Abstract
Purpose
The aims of this study were to determine the prevalence of metal hypersensitivity, and identify pre-operative factors which could predict susceptibility to hypersensitivity reactions among patients scheduled for primary total knee arthroplasty (TKA). The present study used a testing method consistent with the recognised biological response to metals.
Methods
A prospective cross-sectional analysis of 220 patients was conducted. All patients received a testing protocol using lymphocyte transformation test to evaluate reactivity to possible contents of orthopaedic implants. Test response is interpreted as stimulation index (SI) values. A comprehensive questionnaire was used to evaluate prior exposure. Patients were categorised according to SI values and the odds ratios (OR) were calculated as comparative effect measure for each predetermined prior exposure factor.
Results
The prevalence of metal sensitivity response was 28% (n = 61) among patients with susceptibility to at least one agent (SI = 2 to 4.9), and 3.2% (n = 7) among patients with true hypersensitivity (SI ≥ 5). The population-weighted prevalence, adjusted for sampling weights of symptomatic knee osteoarthritis, was SI ≥ 5 = 4.7% (95% CI 0.4–11.8%) and SI ≥ 2 = 35.2% (95% CI 24.8–48.6%). Stimulation index levels of response to materials were markedly varied with the highest being aluminium. Female sex, smoking history, cutaneous reaction to jewellery, occupational exposure, and dental procedures were among factors shown to increase the odds of having higher reactivity response to tested metals. Nevertheless, patients with well-functioning prior contralateral TKA did not appear at greater risk of having either sensitivity or susceptibility with odds ratio (OR) = 0.2 (95% CI 0.01–3.2), p: NS and OR = 0.6 (95% CI 0.3–1.2), p: NS, respectively. Prior positive patch test was neither predictor of susceptibility to hypersensitivity OR = 1.2 (95% CI 0.6–2.6) p: NS nor predictor of true hypersensitivity OR = 0.7 (95% CI 0.08–6.1), p: NS.
Conclusion
Among patients scheduled for primary TKA with no prior clinical features of metal allergy the prevalence of true hypersensitivity to at least one metal is just over 3%. Patients are likely to encounter a material to which they have pre-existing susceptibility to hypersensitivity. With certain prior exposure factors, there was increased susceptibility to metal hypersensitivity reaction evoking an acquired condition.
Level of evidence: Level II, prospective cross-sectional study.
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The study was funded through a research grant awarded by Smith & Nephew, Inc. 150 Minuteman Road Andover, Massachusetts 01810 USA.
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TB: data analysis and interpretation, and manuscript writing. FV: data acquisition, interpretation of data, and manuscript writing. JD: design, data acquisition, and analysis and interpretation of data. MB: design, data acquisition, and critical revision of manuscript. JF: design, data acquisition, and critical revision of manuscript. All the authors have been actively involved in the writing and revision of the manuscript.
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Institutional review ethics body approval. Reference Number: 2014–1101. Comité d'éthique de la recherche du CIUSSS du Nord-de-l’Île-de-Montréal (CÉR) Montreal, Canada.
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Boutefnouchet, T., Vallières, F., Delisle, J. et al. Lymphocyte transformation test reveals low prevalence of true metal hypersensitivity among pre-operative total knee arthroplasty patients. Knee Surg Sports Traumatol Arthrosc 30, 4123–4133 (2022). https://doi.org/10.1007/s00167-022-06951-2
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DOI: https://doi.org/10.1007/s00167-022-06951-2