Clinical Trial

Reliability and Reproducibility of CT-Based Facet Joint Measurements in Patients With AOSpine Type A2, A3, and A4 Thoracolumbar Fractures

Study acronym: REFACT
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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.
Protocol Amendment History 3 changes
critical Primary endpoint(s) modified 2026-07-16
notable Primary completion pushed: 2026-09-01 -> 2026-11-01 2026-07-16
minor Completion pushed: 2026-11-01 -> 2026-12-01 2026-07-16
Trial Details
NCT Number NCT07670039
Lead Sponsor Sklifosovsky Institute of Emergency Care
Conditions Facet Joint Arthritis, Facet Joints; Degeneration, Facet Joint Disease, Intervertebral Disk Degeneration, Pathria Classification
Enrollment 12 participants
Start Date 2026-08-01
Primary Completion 2026-11-01 (estimated)
Study Completion 2026-12-01 (estimated)
Updated on ClinicalTrials.gov 2026-07-15