EP3166536A1 - Vollkeramischer kniegelenksersatz mit poröser knochenzugewandter rückseite - Google Patents

Vollkeramischer kniegelenksersatz mit poröser knochenzugewandter rückseite

Info

Publication number
EP3166536A1
EP3166536A1 EP15732279.3A EP15732279A EP3166536A1 EP 3166536 A1 EP3166536 A1 EP 3166536A1 EP 15732279 A EP15732279 A EP 15732279A EP 3166536 A1 EP3166536 A1 EP 3166536A1
Authority
EP
European Patent Office
Prior art keywords
porous
knee joint
joint replacement
replacement according
bone
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
EP15732279.3A
Other languages
German (de)
English (en)
French (fr)
Inventor
Roman Preuss
Marita Raschke
Peter STRÖTGEN
Tobias Weiss
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Ceramtec GmbH
Original Assignee
Ceramtec GmbH
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Ceramtec GmbH filed Critical Ceramtec GmbH
Publication of EP3166536A1 publication Critical patent/EP3166536A1/de
Ceased legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/38Joints for elbows or knees
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/30767Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2/30771Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/30767Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/3094Designing or manufacturing processes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/38Joints for elbows or knees
    • A61F2/3859Femoral components
    • AHUMAN NECESSITIES
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    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/38Joints for elbows or knees
    • A61F2/389Tibial components
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/02Inorganic materials
    • A61L27/10Ceramics or glasses
    • AHUMAN NECESSITIES
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    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/14Macromolecular materials
    • A61L27/16Macromolecular materials obtained by reactions only involving carbon-to-carbon unsaturated bonds
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    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/28Materials for coating prostheses
    • A61L27/30Inorganic materials
    • A61L27/306Other specific inorganic materials not covered by A61L27/303 - A61L27/32
    • AHUMAN NECESSITIES
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    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/28Materials for coating prostheses
    • A61L27/30Inorganic materials
    • A61L27/32Phosphorus-containing materials, e.g. apatite
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/28Materials for coating prostheses
    • A61L27/34Macromolecular materials
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/52Hydrogels or hydrocolloids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/56Porous materials, e.g. foams or sponges
    • CCHEMISTRY; METALLURGY
    • C08ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08LCOMPOSITIONS OF MACROMOLECULAR COMPOUNDS
    • C08L23/00Compositions of homopolymers or copolymers of unsaturated aliphatic hydrocarbons having only one carbon-to-carbon double bond; Compositions of derivatives of such polymers
    • C08L23/02Compositions of homopolymers or copolymers of unsaturated aliphatic hydrocarbons having only one carbon-to-carbon double bond; Compositions of derivatives of such polymers not modified by chemical after-treatment
    • C08L23/04Homopolymers or copolymers of ethene
    • C08L23/06Polyethene
    • CCHEMISTRY; METALLURGY
    • C08ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08LCOMPOSITIONS OF MACROMOLECULAR COMPOUNDS
    • C08L89/00Compositions of proteins; Compositions of derivatives thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2002/30001Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30003Material related properties of the prosthesis or of a coating on the prosthesis
    • A61F2002/30004Material related properties of the prosthesis or of a coating on the prosthesis the prosthesis being made from materials having different values of a given property at different locations within the same prosthesis
    • A61F2002/30011Material related properties of the prosthesis or of a coating on the prosthesis the prosthesis being made from materials having different values of a given property at different locations within the same prosthesis differing in porosity
    • AHUMAN NECESSITIES
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    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/30767Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2002/30769Special external or bone-contacting surface, e.g. coating for improving bone ingrowth madreporic
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    • A61F2002/3092Special external or bone-contacting surface, e.g. coating for improving bone ingrowth having an open-celled or open-pored structure
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    • A61F2002/3093Special external or bone-contacting surface, e.g. coating for improving bone ingrowth for promoting ingrowth of bone tissue
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    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
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    • A61F2/30942Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques
    • A61F2002/30957Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques using a positive or a negative model, e.g. moulds
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    • A61F2310/00005The prosthesis being constructed from a particular material
    • A61F2310/00179Ceramics or ceramic-like structures
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    • A61L2430/00Materials or treatment for tissue regeneration
    • A61L2430/24Materials or treatment for tissue regeneration for joint reconstruction

Definitions

  • the invention relates to a knee joint replacement with a femoral component and a tibial component, each having a front side forming the joint and a rear side facing the bone and having a polyethylene (PE) liner.
  • PE polyethylene
  • the current state of the art for replacement of the knee joint provides for over 90% cemented endoprostheses.
  • the bone cement adheres very well to the strongly roughened surfaces of the metallic endoprostheses (CoCrMo or Ti alloys), but dissolves over time due to the action of the aqueous environment in the human body on the component (so-called "debonding")
  • Micro-movements of the knee endoprostheses on the bone cement quiver and the progressive subcritical crack growth of the bone cement due to the dynamic loading of the joint shatters the bone cement over time, resulting in abrasion particles which enter the surrounding tissue and also in the sliding surface of the bone
  • the resulting bone cement as well as PE abrasion usually leads to a biological reaction of the surrounding tissue resulting in local inflammation and osteolysis (regression of the bone) to aseptic loosening of the Implants can lead.
  • This mechanism is indispensable for cemented knee endoprostheses and also explains why the average life of a cemented knee joint endopros
  • Cementless knee endoprostheses represent an alternative with great potential for longer prosthesis service life.
  • Metal knee joint endoprostheses that are frequently provided with a likewise metallic osseointegrative coating, which is the direct ingrowth of the knee joint endoprostheses, are currently established on the market Bone in the implant surface allows.
  • Such metal-free knee joint components combine the advantages of a biocompatible, allergy-friendly material and low wear of the sliding pair with excellent osseointegration.
  • An inventive knee joint replacement with a femoral component and a tibial component, each with a front side forming the joint and a back side facing the bone and with a polyethylene (PE) liner is characterized in that the femoral component and the tibial component consist of a full ceramic and with porous osseointegrative bone-facing Rear of both components.
  • the femoral component and the tibial component are each made of a ceramic sintered shaped body, wherein the sintered shaped bodies have a porous layer on their rear side facing the bone.
  • the porous bone-facing rear side is formed by applying a ceramic slip and spacers (pore-forming agent) on the base body (component) in the green state. About the sintering process, a compound of the layer is achieved with the body. Burning out the placeholders during sintering creates an open - pored structure with a fissured surface, which advantageously supports bone ingrowth and ingrowth. See also EP 1 268 364 A1.
  • the ceramic slip consists of the same material as the ceramic base body.
  • the complete implant, including the coating is completely free of metals and advantageous in terms of allergic reactions.
  • the porous bone-facing rear side is formed by foaming a ceramic slip and spacers (pore formers) on the base body (component) in the green state.
  • the porous bone-facing rear side can also be formed by joining a dense molding with a porous ceramic molding in the sintered state.
  • the porous molding can be made by foaming ceramic Slurry and sintering or infiltration of a porous carrier material with slip and sintering arise.
  • the joining is preferably carried out by soldering or gluing. This type of coating in combination with a ceramic base body is metal-free advantageous in terms of allergic reactions.
  • the integrated porous osseointegrative bone-facing back may also be formed by 2K injection molding (dense phase and porous or pore-forming phase) and sintering. This type of coating in combination with a ceramic base body is metal-free.
  • the porous bone-facing rear side can preferably be given additional functionality by further coating, such as a higher rate of integration or antibacterial effects. Integration speed is the time of ingrowth with the bone. This can preferably be achieved with Biogläsern, Hydroxilapatit, functionalized proteins or hydrogels.
  • the porous bone-facing rear side is formed by applying a porous metallic biocompatible layer on the already sintered ceramic base body (see EP 1 052 949 B1).
  • Figure 1 shows a total ceramic knee joint endoprosthesis consisting of femoral component 1, a tibial component 2 and ziwscheneaudem polyethylene (PE) liner 3 in the implanted state.
  • the porous bone-facing back is identified by the reference numeral 4.

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Medicinal Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Dermatology (AREA)
  • Epidemiology (AREA)
  • Cardiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Inorganic Chemistry (AREA)
  • Dispersion Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Ceramic Engineering (AREA)
  • Polymers & Plastics (AREA)
  • Organic Chemistry (AREA)
  • Manufacturing & Machinery (AREA)
  • Prostheses (AREA)
  • Materials For Medical Uses (AREA)
EP15732279.3A 2014-07-09 2015-07-01 Vollkeramischer kniegelenksersatz mit poröser knochenzugewandter rückseite Ceased EP3166536A1 (de)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102014213356 2014-07-09
PCT/EP2015/064924 WO2016005235A1 (de) 2014-07-09 2015-07-01 Vollkeramischer kniegelenksersatz mit poröser knochenzugewandter rückseite

Publications (1)

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EP3166536A1 true EP3166536A1 (de) 2017-05-17

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EP15732279.3A Ceased EP3166536A1 (de) 2014-07-09 2015-07-01 Vollkeramischer kniegelenksersatz mit poröser knochenzugewandter rückseite

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Country Link
US (1) US20170252168A1 (ja)
EP (1) EP3166536A1 (ja)
JP (1) JP2017521160A (ja)
KR (1) KR20170028977A (ja)
CN (1) CN106659571A (ja)
AU (1) AU2015286968A1 (ja)
DE (1) DE102015212258A1 (ja)
RU (1) RU2017104139A (ja)
WO (1) WO2016005235A1 (ja)

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CN110755681B (zh) * 2019-10-31 2023-09-08 吉瑞骨科有限公司 一种金属和陶瓷复合的关节假体及其制作方法

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JPS6485644A (en) * 1987-09-28 1989-03-30 Asahi Optical Co Ltd Preparation of ceramics composite
JPH03267055A (ja) * 1990-03-16 1991-11-27 Koshino Nariko 人工膝関節の脛骨側コンポーネント
JP3222134B2 (ja) 1990-08-06 2001-10-22 セラシヴ ゲゼルシャフト ミット ベシュレンクテル ハフツング イノヴェイティヴズ ケラミク―エンジニアリング 焼結成形体及びその使用
US5609641A (en) * 1995-01-31 1997-03-11 Smith & Nephew Richards Inc. Tibial prosthesis
DE19755536A1 (de) 1997-12-13 1999-06-17 Ceramtec Ag Hüftgelenkspfanne
DE10015614B4 (de) * 2000-03-29 2009-02-19 Ceramtec Ag Gesinterter Formkörper mit poröser Schicht auf der Oberfläche sowie Verfahren zu seiner Herstellung und seine Verwendungen
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DE102007020471A1 (de) * 2007-04-27 2008-11-06 Ceramtec Ag Innovative Ceramic Engineering Sinterformkörper
ITTO20070373A1 (it) * 2007-05-29 2008-11-30 Torino Politecnico Coppa acetabolare ceramica monoblocco per protesi d'anca.
WO2010009242A2 (en) * 2008-07-16 2010-01-21 Zimmer, Inc. Thermally treated ceramic coating for implants
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DE102011005424A1 (de) * 2010-10-29 2012-05-03 Mathys Ag Bettlach Keramik-Endoprothese mit keramischer Beschichtung und Verfahren zu dessen Herstellung
US9237950B2 (en) * 2012-02-02 2016-01-19 Biomet Manufacturing, Llc Implant with patient-specific porous structure
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Also Published As

Publication number Publication date
DE102015212258A1 (de) 2016-01-14
CN106659571A (zh) 2017-05-10
AU2015286968A1 (en) 2017-02-16
US20170252168A1 (en) 2017-09-07
JP2017521160A (ja) 2017-08-03
RU2017104139A (ru) 2018-08-10
RU2017104139A3 (ja) 2018-12-28
WO2016005235A1 (de) 2016-01-14
KR20170028977A (ko) 2017-03-14

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