NL-OMON47142招募中不适用
ORthosis vs No Orthosis after surgically Treated traumatic thoracolumbar fractures - ORNOT-study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 45
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •- Age 18 * 65 years
- •- Traumatic thoracolumbar spine fracture from thoracic 7 * lumbar 4
- •- AO fracture types A-C
- •- Undergoing surgical dorsal fixation for fracture
排除标准
- •- Inadequate knowledge of Dutch language or to fill in questionnaire
- •- Complete or partial spinal cord injury (ASIA A to D)
- •- (Additional) anterior surgical stabilization
- •- Thoracolumbar fracture of other aetiology than traumatic, e.g. pathologic, infectious
- •- Not able to walk before fracturing vertebra
- •- Unable to come to the outpatient clinic (e.g. residing outside the Netherlands)
- •- Injury Severity Score (ISS) * 16
- •- Brain injury with Abbreviated Injury Score (AIS) * 4
- •- Solitary Lumbar 5 fracture
- •- Diagnosed osteoporosis; using bisphosphonates or diagnosed by DEXA-scan
- •- Psychiatric history
- •- Inability to wear an orthosis, most probable reasons:
- •o BMI > 35
- •o Thoraco-abdominal wounds (through trauma or secondary from surgery) on places at which the orthosis contacts the body so aggravation of pain or chances of infection increase significantly.
- •o Pre-existing spine deformities (scoliosis or very severe kyphosis/lordosis) which impair the use of the orthosis or aggravate pain.
研究者
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