EP2023861A1 - Composant fémoral pour prothèse totale de hanche - Google Patents

Composant fémoral pour prothèse totale de hanche

Info

Publication number
EP2023861A1
EP2023861A1 EP06721966A EP06721966A EP2023861A1 EP 2023861 A1 EP2023861 A1 EP 2023861A1 EP 06721966 A EP06721966 A EP 06721966A EP 06721966 A EP06721966 A EP 06721966A EP 2023861 A1 EP2023861 A1 EP 2023861A1
Authority
EP
European Patent Office
Prior art keywords
femoral component
component according
shaft
longitudinal grooves
femoral
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.)
Withdrawn
Application number
EP06721966A
Other languages
German (de)
English (en)
Inventor
Hans Ulrich Stäubli
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.)
STAEUBLI, HANS ULRICH
Original Assignee
Individual
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 Individual filed Critical Individual
Publication of EP2023861A1 publication Critical patent/EP2023861A1/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2/00—Filters 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/32—Joints for the hip
    • A61F2/36—Femoral heads ; Femoral endoprostheses
    • A61F2/3662—Femoral shafts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2/00—Filters 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2/00—Filters 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/32—Joints for the hip
    • A61F2/36—Femoral heads ; Femoral endoprostheses
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2/00—Filters 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/32—Joints for the hip
    • A61F2/36—Femoral heads ; Femoral endoprostheses
    • A61F2/3662—Femoral shafts
    • A61F2/367—Proximal or metaphyseal parts of shafts
    • A—HUMAN NECESSITIES
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    • A61F2/00—Filters 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/32—Joints for the hip
    • A61F2/36—Femoral heads ; Femoral endoprostheses
    • A61F2/3662—Femoral shafts
    • A61F2/3672—Intermediate parts of shafts
    • A—HUMAN NECESSITIES
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    • A61F2/00—Filters 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/32—Joints for the hip
    • A61F2/36—Femoral heads ; Femoral endoprostheses
    • A61F2/3662—Femoral shafts
    • A61F2/3676—Distal or diaphyseal parts of shafts
    • A—HUMAN NECESSITIES
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    • A61F2/00—Filters 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
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    • A61F2002/30108—Shapes
    • A61F2002/3011—Cross-sections or two-dimensional shapes
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    • A61F2/00—Filters 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30108—Shapes
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    • A61F2002/30112—Rounded shapes, e.g. with rounded corners
    • A61F2002/30125—Rounded shapes, e.g. with rounded corners elliptical or oval
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    • A61F2/00—Filters 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30108—Shapes
    • A61F2002/3011—Cross-sections or two-dimensional shapes
    • A61F2002/30112—Rounded shapes, e.g. with rounded corners
    • A61F2002/30136—Rounded shapes, e.g. with rounded corners undulated or wavy, e.g. serpentine-shaped or zigzag-shaped
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2/00—Filters 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30108—Shapes
    • A61F2002/3011—Cross-sections or two-dimensional shapes
    • A61F2002/30138—Convex polygonal shapes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2/00—Filters 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30316—The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30329—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2002/30331—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements made by longitudinally pushing a protrusion into a complementarily-shaped recess, e.g. held by friction fit
    • A61F2002/30332—Conically- or frustoconically-shaped protrusion and recess
    • A—HUMAN NECESSITIES
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    • A61F2/00—Filters 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2/30771—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
    • A61F2002/3082—Grooves
    • A61F2002/30827—Plurality of grooves
    • A61F2002/30828—Plurality of grooves parallel
    • A—HUMAN NECESSITIES
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    • A61F2/00—Filters 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
    • A61F2/02—Prostheses implantable into the body
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    • A61F2/30771—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
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    • A61F2/02—Prostheses implantable into the body
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    • A61F2/00—Filters 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
    • A61F2/02—Prostheses implantable into the body
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    • A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2/30771—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
    • A61F2002/30878—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves with non-sharp protrusions, for instance contacting the bone for anchoring, e.g. keels, pegs, pins, posts, shanks, stems, struts
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    • A61F2/02—Prostheses implantable into the body
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0017—Angular shapes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00005—The prosthesis being constructed from a particular material
    • A61F2310/00011—Metals or alloys
    • A61F2310/00023—Titanium or titanium-based alloys, e.g. Ti-Ni alloys
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00389—The prosthesis being coated or covered with a particular material
    • A61F2310/00395—Coating or prosthesis-covering structure made of metals or of alloys
    • A61F2310/00407—Coating made of titanium or of Ti-based alloys
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00389—The prosthesis being coated or covered with a particular material
    • A61F2310/00592—Coating or prosthesis-covering structure made of ceramics or of ceramic-like compounds
    • A61F2310/00796—Coating or prosthesis-covering structure made of a phosphorus-containing compound, e.g. hydroxy(l)apatite

Definitions

  • the invention relates to a femoral component according to the preamble of patent claim 1.
  • hip total endoprosthesis The current state of the art of permanently implantable medical products, and especially hip arthroplasty, is to replace the natural human hip joint for painful arthritic and inflammatory changes with an artificial hip implant called the hip total endoprosthesis.
  • the total endoprosthetic replacement of the hip joint is in post-traumatic conditions in degenerative damage to the hip joint in the sense of primary or secondary coxarthrosis, for example, in hip dysplasia, in secondary or idiopathic Hsymmetrickopfnekrose clearly given.
  • Various artificial hip joint implants are available on the market worldwide and are used in large numbers.
  • the femoral portion of the hip-total endoprosthesis system is introduced into the appropriately prepared medullary cavity interior of the proximal femur.
  • the femoral stem component can be connected directly to the bone, either indirectly by means of cement or else by "press fit".
  • the femoral stem component of a total hip prosthesis includes at least the following parts: femoral stem part, neck part with plug cone and usually modular ball head for articulation with the socket inlay, which in turn is connected via conical clamping to the acetabular cup.
  • the cup bearing shell of the so-called acetabular Cup is in turn cemented or cemented stable connected to the milled acetabulum.
  • the neck portion of the shaft component which is designed medially and proximally, starting from the proximal boundary of the shaft component and via throat into a trunkokonische lot, the standard cone opens, is for receiving a spherical head and the inner cylindrical receiving opening for attaching a modular ball head on the femoral stem designed.
  • the cylindrical ball head which may consist of different materials, is attached to the proximal medial conical tapered cone of the neck and forms with the inner interface of the artificial cup inserts, the so-called inserts or inlays of the bearing shell, which in turn are connected to the hip bone, the actual artificial hip joint.
  • the hip, thigh and proximal end of the femur thus articulate with the artificially replaced portion of the acetabular component and are designed as a hip total endoprosthesis system.
  • the first system sometimes referred to as a non-cemented hip system or uncemented shaft system, uses the concepts of positive primary stability and secondary biological stabilization through osseointegration.
  • the primary stability of the prosthesis is achieved by firm, positive fit of the femoral component in the proximal medullary canal.
  • the proximal medullary canal bone after femoral neck resection, is removed or impacted, and the femoral stem component of the femoral neck is inserted into the femoral neck base, proximal femur end trochanteric region, and endomedullary canal of the femoral medullary canal hammered so that a tight fit between the femoral stem implant and the bone is formed.
  • Uncemented total hip arthroplasty systems were introduced more than 40 years ago and are the preferred method for fixation of a hip joint endoprosthesis in young, good bone quality active individuals where a secure connection between endomedullary bone canal and joint implant surface can be expected through osseointegration.
  • the secondary, biological stability of the cementless prostheses is achieved by bone apposition (growth of the bone to the prosthesis surface), osteoconduction, attracting the precursor cells of bone-forming cells, the so-called osteoblasts by suitable surface coating of the implants and by the "de novo" bone formation around the implant , the so-called periprosthetic bone healing.
  • the second system uses bone cement for secure fixation of the femoral stem component in the appropriately prepared, usually distally sealed medullary cavity canal.
  • the use of cement requires the removal of bone tissue from the endomedullary region of the proximal femur.
  • An edge layer of trabecular cancellous bone is left in order to securely fix the femoral implant in the bone with the help of the cement connecting with the bone.
  • This fixation mode has been performed regularly since the beginning of hip arthroplasty, as practiced by Sir John Charnley and Prof. Maurice E. Müller and is now mainly in older individuals with wide medullary cavity and osteoporotic soft bone application.
  • both fixation methods both the uncemented version and the cemented variant, are preferably used when correctly indicated and according to the needs and wishes of the patient.
  • the post-implantation time of the uncemented stem system is 3 months on average until the patient can return to the normal activities of daily life, provided that the new bone biologically binds to the surface structure of the hip implant.
  • the long-term outcome of a successful bony union of a non-cemented hip stem system involves a long revision-free survival of the femoral component, which could be securely fixed endomedullary in the femoral stem, so that preferably in favorable cases, a life of 20 years and more results.
  • the cementless systems are reserved for patients who lead an active lifestyle.
  • Cementless total hip prosthesis assemblies are typically used in relatively biologically relatively young patients with good bone quality.
  • Minimally invasive techniques via a front mini-access to Hueter, via a modified ventral, lateral, transgluteal, posterolateral or posterior, relative to the standard shortened approach are motivated and mediated by patients, users and industry, not least also by mercantile aspects, increased popularity.
  • the dangers of the minimally invasive techniques in the area of the acetabulum to be replaced consist in a reduced overview of the surgical field, increased mispositioning of the bearing shell and thus of the socket inlay with: vertical or flat position, increased anteversion or retroversion, too deep or superficial positioning, more unstable Cup bearing fixation, insufficiently secured cup inlay fixation in the bearing shell.
  • the dangers of the mini-invasive techniques in the femoral stem positioning are an insufficient overview of the proximal operative area, malpositioning, antetorsion, retrotorsion, lateralization and offset, leg extension or leg shortening, ventral and dorsal off-set in the sense of anterior translation and dorsal translation, the varus and valgus positioning of the stem component, and the secure fixation thereof in the metaphyseal region of the internal medullary spongiosa and compacta.
  • Another hybrid fixation method is the dual fit system in which the femoral stem component is cemented proximally and not cemented distally ("Dual Hanka fit")
  • the cemented hip system is used in elderly patients with relatively osteoporotic bone or deep medullary canal to minimize postoperative pain and to allow immediate exercise in seniors to improve walking ability and joint mobility.
  • the interphase connection between bone cement and bone graft surface may not be as tight as in the non-cemented systems and may result in a phase of premature loosening compared to cementless fixation. Therefore, the cemented version is typically used more in less active, older individuals.
  • loosening of the femoral implant is relatively common observed with respect to the bone or against the bone cement, with first small cement fissures to be observed before the total relaxation of the femoral stem component.
  • cemented systems can sink further into the medullary canal by subsidence, which can lead to a leg length difference, therefore multiple tapered stem components have been produced for secondary reassembly, implanting, for example, the Cerafit triradius pressfit cup with metal / metal Mating and the Cerafit multicone stem. (CeraferOsteal Paris France).
  • the shaft is produced so-called lateralized with an increased lateral off-set.
  • the distance between the acetabular cup center of the new artificial socket and the corresponding center of the ball head on the one hand and the longitudinal axis of the shaft component on the other hand is increased.
  • the lever arm of the hip-like musculature (the so-called hip abductors and external rotators) is lengthened, thus improving the hip abductor force, which counteracts possible limping in the postoperative phase.
  • the uncemented systems are firmly fixed in the distal shaft area in the endomedullary canal and the prosthesis remains proximally fixed in the greater trochanter area and the femoral neck area, vibrations of the prosthesis in the proximal area with zero passage occur, which is manifested in thigh pain in the patient.
  • the prior art has been improved in that the efficiency of the implant-bone connection in the uncemented systems has been improved by biomimetic substances and between the bone prosthesis and cement in the cemented systems, so that the rate of loosening of the implants compared to the endomedullary channel diminished over time.
  • a hip joint prosthesis is disclosed in DE 35 05 997 GRISS.
  • This known from the prior art prosthesis has a shaft provided with longitudinal ribs for cementless anchoring in tubular bones, wherein the cross section of the shaft is formed lens-shaped.
  • the longitudinal grooves are arranged parallel to the longitudinal axis of the shank. The disadvantage of this arrangement is an undesirable variation of the femoral stem component during its insertion.
  • the shaft is bent in the proximal half and the longitudinal grooves extending in the distal half parallel to the longitudinal axis have the same bend in the proximal half as the shaft.
  • This arrangement has the disadvantage that the shaft is guided into an undesired varus position.
  • the invention aims to remedy this situation.
  • the invention is based on the object of improving the angle-appropriate, low-impingement, landmark-specific, fluorometry-friendly implantation in the body's proximal femoral shaft and to improve the intrinsic primary stability between the outer shape of the femoral component and the inner medullary space configuration including support on the compacta of the caudal femoris and in the Trabecular system of the proximal femur end and femoral neck and improvement of the secondary stability by suitable surface finish and surface coating for peri-implant osseointegration in the sense of osteogenic, osteoinductive and osteoconductive Knochenapposition and "de novo" bone formation for solid anchoring in the endosteal system of the proximal end of the femur.
  • the invention solves this problem with a femoral component having the features of claim 1.
  • the femoral component according to the invention thus leads to a fixed primary seat in the endomedullary canal and a favorable secondary osseointegration.
  • the longitudinal grooves extend at least over the region of the second quarter of the distal half of the shaft.
  • the longitudinal grooves extend at least over the region of the third quarter of the proximal half of the shaft. In yet another embodiment, the longitudinal grooves are disposed on the anterior and posterior sides of the sheet.
  • the angle alpha is 4 °.
  • the ratio V / L between the volume of the stem and its length L is less than 2.25 cm 2 , preferably less than 2.12 cm 2 .
  • the ratio V / L between the volume of the stem and its length L is greater than 1.90 cm 2 , preferably greater than 2.00 cm 2 .
  • the anterior leaflet side has a mean distance D from the posterior leaflet side, and the length L of the stem is in the range of 8D ⁇ L ⁇ 12D.
  • the lateral side surface has a mean distance B from the medial side surface, and the length L of the shaft is in the range of 6B ⁇ L ⁇ 10B.
  • the longitudinal grooves are rectilinear, resulting in a better guidance of the femoral shaft during insertion into the medullary canal, a better alignment parallel to the lateral stem cortex as well as a better and simpler compaction technique results.
  • the longitudinal grooves are continuous over the entire length of the shaft, resulting in an improved rotational stability of the shaft.
  • the longitudinal grooves have a depth of at least 0.05 mm.
  • the longitudinal grooves extend substantially parallel to the lateral side surface.
  • the shaft is designed as a straight shaft.
  • the longitudinal grooves have a distance H of less than 2.0 mm, preferably less than 1.7 mm from one another.
  • the longitudinal grooves have a distance H of greater than 1, 2 mm, preferably greater than 1, 3 mm to each other.
  • the profile of the longitudinal grooves is wave-shaped, wherein the wave troughs between the individual longitudinal grooves have a greater radius of curvature than the wave crests.
  • the two side surfaces are formed without grooves.
  • the two side surfaces include a wedge angle gamma> 0 °.
  • the wedge angle gamma is preferably 4 ° -6 °, typically 5 °.
  • the anterior leaf side with the posterior leaf side encloses a wedge angle beta> 0 °.
  • the wedge angle beta is preferably 2.1 ° to 3.3 °, typically 2.7 °.
  • the asymmetric biconic shape of the femoral stem component in the antero-posterior oriented plane, in combination with the rounded anterior and posterior anterior and posterior surfaces of the progressive asymmetric, from distal to proximal increasing, octagonal cross-sectional areas of the prosthesis stem results in an advantageous wedging of the prosthesis between the femoral neck cortex and the compact lamellar bone of the caudal femoris.
  • the two side surfaces and the two blade sides are formed so that the shaft formed axially behind one another, has a multiple, preferably triple wedge or cone shape. Due to the laterally projecting, triple wedge-shaped or cone-like embodiments, an advantageous form fit results on the Kompacta the medial inner femoral neck, the Kaikar femoris and the trabecular system of Spongiosabälkchen the Trochanter majors, in the sense of a firm primary fixation including inner femoral neck support.
  • the cross section orthogonal to the longitudinal central axis has a substantially oval or elliptical shape, wherein the two vertices of the major axis are flattened, so that a barrel-shaped cross-section results.
  • This provides the advantage that compared to other known cross-sections, for example rectangular or trapezoidal, a better fit and a better vascularization results.
  • a rectangular or Trapezoidal cross-section also generates undesirable voltage peaks in the contact zones.
  • the cross-sectional areas orthogonal to the longitudinal center axis progressively increase from the tip of the shaft to terminally adjacent to the fourth quarter of the proximal half of the shaft.
  • This embodiment has a scaled three-dimensional conically shaped (wedge in) basic shape with outwardly curved front and rear surfaces having rounded to the flat formed medial and lateral shaft boundaries corner radii and no sharp-edged, leaf-shaped contours.
  • the outer diameter of this conical shape in 3 planes decreases from proximal to distal according to the individual medullary canal configuration.
  • ventral and dorsal support surface of the femoral stem component are slightly outwardly curved, ie slightly curved against the medullary cavity and the trabecular system of the medullary canal and the shoulder of the greater trochanter and convexly shaped around this wedge-in effect in the sense of marrow clamping due to the size growth of distal to accomplish proximally.
  • the lateral side surface has at its end facing away from the tip a medially directed bevel, which preferably extends over a quarter of the shaft length.
  • This bevel facilitates insertion of the shaft and prevents fissures of the greater trochanter.
  • the lateral shoulder part of the shaft component which is proximally laterally convex in the frontal plane, is much simpler in comparison to the straight shafts straight up to the lateral side, without danger of coming to rest on the greater trochanter, plane-parallel into the interior of the cancellous bone of the greater trochanter, while avoiding the varization effect, insert, sink and impact.
  • the CCD angle defined as the medially open angle eta between the central femoral neck axis and the longitudinal central axis, is between 130 degrees and 134 degrees, preferably 132 degrees. In yet another embodiment, the CCD angle is defined as medially open angle eta between the central femoral neck axis and the central longitudinal axis between 123 degrees and 129 degrees, preferably 126 degrees.
  • the CCD angle defined as the medially open angle eta between the central femoral neck axis and the longitudinal center axis, is between 135 degrees and 141 degrees, preferably 138 degrees.
  • the offer of different embodiments with different CCD angles of appropriately adapted femoral stem components for the Coxa normalis, for the Coxa vara and for the Coxa valga propels the best possible, morphology and positive implantation implantation.
  • the proximal medial femoral stem component boundary is designed with a parabolic medial concave, tangential transition to the distally straight medial stem boundary.
  • the shaft / neck transition between a distally straight and proximal circular designed medial shaft boundary and a medially parabolically designed in the neck area neck area of his turn in another parabolically designed harmonic transition to the plug-in cone designed obtuse.
  • the shaft portion whose upper end is harmoniously and firmly connected to the neck portion, designed harmonically tangential in the "impingementless” designed subconical region of the neck portion.
  • the symmetrically tapering portion of the femoral neck immediately adjacent to the cone base of the standard cone, guarantees “low impinging” articulation in the end positions of the movement limits and, in combination with the smoothly polished or anodized surface of the neck portion and correspondingly suitably rounded edges of the corresponding socket inserts, reduces Neck / Prank impingement in extreme positions. Overall, a more advantageous anchoring of the shaft results.
  • the successive cross section of the shaft are geometrically similar to each other at least in the distal half.
  • the advantage lies in a better anatomical adaptation.
  • the surface of the shaft has a microstructuring in addition to the longitudinal grooves, preferably in the form of a sandblast or a surface etching.
  • FIG. 1 shows a side view of an embodiment of the inventive femoral component for a total hip endophoresis
  • FIG. 2 is a front perspective view of the embodiment of FIG. 1; FIG.
  • FIG. 3 shows a side view of an embodiment of the femoral component according to the invention with the associated plane of symmetry;
  • FIG. 4 shows a schematic view of an embodiment of the femoral component according to the invention
  • FIG. 5A shows the cross-sectional areas of the femoral component along lines A-A, B-B, C-C, D-D, E-E and G-G in FIG. 4;
  • Fig. 5B is a plan view of the cross-sectional area taken along the line F-F in the neck cone area of Fig. 4;
  • Fig. 6 is a plan view in the direction of the arrow V on the femoral component shown in Fig. 3 together with the plane of symmetry and the median plane.
  • FIGS. 1 to 5 An embodiment of the femoral component for a total hip endoprosthesis is shown in FIGS. 1 to 5, which has a shaft 1 intended for anchoring in the medullary cavity of the femur and a neck part 7 adjoining the proximal half 14 of the shaft 1 with a pin 8 for receiving it a condyle includes.
  • the shaft 1 has a length L and comprises a distal, suitable for insertion into the medullary canal half 13 with a tip 6 and a proximal half 14. Further, the shaft 1 has an anterior leaflet side 2, a posterior leaflet side 3, a lateral side surface 4 and a medial side surface 5.
  • a symmetry plane 9 (FIG.
  • the distal half 13 of the shaft 1 comprises a terminal first quarter 15 and a second quarter 16 abutting the proximal half 14 of the shaft 1 while the proximal half 14 has a third quarter 17 abutting the distal half 13 and a terminal fourth quarter 18.
  • the lateral side surface 4 has at its end facing away from the tip 6 a medially directed bevel, which extends approximately over the fourth quarter 18 of the proximal half 14 of the shaft 1.
  • the neckline extends at an obtuse angle to the longitudinal central axis 11, which coincides with the cutting line 27 (FIG. 3) between the plane of symmetry 9 and the median plane 10.
  • the CCD angle defined as the medially open angle eta between the central femoral neck axis 28 and the longitudinal central axis 11, is 138 ° in the embodiment shown here.
  • the proximal medial side surface 5 (femoral stem component limitation) is designed with a parabolic medial concave, tangential transition to the distally straight medial side surface 5 (stem limitation).
  • the shaft part the upper end of which is connected harmoniously and firmly to the neck part, is preferably designed to be harmoniously tangential in the "impingementless" designed subconical region of the neck part.
  • the shaft 1 is provided on the two blade sides 2, 3 with a multiplicity of longitudinal grooves 12, which do not run parallel to the center plane 10 but parallel to the lateral side surface 4.
  • the longitudinal grooves 12 are rectilinear and formed continuously over the entire length of the shaft 1.
  • the longitudinal axes of the longitudinal grooves 12 extend - viewed orthogonal to the plane of symmetry 9 - parallel to a straight line 25 which with the line of intersection 27 of symmetry plane 9 and center plane 10 (Fig. 6) - measured in the plane of symmetry 9 - a Angle alpha includes.
  • the plane of symmetry 9 coincides with the plane of the drawing while the median plane 10 is perpendicular to the plane of the drawing, so that only the line of intersection 27 in the plane of symmetry 9 is shown.
  • Fig. 6 shows a plan view of the femoral component together with the plane of symmetry 9 and the median plane 10.
  • the shaft 1 and the neck portion 7 with the pin 8 are cut through the plane of symmetry 9 while the plane perpendicular to the plane of symmetry 9 center plane 10 intersects only the shaft.
  • the plane of symmetry 9 lies between the two leaf sides 2, 3 while the median plane 10 lies between the lateral side surface 4 and the medial side surface 5.
  • the pin 8 is formed on the adjacent to the proximal half 14 of the shaft 1 neck portion 7 as a standard cone and used to accommodate different modular spherical femoral head components made of chromium, cobalt, alumina or zirconia for "impingement laminate" articulation with modular Hip inserts made of polyethylene, highly crosslinked polyethylene, alumina or zirconia-reinforced ceramic or other materials comprising a nearly hemispherical, suitably surface-textured and coated pan bearing cup with multiradial profile.
  • the shaft 1 is preferably made of a high-strength titanium alloy (TI6AL4V or Ti6AI7Nb), with different surface structures such as corundum, titanium plasma spray, hydroxyapatite coating or HAX coating or sand blasting or with Combinations of the aforementioned surface treatment including nanotechnical methods are possible.
  • TI6AL4V or Ti6AI7Nb high-strength titanium alloy
  • the shaft 1 in the median plane 10 has an open angle beta of 5 degrees, in the plane of symmetry 9 (FIG. 6) a proximal angle gamma open at the top 2.1 to 3.3 degrees, preferably 2.7 degrees and each having a distal, upwardly open angle gamma of 2.1 to 3.1 degrees, preferably 2.6 degrees, progressively increasing in the axial cross-sectional areas from distal to proximal, a scaled at least three-dimensional cone corresponding.
  • FIG. 5A Shown in FIG. 5A are orthogonal cross-sectional areas of the shaft 1 with respect to the longitudinal center axis 11, these cross-sectional areas increasing in size from distal to proximal in the sections A - G G whose axial locations are plotted in FIG. 4.
  • the cross-sectional areas are substantially oval in shape, with the long sides of the oval lying on the anterior and posterior leaf sides 2, 3 ( Figure 1) being convex, while the short sides of the oval are on the lateral , respectively medial side surface 4, 5 (Fig. 1) lie, are formed in a straight line.
  • cross-sectional areas take from the tip 6 of the shaft 1 to terminal to the fourth quarter 18 of the proximal half 14 of the shaft 1 to progressive.
  • This embodiment has a scaled three-dimensional conically shaped (wedge-in) basic shape with outwardly curved anterior and posterior leaf sides 2, 3 (front and rear surfaces) which have rounded corner radii rounded to the medial and lateral side surfaces 4, 5 (shaft boundaries), so that the cross-sectional areas have no sharp-edged, leaf-shaped contours.
  • the outer diameter of this conical shape in 3 planes decreases from proximal to distal according to the individual medullary canal configuration.
  • ventral and dorsal support surface of the femoral stem component are slightly outwardly curved, ie slightly curved against the medullary cavity and the trabecular system of the medullary canal and the shoulder of the greater trochanter and convexly shaped around this wedge-in effect in the sense of marrow clamping due to the size growth of distal to accomplish proximally.
  • the wedge-in effect is achieved in the illustrated embodiment by directly executing on the spherical Prosthesis tip end distal to the original diameter from the tip of the prosthesis to the prosthetic shoulder increases over the total length in the shaft area in the ventrodorsal extension in percentage by 280 to 360%, preferably by 320%.
  • the wedge-in configuration in the ventrodorsal direction shows a scaled percentage decrease from originally 100% in the area of the upper prosthetic shoulder end to 31% in the immediate area below the ball tip of the prosthetic tip.
  • the percent increase in diameter in the medio-lateral extension decreases from distal immediately from the ball tip to proximally over the length of the shaft - up to a distance from the shoulder boundary (section G - G?) Distally by 43.5% - by 202.75% towards, or in other words the mediolateral shaft extension - measured from 43.45% of the prosthetic shoulder towards the shaft - decreases in percentage by 49.32% towards the tip of the prosthesis.
  • the front and rear boundary of the prosthesis shaft is designed not flat but convexly curved and the longitudinal grooves in the illustrated embodiment parallel to the lateral side surface 4 (shaft boundary) in the distal lateral region of the shaft 1 and not the inner shaft curvature approximately following.
  • the two side surfaces 4, 5 and the two blade sides 2, 3 are formed so that the shaft 1 axially one behind the other, has a multiple, preferably triple wedge or cone shape. This embodiment leads to an advantageous wedging of the prosthesis between the femoral neck cortical bone and the compact lamellar bone of the caudal femoris.

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  • Health & Medical Sciences (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

Ce composant fémoral pour prothèse totale de hanche comporte A) une tige (1) de longueur L, destinée à être ancrée dans la cavité médullaire du fémur, qui comprend une moitié distale (13) destinée à être introduite dans le canal médullaire et pourvue d'une pointe (6), une moitié proximale (14), une face aplatie antérieure (2), une face aplatie postérieure (3), une face latérale externe (4), une face latérale interne (5), un plan de symétrie (9) s'étendant entre les deux faces aplaties (2, 3) et un plan médian (10) perpendiculaire au plan de symétrie (9) et s'étendant entre les deux faces latérales (4, 5) et à travers la pointe (6); la moitié distale (13) présentant un premier quart (15) à l'extrémité et un deuxième quart (16) adjacent à la moitié proximale (14) et la moitié proximale (14) présentant un troisième quart (17) adjacent à la moitié distale (13) et un quatrième quart (18) à l'extrémité; et B) une partie col (7) adjacente à la moitié proximale (14), s'étendant à un angle obtus par rapport à l'axe longitudinal médian (11) - défini en tant que ligne d'intersection entre les deux plans (9, 10) - et pourvue d'une cheville (8) destinée à recevoir un condyle ou un condyle fixé à demeure à la partie col (7); C) la moitié distale (13) étant pourvue au moins en partie d'une pluralité de rainures longitudinales (12), et D) au moins une partie des rainures longitudinales (12) ne s'étendant pas parallèlement au plan médian (10).
EP06721966A 2006-05-22 2006-05-22 Composant fémoral pour prothèse totale de hanche Withdrawn EP2023861A1 (fr)

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FR2592786B1 (fr) * 1986-01-10 1991-07-26 Legrange Jean Tige de prothese de hanche
FR2599245B1 (fr) * 1986-05-28 1990-12-21 Dambreville Alain Prothese d'extremite superieure du femur a appui metaphysaire.
FR2600527B1 (fr) * 1986-06-24 1991-12-20 Setiey Louis Partie femorale de prothese de hanche.
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