Status:
UNKNOWN
Navigation Image Accuracy Test in Cervical Spine Surgery Using Anatase Spine Surgery Navigation System
Lead Sponsor:
China Medical University Hospital
Conditions:
Cervical Spine Fusion
Eligibility:
All Genders
18-70 years
Phase:
NA
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" S...
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 p...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2024
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT06117267
Start Date
November 1 2023
End Date
September 30 2024
Last Update
November 7 2023
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