Aesculap Orthopaedics Columbus AS Knee System. Alternative Surface

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1 Aesculap Orthopaedics Columbus AS Knee System Alternative Surface

2 The Premium Knee Package Columbus AS is Aesculap s new high performance knee system. It offers advantages that have not been available in this combination before. The AS coating for the Columbus Knee System is a highly innovative and reliable surface finish. Advantages of the AS multilayer coating The AS multilayer coating is a further development of the PVD-monolayer on titanium or titanium niobium nitride coatings. Advantages of the AS multilayer coating The Multilayer AS Coating provides significantly improved mechanical ablation resistance compared to a monolayer coating. The advanced coating architecture provides an enhanced barrier against metal ion release. 7 The effectiveness of the coating system has been proven through in vitro tests. The concentration of allergenic ions (cobalt, chrome, molybdenum, nickel) measured after chemical analysis is below every biologic reaction limit. 7 The Premium Knee Package The premium knee package offers benefits to further improve the results of knee replacement surgery. Alignment: The OrthoPilot Navigation System is a proven tool to assist in placement of knee implants. Simple and interactive simulation of femoral and tibial cuts take the patient s ligament relationships into account and allow for optimal implantation results. Since 1997 more than 100,000 knee replacements have been successfully implanted with the guidance of the OrthoPilot Navigation System. Implant Surface Finishing: The AS coating significantly reduces the release of metal ions, specifically Ni which is a common metal allergen. 1,7 Moreover, the AS-coated knee implants allow for less polyethylene wear, which helps to increase the longevity of the knee implant. Polyethylene: The beta sterilized polyethylene (PE) ages more slowly and exhibits better oxidative and tribological characteristics. 2

3 AS Wear Results Excellent Wear Results Almost 50% of total knee revisions are due to either aseptic loosening or polyethylene wear. 8 Columbus AS Femoral implants were tested according to ISO standards and showed polyethylene wear results as low as 3.5 mg/million cycles. 7 Fig. 1: Wear results of the AS Coated Columbus Knee System (* accord. to ISO14243). Small scratches in CoCrMo implants are a known but still unexplained surface damage that can lead to higher PE wear. During wear tests, the ceramic AS layer exhibited a resistance to scratches and also good wettability, which leads to better articulation between the PE bearing surface and the femoral component. The addition of cortical bone chips and bone cement particles caused no damage (scratches, nicks, etc.) to the implant surfaces after 5 and 5.5 million cycles. 7 Identical instrument benefit for standard and AS implants AS finish coating is ZrN a biocompatability material of superior abrasion hardness and durability All metal components are coated (Tibia, Femur, Stems & augments) No mechanical ablation 6 The excellent surface quality in vitro suggests very good clinical characteristics in vivo. 3

4 Metal Ion Barrier Metal Ion Barrier AS coated knees generate fewer particles than CoCr knees, including PE particles and metal ions. 7 According to the literature, dermal hypersensitivity to metal is common, affecting about 10 to 15 % of the population. 1, 2 Currently, there is no generally accepted test for the clinical determination of metal sensitivity to implants. However, the prevalence of dermal sensitivity in a patient with a joint replacement, particularly those with a failed implant, is substantially higher than in the general population to 15% of patients sensitive against nickel, chrome and cobalt 1,2 High barrier function thanks to the multilayer coating Minimal release of nickel, cobalt and chrome ions 6 Considering the growing number of patients receiving implants, biocompa tibility and longevity are two of the most important topics in joint reconstruction. 7 layer protective coating 4

5 AS Coating Results Ni ion concentration during standard wear test [µg] Columbus AS Coated Wear Station Columbus AS Coated Reference Station Ti Based Allergy Implant Uncoated Knee Implant Concentration of Ni ions in the lubricant of wear tests after 0.5 Mio. wear cycles. Ni ion concentration (diluted) Columbus CR ZrN coated [µg/l] reference CoCrMo wear station unused lubricant reference station cycles [Mio.] Concentration of soluble Ni ions in the lubricant of an uncoated implant, the unused lubricant, the lubricant from the wear stations and the lubricant from the only axially loaded reference station. Analysis and exchange of the lubricant every 0.5 Mio. cycles. Literature: 1. Hallab N, Merritt K, Jacobs JJ. Metal sensitivity in patients with orthopaedic implants. J. Bone Joint Surg. Am., Pellengahr C, Mayer W, Refior H.J. Resurfacing knee arthroplasty in patients with allergic sensitivity to metals. Arch Orthop. Trauma Surgery, Bell CJ, et al., Comparison of wear in fixed and mobile bearing knee designs, program and abstracts of the 49th Annual Meeting of the Orthopaedic Research Society, February 2-5, New Orleans, Louisiana, Haider H, et al., Comparison between force-controlled and displacement - controlled in vitro wear testing on a widely used TKR Implant, 48th Annual Meeting of the Orthopaedic Research Society, Poster No Mc Ewen HMJ, et al., The influence of design, kinematics and bearing material on the wear of total knee replacements, Society for Biomaterials 30th Annual Meeting Transaction, Stryker brochure, Introducing X3, the power of technology, preserving strength, reducing wear, resisting oxidation, Ref Data on file at Aesculap 8. Sharkey PF, et al., Why are total knee arthroplasties failing today?, Clin Orthop Relat Res bone chips added cement chips added 5

6 AS Coating Design Design of the AS coating The total layer thickness ranges between 3.5 and 5 µm. It consists of a top coat, five interface coats and a bond and barrier coating in connection with the standard material CoCr29Mo6 (see fig. 2 and 3). Zirconium (Zr): The basic element zirconium is one of the most biocompatible metals with extreme viscosity and endurance strength. Zirconium Nitride (ZrN): Zirconium and nitrogen, a high resistance to wear, low gliding friction and hardness, due to its ceramic nature. Chrome (Cr): The five intermediate layers of the AS coating system are chrome nitride (CrN), an anticorrosive and hard metal. Multilayer coating Implant material (CoCrMo) Fig. 2: Profile of implant and coating ZrN top coat approx. 2.5 µm CrN-CrCN interface coating 5 layers approx. 2 µm total thickness Zr bond and barrier coating approx. 100 nm CoCr29Mo6 base material Fig. 3: Composition of the coating architecture The AS coating process The ceramic coating of the AS implants are applied by a vacuum deposition process (PVD = Physical Vapor Deposition). The elements of the coating are vaporized in the coating process. The molecules condensed from the vapor (plasma) settle on the substrate material. The main advantage of this process is the low coating temperature ( C) which preserves the sensitive substrate materials. By appropriate selection of the coating targets and reaction gases, a large variety of layers can be produced. Diagram of the PVD process This allows the creation of variable layer structures optimally adapted to intended function of the product, especially with regard to adhesion, toughness and hardness gradients. 6

7 Columbus AS Portfolio AS COLUMBUS CR - CEMENTED Size Left Right 1 NN001Z NN011Z 2 NN002Z NN012Z 3 NN003Z NN013Z 4 NN004Z NN014Z 4N NN899Z NN909Z 5 NN005Z NN015Z 5N NN900Z NN910Z 6 NN006Z NN016Z 6N NN901Z NN911Z 7 NN007Z NN017Z AS COLUMBUS PS - CEMENTED Size Left Right 1 NN161Z NN171Z 2 NN162Z NN172Z 3 NN163Z NN173Z 4 NN164Z NN174Z 5 NN165Z NN175Z 6 NN166Z NN176Z 7 NN167Z NN177Z AS COLUMBUS MODULAR TIBIA PLATEAU - CEMENTED Size 0 NN070Z 0+ NN058Z 1 NN071Z 1+ NN072Z 2 NN073Z 2+ NN074Z 3 NN075Z 3+ NN076Z 4 NN077Z 4+ NN078Z 5 NN079Z AS COLUMBUS TIBIAL PLUG Size 12 mm NN261Z 14 mm NN264Z AS COLUMBUS TIBIAL STEM Size Short Long 12 mm NN262Z NN263Z 14 mm NN265Z NN266Z AS PS FIXATION SCREW FOR PE Size 10/12 NN497Z 14/16 NN498Z 18/20 NN499Z 7

8 All rights reserved. Technical alterations are possible. This leaflet may be used for no other purposes than offering, buying and selling of our products. No part may be copied or reproduced in any form. In the case of misuse we retain the rights to recall our catalogs and price lists and to take legal actions AESCULAP. ALL RIGHTS RESERVED. PRINTED IN THE USA. DOC832 2M 2 /09 Aesculap is an equal opportunity employer Aesculap Implant Systems, Inc Corporate Parkway Center Valley, PA Phone:

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