Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-25 @ 4:12 AM
NCT ID:
NCT06059820
Eligibility Criteria:
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 voluntary consent for medical interventions and processing of personal data or personal data processing.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT06059820
Study Brief:
Protocol Section:
NCT06059820