Trademark Trial and Appeal Board Electronic Filing System. https://estta.uspto.gov
`
`ESTTA Tracking number:
`
`ESTTA1148569
`
`Filing date:
`
`07/22/2021
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`BEFORE THE TRADEMARK TRIAL AND APPEAL BOARD
`
`Proceeding
`
`92058781
`
`Party
`
`Correspondence
`Address
`
`Submission
`
`Filer's Name
`
`Filer's email
`
`Signature
`
`Date
`
`Attachments
`
`Defendant
`CeramTec GmbH
`
`ANNA KURIAN SHAW
`HOGAN LOVELLS US LLP
`555 THIRTEENTH STREET NW
`COLUMBIA SQUARE
`WASHINGTON, DC 20004-1109
`UNITED STATES
`Primary Email: anna.shaw@hoganlovells.com
`Secondary Email(s): dctrademark@hoganlovells.com, HLDCTM-
`Group@hoganlovells.com, Ceramtec-hldc@hoganlovells.com,
`clay.james@hoganlovells.com, keith.odoherty@hoganlovells.com,
`lauren.cury@hoganlovells.com, ryan.stephenson@hoganlovells.com
`202-637-5600
`
`Testimony For Defendant
`
`Anna Kurian Shaw
`
`anna.shaw@hoganlovells.com, dctrademark@hoganlovells.com, HLDCTM-
`Group@hoganlovells.com, Ceramtec-hldc@hoganlovells.com
`
`/AKS/
`
`07/22/2021
`
`Petkow Exhibit 15 -CERAM099193_image_Part1.pdf(5660401 bytes )
`Exhibit 15 -CERAM099193_image_Part2.pdf(5444693 bytes )
`Exhibit 15 -CERAM099193_image_Part3.pdf(2216658 bytes )
`Exhibit 16 - CERAM064938_image.pdf(332604 bytes )
`Exhibit 17 - CTEC_054364_Part1.pdf(5433070 bytes )
`Exhibit 17 - CTEC_054364_Part2.pdf(4709220 bytes )
`Exhibit 17 - CTEC_054364_Part3.pdf(4991593 bytes )
`Exhibit 17 - CTEC_054364_Part4.pdf(5382761 bytes )
`Exhibit 17 - CTEC_054364_Part5.pdf(1725820 bytes )
`
`

`

`Exhibit 15
`Exhibit 15
`
`

`

`CeraNews
`
`,.~. Dwiflffliupié‘i
`
`“4:21;? Eiflkfimikfifimm MN MW;
`
`Focus: Knee Arthroplasty
`Evidence-based Medicine in Orthopedics
`
`(Knie)/fotolia ©Galina
`
`enis
`
`Barskaya(Bikher);D
`
`www.ceranews.com
`
`@ Springer Medizin
`
`Attorney's Eyes Only
`
`CERAM099193
`
`

`

`
`
`2 TABLE OF CONTENTS
`
`Guest Commentary
`Benazzo F, MD, Pavia, Italy
`
`Focus: Knee
`
`Future of Knee Endoprosthetics:
`Ceramic Components find their Place
`Interview with Mittelmeier W, MD, Rostock, Germany
`
`Clinical Cases: Primary Knee Arthroplasty in
`Patients with Suspected or Confirmed Metal Allergy
`Benazzo F, Pavia, Italy
`
`Focus: Evidence
`
`Evidence-based Decision-Making and
`Biological Reactions Related to Materials
`Usbeck S, Scheuber LF, Plochingen, Germany
`
`
`10
`
`Science
`
`Mid-term Results of Modern Ceramic-on-Ceramic
`
`Science Report
`
`Science
`
`Total Hip Arthroplasty
`Laforgia R, Bari, Italy
`
`2015 Update on an Evolving Perspective for
`Taper Corrosion in Total Hip Arthroplasty
`Kurtz SM, Philadelphia, USA
`
`Fretting and Corrosion
`Discussion of Methods for Assessment and Testing
`Pandorf T, Plochingen, Germany
`
`Does Bearing Influence Septic Loosening of
`primary Total Hip Arthroplasty?
`Bordini B, Bologna, Italy
`
`Pauwels Commemorative Medal 2014
`
`Materials Research
`
`The Effect of Chromia Content on Hardness of
`
`Zirconia Platelet Toughened Alumina Composites
`Kuntz M, Plochingen, Germany
`
`Science Report
`
`What's New in Endoprosthetics in Russia?
`Tikhilov RM, St, Petersburg, Russia
`
`Tribology: Science and Practice in Korea
`Zimmermann M, Graessel M, Plochingen, Germany
`
`News Ticker
`
`E Heinz-Mittelmeier Research Award
`
`E Congresses & Workshops
`
`E Reading Tips
`
`17
`
`20
`
`22
`
`24
`
`25
`
`26
`
`28
`
`3O
`
`32
`
`34
`
`36
`
`a Cover:
`© Galina Barskaya (Biicher);
`Denis (Knie) Ifotolia
`
`@You can download PDF
`with additional information on
`the articles in this issue via the
`QR codes.
`All articles are online at
`www.ceranews.com
`
`Published by:
`
`Contact Sales:
`
`Chief Editor:
`
`CeramTec GmbH
`Medical Products Division
`CeramTechlau 179
`73207 Plochingen (Germany)
`Telefon: +49 7153 611-828
`Telefax: +49 7153 611950
`E-Mail:
`medicaLproducts@ceramtec,de
`www.binlox.com
`
`Dieter Burkhardt
`Vice President Sales and Marketing
`Telefon: +49 7153 6117485
`EvMeiI: d.burkhardt@ceramtec.de
`
`Paul Silberer
`Vice President Sales
`Telefon: +49 7153 611-522
`E-Mail: p,si|berer@ceramtec.de
`
`'
`(IESPOHSIble Editor,
`address 565 publisher).
`Sylvia Usbeck
`Concept and Editing:
`Sylvia Usbeck
`Clinical Affairs Manager,
`Florence Petkow
`Manager Marketing Communication,
`Leslie F. Scheuber
`Senior Product Specialist Recon
`
`Editorial Team and
`Production:
`Springer~Verlag GmbH
`Tiergartenstr. 17
`69121 Heidelberg (Germany)
`E-Mail: sabine.jost@springer.com
`Printing Office:
`Druckpress GmbH
`Hamburger StraBe 12
`69181 Leimen (Germany)
`
`a5}
`
`CeraNevvs 1/2015
`
`Attorney's Eyes Only
`
`CERAM099194
`
`

`

`GUEST COMMENTARY
`
`Total Knee Arthroplasty is currently Experiencing
`a New Phase
`
`By Benazzo F, MD, Pavia, Italy
`
`he number of prostheses implanted worldwide every year is constantly increasing for several rea—
`sons:
`
`0 more surgeons are being educated to perform this particular class of operation;
`
`0 more patients now have a longer life span and increased articular damage as a consequence of
`the extended utilization of their joints;
`
`- extension of the indications for TKA in a range of young, active patients with damaged knees,
`
`- and implants are becoming more easily available in emerging countries.
`
`Together with the growing number of surgeries, an increased incidence of related problems is also
`becoming evident, including:
`
`- residual symptoms in a high percentage of patients (almost 20 %), such as pain, stiffness, and
`instability, along with other minor but annoying symptoms;
`
`- material—related problems such as wear in young and active patients; and allergies
`
`Thus, it is evident that efforts must be made to improve designs (with a strong shift toward more
`natural kinematics of the knee), materials (that are not harmful for the patients and have a long and
`wear-free life), and techniques and methods of implantation (robotics). There is also new interest be-
`ing shown in partial prosthetic replacement of the affected knee (uni-compartmental, bi-unicondylar,
`patellofemoral joint replacement).
`
`The Biolox®delta composite ceramics, owing to their manufacturing features such as bending
`strength and stress load capacity, could be the new benchmark of biomaterials available for clinical
`use, as demonstrated by the cohort of patients treated with knee devices made of Biolox®delta New
`scenarios are therefore opening, specifically in the so-called small-implants field of partial knee re-
`placement.
`
`However, the safety and reliability of new imp/ant products for patients must be guaranteed. No lon—
`ger can we allow the success of a device to be validated on the basis of biased, by definition, expert
`opinion. All the new phases of applied research entail the problem of demonstrating efficacy and
`safety, clearly and incontrovertib/y Therefore, they must be validated under the umbrella of the evi-
`dence—based medicine (EB/W. The evidence pyramid should be the basis for evaluating the properties
`and quality of any device, material, or surgical method. Critical evaluation has received enhanced at—
`tention with metal—on—meta/ (Mo/VI) failure and consequent clinically devastating effects, such as ad—
`verse reactions to metal debris (AR/MD). Critical evaluation has been extended to the ”new” materials
`such as cross—linked polyethylene (XPE), (for which the claimed lack of wear was not demonstrated),
`and to new phenomena, such as corrosion of the metal junction in all prosthetic designs.
`
`Together with the awareness of the potential drawbacks that any innovation could bring, and of the
`harm any patient could suffer, research on new applications of proven materials such as Bio/ox®delta
`ceramics will continue and will be monitored in accordance with the EBM principle.
`
`This is the message that the new issue of CeraNews wants to bring to the customers.
`
`Attorney's Eyes Only
`
`
`
`Francesco Benazzo, MD
`
`CeraNews 1/2015
`
`fl
`
`CERAM099195
`
`

`

`
`
`4 GUEST COMMENTARY
`
`
`
`Francesco M. Benazzo, MD, studied medicine at the University of Pavia,
`graduating in 1980. He devoted himself to electron microscopy during his
`studies and early in his career. He pioneered the application of special tech—
`niques such as freeze-etching and freeze—fracture to the connective tissue,
`and in particular to cartilage and tendons.
`
`He trained as an orthopedic surgeon in Pavia, completing his education in or—
`thopedics and traumatology in 1985 with a thesis on a rare genetic disease
`involving the long bones (Lipomembranous osteodystrophy), including an
`electron microscopic evaluation of the lesions. During the residenqr program,
`he was introduced by his mentor, Prof. Boni, both to cervical spine surgery
`and to sports traumatology.
`
`Benazzo served as assistant in the Sports Traumatology Section of the orthopedic clinic and finally as—
`sumed an academic position as assistant professor in 1990. In 2000 he became full professor of ortho-
`pedics and traumatology, and two years later Chairman of the Orthopedic and Traumatology Depart—
`ment of the University of Pavia, San Matteo Hospital. Since then, he has also chaired the Program of
`Residency in Orthopedics and Traumatology. In 2002, he became consultant to the Football Club Inter—
`nazionale Milano, where he served until 2014 as surgeon.
`
`His main fields of scientific and clinical interest are connective tissue structure and mechanics, tendi—
`nopathies in athletes and functional overload injuries, spinal osteoarthritis, cementing techniques, hip
`and knee prosthetic surgery, the development of MIS surgical techniques and tools for total knee re—
`placement, and tissue engineering with the use of SAOS—Z and stem cells.
`
`
`
`
`
`In 2005, Benazzo became President of the EFOST (European Federation of National Associations of Or—
`thopedic Sports Traumatology). He is a member of IRCS (International Cartilage Repair Society), of ISA-
`KOS (International Society of Arthroscopy, Knee Surgery and Orthopaedic Sports Medicine), and of the
`European Hip Society, and secretary and member of the Italian College of Professors of Orthopedics
`and Traumatology.
`
`He designed 3 different hip stems, and one knee prosthesis. Benazzo has been a visiting surgeon (Aus—
`tralia, France, South Korea) and an instructor on cadavers for total knee arthroplasty and unicomparti—
`mental replacement.
`
` ACRO NYM S
`
`AAOS
`ARMD
`ASTM
`BMI
`Co
`CoC
`CoCr
`
`American Academy of Orthopaedic Surgeons
`Adverse Reactions to Metallic Debris
`American Society forTesting and Materials
`Body Mass Index
`Cobalt
`Ceramic-on-Ceramic
`Cobalt-Chromium
`
`CoCrMo Cobalt-Chromium-Molybdenum
`CoP
`CeramiceonePolyethylene
`Cr
`Chromium
`CT
`Computer Tomography
`DGOOC Deutsche Gesellschaft fiir Onhopédie und Orthopadische
`Chirurgie (German Soclety of Orthopedics and Orthopedic
`Surgery)
`German Association for Trauma Surgery
`EvidencevBased Medicine
`European Federation of Orthopaedics and Traumatology
`European Hip Society
`Food and Drug Administration
`
`DGU
`EBM
`EFORT
`EH5
`FDA
`
`HHS
`H005
`HR
`HV
`KSS
`LTT
`MoM
`
`MOP
`0K5
`PE
`ROM
`SCC
`SF-12“
`THA
`TJA
`TKA
`XPE
`ZTA
`
`Harris Hip Score
`Hip dysfunction and Osteoarthitis Outcome Score
`Hazard Ratio
`Hardness Vickers
`Knee Society Score
`Lymphocyte Transformation Test
`Metal-on-Metal
`
`Metal-on-Polyethylene
`Oxford Knee Score
`Polyethylene
`Range of Motion
`Squamous Cell Carcinoma
`Short Form, Health Survey Score
`Total Hip Arthroplasty
`Total Joint Arthroplasty
`Total Knee Arthroplasty
`Crosslinked Polyethylene
`Zirconia Toughened Alumina
`
`CeraNews 1/2015
`
`fir
`
`Attorney's Eyes Only
`
`CERAM099196
`
`

`

`
`
`The Future of Knee Endoprosthetics:
`Ceramic Components Find Their Place
`
`Interview with Wolfram Mittelmeier, MD, Rostock, Germany
`
`Whereas ceramic materials have already been accepted in hip arthroplasty, knee arthroplasties
`are still frequently carried out using MoP bearings. However, there are some good arguments
`in favor of using ceramic knee components: For example, in patients with known allergies or
`where replacements are required as a result of septic loosening, Prof. Mittelmeier recommends
`full ceramic or ceramic coated components. The modern alumina matrix composite ceramics
`demonstrate enhanced bending strength and stress-load capacity and are therefore appropriate
`even for the kinematically demanding artificial knee. Current 5-year data from a European mul-
`ticenter study verify that a Biolox®delta ceramic femur condyle shows stable fixation and con-
`vincing durability.
`
`Why is a knee TEP patient so often dissatisfied?
`Mittelmeier: The frequency of patients’ dissatis—
`faction is higher in knee endoprosthetics than in
`hip endoprosthetics. This is very likely due above all
`to the highly complex kinematics of the knee joint
`and to the kinematically more demanding operative
`technique. There is also probably a certain connec-
`tion with the metal/polyethylene procedure, which
`is still being carried out, while ceramic components
`are the gold standard in hip endoprosthetics.
`
`In hip endoprosthetics the problem of metal
`abrasion, corrosion, and fretting with modu-
`lar prostheses is currently under intensive dis-
`cussion, and the use of ceramic-on-ceramic or
`ceramic-on-polyethylene is suggested. Do you
`think this will also be an issue in knee endo-
`
`prosthetics?
`Mittelmeier: The initial euphoria regarding the use
`of metal
`in hip endoprosthetics has given way to
`disillusionment in recent years.
`In particular,
`large
`metal/metal bearings have been the target of crit—
`icism because of pronounced granulomas and in—
`creased incidents of early loosening. These problems
`of metal ions and metal abrasion apply equally to
`knee endoprosthetics, whereby the larger joint vol-
`ume with greater capsule surfaces probably consti—
`tutes a higher level of tolerance, however. Never—
`theless, the long—term application of knee endo-
`prostheses with the well—known increase in allergy
`problems in our population makes it reasonable to
`expect similar problems, although probably not of
`the same magnitude.
`
`For which patients would you choose a ceram-
`ic prosthesis rather than a metal prosthesis?
`
`Mittelmeier: If an allergy is known and a ceram—
`ic solution is available appropriate to the kinemat—
`ics,
`I would favour it. Since no such kinematically
`perfected ceramic solution is available for revisions,
`improved ceramic coatings must be considered as
`an alternative.
`I would also advise that these ce—
`
`ramic-coated knee components be used for pa—
`tients who require a septic revision of their endo—
`prosthesis and have been treated with intermittent
`cement spacer.
`In these cases there is an accumu—
`lation of zirconium oxide particles in the normal
`bone cement, which cannot be reliably removed by
`joint lavage even with the most intensive efforts.
`
`Are there differences in the follow-up care of
`ceramic and metal implants?
`Mittelmeier: No.
`
`Do you see any clinical differences between
`all-ceramic and ceramic-coated knee compo-
`nents?
`
`Mittelmeier: In this regard we have carried out and
`published a retrospective study (comparison of co—
`horts) comparing a particular coated, older type of
`knee with our ceramic components [I ]. These differ—
`ences are almost impossible to document in Short—
`term clinical trials, but in some cases there is slight—
`ly increased abrasion with coated components, at
`least for the type of implant studied by us,
`In the
`long term, however, I would expect to see a signifi—
`cant advantage for the ceramic monoblock solution,
`because the thin coatings on the market to date are
`subject to constant abrasion and their wearing out
`is foreseeable. Newer multiple coatings could yield
`better results, but they must still be tested in clini—
`cal practice.
`
`Attorney‘s Eyes Only
`
`CeraNews I/ZO‘IS
`
`n5!
`
`CERAM099197
`
`

`

`
`
`6 INTERVIEW
`
`What must be taken into consideration when
`
`a ceramic component is implanted?
`Mittelmeier: The alumina matrix composite (Bio-
`lox®delta), from which the current knee compo—
`nents — Multigen Plus Ceramic Knee (Limacorpo-
`rate S.p.A.) b) (Fig. 1), BPK—S ceramic knee (Peter
`Brehm GmbH) , are manufactured, demonstrate
`considerably greater bending strength and stress—
`load capacity. Nonetheless, as with every materi—
`al, a certain maximum load limit remains. The ce-
`
`
`
`
`
`
`Figure 1: Multigen Plus delta Ceramic Knee (Limacorporate)
`
`ramic components should be inserted without a so—
`called wedge load and thus without a strong press
`fit. Hammer blows should be used very cautious—
`ly, analogous to proven practice for ceramic heads
`in hip arthroplasty.* Likewise, the saw cuts in the
`knee joint must be precisely executed, it should be
`noted that we now know to what extent a strong
`press fit situation and sharp blows on metal com—
`ponents lead to internal stress with possible con—
`sequential damage. In the past few years we have
`learned to be even more careful with all of our im—
`
`plants, particularly with all instruments.
`
`What is your experience with the Multigen
`Plus Ceramic Knee following 5 years of clini-
`cal use?
`
`Mittelmeier: We began to introduce the Delta
`Ceramic Knee Joint (femur condyle made of Bio—
`lox®delta) very carefully in 2007. By carefully I mean
`that we worked under strict observation criteria as
`
`part of a multicenter study. The patients were in-
`formed in detail and the surgeons were selected
`and appropriately trained. Our experience with the
`ceramic knee here in Rostock and the experiences of
`the various centers in Germany, Italy, and Spain that
`participated in the study have meanwhile been pub—
`lished [2]. The 5-year results are very convincing. In
`
`* According to the LIMA operation surgical technique, the weight of the
`recommended hammer, eventually used, must be less than 500 gr.
`
`the German center there was one ceramic fracture;
`otherwise we observed a very convincing stable fix—
`ation and durability of the implants. The recorded
`fracture that took place during the study observa—
`tion was the direct result of a trauma and was treat—
`
`ed accordingly [3]. The 10-year results will hopefully
`be published in good time.
`
`How important is cement-free knee arthro-
`plasty in your opinion?
`Mittelmeier: In the majority of cases, particular—
`ly with older patients, we can perform cemented
`knee arthroplasty without hesitation. The frequen—
`cy of cement allergies in the population appears
`to be increasing; however, we still do not know
`enough about the extent to which the cement al—
`lergy actually affects the tissue. The release of ions
`and particles (particle surface) is clearly decisive for
`the development of the allergy. Since the cement
`should not lie in the primary situation of the fric—
`tional load of the joint surfaces, the cement allergy
`will probably not be as significant as the metal al—
`lergy. Nevertheless, cement-free knee replacement
`should be able to draw upon stable, safe solutions
`as well, also in relation to ceramics. For this reason
`we will also need cement—free ceramic solutions
`
`for the knee joint.
`
`Does an ideal treatment cascade already ex-
`ist in knee arthroplasty? How does it look, in
`your opinion?
`Mittelmeier: I very much hope that we will have
`ceramics available in the various treatment cas-
`
`cades, that is, from unicompartmental knee arthro—
`plasty, to total knee replacement, up to and includ—
`ing posterior stabilized prostheses and all revision
`endoprostheses.
`
`How does the future of ceramic knee arthro-
`
`plasty look to you?
`Mittelmeier: There were several failures in the
`
`development of ceramics in hip arthroplasty more
`than 40 years ago, which were the fault of the ear—
`ly material development. Ceramic materials have
`been significantly improved in the meantime and
`offer considerably better conditions for hip and
`for knee arthroplasty. l expect that there will have
`to be a new, very strong trend to develop ceram—
`ic knee arthroplasty with regard to long durability,
`the least possible ion release and solutions for re—
`vision arthroplasty. Current solutions already being
`tested in laboratories are very promising.
`
`Partial resurfacing of the knee or preferably
`corrective osteotomy — where are the indica-
`tion boundaries?
`
`Mittelmeier: A surgical intervention for corrective
`osteotomy must also have a sufficiently long-last—
`ing effect. The same is true for partial knee arthro—
`plasty. The two interventions must be carefully
`
`CeraNews 1/2015
`
`fl
`
`Attorney's Eyes Only
`
`CERAM099198
`
`

`

`Wolfram Mittelmeier, MD, is a professor of
`orthopedics and the Director of the Orthopedic
`Clinic and Polyclinic at the University Medicine in
`Rostock.
`
`
`
`Following his doctoral studies and his qualifica—
`tion as a specialist in orthopedics, Mittelmeier
`worked first as a consultant and later as a se—
`nior consultant at the University Hospital of L0—
`beck, before moving to the Technical Universi—
`ty of Munich as senior consultant in the Hos—
`pital for Orthopedics and Sports Orthopedics. There he established the
`biomechanics laboratory and the cell laboratory. In 1999 he received his
`postdoctoral lecturing qualification; 4 years later he accepted a chair at
`the University of Rostock in the field of orthopedics. Since 2004 he has
`served as the director of the orthopedic division of the University Hospi—
`tal in Rostock.
`
`His main clinical focus is on arthroplasty, revision surgery, children‘s or—
`thopedics, and joint—preserving operations. His scientific focus is on bio—
`mechanics, implant technology, and worst—case simulations. Since 2005,
`he has been a member of the board of the German Society of Orthope—
`dics and Orthopedic Surgery (DGOOC) and of the board of the Associa—
`tion for Orthopedic Research, where he served as president from 2009
`until 2013.
`
`Mittelmeier developed the basis of a quality management system for en—
`doprosthesis centers, which became EndoCert; it is audited by commit—
`tees of the German Society for Orthopedics and Trauma Surgery (DGOU)
`and has been implemented nationwide since 2012. Since 2011 he has
`been the deputy chairman of the advisory board on orthopedic technolo—
`gy of the German Association of Orthopedic Technology.
`
`In 2014 he served as president of the OTWorld /World Congress of Or—
`thopedic Technology.
`
`
`
`
`
`
`
`
`
`
`weighed with regard to the patient’s needs and the
`condition of the joint, The best possible joint—pre-
`serving solution via corrective osteotomy takes pri-
`ority in making the decision for younger patients,
`It is my personal view that the early implantation of
`metallic or metal/polyethylene partial components
`in the knee joint is not yet a perfected mode of
`treatment. Here as well we will be able to choose
`
`ceramic solutions and then have a presumably wid—
`er indication. The effects of metal ions and parti-
`cles on the surrounding, still largely intact cartilage
`cannot be considered beneficial.
`
`Robotics at the knee — a necessity or just
`marketing?
`Mittelmeier: The very adverse results of using ro-
`botics on the hip joint in the past have led to a
`great deal of mistrust towards the use of robots in
`endoprosthetics. The newer types of robots that
`are presently being used in abdominal surgery un-
`der the optical and tactical control of an experi—
`enced surgeon promise a better development. It is
`still not clear to what extent these modern robot
`
`types will actually become established on the mar—
`ket in our country, because the profits that can be
`made with endoprostheses — a prerequisite for fur—
`ther useful developments — have already reached
`the bottom limit. A relatively large amount is be-
`ing, and must be, saved on implants nationwide
`instead of making room for qualitatively better de-
`velopments. On the other hand, a possible future
`form of robot—supported endoprosthetics will have
`to undergo very rigorous clinical testing in advance
`with respect to applicability, application errors and
`error tolerance. In addition, there must then also
`be a detailed clinical evaluation of the extent to
`
`which a robot system actually offers advantages
`compared with standard treatment by an experi—
`enced surgeon.
`
`Knee arthroplasty with preservation of the
`anterior cruciate ligament — is that the fu-
`ture?
`
`Mittelmeier: The preservation of the anterior cru—
`ciate ligament may be a sensible approach in knee
`arthroplasty. To date, however,
`it has been very
`difficult to achieve kinematically satisfactory solu-
`tions, as the kinematics of the knee joint is physiov
`logically very individual, and for the anterior cruci—
`ate ligament in particular, very high standards are
`set regarding the surgical technique and the im—
`plant.
`
`How do you envision the future of knee re-
`placement?
`Mittelmeier: I believe that, as international de—
`velopments show, knee replacement will have to
`be refined. Along with the continually increasing
`number of knee replacement worldwide » with the
`exception of the German region — the number of
`
`revisions will obviously also increase temporarily.
`t will be important to establish good procedures
`that are as long—lasting as possible with very well—
`trained operators in order to keep the revision load
`as small as possible. I
`
`a References
`1. Bergschmidt, Philipp et a|.,Tota| knee replacement system with a ceramic
`femoral component versus two traditional metallic designs: a prospective
`short-term study,l Orthop Surg (Hong Kong). 2013 Dec;21(3):29479,
`2. Bergschmidt, Philipp et al,, Prospective multi—centre study on a com-
`posite ceramic femoral component in total knee arthroplasty: Five-year
`clinical and radiological outcomes, The Knee 2015, DOI: http://dx.doi.
`org/10.1016/j.l<nee.2015.02.003
`3. Krueger A P et al,, Ceramic Femoral Component Fracture in Total Knee
`ArthroplastyzAn analysis using fractography, fourier—transform infrared
`microscopy, contact radiography and histology, J Arthroplasty 2013, doi:
`10.1016/j.arth,2013.l1.003)
`
`Attorney's Eyes Only
`
`CeraNews 1/2015
`
`n5?
`
`CERAM099199
`
`

`

`
`
`8 CASE REPORTS
`
`Primary Knee Arthroplasty in Patients with
`Suspected or Confirmed Metal Allergy
`
`Benazzo F, Ghiara M, Rossi SMP
`
`Clinica Ortopedica e Traumatologica, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy
`
`CASE REPORT 1
`
`Primary TKR for advanced arthritis
`
`Diagnosis
`
`A 68—year—old woman with a history of hyperten-
`sion, coronary artery disease, and multiple allergies
`(asthma, dust). The patient had had a painful right
`knee due to arthritis for two years. The preopera—
`tive X—rays clearly showed severe valgus osteoar—
`thritis with involvement of the lateral compartment
`and patellofemoral joint as well as a lateralization
`of the mechanical axis ”(Fig.1a).
`Indication was for primary TKR with a Multigen
`Plus ceramic knee implant (Lima) to avoid cross—
`linked reaction due to suspected metal allergy.
`
`component (Biolox®de/ta Multigen Plus, size 3) and
`and a poly liner with a height of 12mm P) (Fig. 1b).
`
`Postoperative therapy included a femoral nerve
`block (naropin) for analgesia and fast rehabilitation
`of the knee: The patient began to exercise to regain
`range of motion on the first postoperative day, and
`she walked with two canes on the second postoper—
`ative day. She took non—steroidal anti—inflammatory
`drugs (indomethacin) for 3 weeks, as did the other
`patients who underwent TKR.
`
`After 4 weeks she was able to do without one cane
`
`Therapy
`
`and she had very mild pain, which had disappeared
`at the 3—month follow—up. The range of motion was
`0—115° and the excellent results were confirmed at
`the last follow—up. X—rays showed a good restoration
`of limb alignment and no radiolucent lines at 6 years
`Surgery was performed via a mini mid—vastus ap—
`of follow-up P) (Fig. 1c). The final clinical KSS was
`98 points (excellent), the final functional KSS was
`proach. Replacement of the knee was done with a
`100 points (excellent), and the final OKS was 47.
`ixed Ti tibial plate (size 2) and a ceramic CR femoral
`
`
` Figure 1: Primary TKA 68-year old woman: a) lateralization of mechanical axis preoperative, b) postoperative situa-
`
`
`tion, c) follow-up after six years: good limb alignment (© Benazzo)
`
`CeraNews 1/2015
`
`Attorney‘s Eyes Only
`
`CERAM099200
`
`

`

`
`
`CASE REPORT 2
`
`Primary TKR for advanced arthritis
`
`Diagnosis
`
`The patient was a 75-year—old woman with a history
`of hypertension, pancreatic neuroendocrine cancer,
`diabetes and glaucoma. She had had diffuse pain
`in the left knee for 4 years which had been treated
`without success with hyaluronic acid injections. The
`X—rays showed a primary knee arthritis and a varus
`knee. The cartilage degeneration involved all three
`compartments b) (Fig. 2a), particularly the medial
`side and the patellofemoral joint, and the mechani—
`cal axis was medialized. She also had a metal allergy
`(nickel), so we decided to use a the Multigen Pius
`delta ceramic knee.
`
`knee: The patient began to exercise to restore the
`range of motion on the first postoperative day, and
`she walked with two canes on the second postop—
`erative day. She took, as usual after a TKA, non—ste—
`roidal anti—inflammatory drugs (indomethacin) for 3
`weeks.
`After 4 weeks she was able to do without one
`
`cane and she had no pain. The range of motion was
`0—110” and increased to O—120° at 6 months.
`
`The excellent results were confirmed at the last fol—
`
`low—up at 2 years, and X—rays showed no radio—
`lucent lines, a good patellar height and good pa—
`tellofemoral tracking b) (Fig. 2c). The final clinical
`KSS was 99 points (excellent), the final functional
`KSS was 100 points (excellent), and the final OKS
`was 46. I
`
`Therapy
`
`Surgery was performed via a mini mid—vastus ap—
`proach to the knee. Replacement of the knee was
`performed with a fixed Ti tibial plate (size 1) and a
`ceramic CR femoral component (Biolox®de/ta Mul—
`tigen Plus, size 1) and a poly liner with a height of
`12 mm i) (Fig. 2b).
`
`Postoperative drug therapy consisted of peridural
`analgesia, which allowed fast rehabilitation of the
`
`5 Corresponding Author:
`Francesco Benazzo, MD
`Director
`
`Clinica Ortopedica e Traumatologica
`Fondazione IRCCS Policlinico San Matteo
`
`Viale Camillo Golgi 19
`27100 Pavia (Italy)
`E—mail: f.benazzo@smatteo.pv.it
`
`
`
`a Figure 2: Knee of a 75-year old woman: a) preoperative status (lateral/patella), alle three compartments show arthritis damage, b) postoperative
`CeraNews 1/2015
`
`with fixed tibial plate and ceramic femoral component (lateral/frontal), c) two years after surgical intervention (lateral/patella) (© Benazzo)
`
`Attorney's Eyes Only
`
`CERAM099201
`
`

`

`
`
`10 SCIENCE
`
`Evidence-based Decision-Making and
`Biological Reactions Related to Materials
`
`Usbeck S and Scheuber LF
`
`CeramTec GmbH, Plochingen, Germany
`
`TOPIC 1: EVIDENCE-BASED MEDICINE IN ORTHOPEDICS: WHERE IS THE EVIDENCE?
`
`OCEBM Levels of Evi—
`dence download here:
`www.cebmnet/ocebm-
`levels-of-evidence/
`
`
`
`Evidence-based medicine continues to grow in im-
`portance. Evidence-based medicine came to the fore
`in the early 19905 and has been defined as "the in—
`tegration of best research evidence with clinical ex-
`pertise and patient values" (Sackett et al. 2000)
`[1]. Evidence has always contributed to clinical de—
`cision-making. Murray et al. reviewed the evidence
`for THA in 7995 [2]. They found that only 30% of
`hip-joint replacements available contained any evi—
`dence and emphasized the need for evidence-based
`data.
`
`Additional researchers have concluded that the need
`
`for good—quality evidence in the orthopedic litera—
`ture has remained vital. Unfortunately the continu—
`ous lack of a level of evidence has been established in
`
`transfer ("knowledge translation ") of science and re-
`search into concrete medical practice.
`
`National joint registers have been established to
`monitor and improve the outcomes. However, regis-
`ters differ in methods of data analysis and reporting,
`which limits the interpretation of the data, These dif—
`ferences make comparisons among registries difficult
`or impossible.
`
`Konan and Haddad, University College Hospitals
`London, 2013 summed up the situation in a paper,
`saying [3]: "We now routinely rely on registry data
`to guide our debates and decisions but we would
`be wise to remember that they have inherent weak—
`nesses that limit the interpretation of the data. Com—
`pliance issues associated with any data collection
`and reporting process limit the quality of the regis-
`try data. No robust system is in place to tackle con—
`founding data, and to capture underreported or un—
`reported outcomes. Registries were set up to monitor
`survival but the ancillary data that are collected are
`not validated. Caution must therefore be exercised
`
`in par-
`when using registries as high-level evidence.
`ticular, registry—based results cannot infer causal re—
`lationships. Any trend identified should be used as
`a trigger for further study rather than as a rigid con-
`clusion. "
`
`Evidence-based data should be founded both on re-
`
`sults of well-designed studies and on registers that
`are able to collect data in large populations and to
`identify trends.
`
`Evidence-based medicine includes a classification sys-
`tem that enables a defined evaluation, based on the
`so—ca/led evidence level, of the quality of the stud—
`ies and particular publications. This system ofgrading
`offers clinicians a simplified rating for clear compar-
`ison of performance based on relevant clinical crite—
`ria (D) Fig.1).
`
`CERAM099202
`
`m