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临床试验/NCT02076607
NCT02076607已完成不适用

Thoracic And Lumbar Burst Fracture: Correlation Between Structural Changes And Clinical Outcome Of Treatment

Hospital Ortopedico de Passo Fundo1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2013年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
25
试验地点
1
主要终点
Clinical and radiological outcome after two years of follow up: Pain (VAS), deformity (degrees) and quality of life (SF36 questionary)

研究概览

简要总结

Evaluate the correlation between the structural changes of fractures of the thoracic and lumbar spine burst type with clinical outcome of the treatment.

详细描述

The treatment of burst fractures of the thoracic and lumbar spine is still a subject of much discussion and debate in the literature, especially in patients without neurological deficit. Most authors recommend surgical treatment for patients whose fracture shows signs of instability: 50% loss of vertebral body height, kyphosis with more than 30 degrees, involvement of more than 50% of the spinal canal. The authors advocate that this type of treatment uses the shorter hospital stay, early patient mobility, better kyphosis correction, the possibility of spinal canal decompression and prevention of neurological deterioration, as arguments in its favor.However, observational studies in patients without neurological deficit, showed no difference in long-term functional outcomes in patients with this type of injury, regardless of the type of treatment used (surgical or conservative). This study will express the clinical results and morphological changes of the thoracic and lumbar spine, at a minimum follow-up of 24 months, comparing the findings of the patients undergoing surgical treatment with those found in undergoing conservative treatment.

研究设计

研究类型
Observational
时间视角
Retrospective

入排标准

年龄范围
22 Years 至 69 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with thoracic or lumbar burst fracture, without neurological lesion treated by the principal investigator of the study and periodically monitored in the Service of the researcher, Orthopedic Hospital of Passo Fundo, with minimum follow-up of 24 months fracture.

排除标准

  • Patients with neurological deficit or who have left before 24 months the follow-up.

结局指标

主要结局

Clinical and radiological outcome after two years of follow up: Pain (VAS), deformity (degrees) and quality of life (SF36 questionary)

时间窗: Over Two Years

Retrospective review of medical records and imaging studies (radiographs and CT scans) of 30 patients without neurological deficit, with fractures of the thoracic and lumbar burst-type, in the archives of the Orthopedic Hospital of Passo Fundo, in the period between 2002 to 2011 submitted the clinical follow-up or post-operative periodical by the principal investigator of the study. The fractures, of the selected patients will be classified according to Magerl et al. (AO). Minimum follow-up is 24 months. It should be emphasized that all patients underwent at follow-up, the measurement of visual analog pain scale (VAS), the SF36 quality of life questionnaire, radiographic measurements of kyphosis, collapse and narrowing of the spinal canal. The clinical results obtained with conservative and surgical treatment will be compared and correlated with the morphological changes presented by the fractured vertebra.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Diego da Silva Collares

Spinal surgery fellow

Hospital Ortopedico de Passo Fundo

研究点 (1)

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