25 Reasons to Sell the P.F.C. Sigma Knee. Sigma... · 25 Reasons to Sell the P.F.C. Sigma® Knee...

25 Reasons to Sell the P.F.C. Sigma® Knee

Sigma 25 Reasons.PRINT.indd 1 16/8/10 16:34:48

This information is for exclusive use of the DePuy sales force. Further reproduction or distribution is not permitted. This information is for exclusive use of the DePuy sales force. Further reproduction or distribution is not permitted.


25 Reasons to Sell the P.F.C. Sigma® Knee System

25 Years of progress and innovation

2,000,000 knees implanted worldwide

10,000 orthopaedic surgeons

95 countries

1 P.F.C. Sigma® Knee System

No 1 knee replacement in the world•

The most comprehensive and seamless •primary and revision knee system

Extensive long term clinical data•



1

Around the world success: Most implanted knee in the world

No 1 most implanted knee in the UK National Joint Registry.1

2 No 1 most implanted knee in the Swedish Knee Arthroplasty Register.2

3 No 1 most implanted cemented knee in the Australian Joint Replacement Registry.3

Extensive Clinical Heritage

Sigma® Knee System

P.F.C. Sigma® Total Knee Arthroplasty: 7-9 year results, 99.7% survivorship.

Hunter N, Clayton RAE, Brenkel IJ. Press fit condylar Sigma® Total Knee Arthroplasty: 7-9 year results. Eur J Orthop Surg Traumatol 2009; 19: 409-413.

4

The Wrightington Experience: Excellent clinical results of P.F.C. Sigma® Total Knee Replacement after almost eight years follow-up.

Zaki SH, Rafiq I, Kapoor A, Raut V, Gambhir AK, Porter ML. Medium-term results with the Press Fit Condylar (P.F.C.) Sigma® knee prosthesis the Wrightington experience. Acta Orthop Belg 2007; 73:55-59.

5

Midterm results of the P.F.C. Sigma® Knee System: Minimum 6 year follow-up, 99.6% survivorship.

Dalury DF, Gonzales RA, Adams MJ, Gruen TA, Trier K. Midterm Results with the P.F.C. Sigma® Total Knee Arthroplasty System. Midterm Results with the P.F.C. Sigma® Total Knee Arthroplasty System. J Arthroplasty. 2008 Feb: 23(2):175-81

6



All Poly Tibial Implants

All-poly tibial components can provide excellent performance and survivorship in younger, active patients.

Ranawat AS, Mohanty SS, Goldsmith SE. Experience with an All-Polyethylene Total Knee Arthroplasty in Younger, Active Patients with follow up from 2 to 11 years. J Arthroplasty 2005; 20 (7 Suppl 3): 7-11.

7

A highly polished CoCr tibial tray, oxidatively stable XLK polyethylene and i2 locking mechanism show a significant reduction in wear.

McNulty D, Swope S. Influence of Polyethylene Processing, Tibial Tray Surface Finish and Modular Locking Mechanism Design on in Vitro Wear for TKR. 51st Annual Meeting of the Orthopaedic Research Society 2005, Poster 0840.

8Superior Wear Performance: CoCr Tray, i2 Locking and XLK



9

High Function, Low Wear

Highly polished CoCr tray: when compared to the titanium design, it leads to a 47% reduction in volumetric wear under the same loading conditions – extending implant life especially for active patients.4

10 i2 Locking Mechanism: 85% reduction in micromotion compared to the P.F.C.® locking mechanism creating a class leading micromotion level between the modular tibial tray and the tibial insert.5 This results in a 28% reduction in total volumetric wear when comparing the P.F.C.® locking mechanism and the i2 locking mechanism under the same loading conditions.4

11 Oxidatively Stable XLK Polyethylene: moderately cross-linked at 5MRads, leads to high resistance to multidirectional wear6 whilst maintaining the strength and integrity of the polyethylene.7,8 36% Reduction in total volumetric wear from GVF to XLK under the same loading conditions.9 Cross-linked and re-melted polyethylenes such as XLK are oxidatively stable both on the shelf and in vivo.10

Overall combination of the CoCr Tray, i2 locking and XLK polyethylene gives an 89% reduction in total volumetric wear compared to titanium tray, P.F.C.® locking mechanism and GVF under standard kinematic test conditions.11

12

Sigma® Knee System accommodates the necessity for high function for certain patients with the P.F.C. Sigma® CR150 and RPF femoral components which are designed with an extended J curve to allow safer deep flexion.

13



14

A Complete System

The Sigma® Knee System is a complete system of implant solutions accommodating all surgical and patient needs from early intervention to complex revision surgeries.

15

Sigma® High Performance Partial Knee: Is the only specifically designed Unicocondylar and Patellofemoral Joint System that has the ability to treat knee arthritis, one compartment at a time, restoring patient’s natural kinematics. The system allows for a variety of component placement scenarios, simultaneous or staged, suited to an individual patient’s anatomy.

16

Sigma® Primary Knee System: is a completely modular and extensively proven system with high function, low wear mobile and fixed bearing solutions. The range of Sigma® products provide solutions for all types of patients, meaning potential cost savings can be made by matching specific implants to individual patient demand, ranging from the all poly tibia to femurs designed to support high function.

The new Sigma® PS Femoral Component allows you to target competitor surgeons who have concerns about anterior knee pain, patella crepitus and clunk. The evolution of the already successful CS femoral component includes a smoother trochlear grove designed to enhance patella tracking and reduce the risk of soft tissue impingement.



17 The Sigma® CR150 femur: the design of the posterior condyles has been extended to provide conforming contact up to 150° flexion. This evolution of femoral geometry provides even greater polyethylene protection in deep flexion.12 At 135° flexion the system provides a 31% increase in contact area resulting in a 19% decrease in contact stress and helping to protect the tibial insert and reduce polyethylene damage.13

18 The TC3 Mobile Bearing Revision System: addresses rotation, fixation and stability in revision surgery.

19 The Rotating Platform offers rotation in constrained knee replacement designed to minimise polyethylene wear and reduce loosening forces.

20 Metaphyseal sleeves compensate for substantial bone defects, designed to compressively load the bone resulting in beneficial bone remodelling at the bone-implant interface and providing a strong foundation for implant fixation.14

21 Stability can be achieved with the range of posterior stabilised, varus / valgus constrained or hinged bearing options.



22

High Performance Instruments

Efficiency: through secure instrument locking, colour coded locking mechanisms and the ‘quick connect’ power pinning system.

23 Precision: through macro/micro fine tune adjustment, combined componentry and exact instrumentation to create a 1mm cement mantle or line to line fit for uncemented implants.

24 Flexibility: with femoral preparation available in classic, fixed reference and balanced philosophies. Choice in femoral rotation, femoral referencing and pinning options allow instrumentation to deliver solutions to surgeons regardless of their surgical philosophy.

The Sigma® HP Instruments provide the latest and most advanced instrumentation to date from DePuy Orthopaedics. Modern knee replacement demands high performance instrumentation to achieve accurate alignment and a well balanced knee. The cornerstones of the Sigma® HP instrumentation are efficiency, precision and flexibility.



F U N C

T I ON

WE A R

HIGH FUNCTION

LOW

WEAR

25

25 Years of the P.F.C. Sigma® Knee

2010 is an important year for us at DePuy as it marks 25 years of the P.F.C. Sigma® Knee. Like any modern technology, its success is a result of evolution – a combination of progress and innovation over time to give us what is today a high function, low wear modern knee solution.



F U N C

T I ON

WE A R

HIGH FUNCTION

LOW

WEAR

There is a major focus on this iconic date with many materials, meetings and opportunities to talk to both existing and competitor surgeons about the evolution and success of the Sigma® Knee brand. The continued success of the P.F.C. Sigma® System is reflected in the volume of Sigma® Knees sold worldwide and the high number of surgeon registrations for the Sigma® High Function Low Wear Symposium in Rome, 18–20th October.


References

National Joint Registry for England and Wales. 6th Annual report, 2009. 1.

Swedish Knee Arthroplasty Register. Annual Report, 2009. 2.

Australian Orthopaedic Association. National Joint Replacement Registry. 3. Annual Report 2009.

Data on file at DePuy Orthopaedics, Inc. Data from AMTI knee simulators 4. (WR:010120, 020085 and 030058)

Leisinger S, Hazebrouck S, Deffenbaugh D. A New Approach to 5. Micromotion Characterization of Modular Tibia Implants: 54th Annual Meeting of the Orthopaedic Research Society 2008: Poster No. 1952.

Ries MD. Bearing Surface Selection in Total Knee Arthroplasty. Proceedings 6. of the AAOS 75th Annual Meeting 2007: 117.

Greer KW, Sharp M. Comparison of crosslinked UHMWPE stabilized 7. by sequential annealing or by remelting. 53rd Annual Meeting of the Orthopaedic Research Society 2007: Poster No. 1784.

Morrison ML, Jani S. Comparison of sequential and single-dose irradiation 8. effects on the mechanical and physical properties of UHMWPE. 53rd Annual Meeting of the Orthopaedic Research Society 2007: Poster No. 1786.



Data on file at DePuy Orthopaedics, Inc. Warsaw data from AMTI knee 9. simulators (WR:030058).

Collier JP, Currier BH, Kennedy FE, Currier JH, Timmins GS, Jackson SK, 10. Brewer RL. Comparison of cross-linked polyethylene materials for orthopaedic applications. Clin Orthop Relat Res. 2003;414:289-304.

Data on file at DePuy Orthopaedics, Inc. Data from AMTI knee simulators 11. (WR030085 & WR030058)

Zelle J, Van der Zanden AC, De Waal Malefijt M, Verdonschot N. 12. Biomechanical analysis of posterior cruciate ligament retaining high-flexion total knee arthroplasty. Clin Biomech (Bristol, Avon). 2009;24(10):842-9.

Data on file at DePuy International Ltd. DVE-000861-FEA13.

Jones RE, Barrack RL, Skedros J. Modular, mobile-bearing hinge total knee 14. arthroplasty. Clin Orthop Relat Res. 2001;392:306-14.



Revised: 11/10

DePuy International LtdSt. Anthony’s RoadLeeds LS11 8DTEnglandTel: +44 (0)113 387 7800Fax: +44 (0)113 387 7890

This publication is not intended for distribution in the USA.

Never Stop Moving™ is a trademark of DePuy International Ltd.P.F.C.®, P.F.C. Sigma® and Sigma® are registered trademarks of DePuy Orthopaedics, Inc.© 2010 DePuy International Limited. All rights reserved.Registered Office: St. Anthony’s Road, Leeds LS11 8DT, England.Registered in England No. 3319712

Cat No: 9075-87-000 version 1

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