Validation Sonic Bone's Ultrasound System for Bone Age Assessment (BAUS)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 416
- 试验地点
- 1
- 主要终点
- Bone Age Assessment by imaging method using X-Ray
研究概览
简要总结
The selection of talents in junior sports is strongly influenced by the current physical conditions of the athletes. However, the physical abilities, for example in junior football, are largely dependent on the maturation and show a high degree of variability during puberty. For example, the maturity status in an U14 football team fluctuates by up to 5 years between early and late developed players. It is necessary to include the maturation in junior sports in selections in order to give all athletes the same chance of selection regardless of their maturity status. This will make selections fairer and the promotion of athletes with the highest potential will be better implemented. Bone age is considered to be an objective indicator of the maturation. For this purpose, a practicable and preferably radiation-free method for determining bone age is needed. A new medical device promises to determine bone age based on ultrasound technology. This now offers the chance to switch to a significantly less stressful technique. The aim of the study is to determine the quality criteria (validity and reliability) of this new method in order to decide whether the current gold standard of the X-ray method could be replaced by a less stressful method.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 18 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 10-18
- •voluntary participation
- •consent of the participant or legal representative to participate in the project
- •active in a sports club
排除标准
- •pregnancy
结局指标
主要结局
Bone Age Assessment by imaging method using X-Ray
时间窗: 20 minutes
The gold standard is the determination of bone age according to the Tanner \& Whitehouse (TW2) method using an X-ray image of the hand bone and subsequent calculation based on standardized comparison images (Tanner et al., 1975).
Bone Age Assessment using Ultrasound
时间窗: 20 minutes
The bone age is determined by the use of the new medical device according to the instructions for use.
次要结局
未报告次要终点
