Tibial baseplate with asymmetric placement of fixation structures

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TIBIAL BASEPLATE WITH ASYMMETRIC PLACEMENT OF FIXATION STRUCTURES

FIELD OF THE DISCLOSURE

[0001] The present disclosure relates to orthopaedic prostheses and, more particularly, to tibial baseplate components in a knee prosthesis.

BACKGROUND OF THE DISCLOSURE

[0002] Orthopaedic prostheses are commonly utilized to repair and/or replace damaged bone and tissue in the human body. For a damaged knee, a knee prosthesis may be implanted using a proximal tibial baseplate component, a tibial bearing component, and a distal femoral component. The tibial baseplate component is affixed to a proximal end of the patient's tibia, which is typically resected to accept the baseplate component. The femoral component is implanted on a distal end of the patient's femur, which is also typically resected to accept the femoral component. The tibial bearing component is placed between the tibial baseplate component and the femoral component, and may be fixed or slidably coupled to the tibial baseplate component.

[0003] The tibial baseplate component provides support for the tibial bearing component. Forces generated by use of the knee prosthesis are transferred through the tibial bearing component to the tibial baseplate component, and ultimately to the tibia. In order to ensure long term performance of the knee prosthesis, stable and firm securemcnt of the tibial baseplate component to the proximal end of the patient's tibia is desired.

SUMMARY

[0004] This application is related to U.S. Non-Provisional Patent Application

Serial No. 13/593,339, filed August 23, 2012 and to U.S. Non-Provisional Patent Application Serial No. 14/278,805, filed May 15, 2014.

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[0005] The present disclosure provides an orthopaedic knee prosthesis including a tibial baseplate component having a distal, bone-contacting surface with one or more fixation structures extending distally therefrom, the fixation structures being asymmetrically arranged within the outer periphery of the baseplate.

[0006] For designs utilizing a plurality of fixation pegs that extend distally from the bone-contacting surface of the tibial baseplate, fixation pegs are asymmetrically arranged in opposite anterior/lateral and posterior/medial regions of the tibial baseplate, thereby maximizing distance between the fixation pegs, avoiding overlap with the intramedullary canal, avoiding areas of low bone density, and avoiding cortical impingement by positioning the fixation pegs in regions of cancellous bone.

[0007] For designs utilizing a single keel that extends distally from the bone-contacting surface of the tibial baseplate, the keel is medialized with respect to the outer periphery of the tibial baseplate, where the degree of medialization increases as prosthesis sizes grow progressively.

[0008] According to an embodiment thereof, the present disclosure provides a tibial prosthesis system comprising: a first tibial baseplate comprising: a first proximal surface; a first distal surface opposite the first proximal surface, the first distal surface sized and shaped to substantially cover a proximal resected surface of a tibia; a first medial face; a first lateral face opposite the first medial face; a first total width measured from the first medial face to the first lateral face; and a first keel extending distally from the first distal surface, the first keel spaced from the first medial face by a first medial distance and spaced apart from the first lateral face by a first lateral distance; and a second tibial baseplate comprising: a second proximal surface; a second distal surface opposite the second proximal surface, the second distal surface sized and shaped to substantially cover a proximal resected surface of a tibia; a second medial face; a second lateral face opposite the second medial face; a second total width measured between the second medial face and the second lateral face, the second total width differing from the first total width whereby the first and second tibial baseplates comprise unique nominal sizes; and a second keel extending distally from the second distal surface, the second keel spaced apart from the second medial face by a second medial distance and spaced apart from the second

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PCT/US2012/052132 lateral face by a second lateral distance, a first ratio of the first medial distance to the first total width differing from a second ratio of the second medial distance to the second total width.

[0009] According to another embodiment thereof, the present disclosure provides a tibial baseplate configured for implantation upon a patient's proximal tibia, the tibial baseplate comprising: a medial compartment; a lateral compartment opposite the medial compartment; a proximal surface; a distal surface opposite the proximal surface, the distal surface sized and shaped to substantially cover the patient's proximal tibia; an outer periphery cooperatively defined by an anterior face, a medial face, a lateral face, and at least one posterior face; a first, anterior-posterior axis located between the medial face and the lateral face and intersecting the anterior face, the first axis extending centrally between the medial and lateral compartments throughout its length; a plurality of fixation pegs extending distally from the distal surface, each of the plurality of fixation pegs being positioned inward of the outer periphery for implantation into the patient's proximal tibia, the plurality of fixation pegs comprising: a medial fixation peg located at the medial compartment; and a lateral fixation peg located at the lateral compartment, the lateral fixation peg being positioned more anteriorly than each other fixation peg among the plurality of fixation pegs.

[0010] According to yet another embodiment thereof, the present disclosure provides a tibial baseplate configured for implantation upon a patient's proximal tibia, the tibial baseplate comprising: a medial compartment; a lateral compartment opposite the medial compartment; a proximal surface; a distal surface opposite the proximal surface, the distal surface sized and shaped to substantially cover the patient's proximal tibia; an outer periphery cooperatively defined by an anterior face, a medial face, a lateral face, and at least one posterior face; at most one medial fixation peg associated with the medial compartment, the medial fixation peg extending distally from the distal surface and positioned for implantation into the patient's proximal tibia; and at most one lateral fixation peg associated with the lateral compartment, the lateral fixation peg extending distally from the distal surface and positioned for implantation into the patient's proximal tibia, the lateral fixation peg being located closer to the anterior face than the medial fixation peg.

[0011] According to still another embodiment thereof, the present disclosure provides a tibial baseplate configured for implantation upon a patient's proximal tibia, the tibial baseplate comprising: a medial compartment; a lateral compartment opposite the medial compartment; a proximal surface; a distal surface opposite the proximal surface, the distal

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PCT/US2012/052132 surface sized and shaped to substantially cover the patient's proximal tibia; an outer periphery cooperatively defined by an anterior face, a medial face, a lateral face, and at least one posterior face; a first, anterior-posterior axis located between the medial face and the lateral face and intersecting the anterior face, the first axis extending centrally between the medial and lateral compartments throughout its length; a first fixation peg extending distally from the distal surface, the first fixation peg being inset from the outer periphery for implantation into the patient's proximal tibia, the first fixation peg being medially spaced from the first axis by a first distance; and a second fixation peg extending distally from the distal surface, the second fixation peg being inset from the outer periphery for implantation into the patient's proximal tibia, the second fixation peg being laterally spaced from the first axis by a second distance, the second distance less than the first distance.

BRIEF DESCRIPTION OF THE DRAWINGS

[0012] The above-mentioned and other features and advantages of this disclosure, and the manner of attaining them, will become more apparent and the invention itself will be better understood by reference to the following description of embodiments of the invention taken in conjunction with the accompanying drawings, wherein:

[0013] FIG. 1 is a proximal plan view of a tibial baseplate made in accordance with the present disclosure, the baseplate having a lateral fixation peg and a medial fixation peg, the baseplate shown implanted upon the resected proximal surface of a patient's tibia, the baseplate shown having an asymmetric outer periphery in solid lines and a symmetric outer periphery in phantom;

[0014] FIG. 2A is a first, distal plan view of the baseplate of FIG. 1, showing medial/lateral positioning of the fixation pegs and the overall medial bias thereof;

[0015] FIG. 2B is a second, distal plan view of the baseplate of FIG. 1 similar to FIG.

2A, showing anterior/posterior positioning of the fixation pegs;

[0016] FIG. 2C is a third, distal plan view of the baseplate of FIG. 1 similar to FIGS.

2A and 2B, also showing anterior/posterior positioning of the fixation pegs;

[0017] FIG. 3 is a lateral elevational view of the baseplate of FIG. 1;

[0018] FIG. 4 is a distal plan view of an alternative baseplate;

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[0019] FIG. 5 is a distal plan view of another alternative baseplate;

[0020] FIG. 6 is a graph illustrating the anterior/posterior positioning of the fixation pegs of FIGS. 1-3 across a range of prosthesis sizes;

[0021] FIG. 7 is a posterior perspective view of the baseplate of FIG. 1, shown with a tibial bearing component mounted thereon;

[0022] FIG. 8 is a proximal plan view of another tibial baseplate made in accordance with the present disclosure, the baseplate having a single fixation keel for fixation to the patient's tibia;

[0023]

[0024]

FIG. 9A is an anterior elevational view of the baseplate of FIG. 8;

FIG. 9B is another anterior elevational view of the baseplate of FIG. 8;

[0025] FIG. 10 is a graph illustrating the medialization of the fixation keel of FIGS, and 9 across a range of prosthesis sizes;

[0026] FIG. 11 is another graph illustrating the medialization of the fixation keel of

FIGS. 8 and 9 across a range of prosthesis sizes;

[0027] FIG. 12 is a graph illustrating the anterior/posterior positioning of the fixation keel of FIGS. 8 and 9 across a range of prosthesis sizes; and

[0028] FIG. 13 is a distal plan view of another baseplate similar to the baseplate shown in FIGS. 2A-2C, but having another lateral fixation peg and another medial fixation peg; and

[0029] Fig. 14 is a perspective view of a posterior-stabilized femoral component in accordance with the present disclosure.

[0030] Corresponding reference characters indicate corresponding parts throughout the several views. The exemplifications set out herein illustrate exemplary embodiments of the invention and such exemplifications are not to be construed as limiting the scope of the invention in any manner.

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DETAILED DESCRIPTION

[0031] The present disclosure provides a tibial baseplate component for a knee prosthesis including asymmetrically arranged distal fixation structures which promote secure and stable long term fixation of the tibial baseplate to a patient's proximal tibia.

[0032] In order to prepare the tibia and femur for receipt of a knee joint prosthesis of the present disclosure, any suitable methods or apparatuses for preparation of the knee joint may be used. The surgical procedure may involve, for example, forming an incision in the patient's skin near the knee joint, resecting the distal end of the patient's femur (not shown), and resecting the proximal end of the patient's tibia T (FIG. 1). Resecting the proximal end of the patient's tibia T (FIG. 1), in particular, may involve guiding a saw blade through an appropriate cutting guide slot to form a substantially planar resected surface S of tibia T, as shown in FIG.

1.

[0033] Exemplary surgical procedures and associated surgical instruments are disclosed in Zimmer's LPS-Flex Fixed Bearing Knee, Surgical Technique bearing copyright dates of 2004, 2007 and 2008, NexGen® Complete Knee Solution, Surgical Technique for the CR-Flex Fixed Bearing Knee bearing a copyright date of 2003, NexGen® Complete Knee Solution Extramcdullary/Intramedullary Tibial Rescctor, Surgical Technique bearing copyright dates of 2000, 2008 and 2009, NexGen® Trabecular Metal™ Monoblock Tibial Components, Surgical Technique Addendum, bearing copyright dates of 2005 and 2007, NexGen® Trabecular Metal™ Tibial Tray, Surgical Technique, bearing copyright dates of 2007 and 2009, and Trabecular Metal™ Monoblock Tibial Components, bearing a copyright date of 2007 (collectively, the Zimmer Surgical Techniques).

[0034] As used herein, proximal refers to a direction generally toward the torso of a patient, and distal refers to the opposite direction of proximal (i.e., away from the torso of a patient). Anterior refers to a direction generally toward the front of a patient or knee, and posterior refers to the opposite direction of anterior (i.e., toward the back of the patient or knee). Lateral refers to a direction generally away from the middle of the patient and the sagittal plane, and medial refers to the opposite direction of lateral (i.e., toward the middle of the patient and the sagittal plane). When referring to one of the patient's knees, lateral refers

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[0035] These anatomical regions are labeled in certain drawings for clarity. In FIG. 1, for example, the anterior region of tibia T is labeled A, the posterior region of tibia T is labeled P, the lateral region of tibia T is labeled L, and the medial region of tibia T is labeled M. Therebetween and moving in a clock-wise direction, the anterior/lateral region of tibia T is labeled AL, the posterior/lateral region of tibia T is labeled PL, the posterior/medial region of tibia T is labeled PM, and the anterior/medial region of tibia T is labeled AM. The AL, PL, PM, and AM regions can be described as dividing tibia T into four corners or quadrants. These labels are referenced throughout the following paragraphs.

[0036] The embodiments shown and described herein illustrate components for a right knee prosthesis. Right and left knee prosthesis configurations are generally mirror images of one another about a sagittal plane. Thus, it will be appreciated that the aspects of the prosthesis described herein for a right knee configuration are equally applicable to a left knee configuration.

1. Tibial Baseplate

[0037] Referring now to FIG. 1, tibial baseplate 10 is shown disposed atop a proximal resected surface S of a patient's tibia T. The upper or proximal surface 11 of baseplate 10 is shown in FIG. 1. This proximal surface 11 of baseplate 10 is configured to receive a tibial bearing component 53 (FIG. 7) in a fixed or a sliding relationship, for example. To arrange baseplate 10 and the tibial bearing component 53 in a fixed relationship, the tibial bearing component 53 may be adhered to, mechanically fastened to, molded directly onto (as discussed further below), or otherwise fixedly coupled to baseplate 10. The illustrative baseplate 10 includes a raised rim 13 around proximal surface 11 to receive, surround, and hold the tibial bearing component 53 therein, but it is contemplated that other structures may be provided on baseplate 10 to receive and hold the tibial bearing component 53 on baseplate 10. In turn, tibial bearing component 53 is configured to interact with the patient's distal femur or a prosthetic femoral component, such as femoral component 70 shown in Fig. 14 and described below.

[0038] Baseplate 10 may be partially or entirely constructed of a highly porous biomaterial. A highly porous biomaterial is useful as a bone substitute and as cell and tissue receptive material. A highly porous biomaterial may have a porosity as low as 55%, 65%, or

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75% or as high as 80%, 85%, or 90%. An example of such a material is produced using Trabecular Metal™ Technology generally available from Zimmer, Inc., of Warsaw, Indiana. Trabecular Metal™ is a trademark of Zimmer, Inc. Such a material may be formed from a reticulated vitreous carbon foam substrate which is infiltrated and coated with a biocompatible metal, such as tantalum, by a chemical vapor deposition (CVD) process in the manner disclosed in detail in U.S. Patent No. 5,282,861 to Kaplan. In addition to tantalum, other metals such as niobium, or alloys of tantalum and niobium with one another or with other metals may also be used.

[0039] Generally, the porous tantalum structure includes a large plurality of ligaments defining open spaces therebetween, with each ligament generally including a carbon core covered by a thin film of metal such as tantalum, for example. The open spaces between the ligaments form a matrix of continuous channels having no dead ends, such that growth of cancellous bone through the porous tantalum structure is uninhibited. The porous tantalum may include up to 75%, 85%, or more void space therein. Thus, porous tantalum is a lightweight, strong porous structure which is substantially uniform and consistent in composition, and closely resembles the structure of natural cancellous bone, thereby providing a matrix into which cancellous bone may grow to provide fixation of baseplate 10 to the patient's bone.

[0040] The porous tantalum structure may be made in a variety of densities in order to selectively tailor the structure for particular applications. In particular, as discussed in the above-incorporated U.S. Patent No. 5,282,861, the porous tantalum may be fabricated to virtually any desired porosity and pore size, and can thus be matched with the surrounding natural bone in order to provide an improved matrix for bone ingrowth and mineralization.

[0041] Bearing component 53 may be molded directly onto baseplate 10, specifically proximal surface 11 of baseplate 10. If baseplate 10 is constructed of a highly porous biomaterial, as discussed above, the material that is used to construct bearing component 53 (e.g., polyethylene) may interdigitate into the pores of baseplate 10 during the molding process. The pores may be located at and beneath proximal surface 11 of baseplate 10, so the resulting molded bearing component 53 may also be located at and beneath proximal surface 11 of baseplate 10. The resulting structure may be a monoblock component having a strong,

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[0042] Baseplate 10 includes outer periphery 12, which may be visible in a top plan view (FIG. 1) or a bottom plan view (FIGS. 2A-2C) with baseplate 10 positioned in a generally transverse anatomical plane. As shown in FIG. 1, outer periphery 12 is cooperatively defined by anterior face 18, posterior/lateral face 20, posterior/medial face 22, PCL cutout area 24, lateral face 62, and medial face 60. Each of these surfaces is described further below.

[0043] Baseplate 10 also includes lateral compartment 14, medial compartment 16, and interior compartment 17 therebetween. Lateral compartment 14 and medial compartment 16 are separated by an anterior-posterior home axis Ah, which is discussed further below. Because FIG. 1 is a proximal view of the patient's right tibia T, lateral compartment 14 of baseplate 10 is located on the right side of FIG. 1 and medial compartment 16 of baseplate 10 is located on the left side of FIG. 1.

[0044] With bearing component 53 in place against baseplate 10 (FIG. 7) to articulate with adjacent femoral component 70, for example, lateral compartment 14 of baseplate 10 will be positioned generally beneath lateral condyle 74 of femoral component 70 to support and articulate with lateral condyle 74, and medial compartment 16 of baseplate 10 will be positioned generally beneath medial condyle 72 of femoral component 70 to support medial condyle 72. Tibial bearing component 53 (Fig. 7) may be disposed between medial and lateral condyles 72, 74 of femoral component 70 and medial and lateral compartments 16, 14 to provide a low-friction articular interface, as described below. In the illustrative embodiment, femoral component 70 includes cam 76 adapted to articulate with a spine of a tibial bearing component, e.g., spine 58 of tibial bearing component 53 (Fig. 7). However, it is contemplated that femoral component 70 may omit spine 76 to provide an uninterrupted space between medial and lateral condyles 72, 74 in some prosthesis designs.

[0045] Anterior face 18 of the illustrative baseplate 10 is disposed anteriorly on periphery 12 of baseplate 10 (i.e., in the A region of tibia T). Anterior face 18 is generally centrally located between lateral and medial compartments 14, 16. More specifically, as shown in FIG. 1, anterior face 18 includes a linear or flat portion 18a that is generally centrally located between lateral and medial compartments 14, 16. In this illustrated embodiment, flat portion 18a of anterior face 18 defines the anterior-most extent of baseplate 10.

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[0046] Posterior/lateral face 20 of the illustrative baseplate 10 is disposed generally opposite anterior face 18 in the posterior region of lateral compartment 14 (i.e., near the PL region of tibia T). Posterior/medial face 22 of the illustrative baseplate 10 is disposed generally opposite anterior face 18 in the posterior region of medial compartment 16 (i.e., near the PM region of tibia T). The PCL cutout area 24 is disposed between posterior/lateral face 20 and posterior/medial face 22 (i.e., near the P region of tibia T). From both posterior/lateral face 20 and posterior/medial face 22, the PCL cutout area 24 extends generally anteriorly until reaching apex 24a.

[0047] Lateral face 62 of the illustrative baseplate 10 is disposed laterally of lateral compartment 14 on periphery 12 of baseplate 10 (i.e., near the L region of tibia T). Medial face 60 of the illustrative baseplate 10 is located medially of medial compartment 16 on periphery 12 of baseplate 10 (i.e., near the M region of tibia T).

2. Home Axis and Other Reference Axes of Tibial Baseplate

[0048] In the context of patient anatomy, such as tibia T described herein, home axis

Ah of tibia T extends anteriorly from a posterior point Pp on tibia T to an anterior point Pa on tibia T. The posterior point Pp and the anterior point Pa of tibia T are discussed further below.

[0049] The posterior point P_P is generally disposed in the area where the patient's posterior cruciate ligament (PCL) attaches to tibia T. More specifically, the posterior point Pp is generally disposed at the geometric center of the attachment between the patient's PCL and tibia T. The patient's PCL typically attaches to tibia T in two ligament bundles, the first bundle having a more anterolateral attachment location and the second bundle having a more posteromedial attachment location. In FIG. 1, the posterior point Pp is shown at the geometric center of the first bundle. It is also within the scope of the present disclosure that the posterior point Pp may be located at the geometric center of the second bundle or at the geometric center of the first and second bundles, together.

[0050] The anterior point Pa is disposed on the patient's anterior tibial tubercle B. In

FIG. 1, the anterior point Pa is medially spaced from the tubercle midpoint Bm (at marking 1/2) by an amount equal to 1/6 of the overall medial/lateral tubercle width Bw (which spans between markings 0 and 1). Stated another way, the anterior point Pa is laterally spaced from the tubercle medial end B_ME (at marking 0) by an amount equal to 1/3 of the overall

CA 02856571 2015-01-22 medial/lateral tubercle width Bw (which spans between markings 0 and 1), such that the anterior point P_A lies on the medial third of the anterior tibial tubercle B (at marking 1/3).

[0051] In the context of a prosthesis, such as tibial baseplate 10 described herein, home axis A_H of baseplate 10 refers to an anterior-posterior extending axis of baseplate 10 that aligns with home axis A_H of tibia T upon implantation of baseplate 10 onto resected surface S of tibia T in a proper rotational and spatial orientation (as shown in FIG. 1). According to an exemplary embodiment of the present disclosure, and as shown in FIG. 1, home axis A_H of baseplate 10 is centrally located between the inner-most portion of lateral compartment 14 and the inner-most portion of medial compartment 16 of baseplate 10 throughout its length. In other words, home axis Ah of baseplate 10 is equidistant from the inner-most portion of lateral compartment 14 and the inner-most portion of medial compartment 16 of baseplate 10 to divide the interior compartment 17 therebetween into substantially equal halves.

[0052] In the illustrative embodiment of FIG. 1, home axis Ah of baseplate 10 bisects anterior face 18 of baseplate 10 (which is located anteriorly on periphery 12 of baseplate 10) and is generally perpendicular to flat portion 18a of anterior surface 18. Also, home axis Ah of baseplate 10 bisects PCL cutout area 24 of baseplate 10 (which is located posteriorly on periphery 12 of baseplate 10) and is generally perpendicular to apex 24a of PCL cutout area 24. It is contemplated that home axis Ah of baseplate 10 may be oriented to other features of baseplate 10, it being understood that proper alignment and orientation of baseplate 10 upon resected surface S of tibia T will position home axis Ah of baseplate 10 coincident with home axis Ah of tibia T.

[0053] The home axes Ah of tibia T and baseplate 10 arc further described in U.S.

Patent Application Publication No. 2012/0022659, filed July 22, 2011, entitled ASYMMETRIC TIBIAL COMPONENTS FOR A KNEE PROSTHESIS,.

[0054] A pair of reference axes 26, 28 is presented in FIG. 1. A first reference axis 26 extends diagonally across baseplate 10 from the back-left PM region of tibia T to the front-right AL region of tibia T, intersecting home axis A_H to define a first angle a with home axis A_H, as shown in FIG. 1. A second reference axis 28 extends diagonally across baseplate 10 and perpendicularly to the first axis 26 from the back-right PL region of tibia T to the front-left AM

CA 02856571 2015-01-22 region of tibia T, intersecting home axis Ah to define a second angle β with home axis Ah, as shown in FIG. 1. The first and second angles a and β are each approximately 45 degrees such that, when combined, the first and second angles a and β together total approximately 90 degrees.

[0055] The first and second reference axes 26, 28 illustratively intersect one another and home axis A_H at a common point X within periphery 12 of baseplate 10. According to an exemplary embodiment of the present disclosure, point X is generally centered within periphery 12 of baseplate 10 to maximize the aggregated extent of each reference axis 26, 28 that is located within periphery 12 of baseplate 10 while maintaining the desired first and second angles a and β, as discussed above. Point X is illustratively positioned along home axis Ah between flat portion 18a of anterior face 18 and apex 24a of PCL cutout area 24.

[0056] Illustratively, a medial-lateral axis 50 also extends through point X in a direction perpendicular to home axis Ah. Together, the medial-lateral axis 50 (e.g., the x-axis) and the anterior-posterior home axis A_H (e.g., the y-axis) cooperate to define a component coordinate system (e.g., an x-y coordinate system) useful for quantifying and identifying certain features of baseplate 10.

3. Shape of Outer Periphery of Tibial Baseplate

[0057] According to an exemplary embodiment of the present disclosure, and as shown in FIG. 1, baseplate 10 has an asymmetric outer periphery 12. The asymmetric outer periphery 12 may be designed to closely match the corresponding periphery of resected surface S of tibia T. In the illustrated embodiment of FIG. 1, for example, medial compartment 16 is larger than lateral compartment 14. Medial compartment 16 is wider than lateral compartment 14, so medial face 60 is spaced further apart from the anterior-posterior home axis A_H than lateral face 62. Medial compartment 16 is also deeper than lateral compartment 14, so posterior/medial face 22 is spaced further apart posteriorly from the medial-lateral axis 50 than posterior/lateral face 20. For at least these reasons, the outer periphery 12 of baseplate 10 is asymmetric.

[0058] The asymmetric shape of baseplate 10 is further described in U.S. Patent

Application Publication No. 2012/0022659, filed July 22, 2011, entitled ASYMMETRIC TIBIAL COMPONENTS FOR A KNEE PROSTHESIS,.

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[0059] It is also within the scope of the present disclosure that baseplate 10 may have a symmetric outer periphery 212, as shown in phantom in FIG. 1. In this embodiment, lateral compartment 14 and medial compartment 16 are the same shape and size. Lateral compartment 14 and medial compartment 16 are the same width, so lateral face 62 and the modified medial face 260 (shown in phantom) are equidistant from the anterior-posterior home axis Ah. In this manner, an anterior-posterior axis of symmetry through outer periphery 212 of symmetric baseplate 10 may overlay home axis A_H and may serve as a reference for lateral compartment 14, medial compartment 16, lateral face 62, medial face 260, lateral and fixation pegs 30, 32 (described below) and other components of baseplate 10. Thus, in addition to being centered within interior compartment 17 between lateral compartment 14 and medial compartment 16 of the symmetric embodiment of baseplate 10, the anterior-posterior home axis Ah would also be centered between lateral face 62 and the modified medial face 260 (shown in phantom). Lateral compartment 14 and medial compartment 16 also define a common anterior/posterior depth, so posterior/lateral face 20 and the modified posterior/medial face 222 (shown in phantom) are equidistant from the medial-lateral axis 50. Generally, a symmetric outer periphery 212 allows the same baseplate 10 to be implanted onto either a patient's right tibia or left tibia.

4. Fixation Pegs

[0060] Referring next to FIGS. 2A-2C and 3, the underside or distal surface 34 of baseplate 10 is shown. Distal surface 34 is the surface which contacts resected surface S of tibia T (FIG. 1) after implantation of baseplate 10. As shown in FIG. 3, distal surface 34 is located opposite proximal surface 11. Baseplate 10 includes a plurality of fixation structures, illustratively lateral fixation peg 30 and medial fixation peg 32, that extend distally from distal surface 34 and into tibia T (FIG. 1).

[0061] Each fixation peg 30, 32 is inset from outer periphery 12 of baseplate 10. Each fixation peg 30, 32 may have a minimum inset distance 39 (FIG. 2A) that exceeds 0 mm, such as 1 mm, 3 mm, 5 mm, or more, for example. For purposes of the present disclosure, and as shown in FIG. 2A, the minimum inset distance 39 is the smallest distance measured between outer periphery 12 of baseplate 10 and the outer perimeter of each fixation peg 30, 32.

[0062] According to an exemplary embodiment of the present disclosure, fixation pegs

30, 32 of baseplate 10 are constructed of a highly porous biomaterial, such as the

CA 02856571 2015-01-22 above-described porous tantalum material. Distal surface 34 of baseplate 10 may also be constructed of a highly porous biomaterial. With distal surface 34 of baseplate 10 resting against resected surface S of tibia T and fixation pegs 30, 32 of baseplate 10 extending distally into tibia T, the highly porous biomaterial may provide a matrix into which cancellous bone may grow to provide fixation of baseplate 10 to tibia T.

[0063] As shown in FTG. 3, the illustrative fixation pegs 30, 32 are hexagonal in cross-section near distal surface 34 of baseplate 10. As fixation pegs 30, 32 continue extending distally away from distal surface 34 of baseplate 10, fixation pegs 30, 32 transition to a circular cross-section. The hexagonal to circular transition of fixation pegs 30, 32 is also evident in FIGS. 2A-2C. In FIG. 1, by contrast, each fixation peg 30, 32 is represented by a phantom circle to schematically show the general location of each fixation peg 30, 32, not necessarily the size or shape of each fixation peg 30, 32. Exemplary fixation pegs 30, 32 are shown at pages 16-19 of the Zimmer® Tibial Baseplate, Pocket Guide United States Version,.

[0064] According to an exemplary embodiment of the present disclosure, and as discussed further below, lateral and medial fixation pegs 30, 32 are asymmetrically arranged on distal surface 34 of baseplate 10. In one exemplary embodiment, fixation pegs 30, 32 are asymmetrically arranged about the anterior-posterior home axis A_H, such that the anterior-posterior home axis A_H is not an axis of symmetry of fixation pegs 30, 32. In another embodiment, fixation pegs 30, 32 are asymmetrically arranged about the medial-lateral axis 50, such that the medial-lateral axis 50 is not an axis of symmetry of fixation pegs 30, 32. In yet another embodiment, fixation pegs 30, 32 are asymmetrically arranged about both the anterior-posterior home axis A_H and the medial-lateral axis 50, such that neither the anterior-posterior home axis Ah nor the medial-lateral axis 50 is an axis of symmetry of fixation pegs 30, 32.

5. Anterior/Lateral fAL) and Posterior/Medial (PM) Positioning of Fixation Pegs

[0065] Returning now to FIG. 1, lateral fixation peg 30 in lateral compartment 14 of baseplate 10 is positioned anteriorly relative to the medial-lateral axis 50 and anteriorly of medial fixation peg 32. Thus, lateral fixation peg 30 is more generally positioned in the AL region of tibia T while being substantially distanced from the PL region of tibia T. The AL bias

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PCT/US2012/052132 of lateral fixation peg 30 is evident in FIG. 1, because from the center point X, the first axis 26 extends toward the AL region and approaches or even intersects lateral fixation peg 30, while the second axis 28 extends toward the PL region extends further away from lateral fixation peg 30.

[0066] In the medial compartment 16 of baseplate 10, medial fixation peg 32 is positioned posteriorly relative to the medial-lateral axis 50 and posteriorly of lateral fixation peg 30. Thus, medial fixation peg 32 is more generally positioned in the PM region of tibia T while being substantially distanced from the AM region of tibia T. The PM bias of medial fixation peg 32 is evident in FIG. 1, because from the center point X, the first axis 26 extends toward the PM region and approaches or even intersects medial fixation peg 32, while the second axis 28 extends toward the AM region and travels away from medial fixation peg 32. In this exemplary embodiment, both fixation pegs 30, 32 are generally positioned along the same first reference axis 26 which spans the PM and AL regions.

[0067] An alternative baseplate 10' is shown in FIG. 4 for contrast. Outer periphery 12' of the alternative baseplate 10' of FIG. 4 is generally the same as outer periphery 12 of baseplate 10 (shown in solid lines in FIG. 1) - both are asymmetric in shape. However, unlike fixation pegs 30, 32 of FIGS. 2A-2C, which are located on opposite sides of the medial-lateral axis 50, fixation pegs 30', 32' of FIG. 4 are aligned along and intersect with medial-lateral axis 50'. With respect to baseplate 10', both the anterior-posterior home axis Ah' and the medial-lateral axis 50' are axes of symmetry for fixation pegs 30', 32', such that fixation pegs 30', 32' may be said to be symmetrically oriented with respect to the component coordinate system.

[0068] Another alternative baseplate 10 is shown in FIG. 5 for contrast. Outer periphery 12 of the alternative baseplate 10 of FIG. 5 is generally the same as outer periphery 212 of baseplate 10 (shown in phantom in FIG. 1) - both are symmetric in shape. Lateral compartment 14 of the alternative baseplate 10 is generally the same size and shape as medial compartment 16 of the alternative baseplate 10. Therefore, the anterior-posterior home axis Ah is an axis of symmetry for outer periphery 12 of baseplate 10. Like fixation pegs 30', 32' of FIG. 4, fixation pegs 30, 32 of FIG. 5 are aligned along and intersect with medial-lateral axis 50. With respect to baseplate 10, both the anterior-posterior home axis Ah and the medial-lateral axis 50 are axes of symmetry for fixation pegs 30, 32, such that that fixation

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PCT/US2012/052132 pegs 30, 32 may be said to be symmetrically oriented with respect to the component coordinate system.

[0069] Returning again to FIG. 1, the asymmetric positioning of lateral and medial fixation pegs 30, 32 near opposite AL and PM comers or quadrants, respectively, allows fixation pegs 30, 32 to be widely spaced apart across distal surface 34 of baseplate 10. Advantageously, this wide spacing facilitates avoidance of the anatomic intramedullary canal of tibia T upon implantation (which may be located near the intersection point X), particularly where baseplate 10 is used for a small-stature patient. By avoiding placement of fixation pegs 30, 32 within the intramedullary canal of tibia T, the associated areas of low bone density are avoided and, instead, fixation pegs 30, 32 may be implanted into areas of higher bone density, thereby promoting firm and stable long-term fixation of tibial baseplate 10 to tibia T. If fixation pegs 30, 32 are constructed of a highly porous biomaterial, as discussed above, this firm and stable long-term fixation may be achieved by cancellous bone growth into the porous fixation pegs 30, 32. Also advantageously, the wide spacing between fixation pegs 30, 32 encourages bone ingrowth therebetween. By contrast, if fixation pegs 30, 32 are too close together, there may not be enough space for bone to grow therebetween.

[0070] Also, the asymmetric arrangement of lateral and medial fixation pegs 30, 32 on opposite sides of the medial-lateral axis 50 may enhance the torsional stability of baseplate 10 when implanted upon tibia T (FIG. 1). During normal use, a significant portion of the forces generated on baseplate 10 are directed anteriorly or posteriorly. Activities which primarily generate such anteriorly-directed or posteriorly-directed forces include walking, running, squatting, and climbing stairs, for example. As shown in FIG. 3, such anteriorly-directed and posteriorly-directed forces give rise to anterior torsional moments M_A and posterior torsional moments Mp, respectively, which urge rotation of baseplate 10 anteriorly and posteriorly about the medial-lateral axis 50. Having lateral and medial fixation pegs 30, 32 positioned on opposite sides of the medial-lateral axis 50 (i.e., the axis of rotation), as illustrated in FIG. 3 and discussed in detail above, presents greater resistance to such rotation.

[0071] Furthermore, positioning lateral and medial fixation pegs 30, 32 in the AL and

PM regions of tibia T, rather than the PL and AM regions of tibia T, may avoid impingement of pegs 30, 32 on adjacent cortical bone upon implantation of baseplate 10. Advantageously, the AL and PM regions of tibia T (where fixation pegs 30, 32 are located) are typically populated with substantial areas of cancellous bone, thereby promoting firm and stable long-term fixation

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PCT/US2012/052132 of tibial baseplate 10 to tibia T and promoting bone ingrowth. By contrast, the PL and AM regions of tibia T (where fixation pegs 30, 32 are not located) are typically populated with substantial areas of cortical bone. By avoiding the PL and AM regions of tibia T, the potenital for impingement of fixation pegs 30, 32 upon cortical bone is minimized.

6. Lateral/Medial Positioning of Fixation Pegs

[0072] Because lateral fixation peg 30 extends from lateral compartment 14 and medial fixation peg 32 extends from medial compartment 16, as discussed above, lateral fixation peg 30 can be said to be positioned more laterally on distal surface 34 of baseplate 10 than medial fixation peg 32. Similarly, medial fixation peg 32 is positioned more medially on distal surface 34 of baseplate 10 than lateral fixation peg 30. Thus, as shown in FIG. 2A, fixation pegs 30, 32 are spaced apart by a medial-lateral separation distance 36. For purposes of the present disclosure, the medial-lateral separation distance 36 is measured on center between fixation pegs 30, 32 along a direction perpendicular to home axis Ah and parallel to medial-lateral axis 50 (FIG. 2B). In an exemplary embodiment, the medial-lateral separation distance 36 is between 20 mm and 55 mm, with smaller separation distances 36 corresponding to smaller nominal prosthesis sizes, and larger separation distances 36 corresponding to larger nominal prosthesis sizes.

[0073] According to an exemplary embodiment of the present disclosure, lateral fixation peg 30 and/or medial fixation peg 32 are medially biased in their respective compartments 14, 16. In lateral compartment 14, the illustrative lateral fixation peg 30 is medially biased toward home axis Ah. In medial compartment 16, the illustrative medial fixation peg 32 is medially biased away from home axis Ah. The medial bias of fixation pegs 30, 32, is evident in FIG. 2A, for example, where central peg axis 38 (which is centered along the medial-lateral separation distance 36 between fixation pegs 30, 32) is medially biased toward medial compartment 16 and away from home axis Ah. Because central peg axis 38 is centered along medial-lateral separation distance 36, central peg axis 38 divides medial-lateral separation distance 36 into equal halves - one half being located between lateral fixation peg 30 and central peg axis 38 and the other half being located between medial fixation peg 32 and central peg axis 38.

[0074] If fixation pegs 30, 32 were equally spaced apart from home axis A_H, central peg axis 38 would coincide with home axis A_H. However, in FIG. 2A, pegs 30, 32 are not

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PCT/US2012/052132 equally spaced apart from home axis Ah. Instead, lateral fixation peg 30 is located closer to home axis Ah than medial fixation peg 32. As a result, central peg axis 38 between fixation pegs 30, 32 is medially spaced or offset toward medial compartment 16 and away from home axis A_H by offset distance 40. Therefore, fixation pegs 30, 32 may be said to be asymmetrically, medially biased relative to home axis Ah. In an exemplary embodiment, offset distance 40 is between 3 mm and 6 mm. Smaller prosthesis sizes may have smaller values for offset distance 40, while larger prosthesis sizes may have larger values for offset distance 40.

7. Anterior/Posterior Positioning of Fixation Pegs

[0075] As discussed above, lateral fixation peg 30 is positioned relatively more anteriorly on distal surface 34 of baseplate 10 than medial fixation peg 32. Stated differently, medial fixation peg 32 is positioned relatively more posteriorly on distal surface 34 of baseplate 10 than lateral fixation peg 30. Thus, as shown in FIG. 2B, pegs 30, 32 are spaced apart by an anterior-posterior separation distance 42. For purposes of the present disclosure, the anterior-posterior separation distance 42 is measured on center between fixation pegs 30, 32 along a direction parallel to home axis Ah. In an exemplary embodiment, the anterior-posterior separation distance 42 is between 5 mm and 11 mm, with smaller separation distances 42 corresponding to smaller prosthesis sizes, and larger separation distances 42 corresponding to larger prosthesis sizes.

[0076] The alternative baseplates 10', 10 of FIGS. 4 and 5 are provided for contrast.

Because lateral and medial fixation pegs 30', 32' of the alternative baseplate 10' of FIG. 4, for example, are aligned in an anterior-posterior direction, lateral and medial fixation pegs 30', 32' lack an anterior-posterior separation distance analogous to the anterior-posterior separation distance 42 of FIG. 2B. Or stated differently, lateral and medial fixation pegs 30', 32' have an anterior-posterior separation distance equal to 0 mm. Similarly, lateral and medial fixation pegs 30, 32 of the alternative baseplate 10 of FIG. 5 are aligned in an anterior-posterior direction and, therefore, have an anterior-posterior separation distance equal to 0 mm.

[0077] Turning now to FIG. 2C, another way of quantifying the anterior/posterior asymmetry of fixation pegs 30, 32 is by contrasting their different positions relative to a common reference marker. In FIG. 2C, for example, the common reference marker is flat portion 18a of anterior face 18 of baseplate 10, with measurements being taken posteriorly

CA 02856571 2015-01-22 therefrom in a direction parallel to home axis Ah. Lateral fixation peg 30 is spaced posteriorly from anterior face 18 by a relatively smaller lateral peg distance 46, while medial fixation peg 32 is spaced posteriorly from anterior face 18 by a relatively larger medial peg distance 48. The lateral anterior/posterior depth 44 of lateral compartment 14 of baseplate 10 is also shown being measured from anterior face 18 to posterior/lateral face 20 of baseplate 10, and this lateral anterior/posterior depth 44 exceeds both peg distances 46, 48. Similarly, medial anterior/posterior depth 45 of medial compartment 16 of baseplate 10 is also shown being measured from anterior face 18 to posterior/medial face 22 of baseplate 10, and medial anterior/posterior depth 45 exceeds both peg distances 46, 48, as well as lateral anterior/posterior depth 44. If baseplate 10 had a symmetric outer periphery 212 (shown in phantom in FIG. 1) instead ofthe asymmetric outer periphery 12 ofFIG. 2C, lateral depth 44 and medial depth 45 would be the same.

[0078] The alternative baseplates 10', 10 of FIGS. 4 and 5 are provided for contrast.

Because lateral and medial fixation pegs 30', 32' ofthe alternative baseplate 10' ofFIG. 4, for example, are aligned in an anterior-posterior direction, the lateral peg distance 46' from anterior face 18' to lateral fixation peg 30' is the same as the medial peg distance 48' from anterior face 18' to medial fixation peg 32'. The same is also true for lateral peg distance 46 and medial peg distance 48 of the alternative baseplate 10 ofFIG. 5. Because the alternative baseplate 10' of FIG. 4 has an asymmetric outer periphery 12', medial depth 45' differs from lateral depth 44'. Because the alternative baseplate 10 of FIG. 5 has a symmetric outer periphery 12, on the other hand, medial depth 45 is the same as lateral depth 44.

8. Asymmetric Positioning of Fixation Pegs for Set of Prostheses

[0079] Baseplate 10 may be provided in a kit or set of different prosthesis sizes. In one embodiment, nine baseplates 10 are provided in the set, with baseplates 10 growing progressively in lateral anterior/posterior depth 44 and/or other dimensions, for example. The progressive growth of periphery 12 of baseplates 10 across the set or family of baseplate sizes is described in detail in U.S. Patent Application Publication No. 2012/0022660 filed July 22, 2011 and entitled ASYMMETRIC TIBIAL COMPONENTS FOR A KNEE PROSTHESIS (Attorney Docket: Z1M0815-02).

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[0080] Referring next to FIG. 6, exemplary peg distances 46, 48 are graphically presented for a set of prostheses of different sizes. More specifically, exemplary peg distances 46, 48 are graphically presented for a set of prostheses having different lateral depths 44. The vertical axis of FIG. 6 shows peg distances 46, 48 (in millimeters), while the horizontal axis of FIG. 6 shows various lateral depths 44 (also in millimeters) and the corresponding nominal size indicator (1-9). The data points located farther to the left represent smaller lateral depths 44 (and therefore smaller nominal prosthesis sizes), and data points located farther to the right represent larger lateral depths 44 (and therefore larger nominal prosthesis sizes). In accordance with FIG. 2C, peg distances 46, 48 and lateral depth 44 are measured posteriorly from flat portion 18a of anterior face 18.

[0081] For each given prosthesis size (i.e., each discrete value of lateral depth 44), a pair of points are presented for lateral and medial peg distances 46, 48, respectively, with a space between the pair of points. This space indicates that peg distances 46,48 are different for each of the nine given prosthesis sizes. Medial peg distances 48 consistently exceed the corresponding lateral peg distances 46 for each of the nine given prosthesis sizes. For example, each medial peg distance 48 may exceed the corresponding lateral peg distance 46 by 7 mm to 11 mm. In this manner, each of the given prostheses has anterior/posterior asymmetry of fixation pegs 30, 32 with respect to anterior face 18.

[0082] FIG. 6 also demonstrates that, as the prosthesis size increases, medial peg distances 48 may increase at a faster rate than lateral peg distances 46. In the illustrated embodiment of FIG. 6, medial peg distances 48 increase at a rate (i.e., slope) of approximately 0.9, while lateral peg distances 46 increase at a rate of approximately 0.6. As a result, the difference between medial peg distance 48 and its corresponding lateral peg distance 46 increases as the prosthesis size increases, causing fixation pegs 30, 32 to become more and more spaced apart as the prosthesis size increases.

[0083] With respect to the alternative baseplate 10' of FIG. 4, by contrast, where the lateral peg distance 46' is the same as the medial peg distance 48', the peg distances 46', 48' would overlap graphically in FIG. 6. Thus, for any given prosthesis size, a single point corresponding to both lateral peg distance 46' and medial peg distance 48' would be presented in FIG. 6, without a space therebetween. Also, because fixation pegs 30', 32' of baseplate 10' are aligned along medial-lateral axis 50', and not forward of or behind medial-lateral axis 50' like fixation pegs 30, 32 of baseplate 10, the overlapping peg distances 46', 48' of the

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PCT/US2012/052132 alternative baseplate 10' would fall somewhere between the spaced-apart peg distances 46, 48 of FIG. 6. The same result would occur with the overlapping peg distances 46, 48 of the alternative baseplate 10 of FIG. 5.

[0084] According to an exemplary embodiment of the present disclosure, the above-described distances, including inset distance 39, medial-lateral separation distance 36, offset distance 40, anterior-posterior separation distance 42, lateral peg distance 46, and medial peg distance 48, are measured along distal surface 34 of baseplate 10. As a result, the distances are measured near the intersection of each peg 30, 32 with distal surface 34 (e.g., near the proximal end of each peg 30, 32). In embodiments where pegs 30, 32 are perpendicular to distal surface 34, the distances could also be measured away from distal surface 34 (e.g., near the distal end of each peg 30, 32) without impacting the measurements. In embodiments where pegs 30, 32 are canted relative to distal surface 34, however, the measurements could vary if taken away from distal surface 34 (e.g., near the distal end of each canted peg 30, 32). Therefore, for consistency, the measurements are taken along distal surface 34 of baseplate 10.

9. Force Testing of Asymmetric Fixation Pegs

[0085] A first prosthesis was manufactured, as shown in FIG. 7, by mounting bearing component 53 onto baseplate 10, with baseplate 10 having an asymmetric outer periphery 12 and asymmetrically arranged lateral and medial fixation pegs 30, 32 (FIGS. 1-3). A second prosthesis (not shown) was manufactured by mounting a similar bearing component 53 onto an alternative baseplate 10', with the alternative baseplate 10' having an asymmetric outer periphery 12' but aligned lateral and medial fixation pegs 30', 32' (FIG. 4). A third prosthesis (not shown) was manufactured by mounting a similar bearing component 53 onto another alternative baseplate 10, with the other alternative baseplate 10 having a symmetric outer periphery 12 and aligned lateral and medial fixation pegs 30, 32 (FIG. 5).

[0086] The illustrative bearing component 53 has lateral articular surface 54, medial articular surface 56, and spine 58 located therebetween. When bearing component 53 is assembled onto baseplate 10, as shown in FIG. 7, lateral articular surface 54 of bearing component 53 aligns with lateral compartment 14 of baseplate 10, medial articular surface 56 of bearing component 53 aligns with medial compartment 16 of baseplate 10, and spine 58 aligns with interior compartment 17 (FIG. 1) of baseplate 10. For the first and second prostheses, bearing component 53 had a thickness T of 20 mm. For the third prosthesis,

CA 02856571 2015-01-22 bearing component 53 had a thickness T of 17 mm. Bearing component 53 and its associated articular surfaces 54, 56 are described in detail in :

U.S. Non-Provisional Patent Application Serial No. 13/459,037, filed April 27, 2012;

U.S. Non-Provisional Patent Application Serial No. 14/490,153, filed September 18, 2014; U.S. Non-Provisional Patent Application Serial No. 13/459,041, filed on April 27, 2012; U.S. Non-Provisional Patent Application Serial No. 13/459,048 filed on April 27, 2012; U.S. Non-Provisional Patent Application Serial No. 14/181,033 filed February 14, 2014; U.S. Non-Provisional Patent Application Serial No. 13/459,056 filed April 27, 2012; and U.S. Non-Provisional Patent Application Serial No. 14/284,028 filed May 21, 2014, all entitled TIBIAL BEARING COMPONENT FOR A KNEE PROSTHESIS

WITH IMPROVED ARTICULAR CHARACTERISTICS.

[0087] As shown in FIG. 7, a lateral compressive force Fcl was applied onto lateral articular surface 54 of each bearing component 53, and a medial compressive force Fcm was applied onto medial articular surface 56 of each bearing component 53. The compressive forces F_Cl, Fcm measured 202 N.

[0088] Simultaneously with application of the compressive forces Fcl, Fcm, an anterior-facing force F_Ap was applied to the distal/posterior base of spine 58, as shown in FIG. 7. The anterior-facing force F_AP measured 725 N for the first and second prostheses and was scaled up to 791 N for the third prosthesis to account for the thinner bearing component 53.

[0089] Forces Fcl, Fcm, and F_AP were designed in magnitude and area of application to replicate forces exerted on tibial bearing component 53 by a prosthetic femoral component, e.g., femoral component 70, during a kneeling motion. An exemplary femoral component

CA 02856571 2015-01-22 which articulates with tibial bearing component 53 is described in U.S. Patent Application Serial No. 13/459,061 filed April 27, 2012 (Attorney Docket No. ZIM0915-07), and are further described in U.S. Patent Application Serial No. 13/459,064 filed April 27, 2012 (Attorney Docket No. ZIM0915-08), and are further described in U.S. Patent Application Serial No. 13/459,060 filed April 27, 2012 (Attorney Docket No. ZIM0915-09), and are further described in U.S. Patent Application Serial No. 13/161,624 filed June 16, 2014 all entitled FEMORAL COMPONENT FOR A KNEE PROSTHESIS WITH IMPROVED ARTICULAR CHARACTERISTICS.

[0090] Finite element analysis was performed on the first, second, and third prostheses to evaluate and compare stresses experienced at the interface of baseplates 10, 10', 10 and a simulated tibial bone that was well fixed to each respective baseplate. Peak stresses experienced in the above-described loading scenario were substantially reduced for the first baseplate 10 having asymmetrically arranged fixation pegs 30, 32 as compared to the second baseplate 10' having aligned fixation pegs 30', 32' and the third baseplate 10 having aligned fixation pegs 30, 32. More particularly, a 51% reduction in peak stress was observed in the first baseplate 10 as compared to the second baseplate 10', and a 46% reduction in peak stress was observed in the first baseplate 10 as compared to the third baseplate 10,

10. Additional Fixation Pegs

[0091] In addition to lateral fixation peg 30 described above, lateral compartment 14 of tibial baseplate 100 may further include at least one additional lateral fixation peg 330. As shown in FIG. 13, the additional lateral fixation peg 330 is substantially centered within the PL

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PCT/US2012/052132 quadrant. The illustrative lateral fixation peg 330 is positioned anteriorly/posteriorly between lateral fixation peg 30 and medial fixation peg 32, such that lateral fixation peg 30 is the anterior-most fixation peg on tibial baseplate 100 and medial fixation peg 32 is the posterior-most fixation peg on tibial baseplate 100. As a result of lateral fixation peg 30 being medially biased toward home axis Ah, as described above, the illustrative lateral fixation peg 330 is located laterally outward of lateral fixation peg 30 and is the lateral-most fixation peg on tibial baseplate 100.

[0092] In addition to medial fixation peg 32 described above, medial compartment 16 of tibial baseplate 100 may further include at least one additional medial fixation peg 332. As shown in FIG. 13, the additional medial fixation peg 332 is substantially centered within the AM quadrant. The illustrative medial fixation peg 332 is positioned anteriorly/posteriorly between lateral fixation peg 30 and medial fixation peg 32, such that lateral fixation peg 30 is the anterior-most fixation peg on tibial baseplate 100 and medial fixation peg 32 is the posterior-most fixation peg on tibial baseplate 100. As a result of medial fixation peg 32 being medially biased away from home axis Ah, as described above, the illustrative medial fixation peg 332 is located laterally inward of medial fixation peg 32.

11. Fixation Keel

[0093] Turning to FIGS. 8 and 9, tibial baseplate 100 is provided that is substantially similar to baseplate 10 of FIGS. 1-3, except that baseplate 100 includes a single fixation structure, illustratively keel 130, that extends distally from distal surface 134 and into tibia T (FIG. 1). Keel 130 may be monolithically or integrally formed as part of tibial baseplate 100, or keel 130 may be separately attachable to distal surface 134 of tibial baseplate 100. Structures of baseplate 100 that correspond to structures of baseplate 10 have corresponding reference numerals, with the number 100 being added to the reference numerals of baseplate 10 to arrive at the corresponding reference numerals of baseplate 100, except as otherwise noted.

[0094] The illustrative keel 130 of FIG. 9A has a cylindrical core 131 defining longitudinal axis Ak (i.e., the axis of the cylinder defined by cylindrical core 131) and having two or more fins 133 extending radially outwardly therefrom, the fins being arranged symmetrically relative to the cylindrical core 131. More particularly, fins 133 extend along substantially all of the longitudinal extent PDk (FIG. 9B) of keel 130, as best shown in FIGS. 9 A and 9B , such that fins 133 terminate at or near the distal tip of keel 133. In an exemplary

CA 02856571 2015-01-22 embodiment, longitudinal extent PD_K of tibial keel cylindrical core 131 may range from 27 mm to 48 mm, with smaller nominal sizes of baseplate 100 having relatively lesser extents PD_K and larger nominal sizes of baseplate 100 having relatively greater extents PD_K.

[0095] Keel fins 133 also define keel fin angle γ with respect to longitudinal axis Ak of cylindrical core 131 of keel 130. In an exemplary embodiment, keel angle γ is equal to between 22 degrees and 27 degrees. Keel fin angle γ and longitudinal extent longitudinal extent PD_K of cylindrical core 131 cooperate to define a medial/lateral keel extent MLk (Fig. 9B) of between 38 mm and 54 mm, with smaller nominal sizes of baseplate 100 having relatively lesser extents ML_K and larger nominal sizes of baseplate 100 having relatively greater extents ML_K. Advantageously, this medial/lateral extent MLk defined by fins 133 of keel 130 present high resistance to rotation of tibial baseplate 100 in vivo, and enhance the overall strength of baseplate 100.

[0096] In an exemplary embodiment, keel 130 defines a substantially cylindrical outer profile as illustrated in Fig. 9A. Where such cylindrical outer profile is employed, an exemplary embodiment of core 131 of keel 130 may maintain an outer diameter between 14 mm and 16 mm, with such diameter remaining constant across the longitudinal extent. However, it is contemplated that core 131 of keel 130 may have a conical, tapered outer profile, particularly for small-stature baseplate sizes. The taper angle may be formed, for example, by tapering core 131 of keel 130 from a circular outer diameter of 17.1 mm at the proximal terminus of keel 130 (i.e., at the junction between keel 130 and distal surface 134 of tibial baseplate 100) to a circular diameter of 13.4 mm at the distal terminus of keel 130. An exemplary conical keel used in conjunction with a small-stature baseplate size is disclosed in U.S. Provisional Patent Application Serial No. 61/592,574 filed January 30, 2012 (Attorney Docket No. ZIM0919)and in U.S. Provisional Patent Application SerialNo. 61/621,374 filed April 6, 2012 (Attorney Docket No. ZIM0919-01 ), both entitled ASYMMETRIC TIBIAL COMPONENTS FOR A KNEE PROSTHESIS.

[0097] Prior art tibial baseplates include constant-diameter keels in this diameter range, such as the Zimmer NexGen Stemmed Tibial Plates and Natural Knee II Modular Cemented Tibial Plates. The NexGen Stemmed Tibial Plates and Natural Knee Π Modular Cemented Tibial Plates are shown at pages 14 and 28, respectively, of the Zimmer® Tibial Baseplate, Pocket Guide United States Version,.

CA 02856571 2015-01-22

[0098] In FIG. 8, keel 130 is represented by a phantom oval to show the general location of keel 130, not necessarily the size or shape of keel 130. Rather than being cylindrical in shape, it is also within the scope of the present disclosure that core 131 of keel 130 may be conical in shape, with an outer diameter that tapers distally.

[0099] As discussed above, fixation pegs 30, 32 of baseplate 10 (FIGS. 1-3) may be designed to interact with cancellous bone surrounding the intramedullary canal of the patient's tibia T. To enhance this interaction with the cancellous bone, fixation pegs 30, 32 may be constructed of a highly porous biomaterial that accepts bone ingrowth. Keel 130 of baseplate 100 (FIGS. 8 and 9), by contrast, may be designed to fit into the intramedullary canal of the patient's tibia T. Like fixation pegs 30, 32, keel 130 may also be constructed of a highly porous biomaterial that accepts bone ingrowth. Alternatively, rather than achieving fixation via bone ingrowth, keel 130 may be constructed of a solid metal that achieves fixation via a tight interference fit with the patient's surrounding bone.

[00100] Although keel 130 may be the only fixation structure on baseplate 100, it is also within the scope of the present disclosure to combine keel 130 with additional fixation structures. In one embodiment, keel 130 may be combined with the above-described fixation pegs 30, 32 (FIGS. 1-3). On another embodiment, keel 130 may be combined with sharp spikes (not shown). Such spikes may be located in the same general areas discussed above with respect to fixation pegs 30, 32. However, unlike the blunt-tipped and porous fixation pegs 30, 32, the spikes may be sharp-tipped to pierce the patient's bone and may be solid in construction. The spikes may also have external ribs or barbs to enhance fixation with the patient's bone.

[00101] Keel 130 may also include a tapered bore (not shown) extending proximally into the distal tip of keel 130, designed to mate with a corresponding locking-taper surface of a tibial stem extension.

12. Lateral/Medial Positioning of Fixation Keel

[00102] As shown in FIG. 9A, keel 130 is asymmetrically disposed on distal surface 134 of baseplate 100 with respect to home axis Ah. More particularly, the longitudinal keel axis Ak of keel 130 is biased medially with respect to the vertical plane that contains home axis Ah, i.e.,

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PCT/US2012/052132 keel axis Ak is offset toward medial compartment 116 and away from lateral compartment 114 by offset distance 163. Throughout the following paragraphs, home axis Ah and the vertical plane that contains home axis Ah are used interchangeably.

[00103] According to an exemplary embodiment of the present disclosure, offset distance 163 is measured along distal surface 134 of baseplate 100. As a result, offset distance 163 is measured medially from the intersection of home axis Ah and distal surface 134 to the intersection of keel axis Ak and distal surface 134 (e.g., near the proximal end of keel 130). In embodiments where keel axis A_K is perpendicular to distal surface 134, offset distance 163 could also be measured away from distal surface 134 (e.g., near the distal end of keel 130) without impacting the measurement. In embodiments where keel axis Ak is canted relative to distal surface 134, however, the measurement could vary if taken away from distal surface 134 (e.g., near the distal end of the canted keel 130). Therefore, for consistency, the measurement is taken along distal surface 134 of baseplate 100.

[00104] In embodiments where baseplate 100 has a symmetric outer periphery 112, an anterior-posterior axis of symmetry through outer periphery 112 may be used as a home axis Ah for referencing medial face 160, lateral face 162, keel 130, and other components of baseplate 100. This home axis Ah would be substantially centered between medial face 160 and lateral face 162. With keel axis Ak being medially offset from the central home axis Ah, keel axis Ak would be positioned closer to medial face 160 than lateral face 162. Thus, medial distance 164 between keel axis Ak and the medial-most portion of medial face 160 would be less than lateral distance 166 between keel axis Ak and the lateral-most portion of lateral face 162.

[00105] In embodiments where baseplate 100 has an asymmetric outer periphery 112, as shown in FIGS. 8 and 9, home axis A_H would not constitute an axis of symmetry and would be positioned closer to lateral face 162 than medial face 160. Depending on the degree to which keel axis Ak is medially offset from home axis Ah, keel axis Ak may still be positioned closer to medial face 160 than lateral face 162. Thus, medial distance 164 between keel axis Ak and the medial-most portion of medial face 160 may be less than lateral distance 166 between keel axis Ak and the lateral-most portion of lateral face 162.

[00106] The degree of medialization of keel 130 may be expressed as a ratio or a percentage and may be calculated by dividing the offset distance 163 between keel axis A_K and

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PCT/US2012/052132 home axis Ah by the total medial/lateral width of distal surface 134 (i.e., medial distance 164 plus lateral distance 166). For baseplate 100 having the dimensions set forth in Table 1 below, for example, the degree of medialization would be approximately 6% (calculated as 5 mm / 88 mm x 100%).

Table 1: Sample Dimensions of a Large-Size Baseplate 100

<td> Dimension</td><td> Value (mm)</td><td> % of Total W idth</td>

<td> Offset Distance 163 between Keel Axis A_K and Home Axis A_H</td><td> 5</td><td> 6</td>

<td> Medial Distance 164</td><td> 41</td><td> 47</td>

<td> Lateral Distance 166</td><td> 47</td><td> 53</td>

<td> Total Width (Medial Distance 164 + Lateral Distance 166)</td><td> 88</td><td> N/A</td>

[00107] Advantageously, the medial bias of keel 130 (i.e., the relatively short medial distance 164 and the relatively long lateral distance 166) more closely aligns keel 130 with the intramedullary canal of the patient's tibia T (FIG. 1). Thus, upon implantation of baseplate 100 onto the patient's tibia T, keel 130 may be centered or nearly centered within the intramedullary canal. In this manner, keel 130 may avoid impinging onto hard, cortical bone around the intramedullary canal, thereby promoting firm and stable long-term fixation of tibial baseplate 100 to tibia T. The medial bias of keel 130 may also be important if it becomes necessary to attach a distal stem extension (not shown) to keel 130, such as during a revision surgical procedure. In this manner, tibial baseplate 100 may achieve an optimum metaphyseal fit on tibia T in the region of keel 130 and diaphyseal fit on tibia T in the region of the distal stem extension.

13. Lateral/Medial Positioning of Fixation Keel for Set of Prostheses

[00108] Baseplate 100 may be provided in a kit or set of different prosthesis sizes. In one embodiment, nine nominal sizes of baseplate 100 are provided in the set, with baseplates 100 growing progressively in size.

[0100] According to an exemplary embodiment of the present disclosure, the degree of medialization of keel 130 increases as the prostheses in the set grow in size. Thus, rather than maintaining a fixed relationship between medial distance 164 and lateral distance 166 as the prostheses grow in size, medial distance 164 makes up a smaller and smaller portion of the total width as the prostheses grow in size, and lateral distance 166 makes up a larger and larger

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PCT/US2012/052132 portion of the total width as the prostheses grow in size. Stated differently, the rate at which keel 130 moves toward medial face 160 exceeds that rate at which the prostheses grow in size.

[0101] The dimensions of another sample baseplate 100 are provided in Table 2 below.

Baseplate 100 of Table 2, which has a total width of 58 mm, is smaller than baseplate 100 of Table 1 above, which has a total width of 88 mm.

Table 2: Sample Dimensions of a Small-Size Baseplate 100

<td> Dimension</td><td> Value (mm)</td><td> &lt;&gt; id Total Width</td>

<td> Offset Distance 163 between Keel Axis A_K and Home Axis A_H</td><td> 1</td><td> 2</td>

<td> Medial Distance 164</td><td> 29</td><td> 50</td>

<td> Lateral Distance 166</td><td> 29</td><td> 50</td>

<td> Total Width (Medial Distance 164 + Lateral Distance 166)</td><td> 58</td><td> N/A</td>

[0102] As baseplates 100 of the present set grow in size from Table 2 to Table 1 (i.e., from a small nominal size having a 58 mm total width to a large nominal size having an 88 mm total width), the degree of medialization of keel 130 increases relative to home axis A_H (from 2% to 6%). Also, as keel 130 moves medially from the small size of Table 2 to the large size of Table 1, medial distance 164 makes up a smaller portion of the total width (from 50% to 47%), and lateral distance 166 makes up a larger portion of the total width (from 50% to 53%).

[0103] Advantageously, increasing the degree of medialization of keel 130 as baseplate

100 grows in size may better track the position of the intramedullary canal as the patient's tibia T (FIG. 1) grows in size. Therefore, keel 130 may be positioned inside the intramedullary canal rather than in hard, cortical bone around the intramedullary canal.

[0104] The increasing medialization of keel 130 is presented graphically in FIG. 10, where exemplary offset distances 163 between keel axis Ak and home axis Ah are shown for a set of prostheses of different sizes. More specifically, exemplary offset distances 163 between keel axis Ak and home axis Ah are shown for a set of prostheses having different medial/lateral widths (i.e., medial distance 164 plus lateral distance 166). The data points located farther to the left represent smaller medial/lateral widths (and therefore smaller prosthesis sizes), and data points located farther to the right represent larger medial/lateral widths (and therefore larger prosthesis sizes). Although adjacent nominal prosthesis sizes may share the same offset distance 163 between keel axis Ak and home axis Ah (compare, for example, the corresponding offset distances 163 of the size 5 and size 6 implants, shown as the fifth- and

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PCT/US2012/052132 sixth-from left data points respectively), the overall trend in FIG. 10 is that offset distance 163 increases as total medial/lateral width increases.

[0105] In a smaller bone, the metaphyseal region of tibia T is more closely aligned with the diaphyseal region of tibia T. Therefore, keel 130 may achieve an optimum metaphyseal and diaphyseal fit with a relatively small offset distance 163 (e.g., 1 mm, 2 mm). In a larger bone, by contrast, the metaphyseal region of tibia T is more offset from the diaphyseal region of tibia T. Therefore, keel 130 may require a relatively large offset distance 163 (e.g., 4 mm, 5 mm) to achieve an optimum metaphyseal and diaphyseal fit. FIG. 10 presents exemplary offset distances 163, but for any given size, offset distance 163 may vary by +/- 0.5 mm, +/- 1.0 mm, +/- 1.5 mm, or +/- 2.0 mm, for example.

[0106] As discussed above, the degree of medialization of keel 130 may be expressed as a percentage by dividing the offset distance 163 between keel axis A_K and home axis A_H by the total medial/lateral width. In FIG. 11, the offset distances 163 from FIG. 10 are shown as percentages of the total medial/lateral width. The overall trend in FIG. 11 is that the degree of medialization of keel 130 increases as medial/lateral width increases. With respect to a relatively small nominal size 3 implant, for example, the medial offset of keel 130 from home axis Ah is 3% of the total medial/lateral implant width. With respect to a relatively large nominal size 7 implant, the medial offset of keel 130 from home axis Ah is 5% of the total medial/lateral implant width.

14. Anterior/Posterior Positioning of Fixation Keel for Set of Prostheses

[0107] As shown in FIG. 8, the anterior/posterior keel distance 147 may be measured posteriorly from flat portion 118a of anterior face 118 to keel axis A_K, for example. The lateral depth 144 of lateral compartment 114 is also shown being measured posteriorly from flat portion 118a of anterior face 118 to posterior/lateral face 120 of baseplate 100 in FIG. 8, and this lateral depth 144 exceeds keel distance 147.

[0108] According to an exemplary embodiment of the present disclosure, keel distance

147 is measured along distal surface 134 of baseplate 100. As a result, keel distance 147 is measured posteriorly from the intersection of flat portion 118a of anterior face 118 and distal surface 134 to the intersection of keel axis Ak and distal surface 134 (e.g., near the proximal end of keel 130). In embodiments where keel axis A_K is perpendicular to distal surface 134, keel distance 147 could also be measured away from distal surface 134 (e.g., near the distal end

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PCT/US2012/052132 of keel 130) without impacting the measurement. In embodiments where keel axis Ak is canted relative to distal surface 134, however, the measurement could vary if taken away from distal surface 134 (e.g., near the distal end of the canted keel 130). Therefore, for consistency, the measurement is taken along distal surface 134 of baseplate 100.

[0109] Across a set of different tibial baseplates 100 having varying nominal sizes, the anterior/posterior positioning of keel 130 may vary. In FIG. 12, for example, exemplary anterior/posterior keel distances 147 are shown for a set of prostheses of different sizes. The overall trend in FIG. 12 is that keel distance 147 increases as lateral depth 144 increases. Moving keel 130 further and further from anterior face 118 as baseplate 100 increases in size may avoid anterior cortical bone impingement by keel 130, especially if keel 130 also increases in size (e.g., diameter, length) along with baseplate 100. FIG. 12 depicts exemplary keel distances 147, but for any given size, keel distance 147 may vary by +/- 0.5 mm, +/- 1.0 mm, +/- 1.5 mm, or +/- 2.0 mm, for example.

15. Proximal Keel Expansion

[0110] As shown in FIG. 9A, the illustrative keel 130 includes a blind proximal bore

180 therein that is sized to receive a fixation structure, such as a set screw (not shown), from proximal surface 111 of baseplate 100. The fixation structure may be used to attach a tibial bearing component onto proximal surface 111 of baseplate 100, for example.

[0111] The illustrative bore 180 of FIG. 9 A is centered along home axis Ah. However, because keel axis A_K is offset from home axis A_H, bore 180 becomes offset in keel 130. To ensure that the walls of keel 130 surrounding bore 180 are adequately thick along the axial extent of bore 180 (e.g., 1.5 mm), keel 130 may expand radially outwardly around bore 180 to form bulge 182.

[0112] As keel 130 becomes more and more offset from home axis Ah and bore 180, bulge 182 may become larger and larger in size. For example, for medium nominal prosthesis sizes (e.g., sizes 5 and 6) having medium offset distances 163 between keel axis A_K and home axis Ah (e.g., 3 mm), bulge 182 may increase the diameter of keel 130 by 0.5 mm. For large nominal prosthesis sizes (e.g., sizes 7-9) having large offset distances 163 between keel axis Ak and home axis Ah (e.g., 4 mm, 5 mm), bulge 182 may increase the diameter of keel 130 by

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1.4 mm. For small nominal prosthesis sizes (e.g., sizes 1 -4) having small offset distances 163 between keel axis A_K and home axis A_H (e.g., 1 mm, 2 mm), bulge 182 may be excluded.