Non-contact Intraoperative Optical Imaging During Spinal Procedures

NCT ID: NCT03391089

Last Updated: 2018-01-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-21
• Study Completion Date: 2019-01-21

Brief Summary

Current spine procedures can suffer from a variety of complications resulting in a high incidence (up to 55%) of misplaced screws and implants. This can lead to devastating clinical consequences, including neurologic and vascular injury, and extensive physical, mental, and economic damage. Surgical navigation has a great potential to reduce these risks through accurate guidance; however present technologies rely on intraoperative imaging that uses ionizing radiation (e.g. computed tomography, or fluoroscopy), which limits surgical anatomy registration updates to less than 3-4 time points during surgery. They also require cumbersome and lengthy set-up and registration of fiducial markers and have limited abilities to account for motion that occurs during surgery and patient positioning. 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 screws.

Detailed Description

The hypothesis is that optical visualization of surgically exposed anatomy with the Biophotonics and Bioengineering Laboratory (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. This is based on the completed preliminary study of 40 spinal procedures. The specific research aim is as follows: Validate the ability of the BBL surgical navigation prototype to function as the sole navigation system during spinal surgical procedures. The study will focus on testing the robustness of the system to appropriately function on a variety of spinal surgeries.

Conditions

Computer-assisted Surgery

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BBL Experimental Navigation System

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

Group Type: EXPERIMENTAL

BBL Experimental Navigation System

Intervention Type: DEVICE

Comparison of accuracy of screw placement using experimental system.

Interventions

BBL Experimental Navigation System

Comparison of accuracy of screw placement using experimental system.

Intervention Type: DEVICE

Eligibility Criteria

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 or brain tumor resection or biopsy.
• Scheduled for pre-operative CT/ MRI scan.
• No contra-indication for a post-operative CT/MRI 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sunnybrook Health Sciences Centre

OTHER

Sponsor Role: lead

Responsible Party

Dr. Victor Yang

Senior Scientist, Physical Sciences Platform

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Albert Yee, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Sunnybrook Health Sciences Centre

Victor XD Yang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Sunnybrook Health Sciences Centre

References

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

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 11224881 (View on PubMed)

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.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 23682345 (View on PubMed)

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. doi: 10.1097/00020840-200502000-00008.

Reference Type: BACKGROUND

PMID: 15654212 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 15365528 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18981839 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25694911 (View on PubMed)

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. doi: 10.1097/01.brs.0000252094.64857.ab.

Reference Type: BACKGROUND

PMID: 17224800 (View on PubMed)

Other Identifiers

406-2015

Identifier Type: -

Identifier Source: org_study_id