New Technologies and Challenges Joint Replacement Prof Stephen Graves Director AOA National Joint Replacement Registry

New Technologies and Challenges

Joint Replacement

Prof Stephen Graves

Director AOA National Joint Replacement Registry

AustralianOrthopaedic

Association

National Joint Replacement National Joint Replacement RegistryRegistry

(AOA NJRR)

AOA NJRR • Commenced in 1999 • State by State implementation• Fully National in 2002

• Collaboration of Orthopaedic surgeons, Governments, Hospitals (Public and Private) and Industry

• Funded entirely By Commonwealth

• Quality information on Australian joint replacement surgery not available form any other source

• Determines the outcome in particular the risk of revision

Changing Rate of Joint Replacement

0

5,000

10,000

15,000

20,000

25,000

30,000

35,000

1994-1995

1995-1996

1996-1997

1997-1998

1998-1999

1999-2000

2000-2001

2001-2002

2002-2003

2003-2004

2004-2005

years

Num

bers

hips knees

All Joints 93.8% Hips 61.9% Knees 138.4%

Currently

• Approx 65,000 procedures p.a.• In excess of $1 billion p.a.• Prostheses 35% of cost and increasing• Over 60% of procedures in private• The rate of increase is greater in private

• By 2016 135,000 procedures p.a• What % in private?

Outcomes

Registry uses Revision is an indication of failure of a joint replacement procedure

Proportion of Procedures undertaken that are revisions

2001 Hip 14.2% Knee 10%2005 Hip 12.1% Knee 8.2%

As good or better than most countries

Comparison to Sweden

Proportion of procedures that are revisions Australia Hip 12.1% Knee 8.2%Sweden Hip 7-8% Knee 7%

Risk of Revision Surgery is better indicator of success

Australia 20-25% (Estimated Hip and Knee)

Sweden 10% (Hip and Knee)

Expenditure Implications

Reducing proportion of revisions by 1% decreases revision procedures by 650 p.a.

($ 16 – 32 million)

If Australia had the same rate of revision for hip and knee replacement as Sweden there would be 3250 less revisions a year

($ 81 and 162 million p.a.)

Reduced by 2% p.a. since 2001

Why the difference

• Detailed in Recent Report for the Australian Centre for Health Research (ACHR)

• Data from AOA NJRR 2006 Annual Report • Identical demographics of patients receiving joint

replacement surgery • Some differences in patient selection • Major differences in prostheses selection• Major differences in prostheses fixation• Greater uptake of new prostheses technology in Australia

FNOF outcomes by Age

Data: 1st September 1999 to 31st December 2005

Monoblock Modular

Bipolar

Outcomes related to Category of Prostheses

for Treatment of FNOF

Modular and bipolar better than monoblockModular and bipolar better than monoblock

Differences are greatest in the younger age Differences are greatest in the younger age groups. (less than 75, and 75-84)groups. (less than 75, and 75-84)

Bipolar may be better than Modular except in Bipolar may be better than Modular except in over 85 yr old age groupover 85 yr old age group

Cement fixation much better no matter what type Cement fixation much better no matter what type of prosthesesof prostheses

Outcomes: Conventional Primary Total Hip


Outcomes by Age & FixationUnder 55 55-64

65-74 Over 75

Trends in Prosthesis Fixation Conventional Primary THR

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

2001

2002

2003

2004

2005

2001

2002

2003

2004

2005

2001

2002

2003

2004

2005

2001

2002

2003

2004

2005

2001

2002

2003

2004

2005

2001

2002

2003

2004

2005

2001

2002

2003

2004

2005

2001

2002

2003

2004

2005

AUST NSW VIC QLD WA SA TAS ACT/NT

Cemented Hybrid Cementless

Resurfacing Hip Replacement

•Increasing use (8.9% of primary THR 2005)

•Increasing use of prostheses other than the Birmingham(96.3% 2001 and 63.5% 2002)

Outcomes: Resurfacing V Conventional THR (OA only)


Cumulative Percentage Revision by Gender


Cumulative Percentage Revision by Age


Approach to differences in categories of prostheses and prostheses fixation • Many examples in both hip and knee Many examples in both hip and knee replacementreplacement

• Registry identified variation in general is Registry identified variation in general is responded to very quickly responded to very quickly

• Complexity in understanding and determining Complexity in understanding and determining implication of findingsimplication of findings

• Best left for the profession to decide Best left for the profession to decide

• AOA to establish Guidelines based on AOA to establish Guidelines based on Registry DataRegistry Data

Registry is able to compare outcomes of Individual prosthesis

• Least revised Least revised

• Most revisedMost revised

• Those with a higher than anticipated rate of Those with a higher than anticipated rate of revision revision

Cemented Primary THR’s

Minimum 1000 Observed component years for least revised


Femoral Component

Acetabular Component Year 1 Year 2 Year 3 Year 4

Least Revised MS 30 Low Profile Cup 0.40 (0.10, 1.58) 0.40 (0.10, 1.58) 0.73 (0.23, 2.32) 1.20 (0.42, 3.38)

Exeter Exeter 0.98 (0.37, 2.58) 1.23 (0.51, 2.93) 1.23 (0.51, 2.93) 1.23 (0.51, 2.93)

Spectron EF Reflection 0.62 (0.28, 1.38) 0.76 (0.36, 1.59) 1.45 (0.79, 2.65) 1.67 (0.93, 3.00)

Most Revised Elite Plus Apollo 2.00 (0.28, 13.36) 4.00 (1.02, 15.06) 4.00 (1.02, 15.06) 6.59 (2.15, 19.27) Elite Plus Charnley LPW 1.20 (0.17, 8.25) 4.86 (1.85, 12.44) 6.12 (2.59, 14.07) 9.10 (4.42, 18.22) H Moos Mueller 5.56 (0.80, 33.36) 11.1 (2.90, 37.58) 33.3 (16.57, 59.65) 39.4 (21.04, 65.41)

Least Revised Hybrid and Cementless Primary THR’s

Minimum 1000 Observed component yearsLess than 2% Revision at 2 years


Femoral Component


Hybrid Definition Vitalock 0.28 (0.04, 1.97) 0.28 (0.04, 1.97) 0.28 (0.04, 1.97) 0.28 (0.04, 1.97) MS 30 Fitmore . (0.00, .) . (0.00, .) 0.41 (0.06, 2.90) 0.41 (0.06, 2.90) Exeter Mallory-Head 0.60 (0.15, 2.39) 0.60 (0.15, 2.39) 0.60 (0.15, 2.39) 1.34 (0.39, 4.56)

Exeter V40 ABGII 1.10 (0.59, 2.03) 1.23 (0.68, 2.22) 1.40 (0.79, 2.47) 1.69 (0.95, 3.00)

Exeter V40 Mallory-Head 0.82 (0.31, 2.17) 1.32 (0.59, 2.93) 1.72 (0.80, 3.67) 1.72 (0.80, 3.67)

VerSys Trilogy 1.38 (0.66, 2.88) 1.89 (0.98, 3.63) 1.89 (0.98, 3.63) 1.89 (0.98, 3.63)

Cementless Alloclass SL Allofit 1.14 (0.66, 1.96) 1.50 (0.92, 2.46) 1.77 (1.11, 2.81) 1.77 (1.11, 2.81) S-Rom Option 1.43 (0.75, 2.73) 1.84 (1.02, 3.30) 1.84 (1.02, 3.30) 1.84 (1.02, 3.30)

Most Revised Cementless Components


Femoral Component


Alloclassic Fitmore 3.43 (2.08, 5.64) 3.76 (2.31, 6.10) 3.76 (2.31, 6.10) 3.76 (2.31, 6.10) Esop Altas 4.99 (1.90, 12.74) Margron * 6.60 (4.78, 9.08) 7.09 (5.18, 9.68) 7.40 (5.42, 10.07) 9.23 (6.29, 13.45) Profemur * 7.30 (3.63, 14.40)

Revitan * 2.44 (0.62, 9.40) 6.41 (2.71, 14.75)

** Artek 3.21 (1.35, 7.55) 6.44 (3.52, 11.64) 9.04 (5.46, 14.79) 12.6 (8.19, 19.00)

** Delta 3.07 (1.16, 7.98) ** EDF-Plus 2.10 (1.11, 3.95) 2.51 (1.35, 4.65) ** Inter-Op 11.1 (3.73, 30.61) 11.1 (3.73, 30.61) 14.8 (5.83, 34.80) 18.7 (8.23, 39.24) ** Lineage 4.95 (2.90, 8.38) 4.95 (2.90, 8.38) 4.95 (2.90, 8.38) ** SPH Blind 3.55 (2.42, 5.21) 4.67 (3.32, 6.55) 5.90 (4.26, 8.13) 6.34 (4.56, 8.79) *

*

Revision rates of different Resurfacing prostheses


Femoral Component


BHR BHR 1.62 (1.32, 2.00) 2.13 (1.76, 2.57) 2.62 (2.18, 3.14) 2.92 (2.41, 3.55) ASR ASR 4.19 (2.56, 6.83)

Cormet 2000 Cormet 2000 3.22 (1.74, 5.91) 3.72 (2.06, 6.66) 6.37 (3.53, 11.36) Durom Durom 3.36 (1.85, 6.07) 3.93 (2.19, 6.99)

Preservation Fixed

AMCPreservation MobileNatural KneeOxford 3

Cum

ulat

ive

Perc

ent R

evis

ed

0.00

0.05

0.10

0.15

0.20

years since primary procedure

0.0 0.5 1.0 1.5 2.0 2.5 3.0 3.5 4.0 4.5 5.0

Genesis II Cementless Oxinium

Outcomes of New Prostheses

Prosthesis type Number of prostheses with CRR 3 years or less

Compared to top 3 with CRR of 4 or more years

and over 1000 procedures

Better Same Worse

Uni Knee 14 0 2 12

Cemented TKR 4 0 0 4

Cementless TKR 12 0 6 6

Cemented THR 2 0 0 2

Cementless THR 71 0 63 8

Total 103 0 71 32

New Prostheses

• None have performed better than previously approved and well established prostheses

• Many have higher revision rates• Some have been considerably worse• All are associated with increased

expenditure

New Prostheses Considerations

• Currently Class IIb • Europe recently changed to Class III• What clinical information should be required prior to

approval ?– Clinical Trials– RSA studies

• Do parameters need to be set ?• Is equivalence sufficient for approval ?• How are minor modifications to be handled ?• Innovation and development must be encouraged

Enhancing outcomes

• Focus on what is best for patient outcomes• Guidelines for joint surgery using Registry

information (appropriate patient and appropriate procedure)?

• Reduce prostheses choice? How?• Remove poor performing prostheses from list?• Reduce or cease funding for poor performing

prostheses?• Regulate differently the introduction of new

prostheses?• Is this experience relevant to other devices?

Documents

New Technologies and Challenges Joint Replacement Prof Stephen Graves Director AOA National Joint Replacement Registry