Incidence of Neurogenic Paraosteoarthropathies (NPOA) in a Population of Brain Traumatized and Spinal Cord Injured Patients and Specific Markers of Early Neurogenic Paraosteoarthropathies Development"
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 118
- 主要终点
- Incidence of Neurogenic Paraosteoarthropathies
研究概览
简要总结
Neurogenic paraosteoarthropathies are peri-articular bone formations that may occur as a result of central neurological injury. Their occurrence limits reeducation and recovery capacities. Neurogenic paraosteoarthropathies sometimes cause complications (pain, joint stiffness, vascular and nerve compression, pressure sores) in patients already suffering from severe neurological sequelae affecting functional prognosis. A lot of clinical research work has been carried out within Dr Salga team. Subsequently, a collaboration was born with fundamental research teams (Pr Levesque, Pr Le Bousse Kerdilès, Pr Banzet, Pr Genêt) allowing translational work between humans and animals. The clinical application of recent research findings now makes it possible to launch the very first prospective study on neurogenic paraosteoarthropathies.
详细描述
Based on the results of collaborative and translational (human-animal) work, investigators wish to conduct the first prospective study that would allow:
(i) To assess the incidence of Neurogenic paraosteoarthropathies (clinical suspicion and radiological confirmation). The prospective nature of this clinical data collection will make it possible to avoid the biases attributed to the retrospective studies conducted to date.
ii) Early detection of patients at risk of developing Neurogenic paraosteoarthropathies, using specific biomarkers and clinical parameters. Early diagnosis could prevent complications and functional impact of Neurogenic paraosteoarthropathies.
Investigators have chosen to restrict population to patients most at risk of developing Neurogenic paraosteoarthropathies as a result of the central neurological event in order to have 2 populations appear at the end of the study: a population with Neurogenic paraosteoarthropathies and a population without Neurogenic paraosteoarthropathies that can be compared.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or Female > 18 years old,
- •brain trauma with initial Glasgow score < 8,
- •or brain trauma with an initial Glasgow score between 8 and 14 associated with an Injury Severity Score (ISS) > 15 and surgery within 24 hours of admission or traumatic spinal cord injury with complete neurological impairment (initial para/tetraplegia),
- •Complete traumatic spinal cord injury. Accident less than 48 hours old
- •Informed consent signed by the patient or a family member
排除标准
- •Age < 18 years,
- •Hemorrhagic shock or blood transfusion greater than or equal to 4 red blood cells within 6 hours of the trauma (also include pre-hospital or first hospital red blood cells)
- •Follow-up impossible over one year,
- •Patient not living in the Paris region,
- •Pregnant or breastfeeding woman,
- •Patient under guardianship or curatorship,
- •No affiliation to a social security scheme or universal mutual fund.
结局指标
主要结局
Incidence of Neurogenic Paraosteoarthropathies
时间窗: 9 months
Determine the incidence of Neurogenic Paraosteoarthropathies within 9 months of a brain trauma and/or spinal cord injury
次要结局
- the prognostic performance(12 months)
- the incidence of Neurogenic Paraosteoarthropathies development within 9 months of a brain trauma(9 months)
- a correlation between clinical parameters identified within 9 months of the neurological event and the occurrence of Neurogenic Paraosteoarthropathies within one year of the trauma,(12 months)
- the incidence of Neurogenic Paraosteoarthropathies development within 9 months of a spinal cord injury,(9 months)
- correlation between biological parameters from blood/plasma, urine and cerebrospinal fluid within 15 days of a central neurological injury and the occurrence of Neurogenic Paraosteoarthropathies within 9 months of the trauma(15 days)
- a clinical-biological risk score for Neurogenic Paraosteoarthropathies within 9 months of the trauma(9 months)