RibFix Blu Thoracic Fixation System Versus Non-surgical Treatment in Non-flail Chest Rib Fractures
Prospective Multi-center Comparative Study of RibFix Blu Thoracic Fixation System Versus Non-surgical Treatment in Non-flail Chest Rib Fractures
Zimmer Biomet
167 participants
Jan 2, 2022
OBSERVATIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria5
- 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 Criteria12
- 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.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
For non-surgical group, patients will receive non-surgical treatment (analgesia and symptomatic management treatment). For surgical group, patients will receive surgical treatment using RibFix Blu Thoracic Fixation System.
Locations(5)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05146986