COmpartment Syndrome vaLidation Of Non Invasive Assessment of Tissue Pressure (COLONIA)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Diagnostic performance of MyotonPRO
研究概览
简要总结
Chronic Compartment Syndrome (CCS) is a pathology that affects more specifically subjects exposed to repeated movements, particularly in a professional life or sports. The diagnosis is difficult and often delayed.
Currently, the reference technique is invasive. It consists of measuring by a intramuscular puncture (IMP) pressure in the offending compartment early after effort (usually between 1 and 5 minutes post-exercise). A value greater than or equal to 30 mmHg in the first 5 minutes is used as a diagnostic criterion for CCS.
Other less invasive techniques (scintigraphy) exist but are subject to certain discordances of interpretation. The advent of new assessment tools, like the MyotonPRO, pave the way for a non-invasive diagnostic approach.
详细描述
Patients referred for suspected chronic compartment syndrome causing will be included.
After signing the consent, the subject will have a clinical and paraclinical examination. Age, sex, height, weight, side of clinical symptomatology will be collected. Medical history current treatments will also be noted. Once the consent is collected, the patient performs, according to the data of the literature and service habits a stress test aimed at triggering the painful symptomatology associated with post-exercise IMP and MyotonPRO measurements as the same time.
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
- •Affiliation to the French National healthcare system
- •French speaking patients
- •Referred for investigation of compartment syndrome causing
排除标准
- •Pregnancy
- •Inability to understand the study goal
- •Patients protected by decision of law
- •Extended dermatosis
- •Coagulation disorder
结局指标
主要结局
Diagnostic performance of MyotonPRO
时间窗: 3 years
To study the diagnostic performance of tissue stiffness measurement by MyotonPRO at 1 minute post-exercise in patients suspected of anterolateral of leg
次要结局
- Diagnostic performance of MyotonPRO at 5 minute post-exercise(3 years)
- Diagnostic performance of MyotonPRO at 1 minute post-exercise(3 years)