A review and summary of the National Institute for Health and Care Excellence early value assessment of robotic-assisted surgery for orthopaedic procedures

Robotic-assisted systems are being increasingly integrated into orthopaedic surgery, offering potential improvements in precision, reproducibility, and patient-reported outcome measures (PROMs) for unicompartmental knee arthroplasty (UKA), total knee arthroplasty (TKA), and total hip arthroplasty (THA). A review and summary of the early value assessment (EVA) undertaken by the National Institute for Health and Care Excellence (NICE) to evaluate the clinical effectiveness, cost-effectiveness, and implementation considerations of these technologies is presented. The EVA includes a review of the literature, an evidence gap analysis, and an evidence generation plan. Evidence from 28 studies and two registries suggested that robotic-assisted surgery was noninferior to conventional approaches in key outcomes, including PROMs, complications, hospital stay, and revisions, but it was associated with enhanced implant alignment. Short-term PROMs showed modest improvements, although most differences fell below currently defined clinically meaningful thresholds. Revision data were limited in follow-up, and ergonomic benefits for surgeons were uncertain. Economic evaluations suggested potential cost-effectiveness, particularly for THA, but assumptions regarding utilities, resource use, procedure volume, and implant costs introduced substantial uncertainty. The EVA highlighted the importance of training, equitable access, and national coordination for implementation. Evidence gaps were identified in long-term revision rates, health-related quality of life outcomes, productivity, sub-group effects, surgical team benefits, and learning curves. NICE recommended conditional adoption of six robotic platforms (ApolloKnee (Corin, UK), CORI (Smith & Nephew, UK), Mako (Stryker, USA), ROSA (Zimmer Biomet, USA), SkyWalker (MicroPort, China), and VELYS (DePuy Synthes, USA)) over a three-year evidence generation period, requiring annual reporting and adherence to regulatory standards. While robotic-assisted arthroplasty offers technical advantages, definitive clinical and economic benefits remain unproven. Surgeons, healthcare systems, and industry partners will need to work collaboratively to provide the required evidence in the next three years. A UK robotic registry could help address the evidence gaps more rapidly than individual centres by capturing large-scale national data.