Non-Contact Intraoperative Optical Imaging During Instrumentation Procedure

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.

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Key information

Conditions

Computer-assisted Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BBL Experimental Navigation System

Device

Comparison of accuracy of screw placement using experimental system while navigated with clinically approved system.

Primary outcomes

Pilot hole and screw trajectory accuracy as compared between post-operative CT and intraoperative images

Time frame: Within 1 week of screw placement

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.

Sponsors and collaborators

Lead sponsor

Sunnybrook Health Sciences Centre

Other

Registry information

Important dates

Study start: 2013
Primary completion: 2015
Study completion: 2015
First posted: Jan 5, 2018
Registry last updated: Jan 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed