GB2461149A

GB2461149A - Total knee prosthesis

Info

Publication number: GB2461149A
Application number: GB0908734A
Authority: GB
Inventors: Derek James Wallace Mcminn
Original assignee: Individual
Current assignee: Individual
Priority date: 2005-12-28
Filing date: 2009-05-21
Publication date: 2009-12-30
Anticipated expiration: 2026-12-21
Also published as: GB0908734D0; GB2461149B

Abstract

The prosthesis comprises a femoral component 10 and a patellar component 22. The femoral component 10 has a patellar flange (15, fig 1) into which is built a twist or roller coaster configuration. The patellar component 22 has an off-set dome with respective lateral and medial facets (24, 25, fig 13). The configuration of the patellar flange resists forces from a medial to a lateral direction, whilst the lateral and medial facets of the patellar component are respectively shaped to allow area contact and line contact respectively with the femoral component. Also disclosed is a method of manufacturing the patella component by oscillating a cutter blade about the centre of the lateral fact to produce the medial facet.

Description

Improvements in or Relating to Knee Prostheses This invention relates to improvements in or relating to knee prostheses, and is particularly concerned with the patel1o-femoral interface.

The patello-femoral joint is a troublesome area in conventional total knee replacement design. A significant number of patients are left with discomfort from the patello-femoral region following total knee replacement and others have failure such as lateral patellar mal-tracking, wear through of polyethylene patellar components, fracture of patellar components, loosening of components and fracture of the patella bone itself, requiring revision surgery.

In order to obviate the point loading and high wear using a conventional domed polyethylene patellar button, U.S. Patent No. 4309778 discloses a highly conforming patellar button giving area contact. However because this type of articular surface is highly conforming to the femoral component design that it is matched to, a fixed bearing of this design would not allow the normal patellar rotation which occurs in use. The design thus had to incorporate a metallic base plate and allow rotation of the polyethylene bearing component upon that base plate.

This prior art design was however found to be susceptible to failure, and in The Journal of Arthroplasty, Volume 20 No. 2 2005 pages 202-208, an article by Huang et al describes failures of this type of design, pointing out that this type of patellar replacement is highly sensitive to patellar mal-tracking. As there is a finite allowable thickness of patella replacement, when a (metallic) base plate is added to a patellar button design, of necessity the polyethylene articular portion has a very thin layer, making the design highly susceptible to point loading.

An object of the invention is to provide a knee prosthesis in which the patello-femoral joint is improved. A further object is to provide an improved.

femoral component for use in such a knee prosthesis, and also an improved patellar articular component for use in such a knee prosthesis. A still further object is to provide a device for intra-operative checking of patellar tracking to allow correct insertion of both the femoral component and the patellar component of the knee prosthesis.

According to a first aspect of the invention there is provided a femoral component of a knee replacement comprising lateral and medial condyles, an open intercondylar area between said condyles, a patellar flange, and a patellar groove extending from said open intercondylar area to a free end of the patellar flange, characterised in that the articular surface of the patellar flange for patella contact is for a distance extending inwardly from the free end of the patellar flange configured to resist forces, in use, from a medial to a lateral direction.

Preferably a twist or roller coaster configuration is built into the femoral component to resist forces from a medial to a lateral direction.

Desirably the degree of twist decreases away from said free end, and conveniently the twist is terminated at a spacing from said free end of the patellar flange lying within the open intercondylar area. In a preferred embodiment the open intercondylar area is enclosed by an intercondylar box.

According to a second aspect of the invention there is provided a patellar component of a total knee replacement comprising an articular surface formed with an off-set domed region and providing a lateral facet shaped to allow area contact, in use, and a medial facet shaped to allow line contact, in use, with an associated femoral component of said total knee replacement.

The dome is off-set medially by, for example, 5mm, but it is preferably intended to provide a range of different off-sets available, e.g. 3mm, 5mm or 7mm off-set as required. The patellar component is desirably of one piece and conveniently formed of plastics material, for example polyethylene.

In full extension, the dome has point contact with the femoral component, but in full extension the patello-femoral compressive force is lowest. In slight flexion up to 450 the dome makes line contact in the floor of the patellar groove of the femoral component. At higher degrees of flexion the dome makes no contact in the intercondylar box area and on the lateral side load is taken through the lateral facet with area contact on the lateral femoral condyle of the femoral component. On the medial side, the medial facet has a cross-section similar to a Mexican hat' shape, giving line contact on the medial femoral condyle.

Advantageously the patellar component has a non-articular surface with fixation means for cement fixation. In one embodiment such means could be pegs and recesses. However the component could have a modified surface for cementless fixation.

Preferably the patellar component is manufactured by oscillating a cutter blade about the centre of the lateral facet area to produce the medial facet. This method of manufacture is according to a third aspect of the invention.

According to a fourth aspect of the invention, there is provided a total knee prosthesis comprising a femoral component of said first aspect of the invention and a patellar component of said second aspect of the invention interacting therewith, in use.

According to a fifth aspect of the invention there is provided a device for intra-operative checking of patellar tracking with a total knee replacement, the device comprising a first part having a polymeric patellar component with articular surfaces matching the femoral component of the knee replacement, and an extension member for registering with a second part of the device, the second part having a portion sized to the cut surface of the patellar and with means for engagement with said cut surface, and an extension member for registering with said first part of the device, relative sliding movement being possible, in use, between said first and second parts.

A scale on one of the first or second parts of the device indicates the relative degree of sliding between the two parts. During intra-operative use, the knee is flexed throughout the whole range of movement and the amount of patellar mal-tracking measured by observation of the scale.

As, in one embodiment, the metallic base plate part of the device, the second part, makes low friction sliding contact with the patellar component of the device, then the patella with its attached soft tissues is free medio-laterally to translate to its desired position. The tracking device thus allows the Surgeon to detect any discrepancy between where the patella wants to be' and where the patellar component wants to be' and address such discrepancy.

The invention will now be described, by way of example, with reference to the accompanying drawings, in which: Figure 1 is a schematic front view of a femoral component of a total knee replacement, the femoral component being according to one aspect of the present invention, the Figure showing various degrees of twist' incorporated into the component, the degree of twist decreasing from the line E-E, through the lines D-D, C-C, B-B, to the line A-A; Figure 2 very schematically shows the external profiles of the femoral component of Figure 1 from the line E-E through to the line A-A; Figure 3 shows a lateral profile of the femoral component together with the line E-E; Figure 4 shows transection line E-E at 900 to Figure 3; Figure 5 is a view equivalent to Figure 3, but with the section now showing the line D-D; Figure 6 is a view equivalent to Figure 4 for the transection line D-D; Figure 7 is a view equivalent to Figure 3 for the section along line C-C; Figure 8 is a view equivalent to Figure 4 for the transection line C-C; Figure 9 is a view equivalent to Figure 3 with the section along line B-B; Figure 10 is a view equivalent to Figure 4 for the transection line B-B; Figure 11 is a view equivalent to Figure 3 for the section along line A-A; Figure 12 shows the transection line A-A at 900 to Figure 3; Figure 13 is a perspective view of a patellar component of another aspect of the invention, showing an articular surface thereof; Figure 14 is a horizontal cross section through the mid-patellar component with a degree of off-set of a dome of the component being shown; Figure 15 is a perspective view of the underside surface of the patellar component; Figure 16 schematically represents a method of manufacturing a medial articular surface of the patellar component, according to a further aspect of the invention; Figure 17 shows the patellar component of Figure 13 in interaction with the femoral component of Figure 1, the position of the patellar component being as viewed from the lateral plane with the knee in full extension; Figure 18 shows the patellar component and femoral component at right angles to Figure 17, the patellar component being with neutral tilt; Figure 19 is a view corresponding to Figure 18, with the patellar component with a medially directed tilt; Figure 20 is a view like Figure 19, showing the patellar component entering the patellar groove from a medial direction; Figure 21 is a view like Figure 19, showing the patellar component entering the patellar groove from a lateral direction; Figure 22 is a view like Figure 17, showing the position of the patellar component on the femoral component at approximately 300 flexion as viewed in the lateral plane; Figure 23 is a frontal projection of the patella component at the same 300 flexion as with Figure 22; Figure 24 is a view corresponding to Figures 22 and 23 showing that the dome of the patellar component makes line contact with the floor of the patella groove of the femoral component; Figure 25 is a view corresponding to Figure 17, showing the position of the patellar component on the femoral component at approximately 60Â° flexion as viewed in the lateral plane; Figure 26 is a view corresponding to Figure 25, showing the position of the patellar component viewed in the frontal plane at 60Â° of flexion; Figure 27 shows a transverse cut though the mid-portion of the patellar component at 60Â° of flexion; Figure 28 shows a sagittal section through the lateral femoral condyle and the lateral facet of the patellar component at 60Â° of flexion; Figure 29 is a view normal to the sagittal section of Figure 28 showing line contact between the lateral facet of the patellar component and the lateral femoral condyle as viewed in this plane; Figure 30 shows a sagittal section through the medial femoral condyle and the medial facet of the patellar component at 60Â° of flexion; Figure 31 is a view normal to a sagittal plane of Figure 30 showing that in this projection, point contact only occurs between the medial facet of the patellar component and the medial femoral condyle; Figure 32 shows the patellar component on the femoral component with neutral rotation; Figure 33 is a view similar to Figure 32, showing the patellar component on the femoral component with 7Â° of clockwise rotation; Figure 34 is a view corresponding to Figure 32, but showing the patella component on the femoral component with 70 of anti-clockwise rotation; Figure 35 is a view like Figure 32, showing a transverse section through the mid-patellar component with 70 of anti-clockwise rotation; Figure 36 shows in the transverse plane of Figure 35, line contact of the medial facet on the medial femoral condyle and lateral facet on the lateral femoral condyle is maintained with the patellar component; Figure 37 shows a sagittal section through the lateral fernoral condyle and lateral facet of the patellar component, with the patellar component in the 7Â° anti-clockwise rotated position; Figure 38 is a sagittal section through the medial femoral condyle and the medial facet with the patellar component in 600 of flexion and 7Â° of anti-clockwise rotation; Figure 39 shows one part of a device according to a further aspect of the invention for intra-operative checking of patellar tracking with a total knee replacement; Figure 40 shows a further part of the device for intra-operative checking of patellar tracking; Figure 41 shows the two parts of the device shown in Figure 39 and Figure 40 fitted together; Figure 42 shows schematically the patello-femoral alignment guide of Figure 41 in use with the knee flexed to approximately 550, Figure 43 shows a further view of the alignment guide in use at 900 to Figure 42, Figure 44 shows an alternative form of patello-femoral alignment guide to that shown in Figure 41, Figures 45 and 46 are respective fragmentary enlarged side and perspective views of the guide of Figure 44, and Figure 47 is a fragmentary enlarged perspective view of an end of the guide of Figure 44 at which measurements are taken.

Figure 1 shows a femoral component 10 of a knee prosthesis, the femoral component 10 comprising lateral and medial condyles 11, 12 respectively, between which is an open area 13 which, in this embodiment, is enclosed laterally and longitudinally by an intercondylar box 14. However this box could be omitted in an alternative embodiment. Extending away from the condyles 11, 12 and box 14 is a patellar flange 15, having a central patellar groove 16 extending from the box 14 to the free end of the flange 15.

As shown, for example, in Figure 3, the overall internal surface of the femoral component 10 is formed by six discrete flat surfaces 16 to 21 respectively, these, in use, matching six corresponding flat cut surfaces of the patient's femur. This particular arrangement of six flat surfaces may be formed as defined in the Applicant's co-pending UK Published Patent Application No: 2426200.

According to a first aspect of the invention, as shown best in Figures 1 and 2, a twist is built into the femoral component, particularly the patella flange 15, in the manner of a roller-coaster' so that the articular surface for patella contact is gradually directed in a medial direction. This has the effect -10 -of resisting forces from a medial to a lateral direction which would cause the patella to laterally sublux or dislocate. Figure 1 shows lines A-A through to line E-E taken in different positions through the femoral component, with the line E-E being at the free end of the patella flange, the line C-C being spaced from the line E-E substantially at the commencement of the intercondylar box 14, and the line A-A being taken part way through the length of the interÃ�ondylar box 14.

Figure 2 shows the twists' of the respective lines in isolation, and from this it can be seen that the twist at line E-E is the greatest, the twist thereafter successfully decreasing from line D-D through to line A-A where the twist is minimal or non-existent.

Figure 3 shows a lateral profile of the femoral component 10 with a section through line E-E, whilst corresponding Figure 4 shows transection line E-E at 90Â° to Figure 3. Line P-P is a tangent to the posterior femoral condyles and line E-E is a tangent to the cut surface of the patello-femoral articulation. Line E-P is parallel to the line P-P and the acute angle between E-P and E-E therefore shows the medially directed patello-femoral articulation at this point.

Figure 5 is a view like Figure 3, but shows a lateral projection of the femoral component with a section along line D-D, whilst Figure 6 is a view corresponding to Figure 4, showing the medially directed angle at level D. It can be seen here that the acute angle between the lines D-D and D-P is substantially the same as the angle shown in Figure 4 at the level E. Figure 7. Figure 7 is a view corresponding with Figures 3 and 5, showing a lateral -11-profile of the femoral component with a section at line C-C, whilst Figure 8, corresponding to Figure 7, shows the medially directed patello-femoral articulation angle at point C. Figure 9, corresponding to Figures 3, 5 and 7, shows the lateral projection of the femoral component with a section along line B-B, whilst Figure 10, corresponding to Figures 4, 6 and 8, shows an ever decreasing medially directed angle between lines B-B and B-P at the level B. Finally Figure 11 corresponding to Figures 3, 5, 7 and 9, shows the lateral projection of the femoral component with section at level A-A, with corresponding Figure 12 showing, for a view corresponding to Figures 4, 6, 8 and 10, that the roller-coaster' is fully unwound so that there is now no angle between the line A-A and the posterior femoral condyles.

Figures 13 to 15 show a patellar component 22 in the form of a one-piece plastics material button, for example of polyethylene, the button having, as viewed, an upper surface, which is internal, in use, and a lower surface which is external, in use, and is for fixation to the remnant human patella, using an acrylic grouting agent or cement or other suitable fixing means. The internal (upper) articular surface of the button is in the form of an off-set dome 23 with a lateral facet 24 shaped to allow area contact, and a medial facet 25 shaped to allow line contact. In full extension, the dome of this patellar button has point contact, but in full extension the patello-femoral compressive force is lowest. In slight flexion up to 450 the dome 23 makes line contact in the floor of the patella groove 16 of the femoral component.

At higher degrees of flexion the dome 23 makes no contact in the area of the intercondylar box 14 and on the lateral side load is taken through the lateral -12 -facet 24 with area contact on the lateral femoral coÃ�dyle of the femoral component 10 and on the medial side the medial facet 25 has a cross-section similar to a Mexican hat' shape, giving line contact on the medial femoral condyle 12. Figure 14 shows a horizontal cross-section through the mid-patellar button. As can be seen from this Figure, the dome is off-set in the medial direction by a distance x'. In the embodiment shown there is 5nim of medial off-set of the dome. However it is intended, as will be referred to hereinafter, to have a range of different off-sets available, for example 3mm off-set, 5mm off-set or 7mm off-set. Figure 15 is a view of the non-articular surface of the patella button, and in the example shown this surface is provided with three pegs 26 and an associated recess 27 for cement fixation to the remnant human patella. However this design could also have a modified non-articular surface for cementless fixation also.

Figure 16 shows how the medial facet 25 is manufactured. A cutter blade F-F is oscilated about the centre of the area of the lateral facet 24 to produce the medial facet 25. This ensures that when the patella rotates in use, then the new patella articular surface rotates about the centre of the lateral facet area, retaining lateral area contact and on the medial side line contact is maintained on the medial facet 25.

Figures 17 to 38 show the interaction of the patellar component 22 with the femoral component 10 of Figures 1 to 12. Figure 17 shows the position of the patellar button 22 on the femoral component as viewed from the lateral plane with the knee in full extension, whilst Figure 18 shows that in full extension, the femoral component 10 does not constrain the patellar -13 -button 22 or the patella into any particular direction of tilt. Shown in Figure 18 is the patella with neutral tilt.

Figure 19 shows the patella and the patellar button with a medially directed tilt. In other words, neither the medial nor the lateral facet of the patella button make contact in normal use with the femoral component in full extension, and the soft tissues are therefore able to apply whatever tilt they desire on the patella and the patellar button. The contact between the dome 23 of the patella button and the patellar groove 16 in full extension is point contact. This is not regarded as a concern because in this position of full extension the patello-femoral compressive forces are at their lowest. It can be seen that in extension the radius of curvature at the base of the patella groove on the femur is greater than the radius of curvature of the dome 23 of the patella button. This means that the patella track on the femur in common with previous total knee replacement designs has a funnel' shape at its most proximal end, thus catching' the patella button from whatever direction it enters the patellar groove. Figure 20 shows the patellar button entering the funnel' of the patellar groove 16 from a medial direction, whilst Figure 21 shows the patellar button arriving from a lateral direction with the patella groove funnel' at its most proximal end, catching' the patella button.

Figure 22 shows the position of the pateilar button 22 on the femoral component 10 at approximately 30Â° of flexion as viewed in the lateral plane.

Figure 23 showing a frontal projection of the patellar button 22 at the same 30Â° of flexion.

-14 -Figure 24 shows that the funnel' effect of the top of the patellar groove has now disappeared, and the dome of the patella makes its line contact with the floor of the patellar groove of the femoral component. The medial and lateral facets of patella start to engage the respective parts of the femur, and a medially directed tilt of the patellar button and patella is created.

Figure 25 shows the position of the patella on the femur at approximately 600 of flexion as viewed in the lateral plane, whilst Figure 26 shows the position of the patellar button viewed in the frontal plane at 60Â° of flexion. Figure 27 shows a transverse cut through the mid-portion of the patellar button in 600 of flexion, and it can be seen that the dome 23 of the patellar button no longer makes contact with the femur as it is now in the box region around the patellar groove 16. It can be seen from this transverse view that there is line contact of the lateral facet on the lateral fernoral condyle and line contact of the medial facet on the medial femoral condyle.

Figure 28 shows a sagittal section through the lateral femoral condyle and the lateral facet of the patella, whilst Figure 29 is a view normal to the section of Figure 28, showing line contact between the lateral facet of the patella and the lateral femoral condyle as viewed in this plane. It will be appreciated that since there is line contact visible between the lateral facet and the lateral femoral condyle, both in the transverse and sagittal planes, this means that area Contact exists between the lateral facet of the patella and the lateral femoral condyle. Figure 30 is a similar view to Figure 28, but shows a sagittal section through the medial femoral condyle and the medial facet of the patella at 60Â° of flexion, whilst Figure 31 is a view normal to the -15 -sagittal plane view of Figure 30. This shows that in this projection point contact only occurs between the medial facet of the patella and the medial femoral condyle. However with line contact showing on the transverse plane and point contact showing on the sagittal plane, this means that line contact occurs between the medial facet of the patella and the medial femoral condyle.

Figure 32 shows the patellar button on the femoral component with neutral rotation, whilst Figure 33 shows the patella button on the femur with of clockwise rotation, with Figure 34 showing the patella on the femur with 70 of anti-clockwise rotation. Figure 35 shows a transverse section through the mid-patella with 7Â° of anti-clockwise rotation.

Figure 36 shows that in the transverse plane illustrated, line contact of the medial facet on the medial femoral condyle and lateral facet on the lateral femoral condyle is maintained, the transverse plane being that referred to in Figure 35.

Figure 37 shows a sagittal section through the lateral femoral condyle and lateral facet of patella with the patella in a 7Â° anti-clockwise rotated position. This still shows area contact between the lateral facet of the patella and the lateral femoral condyle. The fact that there is again line contact showing on both the sagittal cut and the transverse cut means that lateral area contact has been maintained despite 70 of rotation. Figure 38 is a sagittal section through the medial femoral condyle and the medial facet with the patella in 60Â° of flexion and 7Â° of anti-clockwise rotation. This shows point contact when viewed in the sagittal plane. However, since in the 70 rotated -16 -position there is still line contact on the transverse view and point contact on the sagittal view means that despite 7Â° of rotation of the patellar button on the femur, medial line contact is maintained.

According to another aspect of the invention, there is provided a patello-femoral alignment guide which is an instrument intended for intra-operative checking of patellar tracking to allow correct insertion of both the femoral component and the patellar button of a total knee replacement.

The structure of this instrument 28 is shown in Figures 39 to 41, while Figures 42 and 43 show the instrument in use in conjunction with the replacement knee components.

The instrument consists of two parts, a first part 29 being shown in Figure 39, a second part 30 being shown in Figure 40 and the instrument with the two parts 29 and 30 assembled together being shown in Figure 41.

From Figure 39 it can be seen that the first part of the instrument has a polymeric patellar button trial component 31 with articular surfaces designed to match the femoral component being inserted into the patient. As illustrated the articular surfaces are in the form of the embodiment hereinbefore described, but this instrument could be applied to any total knee replacement design with a polymeric patellar button surface made to match the particular femoral component being inserted. Extending from the medial side of the patellar button trial component 31 is an extension member in the form of a flat flexible metallic rod 32 which on its underside is provided with two or more lugs 33 for registering, i.e. for sliding and locking engagement with the second part 30 of the instrument. The second part of the instrument, -17 -as shown in Figure 40, consists of a metallic base plate 34 sized to the cut surface of the patella. Desirably this base plate should be of the same size as the patellar button that is being inserted. Base plate 34 has short metallic spikes 35 for temporary engagement into the cut surface of the patella.

Extending from the medial side of the base plate is a flat metallic rod 36 similar to the rod 32 of the first part of the instrument. The rod 36 is provided with a pair of spaced elongated keyhole-like openings 37 to allow the second part to register with the first part by means of the lugs 33 extending through said openings which allow locking and sliding engagement between the two parts, as shown in one position in Figure 41. That Figure shows the two parts of the instrument fitted together, and when sliding of one part of the instrument occurs on another, then the amount of such sliding can be read-off on a millimetre or other scale, which in the example shown, is marked on rod 32, being denoted by the numeral 38. It will be understood that in alternative embodiment, the scale could be provided on the second part 30, and it will also be understood that the respective designs of the extension members can be varied as required.

Figure 42 is a schematic view of the patello-femoral alignment guide instrument, in use, with the knee flexed to approximately 550, in this example. Not only is there shown the replacement femoral component 10, but there is also shown the tibia! base plate 39a and a plastics material bearing component 39b of the total knee replacement or prosthesis. It is intended that during intra-operative use, the knee is flexed throughout the full range of movement, and the amount of patellar mal-tracking measured by observation of the scale of the instrument.

-18 -Figure 43 shows that because the patellar button, i.e. the trial component 31, of this instrument is highly congruent with the respective femoral component, then during flexion and extension of the knee, this patellar button part of the instrument will stay normally aligned with the femoral component. Since the metallic base plate part 34 of the instrument makes low friction sliding contact with the patellar button part of the instrument, then the patella with its attached soft tissues is free to medio-laterally translate to its desired position.

A further, more preferred form of patello-femoral alignment guide instrument is shown in Figures 44 to 47. As with the first embodiment of such an instrument, shown in Figures 39 to 43, the instrument of figures 44 to 47 also consists of two parts, namely a first part 40 and a second part 41 of plastics material.

The first part 40 of the instrument has a polymeric patellar button trial component 42 with articular surfaces designed to match the femoral component being inserted into the patient. As with the instrument of the first embodiment, the patellar button surface could be made to match the particular femoral component being inserted.

Extending from the medial side of the patellar button trial component is a flexible wire 43, this wire forming an extension member for registering with the second part 41 of the instrument, as will be described.

The second part 41 consists of a base plate 44 sized to the cut surface of the patella. Desirably this base plate should be of the same size as the -19 -patellar button that is being inserted. The base plate 44 has three circular opening 45 therein and three spikes 46 for temporary engagement into the cut surface of the patella.

Extending from the medial side of the base plate 44 is an extension member in the form of an integral flexible strap part 47 which at its end is formal as an integral, short cylindrical hollow sleeve 48. As shown best in Figure 46, there is fixed within the sleeve 48, and filling it, a tubular insert 49 through which centrally extends one end of a hollow elongated flexible tube 50 of considerable length, as shown in Figure 44.

The tube 50 is fixed to the insert 49, and at its other end it is fixed to and extends into one end of a short cylindrical sleeve 51. Extending from the other end of the sleeve is an integral reference portion, having a scale 52 on a flat surface through which centrally extends a part-circular cross-section, open-topped channel 53. The tube thus also forms part of the extension member for registering with the first part 40.

When the parts 40 and 41 are fitted together, as shown in Figures 44 to 47, a configured part of the base plate of the second part 41 is received in a recess 54 in the undersurface of the patellar button trial component 42, which recess has undercut (dovetail) sides. The flexible wire 43 extends from the component by following the path of the strap 47 and then being received through the tube 50, relative to which it can slide. The free end of the wire passes out of the tube 50 through its sleeve 51 to emerge disposed within the channel 53, as shown in Figure 47.

-20 -With the arrangement described and illustrated, it will understood that the instrument of Figures 44 to 47 is used with a flexed knee in effectively the same manner as for the first embodiment of the instrument shown in Figures 42 and 43. The main difference is of course in relation to the way in which the amount of any patellar mal-tracking is measured. Accordingly relative sliding movement between the parts 40,41 is translated into sliding movement of the wire in the channel 53, the position of the free end of the wire being measured against the scale 52. The use of this type of flexible Bowden cable has been found to be better than the arrangement of Figures 39 to 43.

The tracking instrument therefore allows the Surgeon to detect any discrepancy between where the patella wants to be' and where the patellar button wants to be'. During the operation, the Surgeon can address any discrepancy by several manoeuvres. If, for example, the patella is laterally mal-tracking, then the Surgeon could address this by: 1) Laterally displacing the trial femoral component on the femur, thus lateralising the patellar groove.

2) Medially displacing the tracker base plate on the cut surface of the patella, provided enough bone exists to allow such medial displacement.

3) Choosing a patellar button with a greater off-set, e.g. choosing a 5mm off-set or a 7mm off-set patellar button in preference to a 3mm patellar off-set button.

-21 - 4) In fixed bearing knee designs, but not appropriate in this illustrated case, the Surgeon could alter the rotational alignment of the trial tibial component upon the tibia, provided enough bone exists to allow such rotational re-alignment.

5) A lateral retinacular release could be performed, but this would be regarded as a last resort measure, as lateral retinacular release carries morbidity because of bruising and also risks injuring the blood supply to the patella.

Further aspects of the present invention are detailed in the following numbered clauses.

1. A femoral component of a knee replacement comprising lateral and medial condyles, an open intercondylar area between said condyles, a patella flange and a patellar groove extending from said open intercondylar area to a free end of the patellar flange, characterised in that the articular surface of the patellar flange for patellar contact is from a distance extending inwardly from the free end of the patellar flange configured to resist forces in use, from a medial to a lateral direction.

2. A femoral component according to clause 1, wherein a twist or roller coaster configuration is built into the femoral component to resist forces from a medial to a lateral direction.

-22 - 3. A femoral component according to clause 2, wherein the degree of twist decreases away from said free end.

4. A femoral component according to clause 3, wherein the twist is terminated at a spacing from said free end of the patellar flange lying within the open intercondylar area.

5. A femoral component according to any one of clauses 1 to 4, wherein the open intercondylar area is enclosed by an intercondylar box.

6. A patellar component of a total knee replacement comprising an articular surface formed with an off-set domed region and providing a lateral facet shaped to allow area contact, in use, and a medial facet shaped to allow line contact, in use, with an associated femoral component of said total knee replacement.

7. A patellar component according to clause 6, wherein the dome is off-set medially.

8. A patellar component according to clause 7, wherein the off-set is a selected value of one of 3mm, 5mm or 7mm.

9. A patellar component according to any one of clauses 6 to 8, which is in one piece.

10. A patellar component according to any one of clauses 6 to 9, which is of plastics material.

-23 - 11. A patellar component according to any one of clauses 6 to 10, which has a non-articular surface.

12. A patellar component according to clause 11, wherein the non-articular surface has fixation means.

13. A method of manufacturing a patellar component for a total knee replacement, comprising providing a patellar component having an off-set domed region and a lateral facet shaped to allow area contact, in use, the method comprising oscillating a cutter blade about the centre of the lateral facet area to produce the medial facet.

14. A total knee prosthesis comprising a femoral component and a patellar component, the femoral component having lateral and medial condyles, an open intercondylar area between said condyles, a patellar flange, and a patellar groove extending from said open intercondular area to a free end of the patellar flange, and the patellar component having an articular surface formed with an off-set domed region and providing a lateral facet and a medial facet, wherein the articular surface of the patellar flange contacting the patellar component, in use, is for a distance expanding inwardly from the free end of the patellar flange configured to resist forces, in use, from a medial to a lateral direction, and wherein the lateral facet and the medial facet are respectively shaped to allow area contact and line contact with the femoral component.

-24 - 15. A prosthesis according to clause 14, wherein on full extension, the dome has point contact with the femoral component, but in full extension the patellar-femoral compressive force is lowest.

16. A prosthesis according to clause 14 or clause 15, wherein in slight flexion up to 450 the dome makes the line contact in a floor of the patellar groove of the femoral component.

17. A prosthesis according to clause 16, wherein at higher degrees of flexion the dome makes no contact in the intercondylar box area and on the lateral side load is taken through the lateral facet with area contact on the lateral femoral condyle of the femoral component.

18. A prosthesis according to clause 17, wherein on the medial side, the medial facet has a cross-section effecting line contact on the medial femoral condyle.

19. A device for intra-operative checking of patellar tracking with a total knee replacement, the device comprising a first part having a polymeric patellar component with articular surfaces matching the femoral component of the knee replacement, and an extension member for registering with a second part of the device, the second part having a portion sized to the cut surface of the patellar and with means for engagement with the cut surface, and an extension member for registering with said first part of the device, relative sliding movement being possible, in use, between said first and second parts.

-25 - 20. A device according to clause 19, wherein a scale on one of the first or second parts of the device indicates the relative degree of sliding between the two parts.

21. A device according to clause 20, wherein during intra-operative use, the knee is flexed throughout the whole range of movement and the amount of patellar mal-tracking measured by observation of the scale.

22. A device according to clause 20 or clause 21, wherein the extension member of the first part is in the form of a flexii wire, a free end of which registers with said scale on the second part to indicate the relative degree of sliding between the two parts.

23. A device according to clause 22, wherein the flexible wire of said first part extends through a flexible tube of said second part.

24. A device according to clause 23, wherein said scale is formed on a reference portion at an end of the flexible tube remote from said portion of the second part sized to the cut surface of the patella.

25. A device according to clause 24, wherein the reference portion defines a flat surface carrying said scale and having an open-topped channel therein, in which said free end of the flexible wire is slidably received.

-26 - 26. A device according to any one of clauses 23 to 25, wherein there is a flexible strap part between said portion of the second part sized to the cut surface of the patella and said flexible tube.

27. A device according to clause 26, wherein the tube extends from a sleeve at one end of the strap.

28. A device according to any one of clauses 19 to 27, wherein the means of the second part for engagement with the cut surface are a plurality of spikes extending from the opposite surface of the second part to that which effects relative sliding movement with the first part.

29. A device according to any one of clauses 19 to 28, wherein the patellar component of the first part has a recess in which is received part of the portion of the second part sized to the cut surface of the patellar.

30. A device according to clause 29, in which said recess has undercut sides.

31. A device according to any one of clauses 19 to 30, wherein the second part is of plastics material.

32. A device according to any one of clauses 19 to 21, wherein the second part is a metallic base plate part of the device.

-27 - 33. A device according to clause 22, wherein as the second part makes low friction sliding contact with the patellar component of the device, then the patella with its attached soft tissues is free medio-laterally to translate to its desired position.

34. A femoral component of a knee replacement substantially as hereinbefore described, with reference to, and as shown in Figures 1 to 12 of the accompanying drawings.

35. A patellar component of a total knee replacement, substantially as hereinbefore described, with reference to and as shown in Figures 13 to 15 of the accompanying drawings.

36. A method of manufacturing a patellar component for a total knee replacement substantially as hereinbefore described, with reference to, and as shown in Figure 16 of the accompanying drawings.

37. A total knee prosthesis substantially as hereinbefore described, with reference to, and as shown in Figures 17 to 38 of the accompanying drawings.

38. A device for intra-operative checking of patellar tracking with a total knee replacement substantially as hereinbefore described, with reference to, and as shown in Figures 39 to 43 of the accompanying drawings.

-28 - 39. A device for intra-operative checking of patellar tracking with a total knee replacement substantially as hereinbefore described, with reference to, and as shown in Figures 44 to 47 of the accompanying drawings.

Claims

Claims 1. A total knee prosthesis comprising a femoral component and a patellar component, the femoral component having lateral and medial condyles, an open intercondylar area between said condyles, a patellar flange, and a patellar groove extending from said open intercondylar area to a free end of the patellar flange, and the patellar component having an articular surface formed with an off-set domed region and providing a lateral facet and a medial facet, wherein the lateral facet and the medial facet are respectively shaped to allow area contact and line contact with the femoral component when in use.
2. The prosthesis according to claim 1 wherein the patellar flange of the femoral component has an articular surface contacting the patellar component, in use, which is for a distance expanding inwardly from the free end of the patellar flange configured to resist forces, in use, from a medial to a lateral direction.
3. The prosthesis as claimed in claim 1 or claim 2, wherein on full extension, the domed region has point contact with the femoral component.
4. The prosthesis as claimed in any preceding claim, wherein in slight flexion up to 45Â° the domed region makes the line contact in a floor of the patellar groove of the femoral component.
5. The prosthesis as claimed in any preceding claim, wherein above 450 degrees of flexion the domed region makes no contact in the intercondylar box area and on the lateral side load is taken through the lateral facet with area contact on the lateral femoral condyle of the femoral component.
6. The prosthesis as claimed in claim 5, wherein on the medial side, the medial facet has a cross-section effecting line contact on the medial femoral condyle.
7. The prosthesis according to any preceding claim, wherein a twist or roller coaster configuration is built into the femoral component to resist forces from a medial to a lateral direction.
8. The prosthesis according to claim 7, wherein the degree of twist decreases away from said free end.
9. The prosthesis according to claim 8, wherein the twist is terminated at a spacing from said free end of the patellar flange lying within the open intercondylar area.
1O.The prosthesis according to any preceding claim, wherein the open intercondylar area is enclosed by an intercondylar box.
11. The prosthesis according to any preceding claim, wherein the domed region is off-set medially.
12.The prosthesis according to claim 11, wherein the off-set is a selected value of one of 3mm, 5mm or 7mm.
13.The prosthesis according to any preceding claim, wherein the patellar component is in one piece.
14. The prosthesis according to any preceding claim, wherein the patellar component is of plastics material.
15. The prosthesis according to any preceding claim, wherein the patellar component has a non-articular surface.
16. The prosthesis according to claim 15, wherein the non-articular surface has fixation means.
17. A method of manufacturing a patellar component for a total knee replacement, comprising providing a patellar component having an off-set domed region and a lateral facet shaped to allow area contact, in use, the method comprising oscillating a cutter blade about the centre of the lateral facet area to produce the medial facet.
18. A method of manufacturing a patellar component for a total knee replacement substantially as hereinbefore described, with reference to, and as shown in Figure 16 of the accompanying drawings.
19. A total knee prosthesis substantially as hereinbefore described, with reference to, and as shown in Figures 17 to 38 of the accompanying drawings.