Rib FracturesNCT06766721
Ultrasound for Diagnosing Costochondral Joint Separation
A study testing Ultrasound (USG) in people with Rib Fractures and Thoracic Injuries, run by Caner İşevi, MD at 1 site in Turkey (Türkiye).
Trial summary
This study aims to evaluate the diagnostic effectiveness of ultrasound in detecting costochondral joint separation in patients with blunt thoracic trauma. By comparing ultrasound findings to computed tomography (CT) results, the study seeks to determine the sensitivity, specificity, and overall accuracy of ultrasound… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rib Fractures, Thoracic Injuries
- What is being tested?
- Ultrasound (USG)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2025to 1 Oct 2026
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 to 80 years
- Patients with blunt thoracic trauma
- Patients suspected of having costochondral joint separation
- Patients who provide consent for ultrasound and CT imaging
Who cannot join
- Patients under 18 or over 80 years of age
- Patients with penetrating thoracic trauma
- Patients with subcutaneous emphysema that prevents ultrasound evaluation
- Patients allergic to ultrasound gel
- Pregnant patients (as CT imaging is contraindicated)
- Patients unable to undergo CT imaging
- Patients who refuse to participate in the study
- Obese patients (body mass index >30), as ultrasound evaluation may be challenging
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diagnostic Effectiveness of Ultrasound in Costochondral Joint Separation: A Prospective Study
This study aims to evaluate the diagnostic effectiveness of ultrasound in detecting costochondral joint separation in patients with blunt thoracic trauma. By comparing ultrasound findings to computed tomography (CT) results, the study seeks to determine the sensitivity, specificity, and overall accuracy of ultrasound as a diagnostic tool. The results will help improve the diagnosis and management of costochondral injuries while minimizing radiation exposure. The study is a prospective, interventional trial conducted at Ondokuz Mayıs University Faculty of Medicine.
Read the detailed description
This study investigates the diagnostic effectiveness of ultrasound (USG) in identifying costochondral joint separation in patients presenting with blunt thoracic trauma. The study aims to assess USG's sensitivity, specificity, and accuracy compared to computed tomography (CT), which is considered the gold standard.
Costochondral separation, a condition where the connection between the rib and its cartilage is disrupted, is often challenging to diagnose with traditional imaging techniques. Ultrasound offers a non-invasive, portable, and radiation-free alternative, potentially allowing for rapid diagnosis and improved patient outcomes.
Participants will undergo both USG and CT imaging as part of the diagnostic protocol. The primary outcome measure will be the diagnostic accuracy of USG in detecting costochondral joint separation. Secondary outcomes include time to diagnosis, patient comfort, and correlation of ultrasound findings with clinical presentations.
The study will be conducted prospectively at Ondokuz Mayıs University Faculty of Medicine from March 2025 to March 2027, involving a sample size of 51 patients based on power analysis. Data collected will include demographic information, trauma specifics, imaging findings, and clinical outcomes.
The results are expected to contribute significantly to the field of thoracic trauma care by demonstrating the utility of ultrasound in settings where quick and accurate diagnosis is critical.
- Conditions
- Rib Fractures, Thoracic Injuries
- Being tested
- Ultrasound (USG)
- Keywords
- Costochondral Joint Separation, Ultrasound, Blunt Thoracic Trauma, Thoracic Surgery, Computed Tomography
- Medical subject headings
- Rib Fractures, Thoracic Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound (USG)Device
The intervention involves the use of a portable ultrasound (USG) device to assess costochondral joint separation in patients with blunt thoracic trauma. The ultrasound examination will focus on detecting disruptions in the connection between the ribs and cartilage, providing a non-invasive, radiation-free diagnostic method. A 12-MHz linear transducer will be used to scan the rib area for fractures or separations. The findings will be compared to those of computed tomography (CT), considered the gold standard. This intervention is designed to evaluate the accuracy, sensitivity, and specificity of ultrasound as a diagnostic tool in this context.
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic Ultrasound Evaluation | Experimental | All participants will undergo both ultrasound (USG) and computed tomography (CT) imaging as part of the diagnostic protocol. The purpose of this arm is to evaluate the diagnostic accuracy of USG in detecting costochondral joint separation. USG findings will be compared to CT results, which serve as the gold standard, to determine sensitivity, specificity, and accuracy.
This single-arm design ensures all participants receive the same diagnostic procedures without assignment to different groups or interventions. Receives: Device: Ultrasound (USG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Accurate Ultrasound Diagnosis Compared to CT
The diagnostic accuracy (sensitivity, specificity, and overall accuracy) of ultrasound (USG) in detecting costochondral joint separation, using computed tomography (CT) as the reference standard.
Measured: Within the first 24 hours of patient admission.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2025
- Study start1 Dec 2025
- Primary completion1 Sep 2026
- Study completion1 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Rib FracturesStudies 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
- This study employs a single-group design where all participants will undergo both ultrasound (USG) and computed tomography (CT) imaging. The purpose is to evaluate the diagnostic accuracy of USG in detecting costochondral joint separation by comparing its findings with those of CT, considered the gold standard. No control or comparison groups are included in this study.
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Caner İşevi, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Caner İşevi, MD, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06766721
- Sponsor's protocol ID
- B.30.2.ODM.0.20.08/517
- Status last verified
- Dec 2024
- First submitted
- 29 Dec 2024
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Stengel D, Leisterer J, Ferrada P, Ekkernkamp A, Mutze S, Hoenning A. Point-of-care ultrasonography for diagnosing thoracoabdominal injuries in patients with blunt trauma. Cochrane Database Syst Rev. 2018 Dec 12;12(12):CD012669. doi: 10.1002/14651858.CD012669.pub2.
PubMed 30548249Wilkerson RG, Stone MB. Sensitivity of bedside ultrasound and supine anteroposterior chest radiographs for the identification of pneumothorax after blunt trauma. Acad Emerg Med. 2010 Jan;17(1):11-7. doi: 10.1111/j.1553-2712.2009.00628.x.
PubMed 20078434
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Effectiveness of Ultrasound in Costochondral Joint Separation: A Prospective Study
- ClinicalTrials.gov ID
- NCT06766721
- Acronym / sponsor ID
- B.30.2.ODM.0.20.08/517
- Conditions
- Rib Fractures, Thoracic Injuries
- Keywords
- Costochondral Joint Separation, Ultrasound, Blunt Thoracic Trauma, Thoracic Surgery, Computed Tomography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Caner İşevi, MDUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 1 Sep 2026 (actual)
- Study completion
- 1 Oct 2026 (actual)
- First posted
- 9 Jan 2025 (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.
This study aims to evaluate the diagnostic effectiveness of ultrasound in detecting costochondral joint separation in patients with blunt thoracic trauma. By comparing ultrasound findings to computed tomography (CT) results, the study seeks to determine the sensitivity, specificity, and overall accuracy of ultrasound as a diagnostic tool. The results will help improve the diagnosis and management of costochondral injuries while minimizing radiation exposure. The study is a prospective, interventional trial conducted at Ondokuz Mayıs University Faculty of Medicine.
Detailed description
This study investigates the diagnostic effectiveness of ultrasound (USG) in identifying costochondral joint separation in patients presenting with blunt thoracic trauma. The study aims to assess USG's sensitivity, specificity, and accuracy compared to computed tomography (CT), which is considered the gold standard.
Costochondral separation, a condition where the connection between the rib and its cartilage is disrupted, is often challenging to diagnose with traditional imaging techniques. Ultrasound offers a non-invasive, portable, and radiation-free alternative, potentially allowing for rapid diagnosis and improved patient outcomes.
Participants will undergo both USG and CT imaging as part of the diagnostic protocol. The primary outcome measure will be the diagnostic accuracy of USG in detecting costochondral joint separation. Secondary outcomes include time to diagnosis, patient comfort, and correlation of ultrasound findings with clinical presentations.
The study will be conducted prospectively at Ondokuz Mayıs University Faculty of Medicine from March 2025 to March 2027, involving a sample size of 51 patients based on power analysis. Data collected will include demographic information, trauma specifics, imaging findings, and clinical outcomes.
The results are expected to contribute significantly to the field of thoracic trauma care by demonstrating the utility of ultrasound in settings where quick and accurate diagnosis is critical.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study employs a single-group design where all participants will undergo both ultrasound (USG) and computed tomography (CT) imaging. The purpose is to evaluate the diagnostic accuracy of USG in detecting costochondral joint separation by comparing its findings with those of CT, considered the gold standard. No control or comparison groups are included in this study.
| Arm | Type | Receives |
|---|---|---|
| Diagnostic Ultrasound Evaluation | Experimental | Device: Ultrasound (USG)All participants will undergo both ultrasound (USG) and computed tomography (CT) imaging as part of the diagnostic protocol. The purpose of this arm is to evaluate the diagnostic accuracy of USG in detecting costochondral joint separation. USG findings will be compared to CT results, which serve as the gold standard, to determine sensitivity, specificity, and accuracy. This single-arm design ensures all participants receive the same diagnostic procedures without assignment to different groups or interventions. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged 18 to 80 years
- Patients with blunt thoracic trauma
- Patients suspected of having costochondral joint separation
- Patients who provide consent for ultrasound and CT imaging
Key exclusion criteria (8 listed)
- Patients under 18 or over 80 years of age
- Patients with penetrating thoracic trauma
- Patients with subcutaneous emphysema that prevents ultrasound evaluation
- Patients allergic to ultrasound gel
- Pregnant patients (as CT imaging is contraindicated)
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 |
|---|---|---|
| Ultrasound (USG)The intervention involves the use of a portable ultrasound (USG) device to assess costochondral joint separation in patients with blunt thoracic trauma. The ultrasound examination will focus on detecting disruptions in the connection between the ribs and cartilage, providing a non-invasive, radiation-free diagnostic method. A 12-MHz linear transducer will be used to scan the rib area for fractures or separations. The findings will be compared to those of computed tomography (CT), considered the gold standard. This intervention is designed to evaluate the accuracy, sensitivity, and specificity of ultrasound as a diagnostic tool in this context. | Device | Diagnostic Ultrasound Evaluation |
Primary outcome
Number of Participants with Accurate Ultrasound Diagnosis Compared to CT
Time frame: Within the first 24 hours of patient admission.
The diagnostic accuracy (sensitivity, specificity, and overall accuracy) of ultrasound (USG) in detecting costochondral joint separation, using computed tomography (CT) as the reference standard.
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 19 Oct 2026.
- Results publication: PubMed 30548249Stengel D, Leisterer J, Ferrada P, Ekkernkamp A, Mutze S, Hoenning A. Point-of-care ultrasonography for diagnosing thoracoabdominal injuries in patients with blunt trauma. Cochrane Database Syst Rev. 2018 Dec 12;12(12):CD012669. doi: 10.1002/14651858.CD012669.pub2.
- Results publication: PubMed 20078434Wilkerson RG, Stone MB. Sensitivity of bedside ultrasound and supine anteroposterior chest radiographs for the identification of pneumothorax after blunt trauma. Acad Emerg Med. 2010 Jan;17(1):11-7. doi: 10.1111/j.1553-2712.2009.00628.x.
- Individual participant dataSharing planned: Yes
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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 Ultrasound (USG) in people with Rib Fractures and Thoracic Injuries, run by Caner İşevi, MD at 1 site in Turkey (Türkiye).
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 4 inclusion and 8 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 19 Oct 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 Turkey (Türkiye). 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?
Number of Participants with Accurate Ultrasound Diagnosis Compared to CT (time frame: Within the first 24 hours of patient admission.). 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 NCT06766721, which also lists 2 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 19 Oct 2026; AzTrials last refreshed its copy on 6 Nov 2026.