Navigation Image Accuracy Test in Cervical Spine Surgery Using Anatase Spine Surgery Navigation S… (NCT06117267) | Clinical Trial Compass
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Navigation Image Accuracy Test in Cervical Spine Surgery Using Anatase Spine Surgery Navigation System
8 participantsStarted 2023-11
Plain-language 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.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Difference between the actual and virtual (navigation system) distance of the probe.
Timeframe: during the surgery
2
Difference between the actual and virtual (navigation system) angle of the probe.