Elbow Fracture Clinical Trial
— SONOELBOfficial title:
The Diagnostic Accuracy of Sonography in Indirect Elbow Trauma Compared With Plain X-ray: a Prospective Single Centre Comparative Diagnostic Accuracy Study
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.
Status | Recruiting |
Enrollment | 130 |
Est. completion date | March 31, 2025 |
Est. primary completion date | March 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Informed Consent signed by the subject - Suspicion for an indirect elbow trauma as part of the routine management at the ED of the MIK. Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Switzerland | Merian Iselin Klinik | Basel |
Lead Sponsor | Collaborator |
---|---|
Eckehart SCHÖLL | Basel Academy for Quality and Research in Medicine; Prof. Dr. Werner Vach (Statistician), Merian Iselin Klinik; Anja Mair (medical specialist), Merian Iselin Klinik; Dr. Thomas Egelhof (head of radiology) |
Switzerland,
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Avci M, Kozaci N, Tulubas G, Caliskan G, Yuksel A, Karaca A, Doganay F, Etli I. Comparison of Point-of-Care Ultrasonography and Radiography in the Diagnosis of Long-Bone Fractures. Medicina (Kaunas). 2019 Jul 9;55(7):355. doi: 10.3390/medicina55070355. — View Citation
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* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Difference in diagnostic accuracy of sonography in radial head fractures compared with plain x-ray | 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 |
within the emergency department stay (1 day) | |
Secondary | Difference in diagnostic accuracy of sonography in other elbow fractures compared with plain x-ray: Fossa olecrani | 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".
Fossa olecrani fractures as part of the distal humerus 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 |
within the emergency department stay (1 day) | |
Secondary | Difference in diagnostic accuracy of sonography in other elbow fractures compared with plain x-ray: supracondylar fracture | 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".
Supracondylar fractures as part of the distal humerus 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 |
within the emergency department stay (1 day) | |
Secondary | Difference in diagnostic accuracy of sonography in other elbow fractures compared with plain x-ray: condylar fracture | 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".
medial or lateral fractures as part of the distal humerus 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 |
within the emergency department stay (1 day) | |
Secondary | Difference in diagnostic accuracy of sonography in other elbow fractures compared with plain x-ray: capitulum humeri fracture | 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".
capitulum humeri fracture as part of the distal humerus 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 |
within the emergency department stay (1 day) | |
Secondary | Difference in diagnostic accuracy of sonography in other elbow fractures compared with plain x-ray: Coronoid process fracture | 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".
Coronoid process fracture as part of the proximal ulna 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 |
within the emergency department stay (1 day) | |
Secondary | Difference in diagnostic accuracy of sonography in other elbow fractures compared with plain x-ray: Olecranon fracture | 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".
Olecranon fracture as part of the proximal ulna 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 |
within the emergency department stay (1 day) |
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