Effectiveness of Conservative Treatment in Patients With Thoracic and Lumbar Fractures Without Ne… (NCT06059820) | Clinical Trial Compass
CompletedNot Applicable
Effectiveness of Conservative Treatment in Patients With Thoracic and Lumbar Fractures Without Neurological Deficit
Russia40 participantsStarted 2023-11-01
Plain-language summary
The goal of this observational study is to compare the long-term clinical outcomes of two treatment methods (conservative therapy and surgical treatment) in patients with fractures of the thoracic and lumbar spine without neurological deficit
Who can participate
Age range
18 Years – 65 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:
* Patients aged 18 to 65 years.
* Isolated fracture of a single thoracic or lumbar vertebra, classified as type A2 or A3 according to the AOSpine classification.
* Absence of clinical evidence of nerve root or spinal cord compression at the injury level.
* Degree of spinal canal space narrowing less than 50% based on CT scans.
* Informed consent to participate in the study.
Exclusion Criteria:
* Sagittal imbalance (Type 4 by C. Barrey).
* Vertebral bone density at the injury level less than 100 HU or osteoporosis exceeding grade 3 in vertebral bodies, pelvic bones, and limbs.
* Previous spinal surgeries.
* Anesthesia risk of 4 or 5 according to ASA.
* Acute exacerbation and decompensation of somatic diseases.
* Malignant tumors at any site.
* Systemic connective tissue disorders.
* Cognitive impairments hindering patient communication.
* Floating and mural thrombosis, regardless of location.
* Newly identified and uncorrectable cardiac rhythm disorders.
* Dizziness.
* Consequences of a previous acute cerebrovascular event.
* Pregnancy at any stage.
* Acute infectious diseases.
* History of fractures of the pelvis, lower limbs, or vertebral bodies.
* Congenital spinal and limb disorders.
* Any conditions contraindicating physiotherapeutic procedures.
* Patient refusal to participate in the study.
* Inability to participate in follow-up examinations for one year after the injury.
* Participation in other clinical trials.
* Absence of a signed informed vol…
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.