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Imaging of Adverse Reactions to Metal Debris Ezekiel Maloney, MD1
Alice S. Ha, MD1
Theodore T. Miller, MD, FACR2
1 Department of Radiology, University of Washington, Seattle,
Washington 2 Department of Radiology and Imaging, Hospital for Special Surgery, New York, New York
Address for correspondence Alice S. Ha, MD, Department of Radiology, University of Washington, Box 354755, 4245 Roosevelt Way NE, Seattle, WA 98105 (e-mail: [email protected]).
Abstract Keywords
► metallosis ► ARMD (adverse reactions to metal debris) ► hip arthroplasty ► imaging
Hip replacements with metal-on-metal components can cause a spectrum of adverse tissue reactions—from benign localized fibrosis and chronic inflammation to delayed hypersensitivity response. In addition to history, physical examination, and relevant laboratory data, imaging plays a critical role in the evaluation of hip arthroplasties. Imaging assessment begins with radiographs and may be followed by ultrasound, computed tomography, or MRI. MRI optimized for metal artifact reduction is the most sensitive and specific imaging modality and is essential in assessing the spectrum of metal-related adverse tissue reactions. In this article, we discuss the history, pathophysiology, and imaging findings of adverse reactions to metal debris.
History
Background Introduction On August 24, 2010, the DePuy Orthopedics unit of Johnson & Johnson issued a recall of 93,000 implanted metal-on-metal (MoM) hip resurfacing devices known as the Articular Surface Replacement (ASR) Total Hip system.1 The ASR XL Acetabular component (commonly used as part of a total hip system) was cited at a higher than expected revision rate of 12 to 13% at 5 years, according to the National Joint Registry for England and Wales.2 The U.S. Food and Drug Administration (FDA) subsequently issued orders for postmarket surveillance studies to 21 manufacturers of MoM hip systems in 2011.3 In 2012, the Australian National Registry published an alarming revision rate of 44% for ASR MoM implants at 7-year follow-up.4 These events heralded a highly publicized accumulation of explanted MoM total hip replacement (THR) reports describing bizarre soft tissue inflammatory responses that would later be described as “adverse reactions to metal debris” (ARMD).5 In recent years, significant research has been dedicated to recognizing and screening for ARMD in high-risk patients, and imaging plays a critical role in this process. To understand the imaging of ARMD, one must first understand the history of hip replacement development.
Issue Theme Imaging of Joint Replacements; Guest Editor, Theodore T. Miller, MD, FACR
Total hip arthroplasty (THA) is one of the most successful orthopedic procedures in modern times. An estimated 400,000 THAs are performed each year in the United States alone,6 and 10- to 15-year follow-up data show that > 87% of THRs are working successfully, are pain free, and are without complication postoperatively.7 The first THRs used MoM bearing surfaces and were pioneered in the 1950s and 1960s including the McKee-Farrar8 and Ring9 prostheses. Some of the early models were prone to frictional torque that resulted in seizing and loosening in an unacceptably short period of time, and yet many would later be discovered to have survived without complication for > 20 years with minimal wear.10–13 Nonetheless, MoM THAs were largely replaced in the 1970s by Sir John Charnley’s lowfriction metal-on-polyethylene (MoP) prosthesis.14 Despite predictably good outcomes of MoP THA for older patients, the rapid wear of polyethylene and resultant aseptic osteolysis of the prostheses was unacceptable for younger, more active patients.15–18 In 1988, the second-generation MoM THA was introduced by Weber19 as a solution to this problem; a smaller femoral diameter head (28–32 mm) made of high-carbon cobalt-chromium alloy led to a low-wear profile, decreased frictional torque, and excellent longevity for young patients over 15 years of follow-up.20–22
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DOI http://dx.doi.org/ 10.1055/s-0034-1396764. ISSN 1089-7860.
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However, as MoM bearings regained favor, significant complications arose with the use of large diameter head ( 36 mm) prostheses including the ASR system. Originally conceived as salvage implants for failed surface replacement arthroplasties, large diameter bearing surfaces became popular due to (1) decreased dislocation risk by increasing the distance the prosthetic head needed to travel to dislocate, (2) improved range of motion for younger, highly active patients, (3) better film lubrication, and (4) decreased edge loading, particularly if the cup was out of the manufacturer’s safe zone.23,24 Unfortunately, the tight tolerance of the ASR system ultimately hindered its film lubricant, leading to marked metal ion shedding.25,26 The disastrous patient outcomes observed with the ASR system are representative of major concerns surrounding the entire class of large-diameter MoM THRs including high revision rates, early aseptic loosening, and increased incidence of ARMD.5,26–32 An additional notable development involving hip arthroplasties came in 2001 with the introduction of modular neck designs.33 Modulation offers surgeons flexible, intraoperative adjustments of the offset and limb length via the head-neck taper, and femoral anteversion via the neck-stem taper to maximize the biomechanics of the replaced hip.34 However, modular systems, by definition, have metal-to-metal interactions at their insertion points, and fretting and corrosion can occur at the head-neck junction (the “trunnion”) and neck-stem junction of modular systems. The associated release of cobalt-alloy debris has been associated with ARMD and prosthetic failure,35–40 and it accounts for cases of ARMD in non MoM THAs such as MoP and metal-on-ceramic designs.38,41 Although the use of MoM articular surfaces has dropped precipitously in recent years due to the adverse events reported in large-head MoM THAs, metal-related soft tissue complications are far from over. In 2009, 35% of THA surgeries in the United States had MoM bearings, and there remain > 500,000 patients with implanted MoM hips in the United States and > 40,000 in the United Kingdom.27 Modular neck prostheses with metal components, as well as low-risk smalldiameter MoM hips will likely continue to be used in modern THAs.
aseptic loosening of prostheses, and bone and soft tissue destruction.46–50 ARMD, also referred to as “adverse local tissue reactions” (ALTR), is an umbrella term that includes a spectrum of histologic findings associated with inflammatory responses in periprosthetic soft tissues.
Pathophysiology
To standardize the histologic diagnosis of ARMD, Campbell et al60 proposed histologic scoring criteria that included assessment of loss of synovial integrity (more loss ¼ higher score), ratio of macrophages and lymphocytes within the inflammatory infiltrate (more lymphocytes ¼ higher score), and loss of overall tissue organization (less organization ¼ higher score) (►Table 1). Lower overall scores correlated with wear-related prosthesis failure (macrophage-dominated response/metallosis), and higher overall scores correlated with delayed hypersensitivity-type reactions in the absence of significant articular surface wear (lymphocyte-dominated response/ALVAL). A recent explant series by Berstock et al61 found a shorter time to surgical revision in patients with pure ALVAL or mixed response ( 4 years versus 7 years for purely macrophage-driven response) and proposed greater nociceptive stimuli from deeper soft tissue inflammatory infiltration,
MoM articulations generate metal ions and particulate debris from mechanical and corrosive wear that stimulate immune responses and can ultimately contribute to prosthetic failure. The mechanisms underlying this response are complex and not yet fully understood. To date, two key inflammatory pathways have been identified: (1) innate immunity, a nonspecific macrophage-mediated granulomatous response (as seen in foreign body reaction), and (2) adaptive immunity, a T-lymphocyte–mediated response that is antigen specific and has immunologic memory.42–45 Activation of these inflammatory pathways by metallic ions and/or complexes manifests in a range of macroscopic tissue reactions—from benign localized fibrosis and chronic inflammation to delayed hypersensitivity response. Lymphocyte-dominated type IV hypersensitivity responses are associated with severe pain, early Seminars in Musculoskeletal Radiology
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• “Metallosis”: the macroscopic gray-black staining of joint lubricant and synovium by metallic wear particles.51 Histologically, it is characterized by sheets of macrophages with intracytoplasmic metallic debris and well-defined granulomas.52 • Aseptic lymphocytic vasculitis associated lesions (ALVALs): a specific histologic reaction originally described by Willert et al46 in association with MoM bearings but also reported with non-MoM acetabular bearings45,53 (of note, these studies did not characterize the taper or neck-stem junction of their failed “non-MOM” bearing cohorts). It is characterized by perivascular lymphocytic infiltration, lymphoid aggregates of B and T cells, plasma cells, tissue necrosis, fibrin exudation, high endothelial venules, and accumulation of macrophages. (High endothelial venules are specialized postcapillary venous swellings found in secondary lymphoid organs and characterized by plump endothelial cells, unlike the usual thinner endothelial cells found in regular venules. They enable lymphocytes circulating in the blood to directly enter a lymph node.) Its appearance is most similar to type IV delayed hypersensitivity reaction. Macroscopically, ALVAL has been described as murky/milk-like purulent-appearing fluid within the joint.54,55 • Type I hypersensitivity: true metal allergy in the context of orthopedic joint prostheses, whereby soluble antigen (e.g., chromium, cobalt, or nickel) reacts with immunoglobulin E and results in mast-cell activation, is exceedingly rare, and remains incompletely understood. Some small series have described a correlation between preoperative cutaneous metal allergy and postimplantation complications.56–58 However, in a large case-control study, there was no increased risk of surgical revision in patients with metal allergies; nor was the incidence of metal allergy increased following surgery.59
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Table 1 Histologic and imaging grading of aseptic lymphocytic vasculitis associated lesion ALVAL scorea
Histologic featuresa
MRI featuresb
7 mm. Note the solid synovitis around the femoral neck. (b) Axial proton-density image of a 40-yearold woman with ALVAL shows a metal-on-metal total hip replacement and synovial expansion and thickening with decompression of thick-walled synovitis (curved arrow) into the greater trochanteric bursa (arrowheads) through a lateral dehiscence in the pseudocapsule, as well as a mixed fluidsolid anterior soft tissue mass (arrow). (c) Coronal multi-acquisition variableresonance image combination image of a 52-year-old woman with ALVAL shows a modular neck stem junction (arrow) with solid synovitis laterally (curved arrow) and distended and thick-walled synovitis medially (arrowheads). (d) Axial proton-density image of a 61-year-old woman with metallosis shows pseudocapsular distension by low signal intensity debris (straight arrow), erosion into the anterior column (curved arrow), and iliac nodes containing wear-induced metallic debris (arrowhead).
dotumors do not represent a unique histologic pattern; rather they are a macroscopic manifestation of ARMD and can be seen with both metallosis and ALVAL. Pseudotumors can also be seen in polyethylene wear. Given the nonspecific nature of pseudotumors and the indiscriminate use of the term for both distended bursae and separate areas of soft tissue reaction, there is a movement away from using this term (Hollis Potter, MD, personal communication). Rather than using the term pseudotumor, it is better to simply describe the findings, keeping in mind that large synovial volumes are nonspecific because they can be seen in metallosis, ALVAL, polyethylene wear, and infection, but that the additional finding of synovial thickening is highly suggestive of ALVAL.26,62,101,107–109 Solid corrosion products from electrochemical deterioration of metallic prosthetic materials can form at any point along the surface of an implant and act as a “third body” in the joint, contributing to implant wear.38 Even with nonMoM bearings, corrosion and fretting movement can occur at modular metallic interfaces (e.g., the neck-stem junction or head-neck junction/trunnion), particularly those with mixed metal components (e.g., titanium stem and cobalt-chrome head) and thus greater electrochemical potential.110,111 These interfaces may predispose the patient to the same types of ARMD seen in MoM bearings.
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11 Schmalzried TP, Szuszczewicz ES, Akizuki KH, Petersen TD,
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Conclusion Hip replacements with MoM components can cause a spectrum of adverse tissue reactions from benign localized fibrosis and chronic inflammation to delayed hypersensitivity response, all of which are described under the umbrella term adverse reactions to metal debris. ARMD is an important consideration in the diagnostic work-up of symptomatic MoM hip replacements or THRs with MoM junctions either at the trunnion or at the stem-neck junction. Various imaging modalities including radiography, CT, ultrasound, and MRI are helpful in routine screening, as well as characterization of problematic THRs. MARS MRI is the most sensitive and specific imaging test for patients who are clinically suspicious for ARMD, and it is highly valuable in assessing the spectrum of ARMD and the need for surgical intervention.
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screening of periarticular soft tissue abnormality around metalon-metal bearings. J Arthroplasty 2012;27(6):895–900 Nishii T, Sakai T, Takao M, Yoshikawa H, Sugano N. Is ultrasound screening reliable for adverse local tissue reaction after hip arthroplasty? J Arthroplasty 2014 April 26 (Epub ahead of print) Siddiqui IA, Sabah SA, Satchithananda K, et al. A comparison of the diagnostic accuracy of MARS MRI and ultrasound of the painful metal-on-metal hip arthroplasty. Acta Orthop 2014;85(4): 375–382 Potter HG, Nestor BJ, Sofka CM, Ho ST, Peters LE, Salvati EA. Magnetic resonance imaging after total hip arthroplasty: evaluation of periprosthetic soft tissue. J Bone Joint Surg Am 2004;86A(9):1947–1954 Weiland DE, Walde TA, Leung SB, et al. Magnetic resonance imaging in the evaluation of periprosthetic acetabular osteolysis: a cadaveric study. J Orthop Res 2005;23(4):713–719 Hargreaves BA, Worters PW, Pauly KB, Pauly JM, Koch KM, Gold GE. Metal-induced artifacts in MRI. AJR Am J Roentgenol 2011; 197(3):547–555 Lee MJ, Kim S, Lee SA, et al. Overcoming artifacts from metallic orthopedic implants at high-field-strength MR imaging and multi-detector CT. Radiographics 2007;27(3):791–803 Koch KM, Lorbiecki JE, Hinks RS, King KF. A multispectral threedimensional acquisition technique for imaging near metal implants. Magn Reson Med 2009;61(2):381–390 Lu W, Pauly KB, Gold GE, Pauly JM, Hargreaves BA. SEMAC: Slice encoding for metal artifact correction in MRI. Magn Reson Med 2009;62(1):66–76 Hayter CL, Koff MF, Shah P, Koch KM, Miller TT, Potter HG. MRI after arthroplasty: comparison of MAVRIC and conventional fast spinecho techniques. AJR Am J Roentgenol 2011;197(3):W405-11 Potter HG, Foo LF. Magnetic resonance imaging of joint arthroplasty. Orthop Clin North Am 2006;37(3):361–373, vi–vii Fritz J, Lurie B, Miller TT. Imaging of hip arthroplasty. Semin Musculoskelet Radiol 2013;17(3):316–327 Nawabi DH, Nassif NA, Do HT, et al. What causes unexplained pain in patients with metal-on metal hip devices? A retrieval, histologic, and imaging analysis. Clin Orthop Relat Res 2014;472(2): 543–554 Anderson H, Toms AP, Cahir JG, Goodwin RW, Wimhurst J, Nolan JF. Grading the severity of soft tissue changes associated with metal-on-metal hip replacements: reliability of an MR grading system. Skeletal Radiol 2011;40(3):303–307 Matthies AK, Skinner JA, Osmani H, Henckel J, Hart AJ. Pseudotumors are common in well-positioned low-wearing metal-onmetal hips. Clin Orthop Relat Res 2012;470(7):1895–1906 Hauptfleisch J, Pandit H, Grammatopoulos G, Gill HS, Murray DW, Ostlere S. A MRI classification of periprosthetic soft tissue masses (pseudotumours) associated with metal-on-metal resurfacing hip arthroplasty. Skeletal Radiol 2012;41(2):149–155 van der Weegen W, Brakel K, Horn RJ, et al. Comparison of different pseudotumor grading systems in a single cohort of metal-on-metal hip arthroplasty patients. Skeletal Radiol 2014; 43(2):149–155 Pandit H, Glyn-Jones S, McLardy-Smith P, et al. Pseudotumours associated with metal-on-metal hip resurfacings. J Bone Joint Surg Br 2008;90(7):847–851 Glyn-Jones S, Roques A, Taylor A, et al. The in vivo linear and volumetric wear of hip resurfacing implants revised for pseudotumor. J Bone Joint Surg Am 2011;93(23):2180–2188 Kwon YM, Glyn-Jones S, Simpson DJ, et al. Analysis of wear of retrieved metal-on-metal hip resurfacing implants revised due to pseudotumours. J Bone Joint Surg Br 2010;92(3):356–361 Grammatopolous G, Pandit H, Kwon YM, et al. Hip resurfacings revised for inflammatory pseudotumour have a poor outcome. J Bone Joint Surg Br 2009;91(8):1019–1024
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2012_05_10_MoM_Consensus_statement1.pdf. Accessed September 22, 2014 United States Food and Drug Administration (FDA). Information about soft tissue imaging and metal ion testing. Available from: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/MetalonMetalHipImplants/ ucm331971.htm. Accessed September 22, 2014 Lewinnek GE, Lewis JL, Tarr R, Compere CL, Zimmerman JR. Dislocations after total hip-replacement arthroplasties. J Bone Joint Surg Am 1978;60(2):217–220 Fisher J. Bioengineering reasons for the failure of metal-on-metal hip prostheses: an engineer’s perspective. J Bone Joint Surg Br 2011;93(8):1001–1004 Miller TT. Imaging of hip arthroplasty. Semin Musculoskelet Radiol 2006;10(1):30–46 Keogh CF, Munk PL, Gee R, Chan LP, Marchinkow LO. Imaging of the painful hip arthroplasty. AJR Am J Roentgenol 2003;180(1): 115–120 Puri L, Wixson RL, Stern SH, Kohli J, Hendrix RW, Stulberg SD. Use of helical computed tomography for the assessment of acetabular osteolysis after total hip arthroplasty. J Bone Joint Surg Am 2002; 84-A(4):609–614 Shon WY, Gupta S, Biswal S, Han SH, Hong SJ, Moon JG. Pelvic osteolysis relationship to radiographs and polyethylene wear. J Arthroplasty 2009;24(5):743–750 Walde TA, Weiland DE, Leung SB, et al. Comparison of CT, MRI, and radiographs in assessing pelvic osteolysis: a cadaveric study. Clin Orthop Relat Res 2005;(437):138–144 Walde TA, Mohan V, Leung S, Engh CA Sr. Sensitivity and specificity of plain radiographs for detection of medial-wall perforation secondary to osteolysis. J Arthroplasty 2005;20(1): 20–24 Ohashi K, El-Khoury GY, Bennett DL, Restrepo JM, Berbaum KS. Orthopedic hardware complications diagnosed with multi-detector row CT. Radiology 2005;237(2):570–577 De Man B, Nuyts J, Dupont P, Marchal G, Suetens P. Metal streak artifacts in X-ray and computed tomography: a simulation study. IEEE Trans Nucl Sci 1999;46(3):691–696 Kataoka ML, Hochman MG, Rodriguez EK, Lin PJ, Kubo S, Raptopolous VD. A review of factors that affect artifact from metallic hardware on multi-row detector computed tomography. Curr Probl Diagn Radiol 2010;39(4):125–136 Buckwalter KA, Parr JA, Choplin RH, Capello WN. Multichannel CT imaging of orthopedic hardware and implants. Semin Musculoskelet Radiol 2006;10(1):86–97 Roth TD, Maertz NA, Parr JA, Buckwalter KA, Choplin RH. CT of the hip prosthesis: appearance of components, fixation, and complications. Radiographics 2012;32(4):1089–1107 Jacobs JJ, Roebuck KA, Archibeck M, Hallab NJ, Glant TT. Osteolysis: basic science. Clin Orthop Relat Res 2001;(393):71–77 Hallab NJ, Jacobs JJ. Biologic effects of implant debris. Bull NYU Hosp Jt Dis 2009;67(2):182–188 Cyteval C, Hamm V, Sarrabère MP, Lopez FM, Maury P, Taourel P. Painful infection at the site of hip prosthesis: CT imaging. Radiology 2002;224(2):477–483 Siddiqui IA, Sabah SA, Satchithananda K, et al. Cross-sectional imaging of the metal-on-metal hip prosthesis: the London ultrasound protocol. Clin Radiol 2013;68(8):e472–e478 Almousa SA, Greidanus NV, Masri BA, Duncan CP, Garbuz DS. The natural history of inflammatory pseudotumors in asymptomatic patients after metal-on-metal hip arthroplasty. Clin Orthop Relat Res 2013;471(12):3814–3821 Garbuz DS, Hargreaves BA, Duncan CP, Masri BA, Wilson DR, Forster BB. The John Charnley Award: Diagnostic accuracy of MRI versus ultrasound for detecting pseudotumors in asymptomatic metal-on-metal THA. Clin Orthop Relat Res 2014;472(2): 417–423
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corrosion-related failure of the rejuvenate modular total hip replacement. J Bone Joint Surg Am 2014;96(6):481–487 113 Molloy DO, Munir S, Jack CM, Cross MB, Walter WL, Walter WK Sr. Fretting and corrosion in modular-neck total hip arthroplasty femoral stems. J Bone Joint Surg Am 2014;96(6):488–493
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Imaging of Adverse Reactions to Metal Debris Ezekiel Maloney, MD1
Alice S. Ha, MD1
Theodore T. Miller, MD, FACR2
1 Department of Radiology, University of Washington, Seattle,
Washington 2 Department of Radiology and Imaging, Hospital for Special Surgery, New York, New York
Address for correspondence Alice S. Ha, MD, Department of Radiology, University of Washington, Box 354755, 4245 Roosevelt Way NE, Seattle, WA 98105 (e-mail: [email protected]).
Abstract Keywords
► metallosis ► ARMD (adverse reactions to metal debris) ► hip arthroplasty ► imaging
Hip replacements with metal-on-metal components can cause a spectrum of adverse tissue reactions—from benign localized fibrosis and chronic inflammation to delayed hypersensitivity response. In addition to history, physical examination, and relevant laboratory data, imaging plays a critical role in the evaluation of hip arthroplasties. Imaging assessment begins with radiographs and may be followed by ultrasound, computed tomography, or MRI. MRI optimized for metal artifact reduction is the most sensitive and specific imaging modality and is essential in assessing the spectrum of metal-related adverse tissue reactions. In this article, we discuss the history, pathophysiology, and imaging findings of adverse reactions to metal debris.
History
Background Introduction On August 24, 2010, the DePuy Orthopedics unit of Johnson & Johnson issued a recall of 93,000 implanted metal-on-metal (MoM) hip resurfacing devices known as the Articular Surface Replacement (ASR) Total Hip system.1 The ASR XL Acetabular component (commonly used as part of a total hip system) was cited at a higher than expected revision rate of 12 to 13% at 5 years, according to the National Joint Registry for England and Wales.2 The U.S. Food and Drug Administration (FDA) subsequently issued orders for postmarket surveillance studies to 21 manufacturers of MoM hip systems in 2011.3 In 2012, the Australian National Registry published an alarming revision rate of 44% for ASR MoM implants at 7-year follow-up.4 These events heralded a highly publicized accumulation of explanted MoM total hip replacement (THR) reports describing bizarre soft tissue inflammatory responses that would later be described as “adverse reactions to metal debris” (ARMD).5 In recent years, significant research has been dedicated to recognizing and screening for ARMD in high-risk patients, and imaging plays a critical role in this process. To understand the imaging of ARMD, one must first understand the history of hip replacement development.
Issue Theme Imaging of Joint Replacements; Guest Editor, Theodore T. Miller, MD, FACR
Total hip arthroplasty (THA) is one of the most successful orthopedic procedures in modern times. An estimated 400,000 THAs are performed each year in the United States alone,6 and 10- to 15-year follow-up data show that > 87% of THRs are working successfully, are pain free, and are without complication postoperatively.7 The first THRs used MoM bearing surfaces and were pioneered in the 1950s and 1960s including the McKee-Farrar8 and Ring9 prostheses. Some of the early models were prone to frictional torque that resulted in seizing and loosening in an unacceptably short period of time, and yet many would later be discovered to have survived without complication for > 20 years with minimal wear.10–13 Nonetheless, MoM THAs were largely replaced in the 1970s by Sir John Charnley’s lowfriction metal-on-polyethylene (MoP) prosthesis.14 Despite predictably good outcomes of MoP THA for older patients, the rapid wear of polyethylene and resultant aseptic osteolysis of the prostheses was unacceptable for younger, more active patients.15–18 In 1988, the second-generation MoM THA was introduced by Weber19 as a solution to this problem; a smaller femoral diameter head (28–32 mm) made of high-carbon cobalt-chromium alloy led to a low-wear profile, decreased frictional torque, and excellent longevity for young patients over 15 years of follow-up.20–22
Copyright © 2015 by Thieme Medical Publishers, Inc., 333 Seventh Avenue, New York, NY 10001, USA. Tel: +1(212) 584-4662.
DOI http://dx.doi.org/ 10.1055/s-0034-1396764. ISSN 1089-7860.
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However, as MoM bearings regained favor, significant complications arose with the use of large diameter head ( 36 mm) prostheses including the ASR system. Originally conceived as salvage implants for failed surface replacement arthroplasties, large diameter bearing surfaces became popular due to (1) decreased dislocation risk by increasing the distance the prosthetic head needed to travel to dislocate, (2) improved range of motion for younger, highly active patients, (3) better film lubrication, and (4) decreased edge loading, particularly if the cup was out of the manufacturer’s safe zone.23,24 Unfortunately, the tight tolerance of the ASR system ultimately hindered its film lubricant, leading to marked metal ion shedding.25,26 The disastrous patient outcomes observed with the ASR system are representative of major concerns surrounding the entire class of large-diameter MoM THRs including high revision rates, early aseptic loosening, and increased incidence of ARMD.5,26–32 An additional notable development involving hip arthroplasties came in 2001 with the introduction of modular neck designs.33 Modulation offers surgeons flexible, intraoperative adjustments of the offset and limb length via the head-neck taper, and femoral anteversion via the neck-stem taper to maximize the biomechanics of the replaced hip.34 However, modular systems, by definition, have metal-to-metal interactions at their insertion points, and fretting and corrosion can occur at the head-neck junction (the “trunnion”) and neck-stem junction of modular systems. The associated release of cobalt-alloy debris has been associated with ARMD and prosthetic failure,35–40 and it accounts for cases of ARMD in non MoM THAs such as MoP and metal-on-ceramic designs.38,41 Although the use of MoM articular surfaces has dropped precipitously in recent years due to the adverse events reported in large-head MoM THAs, metal-related soft tissue complications are far from over. In 2009, 35% of THA surgeries in the United States had MoM bearings, and there remain > 500,000 patients with implanted MoM hips in the United States and > 40,000 in the United Kingdom.27 Modular neck prostheses with metal components, as well as low-risk smalldiameter MoM hips will likely continue to be used in modern THAs.
aseptic loosening of prostheses, and bone and soft tissue destruction.46–50 ARMD, also referred to as “adverse local tissue reactions” (ALTR), is an umbrella term that includes a spectrum of histologic findings associated with inflammatory responses in periprosthetic soft tissues.
Pathophysiology
To standardize the histologic diagnosis of ARMD, Campbell et al60 proposed histologic scoring criteria that included assessment of loss of synovial integrity (more loss ¼ higher score), ratio of macrophages and lymphocytes within the inflammatory infiltrate (more lymphocytes ¼ higher score), and loss of overall tissue organization (less organization ¼ higher score) (►Table 1). Lower overall scores correlated with wear-related prosthesis failure (macrophage-dominated response/metallosis), and higher overall scores correlated with delayed hypersensitivity-type reactions in the absence of significant articular surface wear (lymphocyte-dominated response/ALVAL). A recent explant series by Berstock et al61 found a shorter time to surgical revision in patients with pure ALVAL or mixed response ( 4 years versus 7 years for purely macrophage-driven response) and proposed greater nociceptive stimuli from deeper soft tissue inflammatory infiltration,
MoM articulations generate metal ions and particulate debris from mechanical and corrosive wear that stimulate immune responses and can ultimately contribute to prosthetic failure. The mechanisms underlying this response are complex and not yet fully understood. To date, two key inflammatory pathways have been identified: (1) innate immunity, a nonspecific macrophage-mediated granulomatous response (as seen in foreign body reaction), and (2) adaptive immunity, a T-lymphocyte–mediated response that is antigen specific and has immunologic memory.42–45 Activation of these inflammatory pathways by metallic ions and/or complexes manifests in a range of macroscopic tissue reactions—from benign localized fibrosis and chronic inflammation to delayed hypersensitivity response. Lymphocyte-dominated type IV hypersensitivity responses are associated with severe pain, early Seminars in Musculoskeletal Radiology
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• “Metallosis”: the macroscopic gray-black staining of joint lubricant and synovium by metallic wear particles.51 Histologically, it is characterized by sheets of macrophages with intracytoplasmic metallic debris and well-defined granulomas.52 • Aseptic lymphocytic vasculitis associated lesions (ALVALs): a specific histologic reaction originally described by Willert et al46 in association with MoM bearings but also reported with non-MoM acetabular bearings45,53 (of note, these studies did not characterize the taper or neck-stem junction of their failed “non-MOM” bearing cohorts). It is characterized by perivascular lymphocytic infiltration, lymphoid aggregates of B and T cells, plasma cells, tissue necrosis, fibrin exudation, high endothelial venules, and accumulation of macrophages. (High endothelial venules are specialized postcapillary venous swellings found in secondary lymphoid organs and characterized by plump endothelial cells, unlike the usual thinner endothelial cells found in regular venules. They enable lymphocytes circulating in the blood to directly enter a lymph node.) Its appearance is most similar to type IV delayed hypersensitivity reaction. Macroscopically, ALVAL has been described as murky/milk-like purulent-appearing fluid within the joint.54,55 • Type I hypersensitivity: true metal allergy in the context of orthopedic joint prostheses, whereby soluble antigen (e.g., chromium, cobalt, or nickel) reacts with immunoglobulin E and results in mast-cell activation, is exceedingly rare, and remains incompletely understood. Some small series have described a correlation between preoperative cutaneous metal allergy and postimplantation complications.56–58 However, in a large case-control study, there was no increased risk of surgical revision in patients with metal allergies; nor was the incidence of metal allergy increased following surgery.59
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Table 1 Histologic and imaging grading of aseptic lymphocytic vasculitis associated lesion ALVAL scorea
Histologic featuresa
MRI featuresb
7 mm. Note the solid synovitis around the femoral neck. (b) Axial proton-density image of a 40-yearold woman with ALVAL shows a metal-on-metal total hip replacement and synovial expansion and thickening with decompression of thick-walled synovitis (curved arrow) into the greater trochanteric bursa (arrowheads) through a lateral dehiscence in the pseudocapsule, as well as a mixed fluidsolid anterior soft tissue mass (arrow). (c) Coronal multi-acquisition variableresonance image combination image of a 52-year-old woman with ALVAL shows a modular neck stem junction (arrow) with solid synovitis laterally (curved arrow) and distended and thick-walled synovitis medially (arrowheads). (d) Axial proton-density image of a 61-year-old woman with metallosis shows pseudocapsular distension by low signal intensity debris (straight arrow), erosion into the anterior column (curved arrow), and iliac nodes containing wear-induced metallic debris (arrowhead).
dotumors do not represent a unique histologic pattern; rather they are a macroscopic manifestation of ARMD and can be seen with both metallosis and ALVAL. Pseudotumors can also be seen in polyethylene wear. Given the nonspecific nature of pseudotumors and the indiscriminate use of the term for both distended bursae and separate areas of soft tissue reaction, there is a movement away from using this term (Hollis Potter, MD, personal communication). Rather than using the term pseudotumor, it is better to simply describe the findings, keeping in mind that large synovial volumes are nonspecific because they can be seen in metallosis, ALVAL, polyethylene wear, and infection, but that the additional finding of synovial thickening is highly suggestive of ALVAL.26,62,101,107–109 Solid corrosion products from electrochemical deterioration of metallic prosthetic materials can form at any point along the surface of an implant and act as a “third body” in the joint, contributing to implant wear.38 Even with nonMoM bearings, corrosion and fretting movement can occur at modular metallic interfaces (e.g., the neck-stem junction or head-neck junction/trunnion), particularly those with mixed metal components (e.g., titanium stem and cobalt-chrome head) and thus greater electrochemical potential.110,111 These interfaces may predispose the patient to the same types of ARMD seen in MoM bearings.
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11 Schmalzried TP, Szuszczewicz ES, Akizuki KH, Petersen TD,
12 13
Conclusion Hip replacements with MoM components can cause a spectrum of adverse tissue reactions from benign localized fibrosis and chronic inflammation to delayed hypersensitivity response, all of which are described under the umbrella term adverse reactions to metal debris. ARMD is an important consideration in the diagnostic work-up of symptomatic MoM hip replacements or THRs with MoM junctions either at the trunnion or at the stem-neck junction. Various imaging modalities including radiography, CT, ultrasound, and MRI are helpful in routine screening, as well as characterization of problematic THRs. MARS MRI is the most sensitive and specific imaging test for patients who are clinically suspicious for ARMD, and it is highly valuable in assessing the spectrum of ARMD and the need for surgical intervention.
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Recent explant series of failed modular THR systems have shown MARS MRI to be a valuable tool in identifying adverse local tissue reactions in this context including periprosthetic osteolysis, synovitis, capsular thickening, and pseudotumor formation.112,113
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