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โ† Trials
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RibFix Blu Thoracic Fixation System Versus Non-surgical Treatment in Non-flail Chest Rib Fractures

Recruitingn/aAges 18 Years - anyAllZimmer Biomet
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In plain words

What the trial is, and whether it could suit you

This is a prospective, multi-center, observational, cohort study involving skilled cardiothoracic surgeons who are experienced in implanting the treatment of non-flail chest rib fractures and the use of RibFix Blu Thoracic Fixation System.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Age 18 and above (inclusive) * Simple rib fracture with โ‰ฅ 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.
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What it tests

  • Non surgical and Surgical
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Where

5 sites
Hunter New England Health District
Sydney, Australia
Flinders Medical Centre
Bedford Park, Australia
The Alfred (Alfred Health)
Melbourne, Australia
Yonsei Wonju Severance Christian Hospital
Wลnju, South Korea
Ajou University Hospital
Suwon, South Korea
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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