Efficacy and safety of robotic spinal surgery evaluated in Spain

In February 2021, the Health Technology Assessment Agency of the Health Institute Carlos III published the report for the efficacy and safety of robotic spinal surgery versus manual surgery in spinal fusion. Although the report in PDF document format dates to 2020, it was published on the website only in February 2021.

A systematic review of the scientific literature has been conducted. The identification of studies was made by searching specific databases. The search strategy was adapted to each database using controlled language and free search, combining the terms with boolean operators.

The following conclusions were provided:

• Regarding the efficacy, studies evaluate accuracy in pedicle screws placement as a fundamental outcome variable no significant differences in accuracy between the manual surgery and robotic surgery group

• In relation to other variables related to screw placement, such as the distance of the screw from the facet joint, screw deviation, or invasion of the joint surface, the data was scarce, and the way in which the data was collected differs from one study to another so that a proper assessment of the results was not possible
• The studies showed that the cumulative dose of fluoroscopy required for screw insertion was higher in the manual surgery group than in the robotic surgery group. However, the units of measurement were different, and the information is limited, so the results should be interpreted with caution. On the other hand, information about the time of fluoroscopy and the type of intervention is limited
• In terms of the time related to the surgical intervention, such as the time of fluoroscopy, time of pedicle screw placement, or hospital stay, the results did not favor one or the other type of intervention. Only the operating time seems to be shorter in the manual surgery group than in the robotic surgery group. However, the information is limited, so again, the results should be interpreted with caution
• In terms of safety outcomes, the studies mainly analyze the number of surgical revisions performed to assess the adequate placement of the screws, with no clear results in favor of manual surgery or robotic surgery. No information on other side effects, complications, or cases of death was found
• In relation to economic aspects, there were no costs or cost-effectiveness studies of robotic surgery, nor any studies analyzing organizational, ethical, legal, or implementation aspects. Given that the cost of acquisition and maintenance of the robot is high, it is worth considering extending its use to other surgical procedures
• The review has some limitations. There was heterogeneity in the studies regarding patients operated on, in the type and use of the robot, as well as the outcome measures. The data collected were scarce, so it was not possible to adequately assess the results. In addition, the risk of bias was difficult to assess in most studies, and few clinical variables were analyzed
• Eventually, it was mentioned that it essential to carry out further studies with an adequate selection of patients, type of robot, and comparator

The full details in Spanish can be found here.

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