Spine fracture study to reveal hidden degeneration risks
NCT ID NCT07672184
First seen Jun 27, 2026 · Last updated Jul 02, 2026 · Updated 2 times
Summary
This observational study will follow 150 people with thoracolumbar spine fractures to see how the injury and its treatment (surgery or non-surgical care) affect joint and disc degeneration over time. Researchers will compare CT scans and pain scores between treated patients and a healthy control group. The goal is to understand which factors lead to long-term spine degeneration, but no new treatment or drug is being tested.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 150 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Nov 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a government body.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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.
- Ages
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18 to 50 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Sklifosovsky Research Institute for Emergency Medicine
Moscow, 129090, Russia
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