Digital Navigation Enhances Cervical Pedicle Screw Placement Accuracy and Safety (NCT02880839) | Clinical Trial Compass
UnknownNot Applicable
Digital Navigation Enhances Cervical Pedicle Screw Placement Accuracy and Safety
76 participantsStarted 2013-09
Plain-language summary
To compare the internal fixation results of three pedicle screw implantation methods and investigated the accuracy and safety of digital navigation-assisted pedicle screw placement.
Who can participate
Age range
18 Years – 65 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:
* Fracture of the posterior column of the cervical spine or fracture of the anterior-posterior column of the cervical spine without severe vertebral body injury
* Non-traumatic cervical lamina destabilization, including metastatic tumor and rheumatoid arthritis
* Kyphotic deformity after cervical lamina resection
* Segmental destabilization after nerve root or spinal cord decompression
* Subjected to revision after anterior cervical spine surgery
* Scheduled to undergo internal fixation by cervical pedicle screw
* Age approximately 62 years
* Either sex
* Provision of signed informed consent to participate in the trial
Exclusion Criteria:
* Cervical pedicle injury resulting from trauma or tumor
* Severe osteoporosis
* Anatomical variation of the vertebral artery
* Unable or declined to proceed with internal fixation by pedicle screws
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.
1This trial is specifically looking at how accurately cervical pedicle screws can be placed using digital navigation — how does that compare to the standard, non-navigation-assisted method my surgeon would typically use for my cervical spine fracture?
2Since this trial is listed as 'Phase NA' and its recruitment status is unknown, is this study still actively enrolling patients, and would it even be possible for me to participate at this point?
3The main thing being measured in this trial is how much the screws penetrate the pedicle — what does it mean for my safety if a screw is not placed with perfect accuracy, and how does the navigation technology aim to reduce that risk?
4Cervical pedicle screw surgery is already considered a high-risk procedure near the spinal cord and nerve roots — what would my doctor consider the key safety trade-offs between using digital navigation versus conventional techniques in my specific case?
5Before considering this trial, are there standard-of-care surgical or non-surgical treatment options for my cervical spine fracture that my doctor would recommend exploring first?
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
the penetration degree of the cervical pedicle screws