Non-Contact Intraoperative Optical Imaging During Instrumentation Procedure

Not Applicable

Completed

• Conditions: Computer-assisted Surgery
• Interventions: Device: BBL Experimental Navigation System

• Registration Number: NCT03391024
• Lead Sponsor: Sunnybrook Health Sciences Centre

Brief 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-09-24
• Primary Completion: 2015-08-01
• Study Completion: 2015-08-01
• Status Verified: 2017-12
• Study First Submitted: 2017-12-18
• Study First Submitted QC: 2017-12-28
• Last Update Submitted: 2017-12-28
• Study First Posted: 2018-01-05
• Last Update Posted: 2018-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BBL Experimental Navigation System	BBL Experimental Navigation System	As this is a single arm trial, all participants receive treatment.

Primary Outcome Measures

Name	Time	Method
Pilot hole and screw trajectory accuracy as compared between post-operative CT and intraoperative images	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.

Trial Locations

Locations (1)

Sunnybrook Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada