Preoperative and Peroperative Comparison Between 3D Spine Reconstructions (NCT04611490) | Clinical Trial Compass
UnknownNot Applicable
Preoperative and Peroperative Comparison Between 3D Spine Reconstructions
France15 participantsStarted 2020-07-30
Plain-language summary
The objective is to collect data from a per-operative navigation system called SURGIVISIO during scoliosis surgeries. A research program is in progress in order super-impose pre-operative 3D reconstructions of the spine performed with the EOS system on the per-operative 3D reconstructions performed with the SURGIVISIO system.
The purpose of the study is to collect the pre and per operatives data in order to perform the research and development program.
Who can participate
Age range
12 Years – 20 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 aged between 12 and 20
* Adolescent idiopathic scoliosis
* Fusion surgery planned
Exclusion Criteria:
* Patient under "tutelle" or privation of liberty
* Opposition of parents or patient
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
Comparison between the shape of of the spine in supine position in the OR with the Surgivisio system and the 3D shape with the 3D pre-operative planning with the EOS