verilast technology powerpoint
TRANSCRIPT
VERILAST™
Technology with LEGION™
Primary Knee System
Based on in-vitro wear simulation testing, the LEGION Primary Knee System with VERILAST technology is expected to provide wear performance sufficient for 30 years of actual use under typical conditions. The results of in-vitro wear simulation testing have not been proven to quantitatively predict clinical wear performance. Also, a reduction in total polyethylene wear volume or wear rate alone may not result in an improved clinical outcome as wear particle size and morphology are also critical factors in the evaluation of the potential for wear mediated osteolysis and associated aseptic implant loosening. Particle size and morphology were not evaluated as part of the testing. ™Trademark of Smith & Nephew.
Sharkey et a l, Why Are Tota l Knee Arthroplasties Failing Today? CORR; Number 404, pp. 7–13 2002
Reasons for Revision
Peter F. Sharkey, MD; William J. Hozack, MD; Richard H Rothman, MD, PhD; Shani Shastri,
MD; and Sidney M. Jacoby, BA
Sharkey et a l, Why Are Tota l Knee Arthroplasties Failing Today? CORR; Number 404, pp. 7–13 2002
Reasons for Revision
™Trademark of Smith & Nephew. Reg. US Pat. & TM Off. All Trademarks acknowledged.
Improving wear
Poggie et a l., ASTM STP 1145 Asano et al. Dose Effects of Cross-Linking Polyethylene for Tota l Knee Arthroplasty on Wear Performance and Mechanica l Properties J Biomed Mater Res Part B: Appl Biomater 83B: 615–622, 2007
UHMWPE Wear rate and Radiation
™Trademark of Smith & Nephew. Reg. US Pat. & TM Off. All Trademarks acknowledged.
VERILAST™ Technology in the LEGION™ Primary Knee System was tested for 30 years of simulated wear performance
Ave
rage
vol
umet
ric w
ear (
mm
3 )
Comparison of the mean volumetric wear of the CoCr/CPE and VERILAST couples after simulating 3 years of use.
120
Simulation of 3 yearsVERILASTCoCr/CPE
100
80
60
40
20
0
160
140120.42
98%
2.67
p<0.01
Ave
rage
vol
umet
ric w
ear (
mm
3 )
Based on in-vitro wear simulation testing, the LEGION Primary Knee System with VERILAST technology is expected to provide wear performance sufficient for 30 years of actual use under typical conditions. The results of in-vitro wear simulation testing have not been proven to quantitatively predict clinical wear performance. Also, a reduction in total polyethylene wear volume or wear rate alone may not result in an improved clinical outcome as wear particle size and morphology are also critical factors in the evaluation of the potential for wear mediated osteolysis and associated aseptic implant loosening. Particle size and morphology were not evaluated as part of the testing. ™Trademark of Smith & Nephew. Certain marks Reg. US Pat. & TM Ofc.
22.78
Ave
rage
vol
umet
ric w
ear (
mm
3 )
30 years Simulation3 years Simulation
VERILAST™ Technology in the LEGION™ Primary Knee System was tested for 30 years of simulated wear performance
120
Comparison of the mean volumetric wear of the CoCr/CPE after simulating 3 years of use and VERILAST after simulating 30 years of use.
VERILASTCoCr/CPE
100
80
60
40
20
0
160
140120.42
p<0.01
81%
Based on in-vitro wear simulation testing, the LEGION Primary Knee System with VERILAST technology is expected to provide wear performance sufficient for 30 years of actual use under typical conditions. The results of in-vitro wear simulation testing have not been proven to quantitatively predict clinical wear performance. Also, a reduction in total polyethylene wear volume or wear rate alone may not result in an improved clinical outcome as wear particle size and morphology are also critical factors in the evaluation of the potential for wear mediated osteolysis and associated aseptic implant loosening. Particle size and morphology were not evaluated as part of the testing. ™Trademark of Smith & Nephew.
25
15
20
10
0
-5Mea
n vo
lum
etric
wea
r XLP
E in
sets
(mm
3 ) 35
30
5
Duration Simulation (years)6 9 15.512 19 2622.5 303
VERILAST™ Technology in the LEGION™ Primary Knee System was tested for 30 years of simulated wear performance
Based on in-vitro wear simulation testing, the LEGION Primary Knee System with VERILAST technology is expected to provide wear performance sufficient for 30 years of actual use under typical conditions. The results of in-vitro wear simulation testing have not been proven to quantitatively predict clinical wear performance. Also, a reduction in total polyethylene wear volume or wear rate alone may not result in an improved clinical outcome as wear particle size and morphology are also critical factors in the evaluation of the potential for wear mediated osteolysis and associated aseptic implant loosening. Particle size and morphology were not evaluated as part of the testing. ™Trademark of Smith & Nephew.
Duration Simulation (years)
8.0
6.0
7.0
5.0
4.0
3.00 63 9 15.512 19 2622.5 30
Oxi
de T
hick
ness
(!m
)VERILAST™ Technology in the LEGION™ Primary Knee System was tested for 30 years of simulated wear performance
Based on in-vitro wear simulation testing, the LEGION Primary Knee System with VERILAST technology is expected to provide wear performance sufficient for 30 years of actual use under typical conditions. The results of in-vitro wear simulation testing have not been proven to quantitatively predict clinical wear performance. Also, a reduction in total polyethylene wear volume or wear rate alone may not result in an improved clinical outcome as wear particle size and morphology are also critical factors in the evaluation of the potential for wear mediated osteolysis and associated aseptic implant loosening. Particle size and morphology were not evaluated as part of the testing. ™Trademark of Smith & Nephew.
VERILAST™ Technology demonstrates lower wear rates than other XLPE formulations using similar test conditions
Conventional Material Technologies
XLPE Material Technologies
1. H. M. J. McEwen, P. I. Barnett, C. J. Bell, R. Farrar, D. D. Auger, M. H. Stone and J. Fisher, “The influence of design, materials and kinematics on the in vitro wear of total knee replacements,”J Biomech, 2005;38(2):357-365.
2. A. Parikh, M. Morrison and S. Jani, “Wear testing of crosslinked and conventional UHMWPE against smooth and roughened femoral components,” Orthop Res Soc, San Diego, CA, Feb 11-14, 2007, 0021.3. AA. Essner, L. Herrera, S. S. Yau, A. Wang, J. H. Dumbleton and M. T. Manley, “Sequentially crosslinked and annealed UHMWPE knee wear debris,” Orthop Res Soc, Washington D.C., 2005, 71.4. L. Herrera, J. Sweetgall, A. Essner and A. Wang, “Evaluation of sequentially crosslinked and annealed wear debris,” World Biomater Cong, Amsterdam, May 28-Jun 1, 2008, 583.5. C. Schaerer, K. Mimnaugh, O. Popoola and J. Seebeck, “Wear of UHMWPE tibial inserts under simulated obese patient conditions,” Orthop Res Soc, New Orleans, LA, Feb 6-10, 2010, 2329.6. Biomet publication, “FDA Cleared Claims for E1 Antioxidant Infused Technology,” http:/ /www.biomet.com/orthopedics/getFile.cfm?id=2657&rt= inline7. R. Papannagari, G. Hines, J. Sprague and M. Morrison, “Long-term wear performance of an advanced bearing knee technology,” ISTA, Dubai, UAE, Oct 6-9, 2010.
™Trademark of Smith & Nephew. All Trademarks acknowledged.
VERILAST!
Technology
™Trademark of Smith & Nephew. Reg. US Pat. & TM Off. All Trademarks acknowledged.
Concept
Two major bearings components in TKA
• Hard metallic femoral component
• Soft polyethylene tibial component
Need a system-wide solution
VERILAST™ Bearing Technology
• Provides lowest wear combination
• OXINIUM™ femoral component
– Provides lower wear than CoCr
– Maintains low wear of XLPE
• XLPE tibial insert
– Provides higher performance than CPE
™Trademark of Smith & Nephew. Reg. US Pat. & TM Off. All Trademarks acknowledged.
Hard bearings–OXINIUM™ Oxidized Zirconium
• History
• Properties
• Performance
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The history – OXINIUM™ Oxidized Zirconium
• Award Winning Technology– ASM International
• First Implant in 1997
• > 300,000 implants
™Trademark of Smith & Nephew. Reg. US Pat. & TM Off. All Trademarks acknowledged.
OXINIUM™ material properties
• Surface transformed ceramic
– Not a coating
• Toughness of metal and wear resistance of ceramic
• More wettable than CoCr
– Less friction than CoCr
– Reduces wear of poly
• Surface 2x harder than CoCr alloy
– More scratch resistant
• Nickel content less than 35 ppm
– For metal-sensitive patients
Metal Substrate
Oxygen Enriched MetalOriginal Surface
Air500oCOxygen
Diffusion
Ceramic Oxide
Oxygen Enriched Metal
™Trademark of Smith & Nephew. Reg. US Pat. & TM Off. All Trademarks acknowledged.
Metal sensitivity
• 56 yo homemaker
– Cannot wear jewelry
• 3 yr post CoCr TKA
– Pain, stiffness
– Persistent rash
• Revised to alumina
– Rash resolved
• Contra-lateral TKA
– OXINIUM™ material used
– No sensitivity issues
Nasser et a l., AAOS, San Diego, CA, 2007, 437 ™Trademark of Smith & Nephew. Reg. US Pat. & TM Off. All Trademarks acknowledged.
Hardness – Surface of OXINIUM™ material is 2X that of CoCr
*Long et al., SFB 1998
™Trademark of Smith & Nephew. Reg. US Pat. & TM Off. All Trademarks acknowledged.
Abrasion resistance
Hunter and Long, WBC 2000
4900 times less volumetric wear in bone cement abrasion test compared to CoCr
™Trademark of Smith & Nephew. Reg. US Pat. & TM Off. All Trademarks acknowledged.
Microabrasive performanceCoCr vs. OXINIUM™ Material Retrieved at 30 months
CoCr OXINIUM™
Alloy
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Strength and toughness
• Behaves like metal
• Supports 1000 lbf fatigue load for 10 Mc
– Similar to CoCr
• Condyle bent at 4500 lbf
– No fracture
– No oxide delamination
™Trademark of Smith & Nephew. Reg. US Pat. & TM Off. All Trademarks acknowledged.
Coefficient of friction
• Lower coefficient of friction against polyethylene and against cartilage
• Lower coefficient of friction means less adhesive wear
Poggie et al., ASTM STP 1145™Trademark of Smith & Nephew. Reg. US Pat. & TM Off. All Trademarks acknowledged.
OXINIUM™ alloy on CPE wear performance
• OXINIUM alloy provides improved wear performance
– Under pristine conditions
– Due to lower friction of ceramic surface
• OXINIUM material maintains improved wear performance
– Under microabrasive conditions
– Scratch resistance due to improved hardness
50%50%
™Trademark of Smith & Nephew. Reg. US Pat. & TM Off. All Trademarks acknowledged.
Soft bearing
™Trademark of Smith & Nephew. Reg. US Pat. & TM Off. All Trademarks acknowledged.
Soft bearing
• Hip– More conforming
– Lower contact stresses
– Primarily sliding motion
• Knee– Less Conforming
– Higher contact stresses
– Complex sliding and rolling motions
• Requires different crosslink formulations
™Trademark of Smith & Nephew. Reg. US Pat. & TM Off. All Trademarks acknowledged.
TKA Crosslinked PE Market
MaterialGURResin
Dose(Mrad)
ThermalTreatment Sterilization
FreeRadicals? Oxidation?
Smith & NephewXLPE 1020 7.5 Re-melt EtO No No
DePuy XLK 1020 5 Re-melt Gas Plasma No No
Zimmer Prolong 1050 6.5 Re-melt Gas Plasma No No
BiometE-Poly / E1 1020 10+3 Sub-melt +
Vit E Diffusion Gamma-Inert Yes No
Stryker X3 1020 9 = 3×3 Sub-melt Gas Plasma Yes Yes
™Trademark of Smith & Nephew. Reg. US Pat. & TM Off. All Trademarks acknowledged.
The right amount?
“Although a certain amount of cross-linking would be effective for clinical application of PE tibial inserts, an optimal radiation dose should be much smaller than that used in current XLPE in total hip arthroplasty.”1
Asano et al. Dose Effects of Cross-Linking Polyethylene for Tota l Knee Arthroplasty on Wear Performance and Mechanical Properties J Biomed Mater Res Part B: Appl Biomater 83B: 615–622, 2007
™Trademark of Smith & Nephew. Reg. US Pat. & TM Off. All Trademarks acknowledged.
Asano et al. Dose Effects of Cross-Linking Polyethylene for Tota l Knee Arthroplasty on Wear Performance and Mechanical Properties J Biomed Mater Res Part B: Appl Biomater 83B: 615–622, 2007
™Trademark of Smith & Nephew. Reg. US Pat. & TM Off. All Trademarks acknowledged.
The right amount
Crosslinking and wear
™Trademark of Smith & Nephew. Reg. US Pat. & TM Off. All Trademarks acknowledged.
Knee simulator wear
™Trademark of Smith & Nephew. Reg. US Pat. & TM Off. All Trademarks acknowledged.
Knee simulator wear
™Trademark of Smith & Nephew. Reg. US Pat. & TM Off. All Trademarks acknowledged.
Microabrasive performanceCoCr vs. OXINIUM™ Alloy
CoCr OXINIUM
™Trademark of Smith & Nephew. Reg. US Pat. & TM Off. All Trademarks acknowledged.
Knee simulator wear
™Trademark of Smith & Nephew. Reg. US Pat. & TM Off. All Trademarks acknowledged.
TKA Crosslinked PE market
MaterialGURResin
Dose(Mrad)
ThermalTreatment Sterilization
FreeRadicals? Oxidation?
Smith & NephewXLPE 1020 7.5 Re-melt EtO No No
DePuy XLK 1020 5 Re-melt Gas Plasma No No
Zimmer Prolong 1050 6.5 Re-melt Gas Plasma No No
BiometE-Poly / E1 1020 10+3 Sub-melt +
Vit E Diffusion Gamma-Inert Yes No
Stryker X3 1020 9 = 3×3 Sub-melt Gas Plasma Yes Yes
™Trademark of Smith & Nephew. Reg. US Pat. & TM Off. All Trademarks acknowledged.
Oxidative stability
™Trademark of Smith & Nephew. Reg. US Pat. & TM Off. All Trademarks acknowledged.
Free radical concentration
1200
8900
2800
10
100
1000
10000
100000
S&N CPE S&N XLPE StrykerX3™ StrykerCrossfire™
Gamma-Air
FRC
(Tril
lion
Free
Rad
ical
s/g)
NotDetectable
NotDetectable
1. Wang et al, J Appl Phys, 2006, 39, 3213-32192. Muratoglu et al, Clin Orth Rel Res, 2003, 417, 253-262
™Trademark of Smith & Nephew. Reg. US Pat. & TM Off. All Trademarks acknowledged.
VERILAST™ Technology demonstrates lower wear rates than other XLPE formulations using similar test conditions
1. H. M. J. McEwen, P. I. Barnett, C. J. Bell, R. Farrar, D. D. Auger, M. H. Stone and J. Fisher, “The influence of design, materials and kinematics on the in vitro wear of total knee replacements,”J Biomech, 2005;38(2):357-365.
2. A. Parikh, M. Morrison and S. Jani, “Wear testing of crosslinked and conventional UHMWPE against smooth and roughened femoral components,” Orthop Res Soc, San Diego, CA, Feb 11-14, 2007, 0021.3. AA. Essner, L. Herrera, S. S. Yau, A. Wang, J. H. Dumbleton and M. T. Manley, “Sequentially crosslinked and annealed UHMWPE knee wear debris,” Orthop Res Soc, Washington D.C., 2005, 71.4. L. Herrera, J. Sweetgall, A. Essner and A. Wang, “Evaluation of sequentially crosslinked and annealed wear debris,” World Biomater Cong, Amsterdam, May 28-Jun 1, 2008, 583.5. C. Schaerer, K. Mimnaugh, O. Popoola and J. Seebeck, “Wear of UHMWPE tibial inserts under simulated obese patient conditions,” Orthop Res Soc, New Orleans, LA, Feb 6-10, 2010, 2329.6. Biomet publication, “FDA Cleared Claims for E1 Antioxidant Infused Technology,” http:/ /www.biomet.com/orthopedics/getFile.cfm?id=2657&rt= inline7. R. Papannagari, G. Hines, J. Sprague and M. Morrison, “Long-term wear performance of an advanced bearing knee technology,” ISTA, Dubai, UAE, Oct 6-9, 2010.
™Trademark of Smith & Nephew. All Trademarks acknowledged.
Summary
• VERILAST™ Bearing Technology– Provides industry-leading wear performance
• OXINIUM™ Oxidized Zirconium femoral components– Surface transformed ceramic– ½ frictional forces of CoCr– 2x hardness of CoCr
• XLPE tibial inserts– 7.5 Mrad melt annealed– Undetectable free radical concentration– Oxidation resistant– Delamination resistant
™Trademark of Smith & Nephew. Reg. US Pat. & TM Off. All Trademarks acknowledged.