Should we cement all hip replacements?

Should we cement all hip replacements?

Simon Jameson National Joint

Registry Research Fellow

Northern Deanery Registrar Teaching

Programme

September 2011

Registrar Teaching, Hip term, 5Registrar Teaching, Hip term, 5thth September 2011 September 2011

Implant options• Fixation

– Cement / uncemented / hybrid

• Head size– 22-58mm

• Bearing surface– MoP, MoM, CoC, CoP, (CoM)

• Design characteristics (=Brand)– e.g. ASR


‘The FDA’s approval is based on a two-year, randomized clinical trial, which found no clinical difference between 194 patients who received the new ceramic-on-metal system and 196 patients in a control group who received a metal-on-metal hip implant….’

FDA, June 2011


Which implant to use?

Patient:AgeSexBMIType of arthritisGeneral healthFunctionExpectations

Surgeon:Skills

ExperienceTraining

EvidencePersonal beliefs

Trust policyIncentives


Implant usage 2010• 146 different brands of femoral stem• 123 different brands of cup

• Exeter V40 - 63% cemented market • Contemporary cemented cup - 35%• Corail stem - 47% uncemented• Pinnacle cup system - 34%

National Joint Registry 8th Annual Report


NICE recommendations• Revision rate of less than 10% at

10yrs – Or at least 3-yr revision data, consistent

with the 10-yr benchmark

• Cemented implants - ‘more evidence of the long-term viability’

• ‘no cost-effective data… to support…more costly cementless and hybrid hip prostheses’Technology Appraisal Guidance (TAG) No. 2 - ‘Guidance on the

selection of prostheses for Primary Total Hip Replacements’ (NICE 2003)


Orthopaedic Device Evaluation Panel (ODEP)

Rating• Longevity and quality of evidence

• ODEP 10A (‘benchmark - <10% revision)– 84% of cemented stems– 74% of uncemented stems– 42% of cemented cups– 5% of uncemented cups– 51% resurfacing systems

10-year data

3-, 5- or 7-year data

Listed as pre-entry if less than 3 years data


National joint registries• Scandanavian registries in 1970s/80s

– Sweden, Finland and Norway

• Australian 1999• New Zealand 1999• Scottish Arthroplasty Registry 2000• England and Wales 2002• Canada• (US)


National joint registries• Provide quality demographic data• Reduce revision rates and costs

– AOA estimated $10million annual savings with a 1% reduction in revision*

• Audit hopsitals and surgeons• Improve patient outcomes

– Reduce morbidity and mortality, and improve function

Graves SE, Davidson D, et al. (2004). The Australian Orthopaedic Association National Joint Replacement Registry. Med J Aust 180(5 Suppl): S31-34.


NJR for England & Wales

• THR / TKR / TAR (TSR / TER)

• >1 million procedures (largest NJR)

• Now mandatory across the NHS and independent sector

• Data collected via MDS

• Complication data via HES linkage

• Patient Reported Outcome Measures


Outcome measures

• Revision

• (Death)

• Dislocation

• Infection

• Medical complications

• Satisfaction

• Functional outcome scoresPROMs(EuroQoL & OHS)

Hospital Episode

Statistics (HES)


Risk of revision after THR


For the entire England & Wales primary THR population:

‘Cemented THR has SIGNIFICANTLY LOWER REVISION RATE at 7yrs compared to uncemented and hybrid’

National Joint registry 8th Annual Report


Male


Female


Latest analyses

• Adjusted multivariable competing risks models

• Age group specific

• ASA <3

• OA pts only

• MoM THR separate


In OA patients over 70 years:

CEMENTED THR has SIGNIFICANTLY LOWER REVISION RATES at 5yrs compared to uncemented & hybrids, in both males & females

(35% died by 10 years)


In OA patients aged 60-69 years:

UNCEMENTED THR has SIGNIFICANTLY HIGHER REVISION RATES at 5yrs compared to cemented in males & females

No difference between cemented & hybrid


In OA patients less than 60 years:

UNCEMENTED THR has SIGNIFICANTLY HIGHER REVISION RATES at 5yrs compared to cemented & hybrids in females

No difference between cemented, uncemented & hybrid in males


Is implant use evidence-based?


Australian NJR figures


Trends in New Zealand


Other registry data


Australian Registry

171,000 patients, 6% cemented


Under 55 years

No significant differences


55-64 years

Hybrid significantly LOWER revision rate compared with cemented & uncemented


65-74 years

Cemented significantly HIGHER revision rate compared with uncemented & hybrid


Over 75 years

Uncemented significantly HIGHER revision rate compared with cemented


New Zealand Registry

• 60,000 THRs (since 1999)

• Cemented significantly LOWER risk

• Revision risk stratified by age:– Cemented higher in <55yrs– Hybrid lower in 55-64yrs– Uncemented higher in 65-74– Cemented lower in >75


Scandanavian registries

• Longest follow-up

• Cemented 10yr survival 88% - 95%

• Uncemented have a HIGHER revision risk across all 3 registries (80 - 85%)

• Revision risk is higher in younger pts

– Cemented implants were superior


Problems with NJR data

• Medium term

• Currently revision only– Uncemented hips may allow greater

function / cause less discomfort

• Severity of disease not known prior to surgery

• Lack of indepth analyses


Cost implications

• Tariff for revision = £8196

• Revision rate at 7yrs 5.46% for uncemented versus 3.08% for cemented

• 69,000 THRs in 2010 – – If all uncemented were cemented (43% -

29,670), there would be 2.38% (706) less revisions in 7 yrs, saving £5.8million

• + initial lower cost of cemented hips


Why do cemented?

• Good evidence

• Low failure rates

• Meets NICE guidelines

• Cheaper

– Initially

– Overall revision costs


Why avoid cement?

• Longer surgical time

• Technically more demanding

• Restricts cup to poly only

• Revision more difficult???

• (Industry pressure)


Summary

65I

60I

55I

70I

75I

Uncemented

Hybrid

Cemented

Age


ODEP rating and 5yr failure• Cemented

– Styker Exeter V40 – 10A–

• Hybrid– Styker Exeter V40 – 10A– Styker Trident – 5A

• Uncemented– DePuy Corail stem – 10A– DePuy Pinnacle cup system – 7A

0.92% (0.78-1.08)

1.26% (0.99-1.59)

1.85% (1.63-2.10)

Styker Contemporary cup – 5ADePuy Elite Plus – 10A0.42% (0.24-0.73)


Should we cement all hips?


Conclusion• Patients over 70ys

– Cemented THR

• Patients 60-70ys – Cemented THR

– (Hybrid - option of ceramic bearing)

• Patients under 60ys – Females – hybrid or cemented

– More evidence required for males


Future

• Indepth NJR statistical analyses– Regression analsyis

– Propensity score matching

• PROMs data– Satisfaction

– Functional differences


Acknowledgements

Andy Sprowson, Mike Reed, Andy Port, Prof Gregg, National Joint Registry


Thank you.

Should we cement all hip replacements?

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