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Should we cement all hip replacements?
Simon Jameson National Joint
Registry Research Fellow
Northern Deanery Registrar Teaching
Programme
September 2011
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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
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Registrar Teaching, Hip term, 5Registrar Teaching, Hip term, 5thth September 2011 September 2011
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Registrar Teaching, Hip term, 5Registrar Teaching, Hip term, 5thth September 2011 September 2011
‘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
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Registrar Teaching, Hip term, 5Registrar Teaching, Hip term, 5thth September 2011 September 2011
Which implant to use?
Patient:AgeSexBMIType of arthritisGeneral healthFunctionExpectations
Surgeon:Skills
ExperienceTraining
EvidencePersonal beliefs
Trust policyIncentives
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Registrar Teaching, Hip term, 5Registrar Teaching, Hip term, 5thth September 2011 September 2011
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
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Registrar Teaching, Hip term, 5Registrar Teaching, Hip term, 5thth September 2011 September 2011
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)
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Registrar Teaching, Hip term, 5Registrar Teaching, Hip term, 5thth September 2011 September 2011
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
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Registrar Teaching, Hip term, 5Registrar Teaching, Hip term, 5thth September 2011 September 2011
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)
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Registrar Teaching, Hip term, 5Registrar Teaching, Hip term, 5thth September 2011 September 2011
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.
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Registrar Teaching, Hip term, 5Registrar Teaching, Hip term, 5thth September 2011 September 2011
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
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Registrar Teaching, Hip term, 5Registrar Teaching, Hip term, 5thth September 2011 September 2011
Outcome measures
• Revision
• (Death)
• Dislocation
• Infection
• Medical complications
• Satisfaction
• Functional outcome scoresPROMs(EuroQoL & OHS)
Hospital Episode
Statistics (HES)
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Registrar Teaching, Hip term, 5Registrar Teaching, Hip term, 5thth September 2011 September 2011
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Registrar Teaching, Hip term, 5Registrar Teaching, Hip term, 5thth September 2011 September 2011
Risk of revision after THR
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Registrar Teaching, Hip term, 5Registrar Teaching, Hip term, 5thth September 2011 September 2011
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Registrar Teaching, Hip term, 5Registrar Teaching, Hip term, 5thth September 2011 September 2011
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
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Registrar Teaching, Hip term, 5Registrar Teaching, Hip term, 5thth September 2011 September 2011
Male
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Registrar Teaching, Hip term, 5Registrar Teaching, Hip term, 5thth September 2011 September 2011
Female
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Registrar Teaching, Hip term, 5Registrar Teaching, Hip term, 5thth September 2011 September 2011
Latest analyses
• Adjusted multivariable competing risks models
• Age group specific
• ASA <3
• OA pts only
• MoM THR separate
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Registrar Teaching, Hip term, 5Registrar Teaching, Hip term, 5thth September 2011 September 2011
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Registrar Teaching, Hip term, 5Registrar Teaching, Hip term, 5thth September 2011 September 2011
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)
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Registrar Teaching, Hip term, 5Registrar Teaching, Hip term, 5thth September 2011 September 2011
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Registrar Teaching, Hip term, 5Registrar Teaching, Hip term, 5thth September 2011 September 2011
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
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Registrar Teaching, Hip term, 5Registrar Teaching, Hip term, 5thth September 2011 September 2011
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Registrar Teaching, Hip term, 5Registrar Teaching, Hip term, 5thth September 2011 September 2011
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
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Registrar Teaching, Hip term, 5Registrar Teaching, Hip term, 5thth September 2011 September 2011
Is implant use evidence-based?
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Registrar Teaching, Hip term, 5Registrar Teaching, Hip term, 5thth September 2011 September 2011
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Registrar Teaching, Hip term, 5Registrar Teaching, Hip term, 5thth September 2011 September 2011
Australian NJR figures
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Registrar Teaching, Hip term, 5Registrar Teaching, Hip term, 5thth September 2011 September 2011
Trends in New Zealand
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Other registry data
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Australian Registry
171,000 patients, 6% cemented
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Under 55 years
No significant differences
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55-64 years
Hybrid significantly LOWER revision rate compared with cemented & uncemented
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65-74 years
Cemented significantly HIGHER revision rate compared with uncemented & hybrid
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Over 75 years
Uncemented significantly HIGHER revision rate compared with cemented
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Registrar Teaching, Hip term, 5Registrar Teaching, Hip term, 5thth September 2011 September 2011
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
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Registrar Teaching, Hip term, 5Registrar Teaching, Hip term, 5thth September 2011 September 2011
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
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Registrar Teaching, Hip term, 5Registrar Teaching, Hip term, 5thth September 2011 September 2011
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
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Registrar Teaching, Hip term, 5Registrar Teaching, Hip term, 5thth September 2011 September 2011
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
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Registrar Teaching, Hip term, 5Registrar Teaching, Hip term, 5thth September 2011 September 2011
Why do cemented?
• Good evidence
• Low failure rates
• Meets NICE guidelines
• Cheaper
– Initially
– Overall revision costs
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Registrar Teaching, Hip term, 5Registrar Teaching, Hip term, 5thth September 2011 September 2011
Why avoid cement?
• Longer surgical time
• Technically more demanding
• Restricts cup to poly only
• Revision more difficult???
• (Industry pressure)
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Registrar Teaching, Hip term, 5Registrar Teaching, Hip term, 5thth September 2011 September 2011
Summary
65I
60I
55I
70I
75I
Uncemented
Hybrid
Cemented
Age
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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)
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Registrar Teaching, Hip term, 5Registrar Teaching, Hip term, 5thth September 2011 September 2011
Should we cement all hips?
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Registrar Teaching, Hip term, 5Registrar Teaching, Hip term, 5thth September 2011 September 2011
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
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Registrar Teaching, Hip term, 5Registrar Teaching, Hip term, 5thth September 2011 September 2011
Future
• Indepth NJR statistical analyses– Regression analsyis
– Propensity score matching
• PROMs data– Satisfaction
– Functional differences
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Registrar Teaching, Hip term, 5Registrar Teaching, Hip term, 5thth September 2011 September 2011
Acknowledgements
Andy Sprowson, Mike Reed, Andy Port, Prof Gregg, National Joint Registry
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Registrar Teaching, Hip term, 5Registrar Teaching, Hip term, 5thth September 2011 September 2011
Thank you.