Comparing surgical and non-surgical treatment for rib fractures

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational cohort study aims to evaluate the effectiveness of the RibFix Blu Thoracic Fixation System for surgical stabilization of non-flail chest rib fractures compared to non-surgical treatment methods such as analgesia and symptomatic management. Conducted across multiple centers, the study will enroll up to 167 patients, with a competitive recruitment process among sites. The goal is to assess outcomes from both treatment approaches, providing insights into the benefits of surgical intervention for this specific type of rib fracture.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age 18 and above (inclusive)
* Simple rib fracture with ≥ 3 consecutive ribs, and the broken ends showed clear displacements
* Indicated for surgical repair of rib fractures using RibFix Blu Thoracic Fixation System or non-surgical treatment (analgesia and symptomatic management treatment)
* Willing and able to complete scheduled follow-up evaluations as described in the study protocol
* Has participated in the Informed Consent process and is willing and able to sign an Institutional Review Board or Ethics Committee (IRB/EC) approved Patient Information/ Informed consent Form (PICF)

Exclusion Criteria:

* Flail chest rib fractures based on radiological or clinical findings
* Previous rib fractures or pulmonary problems, requiring continuous oxygen use at home pre-trauma
* Presence of any serious medical issues that placed patient in generally poor conditions such that he or she could not tolerate the surgery
* Chest trauma associated with severe craniocerebral injury, abdominal organ injury, severe spinal injury, limb fracture, or pelvic fracture requiring long-term bed rest
* Has serious medical disease that is a contraindication for general anesthesia, such as cerebral infarction, myocardial infarction and hemorrhagic syndrome
* Any contraindications listed in the manufacturer's Instruction to use for RibFix Blu Thoracic Fixation System as per below:

  * Spanning a midline sternotomy
  * Active Infection
  * Foreign body sensitivity
* Is known to be pregnant
* Is a prisoner, known alcohol or drug user or mentally incompetent or unable to understand what participation in this study entails.
* Participation in another surgical intervention that may influence any of the outcome parameters.

Where it's running

• Flinders Medical Centre
  Bedford Park, South Australia, Australia Recruiting
• The Alfred (Alfred Health)
  Melbourne, Victoria, Australia Recruiting
• Yonsei Wonju Severance Christian Hospital
  Wŏnju, Gangwon-do, South Korea Recruiting
• Ajou University Hospital
  Suwon, Gyeonggi-do, South Korea Recruiting
• Hunter New England Health District
  Sydney, New South Wales, Australia Not yet recruiting

Study contacts

• Principal investigator: Silvana Marasco, Professor — The Alfred
• Study coordinator: Irene Chong
• Email: irene.chong@zimmerbiomet.com
• Phone: 97566687

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.