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 range18 Years – 35 Years

SexALL

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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

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 range18 Years – 35 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.