Spine Surgery
Conditions
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.
Interventions
DEVICEOptical 3D Scanner
An optical 3D scanner used to register spine anatomy to surgical computer navigation systems.
Sponsors
Advanced Scanners Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed