LEGION^◊ / GENESIS^◊ II

Total Knee System

Introduction

Peace of mind

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

Exceptional durability

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

System flexibility

Today’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.

Rich clinical heritage

Smith & 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.

Durability

Durability: Wear Performance

As 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 bearings¹. 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.

Legion Image 2

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 1-7 for testing information.

Durability: Metal Sensitivity

Just 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.

Metal content of implants¹³

Legion Image 3

Legion Image 4

Legion Image 5

Clinical studies¹⁴

Legion Image 6

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 Technology
8. Ref: DePuy Attune 510 K Document K101433 Dec 10, 2010
9. 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) 1019–1026.
11. 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) 1494-1500.
13. 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 – 07.
14. 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).

Flexibility

System Flexibility

LEGION 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.

Legion Image 7

Legion Image 8

Patient Flexibility

Today’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.

Pathology

Primary to Revision and Hinge
Offsets, wedges and augments

Range of motion

Constrained, standard and high flexion inserts

Age

Cemented and porous options
CoCr and VERILAST^◊ Technology

Anatomy

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

Activity level

CoCr and VERILAST Technology
Standard polyethylene and highly cross-linked poly

Biocompatible implants

OXINIUM^◊ Oxidized Zirconium
All-polyethylene tibial components
Titanium tibial base plates

Optimal Sizing

Ideal sizing for male and female anatomy
1mm increment inserts

Clinical Heritage

Rich Clinical Heritage

Proven performance, continuous innovation

GENESIS II clinical results:

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”

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 kneesMean post op Knee Society score of 90.6

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

Legion Image 9

Legion Image 10

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

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 reconstruction¹⁷.

LEGION is carrying on the legacy of excellent clinical results.

LEGION Primary Knee System - Safety and Efficacy Clinical Study¹⁸

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

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.