The Diagnostic Accuracy of Sonography in Indirect Elbow Trauma Compared With Plain X-ray: a Prospective Single Centre Comparative Diagnostic Accuracy Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Difference in diagnostic accuracy of sonography in radial head fractures compared with plain x-ray
研究概览
简要总结
X-rays (XR) are today the standard modality for the diagnosis of bone fractures in the lower or upper limbs in the emergency room. Point-of-care ultrasound (POCUS) is an alternative with some obvious advantages especially in the emergency room setting: It does not require the patient to fix the bone of interest in a stable position, allows observing the bone and joints under movement by the patient, can be performed at bedside, and avoids the exposure to radiation.
The advances in ultrasound technology has increased the interest in using POCUS as an alternative to XR in recent years. POCUS is used routinely prior to XR at the ORTHO-NOTFALL of the Merian Iselin Klinik Basel (MIK) in patients with suspicion for an indirect elbow trauma. It is the aim of this project to use this constellation in order to contribute to a systematic comparison of the value of the two modalities with the long-term aim to establish POCUS as the first-line diagnostic tool.
As a fist project, the SONOELB study was initiated. This study aims at a comparison of the diagnostic accuracy between XR and POCUS using CT as reference. The project started in October 2022 and aims at enrolling 130 patients until March 2025. The project is financially supported by the Merian Iselin Science Research PLC.
详细描述
Objective:
The primary objective is to compare the diagnostic accuracy of POCUS and XR with respect to diagnosing fractures of the elbow after an indirect elbow trauma in the ED setting and to investigate the rate of agreement between the two modalities.
The primary outcome is the difference in diagnostic accuracy between the two modalities with respect to diagnosing a radial head fracture and the degree of agreement between the two modalities.
Secondary outcomes are the difference in diagnostic accuracy between the two modalities and the rate of agreement with respect to the other fracture types, to the decisions "any fracture", and to the decision "any fracture other than radial head".
Experimental Intervention (medical device) POCUS: The ultrasound examination of the injured elbow includes seven standard settings. The probe is placed on the joint in four ventral and in three posterior positions. If hemarthrosis is detected, this is always suspicious of a possible intra-articular fracture. Even the smallest amounts of blood can be detected sonographically.
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
盲法说明
The two modalities to be compared (POCUS and XR) and the reference standard (CBCT) will be applied in a consecutive series of 130 patients with a suspicion of an indirect elbow fracture at the emergency department of a single center. All investigations will be part of the initial, single visit of the patient at the emergency department.
The modalities will be evaluated blinded for each other. The design is well known as a comparative, paired accuracy study. The design allows to estimate the accuracy of the two diagnostic modalities and the corresponding difference as well as the agreement between the two modalities.
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
- •Informed Consent signed by the subject
- •Suspicion for an indirect elbow trauma as part of the routine management at the ED of the MIK.
排除标准
- •Age below 18
- •Patients who are lacking capacity of judgment
- •Patients with (temporary) cognitive impairment which makes an understanding of the patient information unlikely
- •Patients with limited knowledge of German or English which makes an understanding of the patient information unlikely
- •Patients with contraindications for US, XR or CT.
- •Lack of informed consent
研究组 & 干预措施
POCUS and Control Intervention
POCUS: Point of care ultrasound
Control-Intervention: X-ray examination and Cone Beam Computed Tomography (CBCT)
干预措施: POCUS (Device)
结局指标
主要结局
Difference in diagnostic accuracy of sonography in radial head fractures compared with plain x-ray
时间窗: within the emergency department stay (1 day)
In order to assess the diagnostic accuracy, CBCT is used as a reference standard in all patients. The findings from the POCUS, XR, and CBCT with respect to a fracture of the radial head are documented on three different CRFs: POCUS, XR, CBCT. CRF POCUS (7 views): unaffected(Y/N) - haemarthros (y/n) - fractures of the different parts CRF XR: (ap/lateral/Norman): unaffected(Y/N) - fat pad sign (y/n) - fractures of the different parts CRF CBCT: unaffected(Y/N) - fractures of the different parts
次要结局
- Difference in diagnostic accuracy of sonography in other elbow fractures compared with plain x-ray: supracondylar fracture(within the emergency department stay (1 day))
- Difference in diagnostic accuracy of sonography in other elbow fractures compared with plain x-ray: Fossa olecrani(within the emergency department stay (1 day))
- Difference in diagnostic accuracy of sonography in other elbow fractures compared with plain x-ray: condylar fracture(within the emergency department stay (1 day))
- Difference in diagnostic accuracy of sonography in other elbow fractures compared with plain x-ray: capitulum humeri fracture(within the emergency department stay (1 day))
- Difference in diagnostic accuracy of sonography in other elbow fractures compared with plain x-ray: Olecranon fracture(within the emergency department stay (1 day))
- Difference in diagnostic accuracy of sonography in other elbow fractures compared with plain x-ray: Coronoid process fracture(within the emergency department stay (1 day))
研究者
Eckehart SCHÖLL
Head of Emergency Department
Merian Iselin Klinik