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Clinical testing of an alternate method of inserting bone-implanted fiducial markers

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Abstract

Background

   Deep brain stimulation (DBS) surgery utilizes image guidance via bone-implanted fiducial markers to achieve the desired submillimetric accuracy and to provide means for attaching microstereotactic frames. For maximal benefit, the markers must be inserted to the correct depth since over-insertion leads to stripping and under-insertion leads to instability.

Purpose

   The purpose of the study was to test clinically a depth-release drive system, the PosiSeat\(^{\mathrm{TM}}\), versus manual insertion (pilot hole followed by manual screwing until tactile determined correct seating) for implanting fiducial markers into the bone.

Methods

   With institutional review board approval, the PosiSeat\(^{\mathrm{TM}}\) was used to implant markers in 15 DBS patients (57 fiducials). On post-insertion CT scans, the depth of the gap between the shoulder of the fiducial markers and the closest bone surface was measured. Similar depth measurements were performed on the CT scans of 64 DBS patients (250 fiducials), who underwent manual fiducial insertion.

Results

   Median of shoulder-to-bone distance for PosiSeat\(^{\mathrm{TM}}\) and manual insertion group were 0.03 and 1.06 mm, respectively. Fifty percent of the fiducials had the shoulder-to-bone distances within 0.01–0.09 mm range for the PosiSeat group and 0.04–1.45 mm range for the manual insertion group. These differences were statistically significant.

Conclusions

   A depth-release drive system achieves more consistent placement of bone-implanted fiducial markers than manual insertion.

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Acknowledgments

The project described was supported by Award Numbers R01DC008408 from the National Institute on Deafness and Other Communication Disorders. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institute on Deafness and Other Communication Disorders or the National Institutes of Health. Human subjects participation statements All procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1975, as revised in 2008 (5). Informed consent was obtained from all patients for being included in the study.

Conflict of interest

Balachandran, Fritz, Dietrich, Danilchenko, Oldfield, Lipscomb, Neimat, Konrad: No conflict of interest. Mitchell, Fitzpatrick, Labadie: Invented the insertion device that has been licensed to a commercial entity. No payment has been received nor is expected to be received due to the small clinical volume and non-disposable nature of the tool. The licensing agreement is in place to make the device available, from an FDA regulatory standpoint, for routine clinical use.

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Authors and Affiliations

  1. Department of Otolaryngology, Vanderbilt University Medical Center, 1215 21st Avenue South, MCE 7209, South Tower, Nashville, TN , 37232, USA

    Ramya Balachandran, Wendy W. Lipscomb & Robert F. Labadie

  2. Department of Otolaryngology, New York University School of Medicine, New York, NY, USA

    Mark A. Fritz

  3. Schools of Medicine & Nursing, Vanderbilt University, Nashville, TN, USA

    Mary S. Dietrich

  4. MAKO Surgical Corp., Fort Lauderdale, FL, USA

    Andrei Danilchenko

  5. Department of Mechanical Engineering, Vanderbilt University, Nashville, TN, USA

    Jason E. Mitchell

  6. Department of Neurosurgery, Vanderbilt University, Nashville, TN, USA

    Veronica L. Oldfield, Joseph S. Neimat & Peter E. Konrad

  7. Department of Electrical Engineering and Computer Science, Vanderbilt University, Nashville, TN, USA

    J. Michael Fitzpatrick

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  1. Ramya Balachandran
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  2. Mark A. Fritz
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  5. Jason E. Mitchell
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  7. Wendy W. Lipscomb
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  8. J. Michael Fitzpatrick
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  9. Joseph S. Neimat
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  11. Robert F. Labadie
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Correspondence to Ramya Balachandran.

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Balachandran, R., Fritz, M.A., Dietrich, M.S. et al. Clinical testing of an alternate method of inserting bone-implanted fiducial markers. Int J CARS 9, 913–920 (2014). https://doi.org/10.1007/s11548-014-0980-5

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  • DOI: https://doi.org/10.1007/s11548-014-0980-5

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