Point of Care Ultrasound (POCUS) for Diagnosis and Treatment of Fractures in the Costal Cartilage
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Rib Fracture, Cartilage Damage. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Detailed description
Rib fractures occur in one tenth of patients with traumatic injuries. Our knowledge about the treatment of patients with rib fractures has increased in recent years, as interest in surgical treatment of these fractures has grown. We now know more about the healing process for both surgically and conservatively treated rib fractures than we did before. Fractures in the rib cartilage are less studied. We still know very little about how fractures in the rib cartilage heal and how to approach these fractures during surgical treatment. They are also more difficult to diagnose radiologically than fractures in the bone itself.
Computed tomography (CT) is the best radiological method for diagnosing rib fractures. CT with 3D reconstructions is also a valuable preoperative mapping tool for patients who are to undergo stabilizing surgery for rib fractures. However, CT is not as sensitive for fractures in the rib cartilage, which can therefore be missed. Ultrasound has proven to be more sensitive than CT in identifying fractures in the rib cartilage.
It is unknown whether point of care ultrasound (POCUS) performed by surgeons can identify more cartilage fractures or if this affects the treatment strategy.
The purpose of this study is to investigate whether we can find more rib fractures using POCUS in combination with CT than with CT alone. We also want to study the natural course of rib cartilage fractures using POCUS, CT, and clinical examination. We will also examine whether POCUS changes our plan for treating the patients.
The project is designed as a prospective, comparative study to evaluate a standardized protocol for POCUS for identifying cartilage injuries and for assessing radiological healing of cartilage injuries.
Adult patients treated at the Department of Surgery, Sahlgrenska University Hospital with at least one rib fracture and/or sternum fracture will be asked to participate in the study until the predetermined number of 100 patients is reached.
CT scans of included patients will be reviewed by a radiologist for the presence and extent of fractures of the sternum, cartilage, and ribs, as well as the presence of pneumothorax and/or hemothorax, lung contusion, and lung laceration.
The surgeon reviews the patient's medical record to determine if the patient meets the inclusion criteria. The surgeon then performs POCUS and documents any cartilage injuries. Afterward, the surgeon assesses the CT scan. If the surgeon notes fractures during CT review or POCUS that were not described in the radiologist's report, the CT scan is re-reviewed by the radiologist. If the fractures cannot be found during the re-review, they are considered missed. The surgeon decides during CT review whether there is an indication for surgery according to current guidelines and documents which fractures are planned to be fixed. If cartilage injuries are detected by POCUS, an assessment is made to determine whether the cartilage fractures affect the indication for surgery and/or which fractures are planned to be fixed. During surgery, the injuries that are fixed are documented.
Injuries are graded according to the Abbreviated Injury Scale (AIS), the presence of flail segment, Injury Severity Score (ISS), and New Injury Severity Score (NISS).
Demographic data on included patients are collected: age, sex, height, weight, BMI, smoking status, comorbidities (COPD, asthma, pulmonary emphysema, diabetes mellitus).
Patients with cartilage injuries are followed up at 1, 3, and 12 months after the trauma. The following data are collected at follow-up visits: clinical and radiological healing. Clinical healing means absence of tenderness or palpable and/or perceived instability over the fracture. CT and POCUS are performed after 3 months. If complete radiological healing of the chest wall is lacking, repeat CT and POCUS are performed after 12 months. Radiological healing means signs of healing on CT, divided into groups of complete healing, partial healing, and no healing according to the radiologist's assessment, as well as healing or no healing according to the surgeon's assessment during POCUS.
Other variables collected at follow-up visits are lung function measured by spirometry, quality of life estimated with EQ5D, pain estimated by opioid equivalent consumption, visual analogue scale (VAS), and a graphical representation.
The natural course of fractures in the rib cartilage is incompletely explored. Cartilage fractures can contribute to instability in the chest and are currently usually operated on with the same methods as fractures in the bone itself. Knowledge about healing time and the proportion of cartilage fractures that heal may affect the choice of treatment method and improve the patient's chance of recovery from the injuries.
Primary outcome measures
- Sensitivity and specificity of POCUS for injuries in rib cartilage compared to CT. [Time frame: Index examination at patient inclusion.]
Secondary outcome measures (9)
- Number of participants where treatment strategy is changed upon identification of cartilage fractures not seen on CT. [Time frame: Assessment made at patient inclusion.]
- Clinical healing of fractures in the rib cartilage [Time frame: 1, 3 and 12 months after patient inclusion.]
- Healing of cartilage fractures assessed with POCUS [Time frame: 1, 3 and 12 months after inclusion]
- Healing of cartilage fractures assessed with CT [Time frame: 3 and 12 months after patient inclusion.]
- Lung function with spirometry (predicted FVC) [Time frame: 1, 3 and 12 months after patient inclusion.]
- To what extent do costal cartilage fractures cause pain? (opioid consumption) [Time frame: 1, 3 and 12 months after patient inclusion.]
- To what extent do costal cartilage fractures cause pain? (visual analogue scale) [Time frame: 1, 3 and 12 months after patient inclusion.]
- To what extent do costal cartilage fractures cause pain? (graphical representation) [Time frame: 1, 3 and 12 months after patient inclusion.]
- What are the complications of fixation of costal cartilage injuries? [Time frame: 1, 3 and 12 months after patient inclusion.]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- Patients with injuries resulting from CPR, severe head injury, spinal injury, and neurological or musculoskeletal disease affecting chest mobility will be excluded.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- Ziegler DW, Agarwal NN. The morbidity and mortality of rib fractures. J Trauma. 1994 Dec;37(6):975-9. doi: 10.1097/00005373-199412000-00018. PMID 7996614
- Sirmali M, Turut H, Topcu S, Gulhan E, Yazici U, Kaya S, Tastepe I. A comprehensive analysis of traumatic rib fractures: morbidity, mortality and management. Eur J Cardiothorac Surg. 2003 Jul;24(1):133-8. doi: 10.1016/s1010-7940(03)00256-2. PMID 12853057
- Ciraulo DL, Elliott D, Mitchell KA, Rodriguez A. Flail chest as a marker for significant injuries. J Am Coll Surg. 1994 May;178(5):466-70. PMID 8167883
- Tanaka H, Yukioka T, Yamaguti Y, Shimizu S, Goto H, Matsuda H, Shimazaki S. Surgical stabilization of internal pneumatic stabilization? A prospective randomized study of management of severe flail chest patients. J Trauma. 2002 Apr;52(4):727-32; discussion 732. doi: 10.1097/00005373-200204000-00020. PMID 11956391
- Granetzny A, Abd El-Aal M, Emam E, Shalaby A, Boseila A. Surgical versus conservative treatment of flail chest. Evaluation of the pulmonary status. Interact Cardiovasc Thorac Surg. 2005 Dec;4(6):583-7. doi: 10.1510/icvts.2005.111807. Epub 2005 Sep 15. PMID 17670487
- Marasco SF, Davies AR, Cooper J, Varma D, Bennett V, Nevill R, Lee G, Bailey M, Fitzgerald M. Prospective randomized controlled trial of operative rib fixation in traumatic flail chest. J Am Coll Surg. 2013 May;216(5):924-32. doi: 10.1016/j.jamcollsurg.2012.12.024. Epub 2013 Feb 13. PMID 23415550
- Liu T, Liu P, Chen J, Xie J, Yang F, Liao Y. A Randomized Controlled Trial of Surgical Rib Fixation in Polytrauma Patients With Flail Chest. J Surg Res. 2019 Oct;242:223-230. doi: 10.1016/j.jss.2019.04.005. Epub 2019 May 14. PMID 31100568
- Bottlang M, Long WB, Phelan D, Fielder D, Madey SM. Surgical stabilization of flail chest injuries with MatrixRIB implants: a prospective observational study. Injury. 2013 Feb;44(2):232-8. doi: 10.1016/j.injury.2012.08.011. Epub 2012 Aug 19. PMID 22910817
Identifiers
NCT: NCT07338617 · 286117