Non-contact Intraoperative Optical Imaging During Spinal Procedures

NCT03391089 | Unknown

• 1 other identifier: 406-2015
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

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 System DEVICE

Comparison of accuracy of screw placement using experimental system.

BBL Experimental Navigation System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

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

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Related Publications (9)

• 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: 11224881 BACKGROUND

• 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.

  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.

  PMID: 23682345 BACKGROUND

• 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.

  PMID: 15654212 BACKGROUND

• 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. doi: 10.1016/j.otohns.2004.03.002.

  PMID: 15365528 BACKGROUND

• 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.

  PMID: 18981839 BACKGROUND

• 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.

  PMID: 25694911 BACKGROUND

• 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.

  PMID: 17224800 BACKGROUND

Study Officials

• Albert Yee, MD, MSc

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

• 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: January 21, 2016
• Primary Completion: January 21, 2019
• Study Completion: January 21, 2019
• Last Updated: January 5, 2018

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share