Prosthetic trial device

Abstract

The prosthetic trial device (10) includes a proximal trial component (11) and an annular trial sleeve (12), said proximal trial component (11) being associated with said trial sleeve (12) along a common longitudinal axis (X).

Description

[Technical Field]

[0001] The present invention relates to a prosthetic trialing device used during the surgical procedure of revision of a femoral prosthetic implant to temporarily simulate the final prosthetic implant and allow the surgeon to evaluate parameters for the optimal selection of the latter. [Background technology]

[0002] Surgical procedures for revision of femoral prosthetic implants are already known, which require that the original prosthetic implant be replaced with a revision prosthetic implant.

[0003] In this procedure, the surgeon removes the prosthetic implant that needs to be replaced, then inserts a new stem distally into the medullary canal of the femur, and then associates a prosthetic trialing device with this new stem to identify the exact parameters for final selection.

[0004] The prosthetic trial implant includes a proximal trial component, or trial neck, to which a stem is connected on one side and a femoral head is connected on the other side, and a trial sleeve configured to axially accommodate a portion of the neck that is connected to the stem.

[0005] The neck and trial sleeve are available in different sizes and can be oriented in such a manner to define a desired mutual angular position, characterized by a particular version angle about a common longitudinal axis.

[0006] The dimensions of the prosthetic implant and the angular position of its components are verified through a "trial reduction," a surgical procedure to confirm correct joint movement, during which the prosthetic trial device is removed and a definitive prosthetic implant with similar characteristics to the newly verified trialed one is inserted.

[0007] However, some prosthetic trialing devices require additional measuring instruments to define the exact version angle. These instruments are particularly cumbersome and must be positioned by the surgeon during surgery, requiring additional steps and increasing intervention time.

[0008] It is also known that trial devices allow for the adjustment of the mutual angular position between the trial neck and the trial sleeve in a discrete manner and do not allow for trial reduction because these components are not anatomically correct, requiring the surgeon to take additional procedural steps to ensure that the dimensions and version angles of the components are correct, thereby increasing the surgical time.

[0009] Some known devices for measuring the version angle in a prosthetic femoral implant revision procedure are described in US Patent Application Publication Nos. 2012 / 0259338 and 2011 / 0046745.

[0010] Therefore, there is a need to develop a prosthetic trialing system that can overcome at least one of the shortcomings of the prior art.

[0011] To achieve this, the technical challenge of easily adjusting and clamping the trial neck and trial sleeve at a specific angular position must be overcome.

[0012] In particular, one object of the present invention is to provide a prosthetic trialing device that allows easy angular adjustment between the trial neck and trial sleeve without the use of additional external measuring equipment, and that can be extracted from the patient without loss of angular adjustment and replicated with the final components on the "back table."

[0013] Another object of the present invention is to provide a prosthetic trialing device that is anatomically correct, i.e., usable for trial reduction.

[0014] Another object of the present invention is to provide a prosthetic trialing system that is modular, i.e., has interchangeable components that can be assembled in a simple manner to provide a large number of dimensional combinations.

[0015] Applicant has invented, tested and embodied the present invention to overcome the shortcomings of the prior art and to obtain these and other objects and advantages. Summary of the Invention

[0016] The invention is set out and characterized in the independent claims, while the dependent claims describe other features of the invention or variations of the main inventive idea.

[0017] In order to achieve the above-mentioned object, to solve the technical problem disclosed above in a new and original way and also to achieve significant advantages over the prior art, a prosthetic trialing device according to the present invention can be used during a revision replacement surgery of a femoral prosthesis. Advantageously, the prosthetic trialing device has an anatomical shape that allows it to be used for trial reduction.

[0018] The prosthetic trialing device includes a proximal trial component and a trial sleeve having an annular shape, the proximal trial component associated with the trial sleeve along a common longitudinal axis.

[0019] The proximal trial component, in use, is associated with a stem insertable into the medullary canal of the femur.

[0020] Furthermore, a portion of the proximal trial component is configured to be axially inserted into the trial sleeve and to receive the distal end of the stem.

[0021] According to one aspect of the invention, the prosthetic trialing apparatus includes positioning means configured to axially position the proximal trial component relative to the trial sleeve.

[0022] The positioning means is also configured to angularly position the proximal trial component at a plurality of version angular positions about the longitudinal axis in a continuous or discrete manner.

[0023] The prosthetic trialing device includes an angular clamping means configured to clamp the proximal trial component in a particular version angular position.

[0024] Both the positioning means and the angle clamping means are an integral part of the prosthetic trialing device, which means that the prosthetic trialing device is always ready to use without the surgeon having to prepare additional external measuring and clamping equipment.

[0025] Furthermore, both the positioning means and the angular clamping means are integrated into the proximal trial component and the trial sleeve and are contained within their overall dimensions, so that the prosthetic trialing device is compact and has similar overall dimensions to the final prosthetic implant, while integrating all positioning and clamping means useful for establishing the relative position between the components.

[0026] In accordance with another aspect of the present invention, the proximal trial component can advantageously be angularly positionable relative to the trial sleeve or relative to the stem in a continuous manner. In other words, multiple version angular positions can be obtained in a continuous manner without pre-set discrete movements. This extends the operational flexibility of the prosthetic trial device compared to similar devices of the prior art.

[0027] According to one variation, the proximal trial component can be angularly positioned relative to the trial sleeve or relative to the stem in a discrete manner.

[0028] According to another aspect of the invention, the proximal trial component includes a connector axially constrained within the trial sleeve by the positioning means.

[0029] According to another aspect of the invention, the connector is axially received within the trial sleeve and adapted to receive a distal end of the stem.

[0030] According to another aspect of the invention, the positioning means includes at least one resilient tab on the connecting body and a circumferential groove on the trial sleeve.

[0031] According to another aspect of the invention, the positioning means is of the snap-fit ​​type.

[0032] According to another aspect of the invention, the proximal trial component includes an end body projecting laterally from the connecting body and having an axial bore in which the angle clamping means is contained, which makes the device particularly compact without any cumbersome protruding parts.

[0033] According to another aspect of the invention, the end piece has a projection formed along a transverse axis oblique to the longitudinal axis and having the lumen formed therein.

[0034] According to another aspect of the invention, the angular clamping means includes an actuator and a clamping element attached to the actuator and pivotable to the proximal trial component, particularly the end body, and rotatable between a spaced position and a clamped position.

[0035] According to another aspect of the invention, the actuator may include a moving element that slides within the lumen along the transverse axis and a threaded bushing that engages a corresponding threaded portion of the moving element.

[0036] According to another aspect of the present invention, the proximal trial component is monolithic.

[0037] According to another aspect of the invention, the connecting body is pivotally associated with the trial sleeve by means of the at least one resilient tab freely engaged in the circumferential groove, in particular the connecting body is pivotally inserted into the trial sleeve.

[0038] According to another aspect of the invention, the trial sleeve has an annular edge that faces the proximal trial component in use, while the clamping element abuts the proximal trial component when in the clamped position.

[0039] According to another aspect of the invention, the annular edge angularly extends 360 degrees around the longitudinal axis.

[0040] According to another aspect of the invention, the annular edge has a smooth clamping surface.

[0041] According to another aspect of the present invention, the prosthetic trialing device includes axial clamping means configured to temporarily hold the proximal trial component and the stem together.

[0042] According to another aspect of the invention, the connecting body and the end body can be separate, separate entities that can be mechanically associated with each other in a releasable manner, where the connecting body is angularly constrained to the trial sleeve by the positioning means, which positioning means include a clamp pin on the connecting body and a corresponding axial channel on the trial sleeve, the end body is rotationally associated with the connecting body by the angular positioning means, which include at least one additional resilient tab on the connecting body and a circumferential groove on the end body, and the connecting body has an abutment edge facing the end body in use, whereas the clamp element abuts the proximal trial component when in the clamped position.

[0043] Advantageously, the end body is provided with a seat adapted in shape to the connecting body and in which part of the connecting body is received.

[0044] The variant with two separate and separated connecting and end bodies has the advantage that fewer components are required to achieve the same size variability compared to an embodiment in which the proximal trial component is monolithic.

[0045] These and other aspects, features and advantages of the present invention will become apparent from the following description of some embodiments, given by way of non-limiting example with reference to the accompanying drawings. [Brief explanation of the drawings]

[0046] [Figure 1] FIG. 10 is a front view of a revision prosthetic implant. [Figure 2] 1 illustrates one embodiment of a prosthetic trialing device according to the present invention in one in-use application. [Figure 3] 1 illustrates one embodiment of a prosthetic trialing device according to the present invention in one in-use application. [Figure 4]3 is a view of the prosthetic trial device of FIG. 2 with each element separated. [Figure 5] 3 is a view of the prosthetic trial device of FIG. 2 with the elements assembled. [Figure 6] 4 is a view of the prosthetic trial device of FIG. 3 with each element separated. [Figure 7] 4 is a view of the prosthetic trial device of FIG. 3 with the elements assembled. DETAILED DESCRIPTION OF THE INVENTION

[0047] It must be made clear that the phraseology and terms used in this specification, as well as the symbols in the accompanying drawings, have the sole function of better illustrating and explaining the invention, the scope of protection of which is defined by the claims, and that their function is to provide a non-limiting example of the invention itself.

[0048] For ease of understanding, the same reference numerals have been used wherever possible to identify identical common elements in the drawings, it being understood that elements and features of one embodiment may be conveniently combined or incorporated in other embodiments without further description.

[0049] Referring to FIG. 1 , a revision femoral prosthetic implant 100 includes a stem 110 insertable into the medullary canal of the femur, a generally hemispherical head 111 insertable into a corresponding hip joint acetabular seat, a proximal component or neck 112 to which the stem 110 is connected on one side and the head 111 is connected on the other side, and a sleeve 113 configured to receive a portion of the neck 112 connected to the stem 110.

[0050] 2-3, the prosthetic trialing device 10 of the present invention can be positioned over a previously implanted stem 110 during use to allow the surgeon to select the final dimensions of the neck 112 and sleeve 113 and their mutual angular position depending on the patient's anatomical characteristics.

[0051] The prosthetic trialing device 10 includes a proximal trial component 11 , hereinafter referred to as the trial neck, and a trial sleeve 12 .

[0052] The trial neck 11 and trial sleeve 12 are separate, separate components and are available in different sizes that can be combined with each other.

[0053] The trial neck 11 and trial sleeve 12 have an anatomical shape similar to that of the corresponding final components, allowing the prosthetic trialing device 10 to be used to perform a trial reduction prior to installing the final revision prosthetic implant 100.

[0054] The trial neck 11 is associated with the trial sleeve 12 along a common longitudinal axis X and can assume a number of different angular positions relative to the latter.

[0055] As will become clearer in the following description, a portion of the trial neck 11 is operatively inserted into the trial sleeve 12 along the longitudinal axis X.

[0056] 4-7, the prosthetic trialing device 10 includes positioning means 13 configured to axially position the trial neck 11 relative to the trial sleeve 12.

[0057] According to some embodiments, the positioning means 13 is preferably configured to determine a snap-fit ​​connection between the trial neck 11 and the trial sleeve 12. This significantly simplifies the connection, reducing the number of required components and simplifying the construction of the prosthetic device 10.

[0058] The axial positioning between the trial neck 11 and the trial sleeve 12 is unique in the sense that no axial adjustment is provided.

[0059] The positioning means 13 is also configured to angularly position the trial neck 11 in a continuous manner relative to the trial sleeve 12 among a plurality of version angular positions. This can essentially occur by rotating the trial neck 11 inserted into the trial sleeve 12 about the longitudinal axis X.

[0060] The prosthetic trialing device 10 includes an angle clamping means 14 configured to clamp the trial neck 11 at a desired version angle position, as will be described in detail below.

[0061] The prosthetic trialing device 10 includes an axial clamping means 15 configured to temporarily unite the prosthetic trialing device 10 and a previously implanted stem 110 to enable a trial reduction to be performed. In this case, the axial clamping means 15 comprises a surgical screw 16 that cooperates with the threaded portion 110a of the stem 110 during use and that can be inserted along the longitudinal axis X.

[0062] The proximal trial component 11 includes a tubular connecting body 17 extending along the longitudinal axis X and an end body 18 projecting laterally from the connecting body 17. The angular adjustment of the prosthetic trial device 10 functions to angularly position the end body 18 at a plurality of version angular positions.

[0063] The end body 18 has a central portion 19 coaxial with the longitudinal axis X and a protruding portion 20 extending along a transverse axis Y inclined relative to the longitudinal axis X.

[0064] The protrusion 20 terminates in a shank 21 , which may be cylindrical or frusto-conical, and is configured to couple to a trial head 111 .

[0065] The connector 17 is adapted to couple to both the trial sleeve 12 and to a previously implanted stem 110 .

[0066] The connecting body 17 is adapted to be axially received within the trial sleeve 12. The connecting body 17 is also adapted to receive the distal end of the stem 110.

[0067] Thus, in operation, a temporary connection between the prosthetic trialing device 10 and the stem 110 occurs between the stem 110 and the proximal trialing component 11 .

[0068] This coupling mode has the advantage of allowing the rotating components to remain "covered" and limiting protruding elements that may cause interference during rotational movement. Additionally, the prosthetic trialing device 10 is more compact, maneuverable, and less cumbersome.

[0069] Furthermore, the bond thus obtained is similar, if not exactly overlapping, to the bond that will exist between the components of the final prosthesis that will be implanted. Thus, the trial reduction provides a highly accurate result compared to what will be expected after the final prosthesis is implanted.

[0070] The connecting body 17 includes a substantially cylindrical wall 22 defining an outer coupling surface 23 for coupling with the trial sleeve 12 and an inner coupling surface 24 for coupling with the stem 110 .

[0071] The outer mating surface 23 ends where the central portion 19 of the end body 18 begins.

[0072] The internal coupling surface 24, together with the bottom surface 26, defines a seat 27 that is coaxial with the longitudinal axis X and conforms to the proximal end of the stem 110. In this case, the seat 27 has a cylindrical shape that facilitates axial insertion / extraction of the stem 110.

[0073] The trial neck 11 has a through hole 28 coaxial with the longitudinal axis X and communicating with a seat 27 for the insertion of a surgical screw 16 which serves to temporarily clamp the prosthetic trial device 10 relative to the stem 110. The seat 27 is therefore open on two opposite axial sides, i.e. corresponding to the holes 28 through the bottom surface 26 and corresponding to the access openings to the seat 27 for the insertion of the stem 110.

[0074] Preferably, the lateral dimensions, eg diameter, of the holes 28 are smaller than the lateral dimensions, eg corresponding diameter, of the seats 27 .

[0075] The connecting body 17 also has at least one resilient tab or strap 30 cut into the wall 22 parallel to the longitudinal axis X and configured to define an axial constraint between at least the trial neck 11 and the trial sleeve 12, as will be explained in more detail below. The resilient tab 30 is provided at its end with teeth 31 that define the axial constraint.

[0076] The end body 18 extends substantially along the transverse axis Y and has a bore 25 in which the angle clamping means 14 is disposed. In other words, the angle clamping means 14 is disposed within the trial neck 11, and in particular within the protrusion 20 of the end body 18.

[0077] The bore 25 opens outward and corresponds axially to the shank 21 where the end body 18 has an opening 29, and laterally to the connecting body 17 where the end body 18 has at least one slot 36.

[0078] The angle clamping means 14 includes an actuator 32 and a clamping element 33 attached to the actuator 32 and pivoting to the end body 18 near the central portion 19. In this case, the clamping element 33 is a lever with a free end that functions to determine the angle clamping.

[0079] The clamping element 33 is free to pivot and may exit through a slot 36 .

[0080] Actuator 32 includes a moving element 34 that slides within bore 25 along transverse axis Y, and a threaded bushing 35 that engages a corresponding threaded portion of moving element 34 .

[0081] A bushing 35 is located within the bore 25 at a portion corresponding to the shank 21 and is accessible through the opening 29 .

[0082] Rotation of the bushing 35, for example by means of a wrench, screwdriver or other suitable tool, causes the sliding of the moving element 34 along the transverse axis Y and, consequently, the pivoting of the clamping element 33 through the slot 36.

[0083] The clamping element 33 can be rotated between a spaced position and a clamped position to lock into a desired version angle position relative to the trial sleeve 12 (see Figures 2, 4-5) or relative to the connecting body 17 (see Figures 3, 6-7).

[0084] The clamping element 33 has a shape that determines the clamping by friction between the surfaces.

[0085] The trial sleeve 12 has an annular shape and extends along the longitudinal axis X and has a through-hole 37 whose shape corresponds to the shape of the connecting body 17, in particular to the shape of the latter wall 22. In fact, the trial sleeve 12 is configured to receive the connecting body 17 in the axial direction.

[0086] According to some embodiments, the trial sleeve 12 advantageously has an asymmetric shape relative to the longitudinal axis X. In particular, the trial sleeve 12 has an eccentric portion of the end body 18 facing the projection 20 side.

[0087] The trial sleeve 12 has a circumferential groove 38 formed inward on the wall that defines the through hole 37. The circumferential groove 38 faces the through hole 37, extends continuously around the longitudinal axis X, and is configured to receive the teeth 31 of at least one elastic tab 30.

[0088] The walls defining the through-hole 37 have an essentially smooth surface, which is free of threads.

[0089] When the connecting body 17 is inserted into the trial sleeve 12, at least one elastic tab 30, which protrudes slightly beyond the wall 22 of the connecting body 17, bends in contact with the wall of the through hole 37 until the teeth 31 engage with the circumferential groove 38, determining the axial constraint between the trial neck 11 and the trial sleeve 12.

[0090] With particular reference to the embodiment of Figures 2 and 4-5, the trial neck 11 is monolithic, in that the connecting body 17 and the end body 18 are made in one piece.

[0091] The connecting body 17 is rotatable relative to the trial sleeve 12 by means of angular positioning means 13 which angularly position the end body 18 .

[0092] The angular positioning means 13 includes at least one resilient tab 39 and a circumferential groove 38. In this case, the angular positioning means 13 includes two diametrically opposed resilient tabs 30.

[0093] In operation, once inserted into the trial sleeve 12 , the connecting body 17 can be rotated about the longitudinal axis X with the teeth 31 guided by sliding in the circumferential grooves 38 .

[0094] The angle clamping means 14 is configured to temporarily unite the trial neck 11 with the trial sleeve 12 at a particular version angular position of the end body 18 .

[0095] The trial sleeve 12 has an annular edge 39 which, in use, faces the trial neck 11 and has an outer contact surface against which the clamping element 33 abuts when placed in the clamping position. The annular edge 39 is essentially an extension of the wall defining the through hole 37.

[0096] A temporary connection between the clamping element 33 and the annular edge 39 is obtained as a result of the substantially angular positioning. Indeed, advantageously, the clamping element 33 can be placed in any clamping position, since the annular edge 30 has a smooth surface and is free of retentive references, such as grooves, recesses, etc.

[0097] At the top, the annular edge 39 acts as a stabilizing base for the trial neck 11. In particular, the wall 22 of the connecting body 17 has a lateral dimension that is smaller than the lateral dimension of the central portion 19 of the end body 18, so that there is a shoulder between the connecting body 17 and the end body 18 as an end point of movement of the trial neck 11 relative to the trial sleeve 12.

[0098] With particular reference to the embodiment of Figures 3 and 6-7, the trial neck 11 is made in two parts so that the connecting body 17 and the end body 18 are separate and detachable and can be associated with each other.

[0099] The connecting body 17 is clamped axially and angularly relative to the trial sleeve 12 .

[0100] The connecting body 17 includes at least one clamping pin 43 that projects radially from the wall 22 and is configured to engage a corresponding axial channel 44 formed in the wall that defines the through hole 37 of the trial sleeve 12. The clamping pin 43 projects radially outward relative to the seat 27 of the connecting body 17.

[0101] The axial clamping is determined by at least one resilient tab 30 in the manner described above, while the angular clamping is determined by the geometric constraint established between the clamp pin 43 and the axial channel 44 in use.

[0102] The end body 18 is associated with the connecting body 17 in a rotatable manner so as to reach the desired version angular position.

[0103] The end body 18 has a seat 45 conforming to the connecting body 17, in which the connecting body 17 can engage and rotate.

[0104] The seat 45 has, on the wall that defines it, a circumferential groove 46 formed inwardly, which has a continuous development around the longitudinal axis X.

[0105] Accordingly, the connecting body 17 comprises at least one additional resilient tab 40 cut into the wall 22 parallel to the longitudinal axis X, the resilient tab 40 being provided at its end with teeth 41 and configured to define an axial clamping relative to the end body 18, engaging in a circumferential groove 46. This axial clamping occurs in a similar manner to that described above.

[0106] The additional elastic tab 40 is oriented in an opposite direction to the at least one elastic tab 30. In this case, there are two elastic tabs 30 and two additional elastic tabs 40.

[0107] The angular positioning means 13 includes at least one additional resilient tab 40 and a circumferential groove 46 .

[0108] In this case, the angle clamping means 14 is configured to temporarily unite the end body 18 with the connecting body 17 .

[0109] For this purpose, the upper part of the connecting body 17 is provided with an abutment edge 47 facing the projection 20 of the end body 18, to which the clamping element 33 can be connected when it is placed in the clamping position.

[0110] According to one variant, when the trial neck 11 is made in two parts, the end body 18 can be clamped both axially and angularly relative to the connecting body 17, and the connecting body 17 is rotatable relative to the trial sleeve 12, and the version angular position is clamped by stopping the connecting body 17 relative to the trial sleeve 12.

[0111] The trial neck 11 is characterized by a height H, measured as the distance between the center point of the shank 21 and the base of the connecting body 17, and a lateral dimension L, also referred to as the lateral position or offset, measured as the distance between the center point of the shank 21 and the longitudinal axis X.

[0112] As previously mentioned, embodiments in which the trial neck 11 is monolithic are easier to manufacture and operate, however, to achieve a particular dimensional variability, more trial necks 11 are required. For example, if the dimensional variability has three heights H1, H2, H3 and three lateral orientations L1, L2, L3, nine components must be available to obtain all combinations.

[0113] On the other hand, in an embodiment where the trial neck 11 is modular, i.e., made in two parts, there is more flexibility and fewer components are required to obtain similar dimensional variability. Considering the previous example, only six components are sufficient to obtain similar dimensional variability.

[0114] It will be apparent that modifications and / or additions to components may be made to the prosthetic trialing device 10 described above without departing from the field and scope of the present invention as defined by the claims.

[0115] Although the present invention has been described with reference to some specific examples, it will be clear to those skilled in the art that many other equivalent forms of prosthetic trial devices can certainly be realised which have the characteristics set out in the claims and which therefore all fall within the field of protection defined by the claims.

[0116] In the following claims, references in parentheses have the sole purpose of improving readability and shall not be considered as limiting factors with regard to the field of protection defined by the same claims.

Claims

1. a proximal trial component (11) and an annular trial sleeve (12) associated with each other along a common longitudinal axis (X); a prosthetic trialing device (10) configured to be associated with a stem (110) insertable into the medullary canal of a femur to enable trial reduction, a positioning means (13) configured to position the proximal trial component (11) axially relative to the trial sleeve (12) and angularly at a plurality of version angular positions about the longitudinal axis (X); A prosthetic trial device (10) characterized in that it includes both the proximal trial component (11) and an angle clamping means (14) configured to clamp the proximal trial component (11) at a specific version angle position, with a portion of the proximal trial component (11) inserted into the trial sleeve (12) and configured to accommodate the end of the stem (110).

2. The prosthetic trialing device (10) of claim 1, wherein the proximal trial component (11) is angularly positionable in a continuous manner.

3. The prosthetic trialing device (10) of claim 1, wherein the proximal trial component (11) is angularly positionable in a discrete manner.

4. 4. A prosthetic trial device (10) according to any one of claims 1 to 3, characterized in that the proximal trial component (11) includes a connecting body (17) axially constrained within the trial sleeve (12) by the positioning means (13).

5. 5. The prosthetic trial device (10) according to claim 4, wherein the connecting body (17) is axially accommodated within the trial sleeve (12) and adapted to accommodate an end of the stem (110).

6. 6. The prosthetic trial device (10) according to claim 4 or claim 5, characterized in that the positioning means (13) comprises at least one elastic tab (30) on the connecting body (17) and a circumferential groove (38) on the trial sleeve (12).

7. 7. The prosthetic trial device (10) according to any one of claims 1 to 6, characterized in that the positioning means (13) are of the snap-fit ​​type.

8. 8. The prosthetic trial device (10) according to any one of claims 1 to 7, characterized in that the trial component (11) comprises an end body (18) having an axial bore (25) in which the angular clamping means (14) is contained.

9. 9. The prosthetic trial device (10) of claim 8, wherein the end body (18) has a protrusion (20) formed along a transverse axis (Y) inclined relative to the longitudinal axis (X) and in which the bore (25) is formed.

10. The angle clamping means (14) an actuator (32); a clamping element (33) attached to the actuator (32) and pivotable to the proximal trial component (11) and rotatable between a spaced position and a clamped position; The prosthetic trialing device (10) according to any one of claims 1 to 9, comprising:

11. The actuator (32) a moving element (34) that slides within said lumen (25) along said transverse axis (Y); a threaded bushing (35) that engages with a corresponding threaded portion of said moving element (34); 11. The prosthetic trialing device (10) according to claim 10 when dependent on claim 8 or claim 9, comprising:

12. The prosthetic trial device (10) according to any one of claims 1 to 11, characterized in that the proximal trial component (11) is monolithic.

13. A prosthetic trial device (10) according to claim 6 or any one of claims 7 to 12 when dependent on claim 6, characterized in that the connecting body (17) is rotatably associated with the trial sleeve (12) by means of the at least one elastic tab (30) freely engaged in the circumferential groove (38).

14. A prosthetic trial device (10) according to claims 10 and 12, characterized in that the trial sleeve (12) has an annular edge (39) that faces the proximal trial component (11) during use, whereas the clamping element (33) abuts the proximal trial component (11) when in the clamped position.

15. 15. The prosthetic trialing device (10) of claim 14, wherein the annular edge (39) angularly extends 360 degrees around the longitudinal axis (X) and has a smooth clamping surface.

16. 9. The prosthetic trial device (10) according to claim 4 and claim 8, characterized in that the connecting body (17) and the end body (18) are separate and distinct entities and can be mechanically associated with each other in a detachable manner.

17. The connecting body (17) is angularly constrained to the trial sleeve (12) by the positioning means (13), 17. The prosthetic trial device (10) of claim 16, wherein the positioning means (13) includes a clamp pin (43) on the connecting body (17) and a corresponding axial channel (44) on the trial sleeve (12).

18. 18. A prosthetic trial device (10) according to claim 16 or claim 17, characterized in that the end body (18) is provided with a base (45) that is shaped to fit the connecting body (17) and in which a portion of the connecting body (17) is accommodated.

19. The end body (18) is pivotally associated with the connecting body (17) by the angular positioning means (13), the angular positioning means (13) comprises at least one additional elastic tab (40) on the connecting body (17) and a circumferential groove (46) on the end body (18), A prosthetic trialing device (10) according to claim 16 or claim 17.

20. A prosthetic trial device (10) according to any one of claims 10 and 16 to 19, characterized in that the connecting body (17) has an abutment edge (47) facing the end body (18) during use, whereas the clamping element (33) abuts the proximal trial component (11) when in the clamped position.

21. 21. The prosthetic trial device (10) according to any one of claims 1 to 20, comprising axial clamping means (15) configured to temporarily unite the proximal trial component (11) and the stem (110).

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