Reliability and Reproducibility of Facet Joint Measurements in the Thoracolumbar Spine

June 22, 2026 updated by: Ivan Lvov, MD, PhD, Sklifosovsky Institute of Emergency Care

Reliability and Reproducibility of Pathria Scale-Based Grading of Facet Joint Degeneration and Facet Joint Morphometric Measurements in the Thoracolumbar Spine

The purpose is to determine how reliably degenerative changes in the facet joints (FJs) and intervertebral discs (IvDs) can be assessed on computed tomography (CT) scans.

At least six raters, including neurosurgeons and CT specialists, will independently evaluate anonymized CT scans covering the T9-L3 levels. The study will assess reproducibility of the Pathria grading scale for FJ degeneration and of quantitative measurements such as FJ space width and FJ angulation.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The objective is to evaluate the reliability and reproducibility of CT-based assessment methods:

  • Reliability and reproducibility of grading FJ degenerative changes using the Pathria scale;
  • Reliability and reproducibility of grading IvD degenerative changes, including tendency toward ankylosis formation;
  • Reliability and reproducibility of quantitative measurements of FJ space width (mean, minimum, and maximum values);
  • Reliability and reproducibility of FJ angulation measurements in the axial plane, including assessment of FJ tropism.

At least six raters will participate, including three neurosurgeons and three CT specialists. CT scans will be selected in random order from eligible imaging studies. Included scans must cover vertebral levels T9-L3, be obtained in patients aged 18 to 65 years, and be free from imaging artifacts at the levels of interest. Exclusion criteria for scans include vertebral bone density below 100 HU, systemic bone or joint disorders associated with changes in FJs or IvDs, previous spinal surgery, spinal fractures involving injury to posterior spinal structures, and participation in other clinical studies related to spinal disorders or spinal trauma.

Sample size for the quantitative reproducibility analysis was calculated in R using the ICC.Sample.Size package. Assuming a minimum acceptable intraclass correlation coefficient (ICC) of 0.60, an expected ICC of 0.75, alpha 0.05, power 80%, and 6 raters, the minimum required sample size was 47 FJs; after allowing for 10% data loss, the target sample size was 53 FJs. Because up to 12 FJs can be evaluated per patient, this corresponds to at least 5 patients.

Sample size for reproducibility of the 4-grade Pathria classification was calculated in R using the kappaSize package. Assuming a minimum acceptable kappa of 0.50, an expected kappa of 0.60, alpha 0.05, power 80%, and 6 raters, the minimum required sample size was 118 observations; after allowing for 10% loss of evaluable data, the target sample size was 130 FJs, corresponding to at least 11 patients.

Intra- and inter-rater agreement will be assessed using Fleiss' kappa for ordinal variables and the intraclass correlation coefficient (ICC) for continuous variables.

Study Type

Observational

Enrollment (Estimated)

12

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Russia
      • Moscow, Russia, 129090
        • Sklifosovsky Research Institute for Emergency Medicine
        • Principal Investigator:
          • Andrey Grin, MD, PhD
        • Contact:
        • Sub-Investigator:
          • Aleksandr Talypov, MD, PhD
        • Sub-Investigator:
          • Anton Kordonsky, MD, PhD
        • Sub-Investigator:
          • Vasily Karandze, MD, PhD
        • Sub-Investigator:
          • Ivan Lvov, MD, PhD
        • Sub-Investigator:
          • Mikhail Kucherov, MD
        • Sub-Investigator:
          • Rinat Abdrafiev, MD
        • Sub-Investigator:
          • Michael Kalandari, MD
        • Sub-Investigator:
          • Aleksandr Tupikin, MD
        • Sub-Investigator:
          • Ksenia Dmitrenko, MD
        • Sub-Investigator:
          • Maria Nanoyan, MD
        • Sub-Investigator:
          • Olga Minkina, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population will be drawn from adult patients aged 18 to 65 years who underwent thoracolumbar CT at the Sklifosovsky Research Institute for Emergency Medicine. Participants will be identified through available imaging records, and anonymized CT scans meeting predefined eligibility criteria will be selected for reliability and reproducibility analysis.

Description

Inclusion Criteria:

  • availability of CT scans covering the T9-L3 vertebrae;
  • absence of imaging artifacts at the level of interest.

Exclusion Criteria:

  • bone mineral density of the vertebrae of <100 HU;
  • systemic diseases of bone or joints associated with changes in the FJs and IvDs (including diffuse idiopathic skeletal hyperostosis, ankylosing spondylitis, rheumatoid arthritis, etc.);
  • previous spinal surgery, including procedures performed without instrumentation;
  • spinal fractures involving injury to the posterior structures;
  • participation in other clinical studies related to the treatment of spinal disorders or spinal trauma.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Diagnostic test: Computed Tomography Image Review
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Interobserver Reliability of CT-Based Pathria Grading Scale for Facet Joint Degenerative Changes
Time Frame: At baseline CT image review
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 CT-Based Grading Scale for Intervertebral Disc Degenerative Changes
Time Frame: At baseline CT image review
Interobserver agreement for grading intervertebral disc degenerative changes, including tendency toward ankylosis formation, on thoracolumbar CT scans.
At baseline CT image review
Interobserver reliability of facet joint space width measurements
Time Frame: At baseline CT image review
Interobserver reliability of quantitative measurement of facet joint space width, including mean, minimum, and maximum values, assessed using the intraclass correlation coefficient.
At baseline CT image review
Interobserver reliability of facet joint angulation measurements
Time Frame: At baseline CT image review
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraobserver Reliability of CT-Based Pathria Grading Scale for Facet Joint Degenerative Changes
Time Frame: At baseline and 1 month later
Intraobserver agreement for grading facet joint degenerative changes on thoracolumbar CT scans using the 4-grade Pathria classification, assessed on repeated review.
At baseline and 1 month later
Intraobserver Reliability of CT-Based Grading Scale for Intervertebral Disc Degenerative Changes
Time Frame: At baseline and 1 month later
Intraobserver agreement for grading intervertebral disc degenerative changes, including tendency toward ankylosis formation, on repeated CT image review.
At baseline and 1 month later
Intraobserver reliability of facet joint space width measurements
Time Frame: At baseline and 1 month later
Intraobserver reliability of repeated quantitative measurement of facet joint space width, including mean, minimum, and maximum values, assessed using the intraclass correlation coefficient.
At baseline and 1 month later
Intraobserver reliability of facet joint angulation measurements
Time Frame: At baseline and 1 month later
Intraobserver reliability of repeated measurement of facet joint angulation in the axial plane on thoracolumbar CT scans, assessed using the intraclass correlation coefficient.
At baseline and 1 month later

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sklifosovsky Institute of Emergency Care

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

June 16, 2026

First Submitted That Met QC Criteria

June 22, 2026

First Posted (Actual)

June 25, 2026

Study Record Updates

Last Update Posted (Actual)

June 25, 2026

Last Update Submitted That Met QC Criteria

June 22, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SKL052026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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