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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.
The objective is to evaluate the reliability and reproducibility of CT-based assessment methods:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Computed Tomography Image Review | Diagnostic 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 CT-Based Grading Scale for Intervertebral Disc Degenerative Changes | 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 | 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At baseline and 1 month later |
| Intraobserver Reliability of CT-Based Grading Scale for Intervertebral Disc Degenerative Changes |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ivan Lvov, PhD | Contact | +34 654 902 306 | dr.speleolog@gmail.com | |
| Vasiliy Karanadze, PhD | Contact | +7 903 565-68-30 | karanadzevneuro@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sklifosovsky Research Institute for Emergency Medicine | Moscow | 129090 | Russia |
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|
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 | 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 | 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 |
| ID | Term |
|---|---|
| D055959 | Intervertebral Disc Degeneration |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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