Scoliosis, Spinal Fusion, Spinal Stenosis, Spondylolisthesis
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
Healthy volunteers
Yes
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.
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