Clinical trial NCT06766721: Ultrasound for Diagnosing Costochondral Joint Separation
Official title: Diagnostic Effectiveness of Ultrasound in Costochondral Joint Separation: A Prospective Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Rib Fractures
Thoracic Injuries
Keywords: Costochondral Joint Separation
Ultrasound
Blunt Thoracic Trauma
Thoracic Surgery
Computed Tomography
Lead sponsor: Ondokuz Mayıs University
Sponsor class: OTHER
First posted: 2025-01-09
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: DIAGNOSTIC

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants with Accurate Ultrasound Diagnosis Compared to CT
timeFrame: Within the first 24 hours of patient admission.
Secondary outcomes:
Other outcomes:
Locations:
city: Samsun
country: Turkey
facility: Ondokuz Mayıs University
Study officials:
References:
citation: 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.
citation: 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.