Poor Correlation Among Metal Hypersensitivity Testing Modalities and Inferior Patient-Reported Outcomes After Primary and Revision Total Knee Arthroplasties.

Background: Metal allergy testing may influence clinical decision-making for patients undergoing a total knee arthroplasty (TKA). Limited data were found to examine the consistency of available testing modalities. This study compares different metal allergy test results and clinical outcomes after primary and revision TKAs in patients with and without metal hypersensitivity. Methods: Primary (n = 28) and revision (n = 20) TKA patients receiving hypoallergenic implants for metal allergies diagnosed by skin patch testing (SPT), lymphocyte proliferation testing (LPT), or lymphocyte transformation testing (LTT) were retrospectively reviewed. The agreement between tests was assessed by percentage and kappa statistic within patients who used multiple testing modalities. Postoperative clinical outcomes of these patients were compared to those of patients without metal hypersensitivity matched by age (±5 years), body mass index (±5), gender, and follow-up duration (±2 years). Results: SPT and LPT showed weak agreement for nickel and minimal agreement for cobalt. SPT and LTT showed minimal agreement for nickel; weak agreement for titanium, bone cement, vanadium, and zirconium; but strong agreement for chromium and cobalt. LPT and LTT agreement was weak. Compared to matched controls, metal hypersensitivity patients undergoing primary TKAs with hypoallergenic implants experienced less improvement in Knee Society Scores, Veterans RAND 12 physical component scores, and range of motion. Patients undergoing revision TKAs for multiple indications including metal hypersensitivity had worse clinical outcomes with significantly worse improvements in Knee Society functional scores compared to matched controls. Conclusions: Metal allergy tests produce conflicting results. Hypersensitivity patients may experience inferior clinical outcomes even with hypoallergenic implants. Clinician awareness may influence the choice of testing and improve preoperative counseling of this patient population.