Spine Registration Using 3D-Scanning

• Conditions: Spine Surgery

• Registration Number: NCT06267248
• Lead Sponsor: Advanced Scanners Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-12
• Study First Submitted QC: 2024-02-12
• Study First Posted: 2024-02-20
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-30
• Last Update Posted: 2024-07-31
• Study Start: 2024-09
• Primary Completion: 2026-11
• Study Completion: 2028-11

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Mass General Bringham, Hale Building for Transformative Medicine; 🇺🇸 Boston, Massachusetts, United States