Effectiveness of Conservative Treatment in Patients With Thoracic and Lumbar Fractures Without Neurological Deficit

Launched by SKLIFOSOVSKY INSTITUTE OF EMERGENCY CARE · Sep 22, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of two different treatment approaches for patients with fractures in the thoracic (upper) and lumbar (lower) spine who do not have any nerve damage. The main goal is to compare conservative treatment, which might include methods like rest, physical therapy, and medication, against surgical treatment. The researchers want to see which method leads to better long-term recovery outcomes for these patients.

To be eligible for the trial, participants need to be between 18 and 65 years old and have a specific type of single vertebra fracture without any signs of nerve issues. They should not have any serious health conditions or previous spinal surgeries that could complicate their participation. People who join the study can expect to be monitored over the course of a year, allowing researchers to gather important information about their recovery. This study is currently recruiting participants, and it aims to provide valuable insights into the best treatment options for spine fractures.

Gender

ALL

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.