Comparing conservative and surgical treatments for thoracic and lumbar spine fractures without nerve damage
Prospective Cohort Study of the Effectiveness of Conservative Treatment in Patients With AOSpine Type A2 and A3 Fractures of the Thoracic and Lumbar Spine Without Neurological Deficit
This study is trying to see if treating thoracic and lumbar spine fractures without nerve damage with either surgery or conservative methods leads to better long-term results for patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Sklifosovsky Institute of Emergency Care Government |
| Locations | 2 sites (Moscow and 1 other locations) |
| Trial ID | NCT06059820 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the long-term clinical outcomes of conservative therapy versus surgical treatment in patients with thoracic and lumbar spine fractures that do not involve neurological deficits. It will involve a retrospective analysis of surgical outcomes and a prospective assessment of conservative treatment outcomes. The study will also analyze the costs associated with both treatment methods and the duration of disability experienced by patients. A total of 80 patients will be included, with 40 receiving conservative treatment and 40 serving as a historical control group who underwent surgery.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 65 with isolated type A2 or A3 thoracic or lumbar vertebral fractures and no neurological deficits.
Not a fit: Patients with significant comorbidities, previous spinal surgeries, or severe osteoporosis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the most effective treatment options for patients with thoracic and lumbar spine fractures, potentially improving patient outcomes and reducing healthcare costs.
How similar studies have performed: Previous studies have shown varying success with conservative treatment approaches for spine fractures, but this specific comparison of conservative versus surgical methods in this patient population is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Moscow and 1 other locations
- Sklifosovsky Research Institute for Emergency Medicine — Moscow, Russian Federation (Recruiting)
- Moscow Scientific and Practical Center for Medical Rehabilitation, Restorative and Sports Medicine — Moscow, Russian Federation (Not_yet_recruiting)
Study contacts
- Principal investigator: Vasiliy Karanadze, MD, PhD — Sklifosovsky Research Institute for Emergency Medicine
- Study coordinator: Vasiliy Karanadze, MD, PhD
- Email: karanadzev@mail.ru
- Phone: +79035656830
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.