hta_ knee intro.qxp - Ministero della Salute

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VI 5.2 Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11 5.2.1 Description of sample . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11 5.2.2 Description of responding centres . . . . . . . . . . . . . . . . . . . . . .13 5.2.3 Number of procedures performed . . . . . . . . . . . . . . . . . . . . . . .15 5.2.4 Types of prostheses used . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15 5.2.5 Analysis on purchased price of knee prostheses . . . . . . .19 5.3 Stakeholder involvement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .21 6. Assessing the evidence from clinical studies Systematic review . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .23 6.1 Methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .23 6.1.1 Evidence searches . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .23 6.1.2 Inclusion criteria . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .23 6.1.3 Evidence Synthesis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .24 6.2 Assessment of outcome: effectiveness of knee prostheses . . . . . . . . . . . . . . . . . . . . . . . . . . . . .24 6.2.1 Effectiveness and safety of knee prostheses: definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .24 6.2.2 Literature results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .24 6.2.3 Description and quality assessment of included studies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .25 6.3 Results of the systematic review . . . . . . . . . . . . . . . . . . . . . . . . . . . . .26 7. Assessing the evidence from arthroplasty registers . . . . . . . . . . . . . . . .33 7.1 Introduction to arthroplasty registers . . . . . . . . . . . . . . . . . . . . . . . .33 7.2 Methods for the identification and analysis of the knee registers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .34 7.3 Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .34 7.3.1 Comparison of format and content . . . . . . . . . . . . . . . . . . . . .34 7.3.2 Implants performance from arthroplasty registers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .38 7.4 Final considerations on register data . . . . . . . . . . . . . . . . . . . . . . . . .47 8. Economic model and cost effectiveness analysis of knee prostheses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .51 8.1 Methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .51 8.2 Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .52 8.2.1 Results using RIPO data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .53 8.2.2 Results using AOAJRR data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .55 8.3 Conclusions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .58 9. Discussion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .59
10. Recommendations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .63 11. Funding . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .65 12. Competing interests declaration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .67 Bibliography . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .69 Appendices 1 - Technological characteristics of knee prostheses . . . . . . . . . . . . . .71 2 - Survey of the medical devices at 31st December 2007 . . . . . . .81 3 - Sampling methodology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .87 4 - List of responding centres . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .91 5 - List of manufacturers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .95 6 - Search strategy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .97 7 - Data extraction form for single studies . . . . . . . . . . . . . . . . . . . . . . .109 8 - Data extraction form for registry based studies . . . . . . . . . . . . . .115 9. - Quality assessment tool . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .117 10 - List of excluded studies with reasons for exclusion . . . . . . . . .119 11 - List of included studies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .127 Acronyms and abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .129 VII
Page 1 and 2: HTA REPORT Prostheses for primary t
Page 3 and 4: Contributions Authors Marina Cerbo,
Page 5: HTA REPORT Prostheses for primary t
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
Page 55 and 56: Table 7.4: Replies from the key-per
Page 57 and 58:
Table 7.6: Data from the Australian
Page 59 and 60:
Table 7.8: Data from Registro dell
Page 61 and 62:
Table 7.11: Data from the Australia
Page 63 and 64:
Table 7.15: Data from Registro dell
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Table 7.18: Revision rates of uncem
Page 68 and 69:
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.
Page 97 and 98:
Appendix 2 Survey of Medical device
Page 103 and 104:
Appendix 3 Sampling methodology The
Page 105:
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
Page 117 and 118:
#108. (prime) AND (exatech) AND pri
Page 119 and 120:
#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
Page 129 and 130:
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
Page 137 and 138:
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
Page 145 and 146:
Acronyms and abbreviations Agenas A
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hta_ knee intro.qxp - Ministero della Salute

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