Reliability and Reproducibility of CT-Based Facet Joint Measurements in Patients With AOSpine Type A2, A3, and A4 Thoracolumbar Fractures
REFACT
1 other identifier
observational
12
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Aug 2026
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 16, 2026
CompletedFirst Posted
Study publicly available on registry
June 25, 2026
CompletedStudy Start
First participant enrolled
August 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
July 15, 2026
July 1, 2026
3 months
June 16, 2026
July 13, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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.
At baseline CT image review
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.
At baseline CT image review
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.
At baseline CT image review
Secondary Outcomes (3)
Intraobserver Reliability of CT-Based Pathria Grading Scale for Facet Joint Degenerative Changes
At baseline and 1 month later
Intraobserver reliability of facet joint space width measurements
At baseline and 1 month later
Intraobserver reliability of facet joint angulation measurements
At baseline and 1 month later
Study Arms (1)
CT Image Review Cohort
Anonymized CT scans of the thoracolumbar spine (T9-L3) obtained from eligible patients aged 18 to 65 years and reviewed independently by six raters to assess inter-rater and intra-rater reproducibility of CT-based evaluation of facet joint and intervertebral disc degenerative changes
Interventions
Independent 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.
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sklifosovsky Research Institute for Emergency Medicine
Moscow, 129090, Russia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- External investigator
Study Record Dates
First Submitted
June 16, 2026
First Posted
June 25, 2026
Study Start
August 1, 2026
Primary Completion (Estimated)
November 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
July 15, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will not share