Contribution of ESAOTE™ Low Field MRI for Diagnosis of Scaphoid Fractures.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- MRI and radiography interpretation items
研究概览
简要总结
The Alpes Maritimes county administration (France) equipped Nice University Hospital of a 0,2T low field MRI dedicated to distal articulations, devoted to research, installed in the medical imaging unit.
The aim of our project is to study its interest in diagnosis of scaphoid fractures.
Conventional medical care for patients being suspected to have a scaphoid fracture consists in performing a clinical examination and a radiographic check-up with at least 4 incidences, which 2 specific incidences for the scaphoid bone.
Yet, this check up is sometimes defective, causing false positives unnecessary immobilisation and false negatives delays in patient medical care, increasing the risk of complication. Those diagnosis mistakes can bring serious consequences, from permanent partial inability, to professional reclassification.
Alternative imaging exists, but is often irradiating, and never reaches the optimal specificity and sensitivity.
MRI is totally safe, and allows to affirm or invalidate the diagnosis in almost 100% of cases. The problem is the lack of accessibility for emergency cases; therefore there is a great interest in validating the use of a MRI dedicated to distal articulations.
The few studies that study costs of diagnosis strategies including MRI in scaphoid bone fractures diagnosis show a reduction of medical costs if this technique is used early. Our project represents an essential initial step in evaluating the impact of a low field MRI dedicated to peripheral articulations in diagnosis of scaphoid fractures. The next step will be a medico-economical study, since scaphoid fractures occur frequently.
Finally, a new consensus for medical care of scaphoid fracture suspicions could be proposed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical suspicion of scaphoid bone fracture, whatever the radiologic check-up result is.
- •Major patient who signed the informed consent form.
- •Patient affiliated to French national health and pensions organization. NON INCLUSION
- •MRI contraindication.
- •No traumatic antecedent.
- •Pregnant or suckler women.
- •Patient under a guardianship or a trusteeship
- •Patient deprived of liberty consequently to a judiciary procedure
- •Patient holding a pace-maker
- •Patient holding a foreign body or ferromagnetic prosthetic material.
排除标准
- 未提供
结局指标
主要结局
MRI and radiography interpretation items
时间窗: The day of the scaphoid fracture
comparaison between MRI and radiography interpretation items
次要结局
未报告次要终点
