Creation of a Clinical Database of Lumbar Spine MRI
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 500
- 主要终点
- Establish a database of patients who underwent a MRI exam of the lumbar spine at the Centre Hospitalier Universitaire de Montreal (CHUM) in Canada.
研究概览
简要总结
The creation of a clinical database including patients who suffer from low back pain and underwent a lumbar spine MRI Exam.
This database will allow us to :
- Collect patients symptoms, medical history, and MRI exams
- Launch the annotation of the MRI exams by expert radiologists
- Link and relate information between the exams and the diagnostic done by the experts
- Train and develop a diagnostic platform for th spinal pathologies based on artificial intelligence.
详细描述
Low back pain is classically characterized by pain in the lower back, which may be accompanied by varying degrees of restricted mobility and pain radiating down to the feet. The management of low back pain is a global public health issue, since it represents one of the major causes of disability worldwide.
Degenerative disc disease (DDD) is the most common underlying pathology. These include herniated discs, pinched discs and degenerative spondylolisthesis (slippage of one vertebra in relation to its neighbor). Worldwide, 266 million patients suffer from DDD every year. The socio-economic impact of these pathologies is considerable.
DDD results from a variety of pathologies that may interact with each other. The diversity of these pathologies and the complexity of their interactions often lead to failure of a clear diagnosis, and consequently to inappropriate treatment.
In clinical practice, MRI is the reference test for the diagnosis of these pathologies, but inter-observer reliability remains moderate between 2 practitioners (sensitivity 56% and Cohen's κ ⊂ [0.41-0.6]) or even low (κ ⊂ [0.21-0.4]) between 2 practitioners of different specialties. So there is still a major gap to be bridged in order to make radiologists' diagnoses more reliable and standardized.
In this context, the creation of a clinical database including patient symtoms and exams is of hogh interest.Thsi database will allow us to :
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult patient aged ≥ 18, no age limit;
- •Suffering of low back pain ;
- •Patient exam performed at the Centre Hospiralier Universitaire de Montreal (CHUM), Canada
排除标准
- •Patients with orthopedic material
- •Patients with traumatic cases (ex : accidents)
结局指标
主要结局
Establish a database of patients who underwent a MRI exam of the lumbar spine at the Centre Hospitalier Universitaire de Montreal (CHUM) in Canada.
时间窗: 1 year
次要结局
- Data annotation and developpment of artificial intelligence algorithms(2 years)