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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)

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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


Implant options
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
Which implant to use? 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….’

Patient:

Age

Sex

BMI

Type of arthritis

General health

Function

Expectations

Surgeon:

Skills

Experience

Training

Evidence

Personal beliefs

Trust policy

Incentives


Implant usage 2010
Implant usage 2010 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….’

  • 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
NICE recommendations 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….’

  • 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
Orthopaedic Device Evaluation Panel (ODEP) Rating 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….’

  • 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
National joint registries 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….’

  • 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 registries1
National joint registries 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….’

  • 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
NJR for England & Wales 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….’

  • 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
Outcome measures 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….’

  • Revision

  • (Death)

  • Dislocation

  • Infection

  • Medical complications

  • Satisfaction

  • Functional outcome scores

Hospital Episode Statistics (HES)

PROMs

(EuroQoL & OHS)


Risk of revision after thr
Risk of revision after THR 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….’


For the entire England & Wales primary THR population: 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….’

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

National Joint registry 8th Annual Report


Male 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….’


Female
Female 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….’


Latest analyses
Latest analyses 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….’

  • Adjusted multivariable competing risks models

  • Age group specific

  • ASA <3

  • OA pts only

  • MoM THR separate


In OA patients over 70 years: 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….’

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: 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….’

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: 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….’

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
Is implant use evidence-based? 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….’


Australian njr figures
Australian NJR figures 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….’


Trends in new zealand
Trends in New Zealand 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….’


Other registry data
Other registry data 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….’


Australian registry
Australian Registry 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….’

171,000 patients, 6% cemented


Under 55 years
Under 55 years 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….’

No significant differences


55 64 years
55-64 years 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….’

Hybrid significantly LOWER revision rate compared with cemented & uncemented


65 74 years
65-74 years 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….’

Cemented significantly HIGHER revision rate compared with uncemented & hybrid


Over 75 years
Over 75 years 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….’

Uncemented significantly HIGHER revision rate compared with cemented


New zealand registry
New Zealand Registry 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….’

  • 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
Scandanavian registries 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….’

  • 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
Problems with NJR data 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….’

  • 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
Cost implications 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….’

  • 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
Why do cemented? 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….’

  • Good evidence

  • Low failure rates

  • Meets NICE guidelines

  • Cheaper

    • Initially

    • Overall revision costs


Why avoid cement
Why avoid cement? 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….’

  • Longer surgical time

  • Technically more demanding

  • Restricts cup to poly only

  • Revision more difficult???

  • (Industry pressure)


Summary
Summary 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….’

Age

55

I

60

I

65

I

70

I

75

I

Uncemented

Hybrid

Cemented


Odep rating and 5yr failure
ODEP rating and 5yr failure 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….’

  • 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)

0.42% (0.24-0.73)

  • DePuy Elite Plus – 10A

  • Styker Contemporary cup – 5A

1.26% (0.99-1.59)

1.85% (1.63-2.10)


Should we cement all hips
Should we cement all hips? 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….’


Conclusion
Conclusion 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….’

  • 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
Future 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….’

  • 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
Acknowledgements 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….’Andy Sprowson, Mike Reed, Andy Port, Prof Gregg, National Joint Registry


Thank you
Thank you. 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….’


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