Spine Registration Using 3D Scanning

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

1 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-05

Study Completion Date

2023-06-30

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.

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Detailed Description

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Conditions

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Spinal Fusion Spondylolisthesis Scoliosis Sciatica

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Optical 3D Scanner

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Patients that require exposure of bony posterior spine anatomy for localization as standard of care.
2. Have had a CT scan performed prior to the procedure.
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.

Exclusion Criteria

1. Language problems that would prevent from properly understanding instructions.
2. Patients less than 18 years of age.
3. Requirement of an interpreter.
4. Patients who are excluded from consideration for the surgical procedure are therefore excluded from the research study.
5. Special populations: pregnant women, prisoners.
6. Minimally invasive spine surgery that does not expose the necessary bone/s.
7. Spine surgery without posterior exposure.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes