Status:
COMPLETED
Effectiveness of Conservative Treatment in Patients With Thoracic and Lumbar Fractures Without Neurological Deficit
Lead Sponsor:
Sklifosovsky Institute of Emergency Care
Conditions:
Thoracic Spine Fracture
Lumbar; Spine, Fracture
Eligibility:
All Genders
18-65 years
Brief 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...
Detailed Description
The main objectives of the upcoming study include: * to conduct a retrospective analysis of the surgical treatment outcomes in patients with thoracic or lumbar vertebral fractures; * to assess the im...
Eligibility Criteria
Inclusion
- 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
- 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 voluntary consent for medical interventions and processing of personal data or personal data processing.
Key Trial Info
Start Date :
November 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 29 2025
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06059820
Start Date
November 1 2023
End Date
September 29 2025
Last Update
October 3 2025
Active Locations (2)
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1
Sklifosovsky Research Institute for Emergency Medicine
Moscow, Russia, 107045
2
Moscow Scientific and Practical Center for Medical Rehabilitation, Restorative and Sports Medicine
Moscow, Russia, 111674