CompletedNot Applicable

Robot-Assisted US-Based Vertebral Segmentation for Pedicle Screw Trajectory Identification

Switzerland63 participantsStarted 2023-05-15

Plain-language summary

This other clinical trial compares robot-assisted US scanning with handheld US scanning and ground-truth CT data of the lumbar spine in healthy, young volunteers. The main questions it aims to answer are: * Is a 3D reconstruction of a lumbar spine from robot-assisted US scanning equivalent to or better quality than a 3D reconstruction from handheld US scanning? * Can a machine learning algorithm automatically segment the bone anatomy from robot-assisted and handheld US scanning to generate 3D lumbar spine reconstructions? * Can pedicle screw trajectories be identified based on posterior vertebral landmarks of 3D reconstructions of lumbar spines from both robot-assisted and handheld US scanning? Participants will: * fill out a medical history questionnaire * get clinically examined * have an ultra-low-dose (ULD) CT Scan of the vertebra L1 to S1 * have a handheld US scan of the vertebra L1 to S1 * have a robot-assisted US Scan of the vertebra L1 to S1 * fill out a post-study questionnaire

Who can participate

Age range

18 Years – 35 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: * Oral and written informed consent from the volunteer * Volunteers aged ≥18 y/o and ≤35 y/o * BMI above or equal to 19 kg/m2 or below or equal to 25 kg/m2 * Proficient in German or English language Exclusion Criteria: * Documented volunteer refusal * Volunteers in whom CT cannot be performed * Positive pregnancy test prior to radiology (contraindication to CT) * Pregnancy * Chronic pain in the lumbar spine * Moderate or severe deformity of the lumbar spine * Any prior intervention to the lumbar spine: * Chiropractic adjustment therapy * Injections such as local anesthetics and corticosteroids * Surgery * Fracture of the lumbar spine * BMI below 19 kg/m2 or above 25 kg/m2 * Anatomies, such as subcutaneous fat or tendon, occlude the bony surface or do not allow a clear image in the US scan

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

Target registration errors between US reconstructions and ground truth CT data

Timeframe: Up to 1 year

Pedicle screw placement - Trajectory errors in terms of position

Timeframe: Up to 1 year

Pedicle screw placement - Trajectory errors in terms of direction

Timeframe: Up to 1 year

Trial details

NCT IDNCT05904418

SponsorPhilipp Fürnstahl

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-06-09

View on ClinicalTrials.gov More Healthy trials

Plain-language summary

Who can participate

Age range

18 Years – 35 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.