ATTUNE® Cementless Fixed Bearing Knee with AFFIXIUM™ 3DP TechnologyEnhanced Initial Stability• Optimal Peg Location to help prevent cortical impingement1• Scalloped Peg Design• Extended Cruciform KeelATTUNE Knee System Performance• Reduce condylar sliding kinematics3• Higher stability between tibial implant and the bone4Advanced Biological Fixation• Reduced Choke Points to promote in-growth2• Diamond tread surface to increase coefficient of friction
Designed for Initial StabilityBuilt on the foundation of the ATTUNE Knee System’s comprehensive size range for optimal coverage, the tibial base structural design is designed to provide enhanced initial fixation.Since its introduction in 2013, the ATTUNE Knee System has continued to innovate and expand to meet the ever-evolving needs of patients, staying true to the same kinematic features and patented technologies used in the original design. In the past several years, the demand for cementless knee replacement is increasing5, specifically for more active patients for whom biological fixation may help meet the demands of their active lifestyle today and into the future.Extended Central Cruciform KeelProximally coated with AFFIXIUM 3DP Technology, the central cruciform keel is longer than competitive stem designs and is designed to provide torsional and transverse stability.Optimally Located Peg FixationThe 4 peripheral porous pegs feature scallops that allow for comparable insertion force, but achieve higher pull out force vs leading competitor peg design.6Diamond Tread Surface Texture Optimal Surface FrictionAFFIXIUM 3DP Technology features a diamond tread surface to increase the coefficient of friction
Performance for Cementless Fixation Benchtop testing demonstrated better implant stability vs. leading competitor designs Due to the ATTUNE Knee proprietary technologies reducing the stresses through the implant, the tibial base structural design, and the AFFIXIUM 3DP Technology diamond tread surface, the ATTUNE® AFFIXIUM™ Knee demonstrated lower micromotion during Gait versus leading competitive designs.4Significant differences observed in gait for ATTUNE® vs Leading Competitor 1 (p=0.003) and vs Leading Competitor 2(p=0.016)Average Micromotion (Microns)ATTUNE® CR Leading Competitor 1Leading Competitor 2250200150100500MicromotionGait OrtholoadStair Descent OrtholoadMore stable kinematicsThe ATTUNE Knee System is designed to have stability through motion. In particular, the ATTUNE GRADIUS® Curve works with the soft tissues of the knee to reduced condylar sliding versus other widely available knee systems.3ATTUNE® CRLeading Competitor 1Leading Competitor 2
AFFIXIUM™ 3DP TechnologyAFFIXIUM™ 3DP Technology is a porous structure that was designed utilizing 3D printing to create a reproducible porous surface for biological fixation. The design philosophy is to control pore size distribution instead of randomization to enhance bone ingrowth.Reproducible Biological FixationAFFIXIUM 3DP Technology has been designed with controlled variation of pore size distribution to prevent ‘choke points’ (pores less than 100 microns) which could prevent bone to grow into the porous structure. Benchtop testing has revealed the potential for improved bone in-growth vs competitive technologies as AFFIXIUM 3DP Technology has few ‘choke points’ and increased surface porosity.2,7, 8AFFIXIUM has 90% lower choke points than other leading porous structures.TM®1.0%0.0%1.0%0.5%1.5%AFFIXIUM™1.1%0.1%Tritanium®Vol. Fraction of ‘choke’ points at surface2,7,8High surface porosity allows high amount of bone interdigitation at metallic implant surface.TM®4030400200600AFFIXIUM™503590Tritanium®Surface Pore Size (microns)2,7,8
Increased Mechanical StrengthAFFIXIUM 3DP Technology utilizes a stronger titanium alloy and has been designed to maintain structural strength.10 Additionally, a post process heat treatment step is used in order to create a porous structure that is free of internal pore defects.11,12ATTUNE FB Tibial Base demonstrating no pores.Market Leading Tibial Base Pegs showing poresStudies demonstrate Bone In-GrowthA combination of high bulk porosity produced maximum bone ingrowth in a 12 week animal study. The results of the study’s results found AFFIXIUM 3DP Technology to be equivalent to another published study of a leading competitor porous structure.9584736210Total Bone within Implant (mm2)POROCOAT Eqiv AreaTotal Implant Area55-5055-25 65-25 65-50 POROCOAT65% Porosity and 25% Randomization
CR and PS Femoral ComponentsThe ATTUNE Cementless Knee is available in Cruciate Retaining or Cruciate Sacrificing, and Posterior Stabilized constructs. Designed with porous femoral lugs which increases the amount of stability of the femoral component and results in greater dissociation strength and reduced micromotion.The inner A/P femoral surfaces have been designed to ensure that the anterior, posterior, and distal faces achieve full seating onto the bone. While the anterior and posterior chamfers have the addition of a small elevated rail on the medial and lateral edges designed to provide peripheral fixation in the chamfer regions without disrupting distal seating.40030020010035025015050Micromotion (µm)Gait Study140P=0.002*P=0.004*P=0.006*P=0.018*P=0.013*ATTUNELCSRegion of Interest (ROI)ANT MA LA MD LD MP PM PLLPLess micromotion: Overall, micromotions of the ATTUNE Knee System were significantly lower than the LCS® COMPLETE Knee System under both loading conditions (P≤0.001).INTUITION® InstrumentsThe INTUITION® Instruments combines the surgical process with intuitive and efficient instruments that enable the surgeon to balance the soft tissues and precisely control the implant position and fit for each patient. Two full trays and two half trays have been added to the INTUITION Instruments to accommodate the cementless system. These include the Tibial Trial and Preparation Case, FB Tibial Preparation Case, Femoral Cut Assessment Instruments, and Tibial Protection Plate Case. This set configuration could be streamlined by using our essential kitting option.The proven clinical success of POROCOAT® Porous Coating13 along with the established efficiencies of the INTUITION® Instrumentation
Improved patient reported outcome measures compared to other leading knee systems that were tested.21Implant survivorship estimate is ≥96.6% at five years in National Joint Registry for England, Wales, Northern Ireland and the Isle of Man Implant Summary Report, Michigan Arthroplasty Registry, AOA NJR22-2439% lower odds of patient discharge to a skilled nursing facility for ATTUNE Knee patients vs patients who received TKA with a Triathlon™ Knee, according to the results of a large U.S. hospital administrative database review.25The ATTUNE® Knee System continues to grow its portfolio and technologies to provide a broad range of solutions for patients.Current robotics in TKA are complex, the solution is simpleThe VELYS™ Robotic-Assisted Solution was born from the desire to create a new chapter in robotic TKA. This system not only performs with accuracy and consistency, but it also has a streamlined, efcient design that integrates into the OR.15 When purposeful design meets performance, even advanced workows are made simple.16Veried performanceAccurate, consistent plan execution supporting ATTUNE® Knee System in providing better patient outcomes.17-20Valuable insightsGap balance data to help surgeons visualize and predict joint stability. Versatile executionInstinctive, integrated design to give surgeons the control they’re used to while optimizing daily OR ow.16
Third-party trademarks used herein are trademarks of their respective owners. © DePuy Synthes 2021. All rights reserved. 168686-210301 DSUSPlease refer to the instructions for use for a complete list of indications, contraindications, warnings and precautions.For further information on DePuy Synthes products, please contact your local DePuy Synthes representative.DePuy Orthopaedics, Inc.700 Orthopaedic DriveWarsaw, IN 46582USATel: +1 (800) 366-8143Fax: +1 (800) 669-2530www.depuysynthes.comDePuy International, Ltd.St Anthony’s RoadLeeds LS11 8DTEnglandTel: +44 (0) 113 270 0461DePuy Ireland UCLoughbeg, RingaskiddyCo. Cork, IrelandTel: +35 (321) 491 4000Fax: +35 (321) 491 4199References: 1. DePuy Synthes DVA-107010-DVER report. Adaptiv, 20132. DePuy Synthes WR150265 report, Adaptiv, 20193. Fitzpatrick, et al, The Influence of Design on TKR Mechanics during Activities of Daily Living, ORS 2012, Poster #20344. DePuy Synthes TR-000002196 report, Adaptiv, 20185. DRG Q3 2018 Construct Report.6. Kane, R; Miltner, N; Smith, B; Tong, W; Initial mechanical stability of additively manufactured pegs in cancellous bone, ORS, Poster No. 1772, 2020.7. DePuy Synthes WR150266 report, Adaptiv, 20198. DePuy Synthes WR150267 report, Adaptiv, 20199. W. Tong, B. Smith, et al 2020 ORS paper No 337.10. ASTM F67 (unalloyed Ti), ASTM F3001 (Ti64 ELI), ASTM F560 (unalloyed Ta)11. S. Leuders, M. Thone, A. Riemer et al, International J of Fatigue 48 (2013) p300-30712. DePuy Synthes WR150180 report, Adaptiv, 201913. McMahon SE, Doran E, O’Brien S, Cassidy RS, Boldt JG, Beverland DE. Seventeen to Twenty Years of Follow-Up of the Low Contact Stress Rotating-Platform Total Knee Arthroplasty With a Cementless Tibia in All Cases. J Arthroplasty 34(3): 508, 2019. 10.1016/j.arth.2018.11.024.14. Berahmani S, Hendriks M, Wolfson D, Wright A, Janssen D, Verdonschot N. Experimental pre-clinical assessment of the primary stability of two cementless femoral knee components. J Mech Behav Biomed Mater. 2017 Nov;75:322 329. doi: 10.1016/j.jmbbm.2017.07.043. Epub 2017 Jul 27.15. Doan G, Curtis P, Wyss J, Clary C. Resection Accuracy Improved during Robotic-Assisted Total Knee Arthroplasty (December 2020). Internal Report 103720852.16. User experience evaluation of the VELYS Robotic-Assisted Solution for total knee (July 2020). Internal Report 103744839.17. Hamilton WG, Brenkel I, Clatworthy M, et al. Comparison of existing and new total knee arthroplasty implant systems from the same manufacturer: a prospective, multicenter study, 2019. Poster presented at: American Academy of Orthopaedic Surgeons 2019 Annual Meeting; March 12–16, 2019; Las Vegas, NV. Poster PO614.18. |Fisher D, Parkin D. Optimizing the value of your patients’ TKA: how to leverage data from patient reported outcomes. Becker’s Hospital Review webinar. October 3, 2019. Accessed October 18, 2019. www.ATTUNEevidence.com/clinical-evidence. 19. Ranawat CS, White PB, West S, Ranawat AS. Clinical and radiographic results of ATTUNE and PFC SIGMA knee designs at 2-year follow-up: a prospective matched-pair analysis. J Arthroplasty. 2017;32:431-436. 20. Indelli PF, Pipino G, Johnson P, Graceffa A, Marcucci M. Posterior-stabilized total knee arthroplasty: a matched pair analysis of a classic and its evolutional design. Arthroplasty Today. 2016;2:193-198.21. Hamilton W, Brenkel I, Clatworthy M, Dwyer K, Himden S, Lesko J, Kantor S; Early Outcomes with a New Primary TKA System vs. Contemporary TKA: Interim Results of Two Worldwide, Multi-Center Prospective Studies; Poster #106, AAOS 201722. National Joint Registry for England, Wales, Northern Ireland and the Isle of Man, 17th Annual Report. (2020). Table 3.K7(a). Full summary of all data is available from: www.njrreports.org.uk 23. Hughes RE, Hallstrom BR, Zheng H, Kabara J, Cowen M, Igrisan R, Richmond A. (2019) Michigan Arthroplasty Registry Collaborative Quality Initiative (MARCQI) Report: 2012-2018. University of Michigan, Ann Arbor.24. Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR). Hip Knee & Shoulder Arthroplasty Annual Report 2020,AOA, Adelaide; 2020: 249, 281-282, Tables KT7. (Accessed 1 October 2020 from https://aoanjrr.sahmri.com/annual-reports-2020 25. Etter, K., Lerner, J., de Moor, C, Yoo, A., Kalsekar, I. (2016). PMD10-Comparative Effectiveness of ATTUNE® Versus Triathlon™ Total Knee Systems: Real-World Length of Stay and Discharge Status.” Value in Health 19(3): A298