LEGION. Total Knee System. Clinical Heritage

Transcription

1 LEGION Total Knee System Clinical Heritage

2 Proven performance, continuous innovation 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. LEGION Primary Knee System - Safety and Efficacy Clinical Study 1 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 implant survivorship of 98.6%. While the study shown above is based on two year interim results, the LEGION Total Knee System has a rich heritage based on the GENESIS II Design. LEGION and GENESIS II achieve equivalent articulation but do so via different surgical approaches to femoral external rotation. GENESIS II offers built-in external rotation by having asymmetric posterior condyles whereas LEGION offers surgeon-directed external rotation with symmetric posterior condyles. The differing techniques produce identical implant tibio-femoral kinematics and wear performance. 2 When GENESIS II was introduced in 1995, the built-in external rotation was a unique concept and design. It simplified the procedure and surgical technique for primary total knees. Over time, the need to simplify more complex primary and revision procedures has grown. To address this the implant was modified so that the surgeon could set the external rotation based on patient anatomy, resulting in symmetric posterior condyles. At the same time, the instruments were simplified and a seamless transition to a revision procedure was created leading to the evolution of GENESIS II into the LEGION Total Knee System. Same cutting blocks are used for both implants. For LEGION the block is put in external rotation and for GENESIS II the block is neutral to the posterior condyles. LEGION has symmetric posterior condyles while GENESIS II has a thinner medial posterior condyle due to the built in external 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 Built-in Femoral Rotation Surgeon-directed Femoral Rotation 2

3 What do the clinical results look like? National Joint Registry for England, Wales and Northern Ireland, Annual Report Kaplan-Meier Estimated Cumulative % Probability of Revision at Ten Years 5.5% 5% 4.5% 4% 3.5% 3% 2.5% 2% 1.5% 1% 0% 2.74 GENESIS II CoCr NexGen TM PFC Sigma Bicondylar TM TRIATHLON TM 3.41 VANGUARD TM *TRIATHALON and VANGUARD % Probability at eight years only (from 2013 report). Australian Orthopaedic Association National Joint Replacement Registry, Annual Report A 13 year cumulative percent revision is the longest reported outcome for any primary total knee replacement in the Australian Registry. GENESIS II CR CoCr has the lowest cumulative percent revision of all primary total knees with cement fixation at 13 years, 4.6%. Table KT10: Cumulative Percent Revision of Primary Total Knee Replacement with Cement Fixation Femoral Tibial N N 1 Yr 3 Yrs 5 Yrs 7 Yrs 10 Yrs 13 Yrs Component Component Revised Total AGC AGC (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 (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 (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 (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 (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 (0.1, 1.5) 1.1 (0.5, 2.7) 1.5 (0.6, 3.3) Genesis II CR Genesis II (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 (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 (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 (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 (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 (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 (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 (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 (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 (0.7, 3.3) 6.2 (4.2, 9.3) Legion CR Genesis II (1.1, 3.7) 2.7 (1.5, 4.8) Legion Oxinium CR Genesis II (0.4, 1.5) 1.8 (1.1, 2.9) 2.3 (1.3, 4.2) Legion Oxinium PS Genesis II (0.9, 1.7) 3.2 (2.5, 4.1) 3.8 (2.9, 5.1) Legion PS Genesis II (0.4, 1.2) 1.2 (0.7, 2.0) Maxim Maxim (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 (0.4, 1.8) 2.5 (1.5, 4.3) 3.4 (1.8, 6.4) Natural Knee II Natural Knee II (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 (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 (0.1, 1.4) 0.6 (0.2, 2.0) Nexgen CR Flex Nexgen (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 (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 (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 (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 (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 (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 (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 (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 (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 (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 (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 (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 (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 (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 (0.4, 1.6) 1.4 (0.8, 2.5) 1.8 (1.1, 3.0) Scorpio NRG PS Series (0.4, 1.0) 1.9 (1.4, 2.6) 2.6 (1.9, 3.6) Scorpio PS Scorpio (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 (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 (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 (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 (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 (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 (0.2, 1.6) 1.6 (0.7, 3.4) 1.6 (0.7, 3.4) Vanguard PS Maxim (1.4, 2.5) 5.0 (4.1, 6.0) 6.0 (5.0, 7.3) 7.4 (5.6, 9.6) Other (168) (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 Note: Some cementless components have been cemented. Only combinations with over 400 procedures have been listed. 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 Genesis II CR Genesis II (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) At 13 years, the cumulative percent revision of primary total knee replacement undertaken for osteoarthritis is 6.8% 5 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 (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) 3

4 15 17 year GENESIS II Clinical Results 6 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 Outcomes 7 Data analysis from 12 studies showed a Kaplan-Meier survival rate of 99.5% at 5 years, 99.9% at 7 years; 98.8% at nine years 1 study reported a Kaplan-Meier survival rate of 96% at 11.9 years Includes 19 studies total and 2656 knees Mean postop Knee Society score of Year Results % survivorship at a mean follow-up of 77.6 months and 98.2% excellent or good results based on self reported patient satisfaction outcomes Consecutive series of 562 knees Mean post-op ROM Average post-op Knee Society Scores Year Follow-up of First 100 cases 9 Survivorship 98.8% at 5 years Mean flexion % excellent or good results post-op Knee Society Score The Knee 21 (2014) Contents lists available at ScienceDirect The Knee Oxidized zirconium femoral component for TKA: A follow-up note of a previous report at a minimum of 10 years Massimo Innocenti, Fabrizio Matassi, Christian Carulli, Lorenzo Nistri, Roberto Civinini Orthopedic Clinic, Department of Special Surgical Science, University of Florence, CTO-Largo Palagi 1, Florence, Italy Minimum 10 Year Follow-up 10 Excellent survival rate of 97.8% at 10 years 98 TKAs with oxidized zirconium femoral component Good clinical and radiological outcomes 5-year Results of an Oxidized Zirconium Femoral Component for TKA 11 Survival rate of 98.7% at 7 years 98 TKAs with oxidized zirconium femoral component Mean post-op knee society score of 89 4

5 Why do LEGION and GENESIS II have such good results? The clinical results of LEGION and GENESIS II can in large part be attributed to unique design features working together to produce a world class knee implant. Lateralized and deepened trochlear groove Femoral components have an S-curve trochlear groove that, like the natural femur, gently moves the patella from a lateral position in extension towards the midline in flexion. This has shown to reduce lateral release rates to ~3% 12 compared to ~14% 13 for competitive systems. The patella groove has been distally extended to provide full patellofemoral contact throughout the ROM. Mid-flexion Patella position Bone Conserving PS Box Less bone is removed with the femoral components compared to competitive systems, 14 leaving the critical anterior bone bridge intact for stability and strength. GENESIS II/LEGION Other knee systems Asymmetric baseplate for better tibial coverage The asymmetric shape matches the anatomy of the tibia, 15 eliminating the need to undersize which can lead to uncovered bone or oversize which can lead to baseplate overhang. Additionally, maximizing tibial coverage through asymetric baseplate has also been shown to minimize tibia rotational errors. 16 Oversized Symmetric Baseplate Posterior- Lateral Overhang Undersized Symmetric Baseplate Posterior-Medial Uncovered Anatomic Baseplate Full Coverage with No Overhang VERILAST Technology for wear reduction VERILAST Technology is the bearing couple of OXINIUM Oxidized Zirconium and XLPE which has completed wear testing 9 times the industry standard 17 and shown exceptional wear performance. 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. Highly polished baseplate for backside wear reduction LEGION baseplates have a proven locking mechanism with an anterior and posterior dovetail to reduce micromotion and are composed of highly polished titanium to decrease backside wear. 18 Flexion friendly Tightly radiused posterior condyles allow for deeper flexion without the risk of edge loading or excessive collateral ligament tension. The PS and CR High Flex inserts support flexion up to 155. One study by Dr. Laskin showed a mean ROM of 118º five years postoperatively. 19 PS High Flex insert CR High Flex insert 5

6 The legacy continues with LEGION LEGION encompasses the same design features that have demonstrated longterm 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. 2 Updated instruments LEGION is not only offered with updated traditional instrumentation but also with a more cost-effective and simplified approach to total knee arthroplasty. VISIONAIRE FASTPak includes VISIONAIRE Cutting Guides and size-specific disposable instruments. The surgeon has confidence that he will have new, sterile instruments specific for each patient and the OR staff can have confidence that setup, surgery and cleanup will be simple with minimal time commitment. 20 VISIONAIRE FASTPak 6

7 LEGION offers peace of mind 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. Seamless system Same A-P Resection Add PS Box Add Augments Add Constraint Same A-P Resection Add Revision Components Same A-P Resection with Build-up Add Hinge Components Today s orthopaedic environment demands simple solutions with proven clinical history. With the durability of VERILAST Technology, inter-operative 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 will successfully return to their active lifestyles. 7

8 Proven performance, continuous innovation References 1. 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-K , 29 April Version Smith & Nephew Technical Memo TM A Comparison of LEGION and GENESIS II OXINIUM Femoral Designs 3. National Joint Registry for England, Wales, and Northern Ireland, 11th Annual Report, 2014, Table 3.22; Kaplan-Meier estimated cumulative percentage probability of first revision (95% CI) of a primary total knee replacement by main type of implant brand at the indicated number of years after primary operation. 4. 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. 5. 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) 6. Victor J, Ghijselings S, Tajdar F, Van Damme G, Deprez P, Arnout N, Van Der Straeten, Total knee arthroplasty at years: does implant design affect outcome? C., Int Orthop Feb;38(2): 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-Augut S&N literature / Laskin, Richard S. and Davis, John. Total knee replacement using the GENESIS II prosthesis: a 5 year follow up study of the first 100 consecutive cases, The Knee, 2004, July. 10. M. Innocenti, et al, Oxidized zirconiumfemoral component for TKA: A follow-up note of a previous report at a minimum of 10 years, Knee (2014). 11. M. Innocenti, R. Civinini, C. Carulli, F. Matassi, M. Villano The 5-year Results of an Oxidized Zirconium Femoral Component for TKA, Clin Orthop Relat Res (2010) 468: Laskin, Richard S., Davis, John, Total Knee Prosthesis using the GENESIS II Prosthesis: a 5-year follow-up study of the first 100 consecutive patients, The Knee, , pp Yang C.C., McFadden L.A., Dennis D.A., Kim R.H., Sharma A., Lateral retinacular release rates in mobile versus fixed-bearing TK, Clin Orthop Relat Res, Nov 2008; 466(11), pp Haas, S.D.; Nelson, C.L.; Laskin, R.S. Posterior Stabilized Arthroplasty: An Assessment of Bone Resection. The Knee 7 (2000) Westich, GH; Laskin, RS; Haas, SB; Sculco, TD: Resection Specimen Analysis of Tibial Coverage in Total Knee Arthroplasty. Clinical Orthopaedics and Related Research, #309, December Stacey Martin MD, Alex Saurez BS, Sabir Ismaily BS, Kashif Ashfaq MD, Philip Noble PhD, Stephen J. Incavo MD, Maximizing Tibial Coverage Is Detrimental to Proper Rotational Alignment, Clin Orthop Relat Res (2014) 472: ISO Todd, Dwight, et. al., Orthopedic Abstract, The Effect of Tibial Tray Surface Roughness and Insert Micromotion on Backside Wear. Smith & Nephew, Memphis, TN 19. Laskin, Richard S. and Davis, John. Total knee replacement using the GENESIS II prosthesis: a 5 year follow up study of the first 100 consecutive cases, The Knee, 2004, July. 20. VISIONAIRE FastPak Instruments Messaging Brochure, S&N literature V1 01/15. Smith & Nephew, Inc Brooks Road Memphis, TN USA Telephone: Information: Orders/inquiries: Trademark of Smith & Nephew. Reg. US Pat. & TM Off. All trademarks acknowledged 2015 Smith & Nephew, Inc. All rights reserved V1 02/15