Non-contact Intraoperative Optical Imaging During Neurosurgical Procedures
NCT ID: NCT03391011
Last Updated: 2018-09-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
40 participants
INTERVENTIONAL
2015-03-13
2019-03-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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BBL Experimental Navigation System
As this is a single arm trial, all participants receive treatment.
BBL Experimental Navigation System
Comparison of accuracy of screw placement using experimental system while monitored by clinically approved system.
Interventions
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BBL Experimental Navigation System
Comparison of accuracy of screw placement using experimental system while monitored by clinically approved system.
Eligibility Criteria
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Inclusion Criteria
* Scheduled to undergo spinal instrumentation surgery involving pedicle or lateral mass screw insertion.
* Scheduled for pre-operative CT scan and the surgical plan includes open exposure of the posterior bony elements of two or more level(s) of the vertebra(e).
* No contra-indication for a post-operative CT scan.
Exclusion Criteria
* Previous spinal instrumentation with significant metallic artefact on pre-operative CT scan
18 Years
ALL
No
Sponsors
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Sunnybrook Health Sciences Centre
OTHER
Responsible Party
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Dr. Victor Yang
Senior Scientist, Physical Sciences Platform
Principal Investigators
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Albert Yee, MD, MSc
Role: PRINCIPAL_INVESTIGATOR
Sunnybrook Health Sciences Centre
Victor XD Yang, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Sunnybrook Health Sciences Centre
References
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Merloz P, Tonetti J, Eld A, et al, Computer-assisted versus manual spine surgery: Clinical report, Springer Berlin, 1997.
Rampersaud YR, Simon DA, Foley KT. Accuracy requirements for image-guided spinal pedicle screw placement. Spine (Phila Pa 1976). 2001 Feb 15;26(4):352-9. doi: 10.1097/00007632-200102150-00010.
Zdichaversusky M, Blauth M, Knop C, Graessner M, Herrmann H, Krettek C, Bastian L, Accuracy of Pedicle Screw Placement in Thoracic Spine Fractures, European Journal of Trauma, 30:234-240, 2004
Waters JD, Gonda DD, Reddy H, Kasper EM, Warnke PC, Chen CC. Diagnostic yield of stereotactic needle-biopsies of sub-cubic centimeter intracranial lesions. Surg Neurol Int. 2013 Apr 17;4(Suppl 3):S176-81. doi: 10.4103/2152-7806.110677. Print 2013.
Labadie RF, Davis BM, Fitzpatrick JM. Image-guided surgery: what is the accuracy? Curr Opin Otolaryngol Head Neck Surg. 2005 Feb;13(1):27-31. doi: 10.1097/00020840-200502000-00008.
Snyderman C, Zimmer LA, Kassam A. Sources of registration error with image guidance systems during endoscopic anterior cranial base surgery. Otolaryngol Head Neck Surg. 2004 Sep;131(3):145-9. doi: 10.1016/j.otohns.2004.03.002.
Pillai P, Sammet S, Ammirati M. Application accuracy of computed tomography-based, image-guided navigation of temporal bone. Neurosurgery. 2008 Oct;63(4 Suppl 2):326-32; discussion 332-3. doi: 10.1227/01.NEU.0000316429.19314.67.
Mathew JE, Mok K, Goulet B. Pedicle violation and Navigational errors in pedicle screw insertion using the intraoperative O-arm: A preliminary report. Int J Spine Surg. 2013 Dec 1;7:e88-94. doi: 10.1016/j.ijsp.2013.06.002. eCollection 2013.
Rajasekaran S, Vidyadhara S, Ramesh P, Shetty AP. Randomized clinical study to compare the accuracy of navigated and non-navigated thoracic pedicle screws in deformity correction surgeries. Spine (Phila Pa 1976). 2007 Jan 15;32(2):E56-64. doi: 10.1097/01.brs.0000252094.64857.ab.
Other Identifiers
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086-2015
Identifier Type: -
Identifier Source: org_study_id
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