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OXINIUM

Oxidized Zirconium

OXINIUM for hips and Knees

Features

In the past, efforts to reduce wear focused on improving implant design and polyethylene quality. Now there is OXINIUM Oxidized Zirconium, available exclusively from Smith & Nephew. Hardness, lubricity and abrasion resistance are all improved.  Our products may help patients live better. OXINIUM is a material that may last longer.

Features of OXINIUM include:

  • Ceramicized metal bearing surface reduces risk of fracture
  • Surface transformation, not a coating
  • Highly wettable, abrasion resistant and low friction ceramic surface
  • Long term mechanical and chemical stability

  *care needs to be exercised with all bearing surfaces intra-operatively.

 

References

1. R.H. Zimlich, M. Levesque, W. Jones, H.D. Schutte, Jr., B.J. Livingston, W. Sauer, M. Spector, and K. Weaver, "In-vitro and in-vivo effect of particulate debris on TKA articulating surfaces", scientific exhibit SE038, 65th Ann. Mtg. Am. Acad. Orthop. Surg., New Orleans, LA, March 19-23, 1998.

2. M. Levesque, B.J. Livingston, W.M. Jones, and M. Spector, "Scratches on condyles in normal functioning total knee arthroplasty", Trans. 44th Ann. Mtg. Orthop. Res. Soc., Orthopaedic Research Society, Chicago, IL, 1998, p. 247.

3. M. Long, L. Riester, and G. Hunter, “Nano-hardness measurements of oxidized Zr-2.5Nb and various orthopaedic materials”, Trans. Soc. Biomaterials, 21, 1998, p. 528.

4. G. Hunter and M. Long, “Abrasive wear of oxidized Zr-2.5Nb, CoCrMo, and Ti-6Al-4V against bone cement”, 6th World Biomaterials Cong. Trans., Society For Biomaterials, Minneapolis, MN, 2000, p. 835.

5. G. Hunter, “Adhesion testing of oxidized zirconium”, Trans. Soc. Biomaterials, 24, 2001, p. 540.

6. S. Tsai, J. Sprague, G. Hunter, R. Thomas, and A. Salehi, “Mechanical testing and finite element analysis of oxidized zirconium femoral components”, Trans. Soc. Biomaterials, 24, 2001, p. 163.

7. L. Que, L.D.T. Topoleski, and N.L. Parks, "Surface roughness of retrieved CoCrMo alloy femoral components from PCA artificial total knee joints", J. Biomed. Mater. Res., 53 (1), 1999, pp. 111- 118.

8. J.G. Lancaster, D. Dowson, G.H. Isaac, and J. Fisher, "The wear of ultra-high molecular weight polyethylene sliding on metallic and ceramic counterfaces representative of current femoral surfaces in joint replacement", Proc. Instn. Mech. Engrs., 211 (H1), 1997, pp. 17-24.

9. J. Fisher, P. Firkins, E.A. Reeves, J.L. Hailey, and G.H. Isaac, "The influence of scratches to metallic counterfaces on the wear of ultra-high molecular weight polyethylene", Proc. Instn. Mech. Engrs., 209 (H4), 1995, pp. 263-264.

10. J.L. Hailey, E. Ingham, M. Stone, B.M. Wroblewski, and J. Fisher, "Ultra-high molecular weight polyethylene wear debris generated in vivo and in laboratory tests; the influence of counterface roughness", Proc. Instn. Mech. Engrs., 210 (H1), 1996, pp. 3-10.

11. B. Weightman and D. Light, "The effect of the surface finish of alumina and stainless steel on the wear rate of UHMW polyethylene", Biomaterials, 7 (1), 1986, pp. 20-24.

12. H. Oonishi, Y. Hanatate, E. Tsuji, and H. Yunoki, "Comparisons of wear of UHMW polyethylene sliding against metal and alumina in total knee prostheses", Bioceramics, H. Oonishi, H. Aoki, and K. Sawai (eds.), Ishiyaku EuroAmerica, Tokyo, 1989, pp. 219-224.

13. J.A. Davidson, "Characteristics of metal and ceramic total hip bearing surfaces and their effect on long-term ultra high molecular weight polyethylene wear", Clin. Orthop., 294, 1993, pp. 361-378.

14. J. Fisher and D. Dowson, "Tribology of total artificial joints", Proc. Instn. Mech. Engrs., 205 (H2), 1991, pp. 73-79.

15. M. Jasty, C.R. Bragdon, K. Lee, A. Hanson, and W.H. Harris, "Surface damage to cobalt-chrome femoral head prostheses", J. Bone Joint Surg., 76-B (1), 1994, pp. 73-77.

16. R.Barrack, F.Castro, E. Szuszczewicz, T.Schmalzried, “Analysis of Retrieved Uncemented Porous-Coated Acetabular Components in Patients With and Without Pelvic Osteolysis”, Orthopedics, 25:12, 2002, pp. 1373-1378.

17. Sychterz CJ, Engh CA Jr, Swope SW, McNulty DE, Engh CA, “Analysis of prosthetic femoral heads retrieved at autopsy”, Clin Orthop. 1999 Jan; (358):223-34.

18. R.A. Poggie, J.J. Wert, A.K. Mishra, and J.A. Davidson, “Friction and wear characterization of UHMWPE in reciprocating sliding contact with Co-Cr, Ti-6Al-4V and zirconia implant bearing surfaces”, Wear and Friction of Elastomers, ASTM STP 1145, R. Denton and M.K. Keshavan (eds.), American Society for Testing and Materials, Philadelphia, PA, 1992, pp. 65-81.

19. A.M. Patel and M. Spector, “Tribological evaluation of oxidized zirconium using an articular cartilage counterface: a novel material for potential use in hemiarthroplasty”, Biomaterials, 18 (5), 1997, pp. 441-447.

20. M. Spector, M.D. Ries, R.B. Bourne, W.S. Sauer, M. Long, and G. Hunter, “Wear performance of ultra-high molecular weight polyethylene on oxidized zirconium total knee femoral components”, J. Bone Joint Surg., 83-A (S2), 2001, pp. 80-86.

21. N.J. Hallab, K. Merritt, and J.J. Jacobs “Metal sensitivity in patients with Orthopaedic implants”, J. Bone Joint Surg., 83-A, March, 2001, pp. 428-436.

22. G. Hunter, W.M. Jones, and M. Spector, “Oxidized zirconium”, Total Knee Arthroplasty, J. Bellemans, M.D. Ries, and J. Victor (eds.), Springer Verlag, Heidelberg, Germany, 2005, pp. 370-377. Jani et al, ORS, 49, 2002.

23. Good V, Ries M, Barrack RL, Widding K, Hunter G, Heuer D, Reduced Wear with Oxidized Zirconium Femoral Heads, JBJS in print, 2003. M.D. Ries, W.L. Sauer, S.A. Banks, M. Anthony, and K. Weaver, "Effect of femoral component scratches on wear in total knee arthroplasty", Am. Acad. Orthop. Surg. 66th Ann. Mtg. Proc., American Academy of Orthopaedic Surgeons, Rosemont, IL, 1999, p. 231.

24.  M. Ries, S. Banks, W. Sauer, and M. Anthony, "Abrasive wear simulation in total knee arthroplasty", Trans. 45th Ann. Mtg. Orthop. Res. Soc., Orthopaedic Research Society, Chicago, IL, 1999, p. 853.

Living Proof Data

1. Smith and Nephew (2009). The Genesis II Total Knee. Available at: http://global.smith-nephew.com/us/GENESIS_II_TOTAL_KNEE_2968.htm Accessed, November 30, 2009.

2. Smith and Nephew Wins Gender Knee System Clearance (2009). Available at: http://www.allbusiness.com/health-care/medical-practice-orthopedics/5248770-1.html Accessed, December 7, 2009.

3. Bourne RB, Laskin RS, Guerin JS (2007). Ten-year results of the first 100 Genesis II total knee replacement procedures.

4. Orthopedics; 30:83-85.

5. H aas SB, Cook S, Beksac B (2004). Minimally invasive total knee replacement through a mini-midvastus approach: a comparative study. Clin Orthop Relat Res; 428:68-73.

6. H arato K, Bourne RB, Victor J, et al (2008). Midterm comparison of posterior cruciate-retaining versus -substituting total knee arthroplasty using the Genesis II prosthesis. A multicenter prospective randomized clinical trial. Knee; 15:217-221.

7. Karachalios T, Giotikas D, Roidis N, et al (2008). Total knee replacement performed with either a mini-midvastus or a standard approach: a prospective randomized clinical and radiological trial. J Bone Joint Surg Br; 90:584-591.

8. Laskin RS, Maruyama Y, Villaneuva M, et al (2000). Deep-dish congruent tibial component use in total knee arthroplasty: a randomized prospective study. Clin Orthop Relat Res; 36-44.

9. Laskin RS (2003). An oxidized Zr ceramic surfaced femoral component for total knee arthroplasty. Clin Orthop Relat Res; 191-196.

10. Laskin RS, Davis J (2005). Total knee replacement using the Genesis II prosthesis: a 5-year follow-up study of the first 100 consecutive cases. Knee; 12:163-167.

11. Laskin RS (2006). Reduced-incision total knee replacement through a mini-midvastus technique. J Knee Surg; 19:52-57.

12. Laskin RS (2007). The effect of a high-flex implant on postoperative flexion after primary total knee arthroplasty. Orthopedics;30:86-88.

13. McCalden RW, MacDonald SJ, Bourne RB, et al (2009). A randomized controlled trial comparing „high-flex“ vs „standard“ posterior cruciate substituting polyethylene tibial inserts in total knee arthroplasty. J Arthroplasty; 24:33-38.

14. Rothwell A, Taylor J, Wright M, et al (2009). New Zealand Orthopaedic Association: New Zealand Joint Registry Ten Year Report. October 2009. http://www.cdhb.govt.nz/njr/reports/A2D65CA3.pdf Accessed June 6, 2010

15. Emsley D, Newell C, Pickford M, et al (2009). National Joint Registry for England and Wales: 6th Annual Report. www.njrcentre.org.uk Accessed June 6, 2010

Product Information

Surgeon resource for OXINIUM technology

The forces generated as a knee or hip goes through its range of motion require a strong material that can withstand repeated sliding and rotating. High fatigue strength and toughness are needed.

The ideal TJA (total joint arthroplasty) material should also be smooth and resist abrasion to minimize generation of wear particles. This combination of properties has been difficult to find - until the introduction of a revolutionary material for joint implants -
OXINIUM Oxidized Zirconium.

Cobalt Chrome Condyle | Surface Roughness



While a ceramic implant provides a smooth, abrasion-resistant articular surface, it has poor fracture toughness and may shatter when impacted. On the other hand, metal implants have an excellent fracture toughness but tend to roughen and scratch over time, gouging the polyethylene and producing particles. 1,2

Surface of Retrieved Femoral



Efforts to reduce the wear rate of metal implants through surface modifications have had difficulty with durability. Coatings can crack, chip or peel, especially when damaged. Through a patented process, oxygen is absorbed into zirconium metal, actually transforming the surface to ceramic while the rest of the material remains metal to retain its strength. The result is in a superior bearing surface.   Please review the information within this site to learn more about this superior option for TJA or call your local Smith & Nephew sales representative.

References

1. R.H. Zimlich, M. Levesque, W. Jones, H.D. Schutte, Jr., B.J. Livingston, W. Sauer, M. Spector, and K. Weaver, "In-vitro and in-vivo effect of particulate debris on TKA articulating surfaces", scientific exhibit SE038, 65th Ann. Mtg. Am. Acad. Orthop. Surg., New Orleans, LA, March 19-23, 1998.

2. M. Levesque, B.J. Livingston, W.M. Jones, and M. Spector, "Scratches on condyles in normal functioning total knee arthroplasty", Trans. 44th Ann. Mtg. Orthop. Res. Soc., Orthopaedic Research Society, Chicago, IL, 1998, p. 247.

Material

What is the OXINIUM material?

OXINIUM oxidized zirconium is a metallic alloy with a ceramic surface that provides wear resistance without brittleness.

OXINIUM material combines the best of both metal and ceramics.

OXINIUM has unique features:

  • Abrasion Resistance
  • Hardeness
  • Damage Tolerance
  • Fatugue Strength

OXINIUM is a metal, with excellent fracture toughness like cobalt chrome, but it has a ceramic surface that offers outstanding wear resistance.

OXINIUM Profile



The ceramic is an enhanced surface that is part of the metal substrate rather than an external coating, making it very durable.

Zirconium: a biocompatible metallic element in the same family as titanium.

Zirconia: a ceramic compound, wear-resistant but brittle.

Zr-2.5Nb: a metallic alloy of zirconium, with niobium and oxygen for increased strength.

Quality Control for OXINIUM Components

Extensive research and development indicated four critical control points to ensure a consistent quality product, as follows:

  • Raw materials inspection
  • Pre-oxidization surface preparation
  • Oxidization process
  • Post-oxidization surface burnishing

All components undergo inspection to ensure that the ceramic oxide is uniform and the correct thickness. A non-destructive laser measurement technique provides a means for 100% quality assurance inspection of components.

References

1. M. Long, L. Riester, and G. Hunter, “Nano-hardness measurements of oxidized Zr-2.5Nb and various orthopaedic materials”, Trans. Soc. Biomaterials, 21, 1998, p. 528.

Wear

Wear in Total Joint Arthroplasty

Wear of polyethylene components has often been reported in TJA to be a primary cause of complications and failure. Retrieval analyses and published articles support that a high percentage of inserts and patellas develop a significant wear pattern clinically.

Wear in THA

In THA, the reduction in friction and wear with the OXINIUM bearing coupling is significant because aseptic loosening is a leading cause of implant failure, and wear debris is the leading cause of aseptic loosening. While virtually all advanced bearing couplings produce nearly immeasurable wear, metal-on-metal couplings produce cobalt and chromium ions. Ceramic couplings risk fracture. With OXINIUM femoral heads, low wear reduces the chances of aseptic loosening and may extend the life of the joint. The OXINIUM material may offer extended joint life through reduced wear and friction.

Wear in TKA

In eight TKA retrieval studies covering the last 20 years, polyethylene wear was identified in over 50% of the 3,300-plus knees examined. More than 10 publications in the past 10 years have linked polyethylene wear to complications and failure of TKA. 7-17

 

Howmedica Kinematic | 14 years in vivo
 
Protek SAL I | 6 years in vivo
 
DePuy AMK | 6 years in vivo

 

References

1. R.H. Zimlich, M. Levesque, W. Jones, H.D. Schutte, Jr., B.J. Livingston, W. Sauer, M. Spector, and K. Weaver, "In-vitro and in-vivo effect of particulate debris on TKA articulating surfaces", scientific exhibit SE038, 65th Ann. Mtg. Am. Acad. Orthop. Surg., New Orleans, LA, March 19-23, 1998.

2. M. Levesque, B.J. Livingston, W.M. Jones, and M. Spector, "Scratches on condyles in normal functioning total knee arthroplasty", Trans. 44th Ann. Mtg. Orthop. Res. Soc., Orthopaedic Research Society, Chicago, IL, 1998, p. 247.

3. M. Long, L. Riester, and G. Hunter, “Nano-hardness measurements of oxidized Zr-2.5Nb and various orthopaedic materials”, Trans. Soc. Biomaterials, 21, 1998, p. 528.

4. G. Hunter and M. Long, “Abrasive wear of oxidized Zr-2.5Nb, CoCrMo, and Ti-6Al-4V against bone cement”, 6th World Biomaterials Cong. Trans., Society For Biomaterials, Minneapolis, MN, 2000, p. 835.

5. G. Hunter, “Adhesion testing of oxidized zirconium”, Trans. Soc. Biomaterials, 24, 2001, p. 540.

6. S. Tsai, J. Sprague, G. Hunter, R. Thomas, and A. Salehi, “Mechanical testing and finite element analysis of oxidized zirconium femoral components”, Trans. Soc. Biomaterials, 24, 2001, p. 163.

7. L. Que, L.D.T. Topoleski, and N.L. Parks, "Surface roughness of retrieved CoCrMo alloy femoral components from PCA artificial total knee joints", J. Biomed. Mater. Res., 53 (1), 1999, pp. 111- 118.

8. J.G. Lancaster, D. Dowson, G.H. Isaac, and J. Fisher, "The wear of ultra-high molecular weight polyethylene sliding on metallic and ceramic counterfaces representative of current femoral surfaces in joint replacement", Proc. Instn. Mech. Engrs., 211 (H1), 1997, pp. 17-24.

9. J. Fisher, P. Firkins, E.A. Reeves, J.L. Hailey, and G.H. Isaac, "The influence of scratches to metallic counterfaces on the wear of ultra-high molecular weight polyethylene", Proc. Instn. Mech. Engrs., 209 (H4), 1995, pp. 263-264.

10. J.L. Hailey, E. Ingham, M. Stone, B.M. Wroblewski, and J. Fisher, "Ultra-high molecular weight polyethylene wear debris generated in vivo and in laboratory tests; the influence of counterface roughness", Proc. Instn. Mech. Engrs., 210 (H1), 1996, pp. 3-10.

11. B. Weightman and D. Light, "The effect of the surface finish of alumina and stainless steel on the wear rate of UHMW polyethylene", Biomaterials, 7 (1), 1986, pp. 20-24.

12. H. Oonishi, Y. Hanatate, E. Tsuji, and H. Yunoki, "Comparisons of wear of UHMW polyethylene sliding against metal and alumina in total knee prostheses", Bioceramics, H. Oonishi, H. Aoki, and K. Sawai (eds.), Ishiyaku EuroAmerica, Tokyo, 1989, pp. 219-224.

13. J.A. Davidson, "Characteristics of metal and ceramic total hip bearing surfaces and their effect on long-term ultra high molecular weight polyethylene wear", Clin. Orthop., 294, 1993, pp. 361-378.

14. J. Fisher and D. Dowson, "Tribology of total artificial joints", Proc. Instn. Mech. Engrs., 205 (H2), 1991, pp. 73-79.

15. M. Jasty, C.R. Bragdon, K. Lee, A. Hanson, and W.H. Harris, "Surface damage to cobalt-chrome femoral head prostheses", J. Bone Joint Surg., 76-B (1), 1994, pp. 73-77.

16. R.Barrack, F.Castro, E. Szuszczewicz, T.Schmalzried, “Analysis of Retrieved Uncemented Porous-Coated Acetabular Components in Patients With and Without Pelvic Osteolysis”, Orthopedics, 25:12, 2002, pp. 1373-1378.

17. Sychterz CJ, Engh CA Jr, Swope SW, McNulty DE, Engh CA, “Analysis of prosthetic femoral heads retrieved at autopsy”, Clin Orthop. 1999 Jan; (358):223-34.

18. R.A. Poggie, J.J. Wert, A.K. Mishra, and J.A. Davidson, “Friction and wear characterization of UHMWPE in reciprocating sliding contact with Co-Cr, Ti-6Al-4V and zirconia implant bearing surfaces”, Wear and Friction of Elastomers, ASTM STP 1145, R. Denton and M.K. Keshavan (eds.), American Society for Testing and Materials, Philadelphia, PA, 1992, pp. 65-81.

19. A.M. Patel and M. Spector, “Tribological evaluation of oxidized zirconium using an articular cartilage counterface: a novel material for potential use in hemiarthroplasty”, Biomaterials, 18 (5), 1997, pp. 441-447.

20. M. Spector, M.D. Ries, R.B. Bourne, W.S. Sauer, M. Long, and G. Hunter, “Wear performance of ultra-high molecular weight polyethylene on oxidized zirconium total knee femoral components”, J. Bone Joint Surg., 83-A (S2), 2001, pp. 80-86.

21. N.J. Hallab, K. Merritt, and J.J. Jacobs “Metal sensitivity in patients with Orthopaedic implants”, J. Bone Joint Surg., 83-A, March, 2001, pp. 428-436.

22. G. Hunter, W.M. Jones, and M. Spector, “Oxidized zirconium”, Total Knee Arthroplasty, J. Bellemans, M.D. Ries, and J. Victor (eds.), Springer Verlag, Heidelberg, Germany, 2005, pp. 370-377. Jani et al, ORS, 49, 2002. Good V, Ries M, Barrack RL, Widding K, Hunter G, Heuer D, Reduced Wear with Oxidized Zirconium Femoral Heads, JBJS in print, 2003. M.D. Ries, W.L. Sauer, S.A. Banks, M. Anthony, and K. Weaver, "Effect of femoral component scratches on wear in total knee arthroplasty", Am. Acad. Orthop. Surg. 66th Ann. Mtg. Proc., American Academy of Orthopaedic Surgeons, Rosemont, IL, 1999, p. 231. M. Ries, S. Banks, W. Sauer, and M. Anthony, "Abrasive wear simulation in total knee arthroplasty", Trans. 45th Ann. Mtg. Orthop. Res. Soc., Orthopaedic Research Society, Chicago, IL, 1999, p. 853.

Living Proof Data

1. Smith and Nephew (2009). The Genesis II Total Knee. Available at: http://global.smith-nephew.com/us/GENESIS_II_TOTAL_KNEE_2968.htm Accessed, November 30, 2009.
2. Smith and Nephew Wins Gender Knee System Clearance (2009). Available at: http://www.allbusiness.com/health-care/medical-practice-orthopedics/5248770-1.html Accessed, December 7, 2009.
3. Bourne RB, Laskin RS, Guerin JS (2007). Ten-year results of the first 100 Genesis II total knee replacement procedures.
4. Orthopedics; 30:83-85.
5. H aas SB, Cook S, Beksac B (2004). Minimally invasive total knee replacement through a mini-midvastus approach: a comparative study. Clin Orthop Relat Res; 428:68-73.
6. H arato K, Bourne RB, Victor J, et al (2008). Midterm comparison of posterior cruciate-retaining versus -substituting total knee arthroplasty using the Genesis II prosthesis. A multicenter prospective randomized clinical trial. Knee; 15:217-221.
7. Karachalios T, Giotikas D, Roidis N, et al (2008). Total knee replacement performed with either a mini-midvastus or a standard approach: a prospective randomized clinical and radiological trial. J Bone Joint Surg Br; 90:584-591.
8. Laskin RS, Maruyama Y, Villaneuva M, et al (2000). Deep-dish congruent tibial component use in total knee arthroplasty: a randomized prospective study. Clin Orthop Relat Res; 36-44.
9. Laskin RS (2003). An oxidized Zr ceramic surfaced femoral component for total knee arthroplasty. Clin Orthop Relat Res; 191-196.
10. Laskin RS, Davis J (2005). Total knee replacement using the Genesis II prosthesis: a 5-year follow-up study of the first 100 consecutive cases. Knee; 12:163-167.
11. Laskin RS (2006). Reduced-incision total knee replacement through a mini-midvastus technique. J Knee Surg; 19:52-57.
12. Laskin RS (2007). The effect of a high-flex implant on postoperative flexion after primary total knee arthroplasty. Orthopedics;30:86-88.
13. McCalden RW, MacDonald SJ, Bourne RB, et al (2009). A randomized controlled trial comparing „high-flex“ vs „standard“ posterior cruciate substituting polyethylene tibial inserts in total knee arthroplasty. J Arthroplasty; 24:33-38.
14. Rothwell A, Taylor J, Wright M, et al (2009). New Zealand Orthopaedic Association: New Zealand Joint Registry Ten Year Report. October 2009. http://www.cdhb.govt.nz/njr/reports/A2D65CA3.pdf Accessed June 6, 2010
15. Emsley D, Newell C, Pickford M, et al (2009). National Joint Registry for England and Wales: 6th Annual Report. www.njrcentre.org.uk Accessed June 6, 2010

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