should we cement all hip replacements?
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Should we cement all hip replacements?. Simon Jameson National Joint Registry Research Fellow Northern Deanery Registrar Teaching Programme. September 2011. Implant options. Fixation Cement / uncemented / hybrid Head size 22-58mm Bearing surface MoP, MoM, CoC, CoP, (CoM) - PowerPoint PPT PresentationTRANSCRIPT
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
Registrar Teaching, Hip term, 5Registrar Teaching, Hip term, 5thth September 2011 September 2011
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
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
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
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)
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
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)
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.
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
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)
Registrar Teaching, Hip term, 5Registrar Teaching, Hip term, 5thth September 2011 September 2011
Registrar Teaching, Hip term, 5Registrar Teaching, Hip term, 5thth September 2011 September 2011
Risk of revision after THR
Registrar Teaching, Hip term, 5Registrar Teaching, Hip term, 5thth September 2011 September 2011
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
Registrar Teaching, Hip term, 5Registrar Teaching, Hip term, 5thth September 2011 September 2011
Male
Registrar Teaching, Hip term, 5Registrar Teaching, Hip term, 5thth September 2011 September 2011
Female
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
Registrar Teaching, Hip term, 5Registrar Teaching, Hip term, 5thth September 2011 September 2011
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)
Registrar Teaching, Hip term, 5Registrar Teaching, Hip term, 5thth September 2011 September 2011
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
Registrar Teaching, Hip term, 5Registrar Teaching, Hip term, 5thth September 2011 September 2011
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
Registrar Teaching, Hip term, 5Registrar Teaching, Hip term, 5thth September 2011 September 2011
Is implant use evidence-based?
Registrar Teaching, Hip term, 5Registrar Teaching, Hip term, 5thth September 2011 September 2011
Registrar Teaching, Hip term, 5Registrar Teaching, Hip term, 5thth September 2011 September 2011
Australian NJR figures
Registrar Teaching, Hip term, 5Registrar Teaching, Hip term, 5thth September 2011 September 2011
Trends in New Zealand
Registrar Teaching, Hip term, 5Registrar Teaching, Hip term, 5thth September 2011 September 2011
Other registry data
Registrar Teaching, Hip term, 5Registrar Teaching, Hip term, 5thth September 2011 September 2011
Australian Registry
171,000 patients, 6% cemented
Registrar Teaching, Hip term, 5Registrar Teaching, Hip term, 5thth September 2011 September 2011
Under 55 years
No significant differences
Registrar Teaching, Hip term, 5Registrar Teaching, Hip term, 5thth September 2011 September 2011
55-64 years
Hybrid significantly LOWER revision rate compared with cemented & uncemented
Registrar Teaching, Hip term, 5Registrar Teaching, Hip term, 5thth September 2011 September 2011
65-74 years
Cemented significantly HIGHER revision rate compared with uncemented & hybrid
Registrar Teaching, Hip term, 5Registrar Teaching, Hip term, 5thth September 2011 September 2011
Over 75 years
Uncemented significantly HIGHER revision rate compared with cemented
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
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
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
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
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
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)
Registrar Teaching, Hip term, 5Registrar Teaching, Hip term, 5thth September 2011 September 2011
Summary
65I
60I
55I
70I
75I
Uncemented
Hybrid
Cemented
Age
Registrar Teaching, Hip term, 5Registrar Teaching, Hip term, 5thth September 2011 September 2011
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)
Registrar Teaching, Hip term, 5Registrar Teaching, Hip term, 5thth September 2011 September 2011
Should we cement all hips?
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
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
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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Thank you.