Robotic arm assisted surgery in orthopaedics: A Health Technology Assessment evaluation in Liguria Region

Background: Robotic surgery is a mini-invasive technique that involves the execution of interventions with collaborative robots. Among them, the MAKO system is a high-tech robotic platform for prosthetic surgery in orthopaedics. Liguria faces the problem of the balance between demand and offer of arthroplasty due to the high presence of the elderly concerning its demographic configuration. The high passive mobility due to the interventions of orthopaedic prostheses and the presence on Ligurian soil (Local Health Unit 5, LHU5) of a robotic system for the prosthetic implant, suggest to perform an assessment of the assistant consequences, economic, social and ethical caused by the adoption of MAKO technology with an HTA approach.Methods: We conducted a comprehensive review of the scientific literature to find evidence on the benefit of MAKO robotic-arm assisted surgery for partial (UKA) or total (TKA) knee arthroplasty. Data on the number of admissions for UKA and TKA interventions and the hospital stay average in Liguria was extracted from the regional database.Results: The literature search identified 14 papers. Most of them were not considered with proper evidence because not being peer-reviews published in an indexed journal, studies conducted on cadavers, limited to the operative phase and lacking clinical outcomes, non-experimental studies, studies without comparators or with inadequate comparators. Thus, we selected 3 studies. Focusing on the LHU5 data from the regional database, we observed an annual increase of about 90% in hospitalizations and an average decrease of 3-day hospitalization days.Conclusions: The type of studies and the evidence available are rather thin and not consolidated either from clinical effectiveness or safety or cost-effectiveness. It is not possible today to estimate adequately how and how much these costs will be translated into practical clinical benefits and possible economic savings. Therefore, it is believed that the adoption of this technology should exclusively take place in the context of a research activity aimed at defining all the possible dimensions of the technology (safety-efficacy-cost/effectiveness).