Non-Contact Intraoperative Optical Imaging During Instrumentation Procedure

Study Overview
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Brief Summary
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For a significant number of patients suffering from back pain, even basic daily activities become impossible. It is at this time that spinal surgery becomes necessary in order to improve the patient's quality of life. To combat these symptoms, surgical implants (e.g. pedicle screws, rods, etc.) are used to aid in stabilizing and correcting the deformities of the spine, particularly after spinal decompression. Surgical navigation has a great potential to improve the accuracy of correctly implanting these devices; however, present technologies rely on intraoperative imaging that uses ionizing radiation (e.g. computed tomography, fluoroscopy, etc.), require cumbersome set-ups, the physical attachment of fiducial markers, and cannot account for patient motion. Therefore, the investigators propose a real-time intraoperative optical topographical imaging based surgical guidance system capable of accurately guiding the placement of implanted devices such as pedicle screws.

Detailed Description
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The hypothesis is that optical visualization of surgically exposed bony anatomy with computerized navigation can accurately estimate subsurface anatomy and in the future, potentially guide the placement of pedicle screws during spinal surgery. The specific research aims are as follows: i) an intraoperative non-contact optical imaging system can quantify the entry point and trajectory of pedicle screws implanted by the spine surgeon; and ii) intraoperative optical imaging can predict the entry point and trajectory of pedicle screws as verified by post-operative computed tomography (CT) scans.

Official Title
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Non-Contact Intraoperative Optical Imaging During Instrumentation Procedure

Conditions
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Computer-assisted Surgery

Intervention / Treatment
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* Device: BBL Experimental Navigation System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Greater than 18 years of age Able to provide consent, or have substitute decision maker available FOR SPINAL INDICATIONS Scheduled to undergo spinal instrumentation surgery involving pedicle screw insertion Scheduled for pre-operative CT scan and the surgical plan includes open exposure of the posterior bony elements of one or more level(s) of the vertebra(e) No contra-indication for a post-operative CT scan FOR CRANIAL INDICATIONS scheduled to undergo cranial surgery Scheduled for pre-operative CT or MRI scan No contra-indication for post-operative CT scan Exclusion Criteria: Previous spinal decompression with significant laminectomy performed at the level intended for instrumentation Previous spinal decompression with laminoplasty performed at the level intended for instrumentation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BBL Experimental Navigation System<br>As this is a single arm trial, all participants receive treatment. | Device: BBL Experimental Navigation System<br>* Comparison of accuracy of screw placement using experimental system while navigated with clinically approved system.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pilot hole and screw trajectory accuracy as compared between post-operative CT and intraoperative images | Comparison and quantification of accuracy of pilot holes including entry point and trajectory as taken from experimental navigation system as compared to absolute (or actual) entry point and trajectory of screws as determined by post-operative computed tomography scans. | Within 1 week of screw placement |