BIOLOX® Ceramic Knee Joint Components

BIOLOX®delta for Knee Replacement Surgery –
The Metal-Free Knee Arthroplasty

The number of knee joint replacement operations performed each year is rising steadily. Experts estimate that around 2,000,000 knee replacements are implanted every year. As a result, knee replacement is the most frequently performed joint replacement, even taking precedence over hip replacement surgery.

The life expectancy of the of the world’s population is higher now than ever before: as such, the request for greater mobility and improved quality of life following knee replacement has also increased. The incidence of knee replacement in young and active patients is also increasing and therefore knee replacements must be able to offer longer implant lifetime.

In addition to this, infection, polyethylene wear, implant loosening and metal allergy are among the greatest problems in knee arthroplasty. Aseptic loosening is the predominant mechanism of failure and revision (31.2 %), followed by instability (18.7 %), infection (16.2 %), polyethylene wear (10.0 %), arthrofibrosis (6.9 %) and malalignment (6.6 %). 1 This is why the choice of implant material is so important, especially with respect to the wear properties and biological behavior of the selected materials.

Infection in Joint Arthroplasty – One of the Most Common Reasons for Revision 2

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“Periprosthetic joint infection (PJI) is one the most devastating complications of joint arthroplasty … the prevalence of PJI appears to be on the rise, with a projected number exceeding 60,000 to 70,000 hip and knee cases in the United States by 2023.” 3

The resulting increase of hip and knee revision is projected to exceed annual costs to US hospitals of infected revisions by USD 1.62 billion by 2020. 4 Although PJI is an infrequent complication (the reported incidence is 1 % - 2 % in the United States), it is the third most common indication for revision of primary total knee arthroplasty in the Medicare population.27, 28

Problem with Metal Implants: Polyethylene Wear

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Knee replacement implants are usually made from cobalt chromium alloy; titanium alloy is sometimes used for the tibial tray. An insert made of polyethylene is used as bearing articulating against the femoral component. Clinical evidence and long term results show that aseptic loosening limits implant lifetime. One of the most important causes of aseptic loosening is the wear of the polyethylene insert.7

As demonstrated in many investigations, an increased rate of polyethylene wear can lead to an increased rate of loosening as a result of the formation of granuloma and foreign-body reactions with associated destruction of bone stock. Ceramics have been shown to reduce polyethylene wear.

Metal Sensitivity

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Source: CeramTec / Usbeck
 

Source: CeramTec / Usbeck
 

”The prevalence of metal sensitivity among patients with a well-functioning implant is approximately 25%, roughly twice that of the general population.”8

In vivo, metals release ions can cause biological reactions. The alloy used for articulating components typically contains metals such as cobalt, chromium and nickel. Several case reports and clinical studies report the clinical manifestations of metal allergy as eczema, disturbed wound healing, recurrent effusions, local swelling, persistent pain, osteolysis and reactions similar to pseudotumor with subsequent muscle destruction.8,9,16,17,18,19,20

In many cases sensitivity to these allergens has resulted in revision of the knee implants.

BIOLOX®delta Ceramics Provide Advances in Knee Replacement Surgery

”In total knee arthroplasty, ceramics revealed superior experimental data concerning low wear rates as well as promising results of the first clinical applications.“15

”Ceramic implants are a promising solution for patients with allergies against metallic implant materials.“ 13

High-performance ceramics are biocompatible and bioinert.10 The ceramic material does not elicit any known allergic reactions. Case reports of hip and knee replacements have described significant improvement of symptoms and reduced levels of metal ions when revision is performed using ceramic components to address adverse reactions to components of metal implants.21,22,23,24,25,26

BIOLOX® ceramics are extremely stable and well tolerated by tissues.11,12 For this reason, ceramic components are now used also in knee arthroplasty.13,14 The extremely hard and smooth surface minimizes polyethylene wear.15

Studies have already suggested that ceramics could be superior with regard to delivering the lowest possible infection rates.5,29,30,31,32,33,34 These studies compared ceramics with metals and polymers. Analysis based on information from various hospital and national registers of 500,749 hip revisions, several of them implementing Cox multivariate analysis for confounding factors, has confirmed the potential of ceramics to reduce the risk of revision due to infection.6

Worth knowing:

BIOLOX®delta Metal-Free Knee Implants

  • Excellent biological behavior*
  • No known risk of allergy*
  • No metal ion release*
  • No known pathogenic reaction to
    ceramic particles*
  • Reduced risk of infection*
  • Lower wear of polyethylene against ceramic*
  • High hardness and scratch resistance*
  • Resistance to third-body wear*
  • 5 successful years in clinical use*

 
The knee implants made of BIOLOX®delta are not FDA approved and are not available for commercial distribution in the United States.
*References available on file at CeramTec on request.

  • BIOLOX® Ceramics for Medical Products

    BIOLOX®delta Knee

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References

  1. Lombardi AV Jr , Berend KR , Adams JB .: Why knee replacements fail in 2013: patient, surgeon, or implant?. Bone Joint J. 2014 Nov;96-B(11 Supple A):101-4. doi: 10.1302/0301-620X.96B11.34350
  2. Australian Orthopaedic Association National Joint Replacement Registry. Annual Report. Adelaide:AOA; 2014
  3. A Recurring Slippery Slope, Javad Parvizi, M.D., F.R.C.S., CURRENT CONCEPTS IN JOINT REPLACEMENT® Winter 2014 Hyatt Regency Grand Cypress, Orlando, Florida, December 10 - 13, 2014
  4. Kurtz SM1, Lau E, Watson H, Schmier JK, Parvizi J., Economic burden of periprosthetic joint infection in the United States. J Arthroplasty. 2012 Sep;27(8 Suppl):61-5.e1. doi: 10.1016/j.arth.2012.02.022. Epub 2012 May 2.
  5. Liefheit K, Vergleichende Biofilmbildung auf Werkstoffe, Bericht, iba Heiligenstadt e.V. FB Biowerkstoffe, 2013
  6. Streicher R, Porporati A. News on ceramics – beyond wear reduction. Abstract EHS 2014, Streicher RLeto A., Pororati A.. News on ceramic – wear, corrosion and infection. Poster JHS 2014
  7. A. Seth Greenwald, DPhil(Oxon); Jonathan P. Garino, MD: Alternative Bearing Surfaces: The Good, the Bad, and the Ugly. J Bone Joint Surg Am, 2001 Nov; 83 (2 suppl 2): S68 -72 . http://dx.doi.org/
  8. Hallab NJ1, Anderson S, Stafford T, Glant T, Jacobs JJ.: Lymphocyte responses in patients with total hip arthroplasty. J Orthop Res. 2005 Mar;23(2):384-91.
  9. Gawkrodger DJ. Metal sensitivities and orthopaedic implants revisited: the potential for metal allergy with the new metal-on-metal joint prostheses. Br J Dermatol. 2003 Jun;148(6):1089-93.
  10. B. S. Bal, D. D. Greenberg, T. J. Aleto: Primary Total Knee Replacement with a Zirconia Ceramic Femoral Component. Bioceramics and Alternative Bearings in Joint Arthroplasty Ceramics in Orthopaedics2005, pp 183-190
  11. Hinorobu Oonishi M.D., PHD, S.-C. Kim, M. Kyomoto, M. Iwamoto, M. Ueno: Comparison of In-Vivo Wear between Polyethylene Inserts articulating against Ceramic and Cobalt-Chrome Femoral Components in Total Knee Prostheses. Bioceramics and Alternative Bearings in Joint Arthroplasty Ceramics in Orthopaedics2007, pp 149-159
  12. White SE, Whiteside LA, McCarthy DS, Anthony M, Poggie RA.: Simulated knee wear with cobalt chromium and oxidized zirconium knee femoral components. Clin Orthop Relat Res. 1994 Dec;(309):176-84.
  13. Philipp Bergschmidt, Rainer Bader, Dirk Ganzer, Christian Hauzeur, Christoph Lohmann, Alexander Krüger, Wolfgang Rüther, Domenico Tigani, Nicola Rani, José Luis Esteve, Fernando Lopez Prats, Claudio Zorzi, Vincenzo Madonna, Stefano Rigotti, Francesco Benazzo, Stefano Marco Paolo Rossi, Wolfram Mittelmeier: 15-year clinical and radiological outcomes of a prospective international multi-centre study on a ceramic femoral component in total knee arthroplasty. Deutscher Kongress für Orthopädie und Unfallchirurgie (DKOU 2014). Berlin, 28.-31.10.2014. Düsseldorf: German Medical Science GMS Publishing House; 2014. DocPO22-945
  14. Benazzo F, Dalla Pria P, Mittelmeier W, Tigani D, Zorzi C, Ganzer D, Lohmann CH, Cimbrelo EG, Merchan CR, Saura EM, Lizaur AU, Couceiro JF, Burelli S. Reasons using a Ceramic Femoral Component and First Clinical Experience. In:Chang JD, Billau K. (eds.).Bioceramics and Alternative Bearings in Joint Arthroplasty, Steinkopff-Verlag:145–148, 2007
  15. Zietz C, Bergschmidt P, Lange R, Mittelmeier W, Bader R. Third-body abrasive wear of tibial polyethylene inserts combined with metallic and ceramic femoral components in a knee simulator study. Int J Artif Organs 36(1):47-55, 2013
  16. Campbell P, Embrazadeh E, Nelson S et al. Histological features of pseudotumor-like tissues from metal-on-metal hips. Clin Orthop Relat Res 2010;468(9):2321-2327
  17. Kwon YM, Ostlere SJ, McLardy-Smith P et al. “Asymptomatic” pseudotumors after metal-on-metal hip resurfacing arthroplasty prevalence and metal ion study. J Arthroplasty 2010;92:356-361
  18. Malviya A, Holland JP. Pseudotumours associated with metal-on-metal hip resurfacing: 10-year Newcastle experience. Acta Orthop Belg 2009;75:477-483
  19. Registry AOANJRR, Demographics and Outcomes of Shoulder Arthroplasty, Report 2012
  20. Thomas P, Schuh A, Ring J, Thomsen M. [Orthopedic surgical implants and allergies. Joint statement by the Implant Allergy Working Group (AK 20) of the DGOOC (German Association of Orthopedics and Orthopedic Surgery), DKG (German Contact Dermatitis Research Group) and DGAKI (German Society for Allergology and Clinical Immunology], Orthopäde 2008; 37(1):75-88
  21. Algarni AD, Huk OL, Pelmus M. Metallosis-induced Iliopsoas Bursal Cyst Causing Venous Obstruction and Lower-limb Swelling After Metal-on-metal THA. Orthopedics 2012, 35(12):1066-1069
  22. Bergschmidt P, Bader R, Mittelmeier W. Metal hypersensitivity in total knee arthroplasty: Revision surgery using a ceramic femoral component - A case report. Knee 2012;19:144-147
  23. Kosukegawa I, Nagoya S, Kaya M et al. Revision Total Hip Arthroplasty Due to Pain From Hypersensitivity to Cobalt-Chromium in Total Hip Arthroplasty. J Arthroplasty 2011;26(6):978.e1-3
  24. Krenn V, Thomas P, Thomsen M et al. Histopathological Particle Identification. CeraNews 2013:2:12-17
  25. Maurer-Ertl W, Friesenbichler J, Liegl-Atzwanger B et al. Noninflammatory Pseudotumor Simulating Venous Thrombosis After Metal-on-Metal Hip Resurfacing. Orthopedics 2011;34(10):678
  26. Watters TS, Cardona DM, Menon KS et al. Aseptic lymphocyte-dominated vasculitis-associated lesion: a clinicopathologic review of an underrecognized cause of prosthetic failure. Am J Clin Pathol 2010;134(6):886-93
  27. Kurtz SM, Ong KL, Lau E, Bozic KJ, Berry D, Parvizi J. Prosthetic joint infection risk after TKA in the Medicare population. Clin Orthop Relat Res 2010; 468:52-56.
  28. David J. Jaekel M.S., Ph.D., Kevin L. Ong Ph.D., P.E., Edmund C. Lau M.S., Steven M. Kurtz Ph.D.: The Epidemiology of Total Joint Arthroplasty Infections. Infected Total Joint Arthroplasty 2012, pp 35-54
  29. Trebse R, Levasic V, Milosevic I, Kovac S. Does the bearing type influence the incidence of periprosthetic infections of the hip? CeraNews 1/2014, 12-14
  30. Parvizi J. Periprosthetic joint infection: could the bearing surface play a role? CeraNews 1/2014, 11
  31. Smith L, Alijanipour P, Restrepo C, Maltenfort M, Parvizi J, Malkani A. Periprosthetic joint infection: could the bearing surface play a role? Abstract, Meeting of the Eastern Orthopaedic Association 2014
  32. 10th Annual Report: National Joint Registry for England, Wales and Northern Ireland, 2013
  33. Falcioni S, Ancarani C, Bordini B, Pichierri M, Stea S. Influence of articular coupling on septic loosening of total hip arthroplasty. Abstract EHS 2014
  34. Steven M. Kurtz PhD, Edmund Lau MS, Kevin Ong PhD, Ke Zhao MA, MS, Michael Kelly MD, Kevin J. Bozic MD, MBA: Future Young Patient Demand for Primary and Revision Joint Replacement. National Projections from 2010 to 2030. Clin Orthop Relat Res (2009) 467:2606–2612, DOI 10.1007/s11999-009-0834-6

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