Ultrasound for Diagnosing Costochondral Joint Separation

NCT ID: NCT06766721

Last Updated: 2025-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-01

Study Completion Date

2027-03-01

Brief Summary

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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

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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

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Rib Fractures Thoracic Injuries

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Diagnostic Ultrasound Evaluation

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.

Group Type EXPERIMENTAL

Ultrasound (USG)

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Caner İşevi, MD

OTHER

Sponsor Role lead

Responsible Party

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Caner İşevi, MD

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Ondokuz Mayıs University

Samsun, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Central Contacts

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Caner İşevi, MD

Role: CONTACT

+903623121919 ext. 4240

Facility Contacts

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Caner İşevi, MD

Role: primary

+903623121919 ext. 4240

References

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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.

Reference Type BACKGROUND
PMID: 30548249 (View on PubMed)

Wilkerson 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.

Reference Type BACKGROUND
PMID: 20078434 (View on PubMed)

Other Identifiers

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B.30.2.ODM.0.20.08/517

Identifier Type: -

Identifier Source: org_study_id

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