II CR - Surgical Devices and Advanced Wound Care products

II CR

Cruciate Retaining Knee System

The challenge

Graph 1 2 Percent reporting no difficulty

squatting kneeling gardening carrying heavy objects golf racquet sports dancing

0

20

40

60

Control subjects

TKA patients

80

100

Graph 2 3 Sports activity

THA

52%

Post-op

36%

Preop

TKA 42%

Preop

34%

Post-op

Today's fastest growing segment of knee replacement patients is seeking a return to a more active lifestyle.1 Traditional knee replacement options don't meet the need for higher functionality, improved motion or long-term durability.2,3,4,5 Most significantly, these traditional systems fall short in providing a return to a normal pattern of motion. Lack of motion, both selection and kinematics, can mean less satisfaction for patients who are unable to return to the demanding activities of their active lifestyle. Surgeons are left tempering patient expectations and tolerating the limited capabilities of traditional knee replacements.

The solution is

PHYSIOLOGICAL MATCHINGTM Technology

through function, motion and durability

JOURNEY II CR Knee System with PHYSIOLOGICAL MATCHING Conventional TKA

For orthopaedic surgeons seeking treatment solutions beyond traditional knee replacements, the JOURNEYTM II Cruciate Retaining Knee has been engineered to empower patients with a renewed right to an active lifestyle by breaking through traditional knee replacement barriers and delivers Function, Motion and Durability through PHYSIOLOGICAL MATCHING Technology.

Number of patients

Function

Stability

? Anatomic, articular surfaces are designed to restore native anatomy and yield a normal anatomic A/P position throughout the range of motion.

? Anterior stability is provided by a high posterior medial lip which mimics ACL function in full extension and early gait.

? Provides a proper femoro-tibial A/P position yielding a virtual elimination of paradoxical motion, anterior sliding of the femur during flexion.6-13

Lachman test JOURNEYTM TKA patients

16

15

12

9

6

3

0

Normal < 2mm

I

Abnormal > 2mm

Conv. TKA

JOURNEY II TKA

Increased stability through proper AP position and reduction in paradoxical motion

Normal

Conventional

JOURNEY II CR

Mid-line Sulcus

Posterior Medial

PCL

Lip/Horn

Strength

? More normal muscle firing patterns are expected due to the proper A/P positioning, thereby helping to prevent muscle fatigue during activities of daily living.

? Restoration of both the anatomic A/P alignment and the normal kinematic patterns of the knee should produce more normal neuromuscular firing patterns throughout the range of motion--as demonstrated in the original JOURNEYTM BCS design.10, 15

EMG Data 5

110

110

82.5

82.5

55

55

27.5

27.5

0 Conv. CR TKA Normal knee

0 BCS TKA Normal knee

2x increase In Quad Activity

Virtually Identical Quad Activity

Satisfaction (Proprioception)

? Improving patients' ease of activities of daily living can be expected due to the anticipated improvements of strength and stability

? Restoration of more normal neuromuscular firing patterns throughout the range of motion should improve a patient's ability to perform the activities they are demanding--as demonstrated in the original JOURNEYTM BCS design.18, 19

Motion

Tibiofemoral (TF) kinematics

T he kinematic patterns of the femur and tibia of a knee design have a direct impact on patients' reported levels of satisfaction with the outcomes of their knee replacements.19, 20

Extension ? Femur internally rotated to achieve a natural anatomic screw-home position ? Minimal posterior femoral overhang in the sagittal plane (Proper A/P position)

Mid-flexion ? Femur external rotation to maximize quadriceps mechanism efficiency ? Virtual elimination of paradoxical motion to prevent mid-flexion instability

Deep flexion ? Femur remains externally rotated to retain maximal quadriceps efficiency ? Significant posterior femoral rollback occurs to gain clearance for deep flexion

in high demand activities

Extension Mid-Flexion Deep-Flexion

Normal Knee 21

(Right Knee)

JOURNEYTM BCS

(Left Knee)

Medial

15 10 5

-5 -10 -15

Medial

15 10 5

-5 -10 -15

Lateral

Lateral

15 10 5

-5 -10 -15

Lateral

Lateral

15 10 5

-5 -10 -15

Medial Medial

Medial

Lateral

Lateral

15

15

10 5

10 5

-5

-5

-10

-15 FDA Claim Details

-10 -15

Medial

Conventional PS

(Left Knee)

Lateral

Medial

1 3 5 7 9 11

Lateral

Medial

1 3 5 7 9 11

Lateral

Medial

1 3 5 7 9 11

JOURNEY BCS replicates the motion patterns of the normal, healthy knee 6, 7, 8, 9, 10, 11, 12, 13, 21

Degree

0 15 30 45 60 75 90 105 120 MAX

Patellofemoral (PF) kinematics

T he kinematic pattern in the PF joint is critically important to decrease anterior knee pain post operatively and the associated revisions.22, 23, 24, 25

? P rovides improved contact which should improve wear performance 22

? Provides improved patella tracking which should minimize anterior pain 22, 23

? P rovides more freedom of baseplate positioning without maltracking concerns 26

Conventional PS TKA JOURNEY II TKA In Vivo 27 In Vivo +std dev Inv Vivo -std dev

Conventional PS TKA JOURNEY II TKA In Vivo 27 In Vivo +std dev Inv Vivo -std dev

Flexion

The normal kinematic patterns of movement provide the correct environment to allow an anatomic, deep flexion performance.

? Engineered to provide for up to 155? of flexion, following in the superior anatomic, high flexion kinematics proven in the first generation JOURNEYTM BCS. 6, 9, 11, 13, 14, 28, 29

Durability

Volumetric wear rate (mm3/Mcycle)

Combining the award-winning materials of OXINIUMTM Oxidized Zirconium and highly cross-linked polyethylene (XLPE), Smith & Nephew was able to create VERILASTTM Technology, a highly durable and long-lasting material combination.Using this technology, JOURNEYTM II TKA is designed to match the same high standards for wear performance.

Graph 3 VERILAST Technology vs Conventional Technology

50

45

40

43.40

35

34.60

30

25

20

23.00

23.45

15

10

20.20

24.40

13.00

5

5.40

6.41

7.30

6.50

6.10

4.10

0.58

non-detectible

0

43 37

TKS TKA

Vanguard 35

NexGen 34

Triathlon 33

Scorpio 32

Attune 36 PFC Sigma 30 GENESIS II 31

NexGen 34 Vanguard 35

PFC Sigma 30 GENESIS II 31

Scorpio 32 Triathlon 33

LEGION JOURNEY II

CoCr and CPE

CoCr and XLPE

OXINIUM Technology on XLPE

Mean volumetric wear rates (+/- std. dev.) of CoCr against conventional polyethylene (CPE), CoCr against crosslinked polyethylene (XLPE) and OXINIUM against XLPE

Nanohardness (GPa) Coefficient of friction

Graph 4 Increased hardness

16

12 12.1

8

4

5.4

0

OXINIUM Alloy

CoCr

Graph 5 Lower friction

0.10

0.08

0.08

0.06

0.04

0.04

0.02

0

OXINIUM Alloy

CoCr

 ................
................

In order to avoid copyright disputes, this page is only a partial summary.

Google Online Preview   Download