delrin 150: a creep-resistant polymer for total joint prostheses.

A thermoplastic polymer, Delrin 150 (polyoxymethylene homopolymer), with creep resistance ten times that of ultrahigh-molecular-weight polyethylene, is used as a material for total joint prostheses. A study was made of the local and systemic host response to this polymer when implanted in three different mammalian species. 316 LC stainless steel was used as a control. The materials were implanted into muscle and bone as solid cylinders. A total of 446 samples were implanted into 74 animals. The duration of implantation ranged from 2 weeks to 2 years. A semi-quantitative evaluation of local tissue reaction was performed. For each implant, 16 histological criteria were graded for severity of host tissue reaction. The liver, spleen, kidneys, pancreas, and lungs from each animal were also studied for evidence of systemic toxicity. The polymer implants exhibited a mild tissue reaction with the same characteristics as the control. Local tumor formation, bone osteolysis, and surrounding muscle necrosis were not seen. No pathological changes compatible with systemic toxicity by Delrin 150 were observed in the study of the organs. Delrin 150 in solid form did not exhibit local or systemic toxicity and is therefore biocompatible by this study. Powder implantation studies should be performed to simulate tissue response to wear particles.

Effect of pegs and screws on bone ingrowth in cementless total knee arthroplasty.

The purpose of the present study was to assess the effects of pegs and screws on bone ingrowth into the tibial component in cementless total knee replacement. Left total knee replacements were performed in 21 mature male dogs with 3 cementless porous-coated tibial tray configurations (7 animals per group): (1) 4-peg design implanted with cortical screws passing through the pegs; (2) 4-peg design implanted without screws; and (3) pegless design secured by 4 cortical screws. The animals were allowed unrestricted activity and were euthanized 6 months postoperatively. The pegless components (Group 3) had the highest extent of bone ingrowth into the tray (90.3% +/- 9.4%), followed by the components with 4 pegs only (Group 2, 82.8% +/- 9.2%), and the components with 4 pegs and 4 screws (Group 1, 75.9% +/- 11.8%). The difference between Groups 1 and 3 was statistically significant (p < 0.05). The volume fraction of bone ingrowth in the tray did not differ among the 3 groups, with an overall mean of 22.5% (+/- 4.6%). At the posterolateral quadrant, Group 1 had significantly less bone ingrowth than Group 3 within the tray whether measured as the extent (63.6% +/- 20.5% versus 91.0% +/- 10.6%, p < 0.05) or volume fraction (19.1% +/- 8.8% versus 32.9% +/- 10.5%, p < 0.05). There were no between-group differences at the other quadrants. This study indicated that pegs provided no added benefit in a circumstance where sufficient initial fixation was obtained with screws.

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.

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 for 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 half 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.

Postmortem retrieval of total joint replacement components.

Improved understanding of the clinical outcomes of orthopedic implants requires the study of implants at the end of their service life. Previous studies focused on the retrieval of so-called failed implants during surgical revision. Interest is now moving to the study of successful implants, which are those still in place at the patient's death. A procedure was developed for recruitment of implant patients and their families and for safe and effective device and tissue retrieval after death. More than 50 retrievals were performed to support various research efforts.

The susceptibility of smooth implant surfaces to periimplant fibrosis and migration of polyethylene wear debris.

The purpose of this investigation was to establish whether the tissue response and migration of polyethylene debris differed at noncemented smooth and porous implant surfaces. This was accomplished through 3 separate but closely related studies: (1) a canine cylindrical implant model with smooth and porous surfaces exposed to polyethylene debris; (2) a canine total hip arthroplasty model analyzing the interface between bone and femoral implants with various porous-coating configurations; and (3) a histologic analysis of autopsy-retrieved, human, noncemented hip prostheses with noncircumferential porous coating. The cylindrical implant model involved the placement of split cylinders, 1/2 porous and 1/2 smooth, into the distal femur and proximal tibia of 4 dogs. Four control implants and 10 test implants (chronically exposed to simulated polyethylene debris with a mean size of 4.7 microns) were examined histologically as long as 30 weeks after surgery. The canine hip study involved the study of 54 noncemented hip prostheses at periods of 1, 6, and 24 months. The prostheses possessed 4 different porous surface configurations: 1 with circumferential porous coating, 2 with noncircumferential coating, and 1 without porous coating. The human retrieval analysis involved the study of 7 cadaveric femora (age, 6 months-5 years) implanted with a straight titanium-alloy prosthesis possessing proximal pads of titanium fiber metal on the anterior, posterior, and medial aspects. With all implants in all 3 studies, there was the common finding of bone ingrowth at the porous implant surface and a fibrous interface or periprosthetic cavity around the portion of the implant that was smooth surfaced. The periprosthetic cavity typically was encapsulated by a thin continuous shell of trabecular bone. In addition, polyethylene debris was found to have preferentially migrated along the smooth implant surfaces. In the longer-term canine and human hip retrievals, polyethylene particles in the micron size range were present within histiocytes, whereas larger particles as much as 100 microns were found within foreign-body giant cells. Of importance for the implants from all 3 studies, with the exception of some pronounced cavities on the lateral aspect of the human hip prostheses, the periimplant cavities around the smooth surfaces were not detectable radiographically. This study clearly established a fundamental principle of relative barriers to particulate debris migration. Smooth implant surfaces are more susceptible than porous surfaces to the development of a fibrous tissue filled periimplant cavity and the subsequent migration of polyethylene wear debris.(ABSTRACT TRUNCATED AT 400 WORDS)

Local and distant products from modularity.

In this study, the local and distant distribution of solid and soluble products of corrosion from the head and neck junction of modular femoral total hip prosthetic components were characterized. Particulate corrosion products from retrieved implants and surrounding tissues were analyzed. Serum transport and urinary excretion of metal was measured in correlation with the degree of corrosion at the head and neck junction. Particles of metal oxides, metal chlorides, and chromium phosphate corrosion products were identified on implants of 10 designs from 6 manufacturers. The most abundant solid corrosion product on the implant and within the periprosthetic tissues (size range, < 1-200 micrometers) was an amorphous chromium orthophosphate hydrate-rich material. Serum cobalt and urine chromium concentrations were elevated significantly in patients with implants that had moderate to severe corrosion in comparison with those with no to mild corrosion. Solid corrosion products from modular femoral stems may accelerate articular wear via a 3-body mechanism. Phagocytosable particles of these corrosion products may stimulate macrophage-mediated periprosthetic bone loss. Systemic dissemination of metallic corrosion products raises the issue of systemic toxicity; however, no overt evidence of metal toxicity was observed in this study.

Histology of porous-coated acetabular components. 25 cementless cups retrieved after arthroplasty.

25 hemispherical acetabular components retrieved from patients who had a total hip arthroplasty (THA) were studied histologically. All of the components had titanium fiber metal porous coatings and were implanted with adjuvant screw fixation, 18 in primary THA and 7 in revision THA. None of the cups had been removed because of infection or failure of fixation. The components had been in place an average of 30 (1-140) weeks. 18 cups had bone ingrowth into the porous coating. Up to one third of the available void space within the porous coating was occupied by bone, while the maximal proportion of the area of the bone-implant interface with bone ingrowth was over 80 percent. Bone ingrowth was more often observed at the dome and in the vicinity of sites of screw fixation than elsewhere. Peripherally, bone ingrowth was less consistent, and in isolated areas fibrocartilage and mineralized fibrocartilage were occasionally observed. The longer-term cases had more bone ingrowth than the shorter-term cases. Apparent metallic debris was observed within histiocytes adjacent to screw holes, and the amount of this material increased with duration of implantation.