Classification Orthopaedic Implants: NOV Total Hip ...

1 Netherlands Orthopaedic Association (NOV). Bruistensingel 216, 5232 AD 's Hertogenbosch, E: W: Classification Orthopaedic implants : NOV Total Hip Prosthesis 2016. Introduction Numerous scientific publications and in particular also national implant registers show considerable differences in 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 implants used in the Netherlands according to a fixed scheme. This must lead to better user information on the long- term results of specific prosthesis. This assessment starts with a Classification of hip prostheses. Next, knee prosthesis will be assessed. The Board of the NOV appointed a Task Force that was requested to perform this procedure.

2 The Task Force consists of the following persons: Dr. Bom (chair), Dr. Brouwer, Dr. Goosen, van Hellemondt, Prof. dr. Nelissen, Dr. Poolman, Dr. Schreurs 1. In 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 United Kingdom. It was decided to classify hip prostheses in three groups (1A, 1B and 2). General procedure 1. In January 2015, a new NOV advise (benchmark) is established. Every year, the NOV advise will be published 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 was requested with regard to: a. Products that are no longer manufactured or marketed, so these could be removed from the list.

3 B. Additional information which could only be substantiated in accordance with the stipulated criteria 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 be carried out once a year (reference date December 1). The NOV is open to additions to and remarks about the first Classification . It is deemed obvious that cups or stems that now satisfy NOV 1B requirements may move up to category 1A in future. There is no reason to dissuade from the use of implants 1A and 1B. It is also clear that innovations (NOV 2) must still be possible subject to properly defined criteria.

4 The adopted system offers excellent opportunities to inform patients about the type of prosthesis to be used and the current Classification of the relevant prosthesis. The requirements and Classification may change and gather weight after annual review; even more so, when 2. our national prosthesis registration system (LROI) will yield reliable Dutch data over the next years. 1. 2. Netherlands Orthopaedic Association (NOV). Bruistensingel 216, 5232 AD 's Hertogenbosch, E: W: NOV 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 reason endpoint. Revision is defined as every re-operation of parts of the prosthesis. The classified implant must have a minimum follow-up of 10 years of at least 500 implants or an ODEP-rating ( Orthopaedic Data Evaluation 3.)

5 Panel) 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 reason endpoint. Revision is defined as every re-operation of parts of the prosthesis. The classified implant must have a minimum follow-up of 5 years of at least 500 implants or an ODEP-rating ( Orthopaedic Data Evaluation 4. Panel) of 5A, 5A*, 7A or 7A*. NOV 2: New implants 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.

6 Australian National Joint Replacement Registry 3. National Joint Registry for England, Wales and N. Ireland 4. Danish Hip Arthroplasty Register 5. ODEP Orthopaedic Data Evaluation Panel, Changes made compared to Classification list 2015. Cemented cup Prosthesis Change New Classification Corin - Cenator 1B to 1A 1A. JRI Muller type 1B to 1A 1A. ZimmerBiomet - Apollo 1B to 1A 1A. ZimmerBiomet - CMK 1B to 1A 1A. Uncemented cup Prosthesis Change New Classification Lima Delta TT New 1B. Mathys RM TiCP coated cup Change in name (RM Classic cup) 1A. ZimmerBiomet - Continuum New 1B. 3. 4. Netherlands Orthopaedic Association (NOV). Bruistensingel 216, 5232 AD 's Hertogenbosch, E: W: Cemented stem Prosthesis Change New Classification JRI Furlong modular 1B to 1A 1A. ZimmerBiomet CMK Modular 1B to 1A 1A.

7 ZimmerBiomet CMK Monobloc New 1B. Uncemented stem Prosthesis Change New Classification Lima C2 stem New 1B. Mathys CBC stem New 1B. Medacta Quadra H New 1B. Netherlands Orthopaedic Association (NOV). Bruistensingel 216, 5232 AD 's Hertogenbosch, E: W: NOV 1A 10 year results 01-01-2016. Cemented cups Cemented stems Manifacturer Design Manifacturer Design Corin Cenator Corin TaperFit DePuy Charnley Elite DePuy Charnley LF monobloc DePuy Charnley standard DePuy Charnley flanged/modular DePuy Charnley Ogee DePuy Charnley Elite Plus JRI Muller type DePuy C-stem Link FAL JRI Furlong modular Link Interplanta Link SP II. Mathys CCB Low Profile Mathys CCA Muller straight stem Smith & Nephew All Poly Reflection Smith & Nephew Spectron EF. Stryker Exeter / Exeter Duration Smith & Nephew CPCS.

8 Stryker Contemporary Stryker Exeter ZimmerBiomet Apollo Stryker Omnifit cemented ZimmerBiomet CMK ZimmerBiomet Bimetric (Ti) cemented ZimmerBiomet M ller ZimmerBiomet CMK Modular ZimmerBiomet M ller Low Profile ZimmerBiomet CPT. ZimmerBiomet SHP ZimmerBiomet ME M ller straight stem ZimmerBiomet Stanmore ZimmerBiomet MS 30. ZimmerBiomet ZCA ZimmerBiomet Stanmore NOV 1A 10 year results 01-01-2016. Uncemented Uncemented stems cups Manifacturer Design Manifacturer Design Amplitude Saturne Dual mobility BBraun Bi-Contact BBraun Plasmacup SC DePuy AML. DePuy Duraloc DePuy Corail / Corail AMT. DePuy Pinnacle DePuy S-ROM. JRI Furlong CSF DePuy Summit Tapered JRI Furlong Threated JRI Furlong HAC. Mathys RM TiCP coated cup JRI Furlong HAC Active Smith & Nephew Bicon Plus Smith & Nephew SL Plus Smith & Nephew Reflection Smith & Nephew Synergy Stryker ABG II Stryker ABG II HA.

9 Stryker Trident Stryker Accolade Zimmer biomet Allofit / Allofit S Stryker Omnifit HA. ZimmerBiomet CSF Alloclassic Stryker Secur-Fit / Secur-Fit Plus ZimmerBiomet CLS Spotorno ZimmerBiomet Bimetric ZimmerBiomet Fitmore ZimmerBiomet CLS Spotorno ZimmerBiomet Mallory Head ZimmerBiomet Mallory Head Netherlands Orthopaedic Association (NOV). Bruistensingel 216, 5232 AD 's Hertogenbosch, E: W: NOV 1A 10 year results 01-01-2016. Uncemented Uncemented stems cups Manifacturer Design Manifacturer Design ZimmerBiomet Ranawat Burstein Vervolg ZimmerBiomet Universal ZimmerBiomet SL Alloclassic ZimmerBiomet Trilogy / Trilogy HA ZimmerBiomet taperloc / taperloc complete ZimmerBiomet Versys NOV 1B 5 year results 01-01-2016. Cemented cups Cemented stems Manifacturer Design Manifacturer Design Amplitude Saturne Dual Mobility DePuy C-stem AMT.

10 DePuy Marathon ZimmerBiomet BiMetric CoCr ZimmerBiomet Avantage ZimmerBiomet CMK Monobloc ZimmerBiomet MS M ller ZimmerBiomet Olympia ZimmerBiomet taperloc cemented NOV 1B 5 year results 01-01-2016. Uncemented Uncemented stems cups Manifacturer Design Manifacturer Design Adler Fixa Ti-Por BBraun Excia Lima Delta PF Lima C2 stem Lima Delta TT Mathys CBC stem Mathys RM Pressfit cup Mathys Twinsys cementless Medacta Versafit Medacta Quadra H. SERF Novae Evolution Smith & Nephew Anthology SERF Novae Sunfit Smith & Nephew Polar stem Smith & Nephew EP-Fit Plus Stryker Symax Smith & Nephew Polar Dual Mobility Wright Medical Anca Fit Smith & Nephew R3 Wright Medical Profemur E / E plus Stryker ABG II ceramic Wright Medical Profemur L. Stryker Trident Ceramic ZimmerBiomet M/L Taper ZimmerBiomet Continuum ZimmerBiomet taperloc Microplasty ZimmerBiomet Exceed ABT.