Non-Contact Intraoperative Optical Imaging During Instrumentation Procedure

Computer-assisted Surgery Clinical Trial

Official title:

Non-Contact Intraoperative Optical Imaging During Instrumentation Procedure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03391024
• Other study ID #: 177-2013
• Status: Completed
• Phase: N/A
• First received: December 18, 2017
• Last updated: December 28, 2017
• Start date: September 24, 2013
• Est. completion date: August 1, 2015

Study information

• Verified date: December 2017
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 1, 2015
• Est. primary completion date: August 1, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Computer-assisted Surgery

Intervention

Device:
• BBL Experimental Navigation System
Comparison of accuracy of screw placement using experimental system while navigated with clinically approved system.

Locations

Country	Name	City	State
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre

Country where clinical trial is conducted

Canada, 

References & Publications (3)

Merloz P, Tonetti J, Eld A, et al, Computer-assisted versus manual spine surgery: Clinical report, Springer Berlin, 1997.

Rampersaud YR, Simon DA, Foley KT. Accuracy requirements for image-guided spinal pedicle screw placement. Spine (Phila Pa 1976). 2001 Feb 15;26(4):352-9. — View Citation

Zdichavsky M, Blauth M, Knop C, Graessner M, Herrmann H, Krettek C, Bastian L, Accuracy of Pedicle Screw Placement in Thoracic Spine Fractures, European Journal of Trauma, 30:234-240, 2004

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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