Accuracy of Sonography in Elbow Trauma

NCT05602077 | Completed

• 1 other identifier: SONOELB_Vs_2022_09_12_1.1
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Elbow Fracture; Radial Head Fracture; Elbow Sprain; Coronoid Process Fracture; Distal Humerus Fracture

Keywords

elbow; ultrasound; radial head

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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: supracondylar fracture

  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: Coronoid process fracture

  within the emergency department stay (1 day)

Study Arms (1)

POCUS and Control Intervention

EXPERIMENTAL

POCUS: Point of care ultrasound Control-Intervention: X-ray examination and Cone Beam Computed Tomography (CBCT)

Device: POCUS

Interventions

POCUS 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. The surfaces of the bones involved in the joint (humerus, ulna, radius) are accurately displayed in all seven sonography settings. Disrupted bone surface indicates a fracture. XR: The conventional radiograph of the injured elbow consists of three standard views: ap, lateral and Norman oblique. CBCT: The injured elbow is placed in an almost most extended position in the CBCT tube.

Also known as: Control Intervention: XR / CBCT

POCUS and Control Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed Consent signed by the subject
• Suspicion for an indirect elbow trauma as part of the routine management at the ED of the MIK.

You may not qualify if:

• 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

Sponsors & Collaborators

• Eckehart SCHÖLL: lead
• Basel Academy for Quality and Research in Medicine; Prof. Dr. Werner Vach (Statistician): collaborator
• Merian Iselin Klinik; Anja Mair (medical specialist): collaborator
• Merian Iselin Klinik; Dr. Thomas Egelhof (head of radiology): collaborator

Study Sites (1)

Merian Iselin Klinik

Basel, 4009, Switzerland

Location

Related Publications (12)

• Tsou PY, Ma YK, Wang YH, Gillon JT, Rafael J, Deanehan JK. Diagnostic accuracy of ultrasound for upper extremity fractures in children: A systematic review and meta-analysis. Am J Emerg Med. 2021 Jun;44:383-394. doi: 10.1016/j.ajem.2020.04.071. Epub 2020 Apr 27.

  PMID: 32507477 RESULT

• Pourmand A, Shokoohi H, Maracheril R. Diagnostic accuracy of point-of-care ultrasound in detecting upper and lower extremity fractures: An evidence-based approach. Am J Emerg Med. 2018 Jan;36(1):134-136. doi: 10.1016/j.ajem.2017.06.052. Epub 2017 Jun 27. No abstract available.

  PMID: 28669695 RESULT

• Champagne N, Eadie L, Regan L, Wilson P. The effectiveness of ultrasound in the detection of fractures in adults with suspected upper or lower limb injury: a systematic review and subgroup meta-analysis. BMC Emerg Med. 2019 Jan 28;19(1):17. doi: 10.1186/s12873-019-0226-5.

  PMID: 30691395 RESULT

• Hanlon DP, Mavrophilipos V. The Emergent Evaluation and Treatment of Elbow and Forearm Injuries. Emerg Med Clin North Am. 2020 Feb;38(1):81-102. doi: 10.1016/j.emc.2019.09.005.

  PMID: 31757256 RESULT

• Bianchi S. Ultrasound and bone: a pictorial review. J Ultrasound. 2020 Sep;23(3):227-257. doi: 10.1007/s40477-020-00477-4. Epub 2020 May 17.

  PMID: 32419074 RESULT

• De Maeseneer M, Jacobson JA, Jaovisidha S, Lenchik L, Ryu KN, Trudell DR, Resnick D. Elbow effusions: distribution of joint fluid with flexion and extension and imaging implications. Invest Radiol. 1998 Feb;33(2):117-25. doi: 10.1097/00004424-199802000-00010.

  PMID: 9493728 RESULT

• Rutten MJ, Collins JM, de Waal Malefijt MC, Kiemeney LA, Jager GJ. Unsuspected sonographic findings in patients with posttraumatic shoulder complaints. J Clin Ultrasound. 2010 Nov-Dec;38(9):457-65. doi: 10.1002/jcu.20745.

  PMID: 20848574 RESULT

• Malahias MA, Manolopoulos PP, Kadu V, Shahpari O, Fagkrezos D, Kaseta MK. Bedside Ultrasonography for Early Diagnosis of Occult Radial Head Fractures in Emergency Room: A CT-Comparative Diagnostic Study. Arch Bone Jt Surg. 2018 Nov;6(6):539-546.

  PMID: 30637310 RESULT

• Avci M, Kozaci N, Beydilli I, Yilmaz F, Eden AO, Turhan S. The comparison of bedside point-of-care ultrasound and computed tomography in elbow injuries. Am J Emerg Med. 2016 Nov;34(11):2186-2190. doi: 10.1016/j.ajem.2016.08.054. Epub 2016 Aug 27.

  PMID: 27645809 RESULT

• Waterbrook AL, Adhikari S, Stolz U, Adrion C. The accuracy of point-of-care ultrasound to diagnose long bone fractures in the ED. Am J Emerg Med. 2013 Sep;31(9):1352-6. doi: 10.1016/j.ajem.2013.06.006. Epub 2013 Jul 26.

  PMID: 23891601 RESULT

• 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.

  PMID: 31324028 RESULT

• Eckert M, Vach W. On the use of comparison regions in visualizing stochastic uncertainty in some two-parameter estimation problems. Biom J. 2020 May;62(3):598-609. doi: 10.1002/bimj.201800232. Epub 2019 Oct 29.

  PMID: 31661558 RESULT

MeSH Terms

Conditions

Elbow Fractures; Radial Head and Neck Fractures; Humeral Fractures, Distal

Condition Hierarchy (Ancestors)

Elbow Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone; Radius Fractures; Forearm Injuries; Humeral Fractures

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: 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.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Emergency Department

Model Details: Prospective single centre comparative diagnostic accuracy study

Study Record Dates

• First Submitted: October 22, 2022
• First Posted: November 1, 2022
• Study Start: November 1, 2022
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: April 16, 2026

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)