[Preclinical evaluation of coated knee implants for allergic patients].
BACKGROUND
10-15% of the population show allergic reactions against skin contact to metals as nickel, cobalt or chromium and have thus a risk of not tolerating implants containing those materials. The relationship between periimplantary hypersensivity reaction and given cutaneous contact allergy is currently unknown. A new developed multilayer coating system is supposed to prevent long-term allergic reactions that may result from uncoated implants.


METHODS
Stability and function (concerning bonding durability, wear and ion release to the serum) of the multilayer coating system has been examined in a test series.


RESULTS
The specific architecture of the multilayer coating system evidences a very good bonding durability. The results of the test in the simulator show a reduction of wear of approximately 60% compared to the uncoated implants. Ion concentrations within the serum of the wear tests were by magnitudes lower than those measured in reference tests on uncoated components.


CONCLUSIONS
The results of the preclinical evaluation prove that the durability and function of the multilayer coating system are as intended.
Reich
J
J
Forschung & Entwicklung, Aesculap AG, Am Aesculap-Platz, 78532, Tuttlingen, Deutschland. jan.reich@aesculap.de
Hovy
L
L
Lindenmaier
H-L
HL
Zeller
R
R
Schwiesau
J
J
Thomas
P
P
Grupp
T M
TM
D001696:Biomechanical Phenomena; D002858:Chromium Alloys; D020099:Coated Materials, Biocompatible; D017449:Dermatitis, Allergic Contact / Q000276:immunology*; D019544:Equipment Failure Analysis; D006801:Humans; D007477:Ions / Q000276:immunology; D007720:Knee Prosthesis; D008855:Microscopy, Electron, Scanning; D011474:Prosthesis Design; D013499:Surface Properties; D014800:Vitallium / Q000633:toxicity*; D015040:Zirconium
D002858:Chromium Alloys; D020099:Coated Materials, Biocompatible; D007477:Ions; D014800:Vitallium; D015040:Zirconium