Abstract
Objectives
There is ongoing discussion about arthroplasty surgery of patients with metal hypersensitivity. The aim of this study was to compare the functional outcomes and eosinophil counts of unicondylar knee arthroplasty (UKA) patients with and without a history of metal hypersensitivity.
Methods
A retrospective review was made of the medical records of 148 extremities of 140 consecutive patients who underwent primary UKA between January 2016 and December 2017. The patients who met the inclusion criteria were screened for history of metal hypersensitivity using a questionnaire. The functional outcomes of patients and eosinophil levels were evaluated immediately before and at 6 weeks after surgery.
Results
The mean follow-up period was 37 months (range, 18–48 months). Of the total 128 patients, 13 (10.2%) reported a history of metal hypersensitivity before the operation. There was no statistically significant difference between patients with or without a history of metal hypersensitivity in respect of the functional outcomes or eosinophil counts (p > 0.05).
Conclusions
The results of this study showed that the functional outcomes of patients who underwent UKA using a standard alloy did not change between the groups who reported having or not having a history of metal hypersensitivity. Although the study also showed that the eosinophil counts decreased after surgery compared to the preoperative counts, there was no statistical relationship between the eosinophil count and functional outcomes or metal hypersensitivity history.
Keywords: Metal hypersensitivity, Allergy, Unicondylar knee arthroplasty, Self-reported, Unicondylar knee prosthesis, Eosinophil count
1. Introduction
Metal hypersensitivity has been blamed as a possible cause of impaired postoperative function, hypersensitive skin reactions, persistent pain or peri-implant osteolysis-induced implant failure.1,2 The management of an allergic reaction to metal orthopedic implants is controversial in the literature.1,2 First of all, it is difficult to diagnose, because this diagnosis can be made only by excluding all other possible diagnoses.3 Nevertheless, if the diagnosis can be made, the treatment can be precise and successful.4 The first and most effective treatment for metal hypersensitivity is removal of the allergen.5,6 It has been reported that this metal hypersensitivity may be due to hypersensitivity especially to cobalt, chromium and nickel in total knee arthroplasty (TKA), and revision surgery with different alloy implants may be the solution.7 Since revision arthroplasty surgeries may lead to additional bone loss, it is not an easy decision to remove the hypersensitivity-causing implants in patient who have had arthroplasties. The American Contact Dermatitis Society recommends skin patch testing (SPT) before device implantation for patients with a clear history of metal reactions.8 However, there is no consensus on screening tests for the accurate diagnosis of metal hypersensitivity.9 Self-reported hypersensitivity is the first step in determining the risk and has been found to be useful.10 (see Fig. 1)
Fig. 1.
There were no radiographic changes in metal hypersensitive patient (A) compared to non-hypersensitive patient (B) postoperatively.
In literature, there are several knee and hip arthroplasty case reports and series about metal hypersensitivity.2,11 In contrast, unicondylar knee arthroplasty (UKA) has been defined as partial arthroplasty of the degenerated part of the knee with high success rates reported.12 Nevertheless, after most complications have been eliminated, there remains a small group of patients with persistent complaints about and dissatisfaction with UKA.13 Although similar metal alloys are used in both TKA and THA, to date there has only been one case report published and a recent self-reported hypersensitivity-related study regarding UKA and hypersensitivity.14,15 Metal hypersensitivity can be evaluated with preoperative laboratory tests or histological evaluation of neosynovia obtained during surgery.14 However, it should be kept in mind that functional outcome and survival are high in patients with UKA without a history of metal hypersensitivity.15
The aim of the current study was to investigate the relationship between a history of metal hypersensitivity and UKA, in respect of differences in quality of life and functional outcomes in patients with and without a preoperative hypersensitivity history. Evaluation was also made of the relationship between metal hypersensitivity and eosinophil counts of the patients.
2. Methods
A retrospective review was made of the medical records of 148 extremities of 140 consecutive patients who underwent primary UKA for medial knee osteoarthrosis in our hospital between January 2016 and December 2017. Patients were excluded from the study if the follow-up period was <18 months, if they had implant malposition (periprosthetic fracture, insert dislocation), infection, periprosthetic fracture, or early postoperative complications, if they were not willing to participate in the study or could not be reached by telephone. A total of 12 patients were excluded; 4 who were not willing to participate in the study, 5 who could not be contacted, 2 who underwent revision surgery due to implant malposition and periprosthetic fracture, and 1 who was scheduled for revision due to implant malposition. Thus, a total of 136 extremities of 128 patients were included in the study. The mean follow-up period was 37 months (range, 18–48 months). The patients included comprised 11 (8.6%) males and 117 (91.4%) females with a mean age at the time of surgery of 60.3 years (range, 42–77 years). Cementless UKA was applied to 89 patients (69.5%), and cemented UKA to 39 patients (30.5%). UKA was applied to 46 left knees, 74 right knees and 8 bilateral knees (Table 1).
Table 1.
The relation between metal hypersensitivity history and demographic data and implant type.
| Metal hypersensitivity history |
||||
|---|---|---|---|---|
| No | Yes | Total | pb | |
| Gender | ||||
| Female a | 104 (90.4) | 13 (100) | 117 (91.4) | 0.376 |
| Male a | 11 (9.6) | 0 (0) | 11 (8.6) | |
| Side | ||||
| Left | 41 (35.6) | 5 (38.5) | 46 (35.9) | 0.748 |
| Right | 66 (57.4) | 8 (61.5) | 74 (57.8) | |
| Bilateral | 8 (7.0) | 0 (0) | 8 (6.3) | |
| Implant | ||||
| Cementless | 78 (67.8) | 11 (84.6) | 89 (69.5) | 0.341 |
| Cemented | 37 (32.2) | 2 (15.4) | 39 (30.5) | |
| Age (years old)c | 60.65 ± 7.14 | 57.23 ± 6.22 | – | 0.108 |
n (%).
Chi-Square test.
Mean and standard deviation.
The Oxford phase III unicondylar mobile-bearing prosthesis, cemented or cementless (Oxford UKA, Biomet UK Limited, Bridgend, United Kingdom) was implanted in all patients using minimally invasive technique. The femoral and tibial components of the prosthesis are a CoCrMoNi alloy consisting of 64% cobalt, 28% chromium, 6% molybdenum, and 1% nickel. The meniscal bearing of the prosthesis is made of highly crosslinked ultra-high molecular weight polyethylene.
Telephone interviews were held with the 128 patients who met the inclusion criteria and the hypersensitivity survey was administered to investigate the presence of allergic symptoms before surgery (Table 2). The EuroQol-5 Dimensions (EQ-5D-3L) VAS questionnaire was applied to measure quality of life, and the Western Ontario and McMaster (WOMAC) index of osteoarthritis was used to measure functional status. Changes in eosinophil count were evaluated from the hospital records data of complete blood count taken just before surgery, and at the postoperative 6-week routine follow-up examination.
Table 2.
Hypersensitivity questionnaire.
| Demographic data | |
|---|---|
| General allergy | (Was it before the operation? or after?) |
| 1. Metal reactions with earrings and/or jewelery (number of earlobe holes) | |
| 2. Skin reactions to various allergens (rubber, perfume, condoms) | |
| 3. Allergy to food, beverage and cooking equipment. | |
| 4. Medicine | |
| 5. Other | |
| Metal allergy | (If a positive response is given to metal allergy in the above questionnaire) |
| 1. How old were you when you first had a metal allergy? (It will be used to measure how many years metal dermatitis has been present.) | |
| 2. Which metal objects caused allergies. (earrings/nose ring, other jewelery, watches, buttons, glasses, belt buckle, others) | |
| 3. Do you know the metal that causes allergy? |
The statistical analysis was performed using SPSS 20.0 for Windows software (SPSS Inc, Chicago, IL, USA). Descriptive statistics were presented as number (n) and percentage (%) for categorical variables and as mean, standard deviation and minimum-maximum values for numerical variables. In the analysis of numerical data, the compatibility with normal distribution was examined with the Kolmogrov-Simirnov and Shapiro-Wilk tests. Since none of the numerical data conformed to normal distribution, the median difference between the two groups was analyzed with the Mann-Whitney U test, and the median difference between the two dependent groups with the Wilcoxon test. The Chi-square test was applied to the analysis of categorical variables. The data were analyzed at a 95% confidence level. A value of p < 0.05 was considered statistically significant.
The study was approved by the Institutional Ethics Committee and all procedures were performed in accordance with the principles of the Declaration of Helsinki.
3. Results
Preoperative metal hypersensitivity was reported by 13 (10.2%) of the total 128 patients. No statistically significant difference was determined between the patients with and without a history of metal hypersensitivity in respect of age, gender, side or type of implant used (cemented or cementless UKA), (p > 0.05) (Table 1).
At the final follow-up, the mean EQ-5D-3L VAS score was 87.41 ± 9.49 (range, 55–100), and the mean WOMAC score was 95.88 ± 4.59 (range, 76–100). There was no statistically significant difference in the EQ-5D-3L VAS and WOMAC scores between patients with or without a possible history of hypersensitivity (p > 0.05) (Table 3).
Table 3.
The relationship between history of metal hypersensitivity and quality of life and functional results.
| History of metal hypersensitivity (Mean ± Standard deviation) |
|||
|---|---|---|---|
| No | Yes | pa | |
| EQ-5D-3L (VAS) | 87.67 ± 9.58 | 85.15 ± 8.68 | 0,266 |
| WOMAC | 96.03 ± 4.57 | 94.62 ± 4.79 | 0,191 |
Mann-Whitney U test.
There was no statistically significant difference between the hypersensitivity history positive and negative patients in respect of eosinophil counts (Table 4). There were no positive findings in those who were hypersensitive to metals. In the evaluation of the whole patient group, a statistically significant difference was determined between the preoperative and postoperative (at final follow up visit) eosinophil counts (p < 0.05) (Table 5). There was no statistically significant difference between the cemented and uncemented UKA in respect of eosinophil counts both preoperatively and postoperatively (p < 0.05).
Table 4.
The relationship between history of metal hypersensitivity and eosinophil counts.
| History of metal hypersensitivity (Mean ± Standard Derivation) |
|||
|---|---|---|---|
| No | Yes | pa | |
| Eosinophil | |||
| Pre-op | 2.50 ± 1.89 | 2.48 ± 2.14 | 0,518 |
| Post-op | 1.80 ± 1.37 | 1.89 ± 1.40 | 0,667 |
| Post-op/Pre-op difference | −0.7 ± 1.82 | −0.59 ± 1.52 | 0,764 |
Mann-Whitney U test.
Table 5.
Comparison of preoperative and postoperative eosinophil counts.
| Eosinophil | (Mean ± Standard Derivation) | pa |
|---|---|---|
| Pre-operative | 2.50 ± 1.91 | 0.001 |
| Post-operative | 1.81 ± 1.37 |
Wilcoxon test.
4. Discussion
In the current study, metal hypersensitivity was reported by 10.2% of the patients, all of whom were female. Allergic contact dermatitis has been reported to affect approximately 1%–10% of the general population.16 The Europe-wide prevalence of nickel allergies has been reported to be 9–18%,17 with the most common allergens reported as nickel (17.6%), cobalt chloride (5.3%), and potassium dichromate (4.6%) in patients with contact dermatitis.18 Nickel sensitivity is overall 2–10 times more common in females than in males.19,20 In females, early ear piercing and higher exposure contributes to the higher frequency of contact sensitization.21 The incidence of metal hypersensitivity and gender distribution in the current study were seen to be consistent with literature. For this dominant female gender distribution, it is recommended that manufacturers of prostheses for TKA should produce smaller sizes of non-allergen specialized prostheses for females as they report more metal allergies.22 The main differences between UKA and TKA are due to their size. In UKA, there is more preserved bone stock, less blood loss and small incisions compared to TKA. Because of the gender distribution similarity between Bloemke and Clarke’s Self-Reported Metal Allergy study in TKA 22and the current study, it may be suggested that implant manufacturers can produce smaller UKAs in case of nonallergic implant need.
Hallab et al. reported that approximately 25% of patients with a well-functioning metallic implant showed positive metal hypersensitivity in the SPT, which was higher than the rate defined for the general population.23 Nevertheless, despite the high rate of metal hypersensitivity, the resulting complication rate has been found to be very low at 0.1–5%.24,25
Although many case reports and case series have been reported due to metal hypersensitivity after orthopedic implants2,11 (Table 6), to the best of our knowledge, there is only one case report related to UKA.14 Dezulovic et al. reported a 56-year old female with UKA (Oxford III, Biomet) who complained of persistent, burning pain in the knee and underwent revision surgery with a titanium-coated knee prosthesis.14 The diagnosis was confirmed by positive patch testing, lymphocyte transformation test and histological analysis of the neosynovia around the implant.14
Table 6.
Studies of self-reported metal hypersensitivity in orthopedic surgery.
| Implant | N of patients | Prevalence of self-reported cutaneous metal sensitivity | Conclusion | |
|---|---|---|---|---|
| Bloemke et al., 2015 (20) | TKA | 139 | %14 | Surgeons who decided to choose an individualized approach to implant selection could expect to use a specialized implant in approximately 15% of patients. |
| Nam et al., 2016 (31) | THA TKA |
906 598 |
%2.3 4.1% |
Patient-reported metal allergy is associated with decreased functional outcomes after TKA and decreased mental health scores after THA |
| Walker et al., 2019 (15) | UKA | 1737 | 4.7% | Functional outcome and survivorship are on a high-level equivalent to those reported for UKA in patients without a history of metal hypersensitivity. |
| Schultzel et al., 2020 (10) | NA | 840 | 4.9% | Greater awareness of a history to hypersensitivity may prevent patient exposure to implants containing metals that may cause hypersensitivity. |
| Kennon et al., 2020 (33) | Shoulder Arthroplasty | 52 | 82.6% | Shoulder arthroplasty in patients with self-reported metal allergy provides satisfactory pain relief and improved range of motion with low revision rates. |
| Atilla et al. | UKA | 128 | 10.2% | The functional outcomes of patients who underwent UKA using a standard alloy did not change between the groups who reported having or not having a history of metal hypersensitivity |
TKA: Total Knee Arthroplasty, THA: Total Hip Arthroplasty, UKA: Unikondylar Knee Arthroplasty, NA: Non Available, N:Number.
The fact that this type of reaction is less common in UKA raises the question of why? There is uncertain relationship between metal hypersensitivity and peri-implant osteolysis-induced implant failure. It is unknown whether implant failure is occurs due to history of metal hypersensitivity or vice versa.3 Nevertheless, individual studies have indicated that despite high rates of sensitization to nickel sulphate and potassium dichromate, only a few patients have clinical manifestations.26
Metal sensitization is reported to be higher in patients with a knee arthroplasty than in the general population and is even higher in patients undergoing revision surgery.27 However, no clear correlation has been established between metal sensitization and symptomatic knee after surgery.28 Although the relationship between metal hypersensitivity and symptomatic knee cannot be established, the fact that such case reports are frequently found in hip and knee arthroplasty has revealed that this complication can be avoided by using preoperative allergen detection and non-allergen implants.28
Various tests have been used for this purpose. Desai et al. found the prevalence of metal hypersensitivity to be 15.87% using SPT.29 Chromium (11.58%) was found to be most common allergen followed by nickel (8.58%) and then cobalt (6.43%) in a TKA patient cohort. In that study, pre-operative SPT was recommended for the detection of allergic reactions to implants.29
SPT is considered as the gold standard due to its wide-ranging attainability, although it has been scrutinized for its ability to mimic the actual environment of the orthopedic implant.29 However, the SPT is used for assessment of skin hypersensitivity, and not used for the determination of deep-tissue or joint hypersensitivity to metal alloys. The lymphocyte transformation test (LTT) more directly tests the immune components responsible for the hypersensitivity reaction in the peri-implant tissue than the SPT.23 The routine preimplantation LTT testing is not currently recommended.30
Pre-implant testing results has been insufficient for the diagnosis of joint arthroplasty failure due to an metal hypersensitivity. The ability of these tests to diagnose metal hypersensitivity and predict outcomes has not yet been demonstrated. A web-based Delphi consensus study was conducted by Razak et al.31 That panel agreed to proceed with standard CoCrMoNi alloy implants in patients reporting history of metal hypersensitivity or positive SPT.31 Furthermore, the panel stated that SPT is not necessary for the local and systemic immune responses including metal hypersensitivity.31 Possible skin reactions to metals do not transfer one-to-one to the synovium.32
Since there is no clear relationship and exact test between metal hypersensitivity and orthopedic implantology, some authors have investigated the relationship between allergic contact dermatitis history and implants.33, 34, 35 Whether allergens cause contact dermatitis in skin contact has been investigated in self-reported hypersensitivity questionnaires. Josefson et al. evaluated the validity of self-reported nickel hypersensitivity screening, and stated that self-reporting had only 60% positive predictive value compared to SPT.33 Consequently, the self-reported rate of metal hypersensitivity or hypersensitivity may be overestimated compared to the true rate of metal sensitivity.
Kennon et al. reported self-reported metal hypersensitivity (SRMA) in shoulder arthroplasty patients and found that shoulder arthroplasty in patients with self-reported metal hypersensitivity provides satisfactory pain relief and improved range of motion with low revision rates.36 In a large cohort, Schmidt et al. reported that patients with and without SRMA demonstrated similar early functional outcomes. There was no significant difference in functional outcomes between patients with SRMA who received standard cobalt-chrome implants and those with nickel-free implants.35 In contrast, Nam et al. reported that patient-reported metal hypersensitivity is associated with decreased functional outcomes after TKA and decreased mental health scores after THA.34
The current study investigated the metal hypersensitivity history and the outcomes of UKA. No statistically significant relationship was determined between functional outcomes, quality of life measures and the metal hypersensitivity history of patients who underwent UKA. A recent study also reported similar findings, stating that the clinical outcome and implant survival were equivalent at a high level to those reported for UKA in patients without a history of metal hypersensitivity.15 However, although that study had a higher rate of patients with a history of metal hypersensitivity than the current study, there was no control group of patients with a negative history of metal hypersensitivity to allow for a direct comparison of the clinical results. Therefore, the current study is the first to have compared the functional outcomes and quality of life of patients with and without self-reported metal hypersensitivity in the same cohort.
Hypersensitivity reaction to orthopedic implant materials is a delayed hypersensitivity (DTH). This mechanism is mainly attributed to T cells and an over-reaction of the adaptive immune system. There is evidence that pro-inflammatory factors released during DTH reactions enhance osteoclast activity and inhibit osteoblast function, an imbalance characteristic for osteolysis. Even though some mechanisms are understood, hypersensitivity has remained a diagnosis of exclusion.3 Eosinophils are related with type 1 hypersensitivity and not with type-4 metal hypersensitivity, but eosinophilia has been reported in metal hypersensitivity patients who have undergone arthroplasty.37 In contrast, Ishihara et al. reported that nickel ions bind to eosinophils and decrease the viability of eosinophils.38
The results of the present study also showed that the eosinophil count decreased post-operatively compared to the preoperative values. Nevertheless, there was no statistically significant relationship between eosinophil count and functional outcomes or hypersensitivity history.
The importance of a history of metal hypersensitivity or hypersensitivity is a clinical dilemma in patients undergoing arthroplasty surgery, and how it will affect the surgery remains controversial. Most surgeons ignore this condition and use CrCoMo alloy standard implants in each patient. Alternatively, non-allergenic alloy implants such as titanium can be used in patients with a positive screen test for metal sensitivity in the preoperative period. Nevertheless, the cost effectiveness or superior outcomes of these implants is controversial. Although the use of alternative alloy implants seems to be a viable option in theory, there is still insufficient evidence for their use in practice.28
The main limitations of the present study are the retrospective design, the relatively short clinical follow-up period, and the potential impact of self-reported response bias. Although the group with reported metal hypersensitivity was small, it was sufficient for a statistical analysis.
In conclusion, this study is one of the few studies to have examined metal hypersensitivity in UKA. It was seen that the functional outcomes and health-related quality of life of patients who underwent UKA using a standard CoCrMoNi alloy did not vary between the groups who reported having or not having metal hypersensitivity. There is a need for better identifiers of patients at risk for possible allergic reactions due to alloys used in UKA.
Author contributions
Conceptualization; HAA, HBÇ, MA, HA.
Data curation; HAA, HBÇ.
Formal analysis; HAA, HBÇ, MA, HA.
Funding acquisition; HAA, HBÇ, MA, HA.
Investigation; MA, HA.
Methodology; HAA, HBÇ.
Project administration; HAA, HBÇ.
Resources; HAA, HBÇ, MA, HA.
Software; HAA, HBÇ, MA, HA.
Supervision; HAA.
Validation; HAA, HBÇ, MA, HA.
Visualization; HAA, HBÇ, MA, HA.
Roles/Writing - original draft; HAA, HBÇ.
Writing - review & editing; HAA, HBÇ.
Funding/support
This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.
Disclosure of competing interest
The authors report no conflict of interest.
Contributor Information
Halis Atıl Atilla, Email: dratilatilla@hotmail.com.
Hüseyin Bilgehan Çevik, Email: bilgehancevik@gmail.com.
Mutlu Akdoğan, Email: mutluakdogan@yahoo.com.
Hakan Aslan, Email: draslan50@yahoo.com.
References
- 1.Bravo D., Wagner E.R., Larson D.R., Davis M.P., Pagnano M.W., Sierra R.J. No increased risk of knee arthroplasty failure in patients with positive skin patch testing for metal hypersensitivity: a matched cohort study. J Arthroplasty. 2016;31(8):1717–1721. doi: 10.1016/j.arth.2016.01.024. [DOI] [PubMed] [Google Scholar]
- 2.Zondervan R.L., Vaux J.J., Blackmer M.J., Brazier B.G., Taunt C.J., Jr. Improved outcomes in patients with positive metal sensitivity following revision total knee arthroplasty. J Orthop Surg Res. 2019;14(1):182. doi: 10.1186/s13018-019-1228-4. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 3.Ort M.J., Geissler S., Rakow A., Schoon J. The allergic bone marrow? The immuno-capacity of the human bone marrow in context of metal-associated hypersensitivity reactions. Front Immunol. 2019;10:2232. doi: 10.3389/fimmu.2019.02232. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 4.Stathopoulos I.P., Andrianopoulos N., Paschaloglou D., Tsarouchas I. Revision total knee arthroplasty due to bone cement and metal hypersensitivity. Arch Orthop Trauma Surg. 2017;137(2):267–271. doi: 10.1007/s00402-016-2614-6. [DOI] [PubMed] [Google Scholar]
- 5.Busam M.L., Esther R.J., Obremskey W.T. Hardware removal: indications and expectations. J Am Acad Orthop Surg. 2006;14(2):113–120. doi: 10.5435/00124635-200602000-00006. [DOI] [PubMed] [Google Scholar]
- 6.Schalock P.C., Menne T., Johansen J.D. Hypersensitivity reactions to metallic implants - diagnostic algorithm and suggested patch test series for clinical use. Contact Dermatitis. 2012;66(1):4–19. doi: 10.1111/j.1600-0536.2011.01971.x. [DOI] [PubMed] [Google Scholar]
- 7.Munch H.J., Jacobsen S.S., Olesen J.T. The association between metal allergy, total knee arthroplasty, and revision: study based on the Danish Knee Arthroplasty Register. Acta Orthop. 2015;86(3):378–383. doi: 10.3109/17453674.2014.999614. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 8.Schalock P.C., Crawford G., Nedorost S. Patch testing for evaluation of hypersensitivity to implanted metal devices: a perspective from the American contact dermatitis society. Dermatitis. 2016;27(5):241–247. doi: 10.1097/DER.0000000000000210. [DOI] [PubMed] [Google Scholar]
- 9.Hallock K., Vaughn N.H., Juliano P., Marks J.G., Jr. Metal hypersensitivity and orthopedic implants: survey of orthopedic surgeons. Dermatitis. 2017;28(1):76–80. doi: 10.1097/DER.0000000000000236. [DOI] [PubMed] [Google Scholar]
- 10.Schultzel M., Klein C.M., Demirjian M., Blout C., Itamura J.M. Incidence of metal hypersensitivity in orthopedic surgical patients who self-report hypersensitivity history. Perm J. 2020;24 doi: 10.7812/TPP/19.091. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 11.Vermes C., Kuzsner J., Bardos T., Than P. Prospective analysis of human leukocyte functional tests reveals metal sensitivity in patients with hip implant. J Orthop Surg Res. 2013;8:12. doi: 10.1186/1749-799X-8-12. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 12.Koskinen E., Paavolainen P., Eskelinen A., Pulkkinen P., Remes V. Unicondylar knee replacement for primary osteoarthritis: a prospective follow-up study of 1,819 patients from the Finnish Arthroplasty Register. Acta Orthop. 2007;78(1):128–135. doi: 10.1080/17453670610013538. [DOI] [PubMed] [Google Scholar]
- 13.Halawi M.J., Barsoum W.K. Unicondylar knee arthroplasty: key concepts. Journal of clinical orthopaedics and trauma. 2017;8(1):11–13. doi: 10.1016/j.jcot.2016.08.010. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 14.Dezulovic M., Baur U., Stangl R., Baur W., Lenz E. [Nickel allergy and painful unicondylar knee arthroplasty] Z für Orthop Unfallchirurgie. 2012;150(3):269–271. doi: 10.1055/s-0031-1298346. [DOI] [PubMed] [Google Scholar]
- 15.Walker T., Rutkowski L., Innmann M. Unicondylar knee arthroplasty using cobalt-chromium implants in patients with self-reported cutaneous metal hypersensitivity. Bone Joint Lett J. 2019;101-b(2):227–232. doi: 10.1302/0301-620X.101B2.BJJ-2018-0778.R1. [DOI] [PubMed] [Google Scholar]
- 16.Guin J.D. Contact sensitivity to topical corticosteroids. J Am Acad Dermatol. 1984;10(5 Pt 1):773–782. doi: 10.1016/s0190-9622(84)70093-4. [DOI] [PubMed] [Google Scholar]
- 17.Schnuch A., Uter W., Geier J., Gefeller O. Epidemiology of contact allergy: an estimation of morbidity employing the clinical epidemiology and drug-utilization research (CE-DUR) approach. Contact Dermatitis. 2002;47(1):32–39. doi: 10.1034/j.1600-0536.2002.470107.x. [DOI] [PubMed] [Google Scholar]
- 18.Akyol A., Boyvat A., Peksari Y., Gurgey E. Contact sensitivity to standard series allergens in 1038 patients with contact dermatitis in Turkey. Contact Dermatitis. 2005;52(6):333–337. doi: 10.1111/j.0105-1873.2005.00608.x. [DOI] [PubMed] [Google Scholar]
- 19.Schuttelaar M.L.A., Ofenloch R.F., Bruze M. Prevalence of contact allergy to metals in the European general population with a focus on nickel and piercings: the EDEN Fragrance Study. Contact Dermatitis. 2018;79(1):1–9. doi: 10.1111/cod.12983. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 20.Thyssen J.P., Hald M., Avnstorp C. Characteristics of nickel-allergic dermatitis patients seen in private dermatology clinics in Denmark: a questionnaire study. Acta Derm Venereol. 2009;89(4):384–388. doi: 10.2340/00015555-0649. [DOI] [PubMed] [Google Scholar]
- 21.Schuttelaar M.L.A., Ofenloch R.F., Bruze M. Prevalence of contact allergy to metals in the European general population with a focus on nickel and piercings: the EDEN Fragrance Study. Contact Dermatitis. 2018;79(1):1–9. doi: 10.1111/cod.12983. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 22.Bloemke A.D., Clarke H.D. Prevalence of self-reported metal allergy in patients undergoing primary total knee arthroplasty. J Knee Surg. 2015;28(3):243–246. doi: 10.1055/s-0034-1381959. [DOI] [PubMed] [Google Scholar]
- 23.Hallab N., Merritt K., Jacobs J.J. Metal sensitivity in patients with orthopaedic implants. J Bone Joint Surg Am. 2001;83(3):428–436. doi: 10.2106/00004623-200103000-00017. [DOI] [PubMed] [Google Scholar]
- 24.Swiontkowski M.F., Agel J., Schwappach J., McNair P., Welch M. Cutaneous metal sensitivity in patients with orthopaedic injuries. J Orthop Trauma. 2001;15(2):86–89. doi: 10.1097/00005131-200102000-00002. [DOI] [PubMed] [Google Scholar]
- 25.Teo W.Z.W., Schalock P.C. Metal hypersensitivity reactions to orthopedic implants. Dermatol Ther. 2017;7(1):53–64. doi: 10.1007/s13555-016-0162-1. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 26.Armonies S., Zajonz D., Treudler R., Roth A., Ghanem M. Long-term outcome after implantation of a nickel-containing cemented hip stem on the right in a patient with type IV sensitization to nickel sulphate. GMS Interdiscip Plast Reconstr Surg DGPW. 2019;8:Doc18. doi: 10.3205/iprs000144. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 27.Saccomanno M.F., Sircana G., Masci G. Allergy in total knee replacement surgery: is it a real problem? World J Orthoped. 2019;10(2):63–70. doi: 10.5312/wjo.v10.i2.63. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 28.Saccomanno M.F., Sircana G., Masci G. Allergy in total knee replacement surgery: is it a real problem? World J Orthoped. 2019;10(2):63–70. doi: 10.5312/wjo.v10.i2.63. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 29.Desai M.M., Shah K.A., Mohapatra A., Patel D.C. Prevalence of metal hypersensitivity in total knee replacement. J Orthop. 2019;16(6):468–472. doi: 10.1016/j.jor.2019.05.005. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 30.Lachiewicz P.F., Watters T.S., Jacobs J.J. Metal hypersensitivity and total knee arthroplasty. J Am Acad Orthop Surg. 2016;24(2):106–112. doi: 10.5435/JAAOS-D-14-00290. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 31.Razak A., Ebinesan A.D., Charalambous C.P. Metal allergy screening prior to joint arthroplasty and its influence on implant choice: a delphi consensus study amongst orthopaedic arthroplasty surgeons. Knee Surg Relat Res. 2013;25(4):186–193. doi: 10.5792/ksrr.2013.25.4.186. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 32.Thomsen M., Krenn V., Thomas P. Adverse Reaktionen gegenüber orthopädisch-chirurgischen Metallimplantaten nach Kniegelenkersatz. Hautarzt. 2016;67(5):347–351. doi: 10.1007/s00105-016-3793-3. [DOI] [PubMed] [Google Scholar]
- 33.Josefson A., Farm G., Meding B. Validity of self-reported nickel allergy. Contact Dermatitis. 2010;62(5):289–293. doi: 10.1111/j.1600-0536.2010.01702.x. [DOI] [PubMed] [Google Scholar]
- 34.Nam D., Li K., Riegler V., Barrack R.L. Patient-reported metal allergy: a risk factor for poor outcomes after total joint arthroplasty? J Arthroplasty. 2016;31(9):1910–1915. doi: 10.1016/j.arth.2016.02.016. [DOI] [PubMed] [Google Scholar]
- 35.Schmidt K.J., Huang P.S., Colwell C.W., Jr., McCauley J.C., Pulido P.A., Bugbee W.D. Self-reported metal allergy and early outcomes after total knee arthroplasty. Orthopedics. 2019;42(6):330–334. doi: 10.3928/01477447-20190906-01. [DOI] [PubMed] [Google Scholar]
- 36.Kennon J.C., Lee J., Songy C. The effect of patient-reported metal allergies on the outcomes of shoulder arthroplasty. J Shoulder Elbow Surg. 2020;29(2):296–301. doi: 10.1016/j.jse.2019.06.006. [DOI] [PubMed] [Google Scholar]
- 37.Bao W., He Y., Fan Y., Liao Y. Metal allergy in total-joint arthroplasty: case report and literature review. Medicine (Baltim) 2018;97(38) doi: 10.1097/MD.0000000000012475. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 38.Ishihara K., Goi Y., Hong J.J. Effects of nickel on eosinophil survival. Int Arch Allergy Immunol. 2009;149(Suppl 1):57–60. doi: 10.1159/000210655. [DOI] [PubMed] [Google Scholar]