Optical 3D Scanner: An optical 3D scanner used to register spine anatomy to surgical computer navigation systems.
Study 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
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
Accepted
Inclusion Criteria:
1. Patients that require exposure of posterior bony anatomy for visualization as standard of care.
2. 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.
3. Clinically planned for spine surgery.
4. Able to provide written informed consent from subject, using IRB approved consent form and agrees to comply with protocol requirements.
5. 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:
1. Language problems that would prevent from properly understanding instructions in any language.
2. Patients less than 18 years of age or older than 80 years of age
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.
7. Patients considered high risk for anesthesia, as determined by operative surgeon
Primary outcome measure(s)
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.
Trial sites (1)
Facility
City
Region
Status
Mass General Bringham, Hale Building for Transformative Medicine
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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