ASR DDH (H332): surgeon review meeting Date: 14 May 07 Present : T.

Vail

Cc
Present : cc DePuy

R. Oakeshott T.Schmalzried A.Cobb

M.Stewart M. Flett L. Divoux B.Clune M. Bekto P. Berman G. Isaac

T.Siebel

T.O' Sullivan

C. Hunt P.Cary R. Maisonneuve

DDH cups Unfortunately Dr Vail was unable to attend the surgeon design meeting as bad weather caused flight delays. This meeting was used to review the presentation from the 17th April and to give feedback on the outcome of the meeting. Depuy's desire to increase the articulating surface was reviewed. This was because of the increased wear rates seen in cups with a steep inclination angle. In the slides below M. Stewart presented the concept of increasing the height of the cup to maximize the articular surface. Dr Vail agreed that increasing bearing surface was desirable. The main gain came from moving the introducer to the outer surface. The addition increase in 1 mm of cup depth to gain 3 to 6 deg of surface was questionable. The additional lateralization was not desirable in a shallow acetabulum. Dr Vail felt that the 1 mm of additional height should not be added to the cup.
Articulating surface extension VS deflection Articulating surface extension VS deflection

ASR
ID
386 G 48fi 48 fi 48 fi 486 58fi 58 fi 58fi 56 fi8fi 44 16 19 19 18 1819

DDH
m) I OD (mm)I JD ( mm I al1 l nlmmll 159 0 95 3fi 1 42 15 5 44 1fi1 ,9] 86 16 11
48 fi 44 fi 4, f ft 48 50 54 1fi 2136 11 1fi5 1fifi 168 1,3fi 1,Sfi 9a^n on alI 1 1fi 1fi 1fi 1

'na
48 50

165 149 169 150 15 169 -0,1

12 54
56

1111 2819

46 fi

2c S, 21 49

163 1,fi9

58
fit 6 " 64 fifi 68 10

2855 21 55
22 55 23 55 5

151
2 3 156 155 155 15fi

25 5
555 2 21 55

ASRsize 44 VS DDH size 4 = 145 and au CH = 160 AsR 1 nir j mm

fits

mm ID lateralization +0.45mm VS ASR to satisfy the deflection is the functional articulating surface angle Is the exceeding dimension between cup/acetabulum. If "p" >0 then the cup Is out of the acetabulum if "p" < 0 then the cup Is In the acetabulum (By assuming that the teaming depth remains the same as on ASR)

The question of cup insertion and where the team would place the cup relative to the mouth of the acetabulum was reviewed. Dr Vail would tend to place the inferior elements of the cup within the acetabulum and leave the lateral/superior parts per configuration B in slide 7. The issue of pressure on the soft tissue was discussed, (psoas pain and the effect of moving the COR of the cup). The idea of scooping out a region of the cup for the psoas tendon was discussed. Dr. Vail thought that this unnecessary, however, psoas tendon irritation was a concern. Of more concern was the need to try and carve out the bone so the flange is sub-surface, and, avoiding flexion impingement. Page 1/5
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ASR DDH (H332): surgeon review meeting Date: 14 May 07

Articulating surface extension VS deflection Gain on articular surface

B =Increase In articular
surface available A = angle of articulating surface available

cup size 42 44 46 48 50 52 54

primary cup ( A)

primary without introducer slot (A)

DOH angular gain ( B) current angular design (A) gain ( B) subte nded angl e 162 163 9 165 9 167 9 169 9.5 169 9 170 9.5 DDH (Let 3.5) (A') 159 161 163 165 166 167 168 angular gain (B

conflgwatlon B

What is the surgical configuration which Is preferred and com

only used with such type of DDH cups ? j

145 147 149 150 151 151

15 60 160 161 162 162

65 65 5.5 5.5 5.5 5.5

8 8 8 8 8.5

17

The design of the flange was reviewed . M. Stewart explained that in the cadaveric review on the 17th April the flange was unsupported by cadaveric bone and that one of the screws was visible through the acetabular wall. M. Stewart explained that the conclusion from the review on the 17th April was that the radii on the flange needed to be rounder, if possible to reduce the risk of soft tissue pressure . There was a split in the team as to whether the flange should be angled or parallel to the face of the cup. The team on the 17th April compromised on a flange parallel to the face of the cup but with a more sweeping angle on the surface of the flange in contact with the bone. Dr Vail agreed that the flange should be as round as possible to avoid pressure on soft tissues.
Lip design
Question : Could we incline the lip (10 or 20) in order to fit on the exact shape of the pelvis ? Question(s) 1. 2. Could we change the lip lower design from configuration A to configuration B? Could we change the lip upper design from configuration A to configuration C ?

Lip design

B. ular DOri

20 rc.

IDDH

A lip inclination can reduce the pa In (co nflict with muscles or tendons) because of a ga in of 2.5 or 5mm
ConflpwatlonA CofIflQWatloflC

ConflgwatlonA Conflgwatlon B d= L xtan(y)=14 xtan(10) -247-d=x tan(I)=14 x tan( 20)=5mm L 1. We would prefer <( no , because of the casting requirements we may have Interest to keep opened angles at this comer In order to ensure the good material health. Will be definitively n no u If we choose an Inclined lip 10 or 20We mould but will lead to increase the lip height and length to keep enough thickness (screw directions) and the head Into the lip : how many <(mm u can we spent to Increase this radius ( see the anatomy) ? Do we really think that It will change something ?

2.

But need to increase a little the height (+Smm) and length (+Smm) of the lip In order to keep the same directions for the screws (directions In accordance with the cup mouth) and to keep the head Into the lip.

To think about the boundary value to keep In order to avoid any mplngement between the lip and healthy bone ?F 9

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ASR DDH (H332): surgeon review meeting Date: 14 May 07

Screws
u u Possible types of screws for such dyplaslc cups : 1. Bolts Advantage(s) feeling to be more robust because of the threaded interface rigidity and no need to have a contact head/lip to be fixed Disadvantage(s) single direction, high rigidity (opened discussion around Dr. SIE BEL and L.DIVOUX) and small standard pitch to thread the lip 2. Free screws Advantage(s) Commonly used for Hips and a lot of available in DePuy Cat. need to heve a contact head/ lip to be fixed , then risk of biting the cup . The polyoxlol screws Delta Xtend hove the some anchorage obil hies as the Pinnacle rev l slop screws (see the thread height) Polyaxial screws properties :

Screws

Trauma
1 A, 8
ni GM, 8......

Delta Xtend 7,, mni

Pinnacle
7v4,7n7n

3.

Disadvantage ( s) Polyaxal screws

Advantage ( s) poly d rections and m icro motion adjustment by the head friction Disadvantage(s) need to place the head Into the lip, then risk of biting the cup

To try to create a market differentiation, DePuy orientations/ steps are : 1. 2. 3. Study of polyaxlal screws (system abilities tested In Hamburg up to the cold-May 2007 with M.M.MORLOCK) Development ofa tech nlcal solution to avoid the cup tilting during the polyaxlal screws fixation (review here of the SLA concept) Bolts as a backup solution in case of polyaxlal poor results Question why do the ASR surgeons like the BHR bolts ? Because of the threaded Interface with the lip (less risk of tilting ) or because of the cortical threading ? n. . rl

,ia^^

,gym

,ia3^

,am

a,os mm

,iie^

a,o mm

rG
10 11

rG

M.Stewart summarized the discussion on the 17th April regarding the polyaxial screws. Time to market was key for this cup so marketing did not want to debug the polyaxial screw system. M.Stewart explained about the concepts for the anti-tilting devices for the cups and the issues that the team had on the 17th April. That Mr Cobb inserted the polyaxial screws and felt the cup start to tilt with his finger. That Mr O'Sullivan inserted the screws into the cup with the introducer in place to try and stop the cup tilting. That the drill guide and introducer do not work together in the acetabulum as they occupy the same space. That Mr O'Sullivan felt this was an issue, as the anti-tilting device would need to be inserted with the handle in place to stop the cup tilting. Additional when the polyaxial screws are inserted there is a risk they are miss-aligned in the hole as they are inserted and when they align they will tend to rotate the cup.

Dr Vail appreciated that the polyaxial screws were fiddly, and the instrumentation would be difficult to fit into the space, but deferred to T. O'Sullivan's experience at the cadaveric session. Dr Vail emphasized that he liked the additional flexibility that the polyaxial screws give. Dr Vail noted that the anti-tilting device must hold the cup away from the pelvis without pushing the porocoat away from the bone. It also needs to point in the opposite direction and be useable without increasing the size of the incision.

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ASR DDH (H332): surgeon review meeting Date: 14 May 07

Screws
u Polyaxlal screws properties : u The poly-el screws are more ras Iota nt than the Pinnacle in bending ( M2) because of an higher moment of inert ia (+ 3.3%) then the stresses are less ^^

Screws
Proposals to avoid the cup tilting during the polyaxlal screws fixation :

The polyaxlal screws are more resistant than the Pinnacle in tc constant of inertia (+3.3%) then the stresses are less

nigher

The I .' propnsel is less Invasive provided that the extra lug Isn't disturbing the Implant functions The 2n0 proposal can be mounted on trials and Implants but requires some space behind the lip to remove it after use 1, 13

12

M.Stewart explained that time to market was important in this project and that DePuy were unwilling to spend significant time getting the polyaxial solution to work. However, DePuy will continue to file for IP in the area. We are also looking at whether we can angle the bolts. M. Stewart summarized the results from using the introducer in the cadaveric tests. M. Stewart explained the flaw that if the cup was engaged and the drive shaft removed accidentally that it was very difficult to re-engage in the wound. M. Stewart also highlighted that several other features needed tweaking but that introducer did generally work.

Cup introducer

u System based on :

#1 the body (x1)

#2 the driven shaft (x1)

#3 the reference axis (xi)

#4 the jaw holders sub-assemblies (x2) #5 the trial cups (x7)

u Functions : Able to grip several sizes of trial and implants cups with the same jaw holder (2 jaw holders to grip 7 trial cups + 7 implant cups)

Able to control the gripping torque (safety for the system and the cups)
Able to keep the shaft position during the impactions (ratchet mechanism) Able to place the system in accordance with 2 cup inclinations : 45 or 30 Able to control the cup position for adjustment even if some press-fit loads 14

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ASR DDH (H332): surgeon review meeting Date: 14 May 07 Actions.

M. Stewart to plan next meeting. End of document MJStewart Programme Manager

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