Non-contact Intraoperative Optical Imaging During Neurosurgical Procedures

Computer-assisted Surgery Clinical Trial

Official title:

Non-contact Intraoperative Optical Imaging During Neurosurgical Procedures

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03391011
• Other study ID #: 086-2015
• Status: Enrolling by invitation
• Phase: N/A
• Start date: March 13, 2015
• Est. completion date: March 13, 2019

Study information

• Verified date: September 2018
• 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. 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 40
• Est. completion date: March 13, 2019
• Est. primary completion date: March 13, 2019
• 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 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.

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

Related Conditions & MeSH terms

• Computer-assisted Surgery

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre

References & Publications (9)

Labadie RF, Davis BM, Fitzpatrick JM. Image-guided surgery: what is the accuracy? Curr Opin Otolaryngol Head Neck Surg. 2005 Feb;13(1):27-31. Review. — View Citation

Mathew JE, Mok K, Goulet B. Pedicle violation and Navigational errors in pedicle screw insertion using the intraoperative O-arm: A preliminary report. Int J Spine Surg. 2013 Dec 1;7:e88-94. doi: 10.1016/j.ijsp.2013.06.002. eCollection 2013. — View Citation

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

Pillai P, Sammet S, Ammirati M. Application accuracy of computed tomography-based, image-guided navigation of temporal bone. Neurosurgery. 2008 Oct;63(4 Suppl 2):326-32; discussion 332-3. doi: 10.1227/01.NEU.0000316429.19314.67. — View Citation

Rajasekaran S, Vidyadhara S, Ramesh P, Shetty AP. Randomized clinical study to compare the accuracy of navigated and non-navigated thoracic pedicle screws in deformity correction surgeries. Spine (Phila Pa 1976). 2007 Jan 15;32(2):E56-64. — View Citation

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

Snyderman C, Zimmer LA, Kassam A. Sources of registration error with image guidance systems during endoscopic anterior cranial base surgery. Otolaryngol Head Neck Surg. 2004 Sep;131(3):145-9. — View Citation

Waters JD, Gonda DD, Reddy H, Kasper EM, Warnke PC, Chen CC. Diagnostic yield of stereotactic needle-biopsies of sub-cubic centimeter intracranial lesions. Surg Neurol Int. 2013 Apr 17;4(Suppl 3):S176-81. doi: 10.4103/2152-7806.110677. Print 2013. — View Citation

Zdichaversusky 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