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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- Andra Blake
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2 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% Post-op Preop golf 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, 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.
3 The solution is PHYSIOLOGICAL MATCHING Technology through function, motion and durability JOURNEY II BCS Knee System with PHYSIOLOGICAL MATCHING Conventional TKA For orthopaedic surgeons seeking treatment solutions beyond traditional knee replacements, JOURNEY II Bi-Cruciate Stabilized 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 Anatomic, articular surfaces are designed to restore native anatomy and yield a normal anatomic A/P position throughout the range of motion. ACL replicated by anterior cam-post interaction providing anterior stabilization during early gait (up to 2º flexion) and in contact only if needed. A 76% return to normal AP stability is shown in the original BCS design. 14 Provides a proper femoro-tibial A/P position yielding a virtual elimination of paradoxical motion, anterior sliding of the femur during flexion Lachman test JOURNEY TKA patients Normal < 2mm Abnormal > 2mm I Number of patients Anterior stability ACL function Bi-Cruciate Stabilized Normal Conventional JOURNEY II BCS Stability Throughout a Range of Motion Mid-line Sulcus Anterior Cam Posterior Medial Lip/Horn Posterior Cam
5 Strength More normal muscle firing patterns are expected due to the proper A/P positioning, thereby preventing 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 1, 1 BCS design. EMG Data CR TKA Normal knee 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 JOURNEY 18, 19 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.19, 2 reported levels of satisfaction with the outcomes of their knee replacements 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 Normal Knee 21 (Right Knee) JOURNEY BCS (Left Knee) Conventional PS (Left Knee) Medial Lateral Lateral Medial Lateral Medial Extension Degree Mid-Flexion Medial Medial Lateral Lateral Lateral Medial Lateral Medial Lateral Medial Lateral Medial MAX Deep-Flexion FDA Claim Details JOURNEY BCS replicates the motion patterns of the normal, healthy knee 6, 7, 8, 9, 1, 11, 12, 13, 21
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 correct environment to allow an anatomic, deep flexion performance. Engineered to provide for up to 1 of flexion, following in the superior anatomic, high flexion kinematics proven 6, 9, 11, 13, 14, 28, 29 in the first generation 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. Graph 3 VERILAST Technology vs Conventional Technology 4 Volumetric wear rate (mm 3 /Mcycle) PFC Sigma 3 GENESIS II Scorpio Triathlon NexGen Vanguard 3.4 Attune PFC Sigma 3 GENESIS II 31 CoCr and CPE CoCr and XLPE OXINIUM Technology on XLPE Scorpio Triathlon NexGen Vanguard 3.8 non-detectible 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 Graph 4 Increased hardness Graph Lower friction Nanohardness (GPa) Coefficient of friction OXINIUM Alloy CoCr OXINIUM Alloy CoCr
9 3D surface profiles of Oxidized Zirconium and Cobalt-Chromium femoral components Pristine Retrieved. 4. CoCr Sa =.3, Sy =.86 Sa =.11, Sy = OxZr Sa =., Sy = 1.7 Sa =.6, Sy = 1.14 Wear Metal Sensitivity OXINIUM Oxidized Zirconium is an advanced bearing material that combines the strength of metal with the wear resistance of ceramics OXINIUM Technology is 4,9 times more resistant to abrasion than CoCr 38 OXINIUM Technology is more than twice as hard as CoCr (Graph 4) 39 OXINIUM Technology has a coefficient of friction that is up to half that of CoCr (Graph ) 4 We understand d that no measurable nickel content is of immeasurable e benefit to nickel-sensitive sitive patients. OXINIUM Oxidized Zirconium, exclusively from Smith & Nephew, addresses the needs of nickel sensitive patients by having less than.3% nickel content, compared to a maximum content of.% in cobalt chrome and.1% in titanium. Zirconium is a nearly inert material that has not reported to induce immune reactions. 41 OXINIUM alloy femoral components are available for all JOURNEY II Active Knee Solutions products
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 6k 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 1 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: E. Lyle Cain, Jr, MD, Jeffrey R. Dugas, MD, Dr. John Neuman, FRCS, William B. Smith, MD, 2 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 2 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 6, JOURNEY BCS knees have been implanted around the world. Most Significant New Product at AAOS (26) 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 2 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 27 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. 27 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. 29 VISIONAIRE Patient Matched Instrumentation In 29 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. 212 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. 212 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. 28 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. and Jerome Rubini 212 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. 213 VISIONAIRE Technology and Patient Specific Logistics In 213 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. 28 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. 214 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 21
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, 211. Agency for Healthcare Research and Quality, Rockville, MD. 2. Phil Noble et al; Does total knee replacement restore normal knee function? 2; 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. 2 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. 21 Feb; 468(2):42-6. Epub 29 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. 21 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. 29; 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. 29; 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. 211 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. 29 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. 28; 9: 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. 21 Jan; 468(1): doi: 1.17/s Epub 29 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. 212 Oct; 2 (1):22-1. Epub 211 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. 29;33(8): Lester DK and Shantharam R. Objective Sagittal Instability of CR-TKA by Functional EMG During Normal Walking. AAOS. 212; Presentation No Pritchett JW. Patient preferences in knee prostheses. J Bone Joint Surg Br. 24 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. 29; 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. 2 Oct; 13(7):1-6. Epub 2 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. 24;86-A Suppl 2: Carpenter RD, et al, Magnetic resonance imaging of in vivo patellofemoral kinematics after total knee arthroplasty, The Knee (29), doi:1.116/j.knee Brilhault J, Ries MD. Measuring patellar height using the lateral active flexion radiograph: Effect of total knee implant design. Knee. 21 Mar;17(2): doi: 1.116/j.knee Epub 29 Aug Leopold SS, Silverton CD, Barden RM, Rosenberg AG. Isolated revision of the patellar component in total knee arthroplasty. J Bone Joint Surg Am 23; 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. 212 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. 213; 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. 28 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. 27 Aug; 3 (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. 212 Jan; 27(1): doi: 1.116/j.arth Epub 211 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, 2;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, 27, 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., 2, 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, 28, 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 6-1, 21, Biomet publication, FDA Cleared Claims for E1 Antioxidant Infused Technology 36. Ref: DePuy Attune 1 K Document K11433 Dec 1, 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, 2, 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. 27 Aug; 3 (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, V1 8/13
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