metal hypersensitivity reactions to orthopedic implants

doi: 10.1371/journal.pone.0210336. Intradermal testing and sublingual desensitization for nickel. Patient reports of metal allergy prior to implantation were associated with poorer functional outcomes (TKA) and mental health scores (THA) [44]. Dermatitis due to orthopaedic implants: a review of literature and report of three cases. Unfortunately, this is not definitive. Halpin DS. Please enable it to take advantage of the complete set of features! Luque I, Leyva L, Jose Torres M, Rosal M, Mayorga C, Segura JM, Blanca M, Juarez C. In vitro T-cell responses to beta-lactam drugs in immediate and nonimmediate allergic reactions. - 149.28.141.51. Practice gap: the role of patch testing in the selection and management of metal device implants. 2001;83A:428–36. Introduction: Metallic implants are integral to the practice of orthopedic surgery. Muller KE, Valentine-Thon E. Hypersensitivity to titanium: clinical and laboratory evidence. Chronic dermatitis beginning weeks to months after metallic implantation. Teo, W.Z.W., Schalock, P.C.  |  Biomed Res Int. volume 7, pages53–64(2017)Cite this article. 2019 Jan 17;14(1):e0210336. 2016;27:241–7. J Allergy Clin Immunol. Metal debris endocytosis and cytoskeletal rearrangement was visualised by confocal microscopy. However, patient-reported allergy was associated with decreased functional outcomes after TKA and poorer scoring of mental health after THA [44]. Cutaneous reactions to metal implants, orthopedic or otherwise, are well documented in the literature. Patch testing is probably the best pre- and post-implant screening test. 2011; 164:473–8. While uncommon, peri-implant metal allergic reactions may cause significant morbidity for the affected individual—including aseptic loosening, pseudotumor formation and frank device failure. Everness KM, Gawkrodger DJ, Botham PA, Hunter JA. Bravo D, Wagner ER, Larson DR, Davis MP, Pagnano MW, Sierra RJ. 2001 Sep-Oct;49(5):498-503; quiz 504-5. [ 16] T The metals most commonly used in orthopedic implants are … Although there are multiple studies for total hip and knee replacements, unfortunately there is no definitive research that reports a link between metal allergy and morbidity following shoulder arthroplasty [4]. This reluctance may in fact be correct, since the relationship between actual skin reactions in response to implanted metal allergy as well as peri-implant morbidity continues to be unclear [69]. J Pediatr Surg. J Allergy Clin Immunol. 1990;122:293–8. 14 Swelling and pain at the implant site are common, mimicking nonunion or surgical site infection. Adverse reactions to byproducts of joint replacements (AAOS/ORSI). Br Med J. Thyssen JP, Jakobsen SS, Engkilde K, Johansen JD, Soballe K, Menne T. The association between metal allergy, total hip arthroplasty, and revision. 2016;31(9):1910–5. Type IV allergic reactions to these implants occur, though infrequently. The prevalence of metal hypersensitivity in patients with implants is significantly higher than in the general population, with an even higher prevalence rate among patients with failed implanted devices. The dendritic cells present similar, but not the same. 2011;164:473–478. In the skin, the Langerhans cells are the primary antigen-presenting cell, while other similar dendritic cells and macrophages take on this role adjacent to the bone–implant interface. PubMed  In general, allergic risk of titanium material is smaller than that of other metal materials. On the other hand, there are multiple authors reporting opposite data, though the patient groups are smaller. Ann Rheum Dis. J Arthroplasty. In some cases, metallosis (metallic staining of the surrounding tissue), excessive periprosthetic fibrosis and muscular necrosis have also been reported [21,22,23]. 2003;48:49–50. Metal hypersensitivity reactions to implants—opinions and practices of patch testing dermatologists. J Biomed Mater Res. Rates of post-operative pain were similar in those with metal allergy determined by patch testing, compared to control patients. Cramers M, Lucht U. Bruze M. Thoughts on implants and contact allergy. Allergic dermatitis presumably due to metallic foreign bodies containing nickel or cobalt. 1974;8(3):11-26. doi: 10.1002/jbm.820080304. Hallab NJ, Caicedo M, Epstein R, McAllister K, Jacobs JJ. Histology consistent with allergic contact dermatitis. San Francisco. Orthopedic surgeons have different views of metal allergy and the necessity of testing. Morris DL. Article  Individuals reporting a prior history of metal reactions before device implantation were four times more likely to develop implant failure [39]. J Korean Med Sci. Dermatitis. The lymphocyte transformation test for the diagnosis of drug allergy: sensitivity and specificity. At this time, more research is needed to definitively determine the validity and appropriate clinical use of the LTT [81]. Contact Dermatitis. 2012;25(4):463. Baik JJ, Yoon YB, Park HS. ORTHOPEDIC IMPLANTS AND METAL HYPERSENSITIVITY The literature regarding reactions following hip arthroplasty shows conflicting research, and the extent to which metal sensitivity affects implant lifespan and longevity remains debated, without clear evidence-based guidelines. Sensitivity to titanium. Biomaterial hypersensitivity: is it real? Health Qual Life Outcomes. PubMed Google Scholar. In Germany, a consensus group pragmatically suggests using titanium alloys for any patient self-reporting metal allergy. 2012;66(2):55–62. Allergic or hypersensitivity reactions to orthopaedic implants can pose diagnostic and therapeutic challenges. A patient’s psychological status has strong influences on their clinical outcomes [46]. Arch Dermatol. Routine pre-implant screening or testing prior to surgery is not indicated, and opinions regarding the appropriate patients to test prior to surgery are controversial. Hypersensitivity reactions to orthopedic implanted materials exist but are rare. Thus, clear communication and making an effort to define patient expectations is important. This paper aims to answer each question in turn. concluded that testing is indicated in failed metal-on-metal temporomandibular joint replacements with unclear diagnosis [82]. Cousen PJ, Gawkrodger DJ. Br J Dermatol. If an evidence-based approach is desired, there is only one consensus regarding the morbidity of metal allergy from implanted devices—there is no agreement. Thyssen JP, Johansen JD, Menné T, Lidén C, Bruze M, White IR. 1993;29(1):1–5. An alternative approach uses clinical findings to identify those with a high suspicion of metal allergy who may benefit from metal allergy evaluation [77]. Listen to patient’s concerns about metal allergy if the concern arises. Much of Dr. Stejskal’s work involved using the testing to help diagnose patients with reactions to metals, thus facilitating the decision to have the medical and dental implants and devices containing metal safely removed and replaced with safer alternatives, and then, recording the health outcomes, the majority of which have involved significant improvement. Cutaneous reactions to metal implants, orthopedic or otherwise, are well documented in the literature. J Bone Joint Surg Am. 2008;37:75–88. Granchi D, Cenni E, Giunti A, Baldini N. Metal hypersensitivity testing in patients undergoing joint replacement: a systematic review. J Bone Joint Surg Am. CAS  Chronic dermatitis beginning weeks to months after metallic implantation. There are no scientific or expert agreements on whether metal hypersensitivity reactions cause joint morbidity or failure following implant, and thus there is also no agreement on which patients require pre-surgical allergy evaluation. What about the management plan for patients with suspected metal hypersensitivity post-implantation? In essence, hypersensitivity reactions become a diagnosis of exclusion for physicians. Jacobs JJ. CAS  A lymphocyte stimulation test before implantation of a chromium-containing device in those positive for chromium increased the risk of post-implant eczema [39]. Metal allergy and second generation metal on metal arthroplasties. The total incidence of total shoulder arthroplasty has also been steadily increasing, to 27,000 in 2008 [3]. Contact Dermatitis. Determining delayed-type hypersensitivity to metals can be done via two routes: by skin patch testing or through a blood test such as the lymphocyte transformation test (LTT) or leukocyte migration inhibition test. PubMed  Allergy. Protocols for patch testing have been proposed based on implant type and surgical location [60, 77, 78]. In a survey performed at the European Society of Contact Dermatitis (ESCD) and subsequently the ACDS meetings, 54% of respondents considered patch testing prior to surgery indicated for those individuals reporting moderate or severe rashes after metal contact. At this time, the scientific literature and these authors thus favor the skin patch test as the best available test to evaluate potential metal hypersensitivity reactions, both prior to and following implantation. CAS  Patient-reported metal allergy: a risk factor for poor outcomes after total joint arthroplasty. 1991;73(1):25. Orthopedic implants are composed of nickel, cobalt, chromium, molybdenum, zirconium and/or titanium alloys, while stainless steel is used in fixed orthopedic devices such as screws/plates [4, 5, 30]. Even given this, there is a rare subset of patients with metal hypersensitivity who will develop cutaneous and/or systemic reactions to implanted metals. While it is promising that the academic discussion surrounding metal hypersensitivity is thriving, the conflicting conclusions in the literature shed insufficient light on pertinent issues, including but not limited to how patients who suffer from chronic post-surgical pain should be managed and the extent to which symptoms may be caused by metal allergy. Orthopade. Hallab NJ, Mikecz K, Jacobs JJ. Merle C, Vigan M, Devred D, et al. The literature regarding reactions following hip arthroplasty shows conflicting research, and the extent to which metal sensitivity affects implant lifespan and longevity remains debated, without clear evidence-based guidelines. Yamauchi R, Morita A, Tsuji T. Pacemaker dermatitis from titanium. Fisher AA. Management of patients who suffer from residual post-implantation pain is not as well defined. The prospect of biomaterial hypersensitivity developing in response to joint implant materials was first presented more than 30 years ago. There are two reactions that seem to occur in patients who have metal hypersensitivity to a knee replacement implant. Article  Dermatitis. Metal sensitivity in patients with a hinge arthroplasty of the knee. Unfortunately, the LTT is not widely available for clinical use, is not standardized, has inter-laboratory variability and is often not covered by insurance (leading to higher patient costs). Post-operative pain was not different between any of the groups. Early osteolysis following second-generation metal-on-metal hip replacement. Contact Dermatitis. Complete recovery after removal of the offending implant. Injury. Prospective analysis of human leukocyte functional tests reveals metal sensitivity in patients with hip implant. Zamzow H. Allergic reactions to knee prostheses from the viewpoint of a trauma surgeon of the “Medizinischer Dienst der Krankenversicherung”. Earlier perspectives from the United States were from Granchi and Reed, both suggesting patch testing prior to surgery in patients reporting a clinical history or metal sensitivity [56, 57]. Mental health and outcomes in primary total joint arthroplasty. Park CN, White PB, Meftah M, Ranawat AS, Ranawat CS. Given that there is no clear conclusion on the link between metal allergy and implant failure, it logically follows that there is a similar lack of consensus on the approach to the testing and management of patients. The Rising Potential Impact of Metal Hypersensitivity Fang CS, Harvie P, Gibbons CL, Whitwell D, Athanasou NA, Ostlere S. The imaging spectrum of peri-articular inflammatory masses following metal-on-metal hip resurfacing. In the leukocyte migration inhibition test, mixed population leukocyte migration activity is measured in the presence of antigen. Dermatitis. The assumption is that there exist numerous more common causes for pain, loosening and/or failure and that these should be explored prior to considering metal hypersensitivity as the cause. Mikhael MM, Hanssen AD, Sierra RJ. Histopathological examination of periprosthetic tissue supports the correlation between wear particles leading to metal allergy and subsequent implant failure [31,32,33,34,35,36,37]. J Bone Joint Surg. Benson MK, Goodwin PG, Brostoff J. J Arthroplasty. Unsurprisingly, studies for total knee arthroplasty have also not been wholly consistent. J Biomed Mater Res A. Granchi D, Cenni E, Tigani D, Trisolino G, Baldini N, Giunti A. Shoulder arthroplasty in the patient with metal hypersensitivity. There is thus extensive literature on both sides that asserts or renounces a correlation between metal hypersensitivity reaction and metallic implant failure, which only serves to add to the existing confusion. Willert HG, Buchhorn GH, Fayyazi A, Flury R, Windler M, Koster G, Lohmann CH. The result is reported as a stimulation index, comparing the reactions. For patients who experience residual pain after TKA, metal hypersensitivity should only be suspected if the patient had a normal physical exam and radiographs/CT scans or MARS MRI, and normal laboratory work-up [83]. PubMed Central  Failure of metal-on-metal total hip arthroplasty mimicking hip infection. Also, the LTT may produce false negative results if the test is not transported and processed in a timely manner. Metal sensitivity in patients treated for tibial fractures with plates of stainless steel. A reappraisal. Br J Dermatol. 2005;87:28–36. J Bone Joint Surg Am. PubMed  Metal joint implants can cause allergic reactions in some recipients, according to Dr. Sam Nasser, writing at the OrthoSuperSite, the website of "Orthopedics Today" magazine. patients with suspected metal hypersensitivity reactions, this review aims to explore in depth the existing body of evidence pertaining to hypersensitivity reactions to metallic implants in orthopedic surgery, endovascular surgery, obstetrics and gynecology, and dental surgery. Arch Dermatol. 2015;13:1–6. Metal allergy resurfaces in failed hip endoprostheses. However, we suggest that pre-implant patients should be asked about a history of hypersensitivity reactions to metals, and patch testing should be recommended to patients who have experienced such reactions. Article  Other adverse reactions including device failure, chronic inflammation, pain, loosening of joint prostheses or re-stenosis of cardiac stents can also occur [20]. 2016; 98-B:437–41. 2008;144(8):1042–4. J Arthroplasty. Hypersensitivity reactions to metallic implants—diagnostic algorithm and suggested patch test series for clinical use. J Bone Joint Surg Br. While uncommon, peri-implant metal allergic reactions may cause significant morbidity for the … Br J Dermatol. Is this possible, and could it be a cause of pain or irritation after surgery? Google Scholar. Williams SN, Wolford ML, Bercovitz A. Whereas dermal metal hypersensitivity is common, affecting 10% to 15% of the population, the immune reaction from implanted metals is much less common (< 0.1%), but has been associated with metal allergy and hypersensitivity producing a multitude of patient symptoms. In a survey of the ACDS and EACD members, 83% of respondents considered the patch test to be the diagnostic test of choice for evaluation of metal allergy. Another author concluded that there was no evidence of implant failure due to metal allergy [43]. PubMed Central  Innate Immun. Type IV allergic reactions to these implants occur, though infrequently. Most interestingly, those with patch test positives had similar reoperation, revision or complication rates in comparison to those with a normal skin patch testing as well as matched controls. While reports of cutaneous reactions following skin exposure to items containing metal are rela-tively common, similar reactions to implanted metallic orthopedic devices are considerably rarer. 1975;15:374–5. In clinical practice, it is a luxury to have guidelines which are clearly supported by a body of evidence. Epub 2015 Sep 1. A triple assay technique for the evaluation of metal-induced, delayed-type hypersensitivity responses in patients with or receiving total joint arthroplasty. Nam D, Li K, Riegler B, Barrack RL. Routine pre-implant testing in asymptomatic individuals is not indicated. Should hypoallergenic alloys, with which surgeons may be less familiar and are more expensive, be used? Cutis. J Bone Joint Surg Am. 2009;91:443–6. The lack of clear evidence-based clinical guidance in this area creates a potential breeding ground for unwarranted lawsuits, particularly when patients with self–reported metal allergies pre-implantation allege inadequate pre-operative allergy assessment [25]. Google Scholar. Arthritis Care Res (Hoboken). Mitchelson AJ, Wilson CJ, Mihalko WM, Grupp TM, Manning BT, Dennis DA, Goodman SB, Tzeng TH, Vasdev S, Saleh KJ. Arch Orthop Trauma Surg. 2012;66(1):4–19. Nautiyal VP, Mittal A, Agarwal A, Pandey A. Natl J Maxillofac Surg. 2010; 162:235–6. 2007;119:726–30. Metal-on-metal bearings and hypersensitivity in patients with artificial hip joints. Mowad CM. 2008;29:1494–500. Routine pre-implant testing is not recommended. Metal sensitivity in patients with joint replacement arthroplasties. 1977;19:285–6. Langerhans cells seem to have a greater antigen-presenting ability when compared to macrophages in the blood [30, 72]. Thomas P, Schuh A, Ring J, Thomsen M. Orthopedic surgical implants and allergies: joint statement by the implant allergy working group (AK 20) of the DGOOC (German Association of Orthopedics and Orthopedic Surgery), DKG (German Contact Dermatitis Research Group) and DGAKI (German Society for Allergology and Clinical Immunology). Patch testers’ opinions regarding diagnostic criteria for metal hypersensitivity reactions to metallic implants. The association between metal allergy, total knee arthroplasty, and revision. Cutaneous and systemic hypersensitivity reactions to metallic implants. In view of the findings of the study, skin patch testing showed little value for predicting the clinical outcomes and was not recommended as a guide for implant alloy choice. While uncommon, peri-implant metal allergic reactions may cause significant morbidity for the affected individual—including aseptic loosening, pseudotumor formation and frank device failure. 1978;37:373–5. Clin Exp Allergy. Gallo J, Goodman SB, Konttinen YT, Raska M. Particle disease: biologic mechanisms of periprosthetic osteolysis in total hip arthroplasty. 2016;31(8):1717–21. A stronger body of research is needed to clarify the relationship between metal allergy and reactions to implanted metal devices. On the one hand, a case–control study (356 cases/712 controls) reported no increase in the risk of total hip arthroplasty (THA) revision in patients with cases with metal allergy, and metal allergy risk was not elevated after THA [26]. Once a clear understanding of this relationship is defined, if it exists, appropriate guidelines can be drafted in the attempt to clarify management of or completely avoid allergic reactions to metal implants. A group of 18 patients with pre-implant confirmed nickel allergy were followed for 6.3 years following implantation of a nickel-containing device. Antony FC, Holden CA. J Bone Joint Surg Am. 1992;27:257–8. Kim SH, Wise BL, Zhang Y, Szabo RM. Hallab’s literature review in 2001 found a metal allergy prevalence of ~25% in patients with well-functioning THA and 60% in those with poorly functioning or failed implants [30]. Acta Orthop Belg. 1977;2:401–4. This site needs JavaScript to work properly. A recent review lends support to the stance that pre-implantation testing is not routinely needed: the review acknowledged the presence of an association between implant failure and metal hypersensitivity, but concludes that the absence of a casual relationship means that the use of “hypoallergenic” implants cannot be justified [43]. Biomaterials. Basketter DA, Briatico-Vangosa G, Kaestner W, Lally C, Bontinck WJ. Morwood MP, Garrigues GE. 1993;51:251–2. Allergy in total knee arthroplasty: a review of the facts. 2013;11:64. 1998;117:383–6. Lalor PA, Revell PA, Gray AB, et al. Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. Krecisz B, Kiec-Swierczynska M, Chomiczewska-Skora D. Allergy to orthopedic metal implantsda prospective study. In view of the lack of consensus in the field on the appropriate steps to evaluate and manage patients with suspected metal hypersensitivity reactions, this review aims to analyze current evidence on hypersensitivity reactions to metallic implants in orthopedic surgery, endovascular surgery, obstetrics and gynecology, and dental surgery. What is clear, however, is that even if a correlation is purported to exist, none of the authors are able to conclusively report the direction of causation. Metal Hypersensitivity Reactions to Orthopedic Implants. 2010 Jul-Aug;57(4):127-30. Generalized eczema from Vitallium osteosynthesis material. Bourne RB, Chesworth BM, Davis AM, et al. J Bone Joint Surg Br. Nyfeler B, Pichler WJ. David R. Lionberger, MD, orthopedic surgeon and assistant professor at Texas A&M University, said for patients to have a metal hypersensitive reaction to an implant, there needs to be a … Perruccio AV, Davis AM, Hogg-Johnson S, et al. Hypersensitivity to Orthopedic Implants: A Review of the Literature Hypersensitivity to Orthopedic Implants: A Review of the Literature. Park YS, Moon YW, Lim SJ, Yang JM, Ahn G, Choi YL. Sensitivity to implant materials in patients with total knee arthroplasties. Complete recovery after removal of the offending implant. In the United Kingdom, a Delphi Analysis of orthopedic surgeons reported that standard cobalt chromium/stainless steel devices should be implanted regardless of the patient’s metal allergy status [54]. Their general opinion is that there is not a relevant correlation between patch testing on the skin and the immunologic responses in and around the bone–implant interface [68]. J Shoulder Elbow Surg. For those not agreeing with preoperative testing, 38% considered a titanium-based alloy an acceptable alternative [59]. Metal hypersensitivity and total knee arthroplasty. Article  Sensitivity to metals in 40 patients with failed hip endoprosthesis. COVID-19 is an emerging, rapidly evolving situation. In other words, an orthopedic surgeon has to first exclude the more likely causes of continued pain or swelling around an implant such as infection, instability, implant loosening or tendinitis before considering hypersensitivity associated with an implant. Skeletal Radiol. J Biomed Mater Res A. Symptoms of allergies to one or more of the metals contained in orthopedic implants include swelling, itching and rashes on the skin around the site of the implant. Shah B, Cohee A, Deyerle A, Kelly CS, Frantz F, Kelly RE, Kuhn MA, Lombardo M, Obermeyer R, Goretsky MJ. A cause of implant failure? Despite this, we believe several conclusions can be made: routine pre-implant testing in asymptomatic individuals is not indicated; listen to patient’s concerns about metal allergy if the concern arises; patch testing is probably the best pre- and post-implant screening test; post-implantation testing is controversial and even positive LTT or patch test does not definitively diagnose morbidity from a metal allergy; and complete recovery following revision placement of an immunologically inert device is diagnostic. On the one hand, a case–control study (356 cases/712 controls) reported no [Hypersensitivity to metals in patients with orthopedic implants]. Screening for symptomatic metal sensitivity: a prospective study of 92 patients undergoing total knee arthroplasty. Lavernia CJ, Alcerro JC, Brooks LG, et al. 2011;93:2249–54. Merritt K, Brown SA. Cutis. 1. A cohort study of 127 patients with 161 TKA (56 patients with patch test positives) versus 161 matched control TKAs without known metal allergy history or positive patch testing were followed over a period of 5.3 years [41]. All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this manuscript, take responsibility for the integrity of the work as a whole, and have given final approval to the version to be published. These include component malalignment, complex regional pain syndrome, crepitation, early aseptic loosening, infection, instability, patellofemoral symptoms or patellar clunk syndrome [83].

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