Non-contact Intraoperative Optical Imaging During Neurosurgical Procedures

Not Applicable

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

• Registration Number: NCT03391011
• 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. The clinical need for spinal surgery is compounded by current and continuing demographic trends. As the general population continues to age, the number of orthopaedic surgical interventions is expected to rise drastically. Therefore, a significant opportunity exists for the implementation of surgical guidance technologies, for orthopaedic procedures, to combat this overwhelming health care burden.

Detailed Description

The hypothesis is that optical visualization of surgically exposed anatomy with the Biophotonics and Bioengineering Lab (BBL) surgical navigation prototype, when registered with pre-operative imaging (CT or MRI), can accurately estimate subsurface anatomy and allow tracking the position of surgical instruments in real-time, using an intraoperative non-contact optical imaging system during spinal surgical procedures.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2015-03-13
• Study First Submitted: 2017-12-18
• Study First Submitted QC: 2017-12-28
• Study First Posted: 2018-01-05
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-04
• Last Update Posted: 2018-09-05
• Primary Completion: 2019-03-13
• Study Completion: 2019-03-13

Recruitment & Eligibility

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

Inclusion Criteria

• Greater than 18 years of age, able to provide consent, or has substitute decision maker available to consent.
• 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.

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Exclusion Criteria

• Previous spinal decompression with significant laminectomy performed at the level intended for instrumentation.
• Previous spinal instrumentation with significant metallic artefact on pre-operative CT scan

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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.