Clinical testing of an alternate method of inserti

Authors: Ramya Balachandran Mark A Fritz Mary S Dietrich Andrei Danilchenko Jason E Mitchell Veronica L Oldfield Wendy W Lipscomb J Michael Fitzpatrick Joseph S Neimat Peter E Konrad Robert F Labadie

Publish Date: 2014/02/04

Volume: 9, Issue: 5, Pages: 913-920

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Abstract

   Deep brain stimulation DBS surgery utilizes image guidance via boneimplanted 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 overinsertion leads to stripping and underinsertion leads to instability   The purpose of the study was to test clinically a depthrelease drive system the PosiSeatmathrmTM versus manual insertion pilot hole followed by manual screwing until tactile determined correct seating for implanting fiducial markers into the bone   With institutional review board approval the PosiSeatmathrmTM was used to implant markers in 15 DBS patients 57 fiducials On postinsertion 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   Median of shouldertobone distance for PosiSeatmathrmTM and manual insertion group were 003 and 106 mm respectively Fifty percent of the fiducials had the shouldertobone distances within 001–009 mm range for the PosiSeat group and 004–145 mm range for the manual insertion group These differences were statistically significantThe 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 studyBalachandran 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 nondisposable 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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