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  • Question on Consultation

    Has all of the relevant evidence been taken into account?

  • Question on Consultation

    Are the summaries of clinical and and cost effectiveness reasonable interpretations of the evidence?

  • Question on Consultation

    Are the recommendations sound and a suitable basis for guidance to the NHS?

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    Are there any equality issues that need special consideration and are not covered in the medical technology consultation document?

  • Question on Document

    Could the period while surgeons are learning to use the technologies have a significant impact on the clinical and cost-effectiveness of them?

Evidence generation plan

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1 Purpose of this document

NICE's early value assessment of robot-assisted surgery for orthopaedic procedures recommends that 5 technologies can be used in the NHS for knee or hip replacements during the evidence generation period. The technologies are:

  • ApolloKnee System

  • CORI Surgical System

  • Mako SmartRobotics

  • ROSA Knee Solution

  • VELYS Robotic-Assisted Solution.

SkyWalker, the other technology that was assessed, can only be used in research and is not covered in this plan.

This plan outlines the evidence gaps and what real-world data needs to be collected for a NICE review of the technologies again in the future. It is not a study protocol but suggests an approach to generating the information needed to address the evidence gaps. For assessing comparative treatment effects, well-conducted randomised controlled trials are the preferred source of evidence if these are able to address the research gap.

The companies are responsible for ensuring that data collection and analysis takes place.

Guidance on commissioning and procurement of the technologies will be provided by NHS England.

NICE will withdraw the guidance if the companies do not meet the conditions in section 4 on monitoring.

After the end of the evidence generation period (2 years), the companies should submit the evidence to NICE in a form that can be used for decision making. NICE will review all the evidence and assess whether the technologies can be routinely adopted in the NHS.