Spine Registration Using 3D Scanning

N/ATerminatedNCT05195580

Advanced Scanners Inc.2 enrolled

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Spinal Fusion Spinal Stenosis Scoliosis Spondylolisthesis

Interventions

Optical 3D ScannerDEVICE

An optical 3D scanner used to register spine anatomy to surgical computer navigation systems.

Eligibility

Sex: ALLHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

St. David's Round Rock Medical Center

Round Rock, Texas, United States

Outcomes

Primary Outcomes

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.

Time frame: Throughout the surgical procedure

Secondary Outcomes

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.

Time frame: 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.

Time frame: Throughout the surgical procedure

Data from ClinicalTrials.gov

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