Development of the Romanian Register - EAR - EFORT

www.ms.rowww.cnas.rowww.casan.roValue of different types ofliterature and requirements forrunning a successful ArthroplastyRegisterROMANIAN ARTHROPLASTY REGISTER (RAR)REGISTRUL NATIONAL ENDOPROTEZARE (RNE)www.rne.roCristian Ioan Stoica MD PhD

Value of literature, studies, registersOptions for Data collection:►Arthroplasty Registers:(EFORT/EAR-Definition)• Registration of ALL operations on national level►ClinicalClinical Monocenter and Multicenter-StudiesStudies:• Conventional follow up-studies

RCT

Value of literature, studies, registersConclusion for Arthroplasty Studies(Journal of Bone & Joint Surgery (Am))Level of Evidence: Therapeutic study, Level II-2(poor quality randomized controlled trial[e.g., < 80% follow-up)For register studiesLevel of Evidence: Therapeutic study, Level II-1(prospective cohort study)

Value of literature, studies, registers► Clinical studies:• Flexible in definition ofquestions and topics• Flexible in questionairs andFUP-periodes• Centers in Multicenter-studies can be defined byfree choice► Registers:• Strong and compact organisation isrequired• Long term documentation• Every modification of the forms is aproblem => decreasing data quality=> Low flexibility• Main Advantage:Flexibility• Limitation:Standardisation=> decreasedComparability• Complete overview on a marketsituation• Comparability byStandardisation is possible

Necessity for early warning system► Just in case ??!!► Really a permanent “pressure” to quality and savedsolutions for patient treatments► Avoid selling company implant stocks (unsold), in differentmarkets without local neutral surgeon informing system► Open collaboration with industry for permanentcontribution for long survival solutions► Avoid and prevent of high cost solutions for national healthsystems in early - late postoperative complication cases► Permanent attention in surgical technical execution ofinterventions (quality of the surgical act in general withrespect of operating steps of preparing and implantation)

Financial Impact by a Register-Budgets of national Registers:• Sweden: about 400.000€ / year• Norway: about 200.000€ / year• Romania: about 60.000-90.000€ / yearEstimated Expenses for 1 documented patient: : 40 €(including virtual costs like time for documentation,....)Covered in all countries in general by the Public Health System

Financial Impact by a Register-Comparedto the Expenses for Revisions:-Sweden:• if 40 Revisions can be „saved“ by a register it is cost effective.• The Register has reduced the revision burden by about 50%• This is an equivalent of saving 11.630 revisions in the last 10years• Direct (intrahospital) costs: : 139.560.000$= 14.000.000 $ annually for theSwedish Health Care System

Requirements for a successful Register-CompleteDocumentationTo achieve this goal it is necessary to have:• the support by the Orthopaedic/Trauma society• the support by the Health System (Ministery(Ministery,public health insurance,..)• a strong organisation and communication line to thedepartments• build up a Register Center

Requirements for a successful Register-Complianceby the surgeonsTo achieve this goal it is recommended to• Minimize or eliminate the documentation burden onthe individual surgeon• Give Feedback with statistical interpretation• Offer support for other scientific activities(Possibilityto extract lists of the departmentsdataset for clinical studies,...)

Responsability and Competence of theNational Registers- Collection of national Data- Validation of national data and assuring minimalrequirements in data quality- Evaluation of national data or defining parameter(when mathematical procedures are outsorced)- Sending datasets periodically to supranational center(server)- Publication of national data

UEMS & EBOTUKSwitzerlandSwedenSpainNecessity of the RAR (RNE)Population = 21,680,974 / 20029080706050403020100Populatia (milioane)Population (millions)AustriaBelgiumCroatiaCyprusDenmarkFinlandFranceGermanyGreeceHollandHungaryIrelandItalyLuxembourgNorwayPortugalRomaniaPopulatia 1999 Populatia 2002Population 1999 Population 2002

UEMS & EBOTRatio Hip Replacement to Knee Replacement3028.325201512.510501.31.22.41.925 52.5 2.7 2.8 3 3.1 3.5 3.85 4 4 3.73.681.33 1.25 1.7 2 1.68 31.82.5FinlandSwedenSwitzerlandSpainUKDenmarkFranceLuxembourgGermanyIrelandB elgiumCroatiaNorwayRomaniaHollandRatio Hip Replacement to Knee Replacement 1999 Ratio Hip Replacement to Knee Replacement 2002

LuxembourgHolland706050403020100UEMS & EBOTHip Replacement per SpecialistGreeceCroatiaAustriaSpainRomaniaItalySwedenSwitzerlandFinlandNorwayDenmarkBelgiumGermanyUKFranceIrelandHip Replacements per Specialist 1999 Hip Replacements per Specialist 2002

HungaryPortugalCyprus302520151050UEMS & EBOTKnee Replacements per SpecialistCroatiaRomaniaGreeceH ollandItalySpainAustriaNorwayBelgiumDenmarkGermanySwedenSwitzerlandUKFranceIrelandFinlandLuxembourgKnee Replacement per Specialist 1999 Knee Replacements per Specialist 2002

90000000800000007000000060000000Population5000000040000000800070006000500040003000200030000000200000001000000010000Population & Specialists 20020SpecialistsRomaniaCroatiaCyprusHungaryUKIrelandDenmarkSpainPortugalSwitzerlandNorwayFinlandSwedenH ollandFranceLuxembourgB elgiumGermanySpecialists 2002 Population 2002UEMS & EBOT

www.sorot.ro www.rne.rowww.efort.orgChanging CONTEXTDiagnostic Related Groups = DRG1983 USA – start – evaluation finantiantion in the hospitalspublic hospitals finantiantion - Italy, France, Irland, Spain,Hungary, Germany, Singaporehospital regional finantiantion aplication - Norvegia,Finlanda, Suedia, Danemarca, Portugalia, Australia01.01.2004 – start in Romania (185 hospitals)Present – all public hospitals and ambulatory system fromRomania in DRGwww.uems.bewww.uems-ortho.org

www.sorot.roNecessity of the RAR (RNE)Changing CONTEXTwww.rne.roDiagnostic Related Groups = DRGAdministrative reasons and not only for an Arthroplasty Register !limits in different countries of the budget spend with arthroplasty discussions about:• resource of the health system• number of cases expected to by resolvedCost of health!www.efort.org• what is important?: number of resolved cases or quality for long term resultsand revision rate less all public hospitals from Romania in DRG payment methods in our hospitals limit:• the costs of the surgical act• number of arthroplasties resolved cases (long waiting list)• the possibilities for high standard arthroplasty coupling (ceramic/ceramic;metal/metal; crosslink poly/ceramic; etc.) necessity to find a way to demonstrate in front of the authorities:• longevity of an implant in respect with implant quality coupling andimplantation methods• really necessity for good solutions in accord with surgeons and patientsexpectations

RAR (RNE) place in the national health► Nationalorganization structure• Health Ministry (MS)• National Insurance House (CNAS)• Private Insurance► National professional organization• Romanian Orthopaedic and Traumatology Association (SOROT)► Individual surgeon confidence► Database built on non-concurrencialprinciple (everyhospital has own data and permanent live comparing hisown data with general national data)► Collaboration with industry indirectly through local dealersor local representative companies► International contacts for large collaboration andpermanent updating of quality, compare of national dateswith general European body

www.sorot.roS.O.R.O.P.ROMANIANPEDIATRICORTHOPAEDICSOCIETYROMANIANARTHROSCOPICSOCIETYROMANIANHIPSOCIETYORGANIGRAMMS.O.R.O.T.ROMANIAN SOCIETY OF ORTHOPAEDICS AND TRAUMATOLOGYOtherNationalOrthopaedicAssociationsAbout 576 membersExecutive CommitteePresident / Vice president / Secretary /Treasurer / Past President / ChiefScientific / + members from everyprincipal universities centers from thecountry (including pediatricorthopaedics) /A.M.R.RomanianMedicalAssociationCentral OfficeHealth MinistryCNASNational InsuranceHouseNational CollegeCredits CMEROMANIANSPINESOCIETYROMANIANTRAUMASOCIETYE.A.R.EuropeanArthroplastyRegisterR.N.E.NationalArthroplastyRegisterAnnual ReportHealth MinistryScientificBoardEducationCommitteeCNASNationalInsuranceHouseEditorialBoardReviewSOROTEventsINTERNETHomepageSOROT Congress (biannual)SOROT annual meetingsSOROT symposiumsNATIONALRepresentativesEBOT; EFORTESSKA; ISAKOSSICOT; Etc.

www.sorot.roCNASNational InsuranceHousePrivates InsuranceHousePublic HospitalsCity CouncilHealth Ministry(Institutes)Private HospitalsHealth MinistryNational CentrePostgraduateMedicinePharmacyNurseMalpracticeInsuranceMandatory !Medical National CollegeCredits CMERomanian evaluation CMENational Medical CollegeNational Commission for:CME Accreditation / Reaccreditations of CME Suppliers(Mandatory Annual Reaccreditations of CME Suppliers)CME hourCreditsPointsFree practice right !(every 5 years) 200 pointsEvaluation mandatoryCME SuppliersCME:CongressesScientific ConferencesFace to faceWork-shopsReviews publicationsSpecialty books (Monographs)DOCTORATPhDS.O.R.O.T.EXAMGeneralPractitioner(6 years)EXAMEXAMResident(6 years)EXAMSpecialistEXAMConsultantReaccreditations(every 5 years)A.M.R.RomanianMedicalAssociationEducation andResearchMinistryPublicUniversitiesMedicine 10PrivateUniversitiesMedicine 2PublicPostgraduateSpecialtyTeachingSystem

Funds for RAR (RNE) organization andSOFTWAREAND TEHNICAL MAINTENANCE, DATAENTRY, DATA EVALUATION –PERSONNELfunction2001(EUR)FIRST YEAR!INTERNET AND OFFICE COSTS 8.900(128Kbps)2002(EUR)2003(EUR)2004(EUR)9.600 27.000 25.500 28.0009.600(256Kbps)12.500(512Kbps)9.500(1Mbps)HARDWARE AND SERVER LICENSES 20.000 27.400 44.000 56.000TOTAL 38.500 64.000 72.500 93.500A PROBLEM FOR FUTURE OUR BUGET?: Authorities interested now to generateRegisters in Health Care for others: Diabetes; Oncology (revitalization); Cardio; etc.

http://www.rnerne.roro

September 2001Stages of Development• Start of RAR – ONLY HIP – EFORT Minimal Data Set Primary andrevision (Type 2a and Type 3a)• It was a year of testing the reporting methods and data entry• 2 different forms were introduced for Ministry of Health and NationalInsurance House (Type 0 and Type 1)►Type0:• Medium costs on types of endoprosthesis• Number of patients with segmentary spine implants• Other data for MS and CNAS►Type1:• Number of implants bought and implanted by patient• Number of fractures• Number of tumors• Total Number of patients interned and operated

Stages of Development► How it looked at that time – September 2001

Stages of Development►January January 2003New forms were introduced:- Knee (Primary and Revision) (Type 2b & Type3b)- Soft Tissue forms for Hip and Knee implantsForms developed based on EFORT minimal data set

Stages of DevelopmentHow it looked at that time – January 2003

Necessity of standardization

Necessity of standardization

Stages of Development2003 September – Most Important- The EFORT Minimal data set proved to be INCOMPLETE(no databank selection and not all components present)- All forms in use were updated- New database with implants was created (all models onRomanian market)• New form for SPINE – SCOLIOSIS was added (not a great success)• First Activity Report was presented at National SOROT Congress• The online webpage of RAR was updated, more info available for public use,general situations. and English version of the site• A new database with Orthopaedic Surgeonswas added• X-Ray Imagery was introduced as a test onHip Forms

www.ms.rowww.cnas.rowww.casan.roStages of DevelopmentOrtopaedic Surgeons Database

Stages of DevelopmentImplants Database

Stages of Development► September 2004 – very important also- Barcodes were included in all forms (both paper and electronic)- All forms in use were updated (insignificant esthetic changes)- New databases with cement, antibiotics were created (all models onRomanian market)- Updated form for SPINE – SCOLIOSIS (still not a great success)- The online webpage of RAR was updated- Data validation process was started. First – Revisions for theMulticentric Study

Forms in present useex: primary hip

Forms in present useex: spine-scoliosisscoliosis

RAR (RNE) InfrastructureROMANIAN ARTHROPLASTY REGISTERTECHNICAL INFRASTUCTUREHoRARHEADQUARTERS“FOISOR”HOSPITALHoHoTechnical DepartmentData entry &validation DepartmentMINISTRYOF HEALTHNATIONALINSURANCEHOUSE

General info - RAR►Brief description► 75 orthopaedic services registered to this system (about 95% of the total)- 20 will input their data on their own over the internet- 11 are inactive – very few information from time to time, no importantorthopaedic activity- 54 are performing arthroplasty surgery- 12 will only send general data, Form 1 – fractures, tumors, etc,NO arthroplasty forms72% of the data from the orthopaedic services that are reporting to RAR is complete for 2001.84% of the data from the orthopaedic services that are reporting to RAR is complete for 2002.90 % of the data from the orthopaedic services that are reporting to RAR is complete for 2003.93 % of the data from the orthopaedic services that are reporting to RAR is complete for 2004.

Data Control► Main features:> twice a day automatic backup – mirroring between servers and DAT tape> 128 bit encryption connection to the servers> both paper based and computer based systems> constant monitoring of all contacts with all hospitals> all connections and changes to the database are logged> data integrity evaluation

Online Statistics (present version)

Online Statistics (present version)* Statistici pe spitalele din Bucuresti – Formulare Implant Prima Sold

Online Statistics (present version)* Statistici pe Judete – Numar Formulare Implant Prima Sold* Statistici pe Judete si Spitale – Numar Formulare Implant Primar Sold

Online Statistics (present version)

Online Statistics (present version)* Statistici pe formularele de Revizie de Sold - ca exemplu - la nivelul lunii Mai 2004REVIZII ENDOPROTETICE !

Online Statistics (present version)Primary hip Endoprosthesis by type - 2004Detalies primary hip prosthesis implanted / YEAR (HIP)2004PRIMARY HIP IMPLANTCementedCementlessHybridHybridReversed Total %Total HipEndoprosthesisEndoprosthesis 2477 914 46 36 3473 63.45%Bipolar HipEndoprosthesisEndoprosthesis 176 135 10 321 5.86%TypeMoore Type HipEndoprosthesisEndoprosthesis 114 1516 1630 29.78%Monopolar HipEndoprosthesisEndoprosthesis 30 5 35 0.64%Resurfacing HipEndoprothesis 15 15 0.27%TOTAL 2797 2570 71 36 5474

Online Statistics (present version)Incidence by age groups and gender - Primary and revision hip implantsIncidence by age groups and gender for Primary Hip ImplantsIncidence by age groups and gender for revision hip implants35003000250032213121250200192200015001000500019101409131614221089842443324 36236379MaleFemale150100500159139941008258442934161079MaleFemale

Primary Total Hip Endoprosthesis – Femoral Stem Component (page 1)STEM Name Producer Type Oct-Nov-Dec 2003 p2004 Jan-April 2005Omnifit Stryker Howmedica Osteonics cemented 30.44% 28.06% 27.60%Omnifit HA Stryker Howmedica Osteonics uncemented 17.21% 15.91% 18.31%Taperloc Interlock Biomet Merck cemented 7.28% 10.13% 7.77%Filler cemented Biotechni (Franta) cemented 10.01% 9.81% 7.07%Exeter Stryker Howmedica Osteonics cemented 9.59% 9.69% 5.96%Taperloc Interlock Biomet Merck uncemented 4.20% 5.57% 4.16%Filler uncemented Biotechni (Franta) uncemented 5.67% 3.91% 2.64%Legend Stryker Howmedica Osteonics cemented 3.50% 3.53% 1.80%Elite Plus CDH De Puy-Johnson&Johnson cemented 1.47% 2.84% 6.10%Ultima De Puy-Johnson&Johnson cemented 0.70% 1.66% 2.50%Self Locking Permedica cemented 0.00% 1.57% 2.64%Esop AC Fournitures Hospitalieres cemented 3.01% 1.48% 0.55%Omnifit Stryker Howmedica Osteonics hybrid 0.49% 0.95% 0.14%Corail Collarless De Puy-Johnson&Johnson uncemented 0.14% 0.95% 1.80%Omnifit HA Stryker Howmedica Osteonics reversed hybrid 0.56% 0.77% 0.28%Uncemented Bicontact Stem Aesculap KG&Co uncemented 0.21% 0.56% 1.66%Corail Collared De Puy-Johnson&Johnson uncemented 0.84% 0.44% 0.00%Fixkonus Intraplant cemented 0.00% 0.36% 0.14%MK III Kerboull Stryker Howmedica Osteonics cemented 0.00% 0.27% 0.83%Cemented Bicontact Stem Aesculap KG&Co cemented 0.07% 0.21% 0.83%Filler uncemented Biotechni (Franta) reversed hybrid 0.35% 0.15% 0.00%Tip Muller-Self-blocking Femoral Stem Biotechni (Franta) cemented 0.00% 0.15% 1.53%Taperloc Interlock Biomet Merck hybrid 0.21% 0.12% 0.00%Elite Plus CDH De Puy-Johnson&Johnson hybrid 0.00% 0.12% 0.14%Legend Stryker Howmedica Osteonics hybrid 0.21% 0.09% 0.00%

Primary Total Hip Endoprosthesis – Femoral Stem Component (page 2)STEM Name Producer Type Oct-Nov-Dec 2003 p2004 Jan-April 2005Taperloc Interlock Biomet Merck reversed hybrid 0.00% 0.09% 0.28%Centrament cemented stem Aesculap KG&Co cemented 0.00% 0.09% 0.00%CLS Protek Sulzer Medica uncemented 0.14% 0.09% 0.00%B2C Groupe Lepine cemented 0.00% 0.09% 0.00%Exeter Stryker Howmedica Osteonics hybrid 0.07% 0.06% 0.14%Cemented Bicontact Stem Aesculap KG&Co hybrid 0.00% 0.06% 0.14%ABG II Cement Free Stryker Howmedica Osteonics uncemented 0.28% 0.03% 0.14%Filler cemened Biotechni (Franta) hybrid 0.00% 0.03% 0.00%Corail Collared De Puy-Johnson&Johnson reversed hybrid 0.00% 0.03% 0.00%CLS Protek Sulzer Medica reversed hybrid 0.00% 0.03% 0.00%Geradschaftprothese Intraplant uncemented 0.00% 0.03% 0.00%Geradschaftprothese Intraplant reversed hybrid 0.00% 0.03% 0.00%B2C Groupe Lepine uncemented 0.00% 0.03% 0.00%Uncemented Bicontact Stem Aesculap KG&Co reversed hybrid 0.00% 0.03% 0.00%SL-PLUS Plus Endoprothetik uncemented 0.98% 0.00% 0.00%OHST OHST cemented 1.75% 0.00% 0.00%Tip Muller II Protetim cemented 0.49% 0.00% 0.00%Tip Muller II Mathys cemented 0.07% 0.00% 0.00%CBC Mathys uncemented 0.07% 0.00% 0.00%Tip Muller-Self-locking Femoral Stem Biotechni (Franta) hybrid 0.00% 0.00% 0.14%Self-blocking Femoral Stem Surgival (Spania) cemented 0.00% 0.00% 0.69%Helios Biomet Merck uncemented 0.00% 0.00% 0.14%Self Locking Permedica hybrid 0.00% 0.00% 0.14%Jump Titanium Permedica uncemented 0.00% 0.00% 0.42%Hip-Joint Prosthesis Holder Metrimed cemented 0.00% 0.00% 3.19%

Primary Total Hip Endoprosthesis – Cup Component (page 1)TABELE ORDERED BY 2004CUP Name Producer Type oct-nov-dec 2003 p2004 Jan-April 2005Omnifit Stryker Howmedica Osteonics cemented 32.79% 27.56% 27.01%Securfit Stryker Howmedica Osteonics uncemented 14.99% 14.52% 15.52%Muller Type Biotechni (Franta) cemented 9.36% 9.84% 8.48%Cemented Acetabular Cup Biomet Merck cemented 6.68% 9.78% 8.19%Exeter Stryker Howmedica Osteonics cemented 9.03% 9.63% 6.18%L-Cup sau Mallory-Head Biomet Merck uncemented 3.93% 5.51% 4.17%Coriolis Fournitures Hospitalieres cemented 2.75% 3.92% 3.74%Swing Biotechni (Franta) uncemented 5.50% 3.71% 2.73%Contemporary Stryker Howmedica Osteonics cemented 2.81% 3.15% 0.86%Elite Plus-LPW De Puy-Johnson&Johnson cemented 1.64% 2.18% 6.03%Elite Plus Ogee LPW De Puy-Johnson&Johnson cemented 0.33% 2.00% 2.87%MK III Kerboull Stryker Howmedica Osteonics cemented 0.07% 1.15% 1.15%Plasmacup SC Aesculap KG&Co uncemented 0.85% 1.06% 1.58%Securfit Stryker Howmedica Osteonics hybrid 0.52% 0.94% 0.43%Duraloc 300 De Puy-Johnson&Johnson uncemented 0.00% 0.80% 1.01%ABG II Hole Cup Stryker Howmedica Osteonics uncemented 0.52% 0.50% 3.02%Duraloc Sector De Puy-Johnson&Johnson uncemented 0.85% 0.50% 0.86%Azur Biotechni (Franta) uncemented 0.00% 0.38% 0.00%Huftpfanne-Muller Intraplant cemented 0.00% 0.35% 0.00%Acetabular Cup PE –Chirulen Aesculap KG&Co cemented 0.33% 0.32% 0.86%Omnifit Stryker Howmedica Osteonics reversed hybrid 0.33% 0.29% 0.14%Muller Type Biotechni (Franta) reversed hybrid 0.52% 0.27% 0.00%Elite Plus LPW Flanged De Puy-Johnson&Johnson cemented 0.07% 0.27% 0.00%L-Cup sau Mallory-Head Biomet Merck hybrid 0.20% 0.18% 0.14%Exeter Stryker Howmedica Osteonics reversed hybrid 0.00% 0.15% 0.14%

Primary Total Hip Endoprosthesis – Cup Component (page2)CUP Name Producer Type Oct-Nov-Dec 2003 p2004 Jan-April 2005Contemporary Stryker Howmedica Osteonics reversed hybrid 0.00% 0.12% 0.00%Cemented acetabular cup Biomet Merck reversed hybrid 0.00% 0.12% 0.00%MBA Groupe Lepine cemented 0.00% 0.12% 0.00%Plasmacup SC Aesculap KG&Co hybrid 0.07% 0.09% 0.00%Duraloc 100 De Puy-Johnson&Johnson uncemented 0.07% 0.09% 0.00%Duraloc 300 De Puy-Johnson&Johnson hybrid 0.00% 0.09% 0.14%CLS Protek Sulzer Medica uncemented 0.13% 0.09% 0.00%Coriolis Fournitures Hospitalieres reversed hybrid 0.13% 0.06% 0.29%Elite Plus-LPW De Puy-Johnson&Johnson reversed hybrid 0.00% 0.06% 0.00%ABG II Hole Cup Stryker Howmedica Osteonics hybrid 0.13% 0.03% 0.00%MK III Kerboull Stryker Howmedica Osteonics reversed hybrid 0.00% 0.03% 0.00%Swing Biotechni (Franta) hybrid 0.00% 0.03% 0.00%Elite Plus Ogee LPW De Puy-Johnson&Johnson reversed hybrid 0.00% 0.03% 0.00%OHST OHST cemented 1.64% 0.03% 0.00%Muller Type Protetim cemented 0.46% 0.03% 0.14%MBA Groupe Lepine uncemented 0.00% 0.03% 0.00%Igloo Biotechni (Franta) uncemented 0.00% 0.03% 0.14%Omnifit Stryker Howmedica Osteonics hybrid 0.59% 0.00% 0.00%Bicon Plus Plus Endoprothetik uncemented 0.92% 0.00% 0.00%Muller Type Mathys cemented 0.07% 0.00% 0.00%CBF Mathys uncemented 0.07% 0.00% 0.00%P si PF (with claw) Metrimed Kft-Ungaria cemented 0.00% 0.00% 0.00%Muller Type Surgival (Spania) cemented 0.00% 0.00% 0.43%Jump System Permedica uncemented 0.00% 0.00% 0.43%Hip-Joint Prosthesis Acetabulum Metrimed cemented 0.00% 0.00% 3.30%Omnifit Stryker Howmedica Osteonics uncemented 1.70% 0.00% 0.00%

Primary Total Hip Endoprosthesis – Femoral Head Component (page 1)HEAD Name Producer Type Oct-Nov-Dec 2003 p2004 Jan-April 2005C-Taper Stryker Howmedica Osteonics cemented 30.73% 28.78% 29.98%C-Taper Stryker Howmedica Osteonics uncemented 17.32% 16.17% 20.70%Modular Femoral Head Biomet Merck cemented 7.26% 10.23% 8.22%Exeter Stryker Howmedica Osteonics cemented 9.43% 9.80% 6.70%INOX / ALUMINA Biotechni (Franta) cemented 9.99% 8.78% 0.91%Modular Femoral Head Biomet Merck uncemented 4.12% 5.67% 4.57%V40 Stryker Howmedica Osteonics cemented 3.28% 3.53% 1.98%INOX / ALUMINA Biotechni (Franta) uncemented 5.66% 3.47% 0.46%Elite Modular Head De Puy-Johnson&Johnson cemented 1.61% 2.96% 5.94%Inox Head Fournitures Hospitalieres cemented 2.93% 1.69% 1.22%Ultima De Puy-Johnson&Johnson cemented 0.63% 1.63% 2.74%Articuleze De Puy-Johnson&Johnson uncemented 0.98% 1.42% 1.83%Standard Permedica cemented 0.00% 1.36% 2.13%C-Taper Stryker Howmedica Osteonics hybrid 0.49% 0.97% 0.15%C-Taper Stryker Howmedica Osteonics reversed hybrid 0.70% 0.81% 0.30%Isodur Aesculap KG&Co uncemented 0.14% 0.36% 0.00%Huftkopf Intraplant cemented 0.00% 0.36% 0.00%MK III Kerboull Stryker Howmedica Osteonics cemented 0.00% 0.27% 0.61%Inox Head Protetim cemented 0.49% 0.24% 0.00%INOX / ALUMINA Biotechni (Franta) reversed hybrid 0.35% 0.12% 0.00%Modular Femoral Head Biomet Merck hybrid 0.21% 0.12% 0.00%Biolox Aesculap KG&Co cemented 0.00% 0.12% 0.00%Elite Modular Head De Puy-Johnson&Johnson hybrid 0.00% 0.12% 0.15%C Surgival (Spania) uncemented 0.00% 0.12% 0.15%V40 Stryker Howmedica Osteonics hybrid 0.21% 0.09% 0.00%

Primary Total Hip Endoprosthesis – Femoral Head Component (page 2)HEAD Name Producer Type Oct-Nov-Dec 2003 p2004 Jan-April 2005Modular Femoral Head Biomet Merck reversed hybrid 0.00% 0.09% 0.15%Isodur Aesculap KG&Co cemented 0.07% 0.09% 0.30%Biolox Aesculap KG&Co uncemented 0.28% 0.09% 0.00%Protasul Centerpulse uncemented 0.14% 0.09% 0.00%B2C Groupe Lepine cemented 0.00% 0.09% 0.00%Exeter Stryker Howmedica Osteonics hybrid 0.07% 0.06% 0.15%Huftkopf Intraplant uncemented 0.00% 0.06% 0.00%Cabeza femoral Surgival (Spania) cemented 0.00% 0.06% 3.81%Modular Femoral Head Biotechni (Franta) cemented 0.00% 0.03% 0.00%Articuleze De Puy-Johnson&Johnson reversed hybrid 0.00% 0.03% 0.00%OHST OHST cemented 1.75% 0.03% 0.00%B2C Groupe Lepine uncemented 0.00% 0.03% 0.00%Biolox Aesculap KG&Co reversed hybrid 0.00% 0.03% 0.00%Biolox Aesculap KG&Co hybrid 0.00% 0.03% 0.00%Modular Head Aesculap KG&Co uncemented 0.07% 0.00% 1.37%Sikomet Plus Endoprothetik uncemented 0.98% 0.00% 0.00%Cap Inox Mathys cemented 0.07% 0.00% 0.00%Cap Inox Mathys uncemented 0.07% 0.00% 0.00%INOX / ALUMINA Biotechni (Franta) hybrid 0.00% 0.00% 0.15%Cabeza Femoral Surgival (Spania) uncemented 0.00% 0.00% 0.76%Modular Head Aesculap KG&Co cemented 0.00% 0.00% 0.61%Femoral Head Permedica uncemented 0.00% 0.00% 0.46%Hip-Joint Prosthesis Head Metrimed cemented 0.00% 0.00% 3.50%

RAR (RNE) REALY ISFUNCTIONINGAND SURVIVE !

►Problems:• Unfortunately it is not Mandatory for Hospitals to senddata to RAR (voluntary action but “in the back” withannual report for health care system about surgicalindividual activity)• Not all Hospitals report evenly through time, sometimesgaps are filled after several months• There is no Centralized National Database available toidentify the deceased patients, leading to altered statistics►Solutions:RAR (RNE) past, present and futurefunctioning problems• MS & CNAS – health authorities will prepare an order formandatory data RAR (RNE) collecting system• Serious problem – RAR (RNE) is in contact with authoritiesto find a way for a Centralized National Database (inpresent only local territorial evidences)

RAR (RNE) past, present and futurefunctioning problems► Problems: national accept of necessity to startRAR (RNE)• Suspicions (what is happened with data in national levelin relation with insurance and health ministry)• Suspicions (the other hospitals know about the resultsfrom your hospital)• Centralized control system for implantation number(congress, conference – data communicated by differentclinics under control)► Solution:• By EFORT supervision• International body• National confidence of data every one can comparepermanent his results with general data

RAR (RNE) past, present and futurefunctioning problems►Problems:• Accept of minimum data sets forms (every clinicstarted his own tracking system aboutevolution)• Accept of forms changes along the way(protests more dates for communication)►Solution: Solution:• “Magic word” = by EFORT supervision• International standards in evaluations

RAR (RNE) past, present and futurefunctioning problems►Problem: Problem:• Delays collecting data• Communication system data (in beginningdifferent clinics no equal access incommunication technology)►Solution: Solution:• Pushing time to time the late clinics• Authorities letter about necessity of collectingdata• Accept in beginning of all communicationpossibilities (including: Fax, post, directelectronic format)

RAR (RNE) past, present and futurefunctioning problems►Problem: Problem:• Financial sustaining►Solution: Solution:• Mutual interest:►Authorities: data base for a national phenomena►National National specialty association: growing in qualityimplants and implantations + standardization +leveling of final results in all orthopaedic services

RAR (RNE) past, present and futurefunctioning problems►Problem: Problem:• Data accuracy• Correct catalog name, number, etc. data of theimplants• Frequent changing of implant catalog number• Changing in implant product structure►Solution: Solution:• Data validation (each form is validatedindividually – very slow but sure process)• Necessity of collaboration with producers forgeneral standardization and barcode system

RAR (RNE) past, present and futurefunctioning problems►Problem: Problem:• Statistic analysis• Data quality (data credibility) from thecommunicators (clinics)►Solution: Solution:• Common statistical range to be developed byEFORT• Feed back solution systems for every nationalregister (example: our CNP include someinformation)• Improving IT infrastructure

Improvements possible► Virtual Private Network between Orthopaedic Clinics► Interconnection with DRG system (more informationwith applications in multicentric studies)

►NEW RAR SOFTWARE IN TESTSBeta1 release- June 2005Official launch – September 2005 at national congressFeatures of the new software (it took 9 months of development)• More complex Asp.Net and MSSQL architecture (Vs. Opensource Mysql and PHP for old RAR)• Multi-lingual lingual architecture (the whole software can be fully translated in a matter of days)• Individual security certificates for all users• Extended databases for Implants, Ciment, Antibiotics, etc (including barcodes) – extendedstandardisation• Better forms – including Scoliosis form in a final version agreed by all participants• ONLINE STATISTICS ENGINE (similar to scandinavian paper reports) - configurable andmodular - aplicable on Minimal or other Data Set for hip and knee; other statistics will beadded after EFORT defines the statistical range• ONLINE Help Module• X-Ray as a standard feature on all forms for all users; also any type tof file can be stored to apatient’s s file• Modular users access• Better support for data validation• Extended online situatinons available for the public

www.ear.efort.org