Degenerative Changes After Treatment of Thoracolumbar Junction Fractures (NCT07672184) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Degenerative Changes After Treatment of Thoracolumbar Junction Fractures
Russia150 participantsStarted 2026-11-01
Plain-language 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.
Who can participate
Age range
18 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Facet Joint Degeneration Grade on Computed Tomography
Timeframe: From baseline CT to the last available follow-up CT, with a minimum interval of 1 year