[The use of knee prostheses with a hypoallergenic coating is safe in the medium term : A randomized controlled study].

Background In Germany, patients with contact allergy to implant components usually receive coated joint arthroplasties. Whether the treatment using these hypoallergenic implants achieves comparable results to standard treatment with implants consisting of cobalt-chromium alloy (CoCr) implants is controversially discussed internationally and has rarely been investigated in the mid-term. Objectives Are there differences in blood metal ion concentrations, knee function, and patient-reported outcomes (PROM) between coated and standard implants? Material and methods 118 patients were randomized to receive either a coated or a standard implant. Knee function as well as patient-reported outcome measures were assessed. Metal ion concentrations in blood samples were additionally determined for chromium, cobalt, molybdenum, and nickel, preoperatively, one and five years after surgery. Results After five years, it was possible to analyse the results of 97 patients. In metal ion concentrations, as well as PRO, consistently good results were seen, without any difference between the groups. While in 13 patients there was an increase in chromium concentration above 2 µg/l one year after surgery, there was no measured value above 1 µg/l after five years. Conclusion In our study, similar mid-term results were detected for coated (TiNiN) and standard (CoCr)TKA. With respect to metal ion concentrations and PRO there are no disadvantages in using coated TKA.