Point of Care Ultrasound (POCUS) for Diagnosis and Treatment of Fractures in the Costal Cartilage
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSahlgrenska University Hospital
About this trial
The goal of this observational study is to learn if combining ultrasound and CT scans can better diagnose cartilage fractures in the ribs, and to understand how finding these injuries affects treatment decisions for patients with injuries to the Chest wall.
The main questions it aims to answer are:
* Does using both ultrasound and CT scans find more costal cartilage fractures than CT scans alone? * Does discovering costal cartilage fractures change how patients are treated, such as whether more patients receive surgery or if different fractures are repaired? * How do costal cartilage fractures heal, and do they affect lung function, pain, or the risk of complications after surgery?
Patients with cartilage injuries will be followed up at 1, 3, and 12 months after their injury. They will be checked for pain, instability, and healing using ultrasound and sometimes CT scans. The study will also assess lung function, quality of life, and pain levels.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Trauma patients (≥18 years) treated at the Department of Surgery, Sahlgrenska University Hospital, where CT has shown at least one recent injury to the chest wall.
Disqualifiers
Patients with injuries resulting from CPR, severe head injury, spinal injury, and neurological or musculoskeletal disease affecting chest mobility will be excluded.
Trial population
Patients treated at the Department of Surgery, Sahlgrenska University Hospital
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
100 Participants
are grouped into 1 trial groupGroup A: Study group
Trial outcomes
Primary outcomes
1
Sensitivity and specificity of POCUS for injuries in rib cartilage compared to CT.
Time frame
Index examination at patient inclusion.Secondary outcomes
1
Number of participants where treatment strategy is changed upon identification of cartilage fractures not seen on CT.
When cartilage injuries are detected by POCUS, an assessment is made by the surgeon to determine whether the cartilage fractures affect the indication for surgery and/or which fractures are planned to be fixed. This is a binary outcome which will be answered with "yes" or "no".
Time frame
Assessment made at patient inclusion.2
Clinical healing of fractures in the rib cartilage
Assessment of clinical healing will be made at the follow-up visits at 1, 3 and 12 months. Fractures will be regarded as clinically healed if the patient is not sore at the fracture site and there is no palpable instability. The findings will be related to whether the patient has undergone surgical fixation of rib fractures or not.
Time frame
1, 3 and 12 months after patient inclusion.3
Healing of cartilage fractures assessed with POCUS
At 1, 3 and 12 months follow-up healing will be assessed with POCUS. The fractures will be considered healed if there is no visible fracture line and/or movement at the fracture site. The findings will be related to whether the patient has undergone surgical fixation of rib fractures or not.
Time frame
1, 3 and 12 months after inclusion4
Healing of cartilage fractures assessed with CT
At 3 month follow-up a CT examination will be performed to determine if the fractures are healed, an additional CT examination will be performed at 12 months if healing was not seen at 3 months. Fractures will be considered completely healed if there is no visible fracture line. Fractures with visible fracture line but signs of healing such as callus will be considered partially healed. Fractures with no signs of healing will be considered non-healed. The findings will be related to whether the patient has undergone surgical fixation of rib fractures or not.
Time frame
3 and 12 months after patient inclusion.Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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