Reliability and Reproducibility of CT-Based Facet Joint Measurements in Patients With AOSpine Type A2, A3, and A4 Thoracolumbar Fractures (REFACT)
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.
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Ivan Lvov, PhD
- 電話番号：+34 654 902 306
- メール：dr.speleolog@gmail.com
研究連絡先のバックアップ
- 名前：Vasiliy Karanadze, PhD
- 電話番号：+7 903 565-68-30
- メール：karanadzevneuro@gmail.com
研究場所
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Moscow、ロシア、129090
- Sklifosovsky Research Institute for Emergency Medicine
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主任研究者：
- Andrey Grin, MD, PhD
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コンタクト：
- Vasiliy Karanadze, MD, PhD
- 電話番号：+7 (495) 280-15-61
- メール：sklif@zdrav.mos.ru
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副調査官：
- Aleksandr Talypov, MD, PhD
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副調査官：
- Anton Kordonsky, MD, PhD
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副調査官：
- Vasily Karandze, MD, PhD
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副調査官：
- Ivan Lvov, MD, PhD
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副調査官：
- Mikhail Kucherov, MD
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副調査官：
- Rinat Abdrafiev, MD
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副調査官：
- Aleksandr Tupikin, MD
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副調査官：
- Ksenia Dmitrenko, MD
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副調査官：
- Maria Nanoyan, MD
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副調査官：
- Olga Minkina, MD
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副調査官：
- Layla Khamidova, MD, PhD
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副調査官：
- Roman Elokhovskiy, MD, PhD
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
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
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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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Interobserver Reliability of CT-Based Pathria Grading Scale for Facet Joint Degenerative Changes
時間枠：At baseline CT image review
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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.
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At baseline CT image review
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Interobserver reliability of facet joint angulation measurements
時間枠：At baseline CT image review
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Interobserver reliability of measurement of facet joint angulation in the axial plane on thoracolumbar CT scans, assessed using the intraclass correlation coefficient.
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At baseline CT image review
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Interobserver reliability of facet joint space width measurements
時間枠：At baseline CT image review
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Interobserver reliability of quantitative measurement of mean facet joint space width assessed using the intraclass correlation coefficient.
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At baseline CT image review
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Intraobserver Reliability of CT-Based Pathria Grading Scale for Facet Joint Degenerative Changes
時間枠：At baseline and 1 month later
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Intraobserver agreement for grading facet joint degenerative changes on thoracolumbar CT scans using the 4-grade Pathria classification, assessed on repeated review.
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At baseline and 1 month later
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Intraobserver reliability of facet joint angulation measurements
時間枠：At baseline and 1 month later
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Intraobserver reliability of repeated measurement of facet joint angulation in the axial plane on thoracolumbar CT scans, assessed using the intraclass correlation coefficient.
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At baseline and 1 month later
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Intraobserver reliability of facet joint space width measurements
時間枠：At baseline and 1 month later
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Intraobserver reliability of repeated quantitative measurement of mean facet joint space width, assessed using the intraclass correlation coefficient.
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At baseline and 1 month later
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- SKL052026
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