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NCT05602077
Accuracy of Sonography in Elbow Trauma
Conditions: Elbow Fracture, Radial Head Fracture, Elbow Sprain, Coronoid Process Fracture, Distal Humerus Fracture
Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 130
Sponsor: Eckehart SCHÖLL
Location: Switzerland
Summary
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.
Eligibility Criteria
Inclusion Criteria:Informed Consent signed by the subjectSuspicion for an indirect elbow trauma as part of the routine management at the ED of the MIK.Exclusion Criteria:Age below 18Patients who are lacking capacity of judgmentPatients with (temporary) cognitive impairment which makes an understanding of the patient information unlikelyPatients with limited knowledge of German or English which makes an understanding of the patient information unlikelyPatients with contraindications for US, XR or CT.Lack of informed consent
Source: ClinicalTrials.gov (NCT05602077). StuddyBuddy aggregates publicly available trial information.