Abstract
Introduction
The implementation of 3D-navigation in the operating theater is reported to be complex, time consuming, and radiation intense. This prospective single-center cohort study was performed to objectify these assumptions by determining navigation-related learning curves in lumbar single-level posterior fusion procedures using 3D-fluoroscopy for real-time image-guided pedicle screw (PS) insertions.
Materials and methods
From August 2011 through July 2016, a total of 320 navigated PSs were inserted during 80 lumbar single-level posterior fusion procedures by a single surgeon without any prior experience in image-guided surgery. PS misplacements, navigation-related pre- and intraoperative time demand, and procedural 3D-radiation dose (dose-length-product, DLP) were prospectively recorded and congregated in 16 subgroups of five consecutive procedures to evaluate improving PS insertion accuracy, decreasing navigation-related time demand, and reduction of 3D-radiation dose.
Results
After PS insertion and intraoperative O-arm control scanning, 11 PS modifications were performed sporadically without showing “learning curve dependencies” (PS insertion accuracies in subgroups 96.6 ± 6.3%). Average navigation-related pre-surgical time from patient positioning on the operating table to skin incision decreased from 61 ± 6 min (subgroup 1) to 28 ± 2 min (subgroup 16, p < 0.00001). Average 3D-radiation dose per surgery declined from 919 ± 225 mGycm (subgroup 1) to 66 ± 4 mGycm (subgroup 16, p < 0.0001).
Conclusions
In newly inaugurated O-arm based image-guidance, lumbar PS insertions can be performed at constantly high accuracy, even without prior experience in navigated techniques. Navigation-related time demand decreases considerably due to accelerating workflow preceding skin incision. Procedural 3D-radiation dose is reducible to a fraction (13.2%) of a lumbar diagnostic non-contrast-enhanced computed tomography scan’s radiation dose.
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The author declares that he has no conflict of interest. The author declares that he has full control of all primary data and that he allows the journal to review his data if requested.
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All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. This article does not contain any studies with animals performed by any of the authors.
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Informed consent was obtained from all individual participants included in the study.
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The devices (O-arm, StealthStation S7) are FDA-approved or approved by corresponding national agency for this indication.
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Balling, H. Learning curve analysis of 3D-fluoroscopy image-guided pedicle screw insertions in lumbar single-level fusion procedures. Arch Orthop Trauma Surg 138, 1501–1509 (2018). https://doi.org/10.1007/s00402-018-2994-x
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DOI: https://doi.org/10.1007/s00402-018-2994-x