Facet Joint ArthritisREFACTNCT07670039
Reliability and Reproducibility of CT-Based Facet Joint Measurements in Patients With AOSpine Type A2, A3, and A4 Thoracolumbar Fractures
An observational study of Facet Joint Arthritis and Facet Joints; Degeneration, run by Sklifosovsky Institute of Emergency Care at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Facet Joint Arthritis, Facet Joints; Degeneration, Facet Joint Disease
- What is being tested?
- Computed Tomography Image Review
- How many people
- 12 participants
- Where
- 1 siteRussia
- Study dates
- 1 Aug 2026to 1 Dec 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site
Sklifosovsky Research Institute for Emergency Medicine
Moscow, 129090
Vasiliy Karanadze, MD, PhD, +7 (495) 280-15-61, sklif@zdrav.mos.ru
Andrey Grin, MD, PhD
About this study
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:
Read more
- 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.
Read the detailed description
The Reliability Evaluation of Facet joint Assessment by Computed Tomography in thoracolumbar fractures (REFACT) study is an imaging-based, multirater reliability study designed to evaluate the reproducibility of computed tomography-based assessment of thoracolumbar facet joints.
The study represents the methodological stage of a broader research program investigating longitudinal degenerative changes in the facet joints after surgical or conservative treatment of thoracolumbar fractures. Before changes in facet joint morphology can be interpreted over time, the reliability of the imaging assessment methods must first be established in the target patient population.
Anonymized CT DICOM datasets will be selected from the institutional imaging archive of the Sklifosovsky Research Institute for Emergency Medicine. The datasets will include patients with AOSpine type A2, A3, or A4 thoracolumbar junction fractures and will cover the anatomical levels required for standardized facet joint assessment. No additional imaging, patient contact, study-specific treatment, or prospective clinical intervention will be performed.
Six independent raters will participate in the study: three neurosurgeons and three specialists in radiology or CT imaging. All raters will use the same standardized assessment protocol and the same DICOM viewing software.
Before the formal assessment, the raters will participate in a joint training session using one representative anonymized CT dataset that will not be included in the main analysis. The session will be used to demonstrate the assessment procedure, standardize image orientation and vertebral level identification, clarify the interpretation of the Pathria grading system, and review the procedures for measuring facet joint angle and facet joint space width. Any ambiguities in the assessment instructions will be resolved before the formal study begins.
During the first assessment round, each rater will independently evaluate the same anonymized CT datasets. The order of the datasets will be randomized separately for each rater. Raters will record the Pathria grade of facet joint degeneration and quantitative facet joint measurements according to the standardized protocol.
After a one-month washout interval, the same CT datasets will be re-randomized and reassessed independently by the same six raters during a second assessment round. The changed order and washout period are intended to reduce recall bias and allow evaluation of the reproducibility of repeated assessments by the same rater.
Throughout both assessment rounds, raters will be blinded to patient identifiers, clinical information, previous measurements, and the assessments of the other raters. Raters will not discuss individual study cases or measurement decisions until both rounds have been completed.
The study will evaluate agreement across different raters and the consistency of repeated assessments by the same rater. The assessment will include both ordinal grading of facet joint degeneration and continuous morphometric measurements. Exploratory analyses may examine whether reliability differs according to rater specialty, vertebral level, or anatomical side.
All study data will be entered into a standardized data collection form and stored in a restricted-access institutional database. Missing, technically inadequate, or non-evaluable assessments will not be imputed and will be reported descriptively.
Because the study uses only previously acquired, anonymized imaging data, participants will not undergo any study-related procedures and will not be exposed to additional radiation or treatment-related risk.
- Conditions
- Facet Joint Arthritis, Facet Joints; Degeneration, Facet Joint Disease, Intervertebral Disk Degeneration, Pathria Classification
- Being tested
- Computed Tomography Image Review
- Keywords
- Thoracolumbar Spine, Facet Joint, Intervertebral Disc, Computed Tomography, interobserver reliability, intraobserver reliability
- Medical subject headings
- Intervertebral Disc Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computed Tomography Image ReviewDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: Computed Tomography Image Review |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: At baseline CT image review
Secondary outcomes (3)
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.
Measured: At baseline and 1 month later
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.
Measured: At baseline and 1 month later
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.
Measured: At baseline and 1 month later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2026
- Study start1 Aug 2026 (estimated)
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facet Joint ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sklifosovsky Institute of Emergency Care
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ivan Lvov, MD, PhD, Sklifosovsky Institute of Emergency Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07670039
- Sponsor's protocol ID
- SKL052026
- Acronym
- REFACT
- Status last verified
- Jul 2026
- First submitted
- 16 Jun 2026
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No