Ultrasound for Diagnosing Costochondral Joint Separation

NCT06766721 | Not Yet Recruiting

• 1 other identifier: B.30.2.ODM.0.20.08/517
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Rib Fractures; Thoracic Injuries

Keywords

Costochondral Joint Separation; Ultrasound; Blunt Thoracic Trauma; Thoracic Surgery; Computed Tomography

Outcome Measures

Primary Outcomes (1)

• 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.

  Within the first 24 hours of patient admission.

Study Arms (1)

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.

Device: Ultrasound (USG)

Interventions

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.

Diagnostic Ultrasound Evaluation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Caner İşevi, MD: lead

Study Sites (1)

Ondokuz Mayıs University

Samsun, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 30548249 BACKGROUND

• 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.

  PMID: 20078434 BACKGROUND

MeSH Terms

Conditions

Rib Fractures; Thoracic Injuries

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Central Study Contacts

Caner İşevi, MD

CONTACT

+903623121919; drcanerisevi@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: December 29, 2024
• First Posted: January 9, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: April 1, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share

Locations

TU (1)