Spine Registration Using 3D Scanning - Arise

Study Overview
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Brief Summary
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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.

Official Title
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Pre-pilot Study of Spine Registration Using 3D Scanning

Conditions
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Spinal Fusion, Spondylolisthesis, Scoliosis, Sciatica

Intervention / Treatment
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* Device: Optical 3D Scanner


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients that require exposure of bony posterior spine anatomy for localization as standard of care. Have had a CT scan performed prior to the procedure. 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. Exclusion Criteria: Language problems that would prevent from properly understanding instructions. Patients less than 18 years of age. Requirement of an interpreter. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Optical 3D Scanner|An optical 3D scanner used to register spine anatomy to surgical computer navigation systems.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spine Registration | 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. | Throughout the surgical procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vertebral Shift Measurement | 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. | Throughout the surgical procedure | 
| Determination Of Bony Exposure Requirements | 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. | Throughout the surgical procedure |