The challenge. Today s fastest growing segment of knee replacement patients is seeking a return to a more active lifestyle. 1
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- Isabella Robbins
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1 *smith&nephew JOURNEY II Active Knee Solutions
2 The challenge Graph 1 2 Percent reporting no difficulty Graph 2 3 Sports activity squatting kneeling gardening Control subjects TKA patients THA 2% Post-op TKA 42% Preop carrying heavy objects golf 36% Preop 34% Post-op racquet sports dancing 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, 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.
3 The solution is PHYSIOLOGICAL MATCHING Technology through function, motion and durability For orthopaedic surgeons seeking treatment solutions beyond traditional knee replacements, JOURNEY II Active Knee Solutions has been engineered to empower patients with a renewed right to an active lifestyle by breaking through traditional knee replacement barriers and delivers unmatched Function, Motion and Durability through PHYSIOLOGICAL MATCHING Technology.
4 Function Stability Prominent posterior medial lip provides stability and promotes normal kinematics Femur the Patello-Femoral compartment Anatomic, articular surfaces are designed to restore native anatomy and yield a normal anatomic A/P position throughout the range of motion. JOURNEY PFJ and JOURNEY UNI Provide retention of the ACL and PCL allowing the native anatomy to provide its innate stability. JOURNEY II TKA Provides a proper femoro-tibial A/P position yielding a virtual elimination of paradoxical 6-13 Conventional AP sulcus Normal AP sulcus position prevents paradoxical motion Smaller anterior lateral lip allows screw home Restores anatomic 3 distal and posterior femoral joint line and providing more normal ligament strain and patello-femoral tracking JOURNEY II BCS Knee System with PHYSIOLOGICAL MATCHING Conventional TKA Anterior stability ACL function Bi-Cruciate Stabilized Normal convexity provides increased posterior lateral slope to facilitate anatomic lateral femoral rollback and external rotation ACL replicated by anterior cam-post interaction Provides anterior stabilization during early gait (up to In contact only if needed Has shown a 76% return to normal AP stability in the original BCS design 14 Normal Conventional JOURNEY II CR JOURNEY II BCS
5 Strength the proper A/P positioning, thereby preventing muscle fatigue during activities of daily living. JOURNEY PFJ and JOURNEY UNI Restores patients strength by replacing only the isolated, diseased portion of the knee allowing anatomic A/P alignment for the native anatomy to function as it had before surgery. JOURNEY II TKA Restoration of both the anatomic A/P alignment and the normal kinematic patterns of the knee should produce more normal neuromuscular, 1 demonstrated in the original BCS design. Lachman test JOURNEY TKA patients 0 Normal < 2mm Abnormal > 2mm I EMG Data CR TKA Normal knee 0 BCS TKA Normal knee 0 2x increase In Quad Activity Virtually Identical Quad Activity Number of patients Number of patients Number of patients Satisfaction (Proprioception) Improving patients ease of activities of daily living can be expected due to the anticipated improvements of strength and stability. JOURNEY PFJ and JOURNEY UNI The preservation of the natural structures (ACL and PCL) is preferred by 16, 17 patients. JOURNEY II TKA Restoration of more normal neu- motion should improve a patient s ability to perform the 18, 19 original JOURNEY BCS design.
6 Motion Tibiofemoral (TF) kinematics The 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) 0LG ³H[LRQ )HPXU H[WHUQDO URWDWLRQ WR PD[LPL]H TXDGULFHSV PHFKDQLVP HI²FLHQF\ 9LUWXDO HOLPLQDWLRQ RI SDUDGR[LFDO PRWLRQ WR SUHYHQW PLG ³H[LRQ LQVWDELOLW\ 'HHS ³H[LRQ )HPXU UHPDLQV H[WHUQDOO\ URWDWHG WR UHWDLQ PD[LPDO TXDGULFHSV HI²FLHQF\ 6LJQL²FDQW SRVWHULRU IHPRUDO UROOEDFN RFFXUV WR JDLQ FOHDUDQFH IRU GHHS ³H[LRQ in high demand activities Normal Knee 21 JOURNEY BCS Conventional PS (Right Knee) (Left Knee) (Left Knee) Extension Mid-Flexion Degree Deep-Flexion FD FFDA DA D A Cl Cla Claim aim aim m De D Details etai JOURNEY BCS replicates the motion patterns of the normal, healthy knee 6, 7, 8, 9,, 11, 12, 13, 21 MAX
7 Patellofemoral (PF) kinematics The kinematic pattern in the PF joint is critically important to decrease anterior knee pain post operatively 22, 23, 24, 2 and the associated revisions. Provides improved contact which should improve wear performance 22 Provides improved patella tracking which should 22, 23 minimize anterior pain Provides 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 Flexion The normal kinematic patterns of movement provide the performance. JOURNEY PFJ and JOURNEY UNI Designed to preserve the normal anatomy of the knee, therefore promoting a more natural range of motion. JOURNEY II TKA Engineered to provide for up to 1 6, 9, 11, 13, 14, 28, 29 JOURNEY BCS.
8 Durability Combining the award-winning materials of OXINIUM Oxidized Zirconium and highly cross-linked polyethylene (XLPE), Smith & Nephew was able to create VERILAST Technology, a highly durable and long-lasting material combination.using this technology, JOURNEY II TKA is designed to match the same high standards for wear performance. JOURNEY II CR Graph 3 VERILAST Technology vs Conventional Technology 0 Volumetric wear rate (mm 3 /Mcycle) PFC Sigma 30 GENESIS II Scorpio Triathlon NexGen Vanguard 3.40 Attune PFC Sigma 30 GENESIS II 31 CoCr and CPE CoCr and XLPE OXINIUM Technology on XLPE Scorpio Triathlon NexGen non-detectible Vanguard 3 LEGION TKS 43 JOURNEY II TKA 37 Mean volumetric wear rates (+/- std. dev.) of CoCr against conventional polyethylene (CPE), CoCr against crosslinked polyethylene (XLPE) and OXINIUM against XLPE
9 JOURNEY II BCS Wear OXINIUM Oxidized Zirconium is an advanced bearing material that combines the strength of metal with the wear resistance of ceramics OXINIUM Technology is 4,900 times more resistant to abrasion than CoCr 38 OXINIUM Technology is more than twice as hard as CoCr (Graph 4) 39 up to half that of CoCr (Graph ) 40 JOURNEY UNI JOURNEY PFJ OXINIUM alloy femoral components are available for all JOURNEY II Active Knee Solutions products Metal Sensitivity Graph 4 Increased hardness Graph Lower friction We understand that no measurable nickel content is Nanohardness (GPa) OXINIUM Alloy.4 CoCr Coefficient of friction OXINIUM Alloy 0.08 CoCr OXINIUM Oxidized Zirconium, exclusively from Smith & Nephew, addresses the needs of nickel sensitive patients by having less than 0.003% nickel content, compared to a maximum content of 0.% in cobalt chrome and 0.1% in titanium. Zirconium is a nearly inert material that has not reported to induce immune reactions. 41
10 Innovating for the lifecycle Following on a rich history of partial knee arthroplasty and success of the JOURNEY BCS design which showed recovery of normal patterns of motion and high gains in flexion 6-13, 21, Smith & Nephew has created a seamless, next generation family of partial and primary knee designs intended to restore patients to an unmatched level of function, motion and durability Richards Manufacturing Company Marmor Uni Richards Manufacturing collaborate with Dr. Leonard Marmor to commercially produce the first unicondylar knee on the market GENESIS Total Knee System The introduction of the GENESIS TKS was a significant step in the evolution of the modern knee designs. It was the first system the Address the Unexpected. With a single set of instruments and implants, virtually any interoperative situation could be handled. This technological advancement greatly simplified the process of TKA. Designers: Dr. Ramon Gustilo, Dr. Jim Rand, Dr. Richard Laskin, Dr. James Howe, and Dr. Todd Swanson GENESIS II Total Knee System Launched as one of the first asymmetric femoral component designs, opening up the opportunity for less traditional knee designs. Over 1 million GENESIS II knees have been implanted globally. The first OXINIUM Alloy total knee implantation. Over the past 1 + years over 600k OXINIUM Alloy hips and knees have been implanted worldwide 199 GENESIS UNI GENESIS UNI launched in collaboration with Professor Cartier and Dr. James Andrews has demonstrated to be one of the most clinically successful unicondylar knees on the market (94.% at years) JOURNEY PFJ The JOURNEY PFJ combines the clinically proven performance of its trochlear groove with powerful precision-the first completely instrumented JOURNEY PFJ system for greater reproducibility and ease of use. Designers: Dr. John Neuman, FRCS, William B. Smith, MD, E. Lyle, Dr. E. Lyle Cain Jr., and Dr. Jeffrey R. Dugas 200 Engineering Materials Achievement Awarded to Smith & Nephew for use of OXINIUM Oxidized Zirconium. Established in 1969, this award recognizes an outstanding achievement in materials or materials systems relating to the application of knowledge of materials to an engineering structure or to the design and manufacture of a product. Smith & Nephew is only orthopaedics company to ever win this award. Past recipients include: GE, DuPont, IBM, Texas Instruments, Dow Corning, Northrup Grumman 200 JOURNEY BCS Using advanced biomechanical modeling technologies; the JOURNEY BCS was the first TKA to accurately replicate the normal kinematic patterns of the healthy knee joint. Over 60,000 JOURNEY BCS knees have been implanted around the world. Designers: Prof. Johan Bellemans, Dr. Jonathan Garino, Dr. Steven Haas, Dr. Michael Ries, and Prof. Jan Victor OXINIUM Oxidized Zirconium Patented Patented the usage of Oxidized Zirconium with orthopaedic medical devices 200 LEGION Revision Knee (RK) The LEGION Revision Knee System was designed to strike a perfect balance by providing simple, efficient instruments specific to revision and a broad range of implant options to address even the most demanding surgeries. Combined with Oxidized Zirconium, LEGION Revision helps surgeons give their patients the potential for better outcomes with lower wear
11 2007 PLUS Orthopedics Smith & Nephew purchased the Swiss company PLUS Orthopedics. This added the PLUS SOLUTION KNEE FAMILY to the portfolio: TC-PLUS PRIMARY, TC-PLUS REVISION, and RT-PLUS REVISION. The PLUS Knee family is developed and manufactured in Switzerland and offers a seamless system; from Primary Complex Primary Revision Hinge Knee JOURNEY DEUCE Revolutionary approach to addressing medial femoral and patella-femoral disease in monolithic component. The lessons gained from experiences have allowed advanced kinematic evaluations. Designers: Dr. Lindsey Rolston and Dr. Gerard Engh VISIONAIRE Patient Matched Instrumentation In 2009 Smith & Nephew globally launched the foundation of its patient specific solutions, VISIONAIRE Patient Matched Cutting blocks. Smith & Nephew was the first company to launch patient matched technology developed and manufactured completely in house Acquisition of LifeMod Smith & Nephew announces the acquisition of LifeModeler, Inc. (LMI), the leading provider of biomechanical human body simulation tools and services. LMI s groundbreaking software shortens the time taken to develop new products by enabling the evaluation of innovations in a virtual model of the human body. New orthopaedic products can be tested and validated faster, further and more cost effectively prior to the production of a physical prototype LEGION Hinge (HK) LEGION Hinged Knee is launched as an extension of the clinically successful LEGION Total Knee System. Its kinematic and bone sparing design not only alleviates patients symptoms, but also restores an almost natural knee function. Coupled with its ease of use by allowing surgeons to seamlessly transition intraoperatively from a constrained revision implant to a hinged assembly, it makes knee salvage, knee rescue JOURNEY UNI JOURNEY UNI knee treats isolated compartmental disease with anatomic components coupled with simple, intuitive instrumentation for a streamlined, reproducible technique. Designers: Dr. William Bugbee, Dr. Donald Polakoff, Dr. Jonathan Young, Dr. Stuart Smith, Dr. Douglas Naudie, Dr. Paul Saenger, Dr. Jerome Rubini 2012 JOURNEY II BCS The next generation of normal function, motion and durability. More normal kinematics and function-strength, stability and higher flexion achieved through the unique features of the JOURNEY II BCS system; normal shapes, normal position and normal motion. Designers: Prof. Johan Bellemans, Dr. Jonathan Garino, Dr. Steven Haas, Dr. Michael Ries, and Prof. Jan Victor, Dr. Mark Snyder and Dr. Fred Cushner VISIONAIRE Technology and Patient Specific Logistics In 2013 Smith & Nephew launched its first phase of Patient Specific Logistics with the Universal Instrument Trays. This industry leading initiative allows for Smith & nephew to provide just in time logistics where instruments specific to each patient including size and hand are provided for each surgery helping to reduce hospital costs and improve operating room efficiency Launched VERILAST Technology VERILAST Technology, a one-of-a-kind advanced bearing couple of OXINIUM Oxidized Zirconium with highly-crosslinked polyethylene formulation designed specifically for knees JOURNEY II CR Designed to be the first kinematically correct cruciate retaining TKA on the market designed in collaboration with Professor Johan Bellemans, Dr. David Drucker, Dr. Alois Franz, Dr. Murali Jasty, Dr. Gerald Jerry, Dr. Michael Ries, Mr. Neil Thomas, Dr. Alfred Tria, Professor Jan Victor and Dr. Ate Wymenga 20
12 References 1. US Department of Health and Human Services Agency (HHSA) for Healthcare Research and Quality (AHRQ) Knee Replacements Up Dramatically Among Adults 4 to 64 Years Old. AHRQ News and Numbers, November 3, Agency for Healthcare Research and Quality, Rockville, MD. 2. Phil Noble et al; Does total knee replacement restore normal knee function? 200; CORR. (431): Huch K, Müller KA, Stürmer T, Brenner H, Puhl W, Günther KP. Sports activities years after total knee or hip arthroplasty: the Ulm Osteoarthritis Study. Ann Rheum Dis. 200 Dec; 64 (12): Comparing patient outcomes after THA and TKA: is there a difference? Bourne RB, Chesworth B, Davis A, Mahomed N, Charron K. Clin Orthop Relat Res. 20 Feb; 468(2):42-6. Epub 2009 Sep 4.. Functional comparison of posterior cruciate-retained versus cruciate-sacrificed total knee arthroplasty. Dorr LD, Ochsner JL, Gronley J, Perry J. Clin Orthop Relat Res Nov; (236): Victor J, Mueller JK, Komistek RD, Sharma A, Nadaud MC, Bellemans J. In vivo kinematics after a cruciate-substituting TKA. Clin Orthop Relat Res. 20 Mar; 468(3): Zingde SM, Sharma A, Komistek RD, Dennis, DA, Mahfouz, MR. In vivo comparison of kinematics for 1891 non-implanted and implanted knees. AAOS. 2009; Scientific Exhibit No Zingde SM, Mueller J, Komistek RD, MacNaughton JM, Anderle MR, Mauhfouz MR. In vivo comparison of tka kinematics for subjects having a PS, PCR, or Bi-Cruciate Stabilizing design. Orthopedic Research Society. 2009; Paper No Bicruciate-stabilised total knee replacements produce more normal sagittal plane kinematics than posterior-stabilised designs.ward TR, Burns AW, Gillespie MJ, Scarvell JM, Smith PN J Bone Joint Surg Br Jul;93(7): Catani F, Ensini A, Belvedere C, Feliciangeli A, Benedetti MG, Leardini A, Giannini S. In vivo kinematics and kinetics of a bi-cruciate substituting total knee arthroplasty: a combined fluoroscopic and gait analysis study. J Orthop Res Dec;27(12): Morra EA, Rosca M, Greenwald JFI, Greenwald AS. The influence of contemporary knee design on high flexion: a kinematic comparison with the normal knee. JBJS Am. 2008; 90: The Mark Coventry Award: Articular contact estimation in TKA using in vivo kinematics and finite element analysis. Catani F, Innocenti B, Belvedere C, Labey L, Ensini A, Leardini A. Clin Orthop Relat Res. 20 Jan; 468(1): doi:.07/s Epub 2009 Jun Van Duren BH, Pandit H, Price M, Tilley S, Gill HS, Murray DW, Thomas NP. Bicruciate substituting total knee replacement: how effective are the added kinematic constraints in vivo? Knee Surg Sports Traumatol Arthrosc Oct; 20 (): Epub 2011 Nov Arbuthnot JE, Brink RB. Assessment of the antero-posterior and rotational stability of the anterior cruciate ligament analogue in a guided motion bi-cruciate stabilized total knee arthroplasty. J Med Eng Technol. 2009;33(8): Lester DK and Shantharam R. Objective Sagittal Instability of CR-TKA by Functional EMG During Normal Walking. AAOS. 2012; Presentation No Pritchett JW. Patient preferences in knee prostheses. J Bone Joint Surg Br Sep; 86(7): Pritchett JW. Anterior cruciate-retaining total knee arthroplasty. J Arthroplasty Feb; 11(2): Rajgopal A; Dahiya V; Kochhar H. Bi-Cruciate Substituting Total Knee Arthroplasty Early Experience. International Society for Technology in Arthroplasty: 22 Congress. 2009; Poster No Haas S. Kinematics of the Knee & JOURNEY BCS. Insall Club Annual Meeting. June Banks SA; Fregly BJ; Boniforti F; Reinschmidt C; Romagnoli S. Comparing in vivo kinematics of unicondylar and bi-unicondylar knee replacements. Knee Surg Sports Traumatol Arthrosc. 200 Oct; 13(7):1-6. Epub 200 Jan Mahfouz MR, Komistek RD, Dennis DA, Hoff WA. In vivo assessment of the kinematics in normal and anterior cruciate ligament-deficient knees. J Bone Joint Surg Am. 2004;86-A Suppl 2: Carpenter RD, et al, Magnetic resonance imaging of in vivo patellofemoral kinematics after total knee arthroplasty, The Knee (2009), doi:.16/j.knee Brilhault J, Ries MD. Measuring patellar height using the lateral active flexion radiograph: Effect of total knee implant design. Knee. 20 Mar;17(2): doi:.16/j.knee Epub 2009 Aug Leopold SS, Silverton CD, Barden RM, Rosenberg AG. Isolated revision of the patellar component in total knee arthroplasty. J Bone Joint Surg Am 2003; 8-A: Breugem SJ, van Ooij B, Haverkamp D, Sierevelt IN, van Dijk CN. No difference in anterior knee pain between a fixed and a mobile posterior stabilized total knee arthroplasty after 7.9 years. Knee Surg Sports Traumatol Arthrosc Nov 3. [Epub ahead of print] ( 26. Lee GC, Garino JP, Kim RH, Lenz N. Contributions of Femoral, Tibial and Patellar Malposition to Patellar Maltracking in Total Knee Arthroplasty. AAOS. 2013; Poster No Nha KW, Papannagari R, Gill TJ, Van de Velde SK, Freiberg AA, Rubash HE, Li G. In vivo patellar tracking: clinical motions and patellofemoral indices. J Orthop Res Aug;26(8): Victor J, Ries M, Bellemans J, Robb WM, Van Hellemondt G. High-flexion, motion-guided total knee arthroplasty: who benefits the most? Orthopedics Aug; 30 (8 Suppl): Kuroyanagi Y, Mu S, Hamai S, Robb WJ, Banks SA. In vivo knee kinematics during stair and deep flexion activities in patients with bicruciate substituting total knee arthroplasty. J Arthroplasty Jan; 27(1): doi:.16/j.arth Epub 2011 Apr 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, 200;38(2): 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, 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., 200, 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, 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-, 20, Biomet publication, FDA Cleared Claims for E1 Antioxidant Infused Technology 36. Ref: DePuy Attune K Document K1433 Dec, Ref: Smith & Nephew OR Hunter, G., and Long, M. Abrasive Wear of Oxidized Zr-2.Nb, CoCrMo, and Ti-6Al-4V Against Bone Cement. 6th World Biomaterials Cong. Trans., Society for Biomaterials, Minneapolis, MN, 2000, p Long, M., Riester, L., and Hunter, G. no-hardness Measurements of Oxidized Zr-2.Nb and Various Orthopaedic Materials. Trans. Soc. Biomaterials, 21, 1998, p Poggie RA, Wert J, Mishra A, et al (1992). Friction and wear characterization of UHMWPE in reciprocating sliding contact with Co-Cr, Ti-6Al-4V, and zirconia implant bearing surfaces. Wear and Friction of Elastomers, Denton R and Keshavan MK, Eds., West Conshohocken, PA: ASTM International. 41. Nasser, S.: Biology of Foreign Bodies: Tolerance, Osteolysis and Allergy in Total Knee Arthroplasty, Edited by J. Bellemans, M.D. Ries and J. Victor; Springer -Verlag, Heidelberg, Cartier P, Khefacha A, Sanouiller JL, Frederick K. Unicondylar knee arthroplasty in middle-aged patients: a minimum -year follow-up. Orthopedics Aug; 30 (8 Suppl): 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, 20. Smith & Nephew, Inc. 713 Goodlett Farms Parkway Cordova, TN USA Telephone: Information: Orders and Inquiries: Trademark of Smith & Nephew. Certain marks registered US Patent and Trademark Office. All Trademarks acknowledged Smith & Nephew, Inc V1 09/13 REVA 3/13
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The challenge Graph 1 2 Percent reporting no difficulty Graph 2 3 Sports activity squatting Control subjects kneeling TKA patients THA TKA 2% 42% Preop Post-op gardening 34% carrying heavy objects 36%
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