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Is There an Association Between Contact Allergy and Orthopedic Metal Implants? – a Systematic Review

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Örebro University School of Medicine

Medicine, Advanced course Degree project, 15

ECTS August 2018

Author: Ante Gibson Supervisors: Magnus Lindberg, MD, PhD

School of health and medicine, Örebro University, Örebro, Sweden

Is There an Association Between

Contact Allergy and Orthopedic

Metal Implants? – a Systematic

Review

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Abstract

Introduction

Allergic contact dermatitis is a common disease. Common contact allergens are nickel, cobalt and chromium. The Swedish contact dermatitis research group (SCDRG) made a statement on metal implants and contact allergy stating: “it is a known problem, but there is uncertainty as to what extent”. A systematic review could help finding more information on the subject.

Aim

This study assesses whether there is a known association between contact allergy and orthopedic implants through a systematical review of articles on the subject.

Materials and Method

A search was made using PubMed and it was systematically documented. The search was built from the defined “PICO”. A relevance assessment was made from pre-defined exclusion criteria in two steps; the first from titles and abstracts and the second from full text articles. A quality assessment graded five articles, inspired by GRADE.

Result

The search resulted in 95 articles. The first step of the assessment excluded 79 articles, leaving 16. The second step of the assessment excluded ten articles, one was not acquired leaving five. No significant association was shown in any article. Conclusion

This study cannot show any association between contact allergy and orthopedic implants. The phenomenon is likely rare. Further research is needed.

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Abbreviations

DTH - delayed type hypersensitivity

CD4+ - cluster of differentiation 4 positive T cell

TH cell – T helper cell

MHC - major histocompability complex TJA - total joint arthroplasty

TKA - total knee arthroplasty THA – total hip arthroplasty

LTT – lymphocyte transformations test

SCDRG – Swedish contact dermatitis research group MeSH – Medical subject headings

TiNbN – titanium niobium nitride CrCo – chromium cobalt

RCT – randomized controlled trial ns – no significance

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Table of Contents

Abstract ... 2

Introduction ... 2

Aim ... 2

Materials and Method ... 2

Result ... 2 Conclusion ... 2 Abbreviations ... 3 Introduction ... 5 Contact Dermatitis ... 5 Overview ... 5

Allergic Contact Dermatitis ... 5

Symptoms ... 5

Hypersensitivity Reactions ... Fel! Bokmärket är inte definierat. Overview ... Fel! Bokmärket är inte definierat. Subdivisions ... Fel! Bokmärket är inte definierat. Type IV Hypersensitivity ... Fel! Bokmärket är inte definierat. Allergens ... 6

Nickel and Cobalt ... 6

Chromium ... 6

Contact Allergy Testing ... 6

Patch Testing ... 6

Lymphocyte Transformation Test... 6

Orthopedic implants and Contact Dermatitis ... 6

Aim ... 8 Methods... 9 Search ... 9 Strategy ... 9 Scope ... 9 Relevance Assessment ... 9 Step One ... 10 Step Two ... 10 Quality Assessment ... 10 Ethical Considerations ... 10 Result ... 12 Search ... 12 Relevance Assessment ... 13 Step One ... 13 Step Two ... 13 Quality Assessment ... 14 Discussion ... 15

Strengths and Limitations ... 15

Conclusion ... 17

Appendix ... 18

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Introduction

Contact Dermatitis

Contact dermatitis is an eczematous reaction that takes place when the skin reacts to irritants or allergens[1].

Overview

There are different types of eczematous diseases. They all have similar skin

symptoms and a T-cell driven reaction is common, but they are separated clinically and sometimes when known, based on etiology. Contact dermatitis is one of these diseases.

Contact dermatitis is in turn subdivided into allergic- and irritative contact dermatitis. The latter is more common, though both states can be present in a mixed

presentation[2].

The disease causes an inflammatory reaction in the skin. It is caused by exposure to environmental substances or synthetically produced chemicals. The allergic and irritant conditions can be difficult to distinguish between[3]. This article focuses on allergic contact dermatitis.

Allergic Contact Dermatitis

This type of contact dermatitis requires the individual to be sensitized through

exposure to an allergen. An allergic reaction cannot take place before sensitization has happened. The exposure to an allergen after sensitization results in an immune

response and it can happen anywhere on the body where the individual is exposed to the antigen. It is classified as a type IV-delayed type hypersensitivity[2].

There are two variants of type IV hypersensitivity type: (1) delayed-type

hypersensitivity (DTH) and (2) direct cell cytotoxicity. Allergic contact dermatitis falls under the DTH reaction, which is the focus of this report. The DTH reaction is driven by the TH1-type CD4+ cells, which in turn recruit other immune cells, most

importantly macrophages, that cause most of the host tissue damage.[4]

Among Swedish patients who underwent patch testing in 2009, the prevalence of positive patch test reactions for nickel was 26.7% for women and 7.0% for men. The prevalence of cobalt patch test reactions was 7.3% for women and 3.0% for men. The prevalence for testing positive for chromium was 5.4% for women and 4.6% for men according to the same study. The numbers have gradually declined since the year 2000, when a previous measurement was made[5]. In the general Swedish population, the prevalence of contact allergy to nickel was 8.3%, cobalt 1.1% and chromium 0.2% in 2015[6].

Symptoms

Symptoms usually appear 1-2 days after exposure for the already sensitized;

sometimes sooner with stronger allergies. Itching red skin and rashes are seen in the acute phase[2].

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Allergens

Nickel and Cobalt

Nickel and cobalt are common allergens. When ionized in sweat, they can cause eczema. They are part of many stainless-steel alloys but will not ionize in that state and thus stainless-steel will not cause eczema. Nickel jewelry like earrings is historically a common source of nickel allergy[2].

Chromium

Chromium, especially in its hexavalent form, cause contact allergy. Metallic

chromium is not a source of allergy[2]. Hexavalent chromium is for example used in chrome plating, dyes and leather tanning[7].

Contact Allergy Testing

Patch Testing

The current method in use to diagnostically identify allergen and the contact allergy disease is patch testing. It is performed through applying relevant allergen(s) to the skin of the affected patient in an amount and concentration that is standardized. Later the patch is removed, the result is measured, and the inflammatory reaction is scored. The scoring is conducted through evaluating among other things: the spread of inflammation, edema and vesicles[3].

For the purpose of diagnosis, patch testing has been proven reliable[8]. An unwanted side effect that has been reported in a few cases show that patch testing can sensitize the patient; though, the risk is minimal[3].

Lymphocyte Transformation Test

The lymphocyte transformation test (LTT) is another method that can be used to test the allergic disposition of an individual. It is done by taking memory T-lymphocytes from the blood and then stimulate them with an allergen in vitro, which then results in a response. It might be able to give more extensive information on the exact

properties of the response. It is a newer method and not calibrated with the same precision as patch testing. It might have a tendency to give false positive results (low specificity) though, it does not leave the risk of accidentally sensitizing the patient[3].

Orthopedic implants and Contact Dermatitis

Commonly, metal implants are found in total hip arthroplasty (THA), total knee arthroplasty (TKA) and in fixation of fractures. These are needed because of the common diseases osteoarthrosis and rheumatoid arthritis, but also for fractures and implant revision surgery[9].

The first THA prostheses were metal-on-metal. Their use resulted in elevated levels of cobalt and chromium in the body, leading to cases of metal sensitization and implants failing. It is unclear whether the sensitization caused the failures or if it was the other way around. Thus, they were gradually abandoned, in favor of metal-on-polyethylene prostheses. Allergy and implant failure seem not to be a problem with these newer prostheses[10].

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Use of metal-on-metal prostheses is increasing again, typically in the form of high-carbon cobalt-chromium-molybdenum alloys. This may again lead to increased level of metal particles in the body of the patients with prostheses with potential risk for sensitization[10]. Several potential cases of allergic reactions to metal implants have been described[11-13].

The Swedish contact dermatitis research group (SCDRG) made a statement on metal implants and contact allergy in 2016 stating that it is a known problem, but there is uncertainty as to what extent. A need for more research on the subject to support the existing guidelines was also stated. This statement was based on the current

knowledge of the group[14].

A systematic review could investigate the subject to see if there is more data to find that can improve the current state of knowledge.

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Aim

The aim of this study is to investigate through a systematic review if there is an association between contact allergy and orthopedic implants. Specifically, to clarify if there is a reason or not to give an already allergic implant candidate an implant not containing the allergen in question immediately, or after revision surgery, or never. The result of such a study can further support the clinician’s decision making to improve the health and current treatment for patients with implants and contact allergy.

The primary objective was formulated as follows:

• Is there a known association between orthopedic metal implants and development of contact allergy towards the metals contained in these implants?

The primary objective was then restructured using the PICO-model, resulting in the following:

- P(population) – Patient who gets an orthopedic implant

- I(intervention) – A metal implant containing a relevant allergen.

- C(comparison) – Patient who does not receive an implant or patient who receives

an implant not containing any relevant allergens. - O(outcome) – Development of allergic contact dermatitis.

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Methods

The method of searching and reviewing articles was mainly carried out following instructions from a manual made by the Swedish agency for health technology assessment and assessment of social services (SBU)[15].

Search

The search was made solely in PubMed. Searching the Cochrane library was also considered but does not contain articles in this category. Other databases were excluded due to the limited scope of this study and limited accessibility.

Initially, free text searches were made to get an overview of the field. A field expert and a search strategist were consulted in the early stages of the search process to assist in the execution of these searches. It was done in collaboration with the author, to find search strategies and improve the execution of the main systematic search. The test search gave perspective on the scope of the search result and calibrated the search focus. Articles that were found using this method were checked for index-words or other text that would help guide the main search.

The main search in PubMed was made and documented systematically. The result from the search was imported into the reference management software “Zotero”, where it was checked for duplicates.

Strategy

The strategy for the search was built from the previously created “PICO”, where the parts were represented among the search terms and -phrases, creating search blocks. Though, including every step of the “PICO” made the search too narrow, so the only ones to make it to the main search were blocks built on the “P” and the “I”.

The blocks were searched separately and were then combined through use of parentheses and Boolean operators to trim the search.

PubMed’s Medical subject headings (MeSH)-terms were used combined with free text, to include as many relevant articles as possible.

Scope

Issues rose regarding finding enough material, which lead to a general widening of the search. Articles of other languages than English and Swedish were included in the search and later excluded in the relevance assessment-stage due to language

limitations of the reviewing author. Because of the difficulty of finding enough relevant material, no other limitations were set.

Relevance Assessment

The relevance assessment process was divided into two steps:

1. A swift look through the articles found was made with pre-determined exclusion criteria as a filter.

2. A more thorough review was done where full text articles were checked for relevance according to the same previous criteria. Both steps were done by a single person, the article author.

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Articles were excluded according to the following exclusion criteria: • Non-relevant study design

• Non-relevant population • Non-relevant intervention • Non-relevant outcome • Double publication

• Language other than English or Swedish • Abstract missing

Study designs considered relevant were randomized controlled trials, cohort studies and case-control studies.

The exclusion criteria were related to the main objective of this study and its inclusion criteria that were stated in the “PICO” (see aim).

Step One

This step was made based on the search results gathered before, either through reading the title; and where the title clearly pointed in the wrong direction the article was excluded or, more often, through reading the article abstract.

The results of the assessment were binary, the study could either be included or excluded. The studies were not graded in any way. The aim throughout this process was to rather include than exclude, to minimize the risk of missing out on any relevant data at a later stage.

Step Two

Articles were reviewed in full text regarding relevance. In this step, the studies and the reason for their exclusion were documented. It was done systematically, beginning with the first criteria and continuing downwards. Usually articles failed on multiple criteria, but they are still listed under just one criterium: the first mismatch that was discovered.

Quality Assessment

The quality assessment was inspired by the GRADE approach and followed SBUs quality assessment templates. Adjustments in the templates were made to

accommodate for the different study types. Studies were examined regarding systematic-, treatment-, assessment-, attrition and reporting bias when relevant. Precision, publication bias, effect size, impact of confounders and if the study is relevant to Swedish conditions were also considered.

Four different criteria for quality assessment were set: high, moderate, low and very low, where high is good quality and very low is inadequate. Randomized controlled clinical trials were initially considered to be of high quality. The rating was further lowered if any reason for this was found during the quality assessment. The same was done with cohort and case-control studies, but they started their grading on low quality. They were not assessed with the same quality requirement and used a different template than the randomized controlled trials.

Ethical Considerations

Since this study is about reviewing other articles, few ethical considerations can be made. This study intends to systematically review other studies.

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The goal of this study is to offer opportunity to better health for the patients in question. The measure of choice to reach this goal is reviewing articles and that will not have any known negative effects on the already studied populations. Therefore, the risk/reward ratio is in favor of the project.

This study does not intend to plagiarize other studies. It is written as a part of the education at the school of health and medicine at Örebro university and it is also financed through this institution. The work intends to have a scientific approach and follow common research practice. There is no economic, academic or other conflict of interest with the author.

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Result

Search

The main search was made in PubMed 2018-12-18 (Table 1). Search words used were variants of contact dermatitis, orthopedic implant, delayed hypersensitivity, nickel, cobalt and chromium; these were derived from the “PI-part” of the “PICO”. Three combined search sets were created. The last three search sets were combined in the final set into one collection, with some overlap, resulting in a total of 95 items. Table 1. Search documentation from main search made in PubMed 2018-12-18

Search Blocks Number Search text and terms

Population: Contact dermatitis 1 "Dermatitis, Allergic Contact"[Mesh] 2 contact allergy 3 metal allergy

4 1 OR 2 OR 3

Intervention: Orthopedic implant 5 "Joint Prosthesis"[Mesh] 6 "Internal Fixators"[Mesh] 7 orthopedic implant

8 5 OR 6 OR 7

Intervention:

Hypersensitivity-related metals 9 "Nickel"[Mesh] 10 "Cobalt"[Mesh] 11 "Chromium"[Mesh]

12 9 OR 10 OR 11

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Relevance Assessment

Step One

This step started with 95 studies and 79 were excluded, resulting in 16 studies being included and made it through to the second step.

Step Two

Ten studies were excluded in this step and five included. One article was not acquired and therefore not included. For more information on the excluded studies and the reason why they were excluded, see appendix.

Figure 1. Flow chart describing the relevance assessment process Total articles

identified from search (n=95)

Articles excluded in the first step

(n=79)

Articles assessed in full text

(n=16)

Articles excluded in the second step

(n=10) Article not aquired (n=1) Articles included for quality assessment (n=5)

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Quality Assessment

Five studies were assessed for quality. One randomized controlled trial (RCT), one retrospective cohort and three case-control studies. The quality of the RCT was moderate. The quality of the cohort was very low, as was the quality of one case-control study. The remaining two case-case-control studies were of low quality. None of the studies showed any significance in results regarding a possible association between orthopedic implants and contact allergy.

Table 2. The studies included in the review with quality assessment Author Year

Reference Lützner, 2013 [16]

Thienpont,

2015 [17] Granchi 2008 [18] Granchi 2005 [19] Hallab, 2004 [20] Study Design Randomized

controlled trial

Retrospective

Cohort Case-control Case-control Case-control Population 120 TKAa patients, 61 in intervention and 59 in control 40 TKAa patients matched with 80 controls 94 patients in three groups 223 patients in three groups 57 individuals divided into three groups Intervention Coated TKAa TiNbN d

coated TKAa TKA

a THAb THAb

Control Standard

TKAa Standard CrCoe TKAa TKA a candidates THA b candidates No THA b Effect

Measure Patch testing Clinical observation Patch testing Patch testing LTT

c

Results Nsf, one case

of weak reaction to cobalt in the intervention group. Nsf, no cases were observed. Nsf. Nsf. Nsf, reaction to chromium was slightly more common in the THA group. Quality moderate, potential conflict of interests Very low, short follow-up

Low Low Very low,

high selection bias

a total knee arthroplasty b total hip arthroplasty

c lymphocyte transformation test d titanium niobium nitride e chromium cobalt

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Discussion

This study aimed to find out whether there is an association between contact allergy and orthopedic implants by systematically reviewing articles on the subject. A search in PubMed was made based on the PICO-model, finding 95 articles to review. A relevance assessment was made in two steps where 79 articles were excluded in the first step and ten in the second step. One additional article was not acquired, leaving five articles for quality assessment. The only RCT was considered moderate quality and two case-control studies were considered low quality. The remaining two studies were considered very low quality. No study showed any significant results regarding an association between contact allergy and orthopedic implants.

The RCT found in this study had potential conflict of interests since it was sponsored by a company and the authors had received honoraria from the same company. Though, the authors probably intended to show a statistically significant difference, where the anti-allergic implant performed better than the standard implant. Since this was not the case, it could be considered in favor of their results.

All five articles failed to show a significance in association between allergy and orthopedic implants. This is in line with what other articles researching the same field so far have found[10],[21]. It also shows, together with the quality assessment, that the research to be found today is limited. A larger randomized controlled trial with longer follow-up and good quality, or a large directory study might make the situation clearer.

Few relevant articles were found in this study. One reason that only a few randomized controlled trials have been made comparing anti-allergic custom implants with

standard implants might be lacking evidence for contact dermatitis related to implants. Furthermore, there are ethical issues with patients potentially getting inferior treatment. This last aspect lowered the quality of the RCT included in this study, since the local guidelines stated that patients with confirmed allergy should get an anti-allergic custom implant. Though, the current state of evidence does not support this routine. The economic cost of anti-allergic custom implants may be an additional reason these studies are scarce in numbers.

The two studies with low quality provides limited information on this subject. The two with very low quality were considered inadequate.

Strengths and Limitations

Use of the PICO-model is common practice in these projects and if well executed, it improves the specificity of the search[15]. The choice to make a wide search, including only the “PI-part” of “PICO” and not exclude specific article types, their time of publication or apply other limitations increased the probability of finding relevant studies.

The use of PubMed for searching articles is the first hand choice in this field[15]. The use of reference management software throughout this process decreased the risk for human error and likely improved the result quality. The search documentation makes the study replicable and improves validity.

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Searching more databases would have increased the probability of finding relevant studies to review. The same is true for hand searching journals in the appropriate field. Another thing that could have been done is a search for not yet finished- or unpublished material. Though, these suggestions, especially the latter ones, are very time consuming. Since few relevant articles were found through the search, one could also conclude that there is a general lack of research on the subject.

Including an information expert in the early search process helped greatly in

increasing the search quality. Having a team of information experts closer involved in the whole search process would had likely improved it further. They could have done more extensive searching and been more efficient and exact in their results. The same is true for having field experts in dermatology and orthopedics closely involved in the project. They could have had a better picture of the field and would have been able to more precisely give feedback on the relevance of the search results to further improve them. They might also have been able to better navigate current known literature that treats the subject, which could have helped in finding search words and articles in general that this search might have missed.

The Strategy to rather include than exclude articles in the relevance assessment stage improved the chance of finding relevant articles.

The fact that one article was not acquired lowered the quality of this study. This was the oldest article in the second assessment stage, which makes this article less likely to contain relevant information. The main problem with the assessment part is that it was done by a single person, offering little redundancy and leaving less margin for error. Reading through many abstracts can lead to mistakes and this problem accentuates when it is not done by two persons, which is a common practice.

The quality assessment was done methodically after a template which strengthens the result. Having another person doing the same procedure would have increased the quality, since it makes it possible to discuss narrow cases and the process in general. The results would have probably been more reliable, had someone with greater experience of systematic reviews worked on this article.

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Conclusion

This study could not show any association between contact allergy and orthopedic implants. If there is an association it is probably rare. A study with longer follow-up combined with higher general quality than those found in this review, would probably improve the state of knowledge.

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Appendix

Table 3. Articles failing the second step of the relevance assessment and their corresponding exclusion criteria or not acquired

Reason for

exclusion Article Number of objects

Non-relevant study design

Cobalt release from implants and consumer items and characteristics of cobalt sensitized patients with dermatitis.[22]

Three

A minimum 5-year follow-up of an oxidized zirconium femoral prosthesis used for total knee arthroplasty.[23] Prospective analysis of the incidence of metal allergy in patients listed for total replacement of the

temporomandibular joint.[24]

Non-relevant population

Allergic reactions in arthroplasty: myth or serious

problem?[25] Four

The association between metal allergy, total knee arthroplasty, and revision: study based on the Danish Knee Arthroplasty Register.[26]

The association between metal allergy, total hip arthroplasty, and revision.[10]

Metal sensitivity causing loosened joint prostheses.[27]

Non-relevant control intervention

Metal release and metal allergy after total hip replacement with resurfacing versus conventional hybrid prosthesis.[21]

Three

Cutaneous metal sensitivity in patients with orthopaedic injuries.[28]

Early osteolysis following second-generation metal-on-metal hip replacement.[29]

Unacquired

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References

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Dermatologi, venereologi. 8:3. Lund: Studentlitteratur AB; 2012. 369 p. 3. Popple A, Williams J, Maxwell G, Gellatly N, Dearman RJ, Kimber I. The

lymphocyte transformation test in allergic contact dermatitis: New opportunities. J Immunotoxicol. 2016;13(1):84–91.

4. Kumar V, Abbas AK, Fausto N, Mitchell RN, editors. Robbins Basic Pathology, Eighth Edition. 8th edition. Philadelphia, PA: Saunders/Elsevier; 2007.

5. Fall S, Bruze M, Isaksson M, Lidén C, Matura M, Stenberg B, et al. Contact allergy trends in Sweden – a retrospective comparison of patch test data from 1992, 2000, and 2009. Contact Dermatitis. 2015 May 1;72(5):297–304.

6. Diepgen TL, Ofenloch RF, Bruze M, Bertuccio P, Cazzaniga S, Coenraads P-J, et al. Prevalence of contact allergy in the general population in different European regions. Br J Dermatol. 2016 Feb;174(2):319–29.

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8. Devos SA, Van Der Valk PGM. Epicutaneous patch testing. Eur J Dermatol EJD. 2002 Oct;12(5):506–13.

9. Lidén C, Bruze M. Kontaktallergi mot ortopediska metallimplantat är svårbedömd. 2016;113:D6L9 [Internet]. 2016 Jul 20 [cited 2018 Aug 11]; Available from:

http://lakartidningen.se/Klinik-och- vetenskap/Kommentar/2016/07/Kontaktallergi-mot-ortopediska-metallimpantat-ar-svarbedomd/

10. Thyssen JP, Jakobsen SS, Engkilde K, Johansen JD, Søballe K, Menné T. The association between metal allergy, total hip arthroplasty, and revision. Acta Orthop. 2009 Dec;80(6):646–52.

11. Suwarsa O, Rahardjo RM, Sutedja E, Dharmadji HP, Hindritiani R, Gunawan H. Systemic contact dermatitis due to corrosion of titanium-coated nickel and cobalt bone plate fixation: A case report. Medicine (Baltimore). 2017 Dec;96(50):e9120. 12. Zhubrak M, Bar-David T. Systemic nickel allergy after internal fixation of a

bunionectomy. J Foot Ankle Surg Off Publ Am Coll Foot Ankle Surg. 2014 Aug;53(4):466–7.

13. Guyuron B, Lasa CI. Reaction to stainless steel wire following orthognathic surgery. Plast Reconstr Surg. 1992 Mar;89(3):540–2.

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14. Lidén C. Uttalande av Svenska kontaktdermatitgruppen (SKDG) antaget den 8 april 2016. :7.

15. SBU:s metod [Internet]. [cited 2018 Aug 16]. Available from: https://www.sbu.se/sv/var-metod/

16. Lützner J, Hartmann A, Dinnebier G, Spornraft-Ragaller P, Hamann C, Kirschner S. Metal hypersensitivity and metal ion levels in patients with coated or uncoated total knee arthroplasty: a randomised controlled study. Int Orthop. 2013

Oct;37(10):1925–31.

17. Thienpont E. Titanium niobium nitride knee implants are not inferior to chrome cobalt components for primary total knee arthroplasty. Arch Orthop Trauma Surg. 2015 Dec;135(12):1749–54.

18. Granchi D, Cenni E, Tigani D, Trisolino G, Baldini N, Giunti A. Sensitivity to implant materials in patients with total knee arthroplasties. Biomaterials. 2008 Apr;29(10):1494–500.

19. Granchi D, Cenni E, Trisolino G, Giunti A, Baldini N. Sensitivity to implant materials in patients undergoing total hip replacement. J Biomed Mater Res B Appl Biomater. 2006 May;77(2):257–64.

20. Hallab NJ, Anderson S, Stafford T, Glant T, Jacobs JJ. Lymphocyte responses in patients with total hip arthroplasty. J Orthop Res Off Publ Orthop Res Soc. 2005 Mar;23(2):384–91.

21. Gustafson K, Jakobsen SS, Lorenzen ND, Thyssen JP, Johansen JD, Bonefeld CM, et al. Metal release and metal allergy after total hip replacement with resurfacing versus conventional hybrid prosthesis. Acta Orthop. 2014 Aug;85(4):348–54.

22. Thyssen JP, Menné T, Lidén C, Julander A, Jensen P, Jakobsen SS, et al. Cobalt release from implants and consumer items and characteristics of cobalt sensitized patients with dermatitis. Contact Dermatitis. 2012 Mar;66(3):113–22.

23. Hofer JK, Ezzet KA. A minimum 5-year follow-up of an oxidized zirconium femoral prosthesis used for total knee arthroplasty. The Knee. 2014

Jan;21(1):168–71.

24. Sidebottom AJ, Mistry K. Prospective analysis of the incidence of metal allergy in patients listed for total replacement of the temporomandibular joint. Br J Oral Maxillofac Surg. 2014 Jan;52(1):85–6.

25. Guenther D, Thomas P, Kendoff D, Omar M, Gehrke T, Haasper C. Allergic reactions in arthroplasty: myth or serious problem? Int Orthop. 2016

Feb;40(2):239–44.

26. Münch HJ, Jacobsen SS, Olesen JT, Menné T, Søballe K, Johansen JD, et al. The association between metal allergy, total knee arthroplasty, and revision: study based on the Danish Knee Arthroplasty Register. Acta Orthop. 2015

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27. Christiansen K, Holmes K, Zilko PJ. Metal sensitivity causing loosened joint prostheses. Ann Rheum Dis. 1980 Oct;39(5):476–80.

28. Swiontkowski MF, Agel J, Schwappach J, McNair P, Welch M. Cutaneous metal sensitivity in patients with orthopaedic injuries. J Orthop Trauma. 2001

Feb;15(2):86–9.

29. Park Y-S, Moon Y-W, Lim S-J, Yang J-M, Ahn G, Choi Y-L. Early osteolysis following second-generation metal-on-metal hip replacement. J Bone Joint Surg Am. 2005 Jul;87(7):1515–21.

30. Carlsson A, Möller H. Implantation of orthopaedic devices in patients with metal allergy. Acta Derm Venereol. 1989;69(1):62–6.

References

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