Decreased Robot-Related Complications Following the Development and Adoption of a Standardized Safety Protocol.

BACKGROUND

Robot-assisted spine surgery (RASS) enables precise pedicle screw insertion via pre-planned trajectories, and yet complications remain a notable concern. Prior work suggests that osseous pedicle wall breaches from instrumentation and ensuing complications related to robotic surgery may be from shifting of the reference frame or improper methodology. In this study, we hypothesized that the introduction of standardized institutional guidelines for RASS would reduce complications associated with robotic screw placement.

METHODS

This retrospective cohort study included patients who underwent RASS using 2 robotic systems at a single institution. We analyzed the cases of 264 patients in a historical cohort before, and 290 patients after, the implementation of a standardized institutional protocol developed to ensure safety with robotic placement of pedicle screws. The protocol provided surgeons with detailed guidelines for reference-frame placement, intraoperative screw trajectory and alignment checks, depth of drill insertion, verification of screw positioning, neuromonitoring for thoracic instrumentation, and postoperative imaging. Patient demographics, preoperative diagnoses, surgical characteristics, and complications were collected for all patients.

RESULTS

There was no difference between the pre-protocol and post-protocol groups with respect to patient demographics. In the pre-protocol cohort, 6 (2.3%) of the patients experienced robot-related complications, including nerve injury, durotomy, and malpositioned screws, with half of these complications attributed to reference-frame errors. Following the implementation of the protocol, no patient (0%) experienced a robot-related complication among 290 cases involving 2,030 screws placed with robotic assistance, representing a significant reduction (p = 0.01). The number of patients with open surgery (versus minimally invasive surgery) did not differ significantly between the pre-protocol (132 patients, 50%) and post-protocol (143 patients, 49.3%) groups. The mean number of instrumented levels per patient post-protocol was 3.3 ± 2.1. Non-robot-related complication rates were similar post-protocol (19.7%) versus pre-protocol (26.1%) (p > 0.05). Notably, post-protocol, there were no instances of a pedicle breach with neurostimulation or on postoperative imaging.

CONCLUSIONS

Following the implementation of standardized robotic surgery guidelines, no robot-related screw complications occurred in a post-protocol cohort of 290 patients. This study underscores the importance of protocol standardization, alongside technological advancements, in optimizing patient safety and improving outcomes in RASS. Well-designed institutional protocols may notably reduce robotic surgery complications and can be a valuable model for other institutions.

LEVEL OF EVIDENCE: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.