A 15-years experience in analyses of UHMWPE prosthetic components: state of the art and future perspectives.
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1 A 15-years experience in analyses of UHMWPE prosthetic components: state of the art and future perspectives. P. Bracco, E.M. Brach del Prever*, V. Brunella, M. Zanetti, L. Costa Università di Torino Dipartimento di Chimica IFM *Dipartimento di Ortopedia, Traumatologia e Medicina del Lavoro
2 FACTS AND FIGURES Starting in 1992, in the last 15 years, we collected: KNEE 131 retrieved 69 new 2 TOT HIP 388 retrieved 18 new 496 TOT SHOULDER 1 new 76 TOT 519 retrieved 187 new
3 RETRIEVED UHMWPE KNEE 1% radiation sterilized Avg. time in vivo (y) < HIP 94% radiation sterilized 6% EtO, other Avg. time in vivo (y) <
4 RETRIEVED UHMWPE 11 y 12 y 8 y 11 y 8 y 5 y 7 y 12 y 1 y 1 y 6 y
5 FTIR studies of oxidative degradation.5 Ketones R-C=O 1718 cm (micron) Hydroperoxides (ROOH) (NO derivatization) RONO cm (micron) Costa L, Luda MP, Trossarelli L, Brach del Prever E, Crova M, Gallinaro P. Oxidation in orthopaedic UHMWPE sterilised by gamma-radiation and ethylene oxide. Biomaterials, 1998; 19:
6 5.5 Carboxylic acids (RC=O-OH) OH) (SF 4 derivatization) R(C=O)-F 1848 cm (micron) Dose assessment Trans-vinylene content (microns) L. Costa, M.P. Luda, P. Bracco and L. Trossarelli. Oxidation of UHMWPE during sterilisation by gamma and beta ray. Macro 98, 37th International Symposium on Macromolecules Gold Coast, Australia. 12th 17th July 1998
7 RETRIEVED UHMWPE - Typical FTIR analyses γ, retrieved, 7y Spessore (micron) (micron) Wavenumber Numero d'onda (cm (cm-1) ) 5.5 Assorbanza
8 EtO sterilized 7 y 11 y 17 y EtO, retrieved, 9y Assorbanza Spessore (micron) Numero Wavenumber d'onda (cm (cm-1) )
9 Abundance EtO retrieval extract Hexadecanoic acid, methyl ester Tetradecanoic acid, methyl ester x-octadecenoic acid, methyl ester Octadecanoic acid, methyl ester Cholest-5-ene, 3-methoxy Squalene Cholesterol Time (min) 45 Synovial fluid extract (KBr) Assorbanza EtO retrieval extract (KBr) Numero Wavenumber d'onda (cm-1) ) L. Costa, P. Bracco, E. Brach del Prever, M.P. Luda and L. Trossarelli. Analysis of products diffused into UHMWPE prosthetic components in vivo. Biomaterials, 21; 22(4):
10 EtO, after cyclohexane extraction, 9 C, 2 h (micron) Oxidative degradation does not start in vivo Wavenumber (cm -1 ) Numero d'onda (cm-1) γ, after cyclohexane extraction, 9 C, 2 h Max Oxidation Index (OI): (micron) Assorbanza
11 max OI: y 4 3 (microns) max OI: y (microns)
12 NEW, READY TO IMPLANT UHMWPE Ketones Hydroperoxides 1.8 Ketones Hydroperoxides (microns) (microns) Before 2 (55 samples) Ketones Hydroperoxides 1 Hydroperoxides Radiation sterilized: Oxidation index ca. 2 (up to 6) Hydroperoxide index ca (microns) Bracco P, Brunella V, Luda MP, Brach del Prever EM, Zanetti M, Costa L. Oxidation behaviour in prosthetic UHMWPE components sterilised with high energy radiation in the presence of oxygen Polymer Degrad. Stability 26, 91:
13 1 (69( radiation sterilized), new, ready-to to-implant UHMWPE hip, knee and shoulder components, submitted in by 19 manufacturers (6 Italian,, 8 European,, 5 US). max HI: 1 max OI: (micron) 4 2 Ketones Hydroperoxides max HI:.5 max OI: (micron) Ketones.35.3 Hydroperoxides Hydroperoxides Inert atmosphere Inert atmosphere L Costa, P Bracco, EM Brach del Prever, SM Kurtz, P Gallinaro. A survey of oxidation and oxidation potential in contemporary packaging for polyethylene total joint replacement components. J Biomed Mater Res 26; 78B (1):2-26
14 Variables involved in OXIDATION: Oxygen availability (oxygen is always present into UHMWPE) Purity of the inert gas Actual impermeability of the packaging Shelf-life life Radiation dose and dose rate Temperature
15 ABSORBED DOSE AND RADICALS Out of 79 irradiated samples (69 radiation sterilized + 1 highly crosslinked): kgy kgy 9 >35 kgy 11 5 kgy highly crosslinked (5 manufacturers) Out of 69 radiation sterilized samples, ALL showed a measurable ESR signal! None but one (not( remelted,, gamma sterilized) of the highly crosslinked samples show any measurable ESR signal
16 CONCLUSIONS Residual radicals are always found in radiation-sterilized UHMWPE Residual radicals can react with oxygen,, triggering the oxidation process Given the high number of variables involved, the prediction of the level, distribution and evolution of oxidation is, generally, not a successful activity!
17 ACKNOWLEDGEMENTS This study could not have been possible without the cooperation of the CTO Hospital (Torino). Lima Lto and Zimmer Inc are gratefully acknowledged for their financial support. THANK YOU FOR YOUR ATTENTION!
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