Degenerative Changes After Treatment of Thoracolumbar Junction Fractures
Degenerative Changes in Injured and Adjacent Spinal Motion Segments After Conservative and Surgical Treatment of AOSpine Type A2, A3, and A4 Thoracolumbar Junction Fractures
This observational study will evaluate how degenerative changes in the facet joints and intervertebral discs develop over time after treatment of AOSpine type A2, A3, and A4 fractures of the thoracolumbar junction. Patients treated conservatively and patients treated surgically will be compared with each other and with a control group of patients who underwent repeated computed tomography examinations for reasons unrelated to traumatic or degenerative spinal disease.
The study will assess computed tomography findings at the injured spinal motion segment and adjacent segments, including facet joint degeneration, intervertebral disc degeneration, signs of ankylosis, facet joint space parameters, and facet joint angle. Clinical outcomes in the fracture cohort will be evaluated using pain scores and validated questionnaires. The purpose of the study is to identify factors associated with progression of degenerative changes after thoracolumbar junction fractures and to clarify whether treatment method is associated with long-term degeneration of the injured and adjacent spinal motion segments.
調査の概要
状態
詳細な説明
This is an ambispective longitudinal comparative cohort study designed to evaluate the development and progression of degenerative changes in the facet joints and intervertebral discs after treatment of traumatic fractures of the thoracolumbar junction.
The fracture cohort will include adult patients with AOSpine type A2, A3, or A4 fractures of the thoracolumbar junction who were treated at the N.V. Sklifosovsky Research Institute for Emergency Medicine. Patients will be analyzed according to treatment strategy, including conservative treatment and surgical treatment without disruption of the posterior supporting column. Surgical treatment may include anterior fusion, transpedicular fixation, or combined procedures without direct posterior decompression. Retrospective medical records and imaging data will be reviewed, and available patients will be invited for follow-up clinical and radiological assessment.
A control cohort will include adult patients who underwent at least two computed tomography examinations covering the thoracolumbar junction for conditions unrelated to traumatic or degenerative spinal disease. The interval between computed tomography examinations must be at least 1 year.
Radiological assessment will be performed using computed tomography. The analysis will include the injured spinal motion segment and adjacent segments. Imaging parameters will include facet joint degeneration according to Pathria criteria, intervertebral disc degeneration with assessment of ankylosis, facet joint space width, facet joint angle, facet tropism, fracture type according to the AOSpine classification, bisegmental Cobb angle, anterior vertebral body height, vertebral body index, relative spinal canal stenosis, pedicle screw position, facet joint violation by pedicle screws, radiological evidence of fracture healing or pseudarthrosis, implant-associated complications, and sagittal balance, as applicable.
Clinical outcomes in the fracture cohort will be assessed using the Visual Analog Scale for pain, the Oswestry Disability Index, and the SF-36 quality-of-life questionnaire.
The primary purpose of the study is to compare the longitudinal dynamics of degenerative changes in the facet joints and intervertebral discs between patients treated conservatively, patients treated surgically, and patients without traumatic or degenerative thoracolumbar junction disease. The study will also explore clinical and radiological factors associated with progression of degeneration at the injured and adjacent spinal motion segments.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Ivan Lvov, MD, 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, MD, 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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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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コンタクト：
- Vasiliy Karanadze, MD, PhD
- 電話番号：+7 903 565-68-30
- メール：karanadzevneuro@gmail.com
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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
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:
Conservative Treatment Cohort:
- Age 18 to 50 years.
- Acute or subacute traumatic fracture of the thoracolumbar junction at the start of treatment.
- AOSpine type A2, A3, or A4 fracture.
- No clinical evidence of nerve root or spinal cord compression at the injured level.
- Conservative treatment of the thoracolumbar junction fracture.
- Minimum follow-up period of 1 year.
- Written informed consent for prospective follow-up or additional study procedures, when applicable.
Surgical Treatment Cohort:
- Age 18 to 50 years.
- Acute or subacute traumatic fracture of the thoracolumbar junction at the start of treatment.
- AOSpine type A2, A3, or A4 fracture.
- No clinical evidence of nerve root or spinal cord compression at the injured level.
- Surgical treatment performed without disruption of the posterior supporting column.
- Surgical treatment may include anterior fusion, transpedicular fixation, or combined surgery without direct posterior decompression.
- Minimum follow-up period of 1 year.
- Written informed consent for prospective follow-up or additional study procedures, when applicable.
Control Cohort:
- Age 18 to 50 years.
- At least two computed tomography examinations covering the Th9-L4 vertebral levels.
- Interval of at least 1 year between computed tomography examinations.
- Computed tomography performed for reasons unrelated to traumatic or degenerative thoracolumbar junction disease.
- No imaging artifacts at the spinal levels included in the study assessment.
Exclusion Criteria:
Conservative Treatment Cohort:
- Severe combined trauma.
- Severe concomitant disease.
- Systemic bone or joint disease associated with changes in facet joints or intervertebral discs, including diffuse idiopathic skeletal hyperostosis, ankylosing spondylitis, rheumatoid arthritis, or similar disorders.
- Verified osteoporosis.
- Bone density of thoracolumbar vertebrae less than 100 Hounsfield units.
- Previous spine surgery.
- American Society of Anesthesiologists physical status class 4 or 5.
- Participation in another clinical study related to treatment of spinal disease or spinal trauma.
- Withdrawal of informed consent, when applicable.
Surgical Treatment Cohort:
- Severe combined trauma.
- Severe concomitant disease.
- Systemic bone or joint disease associated with changes in facet joints or intervertebral discs, including diffuse idiopathic skeletal hyperostosis, ankylosing spondylitis, rheumatoid arthritis, or similar disorders.
- Verified osteoporosis.
- Bone density of thoracolumbar vertebrae less than 100 Hounsfield units.
- Previous spine surgery.
- Direct posterior decompression or other surgery disrupting the posterior supporting column.
- American Society of Anesthesiologists physical status class 4 or 5.
- Participation in another clinical study related to treatment of spinal disease or spinal trauma.
- Withdrawal of informed consent, when applicable.
Control Cohort:
- Complicated fracture of any spinal region.
- Combined trauma or severe concomitant disease limiting patient mobility.
- Systemic bone or joint disease associated with changes in facet joints or intervertebral discs, including diffuse idiopathic skeletal hyperostosis, ankylosing spondylitis, rheumatoid arthritis, or similar disorders.
- Grade 4 facet joint degeneration according to the Pathria classification at the studied levels.
- Bone density of thoracolumbar vertebrae less than 100 Hounsfield units.
- Previous spine surgery, including surgery without implants.
- Spinal fracture with injury to the posterior supporting column.
- Participation in another clinical study related to treatment of spinal disease or spinal trauma.
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 |
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Conservative Treatment Cohort
Adult patients with acute or subacute AOSpine type A2, A3, or A4 fractures of the thoracolumbar junction treated conservatively.
Patients will have no clinical evidence of nerve root or spinal cord compression at the injured level and will have a minimum follow-up period of 1 year.
Clinical records, computed tomography imaging, and follow-up clinical outcomes will be analyzed.
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Surgical Treatment Cohort
Adult patients with acute or subacute AOSpine type A2, A3, or A4 fractures of the thoracolumbar junction treated surgically without disruption of the posterior supporting column.
Surgical treatment may include anterior fusion, transpedicular fixation, or combined procedures without direct posterior decompression.
Clinical records, computed tomography imaging, implant-related findings, and follow-up clinical outcomes will be analyzed.
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Control Cohort
Adult patients without traumatic or degenerative thoracolumbar junction disease who underwent at least two computed tomography examinations covering the thoracolumbar junction for reasons unrelated to spinal trauma or degeneration.
The interval between computed tomography examinations will be at least 1 year.
Imaging data will be used to assess the natural dynamics of facet joint and intervertebral disc degenerative changes.
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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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Change in Facet Joint Degeneration Grade on Computed Tomography
時間枠：From baseline CT to the last available follow-up CT, with a minimum interval of 1 year
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Change in the degree of facet joint degeneration from baseline to follow-up, assessed on computed tomography using the Pathria grading system.
Facet joints will be evaluated at the injured or treated spinal motion segment and adjacent segments in the fracture cohorts, and at corresponding thoracolumbar junction segments in the control cohort.
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From baseline CT to the last available follow-up CT, with a minimum interval of 1 year
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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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Change in Intervertebral Disc Degeneration and Ankylosis Grade on Computed Tomography
時間枠：From baseline CT to the last available follow-up CT, with a minimum interval of 1 year
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Change in intervertebral disc degeneration from baseline to follow-up, assessed on computed tomography with specific evaluation of osteophyte formation and ankylosis.
Intervertebral discs will be evaluated at the injured or treated spinal motion segment and adjacent segments in the fracture cohorts, and at corresponding thoracolumbar junction segments in the control cohort.
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From baseline CT to the last available follow-up CT, with a minimum interval of 1 year
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Change in Facet Joint Space Width on Computed Tomography
時間枠：From baseline CT to the last available follow-up CT, with a minimum interval of 1 year
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Change in average, minimum, and maximum facet joint space width measured on computed tomography in millimeters.
Measurements will be performed for facet joints without advanced ankylosis when applicable.
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From baseline CT to the last available follow-up CT, with a minimum interval of 1 year
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Change in Facet Joint Angle and Facet Tropism on Computed Tomography
時間枠：From baseline CT to the last available follow-up CT, with a minimum interval of 1 year
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Change in facet joint angle measured on axial computed tomography images.
Facet tropism will be assessed as the difference between the right and left facet joint angles when applicable.
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From baseline CT to the last available follow-up CT, with a minimum interval of 1 year
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Radiological Treatment Result in the Fracture Cohorts
時間枠：At the last available follow-up, at least 1 year after treatment
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Radiological treatment result will be categorized as fracture healing or fusion, stable pseudarthrosis, or unstable pseudarthrosis with clinical and radiological signs of instability, based on follow-up imaging.
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At the last available follow-up, at least 1 year after treatment
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Pain Intensity on the Visual Analog Scale
時間枠：At the final clinical follow-up, at least 1 year after treatment
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Pain intensity in the fracture cohorts will be assessed using the Visual Analog Scale, where higher scores indicate greater pain intensity.
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At the final clinical follow-up, at least 1 year after treatment
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Functional Disability on the Oswestry Disability Index
時間枠：At the final clinical follow-up, at least 1 year after treatment
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Functional disability in the fracture cohorts will be assessed using the Oswestry Disability Index.
Higher scores indicate greater disability.
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At the final clinical follow-up, at least 1 year after treatment
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Health-Related Quality of Life on the SF-36 Questionnaire
時間枠：At the final clinical follow-up, at least 1 year after treatment
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Health-related quality of life in the fracture cohorts will be assessed using the SF-36 questionnaire.
The questionnaire evaluates multiple domains of physical and mental health, with higher scores indicating better health-related quality of life.
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At the final clinical follow-up, at least 1 year after treatment
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in Bisegmental Cobb Angle
時間枠：From baseline imaging to the last available follow-up imaging, at least 1 year after treatment
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Change in the bisegmental Cobb angle related to the fractured vertebra, measured on computed tomography or radiographic images according to the study protocol.
This parameter will be assessed in the fracture cohorts as a radiological measure of segmental kyphotic deformity.
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From baseline imaging to the last available follow-up imaging, at least 1 year after treatment
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Change in Vertebral Body Height and Vertebral Body Index
時間枠：From baseline imaging to the last available follow-up imaging, at least 1 year after treatment
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Change in anterior vertebral body height and vertebral body index of the fractured vertebra, assessed on computed tomography or radiographic images.
These parameters will be used to evaluate post-treatment vertebral body restoration, collapse, or progression of deformity in the fracture cohorts.
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From baseline imaging to the last available follow-up imaging, at least 1 year after treatment
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Spinal Canal Stenosis
時間枠：At baseline imaging and, when available, at follow-up imaging up to the last available follow-up, at least 1 year after treatment
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Relative spinal canal stenosis at the fractured level will be assessed on computed tomography by comparing the spinal canal area at the injured level with the canal area at adjacent intact levels.
This parameter will be evaluated in the fracture cohorts.
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At baseline imaging and, when available, at follow-up imaging up to the last available follow-up, at least 1 year after treatment
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Pedicle Screw Position and Facet Joint Violation
時間枠：Postoperative CT within 14 days after surgery and follow-up CT at 12 months after surgery.
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In surgically treated patients, pedicle screw position will be assessed according to the Gertzbein-Robbins classification.
Facet joint violation by pedicle screws will be evaluated using cranio-caudal and medio-lateral screw position and screw head depression grades.
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Postoperative CT within 14 days after surgery and follow-up CT at 12 months after surgery.
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Implant-Related Complications
時間枠：From surgery to the last available follow-up, at least 1 year after treatment
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Implant-associated complications in surgically treated patients will be recorded based on clinical records and follow-up imaging.
These may include radiological or clinical evidence of fixation failure, implant loosening, implant malposition, or other implant-related adverse findings.
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From surgery to the last available follow-up, at least 1 year after treatment
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Sagittal Balance Parameters
時間枠：At the last available follow-up, at least 1 year after treatment
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Sagittal balance will be assessed on available standing radiographs or other appropriate imaging studies according to the study protocol.
This parameter will be evaluated in the fracture cohorts when imaging data are available.
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At the last available follow-up, at least 1 year after treatment
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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
キーワード
その他の研究ID番号
- SKL06-2026
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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米国FDA規制機器製品の研究
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