Top

Clinical Orthopaedics and Related Research®

Published in:

01-08-2011 | Symposium: UHMWPE for Arthroplasty: From Powder to Debris

Vitamin E-stabilized UHMWPE for Total Joint Implants: A Review

Authors: Pierangiola Bracco, MD, Ebru Oral, PhD

Published in: Clinical Orthopaedics and Related Research® | Issue 8/2011

Abstract

Background

Osteolysis due to wear of UHMWPE limits the longevity of joint arthroplasty. Oxidative degradation of UHMWPE gamma-sterilized in air increases its wear while decreasing mechanical strength. Vitamin E stabilization of UHMWPE was proposed to improve oxidation resistance while maintaining wear resistance and fatigue strength.

Questions/purposes

We reviewed the preclinical research on the development and testing of vitamin E-stabilized UHMWPE with the following questions in mind: (1) What is the rationale behind protecting irradiated UHMWPE against oxidation by vitamin E? (2) What are the effects of vitamin E on the microstructure, tribologic, and mechanical properties of irradiated UHMWPE? (3) Is vitamin E expected to affect the periprosthetic tissue negatively?

Methods

We performed searches in PubMed, Scopus, and Science Citation Index to review the development of vitamin E-stabilized UHMWPEs and their feasibility as clinical implants.

Results

The rationale for using vitamin E in UHMWPE was twofold: improving oxidation resistance of irradiated UHMWPEs and fatigue strength of irradiated UHMWPEs with an alternative to postirradiation melting. Vitamin E-stabilized UHMWPE showed oxidation resistance superior to that of irradiated UHMWPEs with detectable residual free radicals. It showed equivalent wear and improved mechanical strength compared to irradiated and melted UHMWPE. The biocompatibility was confirmed by simulating elution, if any, of the antioxidant from implants.

Conclusions

Vitamin E-stabilized UHMWPE offers a joint arthroplasty technology with good mechanical, wear, and oxidation properties.

Clinical Relevance

Vitamin E-stabilized, irradiated UHMWPEs were recently introduced clinically. The rationale behind using vitamin E and in vitro tests comparing its performance to older materials are of great interest for improving longevity of joint arthroplasties.

Al-Malaika S. Autoxidation. In: Scott G, ed. Atmospheric Oxidation and Antioxidants. Volume I. Amsterdam, The Netherlands: Elsevier Science Publishers BV; 1993:45–82.

Assink R, Celina M, Dunbar T, Alam T, Clough R, Gillen K. Analysis of hydroperoxides in solid polyethylene by MAS 13C NMR and EPR. Macromolecules. 2000;33:4023–4029.CrossRef

ASTM International. ASTM F 2695-07. Standard Specification for Ultra-high Molecular Weight Polyethylene Powder Blended With alpha-Tocopherol (Vitamin E) and Fabricated Forms for Surgical Implant Applications. West Conshohocken, PA: ASTM International; 2007.

Baker DA, Bellare A, Pruitt L. The effect of degree of crosslinking on the fatigue crack initiation and propagation resistance of orthopedic-grade polyethylene. J Biomed Mater Res A. 2003;66:146–154.PubMedCrossRef

Baker DA, Hastings RS, Pruitt L. Study of fatigue resistance of chemical and radiation crosslinked medical grade UHMWPE. J Biomed Mater Res. 1999;46:573–581.PubMedCrossRef

Bauer T, Schils J. The pathology of total joint arthroplasty. II. Mechanisms of implant failure. Skeletal Radiol. 1999;28:483–497.PubMedCrossRef

Berzen J, Luketic D. Stabilised polyethylene moulding materials, for implants containing polyethylene with molecular wt. 10⁵–10⁷, antioxidant, and tocopherol, α-tocopherol or vitamin E, as stabiliser. European Patent 613,923. 1994.

Bhateja S, Duerst R, Aus E, Andrews E. Free radicals trapped in polyethylene crystals. J Macromol Sci Phys B. 1995;34:263–272.CrossRef

Blunn G, Brach del Preva EM, Costa L, Fisher J, Freeman MA. Ultra high molecular-weight polyethylene (UHMWPE) in total knee replacement: fabrication, sterilisation and wear. J Bone Joint Surg Br. 2002;84:946–949.PubMedCrossRef

10.

Bosetti M, Zanardi L, Bracco P, Costa L, Cannas M. In vitro evaluation of the inflammatory activity of UHMWPE. Biomaterials. 2003;24:1419–1426.PubMedCrossRef

11.

Bracco P, Brunella V, Zanetti M, Luda MP, Costa L. Stabilisation of UHMWPE with vitamin E. Polym Degrad Stab. 2007;92:2155–2162.CrossRef

12.

Brach del Prever EM, Bistolfi A, Costa L, Bracco P, Linari A, Botto Micca F, Crova M, Gallinaro P. The biological reaction to polyethylene wear debris can be related with oxidation of the UHMWPE cups. Chir Organi Mov. 2003;88:291–303.PubMed

13.

Brach del Prever EM, Camino G, Costa L, Crova M, Dallera A, Gallinaro P. Impianto protesico contenente un componente di materiale plastico. Italian Patent 1271590. 1994.

14.

Brigelius-Flohe R, Traber MG. Vitamin E: function and metabolism. FASEB J. 1999;13:1145–1155.PubMed

15.

Brunella V, Bracco P, Carpentieri I, Paganini MC, Zanetti M, Costa L. Lifetime of alkyl macroradicals in irradiated UHMWPE. Polym Degrad Stab. 2007;92:1498–1503.CrossRef

16.

Carlsson D, Chmela S, Lacoste J. On the structures and yields of the first peroxyl radicals in γ-irradiated polyolefins. Macromolecules. 1990;23:4934–4938.CrossRef

17.

Carlsson D, Dobbin C, Wiles D. Direct observations of macroperoxyl radical propagation and termination by electron spin resonance and infrared spectroscopies. Macromolecules. 1985;18:2092–2094.CrossRef

18.

Charlesby A, Libby D, Ormerod M. Radiation damage in polyethylene as studied by electron spin resonance. Proc R Soc Lond A. 1961;262:207–218.CrossRef

19.

Collier J, Sutula L, Currier B, John H, Wooding R, Williams I, Farber K, Mayor M. Overview of polyethylene as a bearing material: comparison of sterilization methods. Clin Orthop Relat Res. 1996;333:76–86.PubMedCrossRef

20.

Costa L, Bracco P. Mechanisms of crosslinking, oxidative degradation and stabilization of UHMWPE. In: Kurtz SM, ed. The UHMWPE Biomaterials Handbook. Burlington, MA: Elsevier Academic Press; 2009:309–323.CrossRef

21.

Costa L, Bracco P, Brach Del Prever EM. Physicochemical and mechanical properties of UHMWPE: 45 years’ experience. Interact Surg. 2007;2:169–173.CrossRef

22.

Costa L, Carpentieri I, Bracco P. Post electron-beam irradiation oxidation of orthopaedic UHMWPE. Polym Degrad Stab. 2008;93:1695–1703.CrossRef

23.

Costa L, Carpentieri I, Bracco P. Post electron-beam irradiation oxidation of orthopaedic UHMWPE stabilized with vitamin E. Polym Degrad Stab. 2009;94:1542–1547.CrossRef

24.

Costa L, Jacobson K, Bracco P, Brach del Prever EM. Oxidation of orthopaedic UHMWPE. Biomaterials. 2002;23:1613–1624.PubMedCrossRef

25.

Costa L, Luda MP, Trossarelli L. Ultra-high molecular weight polyethylene. I. Mechano-oxidative degradation. Polym Degrad Stab. 1997;55:329–338.CrossRef

26.

Costa L, Luda MP, Trossarelli L. Ultra-high molecular weight polyethylene. II. Thermal- and photo-oxidation. Polym Degrad Stab. 1997;58:41–54.CrossRef

27.

Costa L, Luda MP, Trossarelli L, Brach del Prever EM, Crova M, Gallinaro P. Oxidation in orthopaedic UHMWPE sterilized by gamma radiation and ethylene oxide. Biomaterials. 1998;19:659–668.PubMedCrossRef

28.

Costa L, Luda MP, Trossarelli L, Brach Del Prever EM, Crova M, Gallinaro P. In vivo UHMWPE biodegradation of retrieved prosthesis. Biomaterials. 1998;19:1371–1385.PubMedCrossRef

29.

Digas G, Karrholm J, Thanner J, Herberts P. 5-year experience of highly crosslinked polyethylene in cemented and uncemented sockets: two randomized studies using radiostereometric analysis. Acta Orthop. 2007;78:746–754.PubMedCrossRef

30.

Dole M. Free radicals in irradiated polyethylene. In: Dole M, ed. The Radiation Chemistry of Macromolecules. New York, NY: Academic Press. 1972:335–348.

31.

Dolezel B, Adamirova L. Method of hygienically safe stabilization of polyolefines against thermoxidative and photooxidative degradation. Czechoslovakian Socialist Republic Patent 221,403. 1982.

32.

Food and Drug Administration, Department of Health and Human Services. Code of Federal Regulations 184.1890: Direct Food Substances Affirmed as Generally Recognized as Safe–[alpha]-tocopherols. Title 21, Volume 3. Revised April 1, 2004.

33.

Furmanski J. Mechanistic and Clinical Aspects of Fatigue of Ultrahigh Molecular Weight Polyethylene [dissertation]. Berkeley, CA: University of California, Berkeley; 2008.

34.

Gencur SJ, Rimnac CM, Kurtz SM. Fatigue crack propagation resistance of virgin and highly crosslinked thermally treated UHMWPE. Biomaterials. 2006;27:1550–1557.PubMedCrossRef

35.

Harris W. The problem is osteolysis. Clin Orthop Relat Res. 1995;311:46–53.PubMed

36.

Ingham E, Fisher J. Biological reactions to wear debris in total joint replacement. Proc Inst Mech Eng H. 2000;214:21–37.PubMed

37.

Ingram JH, Stone M, Fisher J, Ingham E. The influence of molecular weight, crosslinking and counterface roughness on TNF-alpha production by macrophages in response to UHMWPE particles. Biomaterials. 2004;25:3511–3522.PubMedCrossRef

38.

Jahan MS, King MC, Haggard WO, Sevo KL, Parr JE. A study of long-lived free radicals in gamma-irradiated medical grade polyethylene. Radiat Phys Chem. 2001;62:141–144.CrossRef

39.

Jarrett B, Cofske J, Rosenberg A, Oral E, Muratoglu O, Malchau H. In vivo biological response to vitamin E and vitamin E-doped polyethylene. J Bone Joint Surg Am. 2010;92:2672–2681.PubMedCrossRef

40.

Keller A, Ungar G. Radiation effects and crystallinity in polyethylene. J Phys Chem. 1983;22:155–181.

41.

Kiyose C, Ueda T. Distribution and metabolism of tocopherols and tocotrienols in vivo. J Clin Biochem Nutr. 2004;35:47–52.CrossRef

42.

Kurtz SM, Dumbleton J, Siskey RS, Wang A, Manley M. Trace concentrations of vitamin E protect radiation crosslinked UHMWPE from oxidative degradation. J Biomed Mater Res A. 2009;90:549–563.PubMed

43.

Kurtz SM, Hozack W, Marcolongo M, Turner J, Rimnac C, Edidin A. Degradation of mechanical properties of UHMWPE acetabular liners following long-term implantation. J Arthroplasty. 2003;18(7 Suppl 1):68–78.PubMedCrossRef

44.

Lerf R, Zurbrugg D, Delfosse D. Use of vitamin E to protect cross-linked UHMWPE from oxidation. Biomaterials. 2010;31:3643–3648.PubMedCrossRef

45.

Luisetto Y, Wesslen B, Maurer F, Lidgren L. The effect of irradiation, annealing temperature and artificial aging on oxidation, mechanical properties and fracture mechanisms of UHMWPE. J Biomed Mater Res A. 2003;67:908–917.PubMedCrossRef

46.

Lyons B. Radiolytic unsaturation decay in polyethylene. Part II. The effect of irradiation temperature, thermal history and orientation. Radiat Phys Chem. 2004;69:503–510.CrossRef

47.

Martell JM, Verner JJ, Incavo SJ. Clinical performance of a highly cross-linked polyethylene at two years in total hip arthroplasty: a randomized prospective trial. J Arthroplasty 2003;18(7 Suppl 1):55–59.PubMedCrossRef

48.

McKellop H, Shen FW, Lu B, Campbell P, Salovey R. Development of an extremely wear resistant ultra-high molecular weight polyethylene for total hip replacements. J Orthop Res. 1999;17:157–167.PubMedCrossRef

49.

McKellop H, Shen FW, Lu B, Campbell P, Salovey R. Effect of sterilization method and other modifications on the wear resistance of acetabular cups made of ultra-high molecular weight polyethylene: a hip-simulator study. J Bone Joint Surg Am. 2000;82:1708–1725.PubMed

50.

Muratoglu OK, Bragdon CR, O’Connor DO, Jasty M, Harris WH. 1999 HAP Paul Award. A novel method of crosslinking UHMWPE to improve wear, reduce oxidation and retain mechanical properties. J Arthroplasty. 2001;16:149–160.PubMedCrossRef

51.

Muratoglu OK, Bragdon CR, O’Connor DO, Jasty M, Harris WH, Gul R, McGarry F. Unified wear model for highly crosslinked ultra-high molecular weight polyethylenes (UHMWPE). Biomaterials. 1999;20:1463–1470.PubMedCrossRef

52.

Muratoglu OK, Bragdon CR, O’Connor DO, Perinchief RS, Estok DM, Jasty M, Harris WH. Larger diameter femoral heads used in conjunction with a highly cross-linked ultra-high molecular weight polyethylene: a new concept. J Arthroplasty. 2001;16(8 Suppl):24–30.PubMedCrossRef

53.

Muratoglu OK, Merrill EW, Bragdon CR, O’Connor D, Hoeffel D, Burroughs B, Jasty M, Harris WH. Effect of radiation, heat, and aging on in vitro wear resistance of polyethylene. Clin Orthop Relat Res. 2003;417:253–262.PubMed

54.

Ohnishi S, Sugimoto S, Nitta I. Electron spin resonance study of radiation oxidation of polymers. IIIA. Results for polyethylene and some general remarks. J Polym Sci A Poly Chem. 1963;1:605–623.

55.

Oral E, Christensen S, Malhi A, Wannomae K, Muratoglu O. Wear resistance and mechanical properties of highly crosslinked UHMWPE doped with vitamin E. J Arthroplasty. 2006;21:580–591.PubMedCrossRef

56.

Oral E, Godleski Beckos C, Malhi A, Muratoglu O. The effects of high dose irradiation on the cross-linking of vitamin E-blended UHMWPE. Biomaterials. 2008;29:3557–3560.PubMedCrossRef

57.

Oral E, Greenbaum ES, Malhi AS, Harris WH, Muratoglu OK. Characterization of irradiated blends of alpha-tocopherol and UHMWPE. Biomaterials. 2005;26:6657–6663.PubMedCrossRef

58.

Oral E, Malhi A, Muratoglu O. Mechanisms of decrease in fatigue crack propagation resistance in irradiated and melted UHMWPE. Biomaterials. 2006;27:917–925.PubMedCrossRef

59.

Oral E, Malhi A, Wannomae K, Muratoglu O. 2006 HAP Paul Award. Highly cross-linked UHMWPE with improved fatigue resistance for total joint arthroplasty. J Arthroplasty. 2008;23:1037–1044.PubMedCrossRef

60.

Oral E, Rowell SL, Muratoglu OK. The effect of α-tocopherol on the oxidation and free radical decay in irradiated UHMWPE. Biomaterials. 2006;27:5580–5587.PubMedCrossRef

61.

Oral E, Wannomae K, Rowell S, Muratoglu O. Migration stability of alpha-tocopherol in irradiated UHMWPE. Biomaterials. 2006;27:2434–2439.PubMedCrossRef

62.

Oral E, Wannomae KK, Hawkins NE, Harris WH, Muratoglu OK. α-Tocopherol doped irradiated UHMWPE for high fatigue resistance and low wear. Biomaterials. 2004;25:5515–5522.PubMedCrossRef

63.

Oral E, Wannomae KK, Rowell SL, Muratoglu OK. Diffusion of vitamin E in ultra-high molecular weight polyethylene. Biomaterials. 2007;28:5225–5237.PubMedCrossRef

64.

Packer L. Protective role of vitamin E in biological systems. Am J Clin Nutr. 1991;53:1050S–1055S.PubMed

65.

Parth M, Aust N, Lederer K. Studies on the effect of electron beam radiation on the molecular structure of ultra-high molecular weight polyethylene under the influence of alpha-tocopherol with respect to its application in medical implants. J Mater Sci Mater Med. 2002;13:917–921.PubMedCrossRef

66.

Pruitt LA. Deformation, yielding, fracture and fatigue behavior of conventional and highly cross-linked ultra high molecular weight polyethylene. Biomaterials. 2005;26:905–915.PubMedCrossRef

67.

Reno F, Lombardi F, Cannas M. UHMWPE oxidation increases granulocyte activation: a role in tissue response after prosthesis implant. Biomaterials. 2003;24:2895–2900.PubMedCrossRef

68.

Reno F, Sabbatini M, Cannas M. Surface oxidation of UHMWPE for orthopaedic use increases apoptosis and necrosis in human granulocytes. J Mater Sci Mater Med. 2003;14:241–245.PubMedCrossRef

69.

Seguchi T, Tamura N. Mechanism of decay of alkyl radicals in irradiated polyethylene on exposure to air as studied by electron spin resonance. J Phys Chem. 1973;77:40–44.CrossRef

70.

Sheppard AJ, Pennington JA, Weihrauch JL. Analysis and distribution of vitamin E in vegetable oils and foods. In: Packer L, Fuchs J, eds. Vitamin E in Health and Disease. New York, NY: Marcel Dekker, Inc; 1993:9–31.

71.

Shibata N, Kurtz SM, Tomita N. Advances of mechanical performance and oxidation stability in ultrahigh molecular weight polyethylene for total joint replacement: highly crosslinked and alpha-tocopherol doped. J Biomech Sci Eng. 2006;1:107–123.CrossRef

72.

Shibata N, Tomita N. The anti-oxidative properties of alpha tocopherol in gamma-irradiated UHMWPE with respect to fatigue and oxidation resistance. Biomaterials. 2005;26:5755–5762.PubMedCrossRef

73.

Shibata N, Tomita N, Onmori N, Kato K, Ikeuchi K. Defect initiation at subsurface grain boundary as a precursor of delamination in ultrahigh molecular weight polyethylene. J Biomed Mater Res A. 2003;67:276–284.PubMedCrossRef

74.

Sochart DH. Relationship of acetabular wear to osteolysis and loosening in total hip arthroplasty. Clin Orthop Relat Res. 1999;363:135–150.PubMedCrossRef

75.

Teramura S, Sakoda H, Terao T, Endo MM, Fujiwara K, Tomita N. Reduction of wear volume from ultrahigh molecular weight polyethylene knee components by the addition of vitamin E. J Orthop Res. 2008;26:460–464.PubMedCrossRef

76.

Thomas MJ. Physiological aspects of low-density lipoprotein oxidation. Curr Opin Lipidol. 2000;11:297–301.PubMedCrossRef

77.

Tomita N, Kitakura T, Onmori N, Ikada Y, Aoyama E. Prevention of fatigue cracks in ultrahigh molecular weight polyethylene joint components by the addition of vitamin E. J Biomed Mater Res B. 1999;48:474–478.CrossRef

78.

Traber MG, Sies H. Vitamin E in humans: demand and delivery. Ann Rev Nutr. 1996;16:321–347.CrossRef

79.

Wang A, Zeng H, Yau SS, Essner A, Manely M, Dumbleton J. Wear, oxidation and mechanical properties of a sequentially irradiated and annealed UHMWPE in total joint replacement. J Phys D Appl Phys. 2006;39:3213–3219.CrossRef

80.

Wang XY, Quinn PJ. The location and function of vitamin E in membranes. Mol Membr Biol. 2000;17:143–156.PubMedCrossRef

81.

Wannomae KK, Christensen SD, Freiberg AA, Bhattacharyya S, Harris WH, Muratoglu OK. The effect of real-time aging on the oxidation and wear of highly crosslinked UHMWPE acetabular liners. Biomaterials. 2006;27:1980–1987.PubMedCrossRef

82.

Wolf C, Krivec T, Blassnig J, Lederer K, Schneider W. Examination of the suitability of alpha-tocopherol as a stabilizer for ultra-high molecular weight polyethylene used for articulating surfaces in joint endoprostheses. J Mater Sci Mater Med. 2002;13:185–189.PubMedCrossRef

83.

Wolf C, Lederer K, Muller U. Tests of biocompatibility of α-tocopherol with respect to the use as a stabilizer in ultrahigh molecular weight polyethylene for articulating surfaces in joint endoprostheses. J Mater Sci Mater Med. 2002;13:701–705.PubMedCrossRef

84.

Wolf C, Macho C, Lederer K. Accelerated ageing experiments with crosslinked and conventional ultra-high molecular weight polyethylene (UHMW-PE) stabilised with alpha-tocopherol for total joint arthroplasty. J Mater Sci Mater Med. 2006;17:1333–1344.PubMedCrossRef

85.

Wolf C, Maninger J, Lederer K, Fruhwirth-Smounig H, Gamse T, Marr R. Stabilisation of crosslinked ultra-high molecular weight polyethylene (UHMW-PE)-acetabular components with alpha-tocopherol. J Mater Sci Mater Med. 2006;17:1323–1331.PubMedCrossRef

Title: Vitamin E-stabilized UHMWPE for Total Joint Implants: A Review
Authors: Pierangiola Bracco, MD
Ebru Oral, PhD
Publication date: 01-08-2011
Publisher: Springer-Verlag
Published in: Clinical Orthopaedics and Related Research® / Issue 8/2011
Print ISSN: 0009-921X
Electronic ISSN: 1528-1132
DOI: https://doi.org/10.1007/s11999-010-1717-6

At a glance: The STEP trials

Springer Medicine

Vitamin E-stabilized UHMWPE for Total Joint Implants: A Review

Abstract

Background

Questions/purposes

Methods

Results

Conclusions

Clinical Relevance

At a glance: The STEP trials

Springer Medicine

Abstract

Background

Questions/purposes

Methods

Results

Conclusions

Clinical Relevance

Please log in to get access to this content

Other articles of this Issue 8/2011

Crack Propagation Resistance Is Similar Under Static and Cyclic Loading in Crosslinked UHMWPE: A Pilot Study

History and Systematic Review of Wear and Osteolysis Outcomes for First-generation Highly Crosslinked Polyethylene

The Effect of Antiresorptives on Bone Quality

The Classic: The Metabolic Effects of Steroid Hormones in Osteoporosis

Do First-generation Highly Crosslinked Polyethylenes Oxidize In Vivo?

Diseases Affecting Bone Quality: Beyond Osteoporosis