WO2023099801A1 - Plaque d'ostéosynthèse pour fractures du fémur distal - Google Patents

Plaque d'ostéosynthèse pour fractures du fémur distal Download PDF

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Publication number
WO2023099801A1
WO2023099801A1 PCT/ES2022/070742 ES2022070742W WO2023099801A1 WO 2023099801 A1 WO2023099801 A1 WO 2023099801A1 ES 2022070742 W ES2022070742 W ES 2022070742W WO 2023099801 A1 WO2023099801 A1 WO 2023099801A1
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WO
WIPO (PCT)
Prior art keywords
distal
plate
epiphyseal
screws
area
Prior art date
Application number
PCT/ES2022/070742
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English (en)
Spanish (es)
Inventor
Unai GARCIA DE CORTAZAR ANTOLÍN
Daniel ESCOBAR SÁNCHEZ
Original Assignee
Garcia De Cortazar Antolin Unai
Escobar Sanchez Daniel
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Filing date
Publication date
Application filed by Garcia De Cortazar Antolin Unai, Escobar Sanchez Daniel filed Critical Garcia De Cortazar Antolin Unai
Publication of WO2023099801A1 publication Critical patent/WO2023099801A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/74—Devices for the head or neck or trochanter of the femur
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/80—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates

Definitions

  • Osteosynthesis plate for distal femur fractures Osteosynthesis plate for distal femur fractures.
  • the present invention refers to an osteosynthesis plate for femur fractures that presents a novel structure, from which a lower incidence of pseudarthrosis is achieved, greater axial and rotational stability, a lower rate of early and late implant failure, less probability of iliotibial band syndrome in the knee, as well as a lower rate of screw penetration both in the joint and in the intercondylar groove and notch.
  • the femur is the largest tubular bone in the body and is divided, from proximal to distal, into: head and neck, trochanteric region, diaphysis, and distal epiphysis.
  • the present invention focuses on the anatomy of the last two zones, diaphysis and distal epiphysis.
  • the shaft of the femur has an anterior curvature and an oblique course in the coronal plane at an angle of about 7 o with the vertical plane, so that the distal part of the femur is closer to the midline than the proximal part.
  • the midshaft of the femur is triangular in section, with a posteromedial, a posterolateral, and an anterior surface.
  • some edges are formed, which are the more rounded medial and lateral borders, and the posterior border that has a rough, bilabiate and wide crest called the rough line.
  • the medial and lateral lip diverge to form a posterior surface that forms the floor of the popliteal fossa and its borders, called the medial and lateral supracondylar lines.
  • the medial supracondylar line ends in the notorious tubercle (adductor tubercle) on the superior aspect of the medial condyle at the distal end.
  • the distal epiphysis of the femur is characterized by two large condyles that articulate with the proximal part of the tibia and the patella. These condyles are separated posteriorly by the fossa intercondylar. The latter is delimited in the direction of the posterior face of the diaphysis by the intercondylar line, this being the third of the edges that form the floor of the popliteal fossa (together with the medial and lateral supracondylar lines).
  • the surfaces of the condyles that articulate with the tibia are rounded posteriorly and flatten inferiorly.
  • the condyles join anteriorly, forming a V-shaped intercondylar groove, which is where it articulates with the patella.
  • the lateral surface of the groove is larger and steeper than the medial surface.
  • the epicondyles are bony elevations on the non-articular outer surfaces of the condyles. On one side is the lateral epicondyle, and on the other is the medial epicondyle. Between the lateral epicondyle and the articular surface of the lateral condyle is the popliteal groove. The medial epicondyle is more rounded and prominent, and just posterior to it is the adductor tubercle.
  • the medial condyle and the lateral condyle differ in both size and shape. They diverge in a distal and posterior direction.
  • the lateral condyle is wider anteriorly than posteriorly while the medial condyle is of similar dimensions at both ends.
  • the axis of the femur is oblique in the coronal plane, so in an erect position both condyles rest on the same horizontal plane, despite their dissimilar size.
  • the two condyles In the transverse plane, the two condyles have a slight inclination, almost the same in both, with respect to the sagittal axis. In the sagittal plane there is a curvature that increases backwards. This means that the radius of curvature decreases posteriorly, allowing the characteristic flexion movement of the knee from combined sliding and rolling movements.
  • the most frequent femurs are those that have a narrow/trapezoidal morphology and those that are wide/rectangular.
  • the trabecular bone does not present the same density in all areas of the femur. As in all bones, the trabecular pattern is denser as it is approximates the cortical bone or articular cartilage. In the distal femur, this pattern is not homogeneous either. Nakabayashi et al. studied the different areas of the distal femur and their histomorphology in cadavers. They concluded that the areas with the densest trabecular pattern were the medial condyle, the central area of the intercondylar zone, and the most anterior part of the lateral condyle (or the most lateral part of the intercondylar zone).
  • the most widely used system today is the plate with locked screws. These are precontoured plates that are placed submuscularly-supraperiosteally after direct or indirect reduction. These plates have several distal holes that allow the placement of the screws with an individualized configuration according to the characteristics of the fracture.
  • the locked screws serve as a buttress for the lateral condyle.
  • the locked screws provide angular stability between the screw and the plate that would prevent a possible displacement in varus if the medial cortex is not competent. They are relatively easy to place through minimally invasive approaches. Biomechanically they have proven to be more resistant than other plate designs and, in patients with decreased bone mineral density, they have shown to provide greater stability.
  • the treatment will depend on the stability of the implant. If the implant is not loose, osteosynthesis can be carried out using retrograde intramedullary nails (if the design of the prosthesis and the type of fracture allow it), or using locked plates. The latter are usually of choice in these cases since these fractures are usually accompanied by an osteopenic bone or osteoporotic.
  • plates often do not conform well to the bone surface and screw trajectory is altered, as previously stated, the same occurs with less than average sized femurs where the screw safety corridor is reduced or in periprosthetic fractures, in which the plate may conflict with the shield, forcing the plate to be placed more posteriorly. All these variations mean that, if the plate is not placed in its correct position, it is often highly probable, for the reasons stated above, that the plate may be placed more anteriorly, more posteriorly, or with angular alterations. This means:
  • Placing the plate more anterior than its theoretical position means that the trajectory of the screw can pass through the intercondylar groove, with the consequent injury to the patellar cartilage and the impossibility of flexing-extending the knee due to the mechanical blocking caused by the screws. And placing the plate in a more posterior region increases the likelihood of placing the screws within the intercondylar notch, with risk of injury to ligamentous structures. • Placing the plate with a small angular variation (in valgus or varus), causes the default direction of the screws to be towards the joint, with which the risk of the screws penetrating the joint is very high.
  • the plates fit better in the most proximal part and in the condylar area, leaving the metaphyseal area without contact, resulting in the so-called “plate-bone gap” (PHG).
  • PSG plate-bone gap
  • CPD condyle-to-plate distance
  • DPH plate-to-bone distance
  • Implant failure can occur due to loosening of the screws or breakage of the material, which can occur up to 10% of the time. It is important to differentiate whether implant failure occurs early (in the first 3 months) or late (after 3 months). Late implant failure usually occurs as a consequence of nonunion of the fracture, which with repeated loading of the limb causes the material to reach maximum resistance cycles and break. This problem does not depend so much on the design of the board, since all of them have a maximum number of cycles that they can withstand before breaking. In all current plates, this maximum figure is above the cycles that are supported until fracture consolidation, at which point the bone begins to support the load of the body, ceasing to depend so much on the mounting of the osteosynthesis material. Approximately 75% of material failures occur for this reason.
  • early implant failure is due to a problem with the material, plate design, or surgical technique, as the plate fails before it has had time to consolidate the fracture. This type of failure is less frequent than the previous one, but it can be up to 25% of the time.
  • the invention patent EP 3542739 A1 describes an osteosynthesis plate for fracture treatments that adapt to the anatomy of different types of bone, such as the condylar region of a femur, which presents an anatomical design based on the surface anatomy of real femurs, with a torsional conformation, in which a metaphyseal-epiphyseal screw is intended to be implanted, which provides greater stability to the assembly, due to the trajectory it presents from the lateral face of the metaphysis towards the medial condyle.
  • the osteosynthesis plate for distal femur fractures that is recommended satisfactorily resolves the aforementioned problems.
  • This trajectory coincides with the area of the distal femur that presents a greater bone density, which increases the stability of the assembly by increasing the working length of the screw. Also, the screw is less likely to penetrate the intercondylar groove.
  • the distal-posterior screw goes from the posterior zone of the lateral condyle to the anterior zone of the medial condyle, crossing the intercondylar zone. This trajectory reduces the chances of articular penetration and in the intercondylar notch and groove, being the only plate on the market with this characteristic.
  • This crisscross arrangement of the screws also allows the use of longer screws, all of which translates into greater stability due to the greater working length.
  • Metaphyseal-epiphyseal screw that provides greater stability to the assembly, due to the trajectory it presents from the lateral face of the metaphysis towards the medial condyle. This creates a prism configuration with the distal screws that considerably increases the stability required by certain types of fracture.
  • Figure 1. Shows a latero-anterior perspective view of an osteosynthesis plate for distal femur fractures made according to the object of the present invention.
  • Figure 2. Shows a view of the device of the previous figure according to a perspective opposite to that of said figure.
  • Figure 3. Shows a perspective view of the osteosynthesis plate of figures 1 and 2 arranged on the distal area of the femur where it is applied.
  • Figure 4.- Shows a front elevation view of the assembly of figure 3, but in which the three types of screws provided are applied to the osteosynthesis plate.
  • Figures 5 and 6. Show respective plan views of the arrangement of the fixing screws proximal epiphyseal screws, and of the distal epiphyseal screws, being able to see how in comparison the distal screws have a greater length, being applied on an area of greater bone density.
  • Figure 7.- Shows, finally, a perspective view of the assembly of figure 4.
  • the osteosynthesis plate for distal femur fractures is constituted from an elongated laminar body (1), designed in such a way that it adapts to the anatomy of the surface of the femur, in the In the metaphyseal area it presents a torsional configuration (2), which allows the plate to better adapt to the lateral face (3) of the femur and lateral epicondyle, together with the appropriate metaphyseal angulation, as shown in figures 3, 4. and 7.
  • the torsion of the plate begins in the metaphyseal region.
  • the plate acquires a greater angulation than conventional plates, so that a lower GPH is achieved, thus reducing the possibility of creating a golf club deformity.
  • it presents a greater radius of curvature than other designs, which entails a transition from the diaphyseal region to the more progressive epiphyseal region, thus contributing to a better adaptation.
  • Torsion in the axial plane also begins in the metaphyseal zone. As the plate advances towards the proximal region, it rotates slightly about its longitudinal axis, clockwise for right plates and left-handed for left plates, thereby increasing plate-femur contact.
  • the plate has an alignment of holes (4) for fixing by means of screws to the lateral face (3) of the femur, so that it presents a widening in its distal area in which a pair of holes (5) are established in the proximal epiphyseal area, a pair of distal epiphyseal holes (6) at its distal end, and a centered hole (7) in the metaphyseal-epiphyseal area.
  • the proximal epiphyseals (9) will be implanted in a through the holes (5).
  • the axis of the distal holes (6) presents an inclination such that the distal epiphyseal screws (8-8') in their implantation on them, by means of the corresponding guides, adopt a crossed arrangement, providing greater axial stability and rotational.
  • the distal-anterior screw (8) adopts a direction that goes from the anterior part of the lateral condyle, crosses the intercondyle area, and heads towards the posterior part of the medial condyle. This trajectory coincides with the area of the distal femur that presents a greater bone density which, together with the greater working length of the screw, considerably increases the stability of the assembly.
  • the distal-posterior screw (8') goes from the posterior zone of the lateral condyle to the anterior zone of the medial condyle, crossing the intercondylar zone. This trajectory reduces the chances of articular penetration and in the intercondylar notch and groove, being the only plate on the market with this characteristic.
  • the crisscross arrangement of the distal screws (8-8') allows longer screws to be used than conventional plates, improving plate stability.
  • a metaphyseal-epiphyseal screw (10) is intended to be implanted in the centered hole (7), which provides greater stability to the assembly, said hole including an axis with an inclination from which the epiphyseal screw (10) it adopts a trajectory from the lateral aspect of the metaphysis towards the medial condyle, generating a prism configuration with the distal epiphyseal screws (8-8') which considerably increases the stability required by certain types of fracture.
  • the distal holes (6) and the central hole (7) of the plate accept both locked screws and polyaxial locked screws, screws that include threads in their heads that engage with the threads of the plate holes, so that stability
  • the assembly ceases to depend on the compression applied to the screw, and the plate-screw system starts to function as a unit when it comes to transmitting forces.
  • the locked screws require a drill guide that is threaded into the implantation hole of the locked screw, so that the orientation of the inclination of the corresponding holes (6 and 7) will determine the direction of the drill that will allow the locking screw to be placed (8, 8' and 10) in the appropriate position to achieve maximum integration between its head and the plate, as well as the desired orientation described above.
  • the distal holes (6) and the central hole (7) accept polyaxial locked screws, which require a thread guide for their implantation.
  • the thread guide adapts to the plate without occupying the thread of the plate hole, allowing the direction of the brocade to vary a maximum of 15° with respect to the axis of the plate hole. Maximum limit so that when implanting the polyaxial locking screw, the threads of the head of the screw engage the thread of the corresponding hole in the plate.
  • the intermediate zone or metafisaha (13) of the plate lacks holes, which increases the resistance of the plate in the zone of greatest mechanical stress.
  • the plate incorporates some grooves (11) for optimal coupling of the cerclages in case they are to be placed. This reduces the indentation produced by the plate in the cerclage when it is stressed, with the consequent reduction in the incidence of breakage, technically easier placement, and reduction of the plate-cerclage profile.

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  • Health & Medical Sciences (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Surgical Instruments (AREA)
  • Prostheses (AREA)

Abstract

La présente invention se rapporte à une plaque d'ostéosynthèse ayant une configuration torsionnée qui s'adapte beaucoup mieux à la physionomie du fémur dans sa zone distale et sur laquelle sont disposés des orifices dans un élargissement de la plaque sur l'extrémité distale dans lequel sont implantées des vis épiphysaires distales (8-8') à travers les orifices distaux (6) dont les axes présentent une inclinaison telle que les vis épiphysaires distales (8-8') s'entrecroisent entre elles dans la zone de densité osseuse la plus importante, permettant une longueur plus grande que les vis classiques, et à travers un orifice centré (7) qui guide l'implantation d'une vis métaphysaire-épiphysaire (10) avec une inclinaison telle qu'on obtient une configuration en prisme entre les vis épiphysaires distales (8-8') et la vis métaphysaire-épiphysaire, améliorant notablement la stabilité de la plaque dans son implantation par rapport aux plaques d'ostéosynthèse pour les fractures du fémur distal classiques.
PCT/ES2022/070742 2021-11-30 2022-11-17 Plaque d'ostéosynthèse pour fractures du fémur distal WO2023099801A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
ESU202132382 2021-11-30
ES202132382U ES1284904Y (es) 2021-11-30 2021-11-30 Placa de osteosintesis para fracturas de femur distal

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WO2023099801A1 true WO2023099801A1 (fr) 2023-06-08

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Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20060173458A1 (en) * 2004-10-07 2006-08-03 Micah Forstein Bone fracture fixation system
US20140243906A1 (en) * 2013-02-27 2014-08-28 Biomet C.V. Periprosthetic Plating System Including Plate with System for Retaining Tension on a Cable
CN105520777A (zh) * 2016-02-05 2016-04-27 侯志勇 一种股骨远端前内侧植入骨板
CN208371879U (zh) * 2017-08-10 2019-01-15 常州奥斯迈医疗器械有限公司 股骨远端接骨板
EP3443918A1 (fr) * 2017-08-14 2019-02-20 Stryker European Holdings I, LLC Plaque de fémur
EP3542739A1 (fr) * 2018-03-20 2019-09-25 Globus Medical, Inc. Systèmes de stabilisation d'os

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20060173458A1 (en) * 2004-10-07 2006-08-03 Micah Forstein Bone fracture fixation system
US20140243906A1 (en) * 2013-02-27 2014-08-28 Biomet C.V. Periprosthetic Plating System Including Plate with System for Retaining Tension on a Cable
CN105520777A (zh) * 2016-02-05 2016-04-27 侯志勇 一种股骨远端前内侧植入骨板
CN208371879U (zh) * 2017-08-10 2019-01-15 常州奥斯迈医疗器械有限公司 股骨远端接骨板
EP3443918A1 (fr) * 2017-08-14 2019-02-20 Stryker European Holdings I, LLC Plaque de fémur
EP3542739A1 (fr) * 2018-03-20 2019-09-25 Globus Medical, Inc. Systèmes de stabilisation d'os

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ES1284904U (es) 2022-01-12
ES1284904Y (es) 2022-04-04

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