Spine Registration Using 3D Scanning - Arise
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Outcome Measures
Primary Outcome Measures
- Spine Registration [Throughout the surgical procedure]
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.
Secondary Outcome Measures
- Vertebral Shift Measurement [Throughout the surgical procedure]
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.
- Determination Of Bony Exposure Requirements [Throughout the surgical procedure]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients that require exposure of bony posterior spine anatomy for localization as standard of care.
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Have had a CT scan performed prior to the procedure.
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Clinically planned for spine surgery.
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Able to provide written informed consent from subject, using IRB approved consent form, and agrees to comply with protocol requirements.
Exclusion Criteria:
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Language problems that would prevent from properly understanding instructions.
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Patients less than 18 years of age.
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Requirement of an interpreter.
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Patients who are excluded from consideration for the surgical procedure are therefore excluded from the research study.
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Special populations: pregnant women, prisoners.
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Minimally invasive spine surgery that does not expose the necessary bone/s.
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Spine surgery without posterior exposure.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Arise Austin Medical Center | Austin | Texas | United States | 78746 |
Sponsors and Collaborators
- Advanced Scanners Inc.
Investigators
- Study Director: Aaron Bernstein, PhD, Advanced Scanners Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- 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.
- 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).
- Spine - 001