Spine Registration Using 3D Scanning

Scoliosis Clinical Trial

Official title:

Pre-pilot Study of Spine Registration Using 3D Scanning

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05195580
• Other study ID #: 01500
• Status: Recruiting
• Start date: August 31, 2021
• Est. completion date: August 31, 2022

Study information

• Verified date: October 2021
• Source: Advanced Scanners Inc.
• Contact: Carl Lauryssen, MD
• Phone: (512) 730-0000
• Email: carl.lauryssen[@]hcahealthcare.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The primary objective is to assess the capability of the device as measured by its consistency, its accuracy, and feedback from surgical staff over the study period.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: August 31, 2022
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Patients that require exposure of bony posterior spine anatomy for localization as standard of care.

2. Clinically planned for spine surgery.

3. Able to provide written informed consent from subject or subject's legal representative, using IRB approved consent form, and ability for subject to comply with the protocol requirements of the study.

Exclusion Criteria:

1. Language problems that would prevent from properly understanding instructions.

2. Requirement of an interpreter.

3. Patients who are excluded from consideration for the surgical procedure are therefore excluded from the research study.

4. Special populations: pregnant women, prisoners.

5. Minimally invasive spine surgery that does not expose the necessary bone/s.

6. Spine surgery without posterior exposure.

Related Conditions & MeSH terms

• Scoliosis
• Spinal Fusion
• Spinal Stenosis
• Spondylolisthesis

Intervention

Device:
• Optical 3D Scanner
An optical 3D scanner used to register spine anatomy to surgical computer navigation systems.

Locations

Country	Name	City	State
United States	St. David's Round Rock Medical Center	Round Rock	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Advanced Scanners Inc.

Country where clinical trial is conducted

United States, 

References & Publications (6)

Arlt F, Chalopin C, Müns A, Meixensberger J, Lindner D. Intraoperative 3D contrast-enhanced ultrasound (CEUS): a prospective study of 50 patients with brain tumours. Acta Neurochir (Wien). 2016 Apr;158(4):685-694. doi: 10.1007/s00701-016-2738-z. Epub 2016 Feb 16. — View Citation

Daanen, H. A. M. & Ter Haar, F. B. 3D whole body scanners revisited. Displays 34, 270-275 (2013).

Hameeteman M, Verhulst AC, Vreeken RD, Maal TJ, Ulrich DJ. 3D stereophotogrammetry in upper-extremity lymphedema: An accurate diagnostic method. J Plast Reconstr Aesthet Surg. 2016 Feb;69(2):241-7. doi: 10.1016/j.bjps.2015.10.011. Epub 2015 Oct 22. — View Citation

Kovacs L, Zimmermann A, Brockmann G, Gühring M, Baurecht H, Papadopulos NA, Schwenzer-Zimmerer K, Sader R, Biemer E, Zeilhofer HF. Three-dimensional recording of the human face with a 3D laser scanner. J Plast Reconstr Aesthet Surg. 2006;59(11):1193-202. Epub 2006 Mar 9. — View Citation

Park HK, Chung JW, Kho HS. Use of hand-held laser scanning in the assessment of craniometry. Forensic Sci Int. 2006 Jul 13;160(2-3):200-6. Epub 2005 Nov 9. — View Citation

Zhang, D., Lu, G., Li, W., Zhang, L. & Luo, N. Palmprint Recognition Using 3-D Information. IEEE Transactions on Systems, Man, and Cybernetics, Part C (Applications and Reviews) 39, 505-519 (2009).

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Spine Registration	Closely match the Advanced Scanners optical scan of the partially exposed surface of the patient vertebra to the corresponding patient's preoperative MRI and/or CT scan, thereby learning the position of the rest of the vertebra. This endpoint includes registration of the relevant preoperative MRI or CT scan portion to the portion scanned by Advanced Scanners.	Throughout the surgical procedure
Secondary	Vertebral Shift Measurement	Use the intraoperative x-ray (typically O-arm) measurements taken at various times in the procedure to validate the capability of our scanner to determine relative shifts between vertebra as a function of time.	Throughout the surgical procedure
Secondary	Determination Of Bony Exposure Requirements	Measure the area of the exposed vertebra of registered adjacent segments. Bone regions will be identified in the scan mesh, segmented from the rest of the scan, and their areas determined directly from that surface region by integrating the area of the relevant mesh faces, in units of square millimeters or square centimeters.	Throughout the surgical procedure