The Use of Ultrasonography as a Diagnostic Tool for the Fracture Management
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Mean Change from Baseline in fracture management using x-ray imaging and medical ultrasound within 8 weeks post-injury
研究概览
简要总结
The bone fracture is usually diagnosed using an X-ray examination (the method of choice). However, in the case of the youngest patients (children and adolescents), it carries a potential risk of X-ray radiation exposure. What is important, an X-ray examination often fails to detect occult fractures or the early stages of a fracture with or without bone fusion. The literature emphasizes that from 2 to 36% of fractures may be unnoticed on X-ray images (false negative results). Therefore, additional possibilities are sought to improve the initial diagnosis.
It was shown that ultrasound could be used instead of the conventional imaging. The most important advantages of the usg are the absence of radiation exposure and greater availability. Moreover, the evaluator is able to show neovascularization during usg examination, which is important in bone healing process.
The aim of this study is (1) to validate the ultrasound imaging method for the fracture management; (2) to use an ultrasound imaging to assess the bone fracture and healing process during 8 weeks post injury.
This study consists of 50 patients aged 10-18 years old. The forearm fracture will be diagnosed using an X-ray imaging as well as an ultrasound imaging in the first 3 days post injury (initial study). It is planned to assess the healing process after 2, 4, 6 and/or 8 weeks post injury (comparative study).
详细描述
The physiological fracture healing is based on the proper facilitation of regeneration and proliferation process. The bone fracture is usually diagnosed using an X-ray examination. However, an ultrasound imaging could be used instead of the conventional imaging. It is important in the case of the youngest patients. In these cases, the Hubner protocol/algorithm is often used. The patients with suspected fracture are advised to perform an ultrasound examination. Only after the confirmation of a suspected fracture, an X-ray examination should be performed.
Bone structure show typical characteristics, which make an ultrasonography an attractive medical diagnostic tool. Highly dense tissues such as bone reflect echoes and, therefore, appear bright white on an ultrasound (reflection from the cortical surface of the bone). This allows bone to be clearly distinguished from the surrounding soft tissues.
It was shown that ultrasound is a good diagnostic tool to assess the fracture healing process. The advantage of usg is that it is non-invasive, does not use ionizing radiation and is performed in a real-time.
The first study about the ultrasound in the diagnosis of fracture was carried out in 1988 in a group of 41 newborns with suspected clavicle fractures after complicated delivery. In all cases, the collarbone fracture was easily identifiable by an ultrasound in the first few days after the injury. Moreover, these data correlated with the conventional X-ray imaging.
It was also shown that the ultrasound method in pediatric patients can be used to visualize fractures, e.g. of the ribs or the sternum. In the acute phase, disturbances in the cortical layer of the bone as well as recent hematoma are easily observed. In the later phase, the formation of a callus (callus hypertrophy) could be diagnosed.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Prospective
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
- 否
入选标准
- •the proximal end of the humerus and the distal end of the radius bones fractures
- •voluntary participation and consent to participate in the study signed by the parent and patient
- •declaration of participation in an X-ray and ultrasound examination during all 8 weeks post-injury
- •no medical contraindications to participate in the study program
排除标准
- •previous injuries of a similar body area
- •plaster immobilization
- •fractures referred for surgery
结局指标
主要结局
Mean Change from Baseline in fracture management using x-ray imaging and medical ultrasound within 8 weeks post-injury
时间窗: through study completion, an average of 1 year
The confirmation of fracture and healing process
Mean Change from Baseline in adhesions development using medical ultrasound within 8 weeks post-injury
时间窗: through study completion, an average of 1 year
The assessment of the development of adhesions (changes in soft tissue image)
Mean Change from Baseline in vascularization on POWER Doppler within 8 weeks post-injury
时间窗: through study completion, an average of 1 year
Mean Change from Baseline in vascularization on POWER Doppler within 8 weeks post-injury
Mean Change from Baseline in Pain Scores on the Visual Analog Scale within 8 weeks post-injury
时间窗: through study completion, an average of 1 year
The changes in pain scale will be assessed using Visual Analogue Scale (VAS) and other specific for the selected injuries. The Visual Analogue Scale (VAS) consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' and 'pain as bad as it could be' (from mild to severe pain).
次要结局
未报告次要终点
研究者
Anna Malwina Kamelska-Sadowska
PhD
University of Warmia and Mazury