Anne Postler1, Franziska Beyer1, Cornelia Lützner1, Eric Tille1, Jörg Lützner2. 1. University Center of Orthopaedics and Traumatology, University Medicine Carl Gustav Carus Dresden, Fetscherstr. 74, 01307, Dresden, Germany. 2. University Center of Orthopaedics and Traumatology, University Medicine Carl Gustav Carus Dresden, Fetscherstr. 74, 01307, Dresden, Germany. joerg.luetzner@uniklinikum-dresden.de.
Abstract
PURPOSE:Patients with known hypersensitivity to metals often require hypoallergenic TKA implants. Coating of a standard implant is a common solution, and although in vitro tests have demonstrated reduction of polyethylene wear for these coatings, it is still unknown whether these implants have any clinical benefit. This study was initiated to investigate metal ion concentrations, knee function and patient-reported outcome (PRO) after coated and uncoated TKA. METHODS:One hundred and twenty-two (122) patients were randomized to receive a coated or a standard TKA and, after exclusions, 59 patients were included in each group. Knee function and PRO were assessed with validated scores up to 3 years after surgery. Metal ion concentrations in blood samples were determined for chromium, cobalt, molybdenum and nickel, preoperatively and 1 year after surgery. RESULTS:Chromium concentrations in patient plasma increased from a median of 0.25 to 1.30 µg/l in the standard TKA group, and from 0.25 to 0.75 µg/l in the coated TKA group (p = 0.012). Thirteen patients (3 coated, 10 standard TKA) had chromium concentrations above 2 µg/l. The concentrations of cobalt, molybdenum and nickel did not change. Patient-reported outcome measures (PROM) demonstrated a substantial improvement after TKA, without any differences between the groups. CONCLUSION: The increase in chromium concentration in the standard group needs further investigation. If surgeons use coated implants, they can be confident that these implants perform as well as standard implants. LEVEL OF EVIDENCE: I.
RCT Entities:
PURPOSE:Patients with known hypersensitivity to metals often require hypoallergenic TKA implants. Coating of a standard implant is a common solution, and although in vitro tests have demonstrated reduction of polyethylene wear for these coatings, it is still unknown whether these implants have any clinical benefit. This study was initiated to investigate metal ion concentrations, knee function and patient-reported outcome (PRO) after coated and uncoated TKA. METHODS: One hundred and twenty-two (122) patients were randomized to receive a coated or a standard TKA and, after exclusions, 59 patients were included in each group. Knee function and PRO were assessed with validated scores up to 3 years after surgery. Metal ion concentrations in blood samples were determined for chromium, cobalt, molybdenum and nickel, preoperatively and 1 year after surgery. RESULTS:Chromium concentrations in patient plasma increased from a median of 0.25 to 1.30 µg/l in the standard TKA group, and from 0.25 to 0.75 µg/l in the coated TKA group (p = 0.012). Thirteen patients (3 coated, 10 standard TKA) had chromium concentrations above 2 µg/l. The concentrations of cobalt, molybdenum and nickel did not change. Patient-reported outcome measures (PROM) demonstrated a substantial improvement after TKA, without any differences between the groups. CONCLUSION: The increase in chromium concentration in the standard group needs further investigation. If surgeons use coated implants, they can be confident that these implants perform as well as standard implants. LEVEL OF EVIDENCE: I.
Entities:
Keywords:
Allergy; Coated implant; Metal hypersensitivity; Metal ions; Results; Total knee arthroplasty; Total knee replacement
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