CompletedNot Applicable

Study to Evaluate the Safety and Clinical Outcome of Using Navigation System in Pedicle Screw Placement in Spine Surgery

Taiwan55 participantsStarted 2020-06-29

Plain-language summary

The research project is testing whether in screw insertion of spine surgery using "Anatase" Spine Surgery Navigation System is at least as safe and accurate as using O-arm assisted spine surgery- Medtronic Stealthstation S7 Treatment Guidance System.

Who can participate

Age range

20 Years – 80 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

. Patients who need to undergo pedicle screw placement surgery with indication of spinal tumor, traumatic injury or degenerative spine disease.
. Pedicle screws placed from 10th thoracic vertebra to first sacrum.
. Age ≥20 years and ≤80 years.
. Body Mass Index (BMI) \< 40 kg/m2.
. Spine T-Score by Dual Energy X-ray Absorptiometry ≥ -2.5, 60 days prior to surgery.
. The subject is willing and able to comply with the procedure and requirements of this trial.
. The participant is able to understand and provide informed consent, and has signed their written informed consent in accordance with IRB requirements.

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

Rate of screw outside the vertebral body

Timeframe: not later than discharge, up to 14 days

Trial details

NCT IDNCT04578691

SponsorTaipei Veterans General Hospital, Taiwan

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2022-06-03

View on ClinicalTrials.gov More Spinal Tumor trials

Who can participate

Age range

20 Years – 80 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

. Patients who need to undergo pedicle screw placement surgery with indication of spinal tumor, traumatic injury or degenerative spine disease.
. Pedicle screws placed from 10th thoracic vertebra to first sacrum.
. Age ≥20 years and ≤80 years.
. Body Mass Index (BMI) \< 40 kg/m2.
. Spine T-Score by Dual Energy X-ray Absorptiometry ≥ -2.5, 60 days prior to surgery.
. The subject is willing and able to comply with the procedure and requirements of this trial.
. The participant is able to understand and provide informed consent, and has signed their written informed consent in accordance with IRB requirements.

Study to Evaluate the Safety and Clinical Outcome of Using Navigation System in Pedicle Screw Placement in Spine Surgery

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Study to Evaluate the Safety and Clinical Outcome of Using Navigation System in Pedicle Screw Placement in Spine Surgery

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria