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Netherlands Orthopaedic Association (NOV)Bruistensingel 216, 5232 AD ’s Hertogenbosch, E: nov@orthopeden.org, W: www.orthopeden.orgClassification Orthopaedic Implants: NOV Total Hip Prosthesis 2016IntroductionNumerous scientific publications and in particular also national implant registers show considerable differencesin the results that are achieved by various types of prostheses.With an aim to increase transparency, the NOV intends to assess and classify all available orthopaedic implantsused in the Netherlands according to a fixed scheme. This must lead to better user information on the longterm results of specific prosthesis. This assessment starts with a classification of hip prostheses. Next, kneeprosthesis will be assessed.The Board of the NOV appointed a Task Force that was requested to perform this procedure. The Task Forceconsists of the following persons: Dr. L.P.A. Bom (chair), Dr. R.W. Brouwer, Dr. J.H.M. Goosen, G.G. vanHellemondt, Prof. dr. R.G.H.H. Nelissen, Dr. R.W. Poolman, Dr. B.W. Schreurs1In classifying hip prostheses, the NOV applies principles of the internationally renowned NICE criteria(National Institute for health and Clinical Excellence) of the NHS (National Health Service) in the UnitedKingdom. It was decided to classify hip prostheses in three groups (1A, 1B and 2).General procedure1. In January 2015, a new NOV advise (benchmark) is established. Every year, the NOV advise will bepublished in the General Assembly in the week after the NOV conference.2. On November 10, 2015, all orthopaedic industries received a letter of the Board of the NOV Input wasrequested with regard to:a. Products that are no longer manufactured or marketed, so these could be removed from thelist.b. Additional information which could only be substantiated in accordance with the stipulatedcriteria and details on the source of such information.3. Orthopaedic industries must send input before December 10, 2015.4. All input was processed in January 2016 and a new concept bench mark was established.This document is the outset of a methodology that will be fine-tuned over the next years. An update will becarried out once a year (reference date December 1). The NOV is open to additions to and remarks about thefirst classification. It is deemed obvious that cups or stems that now satisfy NOV 1B requirements may move upto category 1A in future. There is no reason to dissuade from the use of implants 1A and 1B. It is also clear thatinnovations (NOV 2) must still be possible subject to properly defined criteria. The adopted system offersexcellent opportunities to inform patients about the type of prosthesis to be used and the current classificationof the relevant prosthesis.The requirements and classification may change and gather weight after annual review; even more so, when2our national prosthesis registration system (LROI) will yield reliable Dutch data over the next p-replacement-ta2/guidancehttp://www.lroi.nl
Netherlands Orthopaedic Association (NOV)Bruistensingel 216, 5232 AD ’s Hertogenbosch, E: nov@orthopeden.org, W: www.orthopeden.orgNOV 1A: Full Acceptance by NOV (Benchmark)A Hip Implant (cup or stem) with a revision percentage of 10 % or less after 10 years, revision for any reasonendpoint. Revision is defined as every re-operation of parts of the prosthesis. The classified implant must havea minimum follow-up of 10 years of at least 500 implants or an ODEP-rating (Orthopaedic Data Evaluation3Panel) of 10A or 10A*.NOV 1B: Preliminary Acceptance by NOV (Entry benchmark)A Hip Implant (cup or stem) with a revision percentage of 5 % or less after 5 years, revision for any reasonendpoint. Revision is defined as every re-operation of parts of the prosthesis. The classified implant must havea minimum follow-up of 5 years of at least 500 implants or an ODEP-rating (Orthopaedic Data Evaluation4Panel) of 5A, 5A*, 7A or 7A*.NOV 2: New implantsEvery Hip Implant that does not comply to the above 1A or 1B criteria and is included in a Medical EthicalCommittee approved study.Since 4 years the Netherlands Orthopaedic Association publishes its yearly hip categorisation list based onimplant survival data from full members of ISAR and data from ODEP.1. Swedish Hip Arthroplasty Register2. Australian National Joint Replacement Registry3. National Joint Registry for England, Wales and N. Ireland4. Danish Hip Arthroplasty Register5. ODEP Orthopaedic Data Evaluation Panel, U.K.Changes made compared to Classification list 2015Cemented cupProsthesisCorin - CenatorJRI – Muller typeZimmerBiomet - ApolloZimmerBiomet - CMKChange1B to 1A1B to 1A1B to 1A1B to 1ANew classification1A1A1A1AChangeNewChange in name (RM Classic cup)NewNew classification1B1A1BUncemented cupProsthesisLima – Delta TTMathys – RM TiCP coated cupZimmerBiomet - //www.supplychain.nhs.uk/odep/4
Netherlands Orthopaedic Association (NOV)Bruistensingel 216, 5232 AD ’s Hertogenbosch, E: nov@orthopeden.org, W: www.orthopeden.orgCemented stemProsthesisJRI – Furlong modularZimmerBiomet – CMK ModularZimmerBiomet – CMK MonoblocChange1B to 1A1B to 1ANewNew classification1A1A1BChangeNewNewNewNew classification1B1B1BUncemented stemProsthesisLima – C2 stemMathys – CBC stemMedacta – Quadra H
Netherlands Orthopaedic Association (NOV)Bruistensingel 216, 5232 AD ’s Hertogenbosch, E: nov@orthopeden.org, W: www.orthopeden.orgNOV 1A10 year resultsCemented cups01-01-2016Cemented ley EliteCharnley kMathysCharnley OgeeMuller typeFALInterplantaCCB Low ey LF monoblocCharnleyflanged/modularCharnley Elite PlusC-stemFurlong modularSP IICCA Muller straight stemSmith & BiometAll Poly ReflectionExeter / Exeter DurationContemporaryApolloCMKMüllerSmith & NephewSmith & on EFCPCSExeterOmnifit cementedBimetric (Ti) cementedCMK iometMüller Low rBiometZimmerBiometCPTME Müller straight stemMS 30StanmoreNOV 1A10 year results01-01-2016UncementedcupsUncemented thysSmith & NephewDesignSaturne Dual mobilityPlasmacup SCDuralocPinnacleFurlong CSFFurlong ThreatedRM TiCP coated cupBicon ith & NephewDesignBi-ContactAMLCorail / Corail AMTS-ROMSummit TaperedFurlong HACFurlong HAC ActiveSL PlusSmith & NephewStrykerStrykerZimmer biometZimmerBiometZimmerBiometReflectionABG IITridentAllofit / Allofit SCSF AlloclassicCLS SpotornoSmith & rgyABG II HAAccoladeOmnifit HASecur-Fit / Secur-Fit PlusBimetricZimmerBiometZimmerBiometFitmoreMallory HeadZimmerBiometZimmerBiometCLS SpotornoMallory Head
Netherlands Orthopaedic Association (NOV)Bruistensingel 216, 5232 AD ’s Hertogenbosch, E: nov@orthopeden.org, W: www.orthopeden.orgNOV 1A10 year rBiometZimmerBiomet01-01-2016Uncemented stemsDesignRanawat BursteinUniversalTrilogy / Trilogy NOV 1B5 year resultsCemented cupsDesignVervolgSL AlloclassicTaperloc / TaperlocCompleteVersys01-01-2016Cemented DePuyZimmerBiometSaturne Dual metZimmerBiometZimmerBiometZimmerBiometC-stem AMTBiMetric CoCrCMK MonoblocMS MüllerOlympiaTaperloc cementedNOV 1B5 year results01-01-2016UncementedcupsUncemented stemsManifacturerAdlerLimaDesignFixa Ti-PorDelta PFManifacturerBBraunLimaDesignExciaC2 stemLimaMathysMedactaSERFSERFSmith & NephewDelta TTRM Pressfit cupVersafitNovae EvolutionNovae SunfitEP-Fit PlusMathysMathysMedactaSmith & NephewSmith & NephewStrykerCBC stemTwinsys cementlessQuadra HAnthologyPolar stemSymaxSmith & NephewSmith & NephewStrykerStrykerZimmerBiometZimmerBiometPolar Dual MobilityR3ABG II ceramicTrident CeramicContinuumExceed ABTWright MedicalWright MedicalWright MedicalZimmerBiometZimmerBiometAnca FitProfemur E / E plusProfemur LM/L TaperTaperloc MicroplastyZimmerBiometTrabecular metal
Every Hip Implant that does not comply to the above 1A or 1B criteria and is included in a Medical Ethical Committee approved study. Since 4 years the Netherlands Orthopaedic Association publishes its yearly hip categorisation list based on implant survival data from full members of ISAR and data from ODEP. 1. Swedish Hip Arthroplasty Register 2.
