Clinical Study With a Robotic Assistant in Patients Requiring a Spinal Transpedicular Fixation (NCT06153511) | Clinical Trial Compass
CompletedNot Applicable
Clinical Study With a Robotic Assistant in Patients Requiring a Spinal Transpedicular Fixation
Spain13 participantsStarted 2022-11-16
Plain-language summary
This multicenter, non-comparative clinical trial, led by two principal investigators in Spain, aims to evaluate the safety and performance of a robotic assistant, based on a electromechanical tracking system, in patients requiring transpedicular screw fixation. The study, conducted in two different hospital centers, involves patients with vertebral fractures, spinal stenosis, kyphosis, and other related conditions. The primary objective is to determine screw accuracy by assessing the degree of screw invasion into the pedicle using the Gertzbein-Robbins scale, with a target of achieving 96% acceptable screw placement. Trained radiologists will evaluate the screw invasion into the pedicle. The study is scheduled to span 12 months and each intervention includes a 1-month follow-up. Throughout this time frame, patients will undergo regular assessments, and outcomes will be closely monitored.
Who can participate
Age range
18 Years – 85 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:
* Patient scheduled for spinal fusion Surgery requiring pedicle screw insertion.
* Open or minimally invasive (MIS) technique.
* Spinal regions: lumbar, thoracic and/or sacral (one patient may cover several regions).
* Signed informed consent.
Exclusion Criteria:
* Paediatric patient (\< 18 years)
* Pedicular Surgery history with screw insertion in the vertebra to be operated.
* Any contraindication for the pedicular screw placement.
* Severe scoliosis.
* Severe osteoporosis.
* Infection or neoplasia.
* Obesity.
* Pregnancy and lactancy.
* Any other disease or disorder that, in the opinión of the neurosurgeron, may put the patient at risk or may influence the results of the study.
* Simultaneous participation in other clinical studies.
* For whatever reason, the Clinical protocol cannot be followed.
* The patient is unable, or unwilling, to sign the informed consent.
* Patients in emergency situation who are not legally able to participate in the study.
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
Grade of screw invasion into the pedicle based on Gertzbein-Robbins scale (A-E grade)