Top

European Spine Journal

Published in:

01-06-2012 | Original Article

The use of self-mating PEEK as an alternative bearing material for cervical disc arthroplasty: a comparison of different simulator inputs and tribological environments

Authors: Tim Brown, Qi-Bin Bao

Published in: European Spine Journal | Special Issue 5/2012

Abstract

Purpose

The hypothesis for this study was that the simulated wear behavior of a hydroxyapatite coated, self-mating PEEK cervical disc arthroplasty device would be dependent on the simulated testing environment.

Methods

Five groups of devices were evaluated under suggested ASTM and ISO load and motion profiles. The groups utilized different testing frequencies and protein content of simulator fluid, in addition to assessing the potential for third body wear. The average wear rates were determined using linear regression analysis with a generalized estimating equation. Significant differences between groups were determined using the Wald’s test.

Results

The simulated wear behavior was shown to be highly dependent on the testing environment, where protein content more than decreasing the cyclic loading frequency resulted in increased wear, but was not dependent on the suggested load and motion profiles. It was demonstrated that a self-mating PEEK cervical disc arthroplasty device has wear rates that are similar to existing material combinations for cervical disc arthroplasty.

Conclusions

This study showed that at a time when data from retrieval analyses is deficient, it is important to test the wear resistance of cervical disc arthroplasty devices under various conditions. Long-term clinical results and ongoing implant retrievals are required for validation between clinical performance and simulator inputs.

Fernstrom U (1966) Arthroplasty with intercorporal endopothesis in herniated disc and in painful disc. Acta Chir Scand Suppl 357:154–159PubMed

Reitz H, Joubert MJ (1964) Intractable headache and cervico-brachialgia treated by complete replacement of cervical intervertebral discs with a metal prosthesis. S Afr Med J 38:881–884PubMed

Murrey D, Janssen M, Delamarter R, Goldstein J et al (2009) Results of the prospective, randomized controlled multicenter Food and Drug Administration investigational device exemption study of the ProDisc-C total disc replacement versus anterior discectomy and fusion for the treatment of 1-level symptomatic cervical disc disease. Spine J 9(4):275–286PubMedCrossRef

Heller JG, Sasso RC, Papadopoulos SM, Anderson PA et al (2009) Comparison of BRYAN cervical disc arthroplasty with anterior cervical decompression and fusion: clinical and radiographic results of a randomized, controlled, clinical trial. Spine 34(2):101–107PubMedCrossRef

Mummaneni PV, Burkus JK, Haid RW, Traynelis VC et al (2007) Clinical and radiographic analysis of cervical disc arthroplasty compared with allograft fusion: a randomized controlled clinical trial. J Neurosurg Spine 6(3):198–209PubMedCrossRef

Nabhan A, Ahlhelm F, Pitzen T, Steudel WI et al (2007) Disc replacement using Pro-Disc C versus fusion: a prospective randomised and controlled radiographic and clinical study. Eur Spine J 16(3):423–430PubMedCrossRef

American Society of Testing and Materials (2006) Designation: F 2423-05. Standard guide for functional, kinematic, and wear assessment of total disc prostheses. American Society of Testing and Materials, West Conshohocken

International Organization for Standardization (2008) ISO 18192-1: implants for surgery—wear of total intervertebral spinal disc prostheses: Part 1. Loading and displacement parameters for wear testing and corresponding environmental conditions for tests. International Organization for Standardization

Anderson PA, Rouleau JP, Toth JM et al (2004) A comparison of simulator-tested and -retrieved cervical disc prostheses. Invited submission from the Joint Section Meeting on Disorders of the Spine and Peripheral Nerves, March 2004. J Neurosurg Spine 1(2):202–210PubMedCrossRef

10.

Pitzen T, Kettler A, Drumm J et al (2007) Cervical spine disc prosthesis: radiographic, biomechanical and morphological post mortal findings 12 weeks after implantation: a retrieval example. Eur Spine J 16(7):1015–1020PubMedCrossRef

11.

Tumialán LM, Gluf WM (2011) Progressive vertebral body osteolysis after cervical disc arthroplasty. Spine 36(14):E973–E978PubMedCrossRef

12.

Cavanaugh DA, Nunley PD, Kerr EJ et al (2009) Delayed hyper-reactivity to metal ions after cervical disc arthroplasty: a case report and literature review. Spine 34(7):E262–E265PubMedCrossRef

13.

Guyer RD, Shellock J, MacLennan B et al (2011) Early failure of metal-on-metal artificial disc prostheses associated with lymphocytic reaction: diagnosis and treatment experience in four cases. Spine 36(7):E492–E497PubMedCrossRef

14.

American Society of Testing and Materials (2006) Designation: F 2025-06. Standard practice for gravimetric measurement of polymeric components for wear assessment. American Society of Testing and Materials, West Conshohocken

15.

Bushelow M, Nechtow W, Hinter M et al (2006) Wear testing of a cervical total disc replacement: effect of motion and load parameters on wear rate and particle morphology. Transactions of the 54th Orthopedic Research Society, No. 1925

16.

Pare PE, Chan FW, Bhattacharya S et al (2009) Surface slide track mapping of implants for total disc arthroplasty. J Biomech 42(2):131–139PubMedCrossRef

17.

Wang A, Essner A, Schmidig G (2004) The effects of lubricant composition on in vitro wear testing of polymeric acetabular components. J Biomed Mater Res B Appl Biomater 68(1):45–52PubMedCrossRef

18.

Good VD, Clarke IC, Gustafson GA et al (2000) Wear of ultra-high molecular weight polyethylene and polytetrafluoroethylene in a hip simulator: a dose-response study of protein concentration. Acta Orthop Scand 71(4):365–369PubMedCrossRef

19.

Grupp TM, Yue JJ, Garcia R et al (2009) Biotribological evaluation of artificial disc arthroplasty devices: influence of loading and kinematic patterns during in vitro wear simulation. Eur Spine J 18:98–108PubMedCrossRef

20.

Nechtow W, Hintner M, Bushelow M et al (2006) IVD replacement mechanical performance depends strongly on input parameters. Orthopedic Research Society, Chicago

21.

Wang A, Sun DC, Yau SS et al (1997) Orientation softening in the deformation and wear of ultra-high molecular weight polyethylene. Wear 203–204:230–241CrossRef

22.

Bradgon CR, O’Connor DO, Lowenstein JS et al (1996) The importance of multidirectional motion on the wear of polyethylene. Proc Inst Mech Eng [H] 210:157–165

23.

Brown T, Bao QB, Kilpela T et al (2010) An in vitro biotribological assessment of NUBAC, a polyetheretherketone-on-polyetheretherketone articulating nucleus replacement device: methodology and results from a series of wear tests using different motion profiles, test frequencies, and environmental conditions. Spine 35(16):E774–E781PubMedCrossRef

24.

Bragdon CR, O’Connor DO, Weinberg EA et al (1999) The effect of cycle rate on the wear of conventional and highly crosslinked UHMWPE acetabular components using the Boston AMTI hip simulator. Transactions of the 45th Orthopedic Research Society, No. 831

25.

Center of Devices and Radiological Health [DoHaHS P060018] (2011) Summary of safety and effectiveness [Food and Drug Administration]. http://www.accessdata.fda.gov/cdrh_docs/pdf6/P060018b.pdf. Accessed 22 June 2011

26.

Kettler A, Bushelow M, Wilke HJ (2010) Influence of the loading frequency on the wear rate of a polyethylene-on-metal lumbar intervertebral disc replacement. Eur Spine J Oct 10 [Epub ahead of print]

27.

Liao YS, McKellop H, Lu Z et al (2003) The effect of frictional heating and forced cooling on the serum lubricant and wear of UHMW polyethylene cups against cobalt–chromium and zirconia balls. Biomaterials 24(18):3047–3059PubMedCrossRef

28.

Lu Z, McKellop H, Liao P et al (1999) Potential thermal artifacts in hip joint wear simulators. J Biomed Mater Res 48(4):458–464PubMedCrossRef

29.

Lu Z, McKellop H (1997) Frictional heating of bearing materials tested in a hip joint wear simulator. Proc Inst Mech Eng H 211(1):101–108PubMedCrossRef

30.

Heuberger MP, Widmer MR, Zobeley E et al (2005) Protein-mediated boundary lubrication in arthroplasty. Biomaterials 26(10):1165–1173PubMedCrossRef

31.

Grupp TM, Meisel HJ, Cotton JA et al (2010) Alternative bearing materials for intervertebral disc arthroplasty. Biomaterials 31(3):523–531PubMedCrossRef

32.

Scholes SC, Unsworth A (2008) Comparison of PEEK, PEK and CFR-PEEK in self-mating wear couples for use in orthopaedics. Transactions of the 8th World Congress of Biomaterials, No. P-SAT-I-598

33.

Nechtow W, Bushelow M, Hintner M et al (2007) Cervical disc prosthesis polyethylene wear following the ISO cervical test. Transactions of the 54th Orthopedic Research Society, No. 1926

34.

Dooris A, Hester D, Albert T et al (2007) Cervical disc wear depends on bearing materials and test parameters. In: Global Symposium on Motion Preservation Technology

35.

Center of Devices and Radiological Health [DoHaHS P060023b] (2009) Summary of safety and effectiveness [Food and Drug Administration]. http://www.accessdata.fda.gov/cdrh_docs/pdf5/P050010b.pdf. Accessed 1 June 2009

36.

Rappaport JR Kineflex C cervical artificial disc. In: Yue JJ, Bertagnoli R, McAfee PC, An HS (eds) Motion preservation surgery of the spine. Advanced techniques and controversies, 1st edn. Saunders Elsevier, Pennsylvania, pp 258–266

37.

Kim DH, Reo ML, Robinson JC et al (2007) Wear properties and biological response of a novel total artificial disc with compressible artificial nucleus and fiber annulus. Transactions of the 7th Global Symposium on Motion Preservation Technology

Title: The use of self-mating PEEK as an alternative bearing material for cervical disc arthroplasty: a comparison of different simulator inputs and tribological environments
Authors: Tim Brown
Qi-Bin Bao
Publication date: 01-06-2012
Publisher: Springer-Verlag
Published in: European Spine Journal / Issue Special Issue 5/2012
Print ISSN: 0940-6719
Electronic ISSN: 1432-0932
DOI: https://doi.org/10.1007/s00586-012-2252-9

Keynote webinar | Spotlight on medication adherence

Springer Medicine

The use of self-mating PEEK as an alternative bearing material for cervical disc arthroplasty: a comparison of different simulator inputs and tribological environments

Abstract

Purpose

Methods

Results

Conclusions

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Purpose

Methods

Results

Conclusions

Please log in to get access to this content

Other articles of this Special Issue 5/2012

In silico evaluation of a new composite disc substitute with a L3–L5 lumbar spine finite element model

An in vitro biomechanical comparison of Cadisc™-L with natural lumbar discs in axial compression and sagittal flexion

Resect or not to resect: the role of posterior longitudinal ligament in lumbar total disc replacement

Kinematic evaluation of one- and two-level Maverick lumbar total disc replacement caudal to a long thoracolumbar spinal fusion

Parameters that effect spine biomechanics following cervical disc replacement

Use of a personalized hybrid biomechanical model to assess change in lumbar spine function with a TDR compared to an intact spine