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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. | ||
| 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. | ||
| 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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| Measure | Description | Time Frame |
|---|---|---|
| Change in Facet Joint Degeneration Grade on Computed Tomography | 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. | From baseline CT to the last available follow-up CT, with a minimum interval of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Intervertebral Disc Degeneration and Ankylosis Grade on Computed Tomography | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Bisegmental Cobb Angle | 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. | From baseline imaging to the last available follow-up imaging, at least 1 year after treatment |
Inclusion Criteria:
Conservative Treatment Cohort:
Surgical Treatment Cohort:
Control Cohort:
Exclusion Criteria:
Conservative Treatment Cohort:
Surgical Treatment Cohort:
Control Cohort:
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The study population will include adults aged 18 to 50 years enrolled in three cohorts. The conservative treatment cohort will include patients with acute or subacute AOSpine type A2, A3, or A4 thoracolumbar junction fractures treated nonoperatively. The surgical treatment cohort will include patients with the same fracture types treated surgically without disruption of the posterior supporting column. The control cohort will include adults without traumatic or degenerative thoracolumbar junction disease who underwent at least two computed tomography examinations covering Th9-L4 for unrelated clinical indications, with an interval of at least 1 year between examinations.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ivan Lvov, MD, PhD | Contact | +34 654 902 306 | dr.speleolog@gmail.com | |
| Vasiliy Karanadze, MD, 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 |
Individual participant data will not be shared. The study will use clinical records, imaging data, and questionnaire results, which may contain sensitive health information. Data obtained during the study will be stored at the N.V. Sklifosovsky Research Institute for Emergency Medicine. Study results will be reported in aggregate form in peer-reviewed publications and scientific presentations.
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| ID | Term |
|---|---|
| D055959 | Intervertebral Disc Degeneration |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| From baseline CT to the last available follow-up CT, with a minimum interval of 1 year |
| Change in Facet Joint Space Width on Computed Tomography | 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. | From baseline CT to the last available follow-up CT, with a minimum interval of 1 year |
| Change in Facet Joint Angle and Facet Tropism on Computed Tomography | 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. | From baseline CT to the last available follow-up CT, with a minimum interval of 1 year |
| Radiological Treatment Result in the Fracture Cohorts | 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. | At the last available follow-up, at least 1 year after treatment |
| Pain Intensity on the Visual Analog Scale | Pain intensity in the fracture cohorts will be assessed using the Visual Analog Scale, where higher scores indicate greater pain intensity. | At the final clinical follow-up, at least 1 year after treatment |
| Functional Disability on the Oswestry Disability Index | Functional disability in the fracture cohorts will be assessed using the Oswestry Disability Index. Higher scores indicate greater disability. | At the final clinical follow-up, at least 1 year after treatment |
| Health-Related Quality of Life on the SF-36 Questionnaire | 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. | At the final clinical follow-up, at least 1 year after treatment |
| Change in Vertebral Body Height and Vertebral Body Index | 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. | From baseline imaging to the last available follow-up imaging, at least 1 year after treatment |
| Spinal Canal Stenosis | 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. | At baseline imaging and, when available, at follow-up imaging up to the last available follow-up, at least 1 year after treatment |
| Pedicle Screw Position and Facet Joint Violation | 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. | Postoperative CT within 14 days after surgery and follow-up CT at 12 months after surgery. |
| Implant-Related Complications | 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. | From surgery to the last available follow-up, at least 1 year after treatment |
| Sagittal Balance Parameters | 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. | At the last available follow-up, at least 1 year after treatment |