Actively Recruiting
RibFix Blu Thoracic Fixation System Versus Non-surgical Treatment in Non-flail Chest Rib Fractures
Led by Zimmer Biomet · Updated on 2024-03-07
167
Participants Needed
5
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
RibFix Blu Thoracic Fixation System Versus Non-surgical Treatment in Non-flail Chest Rib Fractures
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 and above (inclusive)
- Simple rib fracture with 63 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)
You will not qualify if you...
- 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.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Hunter New England Health District
Sydney, New South Wales, Australia, 2301
Not Yet Recruiting
2
Flinders Medical Centre
Bedford Park, South Australia, Australia, 5042
Actively Recruiting
3
The Alfred (Alfred Health)
Melbourne, Victoria, Australia, 31004
Actively Recruiting
4
Yonsei Wonju Severance Christian Hospital
Wŏnju, Gangwon-do, South Korea, 26426
Actively Recruiting
5
Ajou University Hospital
Suwon, Gyeonggi-do, South Korea, 16499
Actively Recruiting
Research Team
I
Irene Chong
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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