Weight-Bearing Cone Beam CT Arthrogram of the Ankle: a Lower Radiation Dose Technique to Evaluate Osteo-chondral Lesions or Cartilage Lesions: Is it the Future of the arthroCT?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Localisation of the lesions
研究概览
简要总结
This study aims to compare weight-bearing Cone Beam CT arthrogram and conventional CT arthrogram in assessement of patients with ankle osteo-chondral or cartilage lesions.
详细描述
Weight-bearing Cone Beam CT (CBCT) arthrogram, a technique with less radiation dose than conventional CT, is hypothesized non-inferior to conventional CT arthrogram to diagnose osteo-chondral (OCL) or cartilage lesions of the ankle.
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
- •Patients aged ≥ 18 years;
- •Patients require CT arthrogram of the ankle;
- •Affiliated to a social security schema;
- •Informed consent signed by patients.
排除标准
- •Pregnant women;
- •Impossibility of injection of intra-articular contrast product;
- •Hypersensitivity reactions to iodinated contrast agent;
- •Patient refusal;
- •Patient under french AME scheme;
- •Patient under guardianship by tutor or curator.
研究组 & 干预措施
Conventional CT-arthrogram + CBCT arthrogram
Conventional CT-arthrogram + CBCT arthrogram (CBCT in the minutes following the conventional CT arthrogram).
Routine care (arthroCT) and CBCT of ankle.
干预措施: ArthroCT scan (Procedure)
Conventional CT-arthrogram + CBCT arthrogram
Conventional CT-arthrogram + CBCT arthrogram (CBCT in the minutes following the conventional CT arthrogram).
Routine care (arthroCT) and CBCT of ankle.
干预措施: CBCT (Procedure)
结局指标
主要结局
Localisation of the lesions
时间窗: at baseline
Localisation of cartilage and osteochondral lesions assessed by CT scan
Number of the lesions
时间窗: at baseline
Number of cartilage and osteochondral lesions assessed by CT scan
Size of the lesions
时间窗: at baseline
Size of cartilage and osteochondral lesions assessed by CT scan
Unstable displaced lesions
时间窗: at baseline
Displaced osteochondral fragment in the joint.
Unstable non-displaced lesions
时间窗: at baseline
Contrast enhanced fluid from the arthrogram surrounding the osteochondral fragment.
次要结局
未报告次要终点