Expanding implant options in robot-assisted thoracolumbar spine surgery through novel customized instrumentation

Document Type

Article

Publication Title

Journal of Orthopaedics

Abstract

Background: Robot-assisted pedicle screw placement demonstrates superior accuracy over conventional techniques, yet proprietary ecosystems limit implant compatibility and surgical choice. Can a custom screwdriver enable third-party instrumentation while maintaining navigational precision within the Mazor X Stealth Edition robotic system? Methods: This retrospective comparative single-center study analysed 100 consecutive patients undergoing robot-assisted thoracolumbar fusion using custom screwdriver instrumentation (July–December 2024) versus 100 historical controls using standard proprietary instrumentation (October 2023–June 2024). The custom screwdriver had shaft dimensions matched to the robotic arm guide and navigation tracker compatibility. Primary outcomes included pedicle screw placement accuracy using Gertzbein-Robbins classification and technical feasibility. Results: A total of 708 screws were placed in the custom screwdriver group versus 760 in controls. Clinically acceptable screw placement (Gertzbein-Robbins grades A&B) was achieved in 99.15 % (702/708) versus 99.07 % (753/760) respectively (difference: 0.08 %, 95 % CI: 1.14 %–1.30 %, p = 0.880). Non-inferiority was demonstrated with the lower confidence interval (−1.14 %) exceeding the predefined margin (−3 %). Technical feasibility was 100 % with no conversion required. Operative time (142.3 ± 38.5 vs 148.7 ± 40.2 min, p = 0.239), blood loss (537.2 ± 328.0 vs 550.0 ± 359.0 ml, p = 0.793), and per-screw placement time (6.2 ± 1.8 vs 6.4 ± 1.7 min, p = 0.426) were comparable. Implant costs were significantly lower in the custom screwdriver group (USD 559.50 ± 224.35 vs 1973.47 ± 934.80, p < 0.001). Conclusions: Custom instrument design successfully maintained surgical precision while enabling third-party implant integration within robotic spine surgery workflows. This approach demonstrates enhancement of robotic system modularity without compromising accuracy, safety, or operational efficiency. Clinical relevance: This innovation enables surgeons to select optimal implants based on clinical evidence rather than proprietary constraints, potentially improving patient outcomes while reducing healthcare costs through enhanced system flexibility. Level of evidence: III.

First Page

252

Last Page

257

DOI

10.1016/j.jor.2025.08.031

Publication Date

12-1-2025

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