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 range18 Years – 65 Years
SexALL
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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…