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Rib FractureNCT07338617

Point of Care Ultrasound (POCUS) for Diagnosis and Treatment of Fractures in the Costal Cartilage

An observational study of Rib Fracture and Cartilage Damage, run by Sahlgrenska University Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rib Fracture, Cartilage Damage
How many people
100 participants
Where
No sites listed yet
Study dates
Jun 2026to Jan 2028
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients treated at the Department of Surgery, Sahlgrenska University Hospital

Who may be able to join

  • 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.

Who cannot join

  • Patients with injuries resulting from CPR, severe head injury, spinal injury, and neurological or musculoskeletal disease affecting chest mobility will be excluded.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

About this study

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:

Read more
  • 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.

Read the 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.

Keywords
Rib Fractures, Fractures, Cartilage, Ultrasonography, Traumatology
Medical subject headings
Rib Fractures, Fractures, Cartilage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07338617
Study groupRoleWhat they receive
Study groupNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Sensitivity and specificity of POCUS for injuries in rib cartilage compared to CT.

    Measured: Index examination at patient inclusion.

Secondary outcomes (9)
  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".

    Measured: 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.

    Measured: 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.

    Measured: 1, 3 and 12 months after inclusion

  4. 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.

    Measured: 3 and 12 months after patient inclusion.

  5. Lung function with spirometry (predicted FVC)

    Spirometry will be performed to assess whether fractures in costal cartilage affects lung function. The outcome will be predicted FVC.

    Measured: 1, 3 and 12 months after patient inclusion.

  6. To what extent do costal cartilage fractures cause pain? (opioid consumption)

    Pain will be estimated with opioid equivalent consumption.

    Measured: 1, 3 and 12 months after patient inclusion.

  7. To what extent do costal cartilage fractures cause pain? (visual analogue scale)

    Pain will be estimated with a visual analogue scale.

    Measured: 1, 3 and 12 months after patient inclusion.

  8. To what extent do costal cartilage fractures cause pain? (graphical representation)

    Pain will be estimated with a graphical representation of the human body where areas of pain can be marked by the participant.

    Measured: 1, 3 and 12 months after patient inclusion.

  9. What are the complications of fixation of costal cartilage injuries?

    What is the incidence of complications of surgical fixation of rib fractures, for instance infection and osteosynthesis failure.

    Measured: 1, 3 and 12 months after patient inclusion.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jan 2026
  2. Study startJun 2026 (estimated)
  3. Primary completionJan 2027 (estimated)
  4. Study completionJan 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07338617
Sponsor's protocol ID
286117
Status last verified
Jan 2026
First submitted
15 Dec 2025
Last updated
28 Apr 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 22910817
  • Granhed HP, Pazooki D. A feasibility study of 60 consecutive patients operated for unstable thoracic cage. J Trauma Manag Outcomes. 2014 Dec 30;8(1):20. doi: 10.1186/s13032-014-0020-z. eCollection 2014.

    PubMed 25642282
  • Gasparri MG, Tisol WB, Haasler GB. Rib stabilization: lessons learned. Eur J Trauma Emerg Surg. 2010 Oct;36(5):435-40. doi: 10.1007/s00068-010-0048-3. Epub 2010 Sep 24.

    PubMed 26816224
  • Marasco S, Saxena P. Surgical rib fixation - technical aspects. Injury. 2015 May;46(5):929-32. doi: 10.1016/j.injury.2014.12.021. Epub 2015 Jan 10.

    PubMed 25624272
  • Schulz-Drost S, Grupp S, Pachowsky M, Oppel P, Krinner S, Mauerer A, Hennig FF, Langenbach A. Stabilization of flail chest injuries: minimized approach techniques to treat the core of instability. Eur J Trauma Emerg Surg. 2017 Apr;43(2):169-178. doi: 10.1007/s00068-016-0664-7. Epub 2016 Mar 22.

    PubMed 27084543
  • Bauman ZM, Beard R, Cemaj S. When less is more: A minimally invasive, intrathoracic approach to surgical stabilization of rib fractures. Trauma Case Rep. 2021 Mar 11;32:100452. doi: 10.1016/j.tcr.2021.100452. eCollection 2021 Apr.

    PubMed 33778146
  • Pieracci FM, Johnson JL, Stovall RT, Jurkovich GJ. Completely thoracoscopic, intra-pleural reduction and fixation of severe rib fractures. Trauma Case Rep. 2015 Nov 4;1(5-8):39-43. doi: 10.1016/j.tcr.2015.10.001. eCollection 2015 Oct. No abstract available.

    PubMed 30101174
  • Zhang J, Hong Q, Mo X, Ma C. Complete Video-assisted Thoracoscopic Surgery for Rib Fractures: Series of 35 Cases. Ann Thorac Surg. 2022 Feb;113(2):452-458. doi: 10.1016/j.athoracsur.2021.01.065. Epub 2021 Mar 3.

    PubMed 33675706

Questions about this trial

What is this clinical trial studying?

An observational study of Rib Fracture and Cartilage Damage, run by Sahlgrenska University Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Erik Westin, MD (+46313426161, erik.westin@vgregion.se), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sensitivity and specificity of POCUS for injuries in rib cartilage compared to CT. (time frame: Index examination at patient inclusion.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07338617, which also lists 27 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.

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