550 likes | 833 Views
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)
E N D
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) • 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: Age Sex BMI Type of arthritis General health Function Expectations Surgeon: Skills Experience Training Evidence Personal beliefs Trust policy Incentives
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 scores Hospital Episode Statistics (HES) PROMs (EuroQoL & OHS)
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
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
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 Age 55 I 60 I 65 I 70 I 75 I Uncemented Hybrid Cemented
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) 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)
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
AcknowledgementsAndy Sprowson, Mike Reed, Andy Port, Prof Gregg, National Joint Registry