hta_ knee intro.qxp - Ministero della Salute

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Editing and layout Dario Fella Agenas, Agenzia nazionale per i servizi sanitari regionali Acknowledgements The Authors and Agenas would like to thank all the centres (clinical research institutes, private accredited providers, and public health services; see Appendix 4) who contributed to this HTA report by participating to the survey. The Authors would like to thank Barbara Bordini and Susanna Stea (from RIPO - Laboratorio di Tecnologia Medica, Istituto Ortopedico Rizzoli) who shared the Registry data with us, Ann Tomkins from the Australian Orthopaedic Association National Joint Replacement Registry for her help and collaboration and Nicola Barni (from Johnson & Johnson Medical), Brighitte Casteels- Rappagliosi (from Stryker), Mauro Nitto (from Medacta), and Claudio Manidi (from Biomet) who reviewed the first draft of the report. The Authors also thank Davide Perego from the association of producers and distributors of medical devices (ASSOBIOMEDICA).
HTA REPORT Prostheses for primary total knee replacement in Italy Foreword . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .VIII Prefazione . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .IX Executive summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .XI Sintesi . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .XIII 1. Background . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1 1.1 Total knee replacement: indications and clinical problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1 1.2 Epidemiological data and population . . . . . . . . . . . . . . . . . . . . . . . . . .1 2. Technology, procedure and alternatives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5 2.1 The technology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5 2.2 The procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6 2.3 The alternatives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6 3. The marketing status of knee prostheses and current reimbursement arrangements in Italy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7 4. Report's objectives: policy and research questions . . . . . . . . . . . . . . . . . .9 5.Context - specific analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11 5.1 Methods for contextual analysis: national survey . . . . . . . . . . .11 V
Page 1 and 2: HTA REPORT Prostheses for primary t
Page 3: Contributions Authors Marina Cerbo,
Page 7 and 8: 10. Recommendations . . . . . . . .
Page 9: Prefazione Quest’anno l’Agenas
Page 12 and 13: XII Results Literature in this fiel
Page 14 and 15: XIV Obiettivi del report L’interv
Page 16 and 17: XVI formati e delle variabili racco
Page 18 and 19: 2 The procedures were identified ac
Page 21 and 22: 2. Technology, procedure and altern
Page 23: 3. The marketing status of knee pro
Page 27 and 28: 5. Context-specific analysis Contex
Page 29 and 30: Figure 5.1: Type of centres in the
Page 31 and 32: Figure 5.2: Percentage of respondin
Page 33 and 34: Table 5.3: Volume of purchased pros
Page 35 and 36: 5.2.5 Analysis on purchasing price
Page 37: Table 5.6: Distribution of mean wei
Page 40 and 41: 24 6.1.3 Evidence synthesis After t
Page 42 and 43: 26 Survival rate as “revision for
Page 44: 28 Table 6.1: Evidence table for si
Page 49 and 50: 7. Assessing the evidence from arth
Page 51 and 52: Only four reports out of the 9 repo
Page 53 and 54: Table 7.3: Variables used in each r
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Table 7.4: Replies from the key-per
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Table 7.6: Data from the Australian
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Table 7.8: Data from Registro dell
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Table 7.11: Data from the Australia
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Table 7.15: Data from Registro dell
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Table 7.18: Revision rates of uncem
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52 We calculated ICERs only for cla
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54 Figure 8.1 shows prostheses ICER
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56 Table 8.3: ICER (AOAJRR data) fo
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58 8.4 Conclusions Regardless of wh
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60 The gross heterogeneity of repor
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10. Recommendations We recommend th
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12. Competing interests declaration
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70 22. http://www.agenas.it/monitor
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72 • a tibial component: a metall
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74 Retention or sacrifice of the po
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76 Figure A1.2: Examples of femoral
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78 Suggested readings Bronzino JD.
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Appendix 2 Survey of Medical device
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Appendix 3 Sampling methodology The
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Table A2.2: Sample and total centre
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92 Veneto: 050017 Ospedale Sacro Cu
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94 Basilicata: 170011 Presidio Ospe
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Appendix 6 Search strategy The sear
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#50. (hls AND noetos) AND tornier A
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#108. (prime) AND (exatech) AND pri
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#166. (vanguard AND ps) AND ('biome
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Select 6 document(s) Search ("1998-
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Search ("1998-01-01"[Publication Da
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Appendix 7 Data extraction form for
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Common characteristics: Manufacture
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Conclusions: Assessment of generali
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Appendix 8 Data extraction form for
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Appendix 9 Quality assessment tool
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Appendix 10 List of excluded studie
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Studies excluded for short follow-u
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Robinson RP. Five-year follow-up of
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Regnér L, Carlsson L, Kärrholm J,
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Appendix 11 List of included studie
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Acronyms and abbreviations Agenas A
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