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hta_ knee intro.qxp - Ministero della Salute

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4. Objectives, policy and research questions<br />

The policy question of this HTA report was the following:<br />

Are the prostheses for total <strong>knee</strong> replacement (TKR) currently used clinical practice in Italy<br />

supported by sufficient evidence? Can performance of the devices be linked to their price?<br />

This policy question can be broken down into the following research questions:<br />

• Which prostheses for TKR are used in Italy?<br />

• What is the evidence of effectiveness and safety from the literature of TKR prostheses<br />

used in Italy?<br />

• What is the evidence of effectiveness from registers of TKR prostheses used in Italy?<br />

• What are the costs of each single prosthesis model?<br />

• What are the cost effectiveness indicators of the TKR prostheses used in Italy?<br />

The following main objectives were used to draft this report:<br />

• to identify and describe the TKR prostheses currently used in Italy (“context”);<br />

• to retrieve and assess the available evidence about effectiveness and safety of the<br />

prostheses for primary TKR used in Italy;<br />

• to collect TKR prostheses data on effectiveness and safety from arthroplasty registers;<br />

• to compare TKR prostheses performance from published studies with data from<br />

arthroplasty registers;<br />

• to carry out an economic analysis of the TKR prostheses prices in Italy;<br />

• to create a cost-effectiveness model for the evaluation of the TKR prostheses and<br />

their performance.<br />

9

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