Perfected total shoulder prosthesis

Abstract

A shoulder prosthesis includes a humeral portion and a scapular portion, each having an osseointegrable component and an articular component. The osseointegrable component in the humeral portion includes a humeral body produced as a semicircular asymmetrical cage having a proximal circular ring base facing the scapular portion and an eccentric distal cylindrical base in opposite position, which are connected by arms having one or more holes for favoring the growth of bone tissue and facilitating anchorage to the bone, the proximal circular ring base being configured to be interchangeably coupled with the articular component for an anatomical prosthesis or a concave insert for a reverse prosthesis. The osseointegrable component in the scapular portion includes a glenoid base-plate of asymmetric form for coupling to an articular component, such as a concave glenoid insert, for an anatomical prosthesis or a glenosphere for a reverse prosthesis.

Claims

1. A total shoulder prosthesis comprising: a humeral portion; and a scapular portion, the humeral portion and the scapular portion being each provided with an osseointegrable component and an articular component, wherein: said osseointegrable component in the humeral portion comprises a humeral body shaped as a hemispherical asymmetrical cage having a proximal circular ring base facing the scapular portion, in a mounted condition of the shoulder prosthesis, and a distal cylindrical base, which has a longitudinal axis that is offset from a longitudinal axis of the proximal circular ring base and which is disposed to be on a transverse plane to the longitudinal axis of the proximal circular ring base and to be opposite with respect said proximal circular ring base, said proximal circular ring base and said distal cylindrical base being connected to each other by a plurality of arms, of the arms of said humeral body has one or more holes for favoring growth of humeral bone tissue and facilitating an anchorage of the humeral body to a bone, said proximal circular ring base being configured to be interchangeably coupled with a first articular component for an anatomical prosthesis or a concave insert for a reverse prosthesis, and said osseointegrable component in the scapular portion comprises a glenoid base-plate with an asymmetric anatomical form for coupling a second articular component for an anatomical prosthesis or a glenosphere for a reverse prosthesis, said first and said second articular components for anatomical prostheses or said concave insert and said glenosphere for reverse prostheses being intercoupled with each other in an operating condition.

2. The prosthesis according to claim 1, wherein said osseointegrable component in the humeral portion comprises a metaphyseal humeral connector for a morse cone coupling of the distal cylindrical base to a stem fixed inside a humeral bone.

3. The prosthesis according to claim 1, wherein at least the humeral body has, at least on an outer annular side of the proximal circular ring base, a structure with isotropically and irregularly oriented trabeculae, which is highly porous for favoring the anchorage, by press-fit, of the humeral body by pressure interlocking with the bone of a humeral metaphysis and for favoring a secondary biological anchorage through osseoinductivity and osseointegrability.

4. The prosthesis according to claim 1, wherein the plurality of arms consists of a first and a second pair of arms, a first pair having the arms of a smaller size and length than the arms of the second pair, said first pair being configured to be inserted in a bone portion of a humeral neck and said second pair being configured to be inserted in a bone portion of a greater tubercle, the prosthesis being configured to be inserted in a humerus in order to confer greater rotational stability to said humeral body and greater support on a humeral metaphyseal bone, thereby avoiding a distal migration of the humeral body downwards.

5. The prosthesis according to claim 4, wherein the first pair of arms is positioned on a lateral side of the distal cylindrical base, and wherein the second pair of arms having a smaller size and length is positioned on a medial side of the distal cylindrical base according to a direction described by an axis perpendicular to an axis in an anterior-posterior direction passing through a center of the distal cylindrical base.

6. The prosthesis according to claim 1, wherein the proximal circular ring base and the distal cylindrical base, are connected to each other by a first and a second pairs of the arms, the first pair being asymmetric with respect to the second pair with respect to an axis Y in an anterior-posterior direction passing through a center of the distal cylindrical base.

7. The prosthesis according to claim 1, wherein said glenoid base-plate and said concave glenoid insert have an anatomical, pear-shaped asymmetric form with a front profile different from a rear profile and an upper profile different from a lower profile.

8. The prosthesis according to claim 1, wherein said concave insert for the reverse prosthesis has an articulation surface with the glenosphere, said articulation surface of said concave insert having a single radius of curvature.

9. The prosthesis according to claim 1, wherein said glenosphere for the reverse prosthesis has an articulation surface with said concave insert, said articulation surface of said glenosphere being convex with a single radius of curvature.

10. The prosthesis according to claim 1, wherein said concave insert for the reverse prosthesis is made of a metallic material and said glenosphere for the reverse prosthesis is made of a plastic material.

11. The prosthesis according to claim 1, wherein said concave insert for the reverse prosthesis is made of titanium alloy Ti6A14V with a coating of TiNbN and said glenosphere for the reverse prosthesis is made of UHMWPE or UHMWPE with vitamin E.

12. The prosthesis according to claim 1, wherein said humeral body and said glenoid base-plate are made of a metallic material.

13. The prosthesis according to claim 1, wherein said concave insert is coupled with the proximal base of said humeral body by a morse cone coupling.

14. The prosthesis according to claim 1, wherein said glenosphere is coupled with said glenoid base-plate by one or more fixing means.

15. The prosthesis according to claim 1, wherein said glenoid base-plate is configured to be fixed to a scapular bone by means of one or more screws and/or pins.

Description

(1) The structural and functional characteristics of the invention, and its advantages with respect to the known art, can be clearly understood from the following description, referring to the attached drawings, which illustrate non-limiting embodiment examples of the invention itself.

(2) In the drawings:

(3) FIG. 1 is an exploded perspective view illustrating the total shoulder prosthesis system made according to the invention;

(4) FIG. 2 is a raised view of the prosthesis of FIG. 1 in the stemmed anatomical configuration;

(5) FIG. 3 is a view similar to FIG. 2, but showing the prosthesis in the reverse configuration;

(6) FIG. 4 is an overall view of the prosthesis according to the invention, but in the stemless anatomical configuration;

(7) FIGS. 5a, 5b, 5c are sections of the prosthesis of FIG. 4;

(8) FIG. 6 is an overall view of the prosthesis according to the invention, but in the stemless reverse configuration;

(9) FIGS. 7a, 7b, 7c are sections of the prosthesis of FIG. 6;

(10) FIG. 7d is a section showing the glenoid component with glenosphere, a short safety screw, adapter, central fixing screw and lower and upper fixing screws;

(11) FIG. 8a is an anterior-posterior section of the glenoid insert;

(12) FIG. 8b is an upper-lower section of the glenoid insert;

(13) FIG. 9a is a front view of the glenoid base-plate;

(14) FIG. 9b is a front view of the concave glenoid insert;

(15) FIGS. 10a and 10b illustrate the trabecular surface of the humeral body;

(16) FIG. 11 illustrates an embodiment of the humeral body having a trabecular surface on arms, ring base and distal base;

(17) FIG. 12 illustrates various components of the prosthesis object of the present invention with a trabecular surface;

(18) FIG. 13 illustrates the position of the arms of the humeral body;

(19) FIG. 14 illustrates metaphyseal humeral connectors with various offsets and various CCD tilt angles;

(20) FIGS. 15a and 15b illustrate a front and rear view (i.e. that positioned in contact with the bone in a mounted condition of the prosthesis on the glenoid) of the glenoid base-plate with a trabecular structure;

(21) FIGS. 16a and 16b illustrate a front and rear view (i.e. that positioned in contact with the base-plate in a mounted condition of the prosthesis on the glenoid) of the anatomical glenoid insert with the characteristic form object of the present invention;

(22) FIGS. 17a-17c illustrate the anterior-posterior radius RA-P (transverse plane) and the inferior-superior radius RI-S (coronal plane) of the anatomical glenoid insert;

(23) FIG. 18 illustrates the anatomical humeral head with an ellipsoidal geometry;

(24) FIG. 19 illustrates the ratio between the anterior-posterior diameter and the inferior-posterior diameter of the anatomical humeral head in the various sizes;

(25) FIG. 20 is a schematic perspective view illustrating the total shoulder prosthesis of the invention implanted in the human body.

(26) The prosthesis according to the present invention allows, thanks to its modularity:

(27) an anatomical configuration (FIG. 2, FIG. 4, FIGS. 5a, 5b, 5c) and a reverse configuration (FIG. 3, FIG. 6, FIGS. 7a, 7b, 7c);

(28) a stemless configuration (FIG. 4, FIGS. 5a, 5b, 5c, FIG. 6, FIGS. 7a, 7b, 7c) and a stemmed configuration (FIG. 2, FIG. 3) of the humeral portion;

(29) a first plant configuration and a revision configuration.

(30) Thanks to the present invention, it is possible to pass from one configuration to another without having to change prostheses 10 but only by adding/substituting the appropriate components within the same prosthesis 10.

(31) With reference to the figures of the drawings, a total shoulder prosthesis with a stem (FIG. 1) or without a stem, produced according to the present invention, is generally indicated with 10 and is modular or structurally composed of the following components operationally inter-coupled.

(32) FIG. 20 shows the implanted prosthesis 10 with the anterior-posterior and inferior-superior directions highlighted, with respect to a patient in an upright position.

(33) The total prosthesis according to the present invention comprises a humeral portion and a scapular portion, each portion being provided with at least one osseointegrable component and articular component.

(34) The humeral portion of the prosthesis 10 can comprise one or more of the following elements:

(35) a) a humeral body 13, or so-called “humeral core”, which allows the passage intraoperatively and with the same prosthetic system from a stemless humeral configuration to a stemmed configuration and from an anatomical to an reverse configuration.

(36) The humeral body 13 is made of a metallic material.

(37) The humeral body 13 can be made of titanium alloy Ti6Al4V in powder form (according to the standard ASTM F3001).

(38) The body 13 is produced in the form of a semispherical asymmetric cage with multiple arms 132 and having a proximal circular ring base 133 suitable for being interchangeably coupled with the articular component such as a humeral head 15 for an anatomical prosthesis or a concave insert 22 for a reverse prosthesis.

(39) In particular, the body 13 is produced as a semispherical asymmetric cage.

(40) As illustrated in the figures, said humeral body 13 produced as a semispherical asymmetric cage is in the form of a pyramid having as its base the proximal circular ring base 133 and as the apex, to which it is connectable, through a connector 12 (as described hereunder) a stem 11, a base 134 provided opposite and eccentric with respect to said proximal base 133.

(41) Said base 134 has a cylindrical form.

(42) In the embodiments illustrated, said base 134 has a hollow cylindrical form so as to house in its interior an end 121 of the connector 12.

(43) The coupling between said distal base 134 and connector 12 is of the morse cone type.

(44) As can be seen in FIG. 20, in a mounted condition of the prosthesis 10, the proximal circular ring base 133 faces the scapular portion and the distal base 134, opposite, is inserted into the humerus.

(45) The proximal circular ring base 133 and the distal base 134 are connected to each other by arms 132.

(46) As shown in the figures therefore, said humeral body 13 produced as a semispherical asymmetric cage is hollow inside and with empty spaces between adjacent arms 132.

(47) According to an embodiment illustrated, said humeral body 13 is provided with four arms 132.

(48) Advantageously, of the arms 132 has pass-through holes 131 for favouring the growth of new bone tissue inside and facilitating the anchorage of the body 13 to the bone.

(49) As illustrated in FIG. 13, according to a preferred embodiment, the humeral body 13 has four arms 132 positioned asymmetrically with respect to each other, connecting the circular ring of the proximal base 133 to the distal base 134 of the humeral body 13, thus forming a hemispherical cage.

(50) The four arms 132 are asymmetric with respect to an axis Y in an anterior-posterior direction passing through the centre of the distal base 134.

(51) This asymmetry is due to the eccentricity of the distal base 134 with respect to the proximal base 133 on the transverse plane which involves two arms having a greater size and length 135 on the lateral side of the distal base 134 with respect to the two arms having a smaller size and length 136 positioned on the medial side of the distal base 134 according to a direction described by an axis X perpendicular to Y.

(52) These four arms give a greater rotational stability of the humeral body (with respect, for example, to a body with three flaps such as that described in the prior art), greater support on the metaphyseal humeral bone and therefore greater stability against a downward distal migration (sinking) of the humeral body 13.

(53) The two major lateral arms 135 are inserted in the bone portion of the major tubercle. The two minor medial arms 136 are inserted in the bone portion of the humeral neck.

(54) As illustrated in FIGS. 10a, 11 and in the detail illustrated in FIG. 10b, the humeral body 13 has, at least on the outer annular side 137 of the proximal circular ring base 133, an irregularly isotropically oriented trabecular structure, highly porous to facilitate anchorage by the initial press-fit and its osseointegrability and osseoinductivity.

(55) Said annular outer side 137 has, in fact, a highly porous isotropic metal structure, with interconnected trabeculae and irregularly and randomly arranged in space in order to favour the initial anchorage of the humeral body 13 (which in one of the embodiments can be stemless) by pressure interlocking with the bone of the humeral metaphysis and to favour the secondary biological anchorage through its characteristics of osseoinductivity and osseointegrability.

(56) As illustrated in FIGS. 11 and 12, other parts of the humeral body 13 or other components of the prosthesis, both in the humeral and scapular portion, can have a highly porous, isotropic metallic structure, with trabeculae interconnected and arranged irregularly and randomly in space.

(57) The humeral body 13, object of the present invention, is osseointegrable, osseoinductive and modular, i.e. it has a cement-free fixation to the metaphyseal humerus or can be assembled to a humeral stem by a metaphyseal humeral connector 12 (described hereunder) for a distal fixation and no longer metaphyseal to the bone of the limb and is also suitable for housing an interchangeable articular component to effect an anatomic or inverse shoulder prosthesis.

(58) b) a humeral stem 11, obviously provided in the stemmed prosthetic configuration.

(59) Said humeral stem 11 can be available in the first implant configuration and in the revision configuration, with a cementless or cemented fastening mode.

(60) The humeral stem 11 can have various diameters and lengths.

(61) The humeral stem 11 can be made of titanium alloy or titanium alloy and hydroxyapatite.

(62) It can be made, for example, of titanium alloy Ti6Al4V (according to the standard ISO 5832/3) or titanium alloy according to the standard ISO 5832/3 and coated with hydroxyapatite according to the standard ISO 13779;

(63) c) a metaphyseal humeral connector 12 that allows the passage of the prosthetic configuration without a stem (stemless) to the configuration with a stem (stemmed).

(64) It is the component through which the humeral stem 11 is fixed to the humeral body 13 (“humeral core”), in particular said connector 12 is coupled, at one of its ends 121, to the distal base 134 of the humeral body 13 like a cage, provided opposite and eccentric to the proximal base 133.

(65) This component 12 is available in different offsets and CCD angles.

(66) As illustrated in FIG. 14, the metaphyseal humeral connector 12 can have various offsets and various CCD tilt angles for restoring the position of the stemless humeral component 13 with respect to the humerus when using a distal fixation through a humeral stem 11.

(67) The metaphyseal humeral component 12 can be made of titanium alloy Ti6Al4V powder (according to the standard ASTM F3001);

(68) d) a humeral head 15, which forms the articular humeral component in the anatomic prosthetic configuration (conventional).

(69) Advantageously, it has an articulation surface, with the concave glenoid insert 16 illustrated in FIG. 9b, convex with an elliptical cross-section with two diameters (anterior-posterior diameter DA-P and an inferior-upper diameter DI-S).

(70) As illustrated in FIG. 18, the humeral head 15 has an elliptical base with two axes and an ellipsoidal convex articular surface, characterized in each size by two curvature profiles described in two orthogonal planes frontal and transversal and described by two radiuses, one in the anterior-posterior direction (RA-P) (transverse plane) and one in an inferior-superior direction (RI-S) (coronal plane).

(71) The articular surfaces of the two modular anatomical articular components of the humeral head 15 and the glenoid insert 16 coupled together, replicating the radial mismatch between the cartilage surfaces of the glenoid and the anatomical humeral head, create a difference in radius of curvature, different at each considered point of contact between the surfaces.

(72) The humeral head 15 can obviously be of different sizes.

(73) FIG. 19 shows various sizes of the humeral head 15, non-spherical, with a base having an elliptical section.

(74) According to the present invention, the anatomical humeral head 15 therefore has the following characteristics:

(75) a non-spherical head with an ellipsoidal geometry,

(76) a base with an elliptical section with a major axis and a minor axis,

(77) an articular surface with two curvature profiles described by two different medium radiuses,

(78) coupled by means of a morse cone with an adapter 14 for connection to the humeral body 13.

(79) This humeral head in the anatomical prosthesis is made of plastic material.

(80) According to the present invention, it is made, in the anatomical prosthesis, of Ultra-High-Molecular-Weight Polyethylene.

(81) The anatomical humeral head 15 can be made, for example, of UHMWPE or UHMWPE stabilized with vitamin E.

(82) Said humeral head 15 is coupled with said proximal base 133 of the humeral body 13 through:

(83) an adapter for a humeral head 14 for the assembly of an anatomical humeral head 15 on the humeral body (humeral core) 13. It can be made of Ti6Al4V titanium alloy (ISO 5832/3);

(84) a ring for a morse cone of the humeral head 15a which is a component pre-assembled to the female morse cone 151 of the humeral head 15. It can be made of titanium alloy, for example Ti6Al4V (ISO 5832/3).

(85) The scapular portion of the prosthesis 10 can comprise one or more of the following elements:

(86) a) a concave glenoid insert 16, which forms the glenoid articular component in the anatomical prosthetic configuration (conventional).

(87) As illustrated in FIG. 9b, it has an asymmetrical pear shape, i.e. it is asymmetrical with respect to both an anterior-posterior plane and to an inferior-superior plane, said planes being orthogonal to each other, as shown in FIG. 17a, 20, considering the prosthesis implanted on a patient in a vertical position.

(88) Advantageously it has an anatomical asymmetric form with a concave articular surface having an ellipsoidal form described in each size by two curvature profiles described in two orthogonal planes, frontal and transversal, and described by two radiuses, in particular a curvature profile 163 described in the transverse plane in an inferior-superior direction by a first radius (RI-S) and a second curvature profile 164, different from 163, described in the transversal plane in the anterior-posterior direction (orthogonal to said transversal plane in an inferior-superior direction) by a second radius (RA-P) (FIGS. 8a, 8b and 9b, 16a, 16b, 17a, 17b, 17c).

(89) It can obviously have different sizes for both the right side and the left side.

(90) The two radiuses on the glenoid side and an elliptical form of the head allow the stability and the articulation of the glenohumeral joint to be improved.

(91) According to the present invention, it is produced, in the anatomical prosthesis, in a metallic material.

(92) The fact of producing the concave glenoid insert 16 in metal allows the thicknesses of the component to be reduced, thus allowing the anatomy of the glenoid to be respected, maintaining the original articular line, improving the articulation of the shoulder, reducing the risk of over-stuffing (stiff and painful shoulder by compression of the soft tissues).

(93) Furthermore, producing it in TiNbN-coated metal makes it much lighter with respect, for example, to a Chromium-Cobalt alloy and makes it tribologically compatible in articulation with the humeral head in UHMWPE. In particular it can be made of TiNbN-coated titanium alloy.

(94) According to an embodiment, it is made of titanium alloy such as for example Ti6Al4V (ISO 5832/3) and coated via PVD (Physical Vapour Deposition) in TiNbN; b) a glenoid basal plate (so-called base-plate) 17 (FIG. 9a) which forms the anchoring component to the glenoid bone over which it is coupled or the concave glenoid insert 16 in the anatomical prosthesis configuration (conventional) or the glenosphere 23 in the reverse prosthesis configuration.

(95) Advantageously it has an anatomical asymmetric form congruent to the form of the concave glenoid insert 16 (FIGS. 15a-15b and 16a-16b).

(96) It can obviously have different sizes for both the right side and the left side.

(97) According to the present invention, the glenoid base-plate 17 is produced with the SLM (Selective Laser Melting) technology characterized on the glenoid side by a trabecular structure (FIG. 15a), highly porous, in titanium alloy (Traser®), or it is produced with the SLM technology with hydroxyapatite plasma spray coating on the glenoid side without trabecular titanium (Traser®).

(98) The trabecular surface of one or more components of the shoulder object of the present invention, allows an excellent and high bone re-growth within the pores and a rapid osseointegration of the component for an optimal secondary stability.

(99) The trabecular structure, such as, for example, Traser®, has a high friction coefficient with the bone to allow a high initial press-fit of the implant.

(100) One or more of the components are produced with the SLM technology.

(101) The solid and trabecular parts of one or more of the components are produced in a single process without discontinuity or coatings.

(102) The glenoid base-plate 17 is made of a metallic material.

(103) The glenoid base-plate 17 can be made of titanium alloy powder such as for example Ti6Al4V (ASTM F3001/14).

(104) The glenoid base-plate 17 characterized by a highly porous metallic structure, with a trabeculation similar to that of cancellous bone, allows an optimal bone re-growth within its pores and a rapid osseointegration, thus ensuring a stable anchorage of the implant of the scapular glenoid guaranteed by osseointegration of the base-plate 17.

(105) Said concave glenoid insert 16 is coupled with said glenoid base-plate 17 by a morse cone coupling and interlocking.

(106) The assembly between the modular anatomical glenoid insert 16 and the glenoid base-plate 17 is effected by means of a morse cone 165 and the antirotational blocking by means of the outer edge 161, as a peripheral flange, of the glenoid insert 16 which surrounds the step edge 171 of the glenoid base-plate 17 which is thus located, once assembled with the glenoid insert, inside the recess 162 of the glenoid insert 16 produced on the scapular side (i.e. on the side of the insert 16 facing the scapula in a mounted condition of the prosthesis) (FIGS. 8a and 8b), thus blocking it against rotations (anti-rotational blockage). (FIGS. 8a-8b, 5c).

(107) The modular osseointegrable and osseoinductive component in the scapular portion therefore comprises a glenoid base-plate 17 and a concave glenoid insert 16 both having an asymmetric, pear-shaped anatomical shape, with a front profile different from the rear profile and a different upper profile with respect to the lower profile which determines a version for the right side and a version for the left side of the user's body. The glenoid base-plate 17 and the modular anatomical glenoid insert 16, in fact, having the same form and size, have a version for the right side and a version for the left side of the patient's body.

(108) As illustrated in FIG. 1, the glenoid base-plate 17 is fixed to the glenoid bone without the use of cement but through a pair of lower and upper pivot screws 18, 18I, and through a central pin 19, made of titanium alloy powder Ti6Al4V (ASTM F3001/14), with the SLM technology with titanium trabeculation.

(109) Advantageously, the pin 19 is coupled in a hole provided on the glenoid base-plate 17 by means of a morse cone coupling.

(110) Alternatively to or in combination with said screws 18, 18I and said pin 19, as shown in FIG. 7d, threaded screws 20, 20I and/or a threaded central fixing screw and bicortical in compression 21, can be provided.

(111) According to the present invention, in the case of the production of a reverse prosthesis, as illustrated in FIGS. 3, 6, 7a-7c:

(112) the components 14, 15a and 15, i.e. the adapter for the humeral head 14, the anatomical humeral head in polyethylene 15 and the ring for the morse cone 15a provided in the humeral portion of the prosthesis 10, are replaced by a concave insert for the reverse prosthesis 22, i.e. an articular component made of metallic material with an articulation surface with glenosphere 23, which is concave spherical with one radius.

(113) Said concave insert 22 is coupled with the proximal base 133 of the humeral body 13 by means of a morse cone coupling.

(114) Said humeral insert for a reverse prosthesis 22 can be provided in different sizes, with different CCD angles and with different thicknesses.

(115) Advantageously, it is made of titanium alloy Ti6Al4V (ISO 5832/3) coated with TiNbN with the PVD technology (Physical Vapour Deposition) to make it tribologically compatible in articulation with the glenosphere in UHMWPE.

(116) The anatomical glenoid insert 16 with a concave surface is substituted by a glenosphere for a reverse prosthesis 23, i.e. an articular component made of a plastic material such as polyethylene with a convex spherical articular surface with one radius, which can be fixed to the glenoid base plate 17 through an adapter for the glenosphere 24 and a fixing screw 25, for example made of titanium alloy Ti6Al4V (ISO 5832/3).

(117) The glenosphere for a reverse prosthesis 23 is advantageously made of ultra high molecular weight polyethylene.

(118) It can be made, for example, of UHMWPE or UHMWPE stabilized with vitamin E.

(119) As shown in FIGS. 7a, 7c and 7d, the glenosphere 23 is attached to the base glenoid 17 again using the glenosphere adapter 24.

(120) In the case of using a central peg, a long fixing screw for the glenosphere is used for fixing the glenosphere 23, whereas when using the central fixing screw instead of the peg, a short fixing screw must be used for the glenosphere and its relative threaded grub screw inside the adapter 24.

(121) The shoulder prosthesis of the present invention is therefore a modular prosthetic system for total shoulder arthroplasty and total reverse shoulder arthroplasty.

(122) It is in fact possible to convert from an anatomical prosthesis to a reverse prosthesis replacing only the articular components without replacing the components implanted in the humeral and scapular bone.

(123) Furthermore, the modularity of said prosthesis allows the passage from a stemless implant for a first implant to a stemmed implant, intraoperatively and with the same humeral component 13.

(124) Unlike the prior art in which the prosthetic humeral head is spherical with one radius, the prosthetic humeral head 15 in the anatomical prosthesis, object of the present invention, is elliptical with an elliptical base section with two diameters, thus respecting the anatomy of the humeral head. Furthermore, said prosthetic head 15 is made, for an anatomical prosthesis, in UHMWPE or UHMWPE with vitamin E.

(125) The anatomical glenoid insert 16 is advantageously also made of TiNbN-coated titanium alloy with a two-radius surface: a radius of the anterior-posterior profile and a radius of the inferior-superior profile; it also has an asymmetrical, pear-shaped anatomical form, respecting the anatomy of the glenoid.

(126) Similarly, the glenoid base-plate 17 has an asymmetrical pear-shaped anatomical form, respecting the anatomy of the glenoid.

(127) It can be advantageously produced with the SLM technology characterized by a trabecular structure, highly porous, in titanium alloy (Traser®).

(128) For a greater anatomical adaptability of the prosthesis, in the passage from stemless to stemmed implants, the metaphyseal humeral component 12 can have different offsets and CCD angles.

(129) All of the components of the prosthesis are made of materials without the most common allergenic elements, such as nickel, cobalt, chrome, molybdenum.

(130) FIG. 2 shows an overall view of the humeral portion and the scapular portion in the anatomical configuration with a humeral stem 11 (so-called stemmed configuration): with reference to the humeral portion, the humeral head 15 made of polyethylene is coupled with the humeral body 13, by means of the humeral head adapter 14 and the ring of the morse cone 15a. The corresponding scapular portion provides the glenoid base-plate 17 (metal-back) fixed by screws 20, 20I, 21 and/or pins 18, 18I, 19 to the scapular bone and above which the metal anatomical glenoid insert 16 is assembled.

(131) Analogously to FIG. 2, FIG. 4 shows an overall view of the humeral portion and the scapular portion in the anatomical configuration but without the humeral stem 11 (so-called stemless configuration).

(132) FIGS. 5a, 5b and 5c how a sectional view of the portions of the humeral component 13, 14, 15a, 15 and scapular portions 16, 17, 18, 18I, 19 coupled together in the stemless anatomical configuration.

(133) FIG. 3 illustrates an overall view of the humeral portion and the scapular portion in the reverse configuration with a humeral stem 11 (so-called stemmed configuration): with reference to the humeral portion, the metal humeral insert 22 with a concave spherical surface with one radius is coupled with the humeral body 13. The corresponding scapular portion provides the glenoid base-plate 17 (metal-back) fixed to the bone by screws 20,20I, 21 and/or pins 18, 18I, 19 and on which the glenosphere 23 in UHMWPE or UHMWPE with vitamin E, is assembled.

(134) Analogously to FIG. 3, FIG. 6 illustrates an overall view of the humeral portion and the scapular portion in the reverse configuration but without the humeral stem 11 (so-called stemless configuration). FIGS. 7a, 7b and 7c show a sectional view of the portions of the humeral component 13,22 and scapular portions 23,17,18, 18I, 19 coupled together in the reverse configuration without a stem 11 (stemless).

(135) FIG. 7d shows an embodiment with a glenoid component with central, lower and upper fixing screws.

(136) The prosthesis object of the present invention is destined for substituting the scapular glenoid and the humeral head in total shoulder arthroplasty for the first implant and revision or of the humeral head alone in the shoulder endoprosthesis.

(137) The components are destined for being implanted by biological fixation (press-fit technique without using bone cement) and using bone cement (only monoblock glenoid and cemented stems).

(138) The prosthesis system can therefore comprise the following types of components:

(139) TABLE-US-00001 Prosthetic component Description 11 Humeral stem Humeral stem for the stemmed prosthetic configuration. Its function is to anchor the humeral core component to the humeral diaphysis. Available in the versions for first implant or revision by both biological fixation (press-fit) and cement fixation 12 Metaphyseal Component through which the humeral stem is fixed to the humeral humeral core. It allows passage from the stemless prosthetic connector configuration to the stemmed configuration. 13 Humeral This represents the stemless humeral component which can be body or used both in the anatomical configuration and in the reverse humeral core configuration and allows passage intraoperatively from a stemless configuration to a stemmed configuration. The fixation method is through press-fit without bone cement . . . 14 Adapter for Component used for mounting the anatomical humeral head on anatomical the humeral core. humeral head 15 Anatomical Articular component used for the anatomical configuration only. humeral head In the version for total prosthesis it is made of a plastic material and is characterized by an elliptical convex surface for coupling with the glenoid insert. 16 Anatomical Glenoid articular component used in the anatomical prosthetic glenoid insert configuration only. It is characterized by an asymmetrical anatomical form of the glenoid and by a 2-radius concave articular surface for the coupling with the head. It is mounted above the glenoid base-plate. It is coated with TiNbN. 17 Glenoid Metal component for anchorage to the glenoid bone base-plate characterized by an asymmetrical anatomical form. In the anatomical prosthesis configuration, the component is mounted with the anatomical glenoid insert. In the reverse configuration, it is mounted with the glenosphere. Available in two versions, the first with titanium trabeculae, the second with HA coating. The fixing mode is through press-fit without bone cement 18, 18.sup.I Screw-pin Pre-assembled component in the lower and upper holes of the Glenoid glenoid base-plate base-plate 19 Central Peg Component to be enconed on the glenoid base-plate for for glenoid anchorage to the glenoid bone without the use of cement. The base-plate surface in contact with the bone is characterized by a titanium trabeculation. 20, 20.sup.I Fixing screw Cortical screws to be used in substitution of the pin-screws of Glenoid the glenoid base-plate. base-plate 21 Central Bicortical compression screw to be used as an alternative to the glenoid central peg of the glenoid base-plate. base-plate fixing screw 22 Humeral Metal articular component used in the reverse prosthesis insert for configuration. It is characterized by a concave spherical articular reverse surface which articulates with the glenosphere. prosthesis 23 Glenosphere Polyethylene articular component used only for the reverse for reverse prosthesis configuration. prosthesis 24 Glenosphere Component used for mounting the glenosphere on the glenoid adapter base-plate. 25 Safety screws Screw for fixing the glenosphere to the glenoid plate-base for glenosphere

(140) The materials which can be used are the following:

(141) TABLE-US-00002 Applicable ID Prosthetic component Material standards 11 Non-cemented humeral stem Ti6Al4V, ISO 5832/3, hydroxyapatite ISO 13779 11 Cemented humeral stem Ti6Al4V ISO 5832/3 12 Metaphyseal humeral connector Ti6Al4V ASTM F 3001-14 13 Stemless humeral Core Ti6Al4V ASTM F 3001-14 14 Adapter for anatomical humeral Ti6Al4V ISO 5832/3 head 15 Anatomical humeral head UHMWPE ISO 5834/1/2.sup.1/2, UHMWPE + ASTM F 2695-12 0.1% wt ISO 5832/3 Vitamin E Ti6Al4V 16 Anatomical glenoid insertion Ti6Al4V, TiNbN ISO 5832/3 17 Glenoid base-plate Ti6Al4V ASTM F 3001-14 18, 18.sup.I Screw-pin Ti6Al4V ASTM F 3001-14 19 Central peg for glenoid base-plate Ti6Al4V ASTM F 3001-14 20, 20.sup.I Fixing screw for glenoid base-plate Ti6Al4V ISO 5832/3 21 Central fixing screw for glenoid Ti6Al4V ISO 5832/3 base-plate 22 Humeral insert for reverse prosthesis Ti6Al4V, TiNbN ISO 5832/3 23 Glenosphere UHMWPE ISO 5834/1/2, UHMWPE + ASTM F2695-12 0.1% wt ISO 5832/3 Vitamin E Ti6Al4V 24 Safety screw for glenosphere Ti6Al4V ISO 5832/3 25 Glenosphere adapter Ti6Al4V ISO 5832/3

(142) The inversion of the materials of the articular components in the anatomical and reverse configuration (for example anatomical humeral head and glenosphere in UHMWPE with the addition of vitamin E, glenoid insert and humeral insert in titanium alloy TiNAI4V coated via PVD with TiNBN) allows the glenoid insert (compared to the conventional one in polyethylene) to be produced with a lower thickness, reducing the risk of over-stuffing the shoulder, as it is made of metal.

(143) The elimination of the CrCo and steel alloys from the articulation materials in favour of UHMWPE and the alloy Ti&AI4V allows a lower weight of the prosthetic components.

(144) The elimination of the CrCO and steel alloys from the materials makes the prosthesis, object of the present invention, free of cobalt, nickel, chromium and therefore hypoallergenic.

(145) The prosthesis of the present invention is destined for the total substitution, both anatomical and reverse or partial, of the glenohumeral joint. The use of a stemmed or stemless configuration depends on the quality of the bone (previous surgeries, pseudoarthrosis, osteoporosis, bone defects etc.) of the epi-metaphyseal portion of the humerus.

(146) The indications for use are:

(147) Primary non-inflammatory degenerative joint diseases;

(148) Secondary arthritis due to post-traumatic degenerative factors or degenerative rotator cuff diseases;

(149) Avascular necrosis of the humeral head;

(150) Joint degeneration secondary to rheumatoid arthritis, psoriatic arthritis or similar pathologies;

(151) Acute fractures of the humeral head or glenoid;

(152) Failure results of previous prosthetic interventions or osteosynthesis of the glenohumeral compartment.

(153) In particular, the prosthesis, object of the present invention, is particularly suitable for total shoulder arthroplasty surgery in the case of:

(154) arthritis of the glenohumeral joint;

(155) necrosis of the humeral head;

(156) rheumatoid arthritis;

(157) and for total reverse shoulder prosthesis operations in the case of:

(158) arthritis of the glenohumeral joint associated with rotator cuff arthropathy;

(159) massive breakage of the rotator cuff;

(160) outcomes of severe fractures of the proximal humerus;

(161) revision of total or partial shoulder arthroplasty.

(162) The results obtained from in vitro biocompatibility tests and from mechanical tests have demonstrated the high performances, safety and reliability of the prosthesis object of the present invention.

(163) The prosthesis object of the invention therefore provides an anatomical configuration and a reverse configuration, for both the first implant and revision, with (stemmed) or without (stemless) a humeral stem.

(164) The specific feature is its modularity that allows the passage from one configuration to another by adding and/or replacing the appropriate components thanks to their modularity.

(165) The typical configurations with which it can be used are:

(166) TABLE-US-00003 Total Total Total Total Prosthesis anatomical anatomical reverse reverse ID component stemless stemmed stemless stemmed 11 Humeral x x stem 12 Metaphyseal x x central connector 13 Humeral core x x x x 14 Adapter for x x anatomical humeral head 15 Anatomical x x humeral head 16 Anatomical x x glenoid insert 17 Glenoid x x x x base-plate 18, 18.sup.I Screw-pin x x x x for glenoid base-plate 19 Central Peg x x x x for glenoid base-plate 20, 20.sup.I Fixing screw x x x x for glenoid base-plate 21 Central fixing x x x x screw for glenoid base-plate 22 Humeral x x insert for reverse prosthesis 23 Glenosphere x x 24 Glenosphere x x adapter 25 Safety screw x x for glenosphere

(167) The anatomical version (replacement of the humeral and glenoid part) is particularly suitable in the case of:

(168) Concentric arthrosis of the glenohumeral joint with a complete and functioning rotary cuff;

(169) Necrosis of the humeral head; Necrosis of the glenoid;

(170) Aseptic arthritis (A. rheumatoid, A. psoriatica); in the case of a complete rotary cuff.

(171) The reverse version is particularly suitable in the case of:

(172) Arthritis of the glenohumeral joint on extensive breakage of the rotational cuff (cuff arthropathy, disabling shoulder);

(173) Massive irreparable breakage of the rotator cuff;

(174) Outcomes of severe fractures of the non-reconstructable proximal humerus with a total anatomical prosthesis;

(175) Revision of total or partial shoulder arthroplasty.

(176) The suitability for the stemless or stemmed version (anatomical or reverse) depends on the epi-metaphyseal bone quality, in addition to the humeral diaphyseal morphology or possible presence of osteosynthesis means.

(177) In order to obtain good osseointegration, an adequate quantity and quality of the bone is necessary for any stemless humeral implant. In the case of osteoporotic bone and/or general metabolic diseases relating to bone quality, the use of the stemmed version is recommended.

(178) The objective mentioned in the preamble of the description of producing a prosthesis which is both very economical and functional, comprising all the advantages of the known art, but eliminating its drawbacks, has thus been achieved.

(179) The protection scope of the invention is defined by the following claims.