Reliability and Reproducibility of CT-Based Facet Joint Measurements in Patients With AOSpine Typ… (NCT07670039) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Reliability and Reproducibility of CT-Based Facet Joint Measurements in Patients With AOSpine Type A2, A3, and A4 Thoracolumbar Fractures
Russia12 participantsStarted 2026-08-01
Plain-language summary
The Reliability Evaluation of Facet joint Assessment by Computed Tomography in thoracolumbar fractures (REFACT) study aims to evaluate how consistently different specialists assess thoracolumbar facet joints on computed tomography (CT) images in patients with AOSpine type A2, A3, or A4 thoracolumbar fractures.
The main questions are:
* How consistently do different raters classify facet joint degeneration using the Pathria grading system?
* How consistently do different raters measure facet joint angle and mean facet joint space width on CT images?
* How reproducible are these assessments when the same rater repeats the measurements after a one-month interval?
The study will use anonymized retrospective CT DICOM datasets obtained from the institutional imaging archive. Six independent raters (three neurosurgeons and three radiology specialists) will evaluate the same CT datasets using a standardized measurement protocol. Each rater will perform two independent assessment rounds separated by a one-month washout period. The results will be used to determine the inter-rater and intra-rater reliability of qualitative and quantitative CT-based facet joint assessment methods.
Who can participate
Age range
18 Years – 65 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 age from 18 to 50 years;
* thoracolumbar fracture classified as AOSpine type A2, A3, or A4;
* availability of CT images covering vertebral levels from Th9 to L3;
* absence of imaging artifacts at the levels planned for assessment.
Exclusion Criteria:
* bone density of the thoracolumbar junction vertebrae below 100 HU;
* systemic bone or joint disorders associated with changes in the FJs or intervertebral discs, including diffuse idiopathic skeletal hyperostosis, ankylosing spondylitis, rheumatoid arthritis, or other comparable conditions;
* previous spinal surgery, including procedures performed without implants;
* fractures with distraction or translational injury of the posterior supporting column.
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
Interobserver Reliability of CT-Based Pathria Grading Scale for Facet Joint Degenerative Changes
Timeframe: At baseline CT image review
2
Interobserver reliability of facet joint space width measurements
Timeframe: At baseline CT image review
3
Interobserver reliability of facet joint angulation measurements