NCT03391024

Non-Contact Intraoperative Optical Imaging During Instrumentation Procedure

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Sunnybrook Health Sciences Centre · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Computer-assisted Surgery

Interventions

Type	Name	Description
DEVICE	BBL Experimental Navigation System	Comparison of accuracy of screw placement using experimental system while navigated with clinically approved system.

Timeline

• Start date: 2013-09-24
• Primary completion: 2015-08-01
• Completion: 2015-08-01
• First posted: 2018-01-05
• Last updated: 2018-01-05

Locations

1 site across 1 country: Canada