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

2 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-08-31

Study Completion Date

2021-11-02

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 Spinal Stenosis Scoliosis Spondylolisthesis

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. 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.

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes