NCT03391024

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 24, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

December 18, 2017

Completed
18 days until next milestone

First Posted

Study publicly available on registry

January 5, 2018

Completed
Last Updated

January 5, 2018

Status Verified

December 1, 2017

Enrollment Period

1.9 years

First QC Date

December 18, 2017

Last Update Submit

December 28, 2017

Conditions

Computer-assisted Surgery

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

BBL Experimental Navigation System

EXPERIMENTAL

As this is a single arm trial, all participants receive treatment.

Device: BBL Experimental Navigation System

Interventions

BBL Experimental Navigation SystemDEVICE

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

BBL Experimental Navigation System

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Related Publications (3)

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

    BACKGROUND

  • 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. doi: 10.1097/00007632-200102150-00010.

    PMID: 11224881BACKGROUND

  • 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

    BACKGROUND

Study Officials

  • Victor XD Yang, MD, PhD

    Sunnybrook Health Sciences Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Scientist, Physical Sciences Platform

Study Record Dates

First Submitted

December 18, 2017

First Posted

January 5, 2018

Study Start

September 24, 2013

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

January 5, 2018

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)