total knee system proven performance, … narrow...knee system allows surgeons to simplify decision...

©2015 Smith & Nephew, Inc. 03111 V2 08/15

Proven Performance,Continuous Innovation

LEGION™Total Knee System

DurabilityFlexibilityClinical Heritage

Give your patient the potential to regain an active lifestyle. With the LEGION™ Total Knee System you can offer a customized solution to meet your patient’s high expectations. This system is designed to empower surgeons to address diverse challenges and simplify decision-making intraoperatively.

Peace of MindLEGION™ Total Knee System is a comprehensive, state-of-the-art system that empowers surgeons to provide personalized joint care. The system includes simple solutions for addressing the increasingly diverse needs of your patients.

Rich clinical heritageSmith & Nephew has a rich history in the medical field dating back over 150 years. The company has produced many products that demonstrate proven performance. Built upon the world-class GENESIS™ II design and its nearly 20 years of clinical data, the LEGION Total Knee System is carrying on the legacy.

Exceptional durabilityThe LEGION Total Knee System offers biocompatible implant technology with unmatched wear performance. Smith & Nephew is the only company to offer VERILAST™ Technology. With the combination of OXINIUM™ alloy and highly cross-linked polyethylene (XLPE), VERILAST Technology offers the full solution in knee implant materials.

System flexibilityToday’s knee implant patients present increasingly diverse scenarios. The versatility of the LEGION Total Knee System allows surgeons to simplify decision making intraoperatively and deliver personalized joint care.

Durability: Wear PerformanceAs today’s patients seek more active lifestyles, knee implants will be expected to endure more stress without succumbing to wear. However, the functional lifetime demand of younger and active patients is 10-fold greater than the estimated functional lifetime of traditional implant bearings.1 VERILAST™ Technology from Smith & Nephew is the only bearing technology with published results of 45 Million Cycles of knee in-vitro wear simulation testing with the LEGION™ Primary Knee System. This means the replacement may provide improved wear performance. More importantly, if implanted earlier, it may restore patients to their active lifestyles. The implants identified below were tested by their manufacturers using different testing protocols and, therefore, the results are not directly comparable.

40

50

30

20

10

35

45

25

15

5

0

PFC Sigm

aTM 2

GENES

IS™ II 3

Scorpio

TM 4

Triath

lonTM

5

NexGen

TM 6

Vangu

ardTM

7

PFC Sigm

aTM 2

GENES

IS™ II 3

Scorpio

4

Triath

lon 5

NexGen

6

Vangu

ard 7

Attune

TM 8

LEGIO

N TKS 1

Volu

met

ric w

ear r

ate

(mm

3 /M

cycl

e)

23.00 23.45

34.60

20.20

24.40

43.40

5.40

13.00

6.417.30

6.504.10

6.10

CoCr and CPE CoCr and XLPE VERILAST Technology

0.58

Mean volumetric wear rates of CoCr against conventional polyethylene (CPE), CoCr against crosslinked polyethylene (XLPE) and OXINIUM against XLPE as published by the respective companies with their respective implants. Please see references for testing information.

Durability: Metal SensitivityJust as metal ions are a well described problem for many hip replacement patients, cobalt, chromium and nickel are commonly cited allergens for knee replacement patients. In several cases, sensitivity to one or more of the allergens has resulted in revisions for these patients.9-12

Surgeons should be aware that all metal implants contain varying amounts of cobalt, chromium, and nickel. When selecting the appropriate implant, surgeons should consider the composition of each implant before use. To help with this decision, VERILAST™ Technology incorporates proprietary OXINIUM™ alloy. Compared to cobalt chrome, OXINIUM alloy has much less cobalt (<0.002%), chromium (<0.02%) and nickel (<0.0035%) content.

Prevalence of patients demonstrating metal sensitivityMaximum nickel content

0.0% 0.2% 0.4%

<0.0035%

0.6% 0.8%

0.5%

0.1%

Ni content % by weight

Maximum chromium content

0.0% 10% 20% 30% 40%

27-30%

<0.02%

<0.02%

Cr content % by weight

Maximum cobalt content

0.0% 10% 20% 30% 40% 50% 60%

58-68%

<0.01%

<0.002%

Co content % by weight

Clinical studies14Metal content of implants13

System FlexibilityLEGION™ has the flexibility to address diverse surgical challenges and simplify decision making interoperatively. The LEGION instrumentation gives you the ability to move from a cruciate retaining implant all the way to a hinged component.

Seamlesssystem

Same A-P ResectionAdd PS BoxAdd AugmentsAdd Constraint

Same A-P ResectionAdd Revision Components

Same A-P Resection with Build-upAdd Hinge Components

Updated instruments

LEGION is not only offered with updated traditional instrumentation but also with a more cost-effective and simplified approach to total knee arthoplasty. VISIONAIRE™ FastPak includes VISIONAIRE Cutting Guides and size-specific disposable instruments.

VISIONAIRE FastPak

Patient FlexibilityToday’s knee implant patients present increasingly diverse scenarios. Even with thorough pre-operative planning some factors may not be visible until surgery is underway. You have to make decisions fast, and you need a knee system that can react quickly and work with you each step of the way.

PathologyPrimary to Revision and Hinge Offsets, wedges and augments

Range of motionConstrained, standard and high flexion inserts

AgeCemented and porous options CoCr and VERILAST™ Technology

Activity levelCoCr and VERILAST Technology Standard polyethylene and highly cross-linked poly

Biocompatible implantsOXINIUM™ Oxidized Zirconium All-polyethylene tibial components Titanium tibial base plates

Same A-P ResectionAdd Revision Components

Same A-P Resection with posterior build-upAdd Hinge components

Anatomic baseplate offers full coverage

LEGION™ Other knee systems

AnatomyBone-preserving PS box Anatomically designed base plate Offset capability for optimal component position

Optimal SizingIdeal sizing for male and female anatomy 1mm increment inserts

LEGION and GENESIS II achieve equivalent articulation but do so via different surgical approaches to femoral external rotation.

Rich Clinical Heritage

LEGION encompasses the same design features that have demonstrated excellent long-term survivorship with GENESIS II. LEGION CR and PS knees provide the same kinematic motion and articulation as GENESIS II with the addition of updated instrumentation and a seamless total knee system able to handle all stages of knee reconstruction.17

GENESIS II: A Systematic Literature Review of Clinical Outcomes16

• 99.5% cumulative mean survival rate at 5 years 99.9% at 7 years; 98.8% at nine years

• Low revision rate (up to 11.9 year follow-up)• Includes 19 studies and 2656 knees• Mean post op Knee Society score of 90.6

15 – 17 year Clinical Results15

• “Excellent” survivorship of 98.1% at a minimum follow-up of 15 years

• 89 consecutive GENESIS II knee procedures were studied

• “Minimum 15-year follow-up reports after TKA are not abundant”

Built-in Femoral Rotation Surgeon-directed Femoral Rotation

GENESIS II CR GENESIS II PS LEGION CR LEGION PS LEGION RK LEGION HK Cruciate Retaining Knee Posterior Stabilized Knee Cruciate Retaining Knee Posterior Stabilized Knee Revision Knee Hinged Knee

LEGION has symmetric posterior condyles while GENESIS II has a thinner medial posterior condyle due to the built in external rotation.

LEGION GENESIS IIM L M L

Proven performance, continuous innovationSmith & Nephew has a rich history in the medical field dating back over 150 years. The company has produced many products that demonstrate proven performance. Built upon the world-class GENESIS™ II design and its nearly 20 years of clinical data, the LEGION™ Total Knee System is carrying on the legacy. GENESIS II clinical results:

Today’s orthopaedic environment demands simple solutions with proven clinical history. With the DURABILITY of VERILAST™ Technology, interoperative FLEXIBILITY of both implants and instrumentation, and a rich CLINICAL HERITAGE, the LEGION Total Knee System gives surgeons peace of mind not only in the OR but with the knowledge that their patients can return to their active lifestyles.

LEGION™ is carrying on the legacy of excellent clinical results.

LEGIONPrimaryKneeSystem-SafetyandEfficacyClinicalStudy18

• A ten year study spanning five sites and 138 patients. • Two year interim results show just two revisions; one for infection and one

for patella clunk.• LEGION Primary demonstrated excellent clinical survivorship of 98.6%.

Australian Orthopaedic Association National Joint Replacement Registry 2014

LEGION PS CoCr has the lowest cumulative percent revision of all PS knees with cement fixation at 3 years: 1.2%.19 At their longest follow-up, the cumulative percent revision of all other LEGION combinations is at or below the class average for primary total knee replacement (Primary Diagnosis OA.)20

Page | 151 Data Period 1 September 1999 – 31 December 2013

Table KT10: Cumulative Percent Revision of Primary Total Knee Replacement with Cement Fixation

Femoral Component

Tibial Component

N Revised

N Total

1 Yr 3 Yrs 5 Yrs 7 Yrs 10 Yrs 13 Yrs

AGC AGC 146 3451 0.6 (0.4, 0.9) 2.4 (1.9, 2.9) 3.5 (2.9, 4.2) 4.2 (3.5, 5.0) 5.4 (4.6, 6.5) 6.5 (5.3, 8.0)

Active Knee Active Knee 27 1077 0.8 (0.4, 1.6) 2.5 (1.6, 3.9) 3.6 (2.3, 5.5) 4.9 (3.0, 7.9)

Advance Advance II 48 896 1.4 (0.8, 2.5) 4.2 (3.0, 5.8) 5.1 (3.7, 7.0) 6.6 (4.9, 8.8) 8.1 (6.0, 10.9)

BalanSys BalanSys 16 898 0.3 (0.1, 1.0) 1.8 (1.0, 3.4) 2.6 (1.4, 4.6) 3.1 (1.7, 5.6) 4.8 (2.6, 8.8)

Duracon Duracon 377 8971 1.0 (0.8, 1.2) 2.4 (2.1, 2.7) 3.3 (2.9, 3.6) 3.8 (3.4, 4.2) 4.8 (4.4, 5.4) 6.4 (5.5, 7.5)

Evolis Evolis 6 599 0.4 (0.1, 1.5) 1.1 (0.5, 2.7) 1.5 (0.6, 3.3)

Genesis II CR Genesis II 338 11253 0.9 (0.7, 1.1) 2.5 (2.2, 2.8) 3.2 (2.9, 3.6) 4.0 (3.6, 4.5) 4.3 (3.8, 4.8) 4.6 (4.0, 5.3)

Genesis II CR Profix Mobile 24 490 1.7 (0.9, 3.4) 3.2 (1.9, 5.4) 5.0 (3.2, 7.7) 5.9 (3.9, 9.0) 8.0 (5.0, 12.8)

Genesis II Oxinium CR Genesis II 234 5924 1.1 (0.9, 1.4) 2.8 (2.4, 3.2) 3.6 (3.1, 4.2) 4.6 (4.0, 5.3) 6.1 (5.2, 7.2)

Genesis II Oxinium PS Genesis II 493 11510 1.6 (1.4, 1.8) 3.9 (3.5, 4.3) 5.4 (5.0, 6.0) 6.3 (5.7, 6.9) 7.8 (6.8, 9.0)

Genesis II PS Genesis II 419 12395 1.3 (1.1, 1.5) 3.0 (2.7, 3.3) 4.0 (3.6, 4.4) 4.5 (4.0, 5.0) 5.4 (4.7, 6.1) 6.9 (5.0, 9.7)

Journey Journey 161 3132 1.4 (1.0, 1.9) 4.6 (3.9, 5.5) 6.3 (5.4, 7.5) 8.2 (6.9, 9.9)

Kinemax Plus Kinemax Plus 88 1826 0.9 (0.6, 1.5) 2.4 (1.8, 3.3) 3.0 (2.3, 3.9) 3.9 (3.1, 4.9) 4.5 (3.6, 5.7) 8.1 (5.6, 11.6)

LCS CR LCS 269 3936 1.0 (0.7, 1.4) 3.8 (3.2, 4.4) 5.0 (4.4, 5.8) 6.1 (5.3, 6.9) 7.1 (6.3, 8.0) 8.1 (7.2, 9.2)

LCS CR MBT 224 8058 0.7 (0.5, 0.9) 2.2 (1.9, 2.6) 3.2 (2.7, 3.7) 4.1 (3.6, 4.7) 5.4 (4.6, 6.4)

LCS PS MBT 26 452 1.5 (0.7, 3.3) 6.2 (4.2, 9.3)

Legion CR Genesis II 15 573 2.0 (1.1, 3.7) 2.7 (1.5, 4.8)

Legion Oxinium CR Genesis II 19 1537 0.8 (0.4, 1.5) 1.8 (1.1, 2.9) 2.3 (1.3, 4.2)

Legion Oxinium PS Genesis II 80 4020 1.2 (0.9, 1.7) 3.2 (2.5, 4.1) 3.8 (2.9, 5.1)

Legion PS Genesis II 19 2008 0.7 (0.4, 1.2) 1.2 (0.7, 2.0)

Maxim Maxim 33 499 1.2 (0.5, 2.7) 2.6 (1.5, 4.5) 4.7 (3.2, 7.1) 5.2 (3.6, 7.7) 7.0 (4.8, 10.1)

Natural Knee Flex Natural Knee II 15 787 0.8 (0.4, 1.8) 2.5 (1.5, 4.3) 3.4 (1.8, 6.4)

Natural Knee II Natural Knee II 43 1678 0.4 (0.2, 0.8) 1.3 (0.8, 2.0) 1.9 (1.3, 2.8) 2.9 (2.1, 4.0) 3.8 (2.7, 5.3)

Nexgen CR Nexgen 97 3535 0.4 (0.3, 0.7) 1.3 (1.0, 1.8) 1.7 (1.3, 2.2) 2.0 (1.6, 2.6) 2.7 (2.2, 3.4) 5.5 (3.9, 7.6)

Nexgen CR Flex Natural Knee II 3 581 0.3 (0.1, 1.4) 0.6 (0.2, 2.0)

Nexgen CR Flex Nexgen 152 11390 0.6 (0.5, 0.8) 1.3 (1.1, 1.6) 1.9 (1.6, 2.3) 2.2 (1.8, 2.6)

Nexgen LCCK Nexgen 19 449 1.9 (1.0, 3.8) 3.8 (2.2, 6.3) 5.4 (3.3, 8.9) 5.4 (3.3, 8.9)

Nexgen LPS Nexgen 193 5118 1.0 (0.7, 1.3) 2.2 (1.8, 2.7) 2.9 (2.4, 3.4) 3.7 (3.2, 4.3) 4.7 (4.1, 5.4) 5.6 (4.7, 6.7)

Nexgen LPS Flex Nexgen 637 21737 0.9 (0.8, 1.0) 2.4 (2.2, 2.6) 3.3 (3.0, 3.6) 4.2 (3.8, 4.5) 5.3 (4.8, 5.8)

Optetrak-PS Optetrak 133 2078 1.6 (1.1, 2.2) 5.0 (4.1, 6.1) 6.9 (5.8, 8.3) 8.4 (7.0, 10.0) 10.4 (8.3, 13.1)

Optetrak-PS Optetrak-RBK 32 567 2.0 (1.1, 3.6) 4.8 (3.3, 7.1) 6.6 (4.6, 9.4) 7.4 (5.1, 10.7)

PFC Sigma CR MBT 20 1061 0.6 (0.3, 1.3) 1.4 (0.8, 2.4) 1.8 (1.1, 3.0) 2.3 (1.4, 3.7) 3.0 (1.7, 5.2)

PFC Sigma CR PFC Sigma 219 9584 0.8 (0.7, 1.0) 1.9 (1.6, 2.2) 2.4 (2.1, 2.8) 3.0 (2.6, 3.5) 4.0 (3.3, 4.8)

PFC Sigma PS MBT 159 5219 0.8 (0.6, 1.0) 2.6 (2.2, 3.2) 3.5 (3.0, 4.1) 4.2 (3.5, 5.0) 4.7 (3.9, 5.8)

PFC Sigma PS PFC Sigma 171 6238 1.1 (0.8, 1.4) 2.4 (2.0, 2.8) 2.9 (2.5, 3.4) 3.1 (2.7, 3.7) 4.2 (3.5, 5.2)

Profix Profix 133 3285 1.1 (0.8, 1.5) 2.6 (2.1, 3.2) 3.2 (2.7, 3.9) 4.0 (3.4, 4.8) 4.8 (4.0, 5.7) 4.9 (4.1, 5.9)

Profix Oxinium Profix 76 999 1.9 (1.2, 3.0) 5.1 (3.9, 6.7) 6.9 (5.4, 8.7) 7.9 (6.3, 9.8) 8.5 (6.8, 10.6)

RBK RBK 53 1890 0.9 (0.5, 1.4) 2.7 (2.0, 3.7) 3.4 (2.5, 4.5) 3.5 (2.6, 4.7) 5.2 (3.4, 8.1)

Scorpio CR Series 7000 77 1757 0.9 (0.5, 1.4) 2.3 (1.7, 3.1) 3.0 (2.3, 3.9) 4.1 (3.2, 5.2) 5.1 (4.0, 6.4) 6.4 (4.8, 8.4)

Scorpio NRG CR Series 7000 16 964 0.8 (0.4, 1.6) 1.4 (0.8, 2.5) 1.8 (1.1, 3.0)

Scorpio NRG PS Series 7000 43 2416 0.6 (0.4, 1.0) 1.9 (1.4, 2.6) 2.6 (1.9, 3.6)

Scorpio PS Scorpio 29 510 1.2 (0.5, 2.6) 3.8 (2.5, 5.9) 4.4 (2.9, 6.7) 5.4 (3.7, 7.8) 6.7 (4.6, 9.7)

Scorpio PS Scorpio+ 53 900 1.2 (0.7, 2.2) 4.0 (2.9, 5.5) 5.7 (4.3, 7.4) 6.2 (4.7, 8.0) 6.4 (4.9, 8.4)

Scorpio PS Series 7000 131 3057 1.1 (0.8, 1.5) 2.9 (2.3, 3.6) 3.9 (3.2, 4.7) 4.9 (4.1, 5.9) 7.1 (5.7, 8.8)

Triathlon CR Triathlon 304 16914 0.8 (0.7, 1.0) 2.1 (1.9, 2.4) 2.8 (2.4, 3.1) 3.1 (2.7, 3.6)

Triathlon PS Triathlon 122 4118 1.6 (1.2, 2.0) 3.1 (2.6, 3.8) 3.9 (3.2, 4.8) 4.7 (3.7, 5.8)

Vanguard CR Maxim 75 4447 0.6 (0.4, 0.9) 2.1 (1.7, 2.8) 2.9 (2.3, 3.8) 3.4 (2.5, 4.5)

Vanguard CR Vanguard 7 681 0.5 (0.2, 1.6) 1.6 (0.7, 3.4) 1.6 (0.7, 3.4)

Vanguard PS Maxim 118 2692 1.9 (1.4, 2.5) 5.0 (4.1, 6.0) 6.0 (5.0, 7.3) 7.4 (5.6, 9.6)

Other (168) 414 8914 1.4 (1.1, 1.7) 3.9 (3.4, 4.4) 5.6 (5.0, 6.2) 7.0 (6.3, 7.7) 8.5 (7.6, 9.4) 9.5 (8.5, 10.6)

TOTAL 6606 207071

Note: Some cementless components have been cemented. Only combinations with over 400 procedures have been listed.



Femoral Component

Tibial Component

N Revised

N Total


AGC AGC 146 3451 0.6 (0.4, 0.9) 2.4 (1.9, 2.9) 3.5 (2.9, 4.2) 4.2 (3.5, 5.0) 5.4 (4.6, 6.5) 6.5 (5.3, 8.0)




Duracon Duracon 377 8971 1.0 (0.8, 1.2) 2.4 (2.1, 2.7) 3.3 (2.9, 3.6) 3.8 (3.4, 4.2) 4.8 (4.4, 5.4) 6.4 (5.5, 7.5)

Evolis Evolis 6 599 0.4 (0.1, 1.5) 1.1 (0.5, 2.7) 1.5 (0.6, 3.3)






Journey Journey 161 3132 1.4 (1.0, 1.9) 4.6 (3.9, 5.5) 6.3 (5.4, 7.5) 8.2 (6.9, 9.9)


LCS CR LCS 269 3936 1.0 (0.7, 1.4) 3.8 (3.2, 4.4) 5.0 (4.4, 5.8) 6.1 (5.3, 6.9) 7.1 (6.3, 8.0) 8.1 (7.2, 9.2)

LCS CR MBT 224 8058 0.7 (0.5, 0.9) 2.2 (1.9, 2.6) 3.2 (2.7, 3.7) 4.1 (3.6, 4.7) 5.4 (4.6, 6.4)

LCS PS MBT 26 452 1.5 (0.7, 3.3) 6.2 (4.2, 9.3)





Maxim Maxim 33 499 1.2 (0.5, 2.7) 2.6 (1.5, 4.5) 4.7 (3.2, 7.1) 5.2 (3.6, 7.7) 7.0 (4.8, 10.1)



Nexgen CR Nexgen 97 3535 0.4 (0.3, 0.7) 1.3 (1.0, 1.8) 1.7 (1.3, 2.2) 2.0 (1.6, 2.6) 2.7 (2.2, 3.4) 5.5 (3.9, 7.6)








PFC Sigma CR MBT 20 1061 0.6 (0.3, 1.3) 1.4 (0.8, 2.4) 1.8 (1.1, 3.0) 2.3 (1.4, 3.7) 3.0 (1.7, 5.2)


PFC Sigma PS MBT 159 5219 0.8 (0.6, 1.0) 2.6 (2.2, 3.2) 3.5 (3.0, 4.1) 4.2 (3.5, 5.0) 4.7 (3.9, 5.8)


Profix Profix 133 3285 1.1 (0.8, 1.5) 2.6 (2.1, 3.2) 3.2 (2.7, 3.9) 4.0 (3.4, 4.8) 4.8 (4.0, 5.7) 4.9 (4.1, 5.9)


RBK RBK 53 1890 0.9 (0.5, 1.4) 2.7 (2.0, 3.7) 3.4 (2.5, 4.5) 3.5 (2.6, 4.7) 5.2 (3.4, 8.1)












Other (168) 414 8914 1.4 (1.1, 1.7) 3.9 (3.4, 4.4) 5.6 (5.0, 6.2) 7.0 (6.3, 7.7) 8.5 (7.6, 9.4) 9.5 (8.5, 10.6)

TOTAL 6606 207071




Femoral Component

Tibial Component

N Revised

N Total


AGC AGC 146 3451 0.6 (0.4, 0.9) 2.4 (1.9, 2.9) 3.5 (2.9, 4.2) 4.2 (3.5, 5.0) 5.4 (4.6, 6.5) 6.5 (5.3, 8.0)




Duracon Duracon 377 8971 1.0 (0.8, 1.2) 2.4 (2.1, 2.7) 3.3 (2.9, 3.6) 3.8 (3.4, 4.2) 4.8 (4.4, 5.4) 6.4 (5.5, 7.5)

Evolis Evolis 6 599 0.4 (0.1, 1.5) 1.1 (0.5, 2.7) 1.5 (0.6, 3.3)






Journey Journey 161 3132 1.4 (1.0, 1.9) 4.6 (3.9, 5.5) 6.3 (5.4, 7.5) 8.2 (6.9, 9.9)


LCS CR LCS 269 3936 1.0 (0.7, 1.4) 3.8 (3.2, 4.4) 5.0 (4.4, 5.8) 6.1 (5.3, 6.9) 7.1 (6.3, 8.0) 8.1 (7.2, 9.2)

LCS CR MBT 224 8058 0.7 (0.5, 0.9) 2.2 (1.9, 2.6) 3.2 (2.7, 3.7) 4.1 (3.6, 4.7) 5.4 (4.6, 6.4)

LCS PS MBT 26 452 1.5 (0.7, 3.3) 6.2 (4.2, 9.3)





Maxim Maxim 33 499 1.2 (0.5, 2.7) 2.6 (1.5, 4.5) 4.7 (3.2, 7.1) 5.2 (3.6, 7.7) 7.0 (4.8, 10.1)



Nexgen CR Nexgen 97 3535 0.4 (0.3, 0.7) 1.3 (1.0, 1.8) 1.7 (1.3, 2.2) 2.0 (1.6, 2.6) 2.7 (2.2, 3.4) 5.5 (3.9, 7.6)








PFC Sigma CR MBT 20 1061 0.6 (0.3, 1.3) 1.4 (0.8, 2.4) 1.8 (1.1, 3.0) 2.3 (1.4, 3.7) 3.0 (1.7, 5.2)


PFC Sigma PS MBT 159 5219 0.8 (0.6, 1.0) 2.6 (2.2, 3.2) 3.5 (3.0, 4.1) 4.2 (3.5, 5.0) 4.7 (3.9, 5.8)


Profix Profix 133 3285 1.1 (0.8, 1.5) 2.6 (2.1, 3.2) 3.2 (2.7, 3.9) 4.0 (3.4, 4.8) 4.8 (4.0, 5.7) 4.9 (4.1, 5.9)


RBK RBK 53 1890 0.9 (0.5, 1.4) 2.7 (2.0, 3.7) 3.4 (2.5, 4.5) 3.5 (2.6, 4.7) 5.2 (3.4, 8.1)












Other (168) 414 8914 1.4 (1.1, 1.7) 3.9 (3.4, 4.4) 5.6 (5.0, 6.2) 7.0 (6.3, 7.7) 8.5 (7.6, 9.4) 9.5 (8.5, 10.6)

TOTAL 6606 207071



Outcome for Osteoarthritis - Patient Characteristics

Primary total knee replacement has the lowest rate of revision compared to all other classes of primary knee replacement. At 13 years, the cumulative percent revision of primary total knee replacement undertaken for osteoarthritis is 6.8% (Table KT11 and Figure KT9). Age and Gender Age is a major factor affecting the outcome of primary total knee replacement. The rate of revision increases with decreasing age, and this difference increases with time. After four years, those aged less than 55 years have over 4.5 times the rate of revision compared to those aged 75 years or older (Table KT12 and Figure KT10).

Males have a higher rate of revision compared to females (Table KT13 and Figure KT11). Loosening/lysis is the most common reason for revision in both males and females. Males have a higher incidence of revision for surgeon reported infection than females, with a 13 year cumulative incidence of 1.5% and 0.8% respectively (Figure KT12). Age related differences in outcome are evident within both males and females (Table KT13 and Figures KT13 and KT14).

Table KT11: Cumulative Percent Revision of Primary Total Knee Replacement (Primary Diagnosis OA)

Knee Class N

Revised N

Total 1 Yr 3 Yrs 5 Yrs 7 Yrs 10 Yrs 13 Yrs

Total Knee 13277 386242 1.0 (1.0, 1.1) 2.8 (2.7, 2.9) 3.8 (3.7, 3.8) 4.5 (4.4, 4.6) 5.6 (5.4, 5.7) 6.8 (6.6, 7.0)

Figure KT9: Cumulative Percent Revision of Primary Total Knee Replacement (Primary Diagnosis OA)

Number at Risk 0 Yr 1 Yr 3 Yrs 5 Yrs 7 Yrs 10 Yrs 13 Yrs

Total Knee 386242 336702 245413 169367 107475 39239 2405

Cum

ulat

ive

Perc

ent R

evis

ion

0%

2%

4%

6%

8%

10%

12%

14%

16%

18%

20%

Years Since Primary Procedure

0 1 2 3 4 5 6 7 8 9 10 11 12 13

Total Knee

References

1. 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, 2010.2. 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):357-365.3. 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, 0021.4. 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, 71.5. 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, 583.6. 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, 2329.7. Biomet publication, Claims for E1 Antioxidant Infused Technology8. Ref: DePuy Attune 510 K Document K101433 Dec 10, 20109. Hallab NJ, Anderson S, Stafford T, Glant T, Jacobs JJ. “Lymphocyte responses in patients with total hip arthroplasty.” J Orthop Res 2005; 232:384e91.10 Niki, Yasuo et al. “Screening for symptomatic metal sensitivity: a prospective study of 92 patients undergoing total knee arthroplasty.” Biomaterials 26 (2005) 1019–102611. Nasser, S. “Biology of foreign bodies: tolerance, osteolysis, and allergy”, Total Knee Arthroplasty, J. Bellemans, M.D. Ries, and J. Victor (eds.), Springer Verlag, Heidelberg, Germany, 2005, pp. 343-352.12. Granchi, Donatella et al. “Sensitivity to implant materials in patients with total knee arthroplasties.” Biomaterials 29 (2008) 1494-150013 ASTM International Standard Specification for Wrought Zirconium-2.5Niobium Alloy for Surgical Implant Applications (UNS R60901) Designation: F 2384 – 05 and Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075): Designation: F 75 – 0714. Hallab, Nadim et al. Metal Sensitivity in Patients with Orthopaedic Implants, The Journal of Bone & Joint Surgery, Vol 83-A No. 3. March 2001 p428-43616.15. Total knee arthroplasty at 15-17 years: does implant design affect outcome? Victor J, Ghijselings S, Tajdar F, Van Damme G, Deprez P, Arnout N, Van Der Straeten C., Int Orthop. 2014 Feb;38(2):235-41. doi: 10.1007/s00264-013-2231-8. Epub 2013 Dec 18.16. Bhandari, Saccone, Sprague, “The GENESIS II Total Knee System in Primary Total Knee Arthroplasty: A Systematic Literature Review of Clinical Outcomes”, Bone&Joint Outcome, Vol 01, No 01-August 2011.17. Smith & Nephew Technical Memo TM-11-013A Comparison of LEGION and GENESIS II OXINIUM Femoral Designs.18. LEGION Primary Knee System: A Prospective, Multi-Center, Non-Randomized, Safety and Efficacy Clinical Study of the LEGION Primary Knee System for Primary Total Knee Replacement in Subjects with Degenerative Knee Disease. 10-K300-95301, 29 April 2014. Version 1.0.19. Australian Orthopaedic Association National Joint Replacement Registry. Annual Report. Adelaide:AOA; 2014 Table KT10: Cumulative Percent Revision of Primary Total Knee Replacement with Cement Fixation.20. Australian Orthopaedic Association National Joint Replacement Registry. Annual Report. Adelaide:AOA; 2014 Table KT11: Cumulative Percent Revision of Primary Total Knee Replacement (Primary Diagnosis OA)

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