Evidence generation plan for robot-assisted surgery for orthopaedic procedures
5 Minimum evidence standards
The committee heard that the robot-assisted surgery (RAS) technologies may improve patient outcomes and improve surgical efficiencies, although evidence for this is uncertain. All the technologies that have been recommended for use in the NHS during the evidence generation period have some implementation experience in the NHS. The companies did not report any safety concerns for using RAS for knee or hip replacements and this was supported by expert opinion and the identified evidence. The committee agreed and concluded that the safety of RAS for orthopaedic procedures should be monitored as per post-market surveillance.
The committee has indicated that it may in the future be able to recommend new technologies in this topic area if there is evidence on both:
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non-inferiority of the RAS technology compared with conventional surgery for orthopaedic procedures (for primary outcomes including length of hospital stay, complications, patient-reported outcome measures, utilities and revisions), and
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cost or time-savings resulting from resource use associated with the technologies.
Companies can strengthen the evidence base by also having qualitative evidence about healthcare professional opinion, procedure-related discomfort, and ergonomics of the RAS technology for the surgeon.
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