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
1 other identifier
observational
150
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 16, 2026
CompletedFirst Posted
Study publicly available on registry
June 26, 2026
CompletedStudy Start
First participant enrolled
November 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2027
Study Completion
Last participant's last visit for all outcomes
December 31, 2027
July 1, 2026
June 1, 2026
10 months
June 16, 2026
June 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (7)
Change in Intervertebral Disc Degeneration and Ankylosis Grade on Computed Tomography
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
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
From baseline CT to the last available follow-up CT, with a minimum interval of 1 year
Radiological Treatment Result in the Fracture Cohorts
At the last available follow-up, at least 1 year after treatment
Pain Intensity on the Visual Analog Scale
At the final clinical follow-up, at least 1 year after treatment
- +2 more secondary outcomes
Other Outcomes (6)
Change in Bisegmental Cobb Angle
From baseline imaging to the last available follow-up imaging, at least 1 year after treatment
Change in Vertebral Body Height and Vertebral Body Index
From baseline imaging to the last available follow-up imaging, at least 1 year after treatment
Spinal Canal Stenosis
At baseline imaging and, when available, at follow-up imaging up to the last available follow-up, at least 1 year after treatment
- +3 more other outcomes
Study Arms (3)
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.
Eligibility Criteria
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.
You may qualify if:
- 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.
- +8 more criteria
You may not qualify if:
- 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.
- +15 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sklifosovsky Research Institute for Emergency Medicine
Moscow, 129090, Russia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- External investigator
Study Record Dates
First Submitted
June 16, 2026
First Posted
June 26, 2026
Study Start (Estimated)
November 1, 2026
Primary Completion (Estimated)
August 31, 2027
Study Completion (Estimated)
December 31, 2027
Last Updated
July 1, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will not share
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.