Navigation Image Accuracy Test in Cervical Spine Surgery Using Anatase Spine Surgery Navigation System

November 1, 2023 updated by: Cheng-Di Chiu, China Medical University Hospital

A Single-arm, Single-center Clinical Study to Verify the Navigation Image Accuracy in Cervical Spine Surgery Using Anatase Spine Surgery Navigation System

The "Anatase" Spine Surgery Navigation System used in this study has obtained market approval in Taiwan(MOHW-MD-No.006663) and the United States (510(k) Numbers: K180523 and K220348).

The "Anatase" Spine Surgery Navigation System, also known as an Image Guide System, is indicated for precise positioning of surgical instruments or spinal implants, such as pedicle screw placement, during general spinal surgery. The system uses wireless optical tracking technology to track the position of instruments in relation to the surgical anatomy and register to the relative position in preoperative 3D CT imagery.

The aim of the study is to verify the accuracy of "Anatase" Spine Surgery Navigation System in Image-guided Cervical Spine Surgery. This trial will involve 8 subjects using the approved "Anatase" Spine Surgery Navigation System to collect images before screw implantation, and verify the accuracy of navigation images in cervical spine surgery.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The "Anatase" Spine Surgery Navigation System, is composed of an Optical Tracker, Computer, No-Touch Reader and Dynamic Reference Frame (DRF). The Optical Tracker is a position sensor, it tracks the position of instruments with DRF by infrared light, allowing the instrument and vertebra to be positioned. The Computer is a touch screen panel PC running the proprietary spine NAVI software that guides the surgical procedure and display the results of the operation and computation. A No-Touch Reader, which attached on the Optical Tracker, is a no-touch sensor to identify instruments. It's a unique design and identification technology allows the instrument to be wirelessly identified, reducing the risk and time required to set up the instrument type. The system can track the position of patient's vertebra and instruments by mounting the DRF on patient's vertebra and instruments.

The "Anatase" Spine Surgery Navigation System is indicated for precise positioning of surgical instruments or spinal implants during general spinal surgery. The system helps to guide surgeons with real-time image and provides preoperative planning and intraoperative control.

Study Type

Interventional

Enrollment (Estimated)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥18 years and ≤70 years
  • Patients who need to undergo posterior cervical pedicle screw placement surgery
  • The subject is willing to provide preoperative CT images and to use the navigation system during surgery for the verification of navigation image accuracy.
  • Subjects are willing and able to comply with the procedures and requirements of this clinical trial.
  • Subjects are able to understand and willing to sign the informed consent form.

Exclusion Criteria:

  • Creutzfeldt-Jakob disease
  • Known allergy to stainless steel
  • Immunocompromised such as but not limited to Acquired Immunodeficiency Syndrome (AIDS), HIV infection, Severe Combined Immunodeficiency Syndrome, Thymic Hypoplasia
  • Pregnant women
  • Have a systematic or local infection, which may increase study risk
  • Hereditary or acquired hemorrhagic diathesis or coagulation factor deficiency
  • Use of anticoagulants
  • Osteoporosis
  • Be on uncontrolled diabetes mellitus.
  • Immunologically suppressed, or has received systemic steroids, excluding nasal steroids, at any dose daily for > 1 month within last 12 months.
  • Previous history of cervical spine surgery
  • Other medical conditions, as judged by a physician, may affect the physiological status for surgery.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Anatase Spine Surgery Navigation System
Using the navigation system during surgery
Device: Anatase Spine Surgery Navigation System
Collect images with the probe touching the target position before screw implantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference between the actual and virtual (navigation system) distance of the probe.
Time Frame: during the surgery
The assessor will measure the distance (mm) of the probe between the actual and virtual (navigation system) images.
during the surgery
Difference between the actual and virtual (navigation system) angle of the probe.
Time Frame: during the surgery
The assessor will measure the angle (°) of the probe between the actual and virtual (navigation system) images.
during the surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China Medical University Hospital

Investigators

  • Principal Investigator: Cheng-Di Chiu, China Medical University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2023

Primary Completion (Estimated)

September 30, 2024

Study Completion (Estimated)

September 30, 2024

Study Registration Dates

First Submitted

October 27, 2023

First Submitted That Met QC Criteria

November 1, 2023

First Posted (Actual)

November 7, 2023

Study Record Updates

Last Update Posted (Actual)

November 7, 2023

Last Update Submitted That Met QC Criteria

November 1, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMUH112-REC1-144

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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