Thoracolumbar Spine FractureNCT07672184
Degenerative Changes After Treatment of Thoracolumbar Junction Fractures
An observational study of Thoracolumbar Spine Fracture and Facet Joint Degeneration, run by Sklifosovsky Institute of Emergency Care at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Thoracolumbar Spine Fracture, Facet Joint Degeneration, Intervertebral Disc Degeneration
- How many people
- 150 participants
- Where
- 1 siteRussia
- Study dates
- 1 Nov 2026to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: 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.
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site
Sklifosovsky Research Institute for Emergency Medicine
Moscow, 129090
Vasiliy Karanadze, MD, PhD, +7 903 565-68-30, karanadzevneuro@gmail.com
Andrey Grin, MD, PhD
About this study
Official title: 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.
Read the detailed description
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.
- Keywords
- Thoracolumbar Junction Fracture, AOSpine Classification, AOSpine Type A2 Fracture, AOSpine Type A3 Fracture, AOSpine Type A4 Fracture, Facet Joint Degeneration, Intervertebral Disc Degeneration, Adjacent Segment Degeneration, Spinal Motion Segment, Computed Tomography
- Medical subject headings
- Intervertebral Disc Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At the final clinical follow-up, at least 1 year after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2026
- Study start1 Nov 2026 (estimated)
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracolumbar Spine FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sklifosovsky Institute of Emergency Care
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ivan Lvov, MD, PhD, Sklifosovsky Institute of Emergency Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07672184
- Sponsor's protocol ID
- SKL06-2026
- Status last verified
- Jun 2026
- First submitted
- 16 Jun 2026
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Degenerative Changes in Injured and Adjacent Spinal Motion Segments After Conservative and Surgical Treatment of AOSpine Type A2, A3, and A4 Thoracolumbar Junction Fractures
- ClinicalTrials.gov ID
- NCT07672184
- Acronym / sponsor ID
- SKL06-2026
- Keywords
- Thoracolumbar Junction Fracture, AOSpine Classification, AOSpine Type A2 Fracture, AOSpine Type A3 Fracture, AOSpine Type A4 Fracture, Facet Joint Degeneration, Intervertebral Disc Degeneration, Adjacent Segment Degeneration
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Sklifosovsky Institute of Emergency CareOther government
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 26 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 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.
Key inclusion criteria (23 listed)
- 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.
Key exclusion criteria (30 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Facet Joint Degeneration Grade on Computed Tomography
Time frame: From baseline CT to the last available follow-up CT, with a minimum interval of 1 year
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.
7 secondary outcomes
Change in Intervertebral Disc Degeneration and Ankylosis Grade on Computed Tomography
Time frame: 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
Time frame: 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
Time frame: From baseline CT to the last available follow-up CT, with a minimum interval of 1 year
Radiological Treatment Result in the Fracture Cohorts
Time frame: At the last available follow-up, at least 1 year after treatment
Pain Intensity on the Visual Analog Scale
Time frame: At the final clinical follow-up, at least 1 year after treatment
Functional Disability on the Oswestry Disability Index
Time frame: At the final clinical follow-up, at least 1 year after treatment
Health-Related Quality of Life on the SF-36 Questionnaire
Time frame: At the final clinical follow-up, at least 1 year after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thoracolumbar Spine Fracture and Facet Joint Degeneration, run by Sklifosovsky Institute of Emergency Care at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ivan Lvov, MD, PhD (+34 654 902 306, dr.speleolog@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Facet Joint Degeneration Grade on Computed Tomography (time frame: From baseline CT to the last available follow-up CT, with a minimum interval of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.