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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Oswestry Disability Index
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Oswestry Disability Index
时间窗: 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.
次要结局
- 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)
研究者
Ivan Lvov, MD, PhD
neurosurgeon
Sklifosovsky Institute of Emergency Care