Clinical trial NCT05195580: Spine Registration Using 3D Scanning
Official title: Pre-pilot Study of Spine Registration Using 3D Scanning
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Spinal Fusion
Spinal Stenosis
Scoliosis
Spondylolisthesis
Lead sponsor: Advanced Scanners Inc.
Sponsor class: INDUSTRY
First posted: 2022-01-19
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be invited to participate from the Principal Investigator's clinic population. All subjects will be identified as requiring a spine surgery that meets the eligibility requirements.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Spine Registration
timeFrame: Throughout the surgical procedure
Secondary outcomes:
measure: Vertebral Shift Measurement
timeFrame: Throughout the surgical procedure
measure: Determination Of Bony Exposure Requirements
timeFrame: Throughout the surgical procedure
Other outcomes:
Locations:
city: Round Rock
country: United States
facility: St. David's Round Rock Medical Center
state: Texas
Study officials:
affiliation: Advanced Scanners Inc.
name: Aaron Bernstein, PhD
role: STUDY_DIRECTOR
References:
citation: Arlt F, Chalopin C, Muns 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.
citation: Daanen, H. A. M. & Ter Haar, F. B. 3D whole body scanners revisited. Displays 34, 270-275 (2013).
citation: 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.
citation: Kovacs L, Zimmermann A, Brockmann G, Guhring 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. doi: 10.1016/j.bjps.2005.10.025. Epub 2006 Mar 9.
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. doi: 10.1016/j.forsciint.2005.10.007. Epub 2005 Nov 9.
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).