Elbow FractureSONOELBNCT05602077
Accuracy of Sonography in Elbow Trauma
A study testing POCUS in people with Elbow Fracture and Radial Head Fracture, run by Eckehart SCHÖLL at 1 site in Switzerland.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Elbow Fracture, Radial Head Fracture, Elbow Sprain
- What is being tested?
- POCUS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Nov 2022to 31 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed Consent signed by the subject
- Suspicion for an indirect elbow trauma as part of the routine management at the ED of the MIK.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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.
Read the detailed 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.
- Conditions
- Elbow Fracture, Radial Head Fracture, Elbow Sprain, Coronoid Process Fracture, Distal Humerus Fracture
- Being tested
- POCUS
- Keywords
- elbow, ultrasound, radial head
- Medical subject headings
- Elbow Fractures, Radial Head and Neck Fractures, Humeral Fractures, Distal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
POCUSDevice
Also called Control Intervention: XR / CBCT
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.
| Study group | Role | What they receive |
|---|---|---|
| POCUS and Control Intervention | Experimental | POCUS: Point of care ultrasound
Control-Intervention: X-ray examination and Cone Beam Computed Tomography (CBCT) Receives: Device: POCUS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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
Measured: within the emergency department stay (1 day)
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
Measured: within the emergency department stay (1 day)
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
Measured: 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
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
Measured: 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
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
Measured: within the emergency department stay (1 day)
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
Measured: within the emergency department stay (1 day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2022
- Study start1 Nov 2022
- Primary completion31 Mar 2025
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Elbow FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective single centre comparative diagnostic accuracy study
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eckehart SCHÖLL
- Sponsor type
- University, hospital or other
- Collaborators
- Basel Academy for Quality and Research in Medicine, Merian Iselin Klinik; Anja Mair (medical specialist), Merian Iselin Klinik; Dr. Thomas Egelhof (head of radiology)
- Responsible party
- Sponsor-investigator, Eckehart SCHÖLL, Merian Iselin Klinik
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05602077
- Sponsor's protocol ID
- SONOELB_Vs_2022_09_12_1.1
- Acronym
- SONOELB
- Status last verified
- Mar 2025
- First submitted
- 22 Oct 2022
- Last updated
- 16 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32507477Pourmand 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.
PubMed 28669695Champagne 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.
PubMed 30691395Hanlon 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.
PubMed 31757256Bianchi 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.
PubMed 32419074De 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.
PubMed 9493728Rutten 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.
PubMed 20848574Malahias 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.
PubMed 30637310Avci 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.
PubMed 27645809Waterbrook 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.
PubMed 23891601Avci 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.
PubMed 31324028Eckert 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.
PubMed 31661558
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Diagnostic Accuracy of Sonography in Indirect Elbow Trauma Compared With Plain X-ray: a Prospective Single Centre Comparative Diagnostic Accuracy Study
- ClinicalTrials.gov ID
- NCT05602077
- Acronym / sponsor ID
- SONOELB / SONOELB_Vs_2022_09_12_1.1
- Conditions
- Elbow Fracture, Radial Head Fracture, Elbow Sprain, Coronoid Process Fracture, Distal Humerus Fracture
- Keywords
- elbow, ultrasound, radial head
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Eckehart SCHÖLLUniversity, hospital or other
- Collaborators
- Basel Academy for Quality and Research in Medicine, Merian Iselin Klinik; Anja Mair (medical specialist), Merian Iselin Klinik; Dr. Thomas Egelhof (head of radiology)
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 1 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective single centre comparative diagnostic accuracy study
| Arm | Type | Receives |
|---|---|---|
| POCUS and Control Intervention | Experimental | Device: POCUSPOCUS: Point of care ultrasound Control-Intervention: X-ray examination and Cone Beam Computed Tomography (CBCT) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Informed Consent signed by the subject
- Suspicion for an indirect elbow trauma as part of the routine management at the ED of the MIK.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| POCUSAlso: Control Intervention: XR / CBCTPOCUS: 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. | Device | POCUS and Control Intervention |
Primary outcome
Difference in diagnostic accuracy of sonography in radial head fractures compared with plain x-ray
Time frame: 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
6 secondary outcomes
Difference in diagnostic accuracy of sonography in other elbow fractures compared with plain x-ray: Fossa olecrani
Time frame: within the emergency department stay (1 day)
Difference in diagnostic accuracy of sonography in other elbow fractures compared with plain x-ray: supracondylar fracture
Time frame: within the emergency department stay (1 day)
Difference in diagnostic accuracy of sonography in other elbow fractures compared with plain x-ray: condylar fracture
Time frame: 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
Time frame: 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
Time frame: within the emergency department stay (1 day)
Difference in diagnostic accuracy of sonography in other elbow fractures compared with plain x-ray: Olecranon fracture
Time frame: within the emergency department stay (1 day)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Results publication: PubMed 32507477Tsou 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.
- Results publication: PubMed 28669695Pourmand 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.
- Results publication: PubMed 30691395Champagne 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.
- Results publication: PubMed 31757256Hanlon 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.
- Results publication: PubMed 32419074Bianchi 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.
- Results publication: PubMed 9493728De 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.
- Results publication: PubMed 20848574Rutten 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.
- Results publication: PubMed 30637310Malahias 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.
- Results publication: PubMed 27645809Avci 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.
- Results publication: PubMed 23891601Waterbrook 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.
- Results publication: PubMed 31324028Avci 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.
- Results publication: PubMed 31661558Eckert 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.
- Individual participant dataSharing planned: No
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Active, not recruiting
Treatment of Olecranon Fractures in the Elderly
Olecranon Fracture
Not yet recruiting
Comparison of GMI, PNF, and Standard Care for Post-Traumatic Elbow Stiffness Rehabilitation in Adults
Elbow Stiffess, Rehabilitation Treatment
Recruiting
This is a Study to Find Out Whether Surgery Using a Metal Plate to Fix a Broken Elbow in Older Adults Leads to Better Recovery and Arm Function Compared to Non-surgical Treatment
Olecranon Fracture
Recruiting
The With Or Without Olecranon K-wires Trial
Olecranon Fracture
Not yet recruitingObservational study
Clinical Outcomes After Treatment of Distal Humerus Fractures With the LORRAINE 2.5/3.5 mm Distal Humerus System
Intra-Articular or Extra-Articular Distal Humerus Fracture, Distal Humerus Fracture
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing POCUS in people with Elbow Fracture and Radial Head Fracture, run by Eckehart SCHÖLL at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in diagnostic accuracy of sonography in radial head fractures compared with plain x-ray (time frame: within the emergency department stay (1 day)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05602077, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.