About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
The study population will consist of patients aged 18 to 50 years with AOSpine type A2, A3, or A4 thoracolumbar fractures whose previously acquired CT examinations are available in the institutional imaging archive. Eligible CT datasets must cover vertebral levels T9 through L3 and be suitable for standardized facet joint assessment. The study will use anonymized retrospective imaging data only; there will be no direct patient recruitment, additional imaging, treatment allocation, or other study-specific intervention. CT datasets will be selected according to predefined eligibility criteria until at least 142 evaluable facet joints are available for analysis.
Trial design
Other
Retrospective
Treatments tested in this trial
Computed Tomography Image Review
Diagnostic testIndependent review of anonymized thoracolumbar CT scans by six raters for assessment of degenerative changes in facet joints and intervertebral discs using the Pathria scale, as well as measurement of facet joint space width and angulation.
Treatment groups
Trial outcomes
Primary outcomes
Interobserver Reliability of CT-Based Pathria Grading Scale for Facet Joint Degenerative Changes
Interobserver agreement for grading facet joint degenerative changes on thoracolumbar CT scans using the 4-grade Pathria classification, assessed by Fleiss' kappa across six raters.
Interobserver reliability of facet joint space width measurements
Interobserver reliability of quantitative measurement of mean facet joint space width assessed using the intraclass correlation coefficient.
Interobserver reliability of facet joint angulation measurements
Interobserver reliability of measurement of facet joint angulation in the axial plane on thoracolumbar CT scans, assessed using the intraclass correlation coefficient.
Secondary outcomes
Intraobserver Reliability of CT-Based Pathria Grading Scale for Facet Joint Degenerative Changes
Intraobserver agreement for grading facet joint degenerative changes on thoracolumbar CT scans using the 4-grade Pathria classification, assessed on repeated review.
Intraobserver reliability of facet joint space width measurements
Intraobserver reliability of repeated quantitative measurement of mean facet joint space width, assessed using the intraclass correlation coefficient.
Intraobserver reliability of facet joint angulation measurements
Intraobserver reliability of repeated measurement of facet joint angulation in the axial plane on thoracolumbar CT scans, assessed using the intraclass correlation coefficient.
Sponsors and contacts
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