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

NCT06117267 | Unknown FDA Device

• 1 other identifier: CMUH112-REC1-144
• Study Type: interventional
• Target: 8
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Cervical Spine Fusion

Keywords

Spine Surgery Navigation System

Outcome Measures

Primary Outcomes (2)

• Difference between the actual and virtual (navigation system) distance of the probe.

  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.

  The assessor will measure the angle (°) of the probe between the actual and virtual (navigation system) images.

  during the surgery

Study Arms (1)

Anatase Spine Surgery Navigation System

EXPERIMENTAL

Using the navigation system during surgery

Device: Anatase Spine Surgery Navigation System

Interventions

Anatase Spine Surgery Navigation System DEVICE

Collect images with the probe touching the target position before screw implantation

Anatase Spine Surgery Navigation System

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• China Medical University Hospital: lead

MeSH Terms

Conditions

Klippel-Feil Syndrome

Condition Hierarchy (Ancestors)

Dysostoses; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Cheng-Di Chiu

  China Medical University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cheng-Di Chiu

CONTACT

04-22052121; 022459@tool.caaumed.org.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: October 27, 2023
• First Posted: November 7, 2023
• Study Start: November 1, 2023
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: November 7, 2023

Record last verified: 2023-11