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
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Thoracic Spine Fracture
- Sponsor
- Sklifosovsky Institute of Emergency Care
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- Oswestry Disability Index
- Status
- Completed
- Last Updated
- 7 months ago
Overview
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 lumbar spine without neurological deficit
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 immediate and long-term outcomes of conservative therapy in patients with thoracic or lumbar vertebral injuries; * to evaluate the overall cost of surgical and conservative treatment one year post-discharge, as well as the duration of disability in patients with thoracic or lumbar vertebral fractures; * to compare the results of surgical and conservative treatment methods in patients with thoracic or lumbar vertebral fractures. The research focus will be on patients diagnosed with uncomplicated fractures of the thoracic and lumbar spine, classified as type A2 and A3 according to the AOSpine classification. Two patient groups will be formed: The main group (prospective) will consist of patients who underwent conservative therapy. The expected number of observations in the main group will be 40 patients. The control group (historical control) will be comprised of 40 patients who underwent surgery previously at the Sklifosovsky Research Institute for Emergency Medicine. The first stage of conservative therapy will be administered within 7 days at the departments of the Sklifosovsky Research Institute for Emergency Medicine. Subsequently, the patient will be transferred to a rehabilitation center for the second stage of conservative treatment at Branch No. 3 of the State Autonomous Healthcare Institution "Moscow Scientific and Practical Center for Medical Rehabilitation, Restorative and Sports Medicine". The third stage of medical rehabilitation will be carried out at outpatient healthcare facilities based on the patient's place of residence. The study will be considered complete when the data from the final examination of at least 50 patients in each group have been analyzed.
Investigators
Ivan Lvov, MD, PhD
neurosurgeon
Sklifosovsky Institute of Emergency Care
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.
Outcomes
Primary Outcomes
Oswestry Disability Index
Time Frame: admission, 3, 6 and 12 months
This questionnaire allows for a precise numeric assessment of the extent to which an individual's daily functioning is affected by back pain and objectively demonstrates the clinical outcome of the provided treatment. The scale will be applied at all stages of the study, starting from the initial examination and concluding with the follow-up examination one year after intervention. The questionnaire consists of 10 sections, each containing 6 statements. Depending on the response, a score from 0 to 5 is assigned. The maximum total score is 50. Subsequently, the scores are converted into percentages, ranging from 0 to 100%. If one of the sections is not applicable or omitted for ethical reasons, the sum of scores from the remaining 9 sections is divided by 45 to calculate the percentage.
Secondary Outcomes
- EQ-5D-5L(admission, 3, 6 and 12 months)
- ASA(admission)
- The SF-36 v.1 (Standard Form)(admission, 3, 6 and 12 months)
- Rivermead Mobility Index(1, 3, 6 and 12 months)
- Lovett's muscle testing(1, 3, 6 and 12 months)