CONSTRUCT RATIONALE BROCHURE
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1 CONSTRUCT RATIONALE BROCHURE
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3 Introduction Heritage CORAIL PINNACLE World Improving people s lives together Clinical ical Results Versatility y and Flexibilitylity Surgeons Experience Improving people s lives... together is the driving force of the CORAIL PINNACLE Construct Solution and stands for great people working together, and also for great products working together - both are critical to achieving the ultimate goal, to improve people s lives. Building on the great HERITAGE, the good long-term CLINICAL RESULTS and the very positive long-term SURGEONS EXPERIENCE from around the world, CORAIL PINNACLE is able to deliver more than excellent features and benefits of two independent products it s about trust and confidence in a construct solution. Additionally, it offers great FLEXIBILITY and VERSATILITY with more than 1 million possible construct combinations 1 available within the CORAIL PINNACLE family of products. Finally, the construct strives to improve people s lives together in more than 75 countries 2 around the globe and therefore creates the CORAIL PINNACLE WORLD. CORAIL PINNACLE Improving people s lives together.
4 Heritage 2002 CORAIL AMT 2004 CORAIL High Offset 2005 CORAIL became the most implanted cementless stem solution in the National Joint Registry of England and Wales In Q4 2012, CORAIL achieved over 1 million unit sales worldwide since its introduction CORAIL Stem 2003 COXA VARA 2004 Size 6 Dysplasia 2008 CORAIL became the most implanted cementless stem solution in the Australian Orthopaedic Association National Joint Replacement Registry 4
5 2011 In Q3 2011, PINNACLE achieved over 1 million unit sales worldwide since its introduction PINNACLE became the 2nd most implanted cementless acetabular cup solution in the Australian Orthopaedic Association National Joint Replacement Registry PINNACLE Bantam 2004 ESC and ES3 Enhanced Stability Liners 2003 DUOFIX Porous Coating with HA 1998 MARATHON cross-linked polyethylene 2009 GRIPTION Porous Coating 2007 ALTRX Cross-Linked Polyethylene 2006 PINNACLE became the most implanted cementless acetabular cup solution in the National Joint Registry of England and Wales CERAMAX 2000 PINNACLE 1977 POROCOAT Porous Coating
6 Clinicalical Results
7 Over 68,000 documented CORAIL PINNACLE construct implantations in registries 96.4% CORAIL PINNACLE is the most implanted combination in cementless hip joint reconstruction in Australia showing a 96.4 % survival rate at 5 years in 14,961 implantations. 9,10 Combination Year 1 Year 3 Year 5 CORAIL, PINNACLE 1.6% (1.4%-1.8%) 2.6% (2.3%-2.9%) 3.6% (3.1%-4.1%) Australian Orthopaedic Association National Joint Replacement Registry. Yearly Cumulative Percent Revision of Primary Total Conventional Hip Replacement with Cementless Fixation (95% confidence intervals) % CORAIL PINNACLE is the most used combination in hip joint reconstruction in England and Wales showing a 95.9% survival rate at 7 years in 54,019 implantations. 11 Combination Implantations Year 1 Year 3 Year 5 Year 7 CORAIL, PINNACLE % (0.73%-0.89%) 1.80% (1.67%-1.95%) 2.84% (2.61%-3.10%) 4.12% (3.51%-4.85%) National Joint Registry for England and Wales. Revision rates (all-cause) for main hip stem and cup combinations (95% confidence intervals) % Low 1.37% revision rate for the CORAIL PINNACLE with ceramic on polyethylene bearing after 5 years in the National Joint Registry of England and Wales. 12 Combination Implantations Year 1 Year 3 Year 5 Year 7 Ceramic-on-ceramic % (0.74%-1.03%) 1.80% (1.56%-2.07%) 2.49% (2.10%-2.95%) - Ceramic-on-metal % (0.17%-0.85%) 2.95% (1.77%-4.91%) - - Ceramic-on-polyethylene % (0.41%-0.90%) 0.96% (0.66%-1.40%) 1.37% (0.88%-2.14%) - Metal-on-metal % (0.68%-1.02%) 2.32% (2.04%-2.64%) 4.28% (3.77%-4.85%) - Metal-on-polyethylene % (0.68%-0.95%) 1.40% (1.20%-1.62%) 1.66% (1.41%-1.96%) 2.05% (1.57%-2.68%) National Joint Registry for England and Wales. Revision rates (all-cause) for most commonly used brands for hip replacement by fixation and bearing surface (95% confidence intervals). 12
8 Surgeons Experience Mr Steve Young, UK Dr Tarik Ait Selmi, France Prof Tim Board, UK Used in 100% of my patients It became obvious quite quickly that CORAIL was an implant that was suitable for all, so by the middle of 2002, I used it in every patient. I had been using the DURALOC cup for every patient, so when PINNACLE became available in 2005, I used the CORAIL PINNACLE construct in 100% of my patients. Simple, reliable, easy technique to teach, long history of good results and pleased patients! The construct of the CORAIL and PINNACLE has been excellent for me. There are several reasons why I think it s been good. Firstly it s a simple, reliable technique. Secondly it s something I can teach to the juniors easily. Thirdly there s a long history of good results. And fourthly I ve got a bunch of patients who are extremely happy with their results and that feedback is important to me, and I m sure in the future that construct will go on being used in Warwick. Reliable combination I use CORAIL PINNACLE because I do believe, and I consider, based on the scientific data that it s one of the most reliable combinations, and this is something that we need to be able to tell our patient, that implanting this combination will provide long term results without any drawbacks or specific problems. Reliable technique It is extremely important to have a reliable and reproducible technique on implants because we are addressing more and more patients, and we are educating more and more surgeons. Simple solution, reliable and reproducible surgical technique, fast and efficient reliable patient results So, I started using the CORAIL PINNACLE combination as I d been exposed to this in the last year of my training and it really struck me as a very simple solution, easily reliable and reproducible, surgical technique that was relatively fast and efficient. And above all, you know, seeing the patients clinically afterwards gave very reliable function results and the x-rays are always reliably reproduceable and overall I was just really impressed with the whole system. Consistency So, in a world where there s been obviously lots of modifications and other companies producing similar products, I think we have to be very careful and be aware of seemingly very minor modification to a system...
9 Dr Jens Boldt, Switzerland Dr Helge Wangen, Norway Cost effective and suits almost all patients I use CORAIL PINNACLE because of the cost effectiveness in a small set up like the private hospital where I work and also it suits all my patients, all my pathologies I have to face on a day to day basis. Proven and versatile I use the CORAIL PINNACLE construct because, the results are very good, they are very well proven, and it s a very versatile system, and I can use the system on almost all my patients. Prof Ian Learmonth, South Africa Prof David Beverland, UK Heritage, evidence, bone sparing and flexibility I use the CORAIL PINNACLE combination because it has a great clinical heritage, there s really good evidence base for both components and I believe both components provide a conservative option in total joint reconstruction as they are bone sparing and they have huge flexibility to address all the clinical problems that present to the hip surgeon. I use CORAIL PINNACLE for every patient, without exception The only combination I ve used is CORAIL PINNACLE and I use that combination without exception. I use it because it s got a proven track record, it s simple to use, if used properly, and we know that it gives good long term results. Simple Re-usable Technique for Teaching/Training For me it s important to have a straight forward, reproducible technique, because I have fellows, so on every case I do, I m training, and therefore it s valuable that I m doing the same thing, at the same time in every operation.
10 Versatility y and Flexibility lity Cups Liners Sector Multihole CERAMAX Bantam Coatings ALTRX Heads POROCOAT DUOFIX MARATHON Ceramic GRIPTION ULTAMET Metal PINNACLE Cup, Coating and Liner availability varies by size. For a complete reference please refer to the PINNACLE Product Guide
11 Stems Standard KS No Collar Size 8 20 Standard KA Collar Size 8 20 High Offset KHO No Collar Size 9 20 COXA VARA KLA Collar Size 9 20 DDH No Collar Size 6 DDH Collar Size 6 A simple solution for a broad variety of patients More than 1 million construct combinations* available within the CORAIL PINNACLE family of products. 1 * Cup, Liner, Head and Stem
12 CORAIL PINNACLE World Availability of CORAIL PINNACLE CORAIL In December 2012, CORAIL achieved over 1 million unit sales worldwide since its introduction 5 More than 650 patients treated each day Striving to improve people s lives in more than 75 countries around the globe PINNACLE In August 2011, PINNACLE achieved over 1 million unit sales worldwide since its introduction 6 More than 750 patients treated each day Striving to improve people s lives in more than 75 countries around the globe
13 CORAIL PINNACLE is available in more than 75 countries around the globe
14 Great people working together Improving people s lives together Great products working together
15
16 References CORAIL PINNACLE Portfolio data on file, DePuy International Ltd sales data on file, DePuy International Ltd. 3. National Joint Registry for England and Wales, 9th Annual Report Available from URL: Figure Australian Orthopaedic Association National Joint Replacement Registry. Annual Report. Adelaide: AOA; Available from URL: annual-reports Table HT sales data on file, DePuy International Ltd sales data on file, DePuy International Ltd. 7. Australian Orthopaedic Association National Joint Replacement Registry. Annual Report. Adelaide: AOA; Available from URL: Table HT5. 8. National Joint Registry for England and Wales, 9th Annual Report Available from URL: njrcentre/default.aspx. Figure Australian Orthopaedic Association National Joint Replacement Registry. Annual Report. Adelaide: AOA; Available from URL: Table HT Australian Orthopaedic Association National Joint Replacement Registry. Annual Report. Adelaide: AOA; Available from URL: Table HT National Joint Registry for England and Wales, 9th Annual Report Available from URL: Table National Joint Registry for England and Wales, 9th Annual Report Available from URL: Table The third party trademarks used herein are the trademarks of their respective owners. This publication is not intended for distribution in the USA. DePuy Orthopaedics EMEA is a trading division of DePuy International Limited. Registered Office: St. Anthony s Road, Leeds LS11 8DT, England Registered in England No DePuy France S.A.S. 7 Allée Irène Joliot Curie Saint Priest France Tel: +33 (0) Fax: +33 (0) DePuy Orthopaedics, Inc. 700 Orthopaedic Drive Warsaw, IN USA Tel: +1 (800) Fax: +1 (574) DePuy International Ltd St Anthony s Road Leeds LS11 8DT England Tel: +44 (0) Fax: +44 (0) depuysynthes.com DePuy International Ltd. and DePuy Orthopaedics, Inc All rights reserved. CA#DPEM/ORT/0213/0048 version 1 Issued: 03/13
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