Ten-year outcomes of a nitrided Ti-6Al-4V titanium alloy fixed-bearing total knee replacement with a highly crosslinked polyethylene-bearing in patients with metal allergy.

Background: Metal hypersensitivity in patients with a total knee arthroplasty (TKA) is a rare condition and a very controversial topic. Despite the lack of data concerning the real effective impact of allergy on TKA failures, most of the manufactures offer the choice of 'non-allergenic' implants both for primary and revision TKA, some of which provide the same designs and surgical techniques as the conventional ones. Only a few studies are available on outcomes on these 'hypersensitivity-friendly' implants and even fewer specifically on allergic patients with a mid- to long-term follow-up.

Methods: Between 2007 and 2015, we enrolled 72 patients (57 females, 15 males), who underwent TKA treated with a non-allergenic posterior-stabilized (PS) total knee implant for a declared and proven metal allergy. Patients were followed clinically and radiographically for a mean 10 years of follow-up.

Results: With revision as an endpoint the Kaplan-Meier survival estimate showed a survival rate of 97.2% at five years and 95.1% at 10 years. Significant improvements in range of motion (ROM), Knee Society Scoring (KSS) and Hospital for Special Surgery (HSS) knee scores were registered at final follow-up (P < 0.0001). At final follow-up validated Patient-Reported Outcome Measures (PROMs) showed the following scores: Oxford Knee Score (OKS) 42.1, EQ5D 0.80, EQ VAS 80.1, Forgotten Joint Score 71.2.

Conclusions: This nitrided Ti-6Al-4V titanium alloy fixed-bearing total knee replacement with a highly crosslinked polyethylene-bearing showed interesting results and survival rates in patients with metal allergy at mid- to long-term follow-up.