Manufacturing,oxidation,mechanical properties and clinical performance of highly cross-linked polyethylene in total hip arthroplasty

Abstract

Ultra-high molecular weight polyethylene (UHMWPE) continues to be the gold standard bearing surface in total hip arthroplasty (THA) for nearly 5 decades. Highly cross-linked UHMWPE (HXLPE) was adapted for routine use in the early 2000s to reduce the revision rates related to wear, osteolysis, and aseptic loosening resulting from conventional UHMWPE wear. Since its inception, consistent evidence showing reduced wear rates and osteolysis supports the use of HXLPE in THA. High quality studies demonstrating the advantage in long term survivorship of HXLPE over conventional UHMWPE are emerging. Though retrieval studies have demonstrated evidence of in vivo oxidation and fatigue related damage at the rim of the first generation HXLPE liners, clinical significance of this remains to be seen. Second-generation sequentially annealed and vitamin E containing HXLPE liners demonstrate improved mechanical properties, resistance to oxidation, and equivalent wear rates in comparison to their first-generation counterparts, but long term success remains to be seen.

Keywords

Total hip replacement highly crosslinked polyethylene osteolysis oxidation aseptic loosening UHMWPE

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References

Learmonth

Young

Rorabeck

. The operation of the century: total hip replacement. Lancet 2007; 370: 1508–1519.

Berry

Harmsen

Cabanela

et al . Twenty-five-year survivorship of two thousand consecutive primary Charnley total hip replacements: factors affecting survivorship of acetabular and femoral components. J Bone Joint Surg Am 2002; 84–A: 171–177.

McKellop

Shen

et al . Development of an extremely wear-resistant ultra high molecular weight polythylene for total hip replacements. J Orthop Res 1999; 17: 157–167.

Lachiewicz

Soileau

. Highly cross-linked polyethylene provides decreased osteolysis and reoperation at minimum 10-year follow-up. J Arthroplasty 2016; 31: 1959–1962.

Kurtz

Gawel

Patel

. History and systematic review of wear and osteolysis outcomes for first-generation highly crosslinked polyethylene. Clin Orthop Relat Res 2011; 469: 2262–2277.

Glyn-Jones

Thomas

Garfjeld-Roberts

et al . The John Charnley Award: Highly crosslinked polyethylene in total hip arthroplasty decreases long-term wear: a double-blind randomized trial. Clin Orthop Relat Res 2015; 473: 432–438.

Paxton

Inacio

Namba

et al . Metal-on-conventional polyethylene total hip arthroplasty bearing surfaces have a higher risk of revision than metal-on-highly crosslinked polyethylene: results from a US registry. Clin Orthop Relat Res 2015; 473: 1011–1021.

Paxton

Cafri

Havelin

et al . Risk of revision following total hip arthroplasty: metal-on-conventional polyethylene compared with metal-on-highly cross-linked polyethylene bearing surfaces: international results from six registries. J Bone Joint Surg Am 2014; 96(Suppl. 1): 19–24.

Baker

Bellare

Pruitt

. The effects 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.

10.

Currier

Mayor

et al . Evaluation of oxidation and fatigue damage of retrieved crossfire polyethylene acetabular cups. J Bone Joint Surg Am 2007; 89: 2023–2029.

11.

Tower

Currier

et al . Rim cracking of the cross-linked longevity polyethylene acetabular liner after total hip arthroplasty. J Bone Joint Surg Am 2007; 89: 2212–2217.

12.

Furmanski

Anderson

Bal

et al . Clinical fracture of cross-linked UHMWPE acetabular liners. Biomaterials 2009; 30: 5572–5582.

13.

Furmanski

Kraay

Rimnac

. Crack initiation in retrieved cross-linked highly cross-linked ultrahigh-molecular-weight polyethylene acetabular liners: an investigation of 9 cases. J Arthroplasty 2011; 26: 796–801.

14.

Kurtz

Ong

Lau

et al . Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am 2007; 89: 780–785.

15.

Wolford

Palso

Bercovitz

et al . Hospitalization for total hip replacement among inpatients aged 45 and over: United States, 2000–2010. NCHS Data Brief 2015: 1–8.

16.

Bozic

Kamath

Ong

et al . Comparative epidemiology of revision arthroplasty: Failed THA poses greater clinical and economic burdens than failed TKA. Clin Orthop Relat Res 2015; 473: 2131–2138.

17.

Kurtz

. A primer on UHMWPE. In: Kurtz

(ed). UHMWPE biomaterials handbook: ultra high molecular weight polyethylene in total joint replacement and medical devices. 3rd ed. Elsevier: 2015, pp. 1–6.

18.

Kurtz

. From ethylene gas to UHMWPE component: the process of producing orthopedic implants. In: Kurtz

(ed). UHMWPE biomaterials handbook: ultra high molecular weight polyethylene in total joint replacement and medical devices. 3rd ed. Elsevier: 2015, pp. 7–20.

19.

Ansari

Ries

Pruitt

. Effect of processing, sterilisation and crosslinking on UHMWPE fatigue fracture and fatigue wear mechanisms in joint arthroplasty. J Mech Behav Biomed Mater 2016; 53: 329–340.

20.

Burstein

. Ultra-high molecular weight polyethylene. The material and its use in total joint implants. J Bone Joint Surg Am 1994; 76: 1080–1090.

21.

Waugh

. John Charnley. London: Springer London, 1990. https://link-springer-com.web.bisu.edu.cn/10.1007/978-1-4471-3159-5 (accessed 11 September 2016).

22.

Charnley

Halley

. Rate of wear in total hip replacement. Clin Orthop Relat Res 1975; 112: 170–179.

23.

Mathiesen

Lindgren

Reinholt

et al . Tissue reactions to wear products from polyacetal (Delrin) and UHMW polyethylene in total hip replacement. J Biomed Mater Res 1987; 21: 459–466.

24.

Chmell

Poss

Thomas

et al . Early failure of hylamer acetabular inserts due to eccentric wear. J Arthroplasty 1996; 11: 351–353.

25.

Willert

Bertram

Buchhorn

. Osteolysis in alloarthroplasty of the hip. The role of ultra-high molecular weight polyethylene wear particles. Clin Orthop Relat Res 1990: 95–107.

26.

Kurtz

Muratoglu

Evans

et al . Advances in the processing, sterilisation, and crosslinking of ultra-high molecular weight polyethylene for total joint arthroplasty. Biomaterials 1999; 20: 1659–1688.

27.

Sutula

Collier

Saum

et al . The Otto Aufranc Award. Impact of gamma sterilisation on clinical performance of polyethylene in the hip. Clin Orthop Relat Res 1995: 28–40.

28.

Mckellop

Shen

Campbell

et al . Effect of molecular weight, calcium stearate, and sterilisation methods on the wear of ultra high molecular weight polyethylene acetabular cups in a hip joint simulator. J Orthop Res 1999; 17: 329–339.

29.

Wang

Essner

Polineni

et al . Lubrication and wear of ultra-high molecular weight polyethylene in total joint replacements. Tribol Int 1998; 31: 17–33.

30.

Endo

Tipper

Barton

et al . Comparison of wear, wear debris and functional biological activity of moderately crosslinked and non-crosslinked polyethylenes in hip prostheses. Proc Inst Mech Eng H 2002; 216: 111–122.

31.

Fisher

McEwen

HMJ

Tipper

et al . Wear, debris, and biologic activity of cross-linked polyethylene in the knee: benefits and potential concerns. Clin Orthop Relat Res 2004: 114–119.

32.

Patel

. 6 – The clinical performance of highly cross-linked UHMWPE in hip replacements. In: Kurtz

Steven M.

(ed.), UHMWPE Biomaterials Handbook. Waltham, MA: William Andrew, 2016, pp. 57–71.

33.

Zagorski

. 3 – Packaging and Sterilisation of UHMWPE. In: Kurtz

Steven M.

(ed.), UHMWPE Biomaterials Handbook. Waltham, MA: William Andrew, 2016, pp. 21–32.

34.

Dumbleton

D’Antonio

Manley

et al . The basis for a second-generation highly cross-linked UHMWPE. Clin Orthop Relat Res 2006; 453: 265–271.

35.

Kurtz

. Compendium of HXLPEs. In: Kurtz

Steven M.

. UHMWPE biomaterials handbook: ultra high molecular weight polyethylene in total joint replacement and medical devices. 3rd ed. Elsevier: 2015, pp. 449–466.

36.

Oral

Wannomae

Hawkins

et al . Alpha-tocopherol-doped irradiated UHMWPE for high fatigue resistance and low wear. Biomaterials 2004; 25: 5515–5522.

37.

Vivacit-E ® Vitamin E highly crosslinked polyethylene long-term performance for high demand patients. ZIMMER Tech. MEMO. 2014.

38.

Oral

Muratoglu

. Highly cross-linked UHMWPE doped with vitamin E. In: Kurtz

(ed). UHMWPE biomaterials handbook: ultra high molecular weight polyethylene in total joint replacement and medical devices. 3rd ed. Elsevier: 2015, pp. 307–325.

39.

Oral

Neils

Doshi

et al . Effects of simulated oxidation on the in vitro wear and mechanical properties of irradiated and melted highly crosslinked UHMWPE. J Biomed Mater Res Part B Appl Biomater 2016; 104: 316–322.

40.

Kurtz

Oral

. In vivo oxidation of UHMWPE. In: Kurtz

(ed). UHMWPE biomaterials handbook: ultra high molecular weight polyethylene in total joint replacement and medical devices. 3rd ed. Elsevier: 2015, pp. 488–505.

41.

Bhateja

Duerst

Aus

et al . Free radicals trapped in polyethylene crystals. J Macromol Sci Part B 1995; 34: 263–272.

42.

Currier

Van Citters

Currier

et al . In vivo oxidation in remelted highly cross-linked retrievals. J Bone Joint Surg Am 2010; 92: 2809–2816.

43.

Muratoglu

Wannomae

Rowell

et al . Ex vivo stability loss of irradiated and melted ultra-high molecular weight polyethylene. J Bone Joint Surg Am 2010; 92: 2809–2816.

44.

Kurtz

Austin

Azzam

et al . Mechanical properties, oxidation, and clinical performance of retrieved highly crosslinked crossfire liners after intermediate-term implantation. J Arthroplasty 2010; 25: 614–623.e1–2.

45.

MacDonald

Sakona

Ianuzzi

et al . Do first-generation highly crosslinked polyethylenes oxidize in vivo?. Clin Orthop Relat Res 2011; 469: 2278–2285.

46.

Currier

Mayor

et al . In vivo oxidation of gamma-barrier-sterilized ultra-high-molecular-weight polyethylene bearings. J Arthroplasty 2007; 22: 721–731.

47.

Kurtz

MacDonald

Mont

et al . Retrieval analysis of sequentially annealed highly crosslinked polyethylene used in total hip arthroplasty. Clin Orthop Relat Res 2015; 473: 962–971.

48.

Rowell

Reyes

Malchau

et al . In vivo oxidative stability changes of highly cross-linked polyethylene bearings: an ex vivo investigation. J Arthroplasty 2015; 30: 1828–1834.

49.

Hara

Nakashima

Yamamoto

et al . Late failure of annealed highly cross-linked polyethylene acetabular liner. J Mech Behav Biomed Mater 2013; 28: 206–212.

50.

Waewsawangwong

Goodman

. Unexpected failure of highly cross-linked polyethylene acetabular liner. J Arthroplasty 2012; 27: 323.e1–e4.

51.

Spiegelberg

Kozak

Braithwaite

. 29 – Characterization of physical, chemical, and mechanical properties of UHMWPE. In: UHMWPE Biomaterials Handbook. William Andrew, 2016, pp. 531–552.

52.

Guidance for Medical Devices-European Commission. https://ec.europa.eu/growth/sectors/medical-devices/guidance_en (2018, accessed 31 March 2018).

53.

Sobieraj

Rimnac

. Ultra high molecular weight polyethylene: mechanics, morphology, and clinical behavior. J Mech Behav Biomed Mater 2008; 2: 433–443.

54.

Muratoglu

Bragdon

O’Connor

et al . A novel method of cross-linking ultra-high-molecular-weight polyethylene to improve wear, reduce oxidation, and retain mechanical properties. Recipient of the 1999 HAP Paul Award. J Arthroplasty 2001; 16: 149–160.

55.

Pruitt

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

56.

Rimnac

Pruitt

. How do material properties influence influence wear and fracture? J Am Acad Orthop Surg 2007; 16(S1): S94–S100.

57.

Pruitt

Ansari

Kury

et al . Clinical trade-offs in cross-linked ultrahigh-molecular-weight polyethylene used in total joint arthroplasty. J Biomed Mater Res Part B Appl Biomater 2013; 101: 476–484.

58.

Atwood

Van Citters

Patten

et al . Tradeoffs amongst fatigue, wear, and oxidation resistance of cross-linked ultra-high molecular weight polyethylene. J Mech Behav Biomed Mater 2011; 4: 1033–1045.

59.

Gencur

Rimnac

Kurtz

. Fatigue crack propagation resistance of virgin and highly crosslinked, thermally treated ultra-high molecular weight polyethylene. Biomaterials 2006; 27: 1550–1557.

60.

Beksaç

Salas

González Della Valle

et al . Wear is reduced in THA performed with highly cross-linked polyethylene. Clin Orthop Relat Res 2009; 467: 1765–1772.

61.

McCalden

MacDonald

Rorabeck

et al . Wear rate of highly cross-linked polyethylene in total hip arthroplasty. J Bone Joint Surg Am 2009; 91: 773–782.

62.

Kurtz

Gawel

Patel

. History and systematic review of wear and osteolysis outcomes for first-generation highly crosslinked polyethylene. Clin Orthop Relat Res 2011; 469: 2262–2277.

63.

Kuzyk

PRT

Saccone

Sprague

et al . Cross-linked versus conventional polyethylene for total hip replacement: a meta-analysis of randomised controlled trials. J Bone Joint Surg Br 2011; 93: 593–600.

64.

Lee

J-H

Lee

B-J

et al . Midterm results of primary total hip arthroplasty using highly cross-linked polyethylene: minimum 7-year follow-up study. J Arthroplasty 2011; 26: 1014–1019.

65.

Mall

Nunley

Zhu

et al . The incidence of acetabular osteolysis in young patients with conventional versus highly crosslinked polyethylene. Clin Orthop Relat Res 2011; 469: 372–381.

66.

Thomas

Simpson

Mehmood

et al . The seven-year wear of highly cross-linked polyethylene in total hip arthroplasty: a double-blind, randomized controlled trial using radiostereometric analysis. J Bone Joint Surg Am 2011; 93: 716–722.

67.

Johanson

P-E

Digas

Herberts

et al . Highly crosslinked polyethylene does not reduce aseptic loosening in cemented THA 10-year findings of a randomized study. Clin Orthop Relat Res 2012; 470: 3083–3093.

68.

Bragdon

Doerner

Martell

et al . The 2012 John Charnley Award: clinical multicenter studies of the wear performance of highly crosslinked remelted polyethylene in THA. Clin Orthop Relat Res 2013; 471: 393–402.

69.

Garvin

White

Dusad

et al . Low wear rates seen in THAs with highly crosslinked polyethylene at 9 to 14 years in patients younger than age 50 years. Clin Orthop Relat Res 2015; 473: 3829–3835.

70.

Pang

Naudie

McCalden

et al . Highly crosslinked polyethylene improves wear but not surface damage in retrieved acetabular liners. Clin Orthop Relat Res 2015; 473: 463–468.

71.

Sochart

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

72.

Dowd

Sychterz

Young

et al . Characterization of long-term femoral-head-penetration rates. J Bone Joint Surg 2000; 82: 1102–1107.

73.

Dumbleton

Manley

Edidin

. A literature review of the association between wear rate and osteolysis in total hip arthroplasty. J Arthroplasty 2002; 17: 649–661.

74.

Austrailian Orthopaedic Association National Joint Replacement Registry. Annual Report. Adelaide, https://aoanjrr.sahmri.com/annual-reports-2015 (2015, accessed 26 September 2016).

75.

Hanna

Somerville

McCalden

et al . Highly cross-linked polyethylene decreases the rate of revision of total hip arthroplasty compared with conventional polyethylene at 13 years follow-up. Bone Joint J 2016; 98–B: 28–32.

76.

Engh

Jr Hopper

Jr Huynh

et al . Winner of the dorr award a prospective, randomized study of cross-linked and non–cross-linked polyethylene for total hip arthroplasty at 10-year follow-up. http://journals1.scholarsportal.info.proxy1.lib.uwo.ca/pdf/08835403/v27i0008_s/2_aprsocthaa1f.xml (2012, accessed 30 April 2017).

77.

García-Rey

García-Cimbrelo

Cruz-Pardos

. New polyethylenes in total hip replacement: a ten- to 12-year follow-up study. Bone Joint J 2013; 95: 326–332.

78.

Bedard

Callaghan

Stefl

et al . Fixation and wear with a contemporary acetabular component and cross-linked polyethylene at minimum 10-year follow-up. J Arthroplasty 2014; 29: 1961–1969.

79.

Babovic

Trousdale

. Total hip arthroplasty using highly cross-linked polyethylene in patients younger than 50 years with minimum 10-year follow-up. J Arthroplasty 2013; 28: 815–817.

80.

Ast

John

Labbisiere

et al . Fractures of a single design of highly cross-linked polyethylene acetabular liners: an analysis of voluntary reports to the United States Food and Drug Administration. J Arthroplasty 2014; 29: 1231–1235.

81.

Paterson

Teeter

Macdonald

et al . Highly cross-linked vs conventional polyethylene: no differences in rim notching from micromotion on retrieved acetabular liners. J Arthroplasty 2012; 27: 1616–1621.e1.