Ultrasound for Diagnosing Costochondral Joint Separation

March 29, 2025 updated by: Caner İşevi, MD

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

51

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Within the first 24 hours of patient admission.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Caner İşevi, MD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2025

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

December 29, 2024

First Submitted That Met QC Criteria

January 5, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

April 1, 2025

Last Update Submitted That Met QC Criteria

March 29, 2025

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B.30.2.ODM.0.20.08/517

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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