Proposals how EFORT and EAR might contribute to the development of arthroplasty

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Proposals how EFORT and EAR might contribute to
the development of arthroplasty

• N. Böhler, G. Labek

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Register Development
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Register Development
Sweden Knee
Sweden Hip
Norway
Finland
Denmark
1975
1979
1995
1980
1987
EAR
Turkey
Czech Rep.
Slovakia
Moldova
Hungary
Romania
England Wales
Austria
Germany
France
New Zealand
Canada
Australia
2001
1998
1997
2003
1999
2002
2006
Development by remarkable EAR-support
EAR
ISAR
21/11/2009
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GEOGRAPHICALLY THERE IS ALMOST A FULL COVERAGE
WITH REGISTERS
red members EAR
21/11/2009
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EAR CONTRIBUTION TO APL DEVELOPMENT

• ANALYZING EXISTING REGISTERS ABOUT SPECIFIC
  SUCCESSFACTORS
• THE CENTRAL PRODUCT DATA BANK
• SUPPORT THE FOUNDATION OF NEW REGISTERS
• INFLUENCING THE EU LICENSING PROCEDURE BY
  IMPLEMENTING NEW OUTCOME PARAMETERS
• SCIENTIFIC RESEARCH REGARDING THE REPRODUCABILITY
  OF CLINICAL STUDIES IN CLINICAL WORK
• OFFERING A PLATFORM FOR PUBLICATIONS AND EXCHANGE
  OF SCIENTIFIC INFORMATIONS

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Impact of Registers

• Revision burden
• Sweden
• 1979 18
• 2006 7,7
• USA (Medicare)
• Revision burden still 16

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Revision Burden

• Longitudinal Evaluations in One country (SF) are
  reflecting the influence of steering effects

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Differences in Registers comparing special
implants
Revision per 100 observed component years
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Why is the use of some implants so different
Cervicocephalic HIP Implants
AUSTRALIA
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Differences in Registers

• Further research on the explanation of
  differences is necessary without compromizing
  privacy of data from patients and surgeons
• Procedures and concommitant therapies
• Unexplained and unadjusted data might be
  problematic
• Evaluation by scientific societies, not public
  health institutions!!!

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Only optimal Organisation of APL Registers allows
Outcomeimprovement

• Share of duties
• Health authorities
• Legal support
• financial support
• data collection and hosting
• Orthopaedic Society or Orthop.Academic
  Institutions
• evaluations and publications
• assessments
• recommendations on implants and surgical issues
• data collection and hosting

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INFLUENCE OF EAR ON BETTER COMPARISON

• EAR SHOULD MAKE REGISTERDATAS BETTER COMPARABLE
• BESIDE THE MINIMAL DATA SET FOR IMPLANTS THERE
  SHOULD BE A DEFINED STANDARD OF
  OPERATIVE PROCESS
• DIFFERENCES TO THIS STANDARD SHOULD BE DESCRIBED
  PER REGISTER LIKE IN MATERIAL AND METHODS OF
  CLINICAL PUBLIKATIONS

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INPUT OF EAR to the Quality of data

• Comprehensive datasets like Registers are
  superior compared to clinical studies to measure
  revision rate
• Not every Register has the same quality
• comprehensiveness (percentage of covered ops)
• compliance
• control of borders ( Problem of regional R. )
• Appropriate for the issue under evaluation
• Discharge Records for outcome???

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Quality of Datasets - Proposal
Examples Excellent Outcome Register like
Swedish THA-Register A-1.1.1.1 Regional Outcome
Register in Development A-1.2.2.1 Discharge
Records for Outcome Research A-2.1.1.2 Multicente
r-Study A-1.3.3.2
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EAR CONTRIBUTION TO APL DEVELOPMENT

• ANALYZING EXISTING REGISTERS ABOUT SPECIFIC
  SUCCESSFACTORS
• THE CENTRAL PRODUCT DATA BANK
• SUPPORT THE FOUNDATION OF NEW REGISTERS
• INFLUENCING THE EU LICENSING PROCEDURE BY
  IMPLEMENTING NEW OUTCOME PARAMETERS
• SCIENTIFIC RESEARCH REGARDING THE REPRODUCABILITY
  OF CLINICAL STUDIES IN CLINICAL WORK
• OFFER A PLATFORM FOR PUBLICATIONS AND EXCHANGE OF
  SCIENTIFIC INFORMATIONS

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Product databank
OMNIFIT

• ISO-Norm 7206
• Hip
• Knie in development
• Set up of a standardised list in cooperation with
  the manufacturers

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A TIME AND FINANCE-CONSUMING PROCEDURE WITH THE
NEED OF FREQUENT UPDATINGWAS ALREADY PLANED
WITH THE RESTRUCTURING OF THE GERMAN APL
-REGISTER BUT POSTPONED DUE TO POLITICAL
DISCUSSION ABOUT THE ORGANIZING INSTITUTION OF
THE WHOLE REGISTER !
CENTRAL PRODUCT DATA BANK

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EAR CONTRIBUTION TO APL DEVELOPMENT

• ANALYZING EXISTING REGISTERS ABOUT SPECIFIC
  SUCCESSFACTORS
• THE CENTRAL PRODUCT DATA BANK
• SUPPORT THE FOUNDATION OF NEW REGISTERS
• INFLUENCING THE EU LICENSING PROCEDURE BY
  IMPLEMENTING NEW OUTCOME PARAMETERS
• SCIENTIFIC RESEARCH REGARDING THE REPRODUCABILITY
  OF CLINICAL STUDIES IN CLINICAL WORK
• OFFER A PLATFORM FOR PUBLICATIONS AND EXCHANGE OF
  SCIENTIFIC INFORMATIONS

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Registers in Europe
ESPESCIALLY IN THE NEW MEMBER STATES THERE IS A
HIGH ECONOMIC PRESSURE AND ONLY REGISTERS GIVE
EARLY WARNINGS BY THE USE OF LOW QUALITY PRODUCTS
21/11/2009
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EAR CONTRIBUTION TO APL DEVELOPMENT

• ANALYZING EXISTING REGISTERS ABOUT SPECIFIC
  SUCCESSFACTORS
• THE CENTRAL PRODUCT DATA BANK
• SUPPORT THE FOUNDATION OF NEW REGISTERS
• INFLUENCING THE EU LICENSING PROCEDURE BY
  IMPLEMENTING NEW OUTCOME PARAMETERS
• SCIENTIFIC RESEARCH REGARDING THE REPRODUCABILITY
  OF CLINICAL STUDIES IN CLINICAL WORK
• OFFER A PLATFORM FOR PUBLICATIONS AND EXCHANGE OF
  SCIENTIFIC INFORMATIONS

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CE-Licensing procedures

• Goals of the risk class upgrade to class III for
  joint implants will most probably not be reached
  with the data used now
• Register data should be included
• Migration analyzes should be part of the initial
  licensing procedures to keep requested
  FUP-periodes short and guarantee good
  predictability
• More studies will not lead to better quality

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CE-Licensing procedures

• Manufacturers are responsible for the quality of
  their implants
• Do not have access to Register datasets in
  regular procedures
• Can be handled on national level at present
• EU-wide new procedures should be established

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EAR CONTRIBUTION TO APL DEVELOPMENT

• ANALYZING EXISTING REGISTERS ABOUT SPECIFIC
  SUCCESSFACTORS
• THE CENTRAL PRODUCT DATA BANK
• SUPPORT THE FOUNDATION OF NEW REGISTERS
• INFLUENCING THE EU LICENSING PROCEDURE BY
  IMPLEMENTING NEW OUTCOME PARAMETERS
• SCIENTIFIC RESEARCH REGARDING THE REPRODUCABILITY
  OF CLINICAL STUDIES IN CLINICAL WORK
• OFFER A PLATFORM FOR PUBLICATIONS AND EXCHANGE OF
  SCIENTIFIC INFORMATIONS

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Input of EAR

• Benchmark for Results of clinical studies
• crude evaluation if the data will be reproducable
  in regular patient service
• Differences from 4-10-times in revision rates of
  some implants
• Extending this Benchmarking process to all
  impants could be possible
• Joint effort by EFORT and EAR
• Volunteers are welcome

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Further Projects by EAR

• Comprehensive check of clinical Literature
• Set of benchmarks based on the average of
  worldwide arthroplasty register data
• Methodo-logical research
• Cooperation with EU-Institutions
• Development of National Registers and cooperation

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EAR CONTRIBUTION TO APL DEVELOPMENT

• ANALYZING EXISTING REGISTERS ABOUT SPECIFIC
  SUCCESSFACTORS
• THE CENTRAL PRODUCT DATA BANK
• SUPPORT THE FOUNDATION OF NEW REGISTERS
• INFLUENCING THE EU LICENSING PROCEDURE BY
  IMPLEMENTING NEW OUTCOME PARAMETERS
• SCIENTIFIC RESEARCH REGARDING THE REPRODUCABILITY
  OF CLINICAL STUDIES IN CLINICAL WORK
• OFFER A PLATFORM FOR PUBLICATIONS AND EXCHANGE OF
  SCIENTIFIC INFORMATIONS

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Support by EFORT

• Portal shoud grow to a Peer Review and
  Publication platform
• Presentation in cooperation with National
  Societies
• EFORT-Fora
• National Congresses
• Support for Registers as high value instruments
  for outcome measurement
• Plenary session at EFORT-Congress 2010 Madrid

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www.efort.org
21/11/2009
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SUMMARY

• THE INPUT OF EAR TO RAISE THE QUALITY OF
  ARTHROPLASTY OUTCOME IS REMARKABLE AND
  MULTIFACTORIAL !
• EXPECTING A RAPID RAISE OF REGISTRIES WITH
  SOMETIMES DIVERTING RESULTS EAR IS A PERFECT
  ADDITION TO NATIONAL REGISTERS AND A NECESSARY
  CLEARINGFIELD !

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• THANK YOU !

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Interpretation of Register Reports

• Register Evaluations are observations
• High quality data concerning survival rate
• Proper to detect reasons for revisions
• Decrease the publication bias in the
  literatureRegisters refer to the situation in
  the entire area
• USA
• Very low revision rate in metaanalyses of
  clinical studies
• Publications in majority by specialised centers
  (HSS, Mayo, Harvard,..)
• 18 Revision burden in total
• 50 of the primary THA are done by surgeons
  performing less than 7-10 THA a year (no follow
  up, quality control, publications)

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EAR-Section at the EFORT-Portal

• www.efort.org gt Public gt Research and
  Sciencesgt Arthroplasty Registers
• In the futurewww.ear.efort.org

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Retropatellar Replacement (Avon)
Studies from the author of the implant
7 y
Author Studies Others gt 30 cases
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Retropatellar Replacement (Avon)

• Author
• 83 knees out of 109
• 33 knees out of 306
• 3 special patients (patellectomy)
• Independent
• 103 patients, 7 years

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Boneloc

• In favour of the product
• Intermediate or technical
• negative

1991
1995
2000
2003
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What can i use for myself from foreign Register
reports?
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What can i use for myself from foreign Register
reports?

• Demographics
• Cervicocephalic Implants Romania

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Cervicocephalic Implants

• Reference Australia
• Revisions at older patients
• Initial result for RO on unadjusted evaluations
• No Cervicocephalic implants under 75
• Detail analyses with international benchmarks

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Cervicocephalic HIP Implants
AUSTRALIA
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Limitation on Interpretation
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Limitation
15
4
6
7
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Limitation
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Detail Evaluation Alloclassic

• Group Alloclassic consists of a mixture of
  Alloclassic SLO und SLL (- at primary
  Operations!!!!)
• Relatively small sample, 15 Revisions
• Almost all Revisions within the first year

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Detail Evaluation Alloclassic

• Questions
• Case mix Faktor?
• Surgical influence?
• Implant related problem????????
• Not everything whats significant is relevent
• Accurate Analyses by Register staff is
  recommended and essential to give the customer
  surgeon the possibility for proper consequences

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Summary

• Arthroplasty Registers are valid sources for long
  term performance of arthroplasty
• Registers are able to detect potential problems
  in short term
• Foreign Reports refer to their circumstances, if
  they differ gt potential bias
• Implant labeling is worldwide not standardsized

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Organisation of Arthroplasty Registers

• Key factors
• Compliance of the Surgeons
• Compliance of the hospitals and the Public
  Health Authorities
• Set up a Register Centre for Data collection and
  evaluation
• Legal support concerning dealing with
  personalised data(to link primary and revision
  surgery) and access to other public datasets
  (census to identify deceased persons)
• Financial support

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Organisation of Arthroplasty Registers
Health Authorities
Arthroplasty Register
Manufacturer ?
Hospital
Orthopaedic Society
Surgeon
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Interpretation of Register Reports

• Register Evaluations are observations
• High quality data concerning survival rate
• Proper to detect reasons for revisions
• Decrease the publication bias in the
  literatureRegisters refer to the situation in
  the whole area
• USA
• Very low revision rate in metaanalyses
• Publications in majority by specialised centers
  (HSS, Mayo,..)
• 18 Revision burden in total
• 50 of the primary THA are done by surgeons
  performing less than 7-10 THA a year (no follow
  up, quality control, publications)

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Interpretation of Register Reports

• National Register Data are referring to their
  circumstances
• Problems to generalise the results to other
  countries
• Even scandinavian registers have different
  procedures in data collection and statistical
  procedures
• Most of the products (except the most popular)
  are used in a limited number of clinicsgt
  influence of the surgical level, training,...?
• Specific National influence factors (medical
  system, general circumstances,...) can not be
  controled without supranational evaluations

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Interpretation of Register Reports

• Not easy to do conclusions in detail without
  detailed knowledge of the basic datasets
• gt check the epidemiological data in the reports,
  not just the survival curves
• EFORT / EAR will increase the level of
  comparability by time and offer information
  concerning this topic