Accuracy of Sonography in Elbow Trauma

Elbow Fracture Clinical Trial

— SONOELB  

Official title:

The Diagnostic Accuracy of Sonography in Indirect Elbow Trauma Compared With Plain X-ray: a Prospective Single Centre Comparative Diagnostic Accuracy Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05602077
• Other study ID #: SONOELB_Vs_2022_09_12_1.1
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: March 31, 2025

Study information

• Verified date: March 2023
• Source: Merian Iselin Klinik
• Contact: Eckehart Schöll, MD
• Phone: 0049 151 423 01 556
• Email: eckehart.schoell[@]merianiselin.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

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.

POCUS will be performed according to the local SOP.

Control Intervention (standard/routine/comparator) XR: The conventional radiograph of the injured elbow consists of three standard views: ap, lateral and Norman oblique. This X-ray examination is the most commonly performed technique to date to diagnose an injured elbow.

CBCT (Cone Beam Computed Tomography): The injured elbow is placed in an almost most extended position in the CBCT tube. For this purpose, the affected arm is placed and fixed on a carbon-splint. The examination time is about 40 seconds XR will be performed according to the standard procedures of the ED of the MIK. The same holds for CBCT.

Any of the three diagnostic procedures applied can be discontinued in the case of patient discomfort, harm, or risk of harm according to the standard procedures of the MIK.

Compliance of the staff of the ED with performing the three modalities is supported by SOPs and internal training.

In the case of withdrawal of a patient, the reasons are recorded on the CRF. The data of these patients will not be included in the statistical analysis. The data will not be deleted in the data management system. Patients who withdraw themselves are offered a chat with the PI and further consultations.

Patients included in the trial will follow the standard management at the MIK. There are only two changes:

• a CBCT is performed in addition after having performed both POCUS and XR, if there are no positive findings on POCUS or XR.

• an additional blinded evaluation of all CBCTs will be done by one independent rater.

CBCT will be ordered by the staff of the ED in all patients and may be preliminary evaluated. However, these evaluations will not be documented as part of this study. They are also not accessible for the staff at the Radiology Department in the routine evaluation of the XRs.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Distal Humerus Fracture
• Elbow Fracture
• Elbow Sprain
• Fractures, Bone
• Humeral Fractures
• Radial Head Fracture

Intervention

Device:
• POCUS
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.

Locations

Country	Name	City	State
Switzerland	Merian Iselin Klinik	Basel

Sponsors (4)

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)

Country where clinical trial is conducted

Switzerland, 

References & Publications (12)

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. — View Citation

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

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. — View Citation

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/s — View Citation

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: 10.1097/00004424-199802000-00 — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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 — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

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)