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.
Similar content being viewed by others
References
Fernstrom U (1966) Arthroplasty with intercorporal endopothesis in herniated disc and in painful disc. Acta Chir Scand Suppl 357:154–159
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 38:881–884
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):275–286
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):101–107
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):198–209
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):423–430
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):202–210
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):1015–1020
Tumialán LM, Gluf WM (2011) Progressive vertebral body osteolysis after cervical disc arthroplasty. Spine 36(14):E973–E978
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–E265
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–E497
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
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
Pare PE, Chan FW, Bhattacharya S et al (2009) Surface slide track mapping of implants for total disc arthroplasty. J Biomech 42(2):131–139
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):45–52
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):365–369
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 18:98–108
Nechtow W, Hintner M, Bushelow M et al (2006) IVD replacement mechanical performance depends strongly on input parameters. Orthopedic Research Society, Chicago
Wang A, Sun DC, Yau SS et al (1997) Orientation softening in the deformation and wear of ultra-high molecular weight polyethylene. Wear 203–204:230–241
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
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–E781
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
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
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]
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):3047–3059
Lu Z, McKellop H, Liao P et al (1999) Potential thermal artifacts in hip joint wear simulators. J Biomed Mater Res 48(4):458–464
Lu Z, McKellop H (1997) Frictional heating of bearing materials tested in a hip joint wear simulator. Proc Inst Mech Eng H 211(1):101–108
Heuberger MP, Widmer MR, Zobeley E et al (2005) Protein-mediated boundary lubrication in arthroplasty. Biomaterials 26(10):1165–1173
Grupp TM, Meisel HJ, Cotton JA et al (2010) Alternative bearing materials for intervertebral disc arthroplasty. Biomaterials 31(3):523–531
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
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
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
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
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
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
Conflict of interest
Tim Brown is a Employee Pioneer Surgical.
Author information
Authors and Affiliations
Corresponding author
Rights and permissions
About this article
Cite this article
Brown, T., Bao, QB. The use of self-mating PEEK as an alternative bearing material for cervical disc arthroplasty: a comparison of different simulator inputs and tribological environments. Eur Spine J 21 (Suppl 5), 717–726 (2012). https://doi.org/10.1007/s00586-012-2252-9
Received:
Revised:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s00586-012-2252-9