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Enrolling by invitation NCT06267248

Spine Registration Using 3D-Scanning

— Observational Spine Surgery

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Optical 3D Scanner.
Who it may be relevant to
Registry conditions: Spine Surgery. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Pre-pilot Study of Spine Registration Using 3D Scanning

Overview

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.

Interventions

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

Primary outcome measures

  • Spine Registration [Time frame: Throughout the surgical procedure]
Secondary outcome measures (2)
  • Vertebral Shift Measurement [Time frame: Throughout the surgical procedure]
  • Determination Of Bony Exposure Requirements [Time frame: Throughout the surgical procedure]

Eligibility criteria

Inclusion criteria

  • Patients that require exposure of posterior bony anatomy for visualization as standard of care.
  • Patients will have had a CT scan performed prior to the procedure as standard of care, or is expected to have a CT scan intraoperatively as standard of care.
  • Clinically planned for spine surgery.
  • Able to provide written informed consent from subject, using IRB approved consent form and agrees to comply with protocol requirements.
  • Patients who do not speak English will be allowed to participate, with the expectation that the site will provide interpreter services to help with the consent process.

Exclusion criteria

  • Language problems that would prevent from properly understanding instructions in any language.
  • Patients less than 18 years of age or older than 80 years of age
  • Patients who are excluded from consideration for the surgical procedure are therefore excluded from the research study.
  • Special populations: pregnant women, prisoners.
  • Minimally invasive spine surgery that does not expose the necessary bone/s.
  • Spine surgery without posterior exposure.
  • Patients considered high risk for anesthesia, as determined by operative surgeon

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Mass General Bringham, Hale Building for Transformative Medicine — Boston

Publications

  • 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. PMID 26883549
  • 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. PMID 26590631
  • 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. PMID 17046629
  • 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. PMID 16289612
  • 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).

Identifiers

NCT: NCT06267248 · T05100

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗